{ "last_run": "2026-10-07T23:43:05.010886+00:00", "count": 629, "trials": [ { "nct_id": "NCT05874037", "title": "Fluvoxamine for Long COVID-19", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-10-07", "start_date": "2023-05-15", "completion_date": "2025-03-15", "primary_completion_date": "2025-03-15", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Fluvoxamine" ], "sponsor": "Washington University School of Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This clinical trial aims to test the effects of fluvoxamine as a treatment for Long COVID. Fluvoxamine is an FDA approved SSRI for Obsessive Compulsive Disorder (OCD), that has already had success in preventing hospitalization in patients with COVID-19 (STOP COVID and TOGETHER trials). This trial is testing whether fluoxamine helps to improve symptoms and the negative impacts of long COVID in residents of Missouri and Illinois.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Total Symptom Scores", "description": "Participants completed a self-report twice-daily questionnaire which asks about trouble concentrating, anxiety, depression and fatigue. Respondents rate how much of a problem the symptom is \"right now\" on a scale of 0 (no problem) to 100 (severe problem). Results compare the change in average total scores (of the four symptoms) from baseline and endpoint.", "time_frame": "Assessed at Baseline (2 weeks prior to randomization) and Endpoint (last 4 weeks of randomized period)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Change in Total Symptom Scores", "description": "Participants completed a self-report twice-daily questionnaire which asks about trouble concentrating, anxiety, depression and fatigue. Respondents rate how much of a problem the symptom is \"right now\" on a scale of 0 (no problem) to 100 (severe problem). Results compare the change in average total scores (of the four symptoms) from baseline and endpoint.", "time_frame": "Assessed at Baseline (2 weeks prior to randomization) and Endpoint (last 4 weeks of randomized period)" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 191, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05874037", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07388550", "title": "Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)", "status": "NOT_YET_RECRUITING", "phase": "PHASE1", "last_updated": "2026-10-07", "start_date": "2026-10-12", "completion_date": "2028-01-01", "primary_completion_date": "2028-01-01", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Keytruda" ], "sponsor": "National Institute of Neurological Disorders and Stroke (NINDS)", "sponsor_type": "NIH", "primary_purpose": "N/A", "brief_summary": "Background:\n\nSARS-CoV-2 is the virus that causes COVID-19. Some people who recover from an acute COVID-19 infection may continue to have symptoms that persist for months or years. These can include neurological symptoms, such as headaches, loss of taste or smell, dizziness, or trouble walking. Pembrolizumab is a drug approved to treat certain cancers. Researchers think this drug might reduce long-term neurologic symptoms after a COVID-19 infection.\n\nObjective:\n\nTo test pembrolizumab in people with ongoing neurologic symptoms of COVID-19.\n\nEligibility:\n\nPeople aged 18 years or older who had COVID-19 at least 6 months ago and have ongoing neurologic symptoms.\n\nDesign:\n\nParticipants will have 7 clinic visits in 7 months.\n\nParticipants will be screened. They will have a physical exam with blood tests. Swabs will be used to collect cells from inside the mouth and nose. They may opt to have an imaging scan.\n\nParticipants will also have other tests before they are given the study drug. These include eye and skin exams; tests of their memory and thinking; and tests of involuntary body functions, such as heart rate, blood pressure, sweating, and digestion. Their grip strength and walking pace will be measured. They will wear a heart rate monitor for 24 hours. They will wear devices on a wrist and thigh to measure activity for 10 days.\n\nParticipants will have a lumbar puncture (spinal tap): A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.\n\nPembrolizumab is given through a needle inserted into a vein. Participants will receive 1 dose of the drug.\n\nParticipants will have 4 follow-up visits over 6 months. Tests may be repeated during these visits.", "primary_outcomes": [ { "type": "primary", "measure": "The primary outcome of this study is to determine the safety of a single dose of intravenous Pembrolizumab in participants with neurological post-acute sequalae of SARS-CoV-2 infection.", "description": "", "time_frame": "From screening to Day 180." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "To determine if one dose of intravenous Pembrolizumab can lead to clinically relevant improvement in subjective and objective measures of ability.", "description": "", "time_frame": "Comparison between baseline, day 30, day 60 , and day 180 visits." }, { "type": "secondary", "measure": "To determine if one dose of intravenous Pembrolizumab can normalize markers of immune exhaustion in neuro-PASC.", "description": "", "time_frame": "Comparison between baseline, day 30, day 60 , and day 180 visits." } ], "outcome_measures": [ { "type": "primary", "measure": "The primary outcome of this study is to determine the safety of a single dose of intravenous Pembrolizumab in participants with neurological post-acute sequalae of SARS-CoV-2 infection.", "description": "", "time_frame": "From screening to Day 180." }, { "type": "secondary", "measure": "To determine if one dose of intravenous Pembrolizumab can lead to clinically relevant improvement in subjective and objective measures of ability.", "description": "", "time_frame": "Comparison between baseline, day 30, day 60 , and day 180 visits." }, { "type": "secondary", "measure": "To determine if one dose of intravenous Pembrolizumab can normalize markers of immune exhaustion in neuro-PASC.", "description": "", "time_frame": "Comparison between baseline, day 30, day 60 , and day 180 visits." } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Nih" ], "enrollment": 15, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07388550", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06404073", "title": "RECOVER-ENERGIZE Platform Protocol_Appendix B (Structured Pacing (PEM))", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-10-06", "start_date": "2024-07-17", "completion_date": "2025-11-17", "primary_completion_date": "2025-08-18", "conditions_raw": [ "Long COVID", "Long Covid19", "Long Covid-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Structured Pacing" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes.\n\nThis protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).\n\nThe focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Frequency of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)", "description": "Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time.", "time_frame": "Baseline, week 12 (End Of Intervention, EOI)" }, { "type": "primary", "measure": "Change in Severity of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)", "description": "Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.", "time_frame": "Baseline, week 12 (EOI)" }, { "type": "primary", "measure": "Change in Duration of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)", "description": "Ordinal categorical response: \\<=1 hour, 2-3 hours, 4-10 hours, 11-13 hours, 14-23 hours, \\>=24 hours. Reported as the number of participants who provided each response.", "time_frame": "Baseline, week 12 (EOI)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in PASC Symptoms, as Measured by the PROMIS-Cog Questionnaire", "description": "The PROMIS Short Form v.2.0 - Cognitive Function 8a (PROMIS-Cog) is the PROMIS Short Form to assess cognitive function and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days. T-Scores in a healthy reference population have mean=50 and standard deviation = 10, with higher scores indicating higher functioning.", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Quality of Life, as Measured by the PROMIS-29+2", "description": "The PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health).", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Quality of Life, as Measured by the EQ-5D 5L", "description": "The EQ-5D is a standardized measure of health status. Mobility was measured on a scale from 1 (no problems in walking) to 5 (unable to walk).", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Step Count (Physical Activity) as Measured by Actigraphy", "description": "Actigraphy will be measured by Fitbit. Participant steps were considered valid from days where they wore the Fitbit at least 10 waking hours. Average steps were calculated from subjects with at least 5 consecutive days of valid data within a week window of their expected visit dates.", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Physical Activity, as Measured by the PROMIS SF-Physical Function (PROMIS-PF)", "description": "The PROMIS Short Form v2.0 - Physical Function 8b (PROMIS-PF) consists of 8 items. The PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. T-Scores in a healthy reference population have mean = 50 and standard deviation = 10, with higher scores indicating higher functioning.", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Orthostatic Hypotension, as Measured by the Modified Orthostatic Hypotension Questionnaire (mOHQ)", "description": "The Orthostatic Hypotension Questionnaire (OHQ) is a measure of orthostatic intolerance. The modified OHQ (mOHQ) measure used in this study includes a total of ten items related to daily activities and symptoms. The OHQ composite score ranges from 0 (no burden) to 10 (maximal burden). Higher scores are worse. The OHQ composite score includes 6 symptom items (OISA) and 4 daily activity items (OIDAS).", "time_frame": "Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Frequency of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)", "description": "Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time.", "time_frame": "Baseline, week 12 (End Of Intervention, EOI)" }, { "type": "primary", "measure": "Change in Severity of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)", "description": "Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.", "time_frame": "Baseline, week 12 (EOI)" }, { "type": "primary", "measure": "Change in Duration of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)", "description": "Ordinal categorical response: \\<=1 hour, 2-3 hours, 4-10 hours, 11-13 hours, 14-23 hours, \\>=24 hours. Reported as the number of participants who provided each response.", "time_frame": "Baseline, week 12 (EOI)" }, { "type": "secondary", "measure": "Change in PASC Symptoms, as Measured by the PROMIS-Cog Questionnaire", "description": "The PROMIS Short Form v.2.0 - Cognitive Function 8a (PROMIS-Cog) is the PROMIS Short Form to assess cognitive function and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days. T-Scores in a healthy reference population have mean=50 and standard deviation = 10, with higher scores indicating higher functioning.", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Quality of Life, as Measured by the PROMIS-29+2", "description": "The PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health).", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Quality of Life, as Measured by the EQ-5D 5L", "description": "The EQ-5D is a standardized measure of health status. Mobility was measured on a scale from 1 (no problems in walking) to 5 (unable to walk).", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Step Count (Physical Activity) as Measured by Actigraphy", "description": "Actigraphy will be measured by Fitbit. Participant steps were considered valid from days where they wore the Fitbit at least 10 waking hours. Average steps were calculated from subjects with at least 5 consecutive days of valid data within a week window of their expected visit dates.", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Physical Activity, as Measured by the PROMIS SF-Physical Function (PROMIS-PF)", "description": "The PROMIS Short Form v2.0 - Physical Function 8b (PROMIS-PF) consists of 8 items. The PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. T-Scores in a healthy reference population have mean = 50 and standard deviation = 10, with higher scores indicating higher functioning.", "time_frame": "Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" }, { "type": "secondary", "measure": "Change in Orthostatic Hypotension, as Measured by the Modified Orthostatic Hypotension Questionnaire (mOHQ)", "description": "The Orthostatic Hypotension Questionnaire (OHQ) is a measure of orthostatic intolerance. The modified OHQ (mOHQ) measure used in this study includes a total of ten items related to daily activities and symptoms. The OHQ composite score ranges from 0 (no burden) to 10 (maximal burden). Higher scores are worse. The OHQ composite score includes 6 symptom items (OISA) and 4 daily activity items (OIDAS).", "time_frame": "Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 300, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06404073", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06928272", "title": "Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study", "status": "RECRUITING", "phase": "PHASE3", "last_updated": "2026-10-06", "start_date": "2025-09-10", "completion_date": "2027-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Pirfenidone", "Upadacitinib" ], "sponsor": "Douglas D. Fraser", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The Long-Covid (LC)-Revitalize clinical study is testing repurposed drug treatments for Long Covid, involving adult participants from Brazil, Canada, Italy, South Africa, Uganda, the United States, and Zambia. To qualify, participants must have had Covid-19 and experienced Long Covid symptoms for at least three months. The main goal of the study is to determine whether the drug treatments can improve symptoms in five key areas: 1) fatigue, 2) breathing, 3) memory, thinking, and communication, 4) muscle and joint pain, and 5) circulation. A secondary goal is to assess changes in the body, such as reducing inflammation, as well as to confirm the safety and tolerability of the treatments. In the first phase, 348 participants will take either one of two existing medications (upadacitinib or pirfenidone) or a placebo (a pill with no active ingredient) for three months. Although these medications are not yet approved for Long Covid, they are authorized for use in treating other health conditions. This study is adaptive, meaning it may adjust based on early results. In the second phase, the study could continue testing the most effective drug(s) against a placebo with new participants, explore combinations of drugs to see if they improve results, or discontinue the drugs if they prove ineffective or unsafe and test alternative treatments.", "primary_outcomes": [ { "type": "primary", "measure": "Symptom Burden Questionnaire (SBQ) Subscales", "description": "The aim of this study is to evaluate the efficacy of two repurposed drugs in reducing symptom severity in participants with Long Covid. The change in symptom score (transformed scale of 0-100) from baseline to both the interim and final analyses will be compared across one of the five validated subscales, relative to the placebo.\n\nThis study will utilize five validated subscales: 1) Fatigue, 2) Breathing, 3) Memory, Thinking, and Communication, 4) Muscles and Joints, and 5) Circulation. Each subscale is based on a 4-point ordinal scale that assesses frequency, severity, or interference, or it uses a dichotomous yes/no response. The subscale with the highest symptom burden, determined by the highest transformed symptom score (ranging from 0 to 100, with a higher score indicating greater symptom burden) at baseline, will be selected for evaluating treatment effects.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "General participant reported overall well-being using the Patient Reported Outcome Measurement Information System (PROMIS)-29 questionnaire", "description": "To compare symptom burden of participants with Long Covid treated with study drug versus placebo by measuring the change in total scores of the Patient Reported Outcome Measurement Information System (PROMIS)-29 questionnaire.\n\nThe PROMIS-29 questionnaire consists of 29 items covering an overview of the participant's physical, mental, and social health. Each item is scored on a scale of 1 to 5, with the interpretation of lower scores varying by domain-indicating either better or worse symptom experience.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "General participant reported overall well-being using the Generalized Anxiety Disorder (GAD)-7 questionnaire", "description": "To compare symptom burden of participants with Long Covid treated with study drug versus placebo by measuring the change in total scores of the Generalized Anxiety Disorder (GAD)-7 questionnaire from baseline to the interim and final analyses.\n\nThe GAD-7 questionnaire consists of 7 items relating to the symptoms of stress and anxiety levels. Each item is scored on a scale of 0-3 with higher scores indicating more severe symptoms. Overall scores can range from 0-21 with scores of 5, 10, and 15 taken as the cut-off points for mild, moderate, and severe anxiety, respectively.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "General participant reported overall well-being using the Patient Health Questionnaire (PHQ)-9", "description": "To compare symptom burden of participants with Long Covid treated with study drug versus placebo by measuring the change in total scores of the Patient Health Questionnaire (PHQ)-9 from baseline to the interim and final analyses.\n\nThe PHQ-9 questionnaire consists of 9 items related to the symptoms of depression. Each item is scored on a scale of 0-3 with higher scores indicating more severe symptoms. Overall scores can range from 0-27 with scores of 5, 10, 15, and 20 taken as cut off points for mild, moderate, moderately severe, and severe depression, respectively.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "General participant reported severity of post-exertional malaise (PEM) using the FUNCAP27 questionnaire", "description": "To compare symptom burden of participants with Long Covid treated with study drug versus placebo by measuring the change in scores of the Functional Capacity (FUNCAP)27 questionnaire from baseline to the interim and final analyses. The FUNCAP27 questionnaire consists of 27 items related to assessing functional capacity and the consequences of performing activities. Each item is scored on a scale of 0-6, with 0 indicating the participant is unable to complete the activity and 6 indicating the activity is unproblematic and does not affect other activities.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "Worsening Long Covid Symptoms Measured by SBQ Subscales", "description": "To assess whether symptom burden worsens in participants with Long Covid treated with study drugs versus placebo, specifically when symptoms are reported across multiple scales indicated by the total number of participants with increased SBQ subscale scores.\n\nThe following SBQ subscales will be used during this study: 1) Fatigue, 2) Breathing, 3) Memory, thinking, and communication, 4) Muscles and joints, and 5) Circulation.\n\nEach subscale is based on a 4-point ordinal scale that assesses frequency, severity, or interference, or it uses a dichotomous yes/no response. The subscale with the highest symptom burden, determined by the highest transformed symptom score (ranging from 0 to 100, with a higher score indicating greater symptom burden) at baseline, will be selected for evaluating treatment effects.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "Quantitative measurement of biomarkers specific to relevant inflammatory pathways and to Long Covid identified previously (The LC-Optimize Study)", "description": "To measure specific pathophysiological biomarkers of study drugs versus placebo indicated by the normalization of blood biomarkers after treatment in picograms per milliliter (pg/mL).", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "Exercise capacity assessed by the 6-minute walk test (6MWT)", "description": "To assess changes in exercise capacity over time of participants with Long Covid treated with study drugs versus placebo. The score is determined by the distance a participant walks in six minutes around the perimeter of a designated circuit.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "Safety and tolerability of the study drugs in participants with Long Covid", "description": "The frequency and severity of adverse events and laboratory abnormalities will be monitored to assess safety and tolerability. A lower incidence and severity will indicate that the drugs are safer and more tolerable.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." } ], "outcome_measures": [ { "type": "primary", "measure": "Symptom Burden Questionnaire (SBQ) Subscales", "description": "The aim of this study is to evaluate the efficacy of two repurposed drugs in reducing symptom severity in participants with Long Covid. The change in symptom score (transformed scale of 0-100) from baseline to both the interim and final analyses will be compared across one of the five validated subscales, relative to the placebo.\n\nThis study will utilize five validated subscales: 1) Fatigue, 2) Breathing, 3) Memory, Thinking, and Communication, 4) Muscles and Joints, and 5) Circulation. Each subscale is based on a 4-point ordinal scale that assesses frequency, severity, or interference, or it uses a dichotomous yes/no response. The subscale with the highest symptom burden, determined by the highest transformed symptom score (ranging from 0 to 100, with a higher score indicating greater symptom burden) at baseline, will be selected for evaluating treatment effects.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "General participant reported overall well-being using the Patient Reported Outcome Measurement Information System (PROMIS)-29 questionnaire", "description": "To compare symptom burden of participants with Long Covid treated with study drug versus placebo by measuring the change in total scores of the Patient Reported Outcome Measurement Information System (PROMIS)-29 questionnaire.\n\nThe PROMIS-29 questionnaire consists of 29 items covering an overview of the participant's physical, mental, and social health. Each item is scored on a scale of 1 to 5, with the interpretation of lower scores varying by domain-indicating either better or worse symptom experience.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "General participant reported overall well-being using the Generalized Anxiety Disorder (GAD)-7 questionnaire", "description": "To compare symptom burden of participants with Long Covid treated with study drug versus placebo by measuring the change in total scores of the Generalized Anxiety Disorder (GAD)-7 questionnaire from baseline to the interim and final analyses.\n\nThe GAD-7 questionnaire consists of 7 items relating to the symptoms of stress and anxiety levels. Each item is scored on a scale of 0-3 with higher scores indicating more severe symptoms. Overall scores can range from 0-21 with scores of 5, 10, and 15 taken as the cut-off points for mild, moderate, and severe anxiety, respectively.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "General participant reported overall well-being using the Patient Health Questionnaire (PHQ)-9", "description": "To compare symptom burden of participants with Long Covid treated with study drug versus placebo by measuring the change in total scores of the Patient Health Questionnaire (PHQ)-9 from baseline to the interim and final analyses.\n\nThe PHQ-9 questionnaire consists of 9 items related to the symptoms of depression. Each item is scored on a scale of 0-3 with higher scores indicating more severe symptoms. Overall scores can range from 0-27 with scores of 5, 10, 15, and 20 taken as cut off points for mild, moderate, moderately severe, and severe depression, respectively.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "General participant reported severity of post-exertional malaise (PEM) using the FUNCAP27 questionnaire", "description": "To compare symptom burden of participants with Long Covid treated with study drug versus placebo by measuring the change in scores of the Functional Capacity (FUNCAP)27 questionnaire from baseline to the interim and final analyses. The FUNCAP27 questionnaire consists of 27 items related to assessing functional capacity and the consequences of performing activities. Each item is scored on a scale of 0-6, with 0 indicating the participant is unable to complete the activity and 6 indicating the activity is unproblematic and does not affect other activities.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "Worsening Long Covid Symptoms Measured by SBQ Subscales", "description": "To assess whether symptom burden worsens in participants with Long Covid treated with study drugs versus placebo, specifically when symptoms are reported across multiple scales indicated by the total number of participants with increased SBQ subscale scores.\n\nThe following SBQ subscales will be used during this study: 1) Fatigue, 2) Breathing, 3) Memory, thinking, and communication, 4) Muscles and joints, and 5) Circulation.\n\nEach subscale is based on a 4-point ordinal scale that assesses frequency, severity, or interference, or it uses a dichotomous yes/no response. The subscale with the highest symptom burden, determined by the highest transformed symptom score (ranging from 0 to 100, with a higher score indicating greater symptom burden) at baseline, will be selected for evaluating treatment effects.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "Quantitative measurement of biomarkers specific to relevant inflammatory pathways and to Long Covid identified previously (The LC-Optimize Study)", "description": "To measure specific pathophysiological biomarkers of study drugs versus placebo indicated by the normalization of blood biomarkers after treatment in picograms per milliliter (pg/mL).", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "Exercise capacity assessed by the 6-minute walk test (6MWT)", "description": "To assess changes in exercise capacity over time of participants with Long Covid treated with study drugs versus placebo. The score is determined by the distance a participant walks in six minutes around the perimeter of a designated circuit.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." }, { "type": "secondary", "measure": "Safety and tolerability of the study drugs in participants with Long Covid", "description": "The frequency and severity of adverse events and laboratory abnormalities will be monitored to assess safety and tolerability. A lower incidence and severity will indicate that the drugs are safer and more tolerable.", "time_frame": "The Phase 1 time frame is from enrollment on Day 1 through to the end of follow-up at Month 6, and the Phase 2 time frame will be determined based on the results of Phase 1." } ], "relevance_tags": [ "Repurposed", "Anti-inflammatory", "Phase 3", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 348, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06928272", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07661862", "title": "PERCEIVE-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-10-06", "start_date": "2026-04-01", "completion_date": "2029-04-01", "primary_completion_date": "2029-04-01", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Perceive-Outreach Disease Management Program" ], "sponsor": "University of Tasmania", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Some people who had COVID-19 continue to have symptoms for weeks, months, or even years after their infection. This is often called \"Long COVID\" or Post-Acute Sequelae of SARS-CoV-2 (PASC). For some people, Long COVID can affect the heart and lungs, making it harder to exercise or carry out daily activities. It can also affect mental health and quality of life.\n\nThis study is testing a new care model called PERCEIVE-Outreach, designed to help people living with Long COVID who may have ongoing heart or lung problems. The model involves three parts:\n\n1. Screening: A simple assessment to identify people most likely to benefit from further care, based on symptoms and activity levels.\n2. Clinical review: A thorough check of heart and lung health conducted remotely via telehealth.\n3. Personalised exercise program: A tailored program to help improve fitness and reduce time spent sitting, delivered entirely via telehealth.\n\nThe main thing this study is measuring is whether participants can walk further after 6 months compared to when they started (measured using a 6-minute walk test), which correlates well with an individuals ability to complete normal daily functions. The study will also look at quality of life, mental health, physical activity, heart function, and hospital visits over 2 years.\n\nThe study is designed with input from patients and healthcare providers to ensure it meets real-world needs. All care is delivered remotely, meaning participants can take part from home anywhere in Australia.", "primary_outcomes": [ { "type": "primary", "measure": "Changes in 6-min walk distance (6MWD) at 6 months", "description": "6MWD in metres", "time_frame": "From enrolment until the 6-month visit" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in 6MWD at 12 and 24 months", "description": "6MWD in metres", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Change in Assessment of Quality of Life (AQoL) 8D at 12 & 24 months", "description": "Publicly accessible Australian utility score (online); range 0.06 (worse) to 1.00 (better)", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ)-9 at 12 & 24 months;", "description": "Range 0 (less depressive symptoms) to 27 (more depressive symptoms)", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "International Physical Activity Questionnaire (IPAQ) short form at 12 & 24 months", "description": "Range 0 to over 20,000 MET-minutes/week;\n\n* Low: Under 600 MET-minutes/week\n* Moderate: 600 to 2,999 MET-minutes/week\n* High: 3,000+ MET-minutes/week", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Sedentary-break adherence measured by Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM)", "description": "Sedentary-break adherence will be assessed using SCRAM-recorded activity-break completion, including the number of 3-minute sitting breaks completed per day and total daily activity-break duration in minutes/day. The intervention target is 30 minutes/day of activity breaks, equivalent to 10 breaks/day. Higher values indicate greater adherence to sedentary-time interruption.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Change in cardiac function measured by transthoracic echocardiography at 12 & 24 months", "description": "Left ventricular dysfunction will be assessed using resting 2-dimensional and Doppler transthoracic echocardiography. Left ventricular dysfunction will be defined as any of the following: left ventricular ejection fraction \\<40%, reduced left ventricular global longitudinal strain ≤16%, diastolic dysfunction, or left ventricular hypertrophy. Diastolic dysfunction will be assessed using mitral inflow velocities, E/A ratio, mitral annular e' velocities, E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity. Left ventricular hypertrophy will be defined as left ventricular mass index \\>95 g/m² in women and \\>115 g/m² in men. The outcome will be reported as the number of participants meeting criteria for left ventricular dysfunction at follow-up and/or developing new left ventricular dysfunction from baseline.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Incidence of cardiovascular over the 24-month trial period", "description": "Cardiovascular hospitalisation will be assessed as the number of participants admitted to hospital for a cardiovascular cause, including heart failure, acute coronary syndrome, arrhythmia, stroke, venous thromboembolism, or other cardiovascular events.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Incidence of all-cause hospitalisation over the 24-month trial period", "description": "All-cause hospitalisation will be assessed as the number of participants admitted to hospital for any cause during the follow-up period.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Incremental cost-effectiveness ratio of the care model", "description": "Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio, calculated as the difference in costs between study groups divided by the difference in health outcomes. Costs will be reported in Australian dollars. Health outcomes may include quality-adjusted life years derived from health-related quality-of-life data. Lower incremental cost per quality-adjusted life year gained indicates greater cost-effectiveness.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Post-exertional malaise measured by the DePaul Symptom Questionnaire - Post-Exertional Malaise", "description": "Post-exertional malaise will be assessed using the DePaul Symptom Questionnaire - Post-Exertional Malaise. Frequency and severity items are scored on 5-point Likert scales from 0 to 4, with higher scores indicating more frequent or more severe post-exertional malaise. Prevalence of post-exertional malaise and change in symptom burden from baseline will be reported.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Change in peak oxygen consumption (peakVO2) at 12 and 24 months", "description": "Measured in mL/kg/min", "time_frame": "From enrolment until the 12- and 24-month visits, each." } ], "outcome_measures": [ { "type": "primary", "measure": "Changes in 6-min walk distance (6MWD) at 6 months", "description": "6MWD in metres", "time_frame": "From enrolment until the 6-month visit" }, { "type": "secondary", "measure": "Change in 6MWD at 12 and 24 months", "description": "6MWD in metres", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Change in Assessment of Quality of Life (AQoL) 8D at 12 & 24 months", "description": "Publicly accessible Australian utility score (online); range 0.06 (worse) to 1.00 (better)", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ)-9 at 12 & 24 months;", "description": "Range 0 (less depressive symptoms) to 27 (more depressive symptoms)", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "International Physical Activity Questionnaire (IPAQ) short form at 12 & 24 months", "description": "Range 0 to over 20,000 MET-minutes/week;\n\n* Low: Under 600 MET-minutes/week\n* Moderate: 600 to 2,999 MET-minutes/week\n* High: 3,000+ MET-minutes/week", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Sedentary-break adherence measured by Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM)", "description": "Sedentary-break adherence will be assessed using SCRAM-recorded activity-break completion, including the number of 3-minute sitting breaks completed per day and total daily activity-break duration in minutes/day. The intervention target is 30 minutes/day of activity breaks, equivalent to 10 breaks/day. Higher values indicate greater adherence to sedentary-time interruption.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Change in cardiac function measured by transthoracic echocardiography at 12 & 24 months", "description": "Left ventricular dysfunction will be assessed using resting 2-dimensional and Doppler transthoracic echocardiography. Left ventricular dysfunction will be defined as any of the following: left ventricular ejection fraction \\<40%, reduced left ventricular global longitudinal strain ≤16%, diastolic dysfunction, or left ventricular hypertrophy. Diastolic dysfunction will be assessed using mitral inflow velocities, E/A ratio, mitral annular e' velocities, E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity. Left ventricular hypertrophy will be defined as left ventricular mass index \\>95 g/m² in women and \\>115 g/m² in men. The outcome will be reported as the number of participants meeting criteria for left ventricular dysfunction at follow-up and/or developing new left ventricular dysfunction from baseline.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Incidence of cardiovascular over the 24-month trial period", "description": "Cardiovascular hospitalisation will be assessed as the number of participants admitted to hospital for a cardiovascular cause, including heart failure, acute coronary syndrome, arrhythmia, stroke, venous thromboembolism, or other cardiovascular events.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Incidence of all-cause hospitalisation over the 24-month trial period", "description": "All-cause hospitalisation will be assessed as the number of participants admitted to hospital for any cause during the follow-up period.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Incremental cost-effectiveness ratio of the care model", "description": "Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio, calculated as the difference in costs between study groups divided by the difference in health outcomes. Costs will be reported in Australian dollars. Health outcomes may include quality-adjusted life years derived from health-related quality-of-life data. Lower incremental cost per quality-adjusted life year gained indicates greater cost-effectiveness.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Post-exertional malaise measured by the DePaul Symptom Questionnaire - Post-Exertional Malaise", "description": "Post-exertional malaise will be assessed using the DePaul Symptom Questionnaire - Post-Exertional Malaise. Frequency and severity items are scored on 5-point Likert scales from 0 to 4, with higher scores indicating more frequent or more severe post-exertional malaise. Prevalence of post-exertional malaise and change in symptom burden from baseline will be reported.", "time_frame": "From enrolment until the 12- and 24-month visits, each." }, { "type": "secondary", "measure": "Change in peak oxygen consumption (peakVO2) at 12 and 24 months", "description": "Measured in mL/kg/min", "time_frame": "From enrolment until the 12- and 24-month visits, each." } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 577, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT07661862", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07621588", "title": "Diaphragmatic Breathing Exercises With KOTS Currents in Patients With Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-09-29", "start_date": "2026-06-14", "completion_date": "2026-08-07", "primary_completion_date": "2026-07-31", "conditions_raw": [ "Long COVID Syndrome", "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Diaphragmatic Electrostimulation Using Kots Currents", "Diaphragmatic Breathing Exercises" ], "sponsor": "Universidad Pontificia de Salamanca", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will evaluate the effects of diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents in patients with Long COVID. Participants will be randomly assigned to one of two groups. The control group will perform diaphragmatic breathing exercises, while the intervention group will perform diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents. The intervention will last three weeks, with two sessions per week. The study will assess respiratory function, quality of life, physical function, dyspnea, fatigue, and basal oxygen saturation.", "primary_outcomes": [ { "type": "primary", "measure": "Forced Vital Capacity", "description": "Forced vital capacity will be assessed using spirometry. The outcome will evaluate the change in forced vital capacity from baseline to after the three-week intervention.", "time_frame": "Baseline and 3 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Forced Expiratory Volume in One Second", "description": "Forced expiratory volume in one second will be assessed using spirometry. The outcome will evaluate the change in FEV1 from baseline to after the three-week intervention.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Peak Expiratory Flow", "description": "Peak expiratory flow will be assessed using spirometry. The outcome will evaluate the change in PEF from baseline to after the three-week intervention.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "FEV1/FVC Ratio", "description": "The FEV1/FVC ratio will be calculated from spirometry measurements. The outcome will evaluate the change in the FEV1/FVC ratio from baseline to after the three-week intervention.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Basal Oxygen Saturation", "description": "Basal oxygen saturation will be measured using a finger pulse oximeter. The outcome will evaluate the change in basal oxygen saturation from baseline to after the three-week intervention", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Physical Function", "description": "Physical function will be assessed using the 30-second Sit-to-Stand test. The outcome will evaluate the change in the number of completed sit-to-stand repetitions from baseline to after the three-week intervention", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Dyspnea", "description": "Dyspnea will be assessed using the modified Medical Research Council scale. The outcome will evaluate the change in perceived dyspnea from baseline to after the three-week intervention. Lower scores indicate lower dyspnea.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Quality of Life with SF-36 questionnaire", "description": "Quality of life will be assessed using the SF-36 questionnaire. The outcome will evaluate the change in quality-of-life dimensions from baseline to after the three-week intervention. Higher scores indicate better quality of life.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Fatigue", "description": "Fatigue will be assessed using the DePaul Symptom Questionnaire. Higher scores indicate greater fatigue.", "time_frame": "Baseline and 3 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Forced Vital Capacity", "description": "Forced vital capacity will be assessed using spirometry. The outcome will evaluate the change in forced vital capacity from baseline to after the three-week intervention.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Forced Expiratory Volume in One Second", "description": "Forced expiratory volume in one second will be assessed using spirometry. The outcome will evaluate the change in FEV1 from baseline to after the three-week intervention.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Peak Expiratory Flow", "description": "Peak expiratory flow will be assessed using spirometry. The outcome will evaluate the change in PEF from baseline to after the three-week intervention.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "FEV1/FVC Ratio", "description": "The FEV1/FVC ratio will be calculated from spirometry measurements. The outcome will evaluate the change in the FEV1/FVC ratio from baseline to after the three-week intervention.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Basal Oxygen Saturation", "description": "Basal oxygen saturation will be measured using a finger pulse oximeter. The outcome will evaluate the change in basal oxygen saturation from baseline to after the three-week intervention", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Physical Function", "description": "Physical function will be assessed using the 30-second Sit-to-Stand test. The outcome will evaluate the change in the number of completed sit-to-stand repetitions from baseline to after the three-week intervention", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Dyspnea", "description": "Dyspnea will be assessed using the modified Medical Research Council scale. The outcome will evaluate the change in perceived dyspnea from baseline to after the three-week intervention. Lower scores indicate lower dyspnea.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Quality of Life with SF-36 questionnaire", "description": "Quality of life will be assessed using the SF-36 questionnaire. The outcome will evaluate the change in quality-of-life dimensions from baseline to after the three-week intervention. Higher scores indicate better quality of life.", "time_frame": "Baseline and 3 weeks" }, { "type": "secondary", "measure": "Fatigue", "description": "Fatigue will be assessed using the DePaul Symptom Questionnaire. Higher scores indicate greater fatigue.", "time_frame": "Baseline and 3 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 9, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07621588", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07021794", "title": "SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-09-29", "start_date": "2025-07-28", "completion_date": "2027-09-30", "primary_completion_date": "2027-09-30", "conditions_raw": [ "Post-COVID / Long-COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Sipavibart" ], "sponsor": "Nancy Klimas", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This placebo-controlled, randomized, blinded, two-arm phase II study will test the safety and potential efficacy of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System-29", "description": "Comprehensive Symptom Burden Index (CSBI) total scores will serve as a composite outcome measure derived from eight PROMIS domains to capture overall symptom burden. Scores will be calculated at baseline and Week 12. Efficacy will be determined by the proportion of participants classified as IMPROVED, defined as having a ≥4.5-point increase in CSBI from baseline, a threshold representing moderate and clinically meaningful improvement.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Review of Treatment Related Adverse Events", "description": "Number of participants with treatment-related adverse events as assessed by frequency of safety events during the study period.", "time_frame": "24 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptom-specific participant-reported outcome measures", "description": "Evaluate change in Comprehensive Symptom Burden Index (CSBI) score from baseline to Week 24 between Sipavibart and placebo groups.", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Change in Simple Reaction Time (Milliseconds)", "description": "Change in raw Simple Reaction Time, measured in milliseconds using the CNS Vital Signs computerized test battery, from baseline to Weeks 12 and 24.", "time_frame": "Baseline, 12 and 24 weeks" }, { "type": "secondary", "measure": "Self-reported fatigue using MFI", "description": "Change in Multidimensional Fatigue Inventory (MFI) total and subscale scores (General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, Reduced Motivation) from baseline to Weeks 12 and 24.\n\nCorrelation of MFI scores with PROMIS Fatigue and DSQ-PEM subscales (convergent validity).", "time_frame": "12 and 24 weeks" }, { "type": "secondary", "measure": "Change in Heart Rate Post-6MWT", "description": "Change in Heart Rate post 6-minute walk distance (6MWT), in meters, from baseline to Weeks 12 and 24.Unit: Beats per minute (bpm)", "time_frame": "12 and 24 weeks" }, { "type": "secondary", "measure": "Processing Speed", "description": "Change in Processing Speed score (Standard score or percentile) from baseline to Weeks 12 and 24 as measured by CNS Vital Signs.", "time_frame": "12 and 24 weeks" }, { "type": "secondary", "measure": "Attention", "description": "Change in Attention (Standard Score) from baseline to Weeks 12 and 24 as measured by CNS Vital Signs.", "time_frame": "Baseline, 12 and 24 weeks" }, { "type": "secondary", "measure": "Systolic Blood Pressure Response During NASA Lean Test", "description": "Change in systolic blood pressure (mmHg) from baseline to 10 minutes upright during the NASA Lean Test", "time_frame": "Baseline, 12 and 24 Weeks" }, { "type": "secondary", "measure": "Diastolic Blood Pressure Response During NASA Lean Test", "description": "Change in diastolic blood pressure (mmHg) from baseline to 10 minutes upright during the NASA Lean Test", "time_frame": "Baseline, 12 and 24 Weeks" }, { "type": "secondary", "measure": "Symptom Score During NASA Lean Test", "description": "Change in self-reported orthostatic intolerance symptom score, measured using a 0-10 numeric scale, during the NASA 10-minute Lean Test", "time_frame": "Baseline, 12 and 24 weeks" }, { "type": "secondary", "measure": "Within-participant change in PROMIS Fatigue scores from baseline to Week 24", "description": "PROMIS Fatigue domain score measured at baseline, Week 12, and Week 24 to assess change over time.", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Within-participant change in PROMIS Pain Interference scores", "description": "PROMIS Pain Interference domain score measured at baseline, Week 12, and Week 24 to assess change over time.", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Within-participant change in PROMIS Physical Function scores", "description": "PROMIS Physical Function domain score measured at baseline, Week 12, and Week 24 to assess change over time.", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in PROMIS Cognitive Function 8a T-score", "description": "Evaluates cognitive function using PROMIS Cognitive Function 8a at baseline, Week 12, and Week 24. Used to assess differential treatment effects by baseline symptom cluster (Cognitive Dysfunction group).", "time_frame": "Baseline, 12 Week, 24 week" }, { "type": "secondary", "measure": "Change in Orthostatic Hypotension Questionnaire (OHQ) composite score", "description": "Evaluates autonomic dysfunction using the OHQ at baseline, Week 12, and Week 24. Used to assess differential treatment effects by baseline symptom cluster (Autonomic Dysfunction group).", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in DePaul Symptom Questionnaire-Post-Exertional Malaise (DSQ-PEM)", "description": "Evaluates post-exertional malaise and exercise intolerance using the DSQ-PEM T score at baseline, Week 12, and Week 24. Used to assess differential treatment effects by baseline symptom cluster .", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in DePaul Symptom Questionnaire (DSQ) score", "description": "Assesses symptom burden using the DSQ at baseline, Week 12, and Week 24.", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Pittsburgh Sleep Quality Index (PSQI) global score", "description": "Assesses sleep quality using the PSQI at baseline, Week 12, and Week 24. Scores (0-21)", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Brief Pain Inventory (BPI) severity score", "description": "Assesses pain severity using the BPI at baseline, Week 12, and Week 24. Scores (1-10).", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Modified Medical Research Council (mMRC) Dyspnea Scale score", "description": "Assesses dyspnea using the mMRC scale at baseline, Week 12, and Week 24. Score range 0-4", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Generalized Anxiety Disorder-7 (GAD-7) score", "description": "Assesses anxiety symptoms using the GAD-7 at baseline, Week 12, and Week 24. Score range 0-21", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire-8 (PHQ-8) score", "description": "Assesses depressive symptoms using the PHQ-8 at baseline, Week 12, and Week 24. Score range 0-24", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Brief Illness Perception Questionnaire (B-IPQ) total score", "description": "Assesses illness perception using the B-IPQ at baseline, Week 12, and Week 24. Score range 0-80", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Functional Capacity Scale (FUNCAP) score", "description": "Assesses functional impairment using the FUNCAP scale at baseline, Week 12, and Week 24. Score range 0-100", "time_frame": "Baseline, 12 weeks, 24 weeks." }, { "type": "secondary", "measure": "Change in Composite Symptom Burden Index (CSBI) score", "description": "The CSBI is a derived score summarizing symptom burden across multiple validated domains (e.g., fatigue, pain, sleep, mood, cognitive function). Domain scores are standardized and averaged to produce a single CSBI value per participant. Paired differences from baseline to Week 12 and Week 24 will be analyzed to assess intra-individual changes and overall cohort-level trends.", "time_frame": "Baseline, 12 weeks, 24 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System-29", "description": "Comprehensive Symptom Burden Index (CSBI) total scores will serve as a composite outcome measure derived from eight PROMIS domains to capture overall symptom burden. Scores will be calculated at baseline and Week 12. Efficacy will be determined by the proportion of participants classified as IMPROVED, defined as having a ≥4.5-point increase in CSBI from baseline, a threshold representing moderate and clinically meaningful improvement.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Review of Treatment Related Adverse Events", "description": "Number of participants with treatment-related adverse events as assessed by frequency of safety events during the study period.", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Symptom-specific participant-reported outcome measures", "description": "Evaluate change in Comprehensive Symptom Burden Index (CSBI) score from baseline to Week 24 between Sipavibart and placebo groups.", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Change in Simple Reaction Time (Milliseconds)", "description": "Change in raw Simple Reaction Time, measured in milliseconds using the CNS Vital Signs computerized test battery, from baseline to Weeks 12 and 24.", "time_frame": "Baseline, 12 and 24 weeks" }, { "type": "secondary", "measure": "Self-reported fatigue using MFI", "description": "Change in Multidimensional Fatigue Inventory (MFI) total and subscale scores (General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, Reduced Motivation) from baseline to Weeks 12 and 24.\n\nCorrelation of MFI scores with PROMIS Fatigue and DSQ-PEM subscales (convergent validity).", "time_frame": "12 and 24 weeks" }, { "type": "secondary", "measure": "Change in Heart Rate Post-6MWT", "description": "Change in Heart Rate post 6-minute walk distance (6MWT), in meters, from baseline to Weeks 12 and 24.Unit: Beats per minute (bpm)", "time_frame": "12 and 24 weeks" }, { "type": "secondary", "measure": "Processing Speed", "description": "Change in Processing Speed score (Standard score or percentile) from baseline to Weeks 12 and 24 as measured by CNS Vital Signs.", "time_frame": "12 and 24 weeks" }, { "type": "secondary", "measure": "Attention", "description": "Change in Attention (Standard Score) from baseline to Weeks 12 and 24 as measured by CNS Vital Signs.", "time_frame": "Baseline, 12 and 24 weeks" }, { "type": "secondary", "measure": "Systolic Blood Pressure Response During NASA Lean Test", "description": "Change in systolic blood pressure (mmHg) from baseline to 10 minutes upright during the NASA Lean Test", "time_frame": "Baseline, 12 and 24 Weeks" }, { "type": "secondary", "measure": "Diastolic Blood Pressure Response During NASA Lean Test", "description": "Change in diastolic blood pressure (mmHg) from baseline to 10 minutes upright during the NASA Lean Test", "time_frame": "Baseline, 12 and 24 Weeks" }, { "type": "secondary", "measure": "Symptom Score During NASA Lean Test", "description": "Change in self-reported orthostatic intolerance symptom score, measured using a 0-10 numeric scale, during the NASA 10-minute Lean Test", "time_frame": "Baseline, 12 and 24 weeks" }, { "type": "secondary", "measure": "Within-participant change in PROMIS Fatigue scores from baseline to Week 24", "description": "PROMIS Fatigue domain score measured at baseline, Week 12, and Week 24 to assess change over time.", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Within-participant change in PROMIS Pain Interference scores", "description": "PROMIS Pain Interference domain score measured at baseline, Week 12, and Week 24 to assess change over time.", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Within-participant change in PROMIS Physical Function scores", "description": "PROMIS Physical Function domain score measured at baseline, Week 12, and Week 24 to assess change over time.", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in PROMIS Cognitive Function 8a T-score", "description": "Evaluates cognitive function using PROMIS Cognitive Function 8a at baseline, Week 12, and Week 24. Used to assess differential treatment effects by baseline symptom cluster (Cognitive Dysfunction group).", "time_frame": "Baseline, 12 Week, 24 week" }, { "type": "secondary", "measure": "Change in Orthostatic Hypotension Questionnaire (OHQ) composite score", "description": "Evaluates autonomic dysfunction using the OHQ at baseline, Week 12, and Week 24. Used to assess differential treatment effects by baseline symptom cluster (Autonomic Dysfunction group).", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in DePaul Symptom Questionnaire-Post-Exertional Malaise (DSQ-PEM)", "description": "Evaluates post-exertional malaise and exercise intolerance using the DSQ-PEM T score at baseline, Week 12, and Week 24. Used to assess differential treatment effects by baseline symptom cluster .", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in DePaul Symptom Questionnaire (DSQ) score", "description": "Assesses symptom burden using the DSQ at baseline, Week 12, and Week 24.", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Pittsburgh Sleep Quality Index (PSQI) global score", "description": "Assesses sleep quality using the PSQI at baseline, Week 12, and Week 24. Scores (0-21)", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Brief Pain Inventory (BPI) severity score", "description": "Assesses pain severity using the BPI at baseline, Week 12, and Week 24. Scores (1-10).", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Modified Medical Research Council (mMRC) Dyspnea Scale score", "description": "Assesses dyspnea using the mMRC scale at baseline, Week 12, and Week 24. Score range 0-4", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Generalized Anxiety Disorder-7 (GAD-7) score", "description": "Assesses anxiety symptoms using the GAD-7 at baseline, Week 12, and Week 24. Score range 0-21", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire-8 (PHQ-8) score", "description": "Assesses depressive symptoms using the PHQ-8 at baseline, Week 12, and Week 24. Score range 0-24", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Brief Illness Perception Questionnaire (B-IPQ) total score", "description": "Assesses illness perception using the B-IPQ at baseline, Week 12, and Week 24. Score range 0-80", "time_frame": "Baseline, 12 weeks, 24 weeks" }, { "type": "secondary", "measure": "Change in Functional Capacity Scale (FUNCAP) score", "description": "Assesses functional impairment using the FUNCAP scale at baseline, Week 12, and Week 24. Score range 0-100", "time_frame": "Baseline, 12 weeks, 24 weeks." }, { "type": "secondary", "measure": "Change in Composite Symptom Burden Index (CSBI) score", "description": "The CSBI is a derived score summarizing symptom burden across multiple validated domains (e.g., fatigue, pain, sleep, mood, cognitive function). Domain scores are standardized and averaged to produce a single CSBI value per participant. Paired differences from baseline to Week 12 and Week 24 will be analyzed to assess intra-individual changes and overall cohort-level trends.", "time_frame": "Baseline, 12 weeks, 24 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07021794", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06928116", "title": "Heat thErapy And mobiLity in COVID-19 Survivors", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-09-28", "start_date": "2025-01-16", "completion_date": "2029-08", "primary_completion_date": "2028-08-31", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Heat Therapy", "Walking" ], "sponsor": "University of Nebraska", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Post-acute sequelae of SARS-CoV-2 infection (PASC) is becoming a major risk factor for chronic diseases, with older adults and those with underlying health conditions at risk of developing persistent mobility limitations and disabilities. Although exercise intervention is a common strategy to restore functional capacity, it may not be feasible or enticing to many people with PASC. This clinical trial seeks to establish the tolerability and efficacy of at home lower-body heat therapy for improving functional capacity along with metabolic and vascular health in late-middle aged and older adults with PASC, also known as \"long COVID\".", "primary_outcomes": [ { "type": "primary", "measure": "6 min walking distance", "description": "Distance covered during 6 min of walking", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Short Physical Performance Battery Test", "description": "Test of physical functional capacity", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Arterial stiffness", "description": "Pulse Wave velocity", "time_frame": "8 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "6 min walking distance", "description": "Distance covered during 6 min of walking", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Short Physical Performance Battery Test", "description": "Test of physical functional capacity", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Arterial stiffness", "description": "Pulse Wave velocity", "time_frame": "8 weeks" } ], "relevance_tags": [ "Metabolic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 99, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06928116", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06631287", "title": "Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID", "status": "RECRUITING", "phase": "PHASE3", "last_updated": "2026-09-25", "start_date": "2024-10-21", "completion_date": "2027-07-01", "primary_completion_date": "2026-11-01", "conditions_raw": [ "Long COVID", "Sars-CoV-2 Infection", "Coronavirus Infections", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Baricitinib" ], "sponsor": "Wes Ely", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "CNS-Vital Signs Global Cognitive Index", "description": "Objective neuropsychological function determined using the CNS-Vital Signs Global Cognitive Index between study arms at 6-months, adjusted for baseline.\n\nCNS-Vital Signs Global Cognitive Index subscale is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.", "time_frame": "Month 6" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Objective neuropsychological function domains of executive function, memory, processing speed, and motor speed including the CNS-Vital Signs subscale tests at 6-months.", "description": "CNS-Vital Signs Global Cognitive Index is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.", "time_frame": "Month 6" }, { "type": "secondary", "measure": "Objective neuropsychological function domains of executive function, memory, processing speed, and motor speed including the CNS-Vital Signs subscale tests at 12-months.", "description": "CNS-Vital Signs Global Cognitive Index subscale is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.", "time_frame": "Month 12" }, { "type": "secondary", "measure": "Modified Everyday Cognition (mECog)", "description": "Subjective participant-reported cognitive impairment including modified Everyday Cognition (mECog) scale at 3-, 6-, and 12-months.\n\nThe mECog measure uses the sum score of all of the subscales, and the items are reverse coded (i.e., 1= \"Better or no change\", 2=\"Questionable/occasionally worse\", 3=\"Consistently a little worse\", 4=\"Consistently much worse\"), meaning that lower scores are better. Reported total scores range from 39 (Better or no change) to 156 (Consistently much worse).", "time_frame": "Months 3, 6 and 12" }, { "type": "secondary", "measure": "Exercise capacity including the 6-minute walk test (6MWT) at 6- and 12-months", "description": "Total distance in meters walked in 6 minutes", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Cardiopulmonary exercise testing (CPET)", "description": "Cardiorespiratory fitness (peak VO2) using cardiopulmonary exercise testing (CPET) at 6- and 12- months. CPET is used to assess change in exercise tolerance as measured by VO2max.", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Quality-of-life measures including the EuroQOL-5D-5L at 3-, 6-, and 12-months", "description": "The 5-Level EuroQol-5D health questionnaire (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The index value total (which is country-specific) ranges from a minimum value of -1 to a maximum value of +1. A higher EQ-5D-5L index value represents better quality of life (QoL), thus a positive change in the index value represents improved QoL.", "time_frame": "Months 3, 6, and 12" }, { "type": "secondary", "measure": "Post-exertional malaise including the modified De Paul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM) at 6- and 12-months", "description": "The mDSQ-PEM has 10 questions (5 on severity and 5 on frequency) scored 0-4, with higher scores indicating greater post exertional malaise severity.", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Effect of breathlessness on daily activities including the Modified Medical Research Council Dyspnea Scale (mMRC) at 6- and 12-months", "description": "Modified Medical Research Council Dyspnea Scale (mMRC) ranges from grade 0 to 4. 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Post COVID-19 symptom burden including the Symptom Burden Questionnaire for Long COVID (SBQ-LC) Circulation Subscale at 1-, 3-, 6-, and 12-months", "description": "The SBQ-LC Circulation Subscale consists of 5 questions with a score of 0-11 where higher scores indicate greater circulation-related symptom burden.", "time_frame": "Months 1, 3, 6, and 12" }, { "type": "secondary", "measure": "General participant-reported outcomes using the PROMIS-29 at 1-, 3-, 6-, and 12-months", "description": "The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 has 29 questions across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) each scored 1-5, with higher scores indicating worse symptoms or better function, depending on the domain.", "time_frame": "Months 1, 3, 6, and 12" }, { "type": "secondary", "measure": "Cognitive participant-reported outcomes using the PROMIS-Cognitive Function-Short Form 8a at 1-, 3-, 6-, and 12-months", "description": "The Patient-Reported Outcomes Measurement Information System-Cognitive Function-Short Form 8a (PROMIS-CF-8a) has 8 questions, each scored 1-5, with higher scores indicating better cognitive function.", "time_frame": "Months 1, 3, 6, and 12" }, { "type": "secondary", "measure": "Mental health measures including depression, anxiety, and stress using the DASS-21 at 6- and 12-months", "description": "The Depression Anxiety Stress Scale (DASS)-21 is a set of three (depression, anxiety, stress) self reported scales. Depression: Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+. Anxiety Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe 20+. Stress Normal 0-14, Mild 15-18, Moderate 19-25, Severe 26-33, Extremely Severe 34+.", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Orthostatic intolerance using the Orthostatic Intolerance Questionnaire (OIQ) at 3-, 6-, and 12-months", "description": "Each subscale is scored on a 0-10 scale, with higher scores reflecting more severe symptoms compared to few/no symptoms at lower scores. The OISA has a total possible score of 40 and the OIDAS a total possible score of 60.", "time_frame": "Months 3, 6, and 12" }, { "type": "secondary", "measure": "Autonomic dysfunction using the COMPASS-31 at 3-, 6-, and 12-months.", "description": "The Composite Autonomic Symptom Score (COMPASS)-31 has 31 questions across six health domains (orthostatic Intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor), scored 0-4 with higher scores indicating greater autonomic symptom burden.", "time_frame": "Months 3, 6, and 12" } ], "outcome_measures": [ { "type": "primary", "measure": "CNS-Vital Signs Global Cognitive Index", "description": "Objective neuropsychological function determined using the CNS-Vital Signs Global Cognitive Index between study arms at 6-months, adjusted for baseline.\n\nCNS-Vital Signs Global Cognitive Index subscale is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.", "time_frame": "Month 6" }, { "type": "secondary", "measure": "Objective neuropsychological function domains of executive function, memory, processing speed, and motor speed including the CNS-Vital Signs subscale tests at 6-months.", "description": "CNS-Vital Signs Global Cognitive Index is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.", "time_frame": "Month 6" }, { "type": "secondary", "measure": "Objective neuropsychological function domains of executive function, memory, processing speed, and motor speed including the CNS-Vital Signs subscale tests at 12-months.", "description": "CNS-Vital Signs Global Cognitive Index subscale is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.", "time_frame": "Month 12" }, { "type": "secondary", "measure": "Modified Everyday Cognition (mECog)", "description": "Subjective participant-reported cognitive impairment including modified Everyday Cognition (mECog) scale at 3-, 6-, and 12-months.\n\nThe mECog measure uses the sum score of all of the subscales, and the items are reverse coded (i.e., 1= \"Better or no change\", 2=\"Questionable/occasionally worse\", 3=\"Consistently a little worse\", 4=\"Consistently much worse\"), meaning that lower scores are better. Reported total scores range from 39 (Better or no change) to 156 (Consistently much worse).", "time_frame": "Months 3, 6 and 12" }, { "type": "secondary", "measure": "Exercise capacity including the 6-minute walk test (6MWT) at 6- and 12-months", "description": "Total distance in meters walked in 6 minutes", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Cardiopulmonary exercise testing (CPET)", "description": "Cardiorespiratory fitness (peak VO2) using cardiopulmonary exercise testing (CPET) at 6- and 12- months. CPET is used to assess change in exercise tolerance as measured by VO2max.", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Quality-of-life measures including the EuroQOL-5D-5L at 3-, 6-, and 12-months", "description": "The 5-Level EuroQol-5D health questionnaire (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The index value total (which is country-specific) ranges from a minimum value of -1 to a maximum value of +1. A higher EQ-5D-5L index value represents better quality of life (QoL), thus a positive change in the index value represents improved QoL.", "time_frame": "Months 3, 6, and 12" }, { "type": "secondary", "measure": "Post-exertional malaise including the modified De Paul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM) at 6- and 12-months", "description": "The mDSQ-PEM has 10 questions (5 on severity and 5 on frequency) scored 0-4, with higher scores indicating greater post exertional malaise severity.", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Effect of breathlessness on daily activities including the Modified Medical Research Council Dyspnea Scale (mMRC) at 6- and 12-months", "description": "Modified Medical Research Council Dyspnea Scale (mMRC) ranges from grade 0 to 4. 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Post COVID-19 symptom burden including the Symptom Burden Questionnaire for Long COVID (SBQ-LC) Circulation Subscale at 1-, 3-, 6-, and 12-months", "description": "The SBQ-LC Circulation Subscale consists of 5 questions with a score of 0-11 where higher scores indicate greater circulation-related symptom burden.", "time_frame": "Months 1, 3, 6, and 12" }, { "type": "secondary", "measure": "General participant-reported outcomes using the PROMIS-29 at 1-, 3-, 6-, and 12-months", "description": "The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 has 29 questions across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) each scored 1-5, with higher scores indicating worse symptoms or better function, depending on the domain.", "time_frame": "Months 1, 3, 6, and 12" }, { "type": "secondary", "measure": "Cognitive participant-reported outcomes using the PROMIS-Cognitive Function-Short Form 8a at 1-, 3-, 6-, and 12-months", "description": "The Patient-Reported Outcomes Measurement Information System-Cognitive Function-Short Form 8a (PROMIS-CF-8a) has 8 questions, each scored 1-5, with higher scores indicating better cognitive function.", "time_frame": "Months 1, 3, 6, and 12" }, { "type": "secondary", "measure": "Mental health measures including depression, anxiety, and stress using the DASS-21 at 6- and 12-months", "description": "The Depression Anxiety Stress Scale (DASS)-21 is a set of three (depression, anxiety, stress) self reported scales. Depression: Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+. Anxiety Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe 20+. Stress Normal 0-14, Mild 15-18, Moderate 19-25, Severe 26-33, Extremely Severe 34+.", "time_frame": "Months 6 and 12" }, { "type": "secondary", "measure": "Orthostatic intolerance using the Orthostatic Intolerance Questionnaire (OIQ) at 3-, 6-, and 12-months", "description": "Each subscale is scored on a 0-10 scale, with higher scores reflecting more severe symptoms compared to few/no symptoms at lower scores. The OISA has a total possible score of 40 and the OIDAS a total possible score of 60.", "time_frame": "Months 3, 6, and 12" }, { "type": "secondary", "measure": "Autonomic dysfunction using the COMPASS-31 at 3-, 6-, and 12-months.", "description": "The Composite Autonomic Symptom Score (COMPASS)-31 has 31 questions across six health domains (orthostatic Intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor), scored 0-4 with higher scores indicating greater autonomic symptom burden.", "time_frame": "Months 3, 6, and 12" } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "Phase 3", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 550, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06631287", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07005921", "title": "QEEG-NEUROFEEDBACK FOR COGNITIVE REHABILITATION IN LONG COVID-19 SURVIVORS WITH BRAIN FOG", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-09-25", "start_date": "2025-06-10", "completion_date": "2026-08-14", "primary_completion_date": "2026-08-14", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Long COVID", "Brain Fog" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Qeeg-Neurofeedback" ], "sponsor": "Jade Carvalho Da Silva", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The pandemic has highlighted social, economic, educational, and political issues that have affected the health and quality of life of millions of Brazilians. Currently, attention and memory impairment remains predominant among the cognitive symptoms of Coronavirus observed in adults. The persistance of the reffered impairment after 12 weeks of COVID-19 is known as cognitive impairment in post-COVID-19 syndrome. Despite studies indicating the negative effects of COVID-19 on attention and memory, there is a gap in the literature regarding the investigation of QEEG-neurofeedback training (QEEG-NFT) efficacy for neurocognitive rehabilitation in COVID survivors with brain fog. In this context, quantitative electroencephalogram neurofeedback training (EEGq-NFT) is a promising non-invasive intervention designed to improve cognition, such as attention and working memory. By modifying electrophysiological patterns in the cerebral cortex. Considering the information presented, the question is what is the efficacy of EEGq-NFT training in rehabilitating attention and working memory in adults with cognitive impairment due to post-COVID-19 syndrome. This study aims to verify the efficacy of EEGq-NFT to rehabilitate cognition, more specifically attention, working memory and speed processing, in adults with cognitive impairment related to post-COVID-19 syndrome. A total of 40 participants were be randomly assigned to an EEGq neurofeedback training group (n = 13), an active control group called SHAM EEGq-neurofeedback (n = 13), and a waiting list control group (n = 14). The theta/beta ratio reduction protocol at frontal and central areas were used, with a total of 13 sessions. The Psychological Battery of Attention 2 (BPA-2), Digit Span Test (DST) and Five Digit Test (FDT) were employed to measure attention, working memory and speed processing levels. Statistical analyses were performed using JASP and R softwares with statistical significance set at p \\< 0.05 for a 95% confidence interval. The research followed all ethical standards for studies involving human subjects and was submitted for review and approval at the Research Ethics Committee.", "primary_outcomes": [ { "type": "primary", "measure": "Change from Baseline in the Mean of Psychological Battery of Attention 2 (BPA-2), Digit Span Test (DST), and Five Digit Test (FDT) at 5 weeks", "description": "Psychological Battery for Attention Assessment 2 (BPA-2) evaluates overall attention capacity, which is a somatory of specific types of attention, namely, concentrated attention (CA), divided attention (DA) and alternating attention (AA). Digit Span Test (DST) assesses auditory memory and working memory (in direct and reverse order). It consists on sequences of digits, which increase in length, ranging from two to nine items in sequence that must be repeated. The Five Digit Test measures Executive Functions. It involves routines of reading and number counting, with four tasks: reading digits from 1 to 5; counting quantities from 1 to 5; the ability to ignore an automatic processing routine (digit reading) in favor of a controlled one (digit counting) in incongruent stimuli; and the ability to alternate between reading and counting processes. Participants will achieve a response if they score a performance status of to 3 on a classification ranging from 1 (inferior) to 5 (superior).", "time_frame": "From baseline to the end of treatment at 5 weeks. Finally, at follow-up 30 days post treatment." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Change from Baseline in the Mean of Psychological Battery of Attention 2 (BPA-2), Digit Span Test (DST), and Five Digit Test (FDT) at 5 weeks", "description": "Psychological Battery for Attention Assessment 2 (BPA-2) evaluates overall attention capacity, which is a somatory of specific types of attention, namely, concentrated attention (CA), divided attention (DA) and alternating attention (AA). Digit Span Test (DST) assesses auditory memory and working memory (in direct and reverse order). It consists on sequences of digits, which increase in length, ranging from two to nine items in sequence that must be repeated. The Five Digit Test measures Executive Functions. It involves routines of reading and number counting, with four tasks: reading digits from 1 to 5; counting quantities from 1 to 5; the ability to ignore an automatic processing routine (digit reading) in favor of a controlled one (digit counting) in incongruent stimuli; and the ability to alternate between reading and counting processes. Participants will achieve a response if they score a performance status of to 3 on a classification ranging from 1 (inferior) to 5 (superior).", "time_frame": "From baseline to the end of treatment at 5 weeks. Finally, at follow-up 30 days post treatment." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07005921", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07123727", "title": "A Study to Examine Anktiva for the Treatment of COVID-19.", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-09-24", "start_date": "2025-09-04", "completion_date": "2027-03", "primary_completion_date": "2027-03", "conditions_raw": [ "Long COVID", "Long COVID Syndrome", "Long Covid 19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Anktiva" ], "sponsor": "ImmunityBio, Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remain after the infection is over.", "primary_outcomes": [ { "type": "primary", "measure": "Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of abnormal changes in safety laboratory tests (CBC and CMP).", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as temperature in degrees Fahrenheit.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as heart rate in beats per minute.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as blood pressure in millimeters of mercury (mmHg).", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as respiratory rate in breaths per minute.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as oxygen saturation in percentage.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Percent increase or decrease change in the Absolute lymphocyte count (as measured on CBC) from Screening to End Of Study with various timepoints.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." } ], "outcome_measures": [ { "type": "primary", "measure": "Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of abnormal changes in safety laboratory tests (CBC and CMP).", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as temperature in degrees Fahrenheit.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as heart rate in beats per minute.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as blood pressure in millimeters of mercury (mmHg).", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as respiratory rate in breaths per minute.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "primary", "measure": "Clinically important changes in vital signs such as oxygen saturation in percentage.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." }, { "type": "secondary", "measure": "Percent increase or decrease change in the Absolute lymphocyte count (as measured on CBC) from Screening to End Of Study with various timepoints.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)." } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07123727", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06847191", "title": "NE3107 in Adults With Neurological Symptoms of Long COVID", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-09-22", "start_date": "2025-04-29", "completion_date": "2026-09-02", "primary_completion_date": "2026-08-06", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ne3107" ], "sponsor": "BioVie Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Long COVID is a condition where debilitating symptoms can persist for months after a COVID-19 infection. This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or remembering things (\"brain fog\") and fatigue.\n\nThis study is designed as a signal-seeking proof-of-concept Phase 2 study. The primary outcome is intended for estimation and hypothesis generation rather than formal hypothesis testing. No single endpoint is designated as definitive for study success.\n\nResearchers will compare NE3107 to a placebo (a look-alike substance that contains no drug) to see if NE3107 works to treat neurocognitive and fatigue symptoms of long COVID.\n\nParticipants will:\n\n* Take NE3107 or a placebo twice daily for 84 days\n* Visit the clinic 5 times for checkups and tests and have a follow up phone call", "primary_outcomes": [ { "type": "primary", "measure": "Change from Baseline in performance on the Cogstate Cognition battery*", "description": "\\*This study is designed as a signal-seeking proof-of-concept Phase 2 study. The primary outcome is intended for estimation and hypothesis generation rather than formal hypothesis testing. No single endpoint is designated as definitive for study success. Objective computerized neurocognitive testing using Cogstate battery assessing attention, sustained attention, verbal memory, verbal learning, psychomotor function and processing speed. A composite cognitive score is calculated as the mean of standardized (z-score-transformed) performance scores across the tasks. Higher composite scores indicate better cognitive performance.", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in PROMIS Cognitive Function Short Form 8a (SF-8a)", "description": "Patient-reported assessment of perceived cognitive abilities, including memory, attention, and mental acuity. Scores are standardized T-scores, T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores below 50 represent worse cognitive function.", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in PROMIS Fatigue Short Form 13a (SF-13a)", "description": "The PROMIS Fatigue SF-13a assesses patient-reported fatigue severity and impact over the prior 7 days. Scores are standardized T-scores, T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent worse fatigue severity", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in PROMIS Sleep Disturbance Short Form 8a (SF-8a)", "description": "Patient-reported measure of sleep quality, depth, and restoration. Scores are standardized T scores and T scores are a continuous variable. The mean in the general population 50 (SD=10), with higher scores reflecting greater sleep disturbance.", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in SF-12 Health Survey (Physical Component Scores)", "description": "Generic quality-of-life assessment evaluating physical (PCS) and mental (MCS) health domains which are normalized to a mean of 50 (SD=10) with scores lower scores indicating worse physical function", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in SF-12 Health Survey (Mental Component Scores)", "description": "Generic quality-of-life assessment evaluating physical (PCS) and mental (MCS) health domains which are normalized to a mean of 50 (SD=10) with lower scores indicating worse mental health", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in DePaul Symptom Questionnaire (DSQ) Post-Exertional Malaise", "description": "DSQ-PEM evaluates the presence or absence of PEM and myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) and the severity and frequency of PEM symptoms. Participants rate both frequency and severity of PEM symptoms. Frequency is rated on a 5-point Likert scale (0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, 4 = all of the time). Severity is rated on a 5-point Likert scale (0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).\n\nPost-exertional malaise is considered present if the participant reports at least one PEM symptom with a severity score ≥2 (moderate or greater) and a frequency score ≥2 (about half the time or more). The outcome measure is the change from baseline in the exercise intolerance symptom cluster score derived from the DSQ-PEM.", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Composite Benefit Score", "description": "Composite Benefit Score (CBS), Composite endpoint consisting of clinically relevant symptom measures. Lower scores indicate improvement in Long COVID symptoms.", "time_frame": "12 Weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Exploratory biomarkers", "description": "Exploratory biomarker assessments are intended to characterize the biological effects of bezisterim, identify biomarkers associated with clinical outcomes, identify endotypes, and investigate biological pathways potentially relevant to treatment response.", "time_frame": "12 Weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from Baseline in performance on the Cogstate Cognition battery*", "description": "\\*This study is designed as a signal-seeking proof-of-concept Phase 2 study. The primary outcome is intended for estimation and hypothesis generation rather than formal hypothesis testing. No single endpoint is designated as definitive for study success. Objective computerized neurocognitive testing using Cogstate battery assessing attention, sustained attention, verbal memory, verbal learning, psychomotor function and processing speed. A composite cognitive score is calculated as the mean of standardized (z-score-transformed) performance scores across the tasks. Higher composite scores indicate better cognitive performance.", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in PROMIS Cognitive Function Short Form 8a (SF-8a)", "description": "Patient-reported assessment of perceived cognitive abilities, including memory, attention, and mental acuity. Scores are standardized T-scores, T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores below 50 represent worse cognitive function.", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in PROMIS Fatigue Short Form 13a (SF-13a)", "description": "The PROMIS Fatigue SF-13a assesses patient-reported fatigue severity and impact over the prior 7 days. Scores are standardized T-scores, T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent worse fatigue severity", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in PROMIS Sleep Disturbance Short Form 8a (SF-8a)", "description": "Patient-reported measure of sleep quality, depth, and restoration. Scores are standardized T scores and T scores are a continuous variable. The mean in the general population 50 (SD=10), with higher scores reflecting greater sleep disturbance.", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in SF-12 Health Survey (Physical Component Scores)", "description": "Generic quality-of-life assessment evaluating physical (PCS) and mental (MCS) health domains which are normalized to a mean of 50 (SD=10) with scores lower scores indicating worse physical function", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in SF-12 Health Survey (Mental Component Scores)", "description": "Generic quality-of-life assessment evaluating physical (PCS) and mental (MCS) health domains which are normalized to a mean of 50 (SD=10) with lower scores indicating worse mental health", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Change from Baseline in DePaul Symptom Questionnaire (DSQ) Post-Exertional Malaise", "description": "DSQ-PEM evaluates the presence or absence of PEM and myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) and the severity and frequency of PEM symptoms. Participants rate both frequency and severity of PEM symptoms. Frequency is rated on a 5-point Likert scale (0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, 4 = all of the time). Severity is rated on a 5-point Likert scale (0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).\n\nPost-exertional malaise is considered present if the participant reports at least one PEM symptom with a severity score ≥2 (moderate or greater) and a frequency score ≥2 (about half the time or more). The outcome measure is the change from baseline in the exercise intolerance symptom cluster score derived from the DSQ-PEM.", "time_frame": "12 Weeks" }, { "type": "primary", "measure": "Composite Benefit Score", "description": "Composite Benefit Score (CBS), Composite endpoint consisting of clinically relevant symptom measures. Lower scores indicate improvement in Long COVID symptoms.", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Exploratory biomarkers", "description": "Exploratory biomarker assessments are intended to characterize the biological effects of bezisterim, identify biomarkers associated with clinical outcomes, identify endotypes, and investigate biological pathways potentially relevant to treatment response.", "time_frame": "12 Weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 203, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06847191", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06721949", "title": "Taurine Supplementation in Long COVID", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-09-18", "start_date": "2025-11-18", "completion_date": "2028-12", "primary_completion_date": "2028-02", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Taurine" ], "sponsor": "University of Alberta", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The COVID-19 pandemic has swept across the globe, affecting millions of individuals with varying degrees of severity. While many individuals recover from the acute phase of the infection, a significant proportion continue to experience persistent and debilitating symptoms long after the initial SARS-CoV-2 infection. This condition, known as Long COVID (LC) or sometimes referred to as Post-COVID Condition (PCC) or post-acute sequelae of COVID-19, has emerged as a complex multisystemic condition and challenging health issue, affecting approximately 10% of COVID-19 patients. Various symptoms characterize LC, including fatigue, sleep disturbances, cognitive impairment, and mood disturbances. Some of the symptoms are shared with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) - a condition marked by debilitating fatigue and a host of other symptoms without precise biomarkers or objective tests for diagnosis. Effective LC treatments remain elusive and LC patients continue to grapple with persistent symptoms that significantly impact their quality of life. Given the lack of effective treatments, it is imperative to explore novel therapeutic approaches that may alleviate the suffering of this patient population.", "primary_outcomes": [ { "type": "primary", "measure": "Mean change in Modified Fatigue Impact Scale (MFIS) from baseline to three months", "description": "This study will target detection of a change in the MFIS from baseline to three months", "time_frame": "Three months" }, { "type": "primary", "measure": "Mean change in the ratio of the Trail-Making Tests A & B in the TestMyBrain cognitive testing battery from baseline to three months.", "description": "This test will target detection of a change in the ratio of the Trail-Making Tests A \\& B from baseline to three months", "time_frame": "Three months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Core Outcome Set - Symptoms", "description": "Tracking of symptom trajectory from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Cardiovascular function", "description": "Mean change in results of 6-minute walking test, to include symptoms and conditions", "time_frame": "Three months" }, { "type": "secondary", "measure": "Respiratory function", "description": "Mean change in results of 6-minute walking test, to include symptoms and conditions", "time_frame": "Three months" }, { "type": "secondary", "measure": "Cognitive Function", "description": "Measurement of mean change in cognition using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Memory", "description": "Measurement of mean change in memory using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Concentration", "description": "Measurement of mean change in concentration using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Conceptual Thinking", "description": "Measurement of mean change in conceptual thinking using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Social Functioning", "description": "Measurement of mean change in social functioning using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Mental Health Status - PHQ-9", "description": "Measurement of mean change in mental health status using the Patient Health Questionnaire (PHQ-9).", "time_frame": "Three months" }, { "type": "secondary", "measure": "Mental Health Status - GAD-7", "description": "Measurement of mean change in mental health status using the General Anxiety Disorder Questionnaire (GAD-7).", "time_frame": "Three months" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Symptoms", "description": "Measurement of changes in onset and triggers of PEM, symptoms, duration and recovery using the Post-Exertional Malaise questionnaire, adapted from De Paul's Symptom Questionnaire (PEM-DSQ).", "time_frame": "Three months" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Status (PCFS) Scale", "description": "Measurement of changes in post-COVID functional status using the Post-COVID-19 Functional Status (PCFS) Scale.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Reintegration to Normal Living Index (RNLI)", "description": "Measurement of changes in reintegration to normal social activities using the Reintegration to Normal Living Index (RNLI) assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Health Related Quality of Life - SF-36 (v.1)", "description": "Measurement of change in quality of life using the Quality of Life - SF-36 (v.1) assessment tool.", "time_frame": "Three months" } ], "outcome_measures": [ { "type": "primary", "measure": "Mean change in Modified Fatigue Impact Scale (MFIS) from baseline to three months", "description": "This study will target detection of a change in the MFIS from baseline to three months", "time_frame": "Three months" }, { "type": "primary", "measure": "Mean change in the ratio of the Trail-Making Tests A & B in the TestMyBrain cognitive testing battery from baseline to three months.", "description": "This test will target detection of a change in the ratio of the Trail-Making Tests A \\& B from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Core Outcome Set - Symptoms", "description": "Tracking of symptom trajectory from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Cardiovascular function", "description": "Mean change in results of 6-minute walking test, to include symptoms and conditions", "time_frame": "Three months" }, { "type": "secondary", "measure": "Respiratory function", "description": "Mean change in results of 6-minute walking test, to include symptoms and conditions", "time_frame": "Three months" }, { "type": "secondary", "measure": "Cognitive Function", "description": "Measurement of mean change in cognition using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Memory", "description": "Measurement of mean change in memory using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Concentration", "description": "Measurement of mean change in concentration using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Conceptual Thinking", "description": "Measurement of mean change in conceptual thinking using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Social Functioning", "description": "Measurement of mean change in social functioning using the TestMyBrain assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Mental Health Status - PHQ-9", "description": "Measurement of mean change in mental health status using the Patient Health Questionnaire (PHQ-9).", "time_frame": "Three months" }, { "type": "secondary", "measure": "Mental Health Status - GAD-7", "description": "Measurement of mean change in mental health status using the General Anxiety Disorder Questionnaire (GAD-7).", "time_frame": "Three months" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Symptoms", "description": "Measurement of changes in onset and triggers of PEM, symptoms, duration and recovery using the Post-Exertional Malaise questionnaire, adapted from De Paul's Symptom Questionnaire (PEM-DSQ).", "time_frame": "Three months" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Status (PCFS) Scale", "description": "Measurement of changes in post-COVID functional status using the Post-COVID-19 Functional Status (PCFS) Scale.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Reintegration to Normal Living Index (RNLI)", "description": "Measurement of changes in reintegration to normal social activities using the Reintegration to Normal Living Index (RNLI) assessment tool.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Health Related Quality of Life - SF-36 (v.1)", "description": "Measurement of change in quality of life using the Quality of Life - SF-36 (v.1) assessment tool.", "time_frame": "Three months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 300, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06721949", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06821087", "title": "Evaluating the Neuromodulatory Effect of Ketamine in Long COVID-19", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-09-17", "start_date": "2025-06-05", "completion_date": "2026-06-22", "primary_completion_date": "2026-06-22", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ketamine Only" ], "sponsor": "University of Texas at Austin", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Plain Language Summary:\n\nThis study is a clinical trial to see if ketamine can help treat symptoms of Long COVID, especially fatigue and problems with thinking clearly (often called \"brain fog\"). Long COVID is a condition that affects people even after they have recovered from COVID-19, causing ongoing health issues like tiredness, memory problems, and difficulty concentrating. Right now, there are very few treatments available for these symptoms, and many people are looking for new options to feel better.\n\nWhat is the study trying to find out? Does ketamine help reduce fatigue and improve thinking skills in people with Long COVID? Does ketamine improve overall quality of life and mental health for people with Long COVID? Is ketamine safe and well-tolerated for people with Long COVID? How does ketamine affect the body's biological processes, like inflammation and brain function? How will the study work?\n\nThe study will include 20 adults between 18 and 65 years old who have Long COVID symptoms like fatigue or brain fog.\n\nParticipants will first meet with researchers to answer health questions, take surveys about their symptoms, and do tests to check their thinking skills. All participants will also have a brain scan (MRI) and give a blood sample to look at markers of inflammation.\n\nParticipants will then receive four ketamine treatments over two weeks at a specialized clinic. The ketamine will be given as an injection, with the dose slightly increasing during the treatment period.\n\nAfter six weeks, participants will return for follow-up tests to see if their symptoms have improved. This includes repeating the surveys, thinking tests, MRI and blood test.\n\nWhy ketamine? Ketamine is a medicine originally used for anesthesia but has also been found to help with depression and other mental health issues. Researchers think it might help with Long COVID symptoms because it can reduce inflammation in the brain and improve how the brain functions. People with Long COVID often have signs of inflammation and changes in brain chemicals, which ketamine might help balance.\n\nWhat are the potential benefits? Participants might experience less fatigue and clearer thinking after ketamine treatment. They could also feel better overall in terms of mood and quality of life. Since ketamine can work quickly, some people may notice improvements shortly after starting the treatment.\n\nWhat are the risks? Ketamine can cause side effects like feeling dizzy, anxious, or having an unusual sense of reality (sometimes called dissociation). It may also cause temporary increases in blood pressure or heart rate. All treatments will be carefully monitored by healthcare professionals to ensure safety.\n\nWho can participate? Adults aged 18-65 with Long COVID who have significant fatigue or thinking problems can join. People will not be able to participate if they have certain health conditions like severe heart disease, uncontrolled high blood pressure, or a history of severe mental health disorders.\n\nWhy is this study important? Long COVID affects millions of people, and many are struggling to find treatments that work. This study is one of the first to explore ketamine as a potential treatment for Long COVID symptoms. If ketamine helps, it could lead to more research and eventually new treatment options for people living with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "PROMIS SF v1.0 - Fatigue 8a", "description": "A patient-reported questionnaire measuring the severity and impact of fatigue on daily activities over the past 7 days. Higher scores indicate greater fatigue.", "time_frame": "At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment." }, { "type": "primary", "measure": "PROMIS SF v2.0 Cognitive Function 4a", "description": "A patient-reported tool that measures perceived cognitive abilities, such as memory, concentration, and mental clarity, over the past 7 days. Higher scores reflect better cognitive function.", "time_frame": "At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "PROMIS Global 10 v1.2", "description": "A 10-item questionnaire assessing overall physical, mental, and social health, including pain, fatigue, and emotional well-being.", "time_frame": "Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "NASA Task Load Index (NASA-TLX)", "description": "A tool used to evaluate perceived mental workload, assessing factors like mental demand, effort, and frustration during cognitive tasks like BrainCheck.", "time_frame": "Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "A widely used self-report measure to assess the severity of depressive symptoms over the past two weeks.", "time_frame": "Collected before each ketamine treatment session, at baseline, and at the post-treatment assessment (6 weeks post-treatment)." }, { "type": "secondary", "measure": "Number of participants with treatment-related adverse events as assessed by standardized interview", "description": "A standardized interview conducted post-treatment to identify and record any physical or psychological side effects experienced by participants during the ketamine therapy.", "time_frame": "Adverse events will be assessed at each of the four ketamine treatment sessions and during the final post-treatment assessment, which occurs six weeks after the last ketamine injection." }, { "type": "secondary", "measure": "BrainCheck Cognitive Battery", "description": "A computerized series of neuropsychological tests assessing objective cognitive functions, including memory, attention, executive function, processing speed, and response inhibition. Scores are age-normalized.", "time_frame": "At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment." }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-7 (GAD-7)", "description": "A widely used 7-item scale measuring the severity of anxiety symptoms over the past two weeks.", "time_frame": "Collected before each ketamine treatment session, at baseline, and at the post-treatment assessment (6 weeks post-treatment)." }, { "type": "secondary", "measure": "Depression in Medically Ill 10 Scale (DMI-10)", "description": "A measure designed to assess depressive symptoms specifically in individuals with medical conditions, focusing on somatic and cognitive symptoms.", "time_frame": "Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "Long COVID Review of Systems", "description": "A comprehensive symptom checklist adapted from the WHO's Global COVID-19 Clinical Platform, evaluating the range and severity of Long COVID symptoms.", "time_frame": "Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "Neuroimaging (MRI) Outcomes", "description": "Functional MRI (fMRI) scans will evaluate changes in brain structure and connectivity, providing insight into the neurological effects and mechanisms of ketamine.", "time_frame": "Performed at baseline and repeated at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "Serum Biomarker Analysis", "description": "Blood samples will be analyzed for inflammatory and metabolic markers, including cytokines and metabolites in the kynurenine pathway, to assess biological responses to ketamine treatment.", "time_frame": "Collected at baseline and at the post-treatment assessment (6 weeks after the final ketamine session)." } ], "outcome_measures": [ { "type": "primary", "measure": "PROMIS SF v1.0 - Fatigue 8a", "description": "A patient-reported questionnaire measuring the severity and impact of fatigue on daily activities over the past 7 days. Higher scores indicate greater fatigue.", "time_frame": "At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment." }, { "type": "primary", "measure": "PROMIS SF v2.0 Cognitive Function 4a", "description": "A patient-reported tool that measures perceived cognitive abilities, such as memory, concentration, and mental clarity, over the past 7 days. Higher scores reflect better cognitive function.", "time_frame": "At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment." }, { "type": "secondary", "measure": "PROMIS Global 10 v1.2", "description": "A 10-item questionnaire assessing overall physical, mental, and social health, including pain, fatigue, and emotional well-being.", "time_frame": "Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "NASA Task Load Index (NASA-TLX)", "description": "A tool used to evaluate perceived mental workload, assessing factors like mental demand, effort, and frustration during cognitive tasks like BrainCheck.", "time_frame": "Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "A widely used self-report measure to assess the severity of depressive symptoms over the past two weeks.", "time_frame": "Collected before each ketamine treatment session, at baseline, and at the post-treatment assessment (6 weeks post-treatment)." }, { "type": "secondary", "measure": "Number of participants with treatment-related adverse events as assessed by standardized interview", "description": "A standardized interview conducted post-treatment to identify and record any physical or psychological side effects experienced by participants during the ketamine therapy.", "time_frame": "Adverse events will be assessed at each of the four ketamine treatment sessions and during the final post-treatment assessment, which occurs six weeks after the last ketamine injection." }, { "type": "secondary", "measure": "BrainCheck Cognitive Battery", "description": "A computerized series of neuropsychological tests assessing objective cognitive functions, including memory, attention, executive function, processing speed, and response inhibition. Scores are age-normalized.", "time_frame": "At enrollment and at the post-treatment assessment visit, 6 weeks following completion of the ketamine treatment." }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-7 (GAD-7)", "description": "A widely used 7-item scale measuring the severity of anxiety symptoms over the past two weeks.", "time_frame": "Collected before each ketamine treatment session, at baseline, and at the post-treatment assessment (6 weeks post-treatment)." }, { "type": "secondary", "measure": "Depression in Medically Ill 10 Scale (DMI-10)", "description": "A measure designed to assess depressive symptoms specifically in individuals with medical conditions, focusing on somatic and cognitive symptoms.", "time_frame": "Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "Long COVID Review of Systems", "description": "A comprehensive symptom checklist adapted from the WHO's Global COVID-19 Clinical Platform, evaluating the range and severity of Long COVID symptoms.", "time_frame": "Collected at baseline (pre-treatment) and at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "Neuroimaging (MRI) Outcomes", "description": "Functional MRI (fMRI) scans will evaluate changes in brain structure and connectivity, providing insight into the neurological effects and mechanisms of ketamine.", "time_frame": "Performed at baseline and repeated at the post-treatment assessment (6 weeks after the final ketamine session)." }, { "type": "secondary", "measure": "Serum Biomarker Analysis", "description": "Blood samples will be analyzed for inflammatory and metabolic markers, including cytokines and metabolites in the kynurenine pathway, to assess biological responses to ketamine treatment.", "time_frame": "Collected at baseline and at the post-treatment assessment (6 weeks after the final ketamine session)." } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06821087", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06822179", "title": "Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients With Long COVID", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-09-15", "start_date": "2025-03-01", "completion_date": "2026-09-01", "primary_completion_date": "2026-06-01", "conditions_raw": [ "Long COVID Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Personalised Exercise Program" ], "sponsor": "CEU San Pablo University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to evaluate whether a 12-week tele-rehabilitation programme with monitoring via a mobile app produces medium-term improvements in self-management, fatigue and quality of life in patients affected by persistent COVID.\n\nThe main questions it aims to answer are:\n\n* Will a multimodal program (exercise with education) improve the self-management ability of patients with post-exertional malaise?\n* Does fatigue and quality of life will be improved in these patients?\n\nResearchers will compare an experimental breath program to a control standard care group to see if multimodal program works to treat post-exertion malaise.\n\nParticipants will:\n\n* Follow-up 12 weeks online sessions:\n\n 1 weekly synchronous online session + 1 scheduled asynchronous session + educational resources\n* Daily use of the app: daily log, education and questions", "primary_outcomes": [ { "type": "primary", "measure": "Patient activation measure 13", "description": "Individual's knowledge, skills and confidence to managing one's own health. is a non-disease-specific tool and can be used across different patient populations. The PAM-13 consists of 13 items on a 4-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Item scores are summed up to a raw sum score resulting in theoretical values between 13 and 52, which are then transformed to a standardized metric ranging from 0 to 100. Higher scores indicate a greater patient activation. PAM-13 scores can then be categorized into four stages of activation, corresponding to the difficulty of the PAM-13 items: level 1 (patients believe active role is important; items 1-2), level 2 (patients have confidence and knowledge to take action; items 3-8), level 3 (taking action; items 9-11) and level 4 (staying on course under stress; items 12-13).", "time_frame": "From enrollment to end of treatment and 3 months follow-up" }, { "type": "primary", "measure": "self-care self-efficacy scale", "description": "Measure for self-care self-efficacy for chronic illness. This 10-item instrument measures self-efficacy related to self-care maintenance, monitoring, and management in patients with chronic illness. Each item is rated on a '1-5' rating scale, with a higher score representing a higher level of self-efficacy. Scale scores are standardized mathematically to range from 0-100.", "time_frame": "From enrollment to end of treatment and 3 months follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Health-related quality of life EuroQol-5D", "description": "Quality of life related to dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression.\n\nEach dimension is described by three possible levels of problems (no, mild to moderate and severe). Hence, this descriptive system contains three or 243 combinations, or health states. For each of these combinations, one can assign healthstate utility indices (or ''preference weights'') which are based on different value sets.", "time_frame": "From enrollment to end of treatment and 3 months follow-up" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "Severity of fatigue and its effect on a person's activities and lifestyle. The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity.", "time_frame": "From enrollment to end of treatment and 3 months follow-up" }, { "type": "secondary", "measure": "DePaul Symptom Questionnaire-Short Form (DSQ-SF)", "description": "The DSQ-SF allows investigators to use a small number of items (n = 14) to determine whether patients meet ME/CFS case definitions. Similar to the DSQ, the DSQ-SF uses the mean of the frequency and severity scores for each symptom rated over the past 6 months and linearly transforming it into a 100-point scale", "time_frame": "From enrollment to end of treatment and 3 months follow-up" }, { "type": "secondary", "measure": "Semi-structured interview: Satisfaction and experience with the tele-rehabilitation program", "description": "Data were collected through semi-structured interviews based on a question guide developed to obtain information on specific topics of interest: Satisfaction and user experience with the telerehabilitation program, Current goals and expectations and Social impact of the condition.\n\nOnly participants in the intervention group will be interviewed.", "time_frame": "From the end of treatment to 4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Patient activation measure 13", "description": "Individual's knowledge, skills and confidence to managing one's own health. is a non-disease-specific tool and can be used across different patient populations. The PAM-13 consists of 13 items on a 4-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Item scores are summed up to a raw sum score resulting in theoretical values between 13 and 52, which are then transformed to a standardized metric ranging from 0 to 100. Higher scores indicate a greater patient activation. PAM-13 scores can then be categorized into four stages of activation, corresponding to the difficulty of the PAM-13 items: level 1 (patients believe active role is important; items 1-2), level 2 (patients have confidence and knowledge to take action; items 3-8), level 3 (taking action; items 9-11) and level 4 (staying on course under stress; items 12-13).", "time_frame": "From enrollment to end of treatment and 3 months follow-up" }, { "type": "primary", "measure": "self-care self-efficacy scale", "description": "Measure for self-care self-efficacy for chronic illness. This 10-item instrument measures self-efficacy related to self-care maintenance, monitoring, and management in patients with chronic illness. Each item is rated on a '1-5' rating scale, with a higher score representing a higher level of self-efficacy. Scale scores are standardized mathematically to range from 0-100.", "time_frame": "From enrollment to end of treatment and 3 months follow-up" }, { "type": "secondary", "measure": "Health-related quality of life EuroQol-5D", "description": "Quality of life related to dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression.\n\nEach dimension is described by three possible levels of problems (no, mild to moderate and severe). Hence, this descriptive system contains three or 243 combinations, or health states. For each of these combinations, one can assign healthstate utility indices (or ''preference weights'') which are based on different value sets.", "time_frame": "From enrollment to end of treatment and 3 months follow-up" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "Severity of fatigue and its effect on a person's activities and lifestyle. The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity.", "time_frame": "From enrollment to end of treatment and 3 months follow-up" }, { "type": "secondary", "measure": "DePaul Symptom Questionnaire-Short Form (DSQ-SF)", "description": "The DSQ-SF allows investigators to use a small number of items (n = 14) to determine whether patients meet ME/CFS case definitions. Similar to the DSQ, the DSQ-SF uses the mean of the frequency and severity scores for each symptom rated over the past 6 months and linearly transforming it into a 100-point scale", "time_frame": "From enrollment to end of treatment and 3 months follow-up" }, { "type": "secondary", "measure": "Semi-structured interview: Satisfaction and experience with the tele-rehabilitation program", "description": "Data were collected through semi-structured interviews based on a question guide developed to obtain information on specific topics of interest: Satisfaction and user experience with the telerehabilitation program, Current goals and expectations and Social impact of the condition.\n\nOnly participants in the intervention group will be interviewed.", "time_frame": "From the end of treatment to 4 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 57, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06822179", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05851859", "title": "Evaluation of the Effectiveness of Breathing Control Technique on Long COVID Symptoms at the Reunion University Hospital", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-09-14", "start_date": "2025-05-05", "completion_date": "2027-04", "primary_completion_date": "2026-11", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cardiac Coherence" ], "sponsor": "Centre Hospitalier Universitaire de la Réunion", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Despite the controversy, on October 6, 2021, the World Health Organization (WHO) recognized Long Coronavirus disease (COVID) by officially defining it: \" symptoms appeared 3 months after the onset of the primary infection by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), persisting for at least 2 months and which cannot be explained by any other condition \". Long COVID can affects any type of patient and has polymorphic and fluctuating symptoms over time.\n\nThe Reunion Island is a French overseas department located in the Indian Ocean accounting more than 860,000 inhabitants. It has recorded since March 11, 2020, nearly 491,825 cases of COVID-19 and 961 deaths of hospitalized patients. Reunion's population is multi-ethnic and younger than the metropolitan France's one. It also has a higher prevalence of obesity and type 2 diabetes, two serious form factors of COVID-19. This specific context makes this island a particular study site for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Long COVID.\n\nIn addition, some studies have confirmed the involvement of the autonomic nervous system (ANS) in the symptomatology of Long COVID and demonstrated that patients with a Long COVID present a dysfunction of their ANS which is objectified by a reduced Heart Rate Variability (HRV). The regulation of heart rate by the ANS is strongly favored by respiration. A regular slow and deep breathing training helps to adjust the baroreflex, which connect heart rate, breathing and blood pressure. The result of this training is an induced state called \"cardiac coherence\" (CC).\n\nThe investigator therefore hypothesize that respiratory training to CC could \"re-educate\" the ANS and durably improve the symptomatology of patients with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the reduction in the symptomatology of patients with Long COVID.", "description": "mean score on the Long COVID Symptom Tool (ST) scale Score 0 to 53 / Higher score mean worse outcome", "time_frame": "6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of overall symptoms over time", "description": "Long COVID Symptom Tool (ST) scale Score 0 to 53 / Higher score mean worse outcome", "time_frame": "T0, 1 month, 2 months, 3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : fatigue", "description": "The 11-item Chalder Fatigue Scale (CFS-11) score 0 to 11 / Higher score mean worse outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : dyspnoea", "description": "Modified Medical Research Council (MMRC) dyspnoea scale score 0 to 5 / Higher score mean worse outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : Anxiety and Depression", "description": "Hospital Anxiety and Depression scale (HADS) Score 0 to 42 / Higher score mean worse outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : cognitive disorders", "description": "Montreal Cognitive Assessment (MoCA) Score 0 to 30 / Higher score mean better outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : Post Traumatic Stress Disorder", "description": "Posttraumatic Stress Disorder Checklist for Diagnostic and statistical manual of mental disorders, version 5 (PCL-5) Score 0 to 80 / Higher score mean worse outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to CC on the impact of the disease on daily life", "description": "Long COVID Impact Tool (IT) scale Score 0 to 60 / Higher score mean worse outcome", "time_frame": "T0, 1 month, 2 months, 3 months, 6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the reduction in the symptomatology of patients with Long COVID.", "description": "mean score on the Long COVID Symptom Tool (ST) scale Score 0 to 53 / Higher score mean worse outcome", "time_frame": "6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of overall symptoms over time", "description": "Long COVID Symptom Tool (ST) scale Score 0 to 53 / Higher score mean worse outcome", "time_frame": "T0, 1 month, 2 months, 3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : fatigue", "description": "The 11-item Chalder Fatigue Scale (CFS-11) score 0 to 11 / Higher score mean worse outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : dyspnoea", "description": "Modified Medical Research Council (MMRC) dyspnoea scale score 0 to 5 / Higher score mean worse outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : Anxiety and Depression", "description": "Hospital Anxiety and Depression scale (HADS) Score 0 to 42 / Higher score mean worse outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : cognitive disorders", "description": "Montreal Cognitive Assessment (MoCA) Score 0 to 30 / Higher score mean better outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : Post Traumatic Stress Disorder", "description": "Posttraumatic Stress Disorder Checklist for Diagnostic and statistical manual of mental disorders, version 5 (PCL-5) Score 0 to 80 / Higher score mean worse outcome", "time_frame": "3 months, 6 months" }, { "type": "secondary", "measure": "Evaluation of the effectiveness of a respiratory training to CC on the impact of the disease on daily life", "description": "Long COVID Impact Tool (IT) scale Score 0 to 60 / Higher score mean worse outcome", "time_frame": "T0, 1 month, 2 months, 3 months, 6 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 200, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05851859", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05858515", "title": "REVERSE-Long COVID-19 With Baricitinib Study", "status": "WITHDRAWN", "phase": "PHASE3", "last_updated": "2026-09-09", "start_date": "2024-10-21", "completion_date": "2029-12-30", "primary_completion_date": "2027-12-31", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Baricitinib 4 Mg" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "REVERSE-LC is a phase 3 trial of baricitinib versus placebo in adults with neurocognitive impairment (a form of Alzheimer's Disease and Related Dementias or ADRD) or cardiopulmonary symptoms due to Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Enrollment", "description": "2 participants per month, on average, are randomized", "time_frame": "6 months" }, { "type": "primary", "measure": "Diversity in enrollment", "description": "40% of participants will be from individuals disproportionally affected by COVID (Black, Hispanic, Asian, American Indian)", "time_frame": "6 months" }, { "type": "primary", "measure": "Study drug prescribed", "description": "80% of participants received every prescribed dose of the study drug", "time_frame": "9 months" }, { "type": "primary", "measure": "Study withdrawals", "description": "Less than 20% participants will be deemed lost to follow up", "time_frame": "18 months" }, { "type": "primary", "measure": "Adverse event reporting", "description": "100% of Serious Adverse Events reported to Data Safety Monitoring Board within 24 hours of study team awareness", "time_frame": "18 months" }, { "type": "primary", "measure": "Study dosing", "description": "100% adherence to study drug dose adjustments guidelines", "time_frame": "9 months" }, { "type": "primary", "measure": "Study completion", "description": "80% of participants adhere to all study procedures and requirements", "time_frame": "18 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Severe and Serious Adverse Events", "description": "Compare the percentage of severe and serious adverse events between study arms from baseline to week 12.", "time_frame": "9 months" }, { "type": "secondary", "measure": "Premature study discontinuation", "description": "Compare the rate of study drug/placebo premature discontinuation by study arm (tolerability)", "time_frame": "9 months" }, { "type": "secondary", "measure": "Global Neuropsychological Function", "description": "Assess percentage changes of global neuropsychological function as measured using the CNS Vital Signs Neurocognition Index cognitive battery between baricitinib and placebo study arm from baseline to week 12.", "time_frame": "9 months" }, { "type": "secondary", "measure": "Cardiopulmonary testing", "description": "Assess percentage changes of exercise capacity (peak VO2) using cardiopulmonary exercise testing (CPET) in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Everyday Cognition", "description": "Assess percentage changes of cognitive impairment using Everyday Cognition (ECog) scale in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Functional Status", "description": "Assess percentage changes of functional status measures in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Quality of Life Measures", "description": "Assess percentage changes of quality of life measures in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "Assess percentage changes of post-exertional malaise using De Paul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM) in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Shortness of Breath", "description": "Assess percentage changes of the effect of breathlessness on daily activities using the Modified Medical Research Council Dyspnea Scale (mMRC) in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Symptom Burden", "description": "Assess percentage changes of post COVID-19 symptom burden using the Symptom Burden Questionnaire for Long COVID (SBQ-LC) Circulation Subscale in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Inflammation biomarkers", "description": "Decreases in plasma biomarkers of inflammation in the baricitinib arm compared to placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Viral Reservoirs", "description": "Decreases in viral reservoirs for the baricitinib arm compared to placebo arm from baseline to week 12", "time_frame": "9 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Enrollment", "description": "2 participants per month, on average, are randomized", "time_frame": "6 months" }, { "type": "primary", "measure": "Diversity in enrollment", "description": "40% of participants will be from individuals disproportionally affected by COVID (Black, Hispanic, Asian, American Indian)", "time_frame": "6 months" }, { "type": "primary", "measure": "Study drug prescribed", "description": "80% of participants received every prescribed dose of the study drug", "time_frame": "9 months" }, { "type": "primary", "measure": "Study withdrawals", "description": "Less than 20% participants will be deemed lost to follow up", "time_frame": "18 months" }, { "type": "primary", "measure": "Adverse event reporting", "description": "100% of Serious Adverse Events reported to Data Safety Monitoring Board within 24 hours of study team awareness", "time_frame": "18 months" }, { "type": "primary", "measure": "Study dosing", "description": "100% adherence to study drug dose adjustments guidelines", "time_frame": "9 months" }, { "type": "primary", "measure": "Study completion", "description": "80% of participants adhere to all study procedures and requirements", "time_frame": "18 months" }, { "type": "secondary", "measure": "Severe and Serious Adverse Events", "description": "Compare the percentage of severe and serious adverse events between study arms from baseline to week 12.", "time_frame": "9 months" }, { "type": "secondary", "measure": "Premature study discontinuation", "description": "Compare the rate of study drug/placebo premature discontinuation by study arm (tolerability)", "time_frame": "9 months" }, { "type": "secondary", "measure": "Global Neuropsychological Function", "description": "Assess percentage changes of global neuropsychological function as measured using the CNS Vital Signs Neurocognition Index cognitive battery between baricitinib and placebo study arm from baseline to week 12.", "time_frame": "9 months" }, { "type": "secondary", "measure": "Cardiopulmonary testing", "description": "Assess percentage changes of exercise capacity (peak VO2) using cardiopulmonary exercise testing (CPET) in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Everyday Cognition", "description": "Assess percentage changes of cognitive impairment using Everyday Cognition (ECog) scale in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Functional Status", "description": "Assess percentage changes of functional status measures in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Quality of Life Measures", "description": "Assess percentage changes of quality of life measures in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "Assess percentage changes of post-exertional malaise using De Paul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM) in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Shortness of Breath", "description": "Assess percentage changes of the effect of breathlessness on daily activities using the Modified Medical Research Council Dyspnea Scale (mMRC) in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Symptom Burden", "description": "Assess percentage changes of post COVID-19 symptom burden using the Symptom Burden Questionnaire for Long COVID (SBQ-LC) Circulation Subscale in the baricitinib arm compared to the placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Inflammation biomarkers", "description": "Decreases in plasma biomarkers of inflammation in the baricitinib arm compared to placebo arm from baseline to week 12", "time_frame": "9 months" }, { "type": "secondary", "measure": "Viral Reservoirs", "description": "Decreases in viral reservoirs for the baricitinib arm compared to placebo arm from baseline to week 12", "time_frame": "9 months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 3", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT05858515", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06933173", "title": "RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-09-09", "start_date": "2025-07-10", "completion_date": "2028-03", "primary_completion_date": "2027-12-31", "conditions_raw": [ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Dynamic Neural Retraining System" ], "sponsor": "University of Alberta", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "We are studying the effect of a mind-body treatment for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) with or without Long COVID (LC). Our team recognizes that ME/CFS and Long COVID are serious, debilitating, biomedical conditions.\n\nME/CFS can affect many different parts of the body, such as the nervous system, immune system, and metabolism. It is hypothesized that central sensitization (i.e., when nerves get too excited) may influence these complex conditions and may make symptoms worse.\n\nThis study explores a mind-body program called the Dynamic Neural Retraining System™, or DNRS™.\n\nMind-body interventions (MBIs) focus on how the brain, mind, body, and behaviour interact to improve health and well-being. These techniques help people become more aware of themselves, take better care of their health, and boost mood, quality of life, and coping skills. MBIs use the brain's ability to change (neuroplasticity) by reinforcing certain thoughts, feelings, or behaviours that support changes in biology and function. MBIs may influence physical health by affecting how the brain and body communicate through chemicals such as hormones and neurotransmitters. Objective fMRI evidence shows that practising MBIs can change brain structure and function. This makes MBIs a potential good fit for people with chronic illnesses like ME/CFS and LC, which involve complex interactions between the brain, immune system, and hormones.\n\nThere is no rigorous peer-reviewed evidence that DNRS is effective. Our study will address this question using subjective and objective measurements in a multiple-methods wait-list randomized controlled trial.\n\nThe objectives of this study are to: 1) examine the effectiveness of the DNRS program for individuals diagnosed with ME/CFS with and without Long COVID, compared to a treatment-as-usual wait-list control group on a range of patient-reported outcomes including health-related quality of life, fatigue, pain, anxiety and depression and objective measures including daily steps, heart rate variability, and sleep; 2) quantify metabolic changes through untargeted serum metabolomics profiling, 3) determine if metabolomics screening can predict treatment responsiveness to DNRS; and 4) identify the microbial signatures of large bowel microbiota in Long COVID patients pre and post MBI.\n\nA descriptive qualitative study will also be conducted in a sample of participants to learn more about their experiences during the trial.", "primary_outcomes": [ { "type": "primary", "measure": "Physical functioning", "description": "Physical functioning of health-related quality of life (HRQL) as measured by the Short Form 36-item Health Survey (SF-36) (V1)", "time_frame": "Difference in changes from baseline to post intervention/post waiting (within 4 weeks of completing the DNRS program or waiting period)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Physical functioning", "description": "Physical functioning of health-related quality of life (HRQL) as measured by the Short Form 36-item Health Survey (SF-36) (V1)", "time_frame": "Difference in changes from baseline to post intervention/post waiting (within 4 weeks of completing the DNRS program or waiting period)" } ], "relevance_tags": [ "Metabolic", "Immunomodulatory", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 200, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06933173", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07798570", "title": "Observational Study With CICR-NAM as a Food for Special Medicinal Purposes in Post-COVID Syndrome (PCS)", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-09-01", "start_date": "2026-09-06", "completion_date": "2028-06-30", "primary_completion_date": "2028-06-30", "conditions_raw": [ "Post COVID Syndrome Long Covid" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cicr-Nam" ], "sponsor": "University Hospital Schleswig-Holstein", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In patients with post-COVID syndrome, changes in tryptophan metabolism, energy metabolism, and the gut microbiome may occur. In an earlier nutritional study, patients with COVID-19 recovered their physical performance more quickly when taking nicotinamide (vitamin B3). Patients who responded to nicotinamide also developed post-COVID syndrome less frequently. At the University Hospital Schleswig-Holstein in Kiel, special nicotinamide tablets (CICR-NAM) were developed that release the active substance selectively in the lower intestine and have been shown to be very well tolerated in several studies.\n\nPatients with post-COVID syndrome and documented tryptophan deficiency may therefore take one tablet (500 mg) of CICR-NAM daily for up to approximately 4 months as a food for special medicinal purposes within the therapy groups of the outpatient clinic for patients with post-COVID syndrome at the University Hospital Schleswig-Holstein in Kiel. This intake is far below the Upper Level defined by the European Food Safety Authority for lifelong daily intake (900 mg per day). Therefore, there are no safety concerns. CICR-NAM intake is intended to complement the therapy group programme by supporting energy metabolism.", "primary_outcomes": [ { "type": "primary", "measure": "Serum tryptophan level", "description": "Serum tryptophan level (µmol/L) as a longitudinal marker of tryptophan and NAD+ metabolism during CICR-NAM supplementation. Assessment time points: therapy group session 1 (start of participation, screening for reduced serum tryptophan, T1), session 2 (start of supplementation, T2), session 3 (after approximately 1 month of supplementation, T3), and session 6 (end of the therapy group, after approximately 4 months, T4). Method: quantitative determination of serum tryptophan (UKSH laboratory diagnostics)", "time_frame": "From T1 (start of participation, screening for reduced serum tryptophan) to T6 (end of the therapy group) approximately 5 month." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Serum tryptophan level", "description": "Serum tryptophan level (µmol/L) as a longitudinal marker of tryptophan and NAD+ metabolism during CICR-NAM supplementation. Assessment time points: therapy group session 1 (start of participation, screening for reduced serum tryptophan, T1), session 2 (start of supplementation, T2), session 3 (after approximately 1 month of supplementation, T3), and session 6 (end of the therapy group, after approximately 4 months, T4). Method: quantitative determination of serum tryptophan (UKSH laboratory diagnostics)", "time_frame": "From T1 (start of participation, screening for reduced serum tryptophan) to T6 (end of the therapy group) approximately 5 month." } ], "relevance_tags": [ "Metabolic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07798570", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06517706", "title": "Brain Research and Integrative Neuroscience Network for COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-09-01", "start_date": "2024-11-15", "completion_date": "2026-06-30", "primary_completion_date": "2026-06-30", "conditions_raw": [ "Cognitive Training", "Transcranial Direct Current Stimulation" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Combination Of Tdcs", "Categorization Program" ], "sponsor": "University of Cyprus", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of the experimental study is to investigate two interventions for the management of cognitive symptoms resulting from long COVID. Participants will be randomly assigned into two interventions. 1. Categorization Program (CP) training with active tDCS or 2. Categorization Program training with sham tDCS.", "primary_outcomes": [ { "type": "primary", "measure": "Categorization Program Test 1", "description": "Semantic knowledge and classification behavior", "time_frame": "Administered pre & post training with the Categorization Program, at 6 weeks" }, { "type": "primary", "measure": "Categorization Program Test 2", "description": "Decision-Making and Rule based learning", "time_frame": "Administered pre & post training with the Categorization Program, at 6 weeks" }, { "type": "primary", "measure": "Probe Tasks", "description": "Decision-Making and Rule based learning", "time_frame": "Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks" }, { "type": "primary", "measure": "WHO BREF Quality of Life", "description": "general quality of life", "time_frame": "before and after training, at 6 weeks" }, { "type": "primary", "measure": "Dysexecutive Questionnaire", "description": "Test of everyday executive functioning behaviors; self and informant reports", "time_frame": "pre and post training, at 6 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Categorization Program Test 1", "description": "Semantic knowledge and classification behavior", "time_frame": "Administered pre & post training with the Categorization Program, at 6 weeks" }, { "type": "primary", "measure": "Categorization Program Test 2", "description": "Decision-Making and Rule based learning", "time_frame": "Administered pre & post training with the Categorization Program, at 6 weeks" }, { "type": "primary", "measure": "Probe Tasks", "description": "Decision-Making and Rule based learning", "time_frame": "Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks" }, { "type": "primary", "measure": "WHO BREF Quality of Life", "description": "general quality of life", "time_frame": "before and after training, at 6 weeks" }, { "type": "primary", "measure": "Dysexecutive Questionnaire", "description": "Test of everyday executive functioning behaviors; self and informant reports", "time_frame": "pre and post training, at 6 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 38, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06517706", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07140094", "title": "Long-Covid-19 Alleviation Through Learning Mindfulness Study", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-08-31", "start_date": "2024-05-21", "completion_date": "2027-11-21", "primary_completion_date": "2027-05-21", "conditions_raw": [ "Long COVID", "Long Covid19", "Post-Acute COVID-19", "Post-Acute COVID-19 Syndrome", "Post-Acute COVID-19 Infection", "COVID Long-Haul" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Structured Mindfulness Intervention" ], "sponsor": "Columbia University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This research is being done to study a mindfulness intervention among people who have symptoms of Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Mindfulness is defined as paying attention to the present moment with non-judgment and acceptance. Here the investigators are studying whether a mindfulness intervention can help reduce stress, reduce Long COVID symptoms, and improve quality of life among people living with Long COVID. The mindfulness intervention is a series of recorded mindfulness sessions, which were created by the study team. People who decide to take part will be randomly assigned to receive the study mindfulness intervention immediately after joining the study or to receive the study mindfulness intervention 8 weeks after joining the study. All participants will continue their usual medical care. Participants will complete online surveys to measure symptoms over time. The study will last 6 months.", "primary_outcomes": [ { "type": "primary", "measure": "Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score", "description": "This is to compare the difference between both groups at Month 2. The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health.", "time_frame": "Month 2" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in PROMIS Global 10 Score", "description": "The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Post-Acute Sequelae of SARS-CoV-2 (PASC) Score", "description": "This study uses the PASC score defined by Thaweethai et al., JAMA, 2023. The PASC score is measured as the sum of the scores for each PASC symptom reported by a participant at the specified timepoint. See: doi:10.1001/jama.2023.8823.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Patient Health Questionnaire 9 (PHQ9) Score", "description": "The PHQ9 is a 9-item questionnaire measuring depression symptoms. The scores range from 0 to 27, with higher scores indicating greater severity.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder 7 (GAD7) Score", "description": "The GAD7 is a 7-item scale that measures anxiety symptoms. The scores range from 0 to 21, with higher scores indicating greater severity.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Impact of Event 6 (IES-6) Scores", "description": "IES-6 is a 6-item scale that measures post traumatic stress disorder (PTSD) symptoms. The scores range from 0 to 18, with higher scores indicating greater severity.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "State Mindfulness Scale for Physical Activity Score", "description": "The State Mindfulness Scale for Physical Activity Score measures mindfulness after physical activity. There are twelve questions, each scored between 0-4. The scores for each question are summed and then divided by 12. A higher score indicates a greater degree of mindfulness.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score", "description": "Mean score difference in health-related quality of life, as measured by PROMIS Global 10 criteria. The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health.", "time_frame": "Months 1 and 6" } ], "outcome_measures": [ { "type": "primary", "measure": "Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score", "description": "This is to compare the difference between both groups at Month 2. The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health.", "time_frame": "Month 2" }, { "type": "secondary", "measure": "Change in PROMIS Global 10 Score", "description": "The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Post-Acute Sequelae of SARS-CoV-2 (PASC) Score", "description": "This study uses the PASC score defined by Thaweethai et al., JAMA, 2023. The PASC score is measured as the sum of the scores for each PASC symptom reported by a participant at the specified timepoint. See: doi:10.1001/jama.2023.8823.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Patient Health Questionnaire 9 (PHQ9) Score", "description": "The PHQ9 is a 9-item questionnaire measuring depression symptoms. The scores range from 0 to 27, with higher scores indicating greater severity.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder 7 (GAD7) Score", "description": "The GAD7 is a 7-item scale that measures anxiety symptoms. The scores range from 0 to 21, with higher scores indicating greater severity.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Impact of Event 6 (IES-6) Scores", "description": "IES-6 is a 6-item scale that measures post traumatic stress disorder (PTSD) symptoms. The scores range from 0 to 18, with higher scores indicating greater severity.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "State Mindfulness Scale for Physical Activity Score", "description": "The State Mindfulness Scale for Physical Activity Score measures mindfulness after physical activity. There are twelve questions, each scored between 0-4. The scores for each question are summed and then divided by 12. A higher score indicates a greater degree of mindfulness.", "time_frame": "Months 1, 2, 6" }, { "type": "secondary", "measure": "Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score", "description": "Mean score difference in health-related quality of life, as measured by PROMIS Global 10 criteria. The PROMIS Global 10 is a health-related quality of life measure. Raw scores range from 4 to 20. A higher score indicates better health.", "time_frame": "Months 1 and 6" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 400, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT07140094", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05618574", "title": "Nitrite Supplementation in Long COVID Patients", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-08-26", "start_date": "2023-12-01", "completion_date": "2025-02-14", "primary_completion_date": "2025-02-12", "conditions_raw": [ "Long COVID", "Cardiorespiratory Fitness" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "140 Ml Per Day Of Beet-It Nitrate Beverage" ], "sponsor": "VA Office of Research and Development", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "Potential benefits of a nitrate-rich juice supplement to improve skeletal muscle function and associated physical capacity will be studied in patients with Long COVID. Consenting patients with Long-COVID will be randomized to receive Beet-It nitrate beverage group versus a nitrate-depleted placebo beverage. Both groups will receive physical therapy at the long COVID Clinic at VAPHS with therapeutic goals to improve strength, balance, inspiratory, and aerobic capabilities. Physical therapy will last for 2 weeks and include 2 or 3 sessions with a physical therapist a week depending on each individual's exercise tolerance. These sessions can take place on-site or at home (or a hybrid combination) All participants will undergo functional assessments and tissue assessments before and after the 14-day study intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigability", "description": "Rating of Rate of Perceived Exertion (RPE) during the 5th minute of a 5-min of a 1.5 mile per hour steady-state treadmill walking test is used as an assessment of fatigability. RPE scale is from 6 (no physical exertion) - 20 (maximal exertion/very hard). This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "primary", "measure": "Walking Efficiency", "description": "Walking efficiency (VO2/kg) is assessed by incorporating VO2 assessments during the 5-min steady-state walking protocol. This is assessed using cardiopulmonary exercise testing (CPET) equipment. A lower VO2 for the same functional workload indicates improved efficiency. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "400m Corridor Walk Test (400MCW)", "description": "This test measures the amount of time it takes the participant to walk a 400-meter course to assess cardiovascular and pulmonary fitness or to predict adverse outcomes such as mobility disability. his is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Short Performance Physical Battery (SPPB)", "description": "The SPPB is a test of balance, gait, strength, and endurance that combines gait speed, chair stand and balance tests. SPPB scaled score ranges from 0 - 12. Scores of 0 indicate that the participant is unable/barely able to perform the tasks, while 12 indicates they completed all tasks optimally. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Peak Oxygen Utilization (VO2) Non-normalized", "description": "Peak VO2 (ml/min) non-normalized to weight will be collected using symptom-limited cardiopulmonary exercise testing (CPET). This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Peak Oxygen Utilization (VO2) Normalized to Weight", "description": "Peak VO2 will be collected using symptom-limited cardiopulmonary exercise testing (CPET). The average sedentary male will achieve a peak VO2 of approximately 35 to 40 mL/kg/min. The average sedentary female will score a VO2 max of between 27 and 30 mL/kg/min. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "VO2 at Anaerobic Threshold (AT) Non-normalized", "description": "VO2 (ml/min) non-normalized at AT will be assessed using symptom-limited CPET. The VO2 at AT for the general population occurs at approximately 50-60% of the peak VO2. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "VO2 at Anaerobic Threshold (AT) Normalized to Weight", "description": "VO2 (ml/kg/min) at AT will be assessed using symptom-limited CPET. The VO2 at AT for the general population occurs at approximately 50-60% of the peak VO2. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Mitochondrial Respiration", "description": "To determine the impact of nitrite-rich juice supplementation on skeletal muscle mitochondrial respiration on patients with Long COVID, muscle biopsy of the vastus lateralis will be completed at baseline and following 2 weeks of supplementation. At each time point muscle respiratory capacity will be measured using the Oroboros-2k system. The main outcome will be change in state 3 respiration (maxOXPHOS, pmol/mg/min wet.wt.). Data will be reported as Mean +/- standard deviation.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Serum Nitrate", "description": "5 ml of blood will be collected from participants and spun down using a centrifuge to separate the plasma from the rest of the blood. Serological sampling is completed at baseline and at final visit. Serum nitrite (µmol/L) and nitrate levels (µmol/L) will be measured at baseline and after the study intervention to evaluate the successful metabolism of nitrate (in beetroot juice) to nitrite.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Serum Nitrite", "description": "5 ml of blood will be collected from participants and spun down using a centrifuge to separate the plasma from the rest of the blood. Serological sampling is completed at baseline and at final visit. Serum nitrite (µmol/L) and nitrate levels (µmol/L) will be measured at baseline and after the study intervention to evaluate the successful metabolism of nitrate (in beetroot juice) to nitrite.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Veterans RAND-12 (VR-12)", "description": "The Veterans RAND-12 (VR-12) is a brief self-administered health survey comprised of 12 items used to measure health related quality of life, estimate disease burden, and evaluate disease-specific benchmarks using two score components: Physical Component Score (PCS) and Mental Component Score (MCS). Summary scores are standardized using a t-score transformation (normalized to US population with mean of 50 and standard deviation of 10). A higher PCS represents better self-reported overall physical function; a higher MCS represents better emotional well-being and fewer mental health limitations.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigability", "description": "Rating of Rate of Perceived Exertion (RPE) during the 5th minute of a 5-min of a 1.5 mile per hour steady-state treadmill walking test is used as an assessment of fatigability. RPE scale is from 6 (no physical exertion) - 20 (maximal exertion/very hard). This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "primary", "measure": "Walking Efficiency", "description": "Walking efficiency (VO2/kg) is assessed by incorporating VO2 assessments during the 5-min steady-state walking protocol. This is assessed using cardiopulmonary exercise testing (CPET) equipment. A lower VO2 for the same functional workload indicates improved efficiency. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "400m Corridor Walk Test (400MCW)", "description": "This test measures the amount of time it takes the participant to walk a 400-meter course to assess cardiovascular and pulmonary fitness or to predict adverse outcomes such as mobility disability. his is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Short Performance Physical Battery (SPPB)", "description": "The SPPB is a test of balance, gait, strength, and endurance that combines gait speed, chair stand and balance tests. SPPB scaled score ranges from 0 - 12. Scores of 0 indicate that the participant is unable/barely able to perform the tasks, while 12 indicates they completed all tasks optimally. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Peak Oxygen Utilization (VO2) Non-normalized", "description": "Peak VO2 (ml/min) non-normalized to weight will be collected using symptom-limited cardiopulmonary exercise testing (CPET). This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Peak Oxygen Utilization (VO2) Normalized to Weight", "description": "Peak VO2 will be collected using symptom-limited cardiopulmonary exercise testing (CPET). The average sedentary male will achieve a peak VO2 of approximately 35 to 40 mL/kg/min. The average sedentary female will score a VO2 max of between 27 and 30 mL/kg/min. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "VO2 at Anaerobic Threshold (AT) Non-normalized", "description": "VO2 (ml/min) non-normalized at AT will be assessed using symptom-limited CPET. The VO2 at AT for the general population occurs at approximately 50-60% of the peak VO2. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "VO2 at Anaerobic Threshold (AT) Normalized to Weight", "description": "VO2 (ml/kg/min) at AT will be assessed using symptom-limited CPET. The VO2 at AT for the general population occurs at approximately 50-60% of the peak VO2. This is assessed before and after approx. 14 days of supplementation with Beet-It nitrate beverage vs. placebo. The mean change from baseline to follow-up is used as the outcome measure.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Mitochondrial Respiration", "description": "To determine the impact of nitrite-rich juice supplementation on skeletal muscle mitochondrial respiration on patients with Long COVID, muscle biopsy of the vastus lateralis will be completed at baseline and following 2 weeks of supplementation. At each time point muscle respiratory capacity will be measured using the Oroboros-2k system. The main outcome will be change in state 3 respiration (maxOXPHOS, pmol/mg/min wet.wt.). Data will be reported as Mean +/- standard deviation.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Serum Nitrate", "description": "5 ml of blood will be collected from participants and spun down using a centrifuge to separate the plasma from the rest of the blood. Serological sampling is completed at baseline and at final visit. Serum nitrite (µmol/L) and nitrate levels (µmol/L) will be measured at baseline and after the study intervention to evaluate the successful metabolism of nitrate (in beetroot juice) to nitrite.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Serum Nitrite", "description": "5 ml of blood will be collected from participants and spun down using a centrifuge to separate the plasma from the rest of the blood. Serological sampling is completed at baseline and at final visit. Serum nitrite (µmol/L) and nitrate levels (µmol/L) will be measured at baseline and after the study intervention to evaluate the successful metabolism of nitrate (in beetroot juice) to nitrite.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" }, { "type": "secondary", "measure": "Veterans RAND-12 (VR-12)", "description": "The Veterans RAND-12 (VR-12) is a brief self-administered health survey comprised of 12 items used to measure health related quality of life, estimate disease burden, and evaluate disease-specific benchmarks using two score components: Physical Component Score (PCS) and Mental Component Score (MCS). Summary scores are standardized using a t-score transformation (normalized to US population with mean of 50 and standard deviation of 10). A higher PCS represents better self-reported overall physical function; a higher MCS represents better emotional well-being and fewer mental health limitations.", "time_frame": "Baseline (pre-intervention) to Follow-up (post-intervention); approx. 2 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Fed" ], "enrollment": 17, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05618574", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05350774", "title": "Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2", "status": "ENROLLING_BY_INVITATION", "phase": "PHASE2", "last_updated": "2026-08-26", "start_date": "2023-07-10", "completion_date": "2026-12-15", "primary_completion_date": "2026-12-15", "conditions_raw": [ "Systemic Inflammation", "Neuroinflammation", "Microvascular Thrombosis" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Iv Normal Saline", "Iv Immunoglobulin" ], "sponsor": "National Institute of Neurological Disorders and Stroke (NINDS)", "sponsor_type": "NIH", "primary_purpose": "N/A", "brief_summary": "Background:\n\nCOVID-19 can cause problems in different parts of the body. For most people, it causes fevers or trouble breathing. Some people might not recover all the way. Researchers want to see if a treatment can help with people who have recovered from COVID-19 but still have symptoms (\"Long COVID\").\n\nObjective:\n\nTo learn if human immunoglobulin (IVIG) will help with neurological symptoms of Long COVID.\n\nEligibility:\n\nAdults ages 18 and older who had COVID-19 at least 12 weeks ago and have ongoing neurologic symptoms, such as dizziness, trouble walking, or problems with strength.\n\nDesign:\n\nParticipants will be screened with a medical record review.\n\nParticipants will have a medical history and a physical exam and complete questionnaires about their health and quality of life. They will have a spinal tap. They will give blood samples. They will discuss their symptoms with a neurologist and have a neurological exam.\n\nParticipants will take memory and thinking tests using a tablet. The tests will take 1 hour to complete. They will also take a smell and taste test. It will take approximately 30 minutes to complete.\n\nParticipants will lie on a table that tilts for up to 40 minutes. Their blood pressure and heart rate will be monitored. Blood will be taken through an intravenous (IV) catheter.\n\nParticipants will receive either IVIG, or saline by IV for 5 days. Then the participants will receive IVIG if they first received saline or saline if they first received IVIG by IV for another 5 days. They will not know what they receive.\n\nParticipants will have an MRI of the brain if they have not had one recently. They will receive a contrast agent by IV as part of the MRI scan.\n\nParticipants will be on the study for up to 4 months. They will have follow-up visits at the clinical center as well as fill out questionnaires at home. They may be asked to continue follow-up.", "primary_outcomes": [ { "type": "primary", "measure": "Effects of intravenous immunoglobulin therapy", "description": "Comparison of proportion of participants with a clinically meaningful change in Health Utilities Index Mark 3 (HUI3) after receiving either IVIg or placebo at Week 2.", "time_frame": "2 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Investigate laboratory effects", "description": "Comparison of change in functional / patient-reported scales at 2 weeks after receiving each study intervention:a.\\WHO post-COVID functional scale b.\\PCFSc.\\COVID-19 Yorkshire Rehabilitation Scaled.\\PROMIS GHe.\\PROMIS Depression f.\\PROMIS Anxiety Comparison of change in clinical scales 2 weeks after receiving each study intervention:g.\\Montreal Cognitive Assessment (MoCA)h.\\Brief tablet-based Neuropsychiatric evaluation i.\\Karnofsky Performance Status (KPS)", "time_frame": "2 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Effects of intravenous immunoglobulin therapy", "description": "Comparison of proportion of participants with a clinically meaningful change in Health Utilities Index Mark 3 (HUI3) after receiving either IVIg or placebo at Week 2.", "time_frame": "2 weeks" }, { "type": "secondary", "measure": "Investigate laboratory effects", "description": "Comparison of change in functional / patient-reported scales at 2 weeks after receiving each study intervention:a.\\WHO post-COVID functional scale b.\\PCFSc.\\COVID-19 Yorkshire Rehabilitation Scaled.\\PROMIS GHe.\\PROMIS Depression f.\\PROMIS Anxiety Comparison of change in clinical scales 2 weeks after receiving each study intervention:g.\\Montreal Cognitive Assessment (MoCA)h.\\Brief tablet-based Neuropsychiatric evaluation i.\\Karnofsky Performance Status (KPS)", "time_frame": "2 weeks" } ], "relevance_tags": [ "Immunomodulatory", "Anti-inflammatory", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Nih" ], "enrollment": 45, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05350774", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05703074", "title": "Mental Intervention and Nicotinamide Riboside Supplementation in Long Covid", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-08-25", "start_date": "2023-01-30", "completion_date": "2025-06-23", "primary_completion_date": "2024-09-23", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Nicotinamide Riboside", "Mind-Body Reprocessing Therapy", "Care As Usual" ], "sponsor": "University Hospital, Akershus", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID, also referred to as post-acute sequela of COVID-19 (PASC), is present in a substantial number of individuals, and treatment for this is warranted. Two different hypothetical models of Long COVID suggest attenuated mitochondrial energy production and functional brain alterations associated with psychosocial load, respectively, to be key mechanisms in the underlying pathophysiology. Given the potential importance of metabolic disturbances, dietary supplement by Nicotinamide Riboside (NR, sales name Niagen®) may be beneficial. Given the potential importance of functional brain alterations, a tailored and personalized Mind-Body Reprocessing Therapy (MBRT) may be beneficial. The MBRT consists of 4 to 6 face-to-face therapist encounters in combination with digital resources.\n\nThe primary objective is to determine whether NR 1000 mg twice daily and/or MBRT increase health-related quality of life in individuals with Long COVID compared with care as usual and/or placebo. The Medical Outcome Study 36-item short form (SF-36), general health subscore is the primary endpoint. Secondary endpoints are: Markers of inflammation (hsCRP) and cognitive function (trail making test), cost-effectiveness, and the patient-reported symptoms fatigue, dyspnoea, and global impression of change in symptoms, function and quality of life. Explorative objectives encompass intervention effects on additional cognitive function markers, biological markers (indices of inflammation and autonomic nervous activity), disability markers (work attendance) and patient symptoms, as well as the exploration of long-term effects, differential subgroup effects, intervention effect mediators and intervention effect predictors.\n\nThe study is a randomized controlled trial featuring a 2 x 2 factorial design where MBRT is compared with usual care and NR is compared with placebo. The latter comparison is double blinded. Eligible participants are individuals (18-70 years) with confirmed Long COVID interferring negatively with daily activities. A total of 310 participants will be enrolled. After baseline assessment (T1), the participants will be randomized 1:1 for both treatment comparisons, resulting in four treatment groups: a) MBRT and NR; b) usual care and NR; c) MBRT and placebo; d) usual care and placebo. All treatment periods last for three months, followed by primary endpoint assessment (T2). Total follow-up time is 12 months (T3). A comprehensive investigational program at all time points includes clinical examination, functional testing (spirometry, autonomic cardiovascular control, neurocognitive functions), sampling of biological specimens (blood) and questionnaire charting (background/demographics, clinical symptoms, psychosocial factors, study events).", "primary_outcomes": [ { "type": "primary", "measure": "Health-related quality of life", "description": "The Medical Outcome Study 36-item short form (SF-36), general health subscore (total range 0 - 100, where higher scores indicate better QoL)", "time_frame": "Three months after inclusion (T2)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Inflammation", "description": "Plasma levels of C-reactive protein, high-sensitive assay (hsCRP). Higher levels indicate more inflammation", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Executive functioning", "description": "The Trail Making test, part B, seconds. Longer time indicates poorer executive functioning", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Fatigue", "description": "Chalder Fatigue Questionnaire (CFQ), total sum score (total range is from 0 - 33; higher scores indicate more fatigue)", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Dyspnoea", "description": "Medical Research Council dyspnoea scale. Total range is from 0 - 4, where higher scores indicate more dyspnoea", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Global impression of change", "description": "Patient Global Impression of Change (PGIC) inventory. Total range is from 1 - 7; higher scores imply that the health status is considered worsened", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Cost-effectiveness", "description": "Incremental cost-effectiveness ratio, using the 36-item short form (SF-36) general health subscore to determine quality-adjusted life years.", "time_frame": "Three months after inclusion (T2)" } ], "outcome_measures": [ { "type": "primary", "measure": "Health-related quality of life", "description": "The Medical Outcome Study 36-item short form (SF-36), general health subscore (total range 0 - 100, where higher scores indicate better QoL)", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Inflammation", "description": "Plasma levels of C-reactive protein, high-sensitive assay (hsCRP). Higher levels indicate more inflammation", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Executive functioning", "description": "The Trail Making test, part B, seconds. Longer time indicates poorer executive functioning", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Fatigue", "description": "Chalder Fatigue Questionnaire (CFQ), total sum score (total range is from 0 - 33; higher scores indicate more fatigue)", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Dyspnoea", "description": "Medical Research Council dyspnoea scale. Total range is from 0 - 4, where higher scores indicate more dyspnoea", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Global impression of change", "description": "Patient Global Impression of Change (PGIC) inventory. Total range is from 1 - 7; higher scores imply that the health status is considered worsened", "time_frame": "Three months after inclusion (T2)" }, { "type": "secondary", "measure": "Cost-effectiveness", "description": "Incremental cost-effectiveness ratio, using the 36-item short form (SF-36) general health subscore to determine quality-adjusted life years.", "time_frame": "Three months after inclusion (T2)" } ], "relevance_tags": [ "Metabolic", "Mitochondrial", "Neurological / Autonomic", "Anti-inflammatory", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 310, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05703074", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07726082", "title": "Micro-choice-based Intervention for Multicausal Fatigue", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-08-18", "start_date": "2026-08-13", "completion_date": "2027-08", "primary_completion_date": "2027-08", "conditions_raw": [ "Multicausal Fatigue", "Fatigue", "Post COVID Condition", "Long COVID Syndrome", "Postviral Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Micro-Choice-Based Intervention" ], "sponsor": "University Hospital, Basel, Switzerland", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Retention rate", "description": "defined as the percentage of participants who complete all phases of the study. To assess this, the investigators will evaluate:\n\n* Dropout rates at different phases of the study: preparation, concentrated intervention and follow up\n* Completion rates within each phase to identify potential barriers to adherence and engagement", "time_frame": "up to 6 month" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient satisfaction", "description": "Patient satisfaction will be assessed using the ZUF-8 (Fragebogen zur Messung der Patientenzufriedenheit), the validated German version of the Client Satisfaction Questionnaire (CSQ-8). Items are answered on a 4-point scale. Scores are summed across items once. Some items are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Fatigue", "description": "Fatigue is assessed by the 11-item Chalder Fatigue Scale (46), e.g. by asking \"Do you have difficulty concentrating?\". Items are answered on a 4-point scale ranging from 0 = \"Better than usual\" to 3 = \"much worse than usual\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Somatic Symptom Severity", "description": "The Patient Health Questionnaire (PHQ-15; 34) assesses somatic symptom severity during the past 4 weeks. Patients are asked how impaired they felt by their symptoms, e.g. back pain. Items are answered on a 3-point scale ranging from 0 = \"not bothered at all\" to 2 = \"bothered a lot\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Somatic Distress", "description": "The Somatic Symptom Disorder Questionnaire (SSD-12; 35) assesses psychological features of somatic disorders, e.g. catastrophizing thoughts and health anxiety, e.g. with the statement \"I think that my physical symptoms are signs of a serious illness\". Items are answered on a 5-point scale ranging from 0 = \"never\" to 4 = \"very often\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Depressive Symptoms", "description": "The 8-item Patient Health Questionnaire Depression Scale (PHQ-8; 36) assesses the severity of depressive disorders. Patients are asked if in the past weeks, they were bothered by a problem, e.g. by having little interest or pleasure in doing things. Items are answered on a 4-point scale ranging from 0 = \"not at all\" to 3 = \"nearly every day\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Anxiety Symptoms", "description": "Anxiety is assessed with the Generalized Anxiety Disorder Questionnaire (GAD-7; 44). It assesses if the patient was bothered by complaints related to anxiety during the past 2 weeks, e.g. by asking about having trouble to relax. Items are answered on a 4-point Likert scale ranging from 0 = \"not at all\" to 3 = \"nearly every day\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Functional capacity", "description": "The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assesses and classifies disability due to health problems during the past 4 weeks. This study will utilize the 12-item version. An example item would be \"In the past 4 weeks, how much difficulty did you have in walking a long distance such as a kilometer (or equivalent)?\". Items are answered on a 5-point scale ranging from 0 = \"none\" to 4 = \"extreme or cannot do\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Change in Quality of life", "description": "As a measure of life quality, the EuroHIS Quality-of-Life-8 (QOL-8; 42) will be used. This 8-item instrument assesses quality of life and perceived health during the past 4 weeks, e.g. by asking \"Do you have enough energy for everyday life?\". Items are answered on a 5-point scale, with wording differing between questions (e.g., from \"very dissatisfied\" to \"very satisfied\").", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Work ability", "description": "assessed via questionnaires: at full work, at partial work, not at work.", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Work and Social Adjustment", "description": "Work and Social Adjustment Scale (WSAS;(38) ) assesses functional impairment attributable to a health condition in key areas of daily life, including work, home management, social and private leisure activities, and close relationships. An example item is \"Because of my illness, my ability to work is impaired.\" Items are rated on a 9-point scale ranging from 0 = \"not at all impaired\" to 8 = \"very severely impaired\". Higher total scores indicate greater functional impairment.", "time_frame": "up to 6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Retention rate", "description": "defined as the percentage of participants who complete all phases of the study. To assess this, the investigators will evaluate:\n\n* Dropout rates at different phases of the study: preparation, concentrated intervention and follow up\n* Completion rates within each phase to identify potential barriers to adherence and engagement", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Patient satisfaction", "description": "Patient satisfaction will be assessed using the ZUF-8 (Fragebogen zur Messung der Patientenzufriedenheit), the validated German version of the Client Satisfaction Questionnaire (CSQ-8). Items are answered on a 4-point scale. Scores are summed across items once. Some items are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Fatigue", "description": "Fatigue is assessed by the 11-item Chalder Fatigue Scale (46), e.g. by asking \"Do you have difficulty concentrating?\". Items are answered on a 4-point scale ranging from 0 = \"Better than usual\" to 3 = \"much worse than usual\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Somatic Symptom Severity", "description": "The Patient Health Questionnaire (PHQ-15; 34) assesses somatic symptom severity during the past 4 weeks. Patients are asked how impaired they felt by their symptoms, e.g. back pain. Items are answered on a 3-point scale ranging from 0 = \"not bothered at all\" to 2 = \"bothered a lot\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Somatic Distress", "description": "The Somatic Symptom Disorder Questionnaire (SSD-12; 35) assesses psychological features of somatic disorders, e.g. catastrophizing thoughts and health anxiety, e.g. with the statement \"I think that my physical symptoms are signs of a serious illness\". Items are answered on a 5-point scale ranging from 0 = \"never\" to 4 = \"very often\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Depressive Symptoms", "description": "The 8-item Patient Health Questionnaire Depression Scale (PHQ-8; 36) assesses the severity of depressive disorders. Patients are asked if in the past weeks, they were bothered by a problem, e.g. by having little interest or pleasure in doing things. Items are answered on a 4-point scale ranging from 0 = \"not at all\" to 3 = \"nearly every day\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Anxiety Symptoms", "description": "Anxiety is assessed with the Generalized Anxiety Disorder Questionnaire (GAD-7; 44). It assesses if the patient was bothered by complaints related to anxiety during the past 2 weeks, e.g. by asking about having trouble to relax. Items are answered on a 4-point Likert scale ranging from 0 = \"not at all\" to 3 = \"nearly every day\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Functional capacity", "description": "The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assesses and classifies disability due to health problems during the past 4 weeks. This study will utilize the 12-item version. An example item would be \"In the past 4 weeks, how much difficulty did you have in walking a long distance such as a kilometer (or equivalent)?\". Items are answered on a 5-point scale ranging from 0 = \"none\" to 4 = \"extreme or cannot do\".", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Change in Quality of life", "description": "As a measure of life quality, the EuroHIS Quality-of-Life-8 (QOL-8; 42) will be used. This 8-item instrument assesses quality of life and perceived health during the past 4 weeks, e.g. by asking \"Do you have enough energy for everyday life?\". Items are answered on a 5-point scale, with wording differing between questions (e.g., from \"very dissatisfied\" to \"very satisfied\").", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Work ability", "description": "assessed via questionnaires: at full work, at partial work, not at work.", "time_frame": "up to 6 month" }, { "type": "secondary", "measure": "Work and Social Adjustment", "description": "Work and Social Adjustment Scale (WSAS;(38) ) assesses functional impairment attributable to a health condition in key areas of daily life, including work, home management, social and private leisure activities, and close relationships. An example item is \"Because of my illness, my ability to work is impaired.\" Items are rated on a 9-point scale ranging from 0 = \"not at all impaired\" to 8 = \"very severely impaired\". Higher total scores indicate greater functional impairment.", "time_frame": "up to 6 months" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 24, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07726082", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05747534", "title": "AT1001 for the Treatment of Long COVID", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-08-18", "start_date": "2023-05-31", "completion_date": "2026-06-18", "primary_completion_date": "2026-06-18", "conditions_raw": [ "Long COVID", "Long COVID-19", "Post Acute COVID-19 Syndrome", "Post Acute Sequelae of COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Larazotide Acetate" ], "sponsor": "Massachusetts General Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and adults 7 to ≤50 years of age who present with symptoms of Long COVID in the presence of SARS-CoV-2 antigenemia. AT1001 (n=100) or placebo (n=50) will be administered orally four times a day (QID) for 21 days.", "primary_outcomes": [ { "type": "primary", "measure": "Adverse Event Profiling and Time to Symptom Resolution", "description": "The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and young adults 7 to ≤50 years of age who present with symptoms of Long COVID. Safety will be assessed by means of adverse event monitoring, and efficacy will be evaluated using the Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) survey. Additional surveys will be used to monitor symptoms, quality of life and limitation of activities before, during and after treatment with Larazotide or Placebo.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Cytokine profiling, Antigen Testing and Humoral and Cellular Responses", "description": "The secondary objective of this study is to characterize the inflammatory response observed in children and young adults 7 to ≤21 years of age with Long COVID and SARS-CoV-2 antigenemia. To assess inflammatory responses, blood, stool and nasal epithelial specimens will be obtained at baseline prior to treatment with Larazotide or Placebo, and at completion of the study's treatment phase (21 days). Inflammatory responses will be evaluated by means of antigen testing, cytokine profiling, among others.", "time_frame": "21 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Adverse Event Profiling and Time to Symptom Resolution", "description": "The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and young adults 7 to ≤50 years of age who present with symptoms of Long COVID. Safety will be assessed by means of adverse event monitoring, and efficacy will be evaluated using the Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) survey. Additional surveys will be used to monitor symptoms, quality of life and limitation of activities before, during and after treatment with Larazotide or Placebo.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Cytokine profiling, Antigen Testing and Humoral and Cellular Responses", "description": "The secondary objective of this study is to characterize the inflammatory response observed in children and young adults 7 to ≤21 years of age with Long COVID and SARS-CoV-2 antigenemia. To assess inflammatory responses, blood, stool and nasal epithelial specimens will be obtained at baseline prior to treatment with Larazotide or Placebo, and at completion of the study's treatment phase (21 days). Inflammatory responses will be evaluated by means of antigen testing, cytokine profiling, among others.", "time_frame": "21 days" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 107, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05747534", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05705193", "title": "Brain-Training Treatment for Long COVID in Older Adults", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-08-14", "start_date": "2023-04-07", "completion_date": "2025-12-13", "primary_completion_date": "2025-12-13", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Neuroflex" ], "sponsor": "UConn Health", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This research is being done to collect preliminary data on the potential of computerized \"brain-training\" exercises for treating Long COVID symptoms in older adults. The investigators hypothesize that computerized brain-training will be an acceptable and feasible intervention for treating Long COVID symptoms in older adults. The investigators also expect to provide initial evidence that computerized brain-training has potential for improving thinking, mood, and other aspects of everyday functioning in older adults with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Treatment Acceptability/Adherence Scale (TAAS)", "description": "Treatment acceptability and adherence as measured by the TAAS Total Score; higher scores on this self-report measure indicate greater treatment acceptability and adherence", "time_frame": "The investigators will evaluate TAAS Total Score at the outset of treatment (expected/anticipated acceptability and adherence) and at post-treatment (6 weeks)" }, { "type": "primary", "measure": "Credibility/Expectancy Questionnaire (CEQ)", "description": "Treatment credibility and expectancy as measured by the CEQ Total Score; higher scores on this self-report measure indicate greater treatment credibility and expectancy", "time_frame": "The investigators will evaluate CEQ Total Score at the outset of treatment (to assess initial perceptions of treatment credibility) and at post-treatment (6 weeks)" }, { "type": "primary", "measure": "System Usability Scale (SUS)", "description": "Usability of the intervention as measured by the SUS Total Score; higher scores on this self-report measure indicate greater perceived usability", "time_frame": "The investigators will evaluate SUS Total Score at the outset of treatment (to assess initial perceptions of treatment usability) and at post-treatment (6 weeks)" }, { "type": "primary", "measure": "Feasibility (proportion of subjects who agree to participate in the offered treatment, complete assigned exercises, and complete the entire treatment regimen)", "description": "Feasibility will be assessed according to the following criteria: 1) at least 80% of eligible subjects offered the treatment agree to participate; 2) subjects will complete at least 80% of assigned treatment exercises; 3) at least 80% of participants who start the treatment will finish it.", "time_frame": "Our feasibility criteria will be assessed by calculating percentages at the conclusion of the study" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Trail Making Test Part B", "description": "Set-shifting abilities as measured by time to complete the Trail Making Test Part B in seconds; lower scores indicate better set-shifting performance", "time_frame": "The investigators will evaluate change in time (seconds) to complete the Trail Making Test Part B at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Montgomery-Asberg Depression Scale (MADRS)", "description": "Depressive symptoms as measured by the Total MADRS Score; lower scores indicate less depressive symptoms", "time_frame": "The investigators will evaluate change in Total MADRS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "World Health Organization Disability Assessment Schedule (WHODAS)", "description": "Functional disability as measured by the Total WHODAS Score; lower scores indicate less functional disability", "time_frame": "The investigators will evaluate change in Total WHODAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Everyday Cognition (ECog)", "description": "Subjective cognitive concerns as measured by the Total ECog Score; lower scores indicate less subjective cognitive concern", "time_frame": "The investigators will evaluate change in Total ECog Score at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Verbal Fluency", "description": "Verbal generativity as measured by the total number of words produced according to pre-specified rules; higher scores indicate better verbal generativity performance", "time_frame": "The investigators will evaluate change in total number of words produced at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Stroop Color and Word Test", "description": "Inhibitory control as measured by total correct responses on the inhibition condition of the Stroop Test; higher scores indicate better inhibitory control performance", "time_frame": "The investigators will evaluate change in total correct responses at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Fatigue Assessment Scale (FAS)", "description": "Fatigue as measured by the Total FAS Score; lower scores indicate less fatigue", "time_frame": "The investigators will evaluate change in total FAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "California Verbal Learning Test (CVLT)", "description": "Verbal memory as measured by the total number of words correctly recalled on the long delayed free recall trial; higher scores indicate better episodic memory performance", "time_frame": "The investigators will evaluate change in long delayed free recall at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Short Physical Performance Battery (SPPB)", "description": "Physical performance as measured by the Total SPPB Score; higher scores indicate better physical performance.", "time_frame": "The investigators will evaluate change in physical performance at post-treatment (6 weeks) relative to pre-treatment (baseline)" } ], "outcome_measures": [ { "type": "primary", "measure": "Treatment Acceptability/Adherence Scale (TAAS)", "description": "Treatment acceptability and adherence as measured by the TAAS Total Score; higher scores on this self-report measure indicate greater treatment acceptability and adherence", "time_frame": "The investigators will evaluate TAAS Total Score at the outset of treatment (expected/anticipated acceptability and adherence) and at post-treatment (6 weeks)" }, { "type": "primary", "measure": "Credibility/Expectancy Questionnaire (CEQ)", "description": "Treatment credibility and expectancy as measured by the CEQ Total Score; higher scores on this self-report measure indicate greater treatment credibility and expectancy", "time_frame": "The investigators will evaluate CEQ Total Score at the outset of treatment (to assess initial perceptions of treatment credibility) and at post-treatment (6 weeks)" }, { "type": "primary", "measure": "System Usability Scale (SUS)", "description": "Usability of the intervention as measured by the SUS Total Score; higher scores on this self-report measure indicate greater perceived usability", "time_frame": "The investigators will evaluate SUS Total Score at the outset of treatment (to assess initial perceptions of treatment usability) and at post-treatment (6 weeks)" }, { "type": "primary", "measure": "Feasibility (proportion of subjects who agree to participate in the offered treatment, complete assigned exercises, and complete the entire treatment regimen)", "description": "Feasibility will be assessed according to the following criteria: 1) at least 80% of eligible subjects offered the treatment agree to participate; 2) subjects will complete at least 80% of assigned treatment exercises; 3) at least 80% of participants who start the treatment will finish it.", "time_frame": "Our feasibility criteria will be assessed by calculating percentages at the conclusion of the study" }, { "type": "secondary", "measure": "Trail Making Test Part B", "description": "Set-shifting abilities as measured by time to complete the Trail Making Test Part B in seconds; lower scores indicate better set-shifting performance", "time_frame": "The investigators will evaluate change in time (seconds) to complete the Trail Making Test Part B at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Montgomery-Asberg Depression Scale (MADRS)", "description": "Depressive symptoms as measured by the Total MADRS Score; lower scores indicate less depressive symptoms", "time_frame": "The investigators will evaluate change in Total MADRS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "World Health Organization Disability Assessment Schedule (WHODAS)", "description": "Functional disability as measured by the Total WHODAS Score; lower scores indicate less functional disability", "time_frame": "The investigators will evaluate change in Total WHODAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Everyday Cognition (ECog)", "description": "Subjective cognitive concerns as measured by the Total ECog Score; lower scores indicate less subjective cognitive concern", "time_frame": "The investigators will evaluate change in Total ECog Score at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Verbal Fluency", "description": "Verbal generativity as measured by the total number of words produced according to pre-specified rules; higher scores indicate better verbal generativity performance", "time_frame": "The investigators will evaluate change in total number of words produced at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Stroop Color and Word Test", "description": "Inhibitory control as measured by total correct responses on the inhibition condition of the Stroop Test; higher scores indicate better inhibitory control performance", "time_frame": "The investigators will evaluate change in total correct responses at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Fatigue Assessment Scale (FAS)", "description": "Fatigue as measured by the Total FAS Score; lower scores indicate less fatigue", "time_frame": "The investigators will evaluate change in total FAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "California Verbal Learning Test (CVLT)", "description": "Verbal memory as measured by the total number of words correctly recalled on the long delayed free recall trial; higher scores indicate better episodic memory performance", "time_frame": "The investigators will evaluate change in long delayed free recall at post-treatment (6 weeks) relative to pre-treatment (baseline)" }, { "type": "secondary", "measure": "Short Physical Performance Battery (SPPB)", "description": "Physical performance as measured by the Total SPPB Score; higher scores indicate better physical performance.", "time_frame": "The investigators will evaluate change in physical performance at post-treatment (6 weeks) relative to pre-treatment (baseline)" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 39, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05705193", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07682402", "title": "Taurine Supplementation in Adolescents With Post-COVID Condition", "status": "NOT_YET_RECRUITING", "phase": "PHASE1", "last_updated": "2026-08-13", "start_date": "2026-09-30", "completion_date": "2028-12-31", "primary_completion_date": "2028-03-31", "conditions_raw": [ "Long COVID", "Post COVID-19 Condition", "PASC Post Acute Sequelae of COVID 19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Taurine" ], "sponsor": "University of Alberta", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The COVID-19 pandemic has swept across the globe, affecting millions of individuals with varying degrees of severity. While many individuals recover from the acute phase of the infection, a significant proportion continue to experience persistent and debilitating symptoms long after the initial SARS-CoV-2 infection. This condition, known as Long COVID (LC) or sometimes referred to as Post-COVID Condition (PCC) or post-acute sequelae of COVID-19 (PASC), has emerged as a complex multisystemic condition and challenging public health issue.\n\nContrary to initial perceptions, pediatric Long COVID is a significant health concern, with studies suggesting its prevalence ranges from 10% to 25% following infection. Research in the pediatric population has largely been limited to observational studies based on self-reported symptoms or large electronic healthcare datasets. The long-term outcomes and predictors of LC in children remain poorly described, highlighting an urgent need for further mechanistic research to characterize this complex condition. While acute COVID-19 symptoms are often milder in children relative to adults, some go on to develop a range of chronic physical, immunological, psychological, and neurological symptoms persisting for weeks to years after initial infection. The most commonly reported symptoms are similar to those seen in adults and include debilitating fatigue, respiratory distress, headaches, gastrointestinal symptoms, and neurocognitive impairment. Other frequently reported symptoms include muscle pain, sleep disturbances, olfactory and gustatory disturbances, exercise intolerance, and heart palpitations/cardiovascular symptoms. These symptoms can be new, or they may persist or fluctuate from the initial illness. Additionally, many children with LC experience psychological symptoms such as anxiety, depression, and mood disturbances, which are thought to be exacerbated by experiencing prolonged illness and subsequent lifestyle disruptions.\n\nCurrently, effective treatments for LC remain elusive, leaving patients to contend with persistent symptoms that significantly impair their quality of life. For children and adolescents, these issues can profoundly impact their daily activities, academic performance, and social interactions/friendships. Symptoms like debilitating fatigue, cognitive impairment, and mood disturbances are especially disruptive by interfering with memory, energy levels, and overall development, often leading to school absenteeism, social withdrawal, and psychological distress. Therefore, it is imperative to explore novel therapeutic approaches that may alleviate the suffering of this patient population.", "primary_outcomes": [ { "type": "primary", "measure": "Mean Change in Plasma Taurine Levels from Baseline to Three Months", "description": "This study will measure the plasma taurine levels at baseline and following three months of taurine supplementation.", "time_frame": "Three months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue", "description": "This study will target detection of a change in the PROMIS Pediatric Fatigue Short Form from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Cognitive Function", "description": "This study will target detection of a change in the PROMIS Pediatric Cognitive Function Short Form from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Cardiovascular", "description": "This study will target detection of a change in heart rate and heart rate variability from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Core Outcome Symptoms", "description": "Tracking of symptom trajectory from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Health Related Quality of Life", "description": "Measurement of change in quality of life using the EQ-5D-Y-3L assessment tool.", "time_frame": "Three months" } ], "outcome_measures": [ { "type": "primary", "measure": "Mean Change in Plasma Taurine Levels from Baseline to Three Months", "description": "This study will measure the plasma taurine levels at baseline and following three months of taurine supplementation.", "time_frame": "Three months" }, { "type": "secondary", "measure": "Fatigue", "description": "This study will target detection of a change in the PROMIS Pediatric Fatigue Short Form from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Cognitive Function", "description": "This study will target detection of a change in the PROMIS Pediatric Cognitive Function Short Form from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Cardiovascular", "description": "This study will target detection of a change in heart rate and heart rate variability from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Core Outcome Symptoms", "description": "Tracking of symptom trajectory from baseline to three months", "time_frame": "Three months" }, { "type": "secondary", "measure": "Health Related Quality of Life", "description": "Measurement of change in quality of life using the EQ-5D-Y-3L assessment tool.", "time_frame": "Three months" } ], "relevance_tags": [ "Metabolic", "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07682402", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05530317", "title": "CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19", "status": "TERMINATED", "phase": "NA", "last_updated": "2026-08-13", "start_date": "2022-12-21", "completion_date": "2026-07-31", "primary_completion_date": "2026-07-31", "conditions_raw": [ "Long COVID", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cardiac Rehabilitation" ], "sponsor": "University of California, San Francisco", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this proof-of-concept clinical trial is to determine whether cardiac rehabilitation improves exercise capacity and chronotropic (heart rate) response to exercise among people with Long COVID. The study will include individuals with confirmed SARS-CoV-2 infection, symptoms not present prior to COVID-19 that are persistent for at least 3 months after acute infection (\"Long COVID\"), and who have reduced exercise capacity less than predicted and reduced heart rate response during cardiopulmonary exercise testing (CPET). In addition to the primary outcome of change in peak VO2, secondary outcomes will include change in symptoms including autonomic symptoms (COMPASS-31), anxiety (GAD-7), depression (PHQ-9), endothelial function with brachial artery flow-mediated dilation, and satisfaction (net-promotor score).", "primary_outcomes": [ { "type": "primary", "measure": "Change in adjusted heart rate reserve", "description": "Adjusted heart rate reserve (peak HR-rest HR)/(220-age-rest HR) achieved during symptom-limited maximal cardiopulmonary testing performed with cycle ergometer", "time_frame": "Baseline and 12 weeks" }, { "type": "primary", "measure": "Change in Peak VO2 (ml/kg/min)", "description": "Peak VO2 measured with maximal symptom limited cardiopulmonary exercise testing", "time_frame": "Baseline and 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Peak VO2 (percent predicted)", "description": "Peak VO2 (percent predicted using the Wasserman equations) measured with maximal symptom limited cardiopulmonary exercise testing", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Number of Cardiac Rehabilitation sessions attended", "description": "Number of in person and virtual sessions attended by each participant", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in Proportion with peak VO2 less than 85% predicted", "description": "Proportion with peak VO2\\<85% predicted (using the Wasserman equations) measured with maximal symptom limited cardiopulmonary exercise testing", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Number of Long COVID symptoms", "description": "Long COVID symptoms assessed using the LIINC symptom questionnaire (number of symptoms, more symptoms is worse).", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Composite Autonomic Symptom Scale-31 (Compass 31) Score", "description": "Compass 31 summary score (0-100, with higher score indicating more severe autonomic symptoms).", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire-9 (PHQ-9) Score", "description": "The PHQ-9 is a self-administered diagnostic instrument for depression. The PHQ-9 score ranges from 0 to 21, with higher scores indicating more severe depression.", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Generalized Anxiety Disorder Screener (GAD-7) Score", "description": "The GAD-7 is a self-administered diagnostic instrument for depression. The GAD-7 score ranges from 0 to 27, with higher scores indicating more severe anxiety.", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Short Form Survey (SF-36) Score", "description": "Overall quality of life using the short form health survey (SF-36). Scores range from 0-100 with higher scores representing a more favorable health state. The 36 questions are combined to form 8 scales in the domains of physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Quality of life assessed with EuroQol (EQ-5D) Visual Analogue Scale", "description": "Quality of life on EQ-5D VAS (0-100, with 100 being the best).", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Inflammation", "description": "hsCRP (mg/L) is a marker of inflammation", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Net Promotor Score", "description": "Would you recommend cardiac rehabilitation to your family/friends (1-10 scale). The percentage who report 0-6 (\"detractors\") is subtracted from the percentage who report 9 or 10 (\"promotors\") to calculate a \"Net Promoter Score.\"", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in adjusted heart rate reserve", "description": "Adjusted heart rate reserve (peak HR-rest HR)/(220-age-rest HR) achieved during symptom-limited maximal cardiopulmonary testing performed with cycle ergometer", "time_frame": "Baseline and 12 weeks" }, { "type": "primary", "measure": "Change in Peak VO2 (ml/kg/min)", "description": "Peak VO2 measured with maximal symptom limited cardiopulmonary exercise testing", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Peak VO2 (percent predicted)", "description": "Peak VO2 (percent predicted using the Wasserman equations) measured with maximal symptom limited cardiopulmonary exercise testing", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Number of Cardiac Rehabilitation sessions attended", "description": "Number of in person and virtual sessions attended by each participant", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in Proportion with peak VO2 less than 85% predicted", "description": "Proportion with peak VO2\\<85% predicted (using the Wasserman equations) measured with maximal symptom limited cardiopulmonary exercise testing", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Number of Long COVID symptoms", "description": "Long COVID symptoms assessed using the LIINC symptom questionnaire (number of symptoms, more symptoms is worse).", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Composite Autonomic Symptom Scale-31 (Compass 31) Score", "description": "Compass 31 summary score (0-100, with higher score indicating more severe autonomic symptoms).", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire-9 (PHQ-9) Score", "description": "The PHQ-9 is a self-administered diagnostic instrument for depression. The PHQ-9 score ranges from 0 to 21, with higher scores indicating more severe depression.", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Generalized Anxiety Disorder Screener (GAD-7) Score", "description": "The GAD-7 is a self-administered diagnostic instrument for depression. The GAD-7 score ranges from 0 to 27, with higher scores indicating more severe anxiety.", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Short Form Survey (SF-36) Score", "description": "Overall quality of life using the short form health survey (SF-36). Scores range from 0-100 with higher scores representing a more favorable health state. The 36 questions are combined to form 8 scales in the domains of physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Quality of life assessed with EuroQol (EQ-5D) Visual Analogue Scale", "description": "Quality of life on EQ-5D VAS (0-100, with 100 being the best).", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change in Inflammation", "description": "hsCRP (mg/L) is a marker of inflammation", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Net Promotor Score", "description": "Would you recommend cardiac rehabilitation to your family/friends (1-10 scale). The percentage who report 0-6 (\"detractors\") is subtracted from the percentage who report 9 or 10 (\"promotors\") to calculate a \"Net Promoter Score.\"", "time_frame": "12 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 13, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05530317", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05965739", "title": "RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions on Long COVID Symptoms", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-08-11", "start_date": "2023-09-01", "completion_date": "2024-12-17", "primary_completion_date": "2024-09-19", "conditions_raw": [ "Long COVID", "Long Covid19", "Long Covid-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Brainhq/Active Comparator Activity", "Brainhq", "Pasc Core", "Tdcs-Active" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.\n\nThis protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC-associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains.\n\nThis design seeks to evaluate each intervention relative to the Active Comparator. The BrainHQ (alone) arm is important because the intervention is commercially available, accessible, relatively inexpensive, and does not require trained personnel to administer. BrainHQ has been also been proven effective in other studies of cognitive dysfunction such as studies in aging, mild cognitive impairment, traumatic brain injury, among others. The BrainHQ + PASC CoRE arm and the BrainHQ + tDCS arms are suspected to provide cognitive improvements beyond BrainHQ alone through different mechanisms. Both PASC CoRE and tDCS have extensive prior use and have demonstrated utility in improving aspects of cognitive function in other clinical settings..", "primary_outcomes": [ { "type": "primary", "measure": "Change in Everyday Cognition 2 (ECog2)", "description": "Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. Score ranges from 1 to 5, with 5 being worst.", "time_frame": "Baseline to End of Intervention (EOI) (Day 70)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in PROMIS-cognitive Function - Short Form 8a (PROMIS-Cog) Total Score", "description": "The PROMIS-Cog is the PROMIS short form for the cognitive function domain and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days. Scores range from 22.4 to 63.5. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change on Auditory Verbal Learning Test", "description": "Trials #1-#5 report the total number correct across 5 trials. Trials #1-5 generate one total score, the individual scores for each trial are not analyzed. The Score for Trials #1-#5 range from 0-75; higher scores are better.\n\nTrial #8 reports the total number correct. Scores range from 0-15; higher scores are better.\n\nTrial #9 reports the total number correct recognition hits minus false positive. Scores range from 0-15; higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change on Symbol Digit Modalities Test", "description": "The Symbol Digit Modalities Test reports the total number correct on the test. Scores range from 0-110. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in Verbal Fluency", "description": "The Verbal Fluency Semantic reports the total number correct. Scores range from 0-110. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in Total Time to Complete the Digit Vigilance Test", "description": "", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change on NIH Toolbox Flanker Inhibitory Control and Attention Test", "description": "The Flanker Inhibitory Control and Attention Test Computed Score ranges from 0-10. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in CogState Detection Score", "description": "CogState Detection Score is the mean of log10 transformed reaction times. Lower values are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in CogState Identification Score", "description": "CogState Identification Score is the mean of log10 transformed reaction times for correct responses. Lower values are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in CogState One Back Primary Score", "description": "CogState One Back Primary Score is the arcsine transformation of the square root of the proportion of correct responses. The scale ranges from 0 to π/2. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in Everyday Cognition 2 (ECog2)", "description": "Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's simple reaction time; respond when X happens and Choice reaction time; respond only if X happens.", "time_frame": "Baseline, EOS (Day 160)" }, { "type": "secondary", "measure": "Total Number of Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs)", "description": "An SAE or serious suspected adverse reaction (SAR) or serious adverse reaction an AE that results in any of the following serious outcomes: Death, life-threatening, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, inpatient hospitalization or prolongation of existing hospitalization, congenital abnormality or birth defect, important medical event that may not result in one of the above outcomes, but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the above outcomes from occurring. A UADE is any serious adverse effect, problem, or death caused by or associated with a device if that effect was not previously identified in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.", "time_frame": "Baseline to EOS (Day 160)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Everyday Cognition 2 (ECog2)", "description": "Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. Score ranges from 1 to 5, with 5 being worst.", "time_frame": "Baseline to End of Intervention (EOI) (Day 70)" }, { "type": "secondary", "measure": "Change in PROMIS-cognitive Function - Short Form 8a (PROMIS-Cog) Total Score", "description": "The PROMIS-Cog is the PROMIS short form for the cognitive function domain and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days. Scores range from 22.4 to 63.5. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change on Auditory Verbal Learning Test", "description": "Trials #1-#5 report the total number correct across 5 trials. Trials #1-5 generate one total score, the individual scores for each trial are not analyzed. The Score for Trials #1-#5 range from 0-75; higher scores are better.\n\nTrial #8 reports the total number correct. Scores range from 0-15; higher scores are better.\n\nTrial #9 reports the total number correct recognition hits minus false positive. Scores range from 0-15; higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change on Symbol Digit Modalities Test", "description": "The Symbol Digit Modalities Test reports the total number correct on the test. Scores range from 0-110. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in Verbal Fluency", "description": "The Verbal Fluency Semantic reports the total number correct. Scores range from 0-110. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in Total Time to Complete the Digit Vigilance Test", "description": "", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change on NIH Toolbox Flanker Inhibitory Control and Attention Test", "description": "The Flanker Inhibitory Control and Attention Test Computed Score ranges from 0-10. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in CogState Detection Score", "description": "CogState Detection Score is the mean of log10 transformed reaction times. Lower values are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in CogState Identification Score", "description": "CogState Identification Score is the mean of log10 transformed reaction times for correct responses. Lower values are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in CogState One Back Primary Score", "description": "CogState One Back Primary Score is the arcsine transformation of the square root of the proportion of correct responses. The scale ranges from 0 to π/2. Higher scores are better.", "time_frame": "Baseline, End of Intervention - EOI (Day 70), End of Study (EOS) (Day 160)" }, { "type": "secondary", "measure": "Change in Everyday Cognition 2 (ECog2)", "description": "Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's simple reaction time; respond when X happens and Choice reaction time; respond only if X happens.", "time_frame": "Baseline, EOS (Day 160)" }, { "type": "secondary", "measure": "Total Number of Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs)", "description": "An SAE or serious suspected adverse reaction (SAR) or serious adverse reaction an AE that results in any of the following serious outcomes: Death, life-threatening, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, inpatient hospitalization or prolongation of existing hospitalization, congenital abnormality or birth defect, important medical event that may not result in one of the above outcomes, but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the above outcomes from occurring. A UADE is any serious adverse effect, problem, or death caused by or associated with a device if that effect was not previously identified in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.", "time_frame": "Baseline to EOS (Day 160)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 328, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05965739", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06643299", "title": "Probiotic Use for Recovery Enhancement From Long COVID-19", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-08-07", "start_date": "2025-05-13", "completion_date": "2026-07-02", "primary_completion_date": "2026-07-02", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Probiotic Agent" ], "sponsor": "Rush University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to learn if probiotics can improve symptoms and quality of life in participants with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Difference in Long COVID Severity", "description": "Defined as the percentage change from moderate-to-severe Long COVID to mild Long COVID using the Long COVID Symptoms and Severity Score (LC-SSS) tool between groups with subgroup analysis by Long COVID trajectory", "time_frame": "Baseline, Four, and Eight Months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Difference in LC-SSS Total Score", "description": "Defined as the change in the LC-SSS total score between groups with subgroup analysis by individual symptom scores and Long COVID trajectory", "time_frame": "Baseline, Four, and Eight Months" }, { "type": "secondary", "measure": "Difference in Quality of Life", "description": "Defined as the change in score for PROMIS-29 physical and mental health and the PROMIS SF-Cognitive Function 8a scale between groups with subgroup analysis by Long COVID trajectory", "time_frame": "Baseline, Four, and Eight Months" }, { "type": "secondary", "measure": "Difference in Return to Work and Activity", "description": "Defined as the change in the Work Productivity and Activity Impairment tool scores between groups with subgroup analysis by Long COVID trajectory", "time_frame": "Baseline, Four, and Eight Months" } ], "outcome_measures": [ { "type": "primary", "measure": "Difference in Long COVID Severity", "description": "Defined as the percentage change from moderate-to-severe Long COVID to mild Long COVID using the Long COVID Symptoms and Severity Score (LC-SSS) tool between groups with subgroup analysis by Long COVID trajectory", "time_frame": "Baseline, Four, and Eight Months" }, { "type": "secondary", "measure": "Difference in LC-SSS Total Score", "description": "Defined as the change in the LC-SSS total score between groups with subgroup analysis by individual symptom scores and Long COVID trajectory", "time_frame": "Baseline, Four, and Eight Months" }, { "type": "secondary", "measure": "Difference in Quality of Life", "description": "Defined as the change in score for PROMIS-29 physical and mental health and the PROMIS SF-Cognitive Function 8a scale between groups with subgroup analysis by Long COVID trajectory", "time_frame": "Baseline, Four, and Eight Months" }, { "type": "secondary", "measure": "Difference in Return to Work and Activity", "description": "Defined as the change in the Work Productivity and Activity Impairment tool scores between groups with subgroup analysis by Long COVID trajectory", "time_frame": "Baseline, Four, and Eight Months" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 194, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06643299", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07745699", "title": "Fully Remote, Telehealth-based Ketogenic Metabolic Therapy for Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-08-06", "start_date": "2024-12-10", "completion_date": "2025-06-01", "primary_completion_date": "2025-06-01", "conditions_raw": [ "Long COVID Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ketogenic Metabolic Therapy", "Lifestyle Intervention" ], "sponsor": "National University of Natural Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to learn if a 12-week ketogenic diet program combined with lifestyle strategies (called KMT-LS) is practical and acceptable as a fully remote intervention for adults with Long COVID who also have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. (ME/CFS) and dysautonomia (problems with heart rate, blood pressure, or other automatic body functions).\n\nThe main questions it aims to answer are:\n\nCan a ketogenic diet program be successfully delivered entirely from home using online tools and virtual support?\n\nDo participants stay in the study, follow the diet, and find the program safe and satisfactory?\n\nDo participants experience improvements in fatigue, sleep, mood, daily functioning, and symptom flare-ups after exertion?\n\nParticipants will:\n\nFollow a ketogenic diet for 12 weeks with weekly virtual nutrition support sessions\n\nUse at-home tools to track their ketone levels and confirm they are following the diet\n\nComplete online questionnaires about their symptoms, energy, sleep, mood, and daily functioning at the start of the study, after 12 weeks, and again 3 months later.", "primary_outcomes": [ { "type": "primary", "measure": "Acceptability", "description": "Acceptability data were measured via participants' perception of treatment suitability using a 5-point Likert scale (e.g., 1 = Not at all helpful; 5 = Extremely helpful). Participants were asked to rate their level of satisfaction with the program, the perceived helpfulness and relevance of the program, and the likelihood of recommending the program to others. Assessment burden was measured using a 5-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly Agree). Participants were asked to rate the burden associated with sourcing food, cooking food, and completing assessment procedures. Further, acceptability was explored via questions pertaining to optimization of the study, including opinions on dosing and duration of the intervention.", "time_frame": "Acceptability data was collected at post-intervention (Week 13)." }, { "type": "primary", "measure": "Feasibility", "description": "Feasibility of the research procedures and remote intervention was evaluated using metrics of enrollment (target sample size n = 10), attrition, population characteristics (e.g., percentage of participants identifying as non-white), completion of data-collection procedures within a 2-week window, amount of missing data, dietary adherence, and safety. The target sample size of 10 was selected to optimize group dynamics for the interactive, group-based components of the ketogenic metabolic therapy intervention, including weekly nutrition calls. Attendance at the weekly nutrition calls was recorded. We assessed adherence to dietary recommendations through participant self-report and objective metabolic data. Participants measured fasting capillary blood β-hydroxybutyrate (BHB) and fasting blood glucose using a commercially available, FDA-registered at-home device (Keto Mojo Meter, Keto Mojo, Inc.).", "time_frame": "Acceptability data was collected during at baseline, Weeks 1-12, and post-intervention (Week 13)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "PROMIS-29", "description": "PROMIS-29 to assess self-reported levels of physical, social, and cognitive functioning, anxiety, depression, pain interference, and sleep disturbance. Each subscale is standardized to a T-score (Mean = 50, SD = 10), where higher scores represent more of the concept being measured (e.g., more anxiety or better physical function). A threshold of 3 T-score points is considered a minimal clinically important difference (MCID) for each subscale", "time_frame": "Baseline, Post-intervention (13 Week), and 3-month follow-up" }, { "type": "secondary", "measure": "Duke Activity Status Index", "description": "Measured functional capacity using a 12-item self-report questionnaire that assesses the ability to perform specific activities of daily living. Each item is weighted by its metabolic equivalent value, with total scores ranging from 0 to 58.2. Higher scores indicate greater functional capacity and serve as a validated surrogate marker for peak oxygen uptake .", "time_frame": "Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up" }, { "type": "secondary", "measure": "Modified Medical Research Council Dyspnea Scale", "description": "Measures respiratory limitation, which categorizes breathlessness on a 5-point scale (Grade 0-4) based on the level of physical exertion required to elicit shortness of breath. A 1-point increase represents a significant decline in function and is recognized as the MCID.", "time_frame": "Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up" }, { "type": "secondary", "measure": "Malmö POTS Symptom Score", "description": "MAPS is a self-rated, 12-item visual analogue instrument (0-10 per symptom, total 0-120) that measures orthostatic and autonomic burden. Each item scores current symptom burden; higher totals indicate greater symptom severity.", "time_frame": "Baseline, Post-intervention (13 Weeks), and 3-month follow-up" }, { "type": "secondary", "measure": "Good Day/Bad Day Questionnaire", "description": "The Bateman Horne Center Good Day/Bad Day Questionnaire is not scored as a symptom-severity index; its two anchors are Hours of Upright Activity (HUA) and the number/proportion of good days, both of which are functional-capacity metrics. More upright hours and a higher good:bad day ratio indicate greater functional capacity and less PEM burden; lower values indicate more severe illness.", "time_frame": "Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up" }, { "type": "secondary", "measure": "Satisfaction with Life Scale", "description": "Evaluates global life satisfaction using a 5-item instrument that uses a 7-point Likert scale to assess an individual's conscious evaluative judgment of their life. Scores range from 5 (Extremely dissatisfied) to 35 (Extremely satisfied).", "time_frame": "Baseline, Post-intervention (13-Weeks), and 3-month follow-up" } ], "outcome_measures": [ { "type": "primary", "measure": "Acceptability", "description": "Acceptability data were measured via participants' perception of treatment suitability using a 5-point Likert scale (e.g., 1 = Not at all helpful; 5 = Extremely helpful). Participants were asked to rate their level of satisfaction with the program, the perceived helpfulness and relevance of the program, and the likelihood of recommending the program to others. Assessment burden was measured using a 5-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly Agree). Participants were asked to rate the burden associated with sourcing food, cooking food, and completing assessment procedures. Further, acceptability was explored via questions pertaining to optimization of the study, including opinions on dosing and duration of the intervention.", "time_frame": "Acceptability data was collected at post-intervention (Week 13)." }, { "type": "primary", "measure": "Feasibility", "description": "Feasibility of the research procedures and remote intervention was evaluated using metrics of enrollment (target sample size n = 10), attrition, population characteristics (e.g., percentage of participants identifying as non-white), completion of data-collection procedures within a 2-week window, amount of missing data, dietary adherence, and safety. The target sample size of 10 was selected to optimize group dynamics for the interactive, group-based components of the ketogenic metabolic therapy intervention, including weekly nutrition calls. Attendance at the weekly nutrition calls was recorded. We assessed adherence to dietary recommendations through participant self-report and objective metabolic data. Participants measured fasting capillary blood β-hydroxybutyrate (BHB) and fasting blood glucose using a commercially available, FDA-registered at-home device (Keto Mojo Meter, Keto Mojo, Inc.).", "time_frame": "Acceptability data was collected during at baseline, Weeks 1-12, and post-intervention (Week 13)." }, { "type": "secondary", "measure": "PROMIS-29", "description": "PROMIS-29 to assess self-reported levels of physical, social, and cognitive functioning, anxiety, depression, pain interference, and sleep disturbance. Each subscale is standardized to a T-score (Mean = 50, SD = 10), where higher scores represent more of the concept being measured (e.g., more anxiety or better physical function). A threshold of 3 T-score points is considered a minimal clinically important difference (MCID) for each subscale", "time_frame": "Baseline, Post-intervention (13 Week), and 3-month follow-up" }, { "type": "secondary", "measure": "Duke Activity Status Index", "description": "Measured functional capacity using a 12-item self-report questionnaire that assesses the ability to perform specific activities of daily living. Each item is weighted by its metabolic equivalent value, with total scores ranging from 0 to 58.2. Higher scores indicate greater functional capacity and serve as a validated surrogate marker for peak oxygen uptake .", "time_frame": "Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up" }, { "type": "secondary", "measure": "Modified Medical Research Council Dyspnea Scale", "description": "Measures respiratory limitation, which categorizes breathlessness on a 5-point scale (Grade 0-4) based on the level of physical exertion required to elicit shortness of breath. A 1-point increase represents a significant decline in function and is recognized as the MCID.", "time_frame": "Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up" }, { "type": "secondary", "measure": "Malmö POTS Symptom Score", "description": "MAPS is a self-rated, 12-item visual analogue instrument (0-10 per symptom, total 0-120) that measures orthostatic and autonomic burden. Each item scores current symptom burden; higher totals indicate greater symptom severity.", "time_frame": "Baseline, Post-intervention (13 Weeks), and 3-month follow-up" }, { "type": "secondary", "measure": "Good Day/Bad Day Questionnaire", "description": "The Bateman Horne Center Good Day/Bad Day Questionnaire is not scored as a symptom-severity index; its two anchors are Hours of Upright Activity (HUA) and the number/proportion of good days, both of which are functional-capacity metrics. More upright hours and a higher good:bad day ratio indicate greater functional capacity and less PEM burden; lower values indicate more severe illness.", "time_frame": "Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up" }, { "type": "secondary", "measure": "Satisfaction with Life Scale", "description": "Evaluates global life satisfaction using a 5-item instrument that uses a 7-point Likert scale to assess an individual's conscious evaluative judgment of their life. Scores range from 5 (Extremely dissatisfied) to 35 (Extremely satisfied).", "time_frame": "Baseline, Post-intervention (13-Weeks), and 3-month follow-up" } ], "relevance_tags": [ "Metabolic", "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 11, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07745699", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06585254", "title": "tVNS in Long COVID-19", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-08-03", "start_date": "2024-11-01", "completion_date": "2027-02-01", "primary_completion_date": "2026-12-31", "conditions_raw": [ "Long COVID", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Transcutaneous Vagus Nerve Stimulator" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "A prior open label study has shown that transcutaneous vagus nerve stimulation \\[tVNS\\] can improve the health of some patients with postacute sequelae of SARS-CoV-2 infection (PASC), severely affected enough to also fulfill criteria for myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). The purpose of this study is to compare two sets of stimulus parameters to determine the one that best improves the health-related quality of life of these patients over a period of 6-weeks. Patients using their assigned device for at least 30 of the 42 possible opportunities will receive the best device for an additional 6-week period.", "primary_outcomes": [ { "type": "primary", "measure": "The Chalder Fatigue Questionnaire (CFQ)", "description": "The Chalder Fatigue Questionnaire (CFQ) is used as a measure of fatigue. The CFQ consists of 11 items and uses likert scoring 0, 1, 2, 3, providing a full scale range of 0-33, where lowest score is least fatigue.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "Change in Short Form Health Survey (SF-36)", "description": "The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. SF-36 will be assessed for physical function score improved from baseline by 0.6 SD or 14%.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "Visual Analog Scale (VAS) measuring Fatigue", "description": "VAS total scale from 0-5 scoring system \\[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\\]. Higher score indicates poorer health outcome.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "VAS to measure Widespread Pain", "description": "VAS total scale from 0-5 scoring system \\[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\\]. Higher score indicates poorer health outcome.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "VAS measuring Postexertional malaise (PEM)", "description": "VAS total scale from 0-5 scoring system \\[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\\]. Higher score indicates poorer health outcome.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "VAS measuring brain fog", "description": "VAS total scale from 0-5 scoring system \\[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\\]. Higher score indicates poorer health outcome.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "Global Clinical Assessment of Change", "description": "Global Clinical Assessment of Change --+3 or +2 on a scale ranging from +3 \\[very much improved\\] thru 0 \\[no change\\] to -3 \\[very much worse\\]", "time_frame": "At 6 week (end of blinded phase) and at 12 weeks (end of open label phase)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Heart Rate Variability (HRV)", "description": "Participants will attach a device invented by the co-investigator which detects ECG and can quantify R-R intervals compute root mean square of successive differences (RMSSD) between normal heartbeats. The RMSSD reflects the beat-to-beat variance in heart rate and is the primary time-domain measure used to estimate the vagally mediated changes reflected in heart rate (HR).", "time_frame": "Baseline and at 5-6 week (end of blinded phase)" } ], "outcome_measures": [ { "type": "primary", "measure": "The Chalder Fatigue Questionnaire (CFQ)", "description": "The Chalder Fatigue Questionnaire (CFQ) is used as a measure of fatigue. The CFQ consists of 11 items and uses likert scoring 0, 1, 2, 3, providing a full scale range of 0-33, where lowest score is least fatigue.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "Change in Short Form Health Survey (SF-36)", "description": "The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. SF-36 will be assessed for physical function score improved from baseline by 0.6 SD or 14%.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "Visual Analog Scale (VAS) measuring Fatigue", "description": "VAS total scale from 0-5 scoring system \\[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\\]. Higher score indicates poorer health outcome.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "VAS to measure Widespread Pain", "description": "VAS total scale from 0-5 scoring system \\[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\\]. Higher score indicates poorer health outcome.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "VAS measuring Postexertional malaise (PEM)", "description": "VAS total scale from 0-5 scoring system \\[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\\]. Higher score indicates poorer health outcome.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "VAS measuring brain fog", "description": "VAS total scale from 0-5 scoring system \\[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\\]. Higher score indicates poorer health outcome.", "time_frame": "Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)" }, { "type": "primary", "measure": "Global Clinical Assessment of Change", "description": "Global Clinical Assessment of Change --+3 or +2 on a scale ranging from +3 \\[very much improved\\] thru 0 \\[no change\\] to -3 \\[very much worse\\]", "time_frame": "At 6 week (end of blinded phase) and at 12 weeks (end of open label phase)" }, { "type": "secondary", "measure": "Heart Rate Variability (HRV)", "description": "Participants will attach a device invented by the co-investigator which detects ECG and can quantify R-R intervals compute root mean square of successive differences (RMSSD) between normal heartbeats. The RMSSD reflects the beat-to-beat variance in heart rate and is the primary time-domain measure used to estimate the vagally mediated changes reflected in heart rate (HR).", "time_frame": "Baseline and at 5-6 week (end of blinded phase)" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06585254", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06305780", "title": "RECOVER-AUTONOMIC Platform Protocol", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-08-03", "start_date": "2024-03-11", "completion_date": "2025-07-09", "primary_completion_date": "2025-07-09", "conditions_raw": [ "Long COVID", "Long Covid19", "Long Covid-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "IVIG (Intravenous Immunoglobulin)", "Ivabradine + Coordinated Care" ], "sponsor": "Kanecia Obie Zimmerman", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.\n\nThis protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.", "primary_outcomes": [ { "type": "primary", "measure": "Total Number of Participants Enrolled in Each Appendix", "description": "", "time_frame": "During the enrollment period, approximately 16 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Total Number of Participants Enrolled in Each Appendix", "description": "", "time_frame": "During the enrollment period, approximately 16 months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 381, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06305780", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06305793", "title": "RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-07-31", "start_date": "2024-05-08", "completion_date": "2026-06-22", "primary_completion_date": "2026-03-23", "conditions_raw": [ "Long COVID", "Long Coronavirus Disease 2019 (Covid19)", "Long Covid-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "IVIG (Intravenous Immunoglobulin)", "Coordinated Care" ], "sponsor": "Kanecia Obie Zimmerman", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.\n\nThis protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score", "description": "The OHQ / OIQ is a measure of orthostatic intolerance and includes a 6-item symptom assessment (OHSA) and the 4-item Daily Activity Scale (OHDAS). Each item is scored from 0 (none/no interference) to 10 (worst possible/complete interference), describing the preceding week. The OHSA composite score is the average of the first 6 non-zero items and the OHDAS composite score is the average of the last 4 non-zero items. The OHQ/OIQ composite score is the average of the OHSA and OHDAS composite scores. The OHQ/OIQ scales at post-baseline are calculated using only those items that were included in the baseline scores.", "time_frame": "Baseline to End of Intervention (9 months)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Composite Autonomic Symptoms Score 31 (COMPASS-31)", "description": "The COMPASS-31 is a patient reported outcome that measures autonomic symptoms across multiple domains commonly seen in patients with PASC. Scores range from 0-100 with higher values representing severe symptoms.", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in Malmo POTS Symptom Score", "description": "The Malmo POTS symptom score assesses symptom burden in postural orthostatic tachycardia syndrome (POTS). It is a self-rating, 12-item score (0-10 per item, total range 0-120) based on patients' own perception of symptoms through visual analogue scale assessment. Higher scores represent more pronounced symptoms.", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in Active Stand Test", "description": "Participants will remain supine for 10 minutes, and data will be acquired at 5 and 10 minutes. Standing test should be performed with HR and BP monitoring at 1, 3, 5 and 10 minutes", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in blood pressure", "description": "measured during Active Stand Test", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in heart rate (HR)", "description": "measured during Active Stand Test", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in 6-min Walk Test", "description": "Normal walking speed will be measured using a standard 6 minute walk", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) + 2 Questionnaire", "description": "The PROMIS-29 consists of 29 items that assess general domains of health and functioning, including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.\n\nThe PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Scores will be reported as T scores ranging from 0 to 100, with a score of 60 being 1 standard deviation above the mean. Higher scores indicate worse overall health.", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in step count as measured by a wearable device", "description": "measured by activity tracker", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in heart rate as measured by a wearable device", "description": "measured by activity tracker", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Proportion of participants who experience individual (SAEs", "description": "These will be analyzed in the safety population.", "time_frame": "Baseline to Follow-up (12 months)" }, { "type": "secondary", "measure": "Proportion who experience any one or more ( Serious Adverse Event) SAEs", "description": "These will be analyzed in the safety population.", "time_frame": "Baseline to Follow-up (12 months)" }, { "type": "secondary", "measure": "Incidence of SAEs leading to discontinuation", "description": "These will be analyzed in the safety population.", "time_frame": "Baseline to Follow-up (12 months)" }, { "type": "secondary", "measure": "Incidence of Events of Special Interest (ESIs)", "description": "Each study drug may have a unique list of ESIs", "time_frame": "Baseline to Follow-up (12 months)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score", "description": "The OHQ / OIQ is a measure of orthostatic intolerance and includes a 6-item symptom assessment (OHSA) and the 4-item Daily Activity Scale (OHDAS). Each item is scored from 0 (none/no interference) to 10 (worst possible/complete interference), describing the preceding week. The OHSA composite score is the average of the first 6 non-zero items and the OHDAS composite score is the average of the last 4 non-zero items. The OHQ/OIQ composite score is the average of the OHSA and OHDAS composite scores. The OHQ/OIQ scales at post-baseline are calculated using only those items that were included in the baseline scores.", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in Composite Autonomic Symptoms Score 31 (COMPASS-31)", "description": "The COMPASS-31 is a patient reported outcome that measures autonomic symptoms across multiple domains commonly seen in patients with PASC. Scores range from 0-100 with higher values representing severe symptoms.", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in Malmo POTS Symptom Score", "description": "The Malmo POTS symptom score assesses symptom burden in postural orthostatic tachycardia syndrome (POTS). It is a self-rating, 12-item score (0-10 per item, total range 0-120) based on patients' own perception of symptoms through visual analogue scale assessment. Higher scores represent more pronounced symptoms.", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in Active Stand Test", "description": "Participants will remain supine for 10 minutes, and data will be acquired at 5 and 10 minutes. Standing test should be performed with HR and BP monitoring at 1, 3, 5 and 10 minutes", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in blood pressure", "description": "measured during Active Stand Test", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in heart rate (HR)", "description": "measured during Active Stand Test", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in 6-min Walk Test", "description": "Normal walking speed will be measured using a standard 6 minute walk", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) + 2 Questionnaire", "description": "The PROMIS-29 consists of 29 items that assess general domains of health and functioning, including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.\n\nThe PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Scores will be reported as T scores ranging from 0 to 100, with a score of 60 being 1 standard deviation above the mean. Higher scores indicate worse overall health.", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in step count as measured by a wearable device", "description": "measured by activity tracker", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Change in heart rate as measured by a wearable device", "description": "measured by activity tracker", "time_frame": "Baseline to End of Intervention (9 months)" }, { "type": "secondary", "measure": "Proportion of participants who experience individual (SAEs", "description": "These will be analyzed in the safety population.", "time_frame": "Baseline to Follow-up (12 months)" }, { "type": "secondary", "measure": "Proportion who experience any one or more ( Serious Adverse Event) SAEs", "description": "These will be analyzed in the safety population.", "time_frame": "Baseline to Follow-up (12 months)" }, { "type": "secondary", "measure": "Incidence of SAEs leading to discontinuation", "description": "These will be analyzed in the safety population.", "time_frame": "Baseline to Follow-up (12 months)" }, { "type": "secondary", "measure": "Incidence of Events of Special Interest (ESIs)", "description": "Each study drug may have a unique list of ESIs", "time_frame": "Baseline to Follow-up (12 months)" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 200, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06305793", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05524532", "title": "Effects of Immulina TM Supplements With PASC Patients", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2026-07-31", "start_date": "2023-07-20", "completion_date": "2025-07-29", "primary_completion_date": "2025-07-29", "conditions_raw": [ "Post Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Immulina Tm" ], "sponsor": "University of Mississippi Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a multi-site study that will try to determine the effects of Immulina ™, a natural dietary supplement, on blood chemicals associated with inflammation that are often increased in patients with long COVID (also called PASC).", "primary_outcomes": [ { "type": "primary", "measure": "Plasma IL-6 (Interleukin 6, pg/mL)", "description": "Differences in Interleukin 6 from baseline to 12 weeks", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Plasma CRP (C-Reactive Protein, ng/mL)", "description": "Differences in C-Reactive Protein from baseline to 12 weeks.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Plasma D-Dimer, pg/mL", "description": "Differences in D-Dimer from baseline to 12 weeks.", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "PROMIS-29", "description": "Differences in questionnaire PROMIS-29, Domain T-scores PROMIS-29 is a collection of short forms containing a fixed number of items from the same 7 PROMIS domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) plus a single item on pain intensity. They assess all domains over the past seven days except the Physical Function, which has no timeframe specified. Four questions asked for each of 7 domains, plus the single pain intensity item and scored separately, yielding a total of 7 domain scores. The final score is represented by the T-Score, a standardized score with a mean of 50 and a standard deviation \\[SD\\] of 10. High scores mean more of the concept being measured (e.g., more fatigue, more Physical Function).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "FSS", "description": "Differences in Fatigue Severity Scale (FSS) questionnaire between baseline to 12 weeks\n\nChanges in questionnaire FSS, units on a scale, results that reflect PASC-associated symptoms of fatigue, neurocognitive dysfunction, dyspnea and/or other symptoms.\n\nThe questionnaire FSS contains nine statements that rate the severity of fatigue symptoms. Respondents rate their fatigue severity during the past seven days using a 7 point rating scale. A low value (e.g.1) indicates strong disagreement with the statement, whereas a high value (e.g.7) indicates strong agreement. A total score of less than 36 suggests that the respondent may not be suffering from fatigue. A total score of 36 or more suggests that the respondent may need further evaluation by a physician.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SBQ-LC TM", "description": "Differences in The Symptom Burden Questionnaire for Long COVID (SBQ-LC TM) questionnaire between baseline to 12 weeks\n\nChanges in questionnaire SBQ-LC TM (units on a scale) results that reflect PASC-associated symptoms of fatigue, neurocognitive dysfunction, dyspnea and/or other symptoms .\n\nSBQ-LC TM (version 1.0) is a modular instrument measuring patient reported outcomes and is composed of 17 independent scales with promising psychometric properties. Respondents rate their symptom burden during the past seven days using a dichotomous response or 4 point rating scale. Each scale provides coverage of a different symptom domain and returns a summed raw score that can be transformed to a linear (0-100) score. Higher scores represent higher symptom burden.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SARS-CoV-2-specific antibody responses", "description": "Differences in SARS-CoV-2-specific antibody immune responses: Receptor Binding domain (RBD) and Nucleocapsid (NP) antibody responses between baseline and 12 weeks", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SARS-CoV-2-specific immune responses on memory T cell levels", "description": "Differences in SARS-CoV-2-specific immune responses on memory T cell levels between baseline and 12 weeks", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SARS-CoV-2-specific immune responses on memory B cell levels", "description": "Differences in SARS-CoV-2-specific immune responses on memory B cell levels between baseline and 12 weeks", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Natural Killer cell (NK)-mediated cytotoxicity", "description": "NK cell-mediated cytotoxicity is characterized by cytolysis of a CSFE-labeled (K562) by effector cells (NK cells). Labeled K562 are cultured with NK cells for a period of time, then all cells labeled with a live-dead stain, 7-AAD. The cytolytic actively is expressed as the percent dead K562.\n\nDifference in cytolytic activity (%dead K562) from baseline to 20 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Natural Killer (NK) cell count", "description": "Difference in NK cell counts from baseline to 20 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Cytolytic T lymphocyte (CTL) number", "description": "Difference in CTL cell number from baseline to 20 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "serum Interferon alpha, pg/mL", "description": "Difference in Interferon alpha from baseline to 20 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "serum Interferon gamma, pg/mL", "description": "Difference in Interferon gamma from baseline to 20 weeks.", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Plasma IL-6 (Interleukin 6, pg/mL)", "description": "Differences in Interleukin 6 from baseline to 12 weeks", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Plasma CRP (C-Reactive Protein, ng/mL)", "description": "Differences in C-Reactive Protein from baseline to 12 weeks.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Plasma D-Dimer, pg/mL", "description": "Differences in D-Dimer from baseline to 12 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "PROMIS-29", "description": "Differences in questionnaire PROMIS-29, Domain T-scores PROMIS-29 is a collection of short forms containing a fixed number of items from the same 7 PROMIS domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) plus a single item on pain intensity. They assess all domains over the past seven days except the Physical Function, which has no timeframe specified. Four questions asked for each of 7 domains, plus the single pain intensity item and scored separately, yielding a total of 7 domain scores. The final score is represented by the T-Score, a standardized score with a mean of 50 and a standard deviation \\[SD\\] of 10. High scores mean more of the concept being measured (e.g., more fatigue, more Physical Function).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "FSS", "description": "Differences in Fatigue Severity Scale (FSS) questionnaire between baseline to 12 weeks\n\nChanges in questionnaire FSS, units on a scale, results that reflect PASC-associated symptoms of fatigue, neurocognitive dysfunction, dyspnea and/or other symptoms.\n\nThe questionnaire FSS contains nine statements that rate the severity of fatigue symptoms. Respondents rate their fatigue severity during the past seven days using a 7 point rating scale. A low value (e.g.1) indicates strong disagreement with the statement, whereas a high value (e.g.7) indicates strong agreement. A total score of less than 36 suggests that the respondent may not be suffering from fatigue. A total score of 36 or more suggests that the respondent may need further evaluation by a physician.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SBQ-LC TM", "description": "Differences in The Symptom Burden Questionnaire for Long COVID (SBQ-LC TM) questionnaire between baseline to 12 weeks\n\nChanges in questionnaire SBQ-LC TM (units on a scale) results that reflect PASC-associated symptoms of fatigue, neurocognitive dysfunction, dyspnea and/or other symptoms .\n\nSBQ-LC TM (version 1.0) is a modular instrument measuring patient reported outcomes and is composed of 17 independent scales with promising psychometric properties. Respondents rate their symptom burden during the past seven days using a dichotomous response or 4 point rating scale. Each scale provides coverage of a different symptom domain and returns a summed raw score that can be transformed to a linear (0-100) score. Higher scores represent higher symptom burden.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SARS-CoV-2-specific antibody responses", "description": "Differences in SARS-CoV-2-specific antibody immune responses: Receptor Binding domain (RBD) and Nucleocapsid (NP) antibody responses between baseline and 12 weeks", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SARS-CoV-2-specific immune responses on memory T cell levels", "description": "Differences in SARS-CoV-2-specific immune responses on memory T cell levels between baseline and 12 weeks", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SARS-CoV-2-specific immune responses on memory B cell levels", "description": "Differences in SARS-CoV-2-specific immune responses on memory B cell levels between baseline and 12 weeks", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Natural Killer cell (NK)-mediated cytotoxicity", "description": "NK cell-mediated cytotoxicity is characterized by cytolysis of a CSFE-labeled (K562) by effector cells (NK cells). Labeled K562 are cultured with NK cells for a period of time, then all cells labeled with a live-dead stain, 7-AAD. The cytolytic actively is expressed as the percent dead K562.\n\nDifference in cytolytic activity (%dead K562) from baseline to 20 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Natural Killer (NK) cell count", "description": "Difference in NK cell counts from baseline to 20 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Cytolytic T lymphocyte (CTL) number", "description": "Difference in CTL cell number from baseline to 20 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "serum Interferon alpha, pg/mL", "description": "Difference in Interferon alpha from baseline to 20 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "serum Interferon gamma, pg/mL", "description": "Difference in Interferon gamma from baseline to 20 weeks.", "time_frame": "12 weeks" } ], "relevance_tags": [ "Anti-inflammatory", "Phase 3", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 101, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05524532", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07714889", "title": "Development of an Accessible Cognitive Behavioral Therapy Digital Therapeutic for Individuals With Long COVID", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2026-07-29", "start_date": "2026-07", "completion_date": "2026-09", "primary_completion_date": "2026-09", "conditions_raw": [ "Long Covid", "Depression", "Anxiety" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rauha® Digital Therapeutic Platform" ], "sponsor": "Toivoa Inc", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This study will evaluate Toivoa-004 as an experimental digital therapeutic for persons with Long COVID suffering from anxiety or depression. This study will evaluate the completion rates of the Toivoa-004 program and survey the user's experience upon completion. Changes in anxiety and depression scores will be monitored during the study.", "primary_outcomes": [ { "type": "primary", "measure": "Proportion of active users at Week 12", "description": "The primary endpoint is participant engagement with Toivoa-004, defined as the completion of at least 75% of the Toivoa-004 modules over the 12-week study period. Engagement will be measured via system analytics (module completions and usage logs). Feasibility will be considered achieved if more than 50% of enrolled participants meet this completion criterion.", "time_frame": "12 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Proportion of active users at Week 12", "description": "The primary endpoint is participant engagement with Toivoa-004, defined as the completion of at least 75% of the Toivoa-004 modules over the 12-week study period. Engagement will be measured via system analytics (module completions and usage logs). Feasibility will be considered achieved if more than 50% of enrolled participants meet this completion criterion.", "time_frame": "12 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT07714889", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04924881", "title": "Chinese Medicine for Patients With LCOVID-19 Symptoms", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-07-27", "start_date": "2021-07-02", "completion_date": "2022-10-03", "primary_completion_date": "2022-10-03", "conditions_raw": [ "Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Covid Rehab Formula Granules" ], "sponsor": "Chinese University of Hong Kong", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "COVID-19 has spread rapidly and now affects all over the world. On 11 March 2020, coronavirus disease 2019 (COVID-19) was declared a global pandemic by the World Health Organization (WHO).\n\nMost of the infected people will develop mild to moderate illness, for example fever, cough, tiredness and joint pain etc. For some older people, and those with comorbidities like cardiovascular disease, diabetes, chronic respiratory disease, and malignancy are more likely to develop serious illness. Also long-term problems such as fatigue, breathlessness and joint pain experienced by survivors of COVID-19 after discharge from hospital.\n\nSome clinical and pharmacological studies have suggested Traditional Chinese Medicine (TCM) has achieved remarkable therapeutic effect for active COVID cases of different severity during SARS epidemic in 2003. Also, some studies shown that using Chinese medicine interventions together with conventional treatment is more effective than using the conventional treatment alone in treating chronic fatigue syndrome.\n\nTraditional Chinese Medicine (TCM) has a long history and played an important role in the prevention and treatment of several epidemic diseases. However, there is a lack of clinical study of using TCM to treat the residue symptom of COVID-19 recovered patients.\n\nCOVID-19 recovered patients will be screened and randomized into TCM group or placebo group for 8 weeks and followed by a post-treatment visits at week 12.", "primary_outcomes": [ { "type": "primary", "measure": "The Change of Fatigue Severity Score", "description": "Improvement of residue COVID-19 symptoms of fatigue after study treatment at week 8, using a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Scores range from 9 - 63; the higher the score, the greater fatigue severity.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Long Term Symptom Assessment", "description": "Self-reported long term COVID-19 symptoms For the symptom questionnaire, participants will be asked to report newly occurring and persistent symptoms, or any symptoms worse than before COVID 19 development. The symptom assessment has 5 scale, from none to very severe.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "The Change of Fatigue Severity Score (FSS)", "description": "FSS is a 9 item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Scores range from 9-63; the higher the score, the greater fatigue severity.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Improvement of dyspnoea using modified British Medical Research Council (mMRC) dyspnoea scale", "description": "The mMRC scale is a five-category scale to characterize the level of dyspnoea with physical activity in which higher scores correspond with increased dyspnoea.", "time_frame": "8 weeks and 12weeks" }, { "type": "secondary", "measure": "The change of EuroQol five-dimension five-level (EQ-5D-5L)5L) questionnaire and it's Visual Analogue Scale (VAS)", "description": "To evaluate patients quality of life (QoL) by using EQ-5D-5L, higher score better QoL. EuroQol Visual Analogue Scale assess generic health ranging from 0-100, higher score better health experience.", "time_frame": "8 weeks and 12weeks" }, { "type": "secondary", "measure": "Pulmonary function assessment on FEV1, FVC, and FEV1/FVC ratio", "description": "FEV1, FVC, and FEV1/FVC ratio will be measured with the Air Next Spirometer (NuvoAir, Sweden) in combination with the mobile coaching system. The higher of FEV1/FVC ratio, the healthier of subjects.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Adverse event assessment", "description": "Any reported adverse event related to study treatment will be analyzed throughout the study.", "time_frame": "8 weeks and 12weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "The Change of Fatigue Severity Score", "description": "Improvement of residue COVID-19 symptoms of fatigue after study treatment at week 8, using a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Scores range from 9 - 63; the higher the score, the greater fatigue severity.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Long Term Symptom Assessment", "description": "Self-reported long term COVID-19 symptoms For the symptom questionnaire, participants will be asked to report newly occurring and persistent symptoms, or any symptoms worse than before COVID 19 development. The symptom assessment has 5 scale, from none to very severe.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "The Change of Fatigue Severity Score (FSS)", "description": "FSS is a 9 item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Scores range from 9-63; the higher the score, the greater fatigue severity.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Improvement of dyspnoea using modified British Medical Research Council (mMRC) dyspnoea scale", "description": "The mMRC scale is a five-category scale to characterize the level of dyspnoea with physical activity in which higher scores correspond with increased dyspnoea.", "time_frame": "8 weeks and 12weeks" }, { "type": "secondary", "measure": "The change of EuroQol five-dimension five-level (EQ-5D-5L)5L) questionnaire and it's Visual Analogue Scale (VAS)", "description": "To evaluate patients quality of life (QoL) by using EQ-5D-5L, higher score better QoL. EuroQol Visual Analogue Scale assess generic health ranging from 0-100, higher score better health experience.", "time_frame": "8 weeks and 12weeks" }, { "type": "secondary", "measure": "Pulmonary function assessment on FEV1, FVC, and FEV1/FVC ratio", "description": "FEV1, FVC, and FEV1/FVC ratio will be measured with the Air Next Spirometer (NuvoAir, Sweden) in combination with the mobile coaching system. The higher of FEV1/FVC ratio, the healthier of subjects.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Adverse event assessment", "description": "Any reported adverse event related to study treatment will be analyzed throughout the study.", "time_frame": "8 weeks and 12weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 68, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04924881", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07724834", "title": "CD19-B Cell Depletion in PAIS-ME/CFS Patients", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2026-07-24", "start_date": "2026-12-01", "completion_date": "2029-03-01", "primary_completion_date": "2029-02-01", "conditions_raw": [ "Post-acute Infectious Syndrome (PAIS)", "Post-COVID 19 Condition (PCC or Long COVID)", "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Inebilizumab" ], "sponsor": "Charite University, Berlin, Germany", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Post-acute infection syndromes (PAIS) are long-lasting health problems that can develop after an infection. They include post-COVID-19 syndrome and similar illnesses following other infections. Some people with PAIS develop myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a serious and disabling illness that can greatly limit everyday activities. People with ME/CFS may experience severe fatigue, reduced physical and mental function, pain, sleep problems, and problems with the regulation of heart rate and blood pressure. A key feature is post-exertional malaise (PEM), in which symptoms become worse after physical or mental activity. The biological causes of PAIS and ME/CFS are not fully understood, and there is currently no established treatment that targets the underlying disease process.\n\nResearch suggests that changes in the immune system may contribute to PAIS and ME/CFS in some patients. In particular, B cells (a type of immune cell) and autoantibodies (antibodies that react with the body's own structures) may play a role. Previous studies of immunoadsorption, a procedure that removes antibodies from the blood, have shown improvements in some patients with ME/CFS. These findings support further investigation of treatments that target B cells in selected patients.\n\nThe PIONEER\\_PAIS study will investigate whether inebilizumab can improve physical function in adults with PAIS who meet the diagnostic criteria for ME/CFS. The study includes a selected group of patients with evidence of autoantibodies and immune activation who previously improved after immunoadsorption but later experienced worsening of their symptoms. Inebilizumab is a monoclonal antibody that targets CD19, a protein found on B cells, and leads to the depletion of these cells.\n\nParticipants will be randomly assigned to receive either inebilizumab or placebo (saline solution) as an infusion into a vein. Inebilizumab will be given at a dose of 300 mg on Day 1, Day 15, and Week 24. The study is double-blind, meaning that neither the participants nor the study team assessing them will know which treatment they receive.\n\nThe main research question is whether treatment with inebilizumab leads to a greater improvement in physical function (PF) than placebo. PF will be measured using the PF scale of the SF-36 health questionnaire, comparing the change from the start of the study to Month 9 (Week 36).\n\nThe study will also examine other aspects of health and daily functioning, including fatigue, post-exertional malaise, pain and headache, disability, symptoms related to the autonomic nervous system, muscle strength and fatigability, heart rate and blood pressure responses during standing, daily step count, and cognitive function. Adverse events will be monitored to assess the safety of the treatment. In addition, the study includes biomarker research focusing on B cells, autoantibodies, and other markers in the blood.\n\nThis research aims to explore biological characteristics that may be associated with response to treatment and may help inform future studies of B-cell-targeted treatment in PAIS and ME/CFS.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36) comparing Inebilizumab with placebo", "description": "The SF-36 is an established and widely used measure of health-related quality of life. The PF domain assesses limitations in ten activities related to mobility and self-care, such as walking specified distances, carrying groceries, bathing, and dressing. Scores are weighted and transformed to a scale ranging from 0 (severe functional limitations) to 100 (no functional limitations). The intra-patient change in SF-36 PF will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Difference in responder rate in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36) comparing Inebilizumab with placebo", "description": "Occurrence of responders in patients that receive Vericiguat compared with placebo. Responders are defined as an intra-patient 20-point increase in SF-36-PF from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in other sub-domains of the Short Form 36 Health Survey Questionnaire (SF-36) comparing Inebilizumab with placebo", "description": "The intra-patient change in other SF-36 subdomains will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in severity of muscle pain and headache as measured by the Canadian Consensus Criteria (CCC) Symptom Score", "description": "The CCC Symptom Score quantifies ME/CFS symptoms. Its score ranges from 1 (no symptoms) to 10 (extreme symptoms). The intra-patient change in muscle pain and headache will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in symptoms of ME/CFS as measured by Canadian Consensus Criteria (CCC) Symptom Score", "description": "The intra-patient change in ME/CFS symptoms will be assessed from baseline to month 9 (week 36) as indexed by the CCC Symptom Score.", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in functional disability as measured by the Bell Disability Scale", "description": "The Bell Disability Scale is a standard assessment tool used to evaluate functional ability in adults with ME/CFS. It comprises 11 statements describing the patient's functional status, including symptom severity at rest and during activity, overall activity level, and the ability to work, travel, and perform self-care activities. Scores range from 0 (bedridden) to 100 (no symptoms and fully functional). The intra-patient change in Bell score will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)", "description": "The COMPASS-31 is a refined, internally consistent, and markedly abbreviated quantitative measure of autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, applies a much-simplified scoring algorithm, and is suitable for widespread use in autonomic research and practice. It evaluates six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The score ranges from 0 (no symptoms) to 100 (strong autonomic dysfunction). The intra-patient change in autonomic dysfunction will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in fatigue as measured by the Fatigue Severity Score (FSS)", "description": "The FSS is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle. Answers are scored on a seven-point scale (1 = strongly disagree; 7 = strongly agree). Thus, the minimum score is 9 (no fatigue), and the highest is 63 (heavy fatigue). The intra-patient change in fatigue severity will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in post exertional malaise (PEM) frequency, strength and severity as measured by the PEM questionnaire", "description": "The PEM questionnaire determines frequency (from 0 to 20 points, higher scores equate to greater frequency), severity (from 0 to 20 points, higher scores equate to greater severity), and length (from 0 to 6 points, higher scores equate to longer duration) of PEM. The intra-patient change in PEM score will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in muscle fatigue measured by the repetitive hand grip strength test (HGS)", "description": "The intra-patient change in hand grip force (maximum, mean), fatigue ratio and recovery rate will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in cognitive function measured by the Symbol Digit Modalities Test (SDMT)", "description": "The Symbol Digit Modalities Test (SDMT) is a screening instrument commonly used to assess neurological dysfunction. It detects cognitive impairment as well as changes in cognitive functioning over time and in response to treatment. The scores range between 0 and 110 (higher scores equate to greater cognitive functioning). The intra-patient change in cognitive score will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Difference in the occurrence of occurring Adverse Events (AE) and Serious Adverse Events (SAE) comparing Inebilizumab with placebo (IMP safety).", "description": "Occurrence of IMP side and adverse effects, assessed with AE, SAE and SUSAR reports.", "time_frame": "1 day, 15 days, 3 months, 6 months, and 9 months (36 weeks) after first IMP administration" } ], "outcome_measures": [ { "type": "primary", "measure": "Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36) comparing Inebilizumab with placebo", "description": "The SF-36 is an established and widely used measure of health-related quality of life. The PF domain assesses limitations in ten activities related to mobility and self-care, such as walking specified distances, carrying groceries, bathing, and dressing. Scores are weighted and transformed to a scale ranging from 0 (severe functional limitations) to 100 (no functional limitations). The intra-patient change in SF-36 PF will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Difference in responder rate in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36) comparing Inebilizumab with placebo", "description": "Occurrence of responders in patients that receive Vericiguat compared with placebo. Responders are defined as an intra-patient 20-point increase in SF-36-PF from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in other sub-domains of the Short Form 36 Health Survey Questionnaire (SF-36) comparing Inebilizumab with placebo", "description": "The intra-patient change in other SF-36 subdomains will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in severity of muscle pain and headache as measured by the Canadian Consensus Criteria (CCC) Symptom Score", "description": "The CCC Symptom Score quantifies ME/CFS symptoms. Its score ranges from 1 (no symptoms) to 10 (extreme symptoms). The intra-patient change in muscle pain and headache will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in symptoms of ME/CFS as measured by Canadian Consensus Criteria (CCC) Symptom Score", "description": "The intra-patient change in ME/CFS symptoms will be assessed from baseline to month 9 (week 36) as indexed by the CCC Symptom Score.", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in functional disability as measured by the Bell Disability Scale", "description": "The Bell Disability Scale is a standard assessment tool used to evaluate functional ability in adults with ME/CFS. It comprises 11 statements describing the patient's functional status, including symptom severity at rest and during activity, overall activity level, and the ability to work, travel, and perform self-care activities. Scores range from 0 (bedridden) to 100 (no symptoms and fully functional). The intra-patient change in Bell score will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)", "description": "The COMPASS-31 is a refined, internally consistent, and markedly abbreviated quantitative measure of autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, applies a much-simplified scoring algorithm, and is suitable for widespread use in autonomic research and practice. It evaluates six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The score ranges from 0 (no symptoms) to 100 (strong autonomic dysfunction). The intra-patient change in autonomic dysfunction will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in fatigue as measured by the Fatigue Severity Score (FSS)", "description": "The FSS is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle. Answers are scored on a seven-point scale (1 = strongly disagree; 7 = strongly agree). Thus, the minimum score is 9 (no fatigue), and the highest is 63 (heavy fatigue). The intra-patient change in fatigue severity will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in post exertional malaise (PEM) frequency, strength and severity as measured by the PEM questionnaire", "description": "The PEM questionnaire determines frequency (from 0 to 20 points, higher scores equate to greater frequency), severity (from 0 to 20 points, higher scores equate to greater severity), and length (from 0 to 6 points, higher scores equate to longer duration) of PEM. The intra-patient change in PEM score will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in muscle fatigue measured by the repetitive hand grip strength test (HGS)", "description": "The intra-patient change in hand grip force (maximum, mean), fatigue ratio and recovery rate will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Improvement in cognitive function measured by the Symbol Digit Modalities Test (SDMT)", "description": "The Symbol Digit Modalities Test (SDMT) is a screening instrument commonly used to assess neurological dysfunction. It detects cognitive impairment as well as changes in cognitive functioning over time and in response to treatment. The scores range between 0 and 110 (higher scores equate to greater cognitive functioning). The intra-patient change in cognitive score will be assessed from baseline to month 9 (week 36).", "time_frame": "9 months (36 weeks) after first IMP administration" }, { "type": "secondary", "measure": "Difference in the occurrence of occurring Adverse Events (AE) and Serious Adverse Events (SAE) comparing Inebilizumab with placebo (IMP safety).", "description": "Occurrence of IMP side and adverse effects, assessed with AE, SAE and SUSAR reports.", "time_frame": "1 day, 15 days, 3 months, 6 months, and 9 months (36 weeks) after first IMP administration" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 38, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07724834", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07709234", "title": "Transcranial Direct Current Stimulation for Long COVID Brain Fog and Fatigue", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-07-22", "start_date": "2026-09-15", "completion_date": "2028-03-01", "primary_completion_date": "2027-12-22", "conditions_raw": [ "Long COVID", "Post-COVID Conditions", "Fatigue", "Cognitive Dysfunction" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Transcranial Direct Current Stimulation" ], "sponsor": "University of Las Palmas de Gran Canaria", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID can cause persistent symptoms such as fatigue, cognitive difficulties commonly described as brain fog, reduced exercise tolerance, and impaired quality of life. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may help modulate brain activity in regions involved in cognition, fatigue, and executive function.\n\nThe NEUROSTIM-LC study will evaluate the feasibility and potential effects of repeated tDCS sessions in adults with long COVID presenting fatigue and/or brain fog. Participants will receive 30 sessions of tDCS applied over the left dorsolateral prefrontal cortex. Assessments will be performed before and after the intervention to evaluate changes in quality of life, fatigue, cognitive function, brain metabolism, physical performance, autonomic function, sleep quality, psychological symptoms, respiratory function, and blood biomarkers.", "primary_outcomes": [ { "type": "primary", "measure": "Change in EuroQol 5-Dimension 5-Level Questionnaire Score", "description": "Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across five levels of severity. Higher scores or index values reflect better health status, depending on the scoring method used. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Modified Fatigue Impact Scale Score", "description": "Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS). The MFIS assesses the impact of fatigue on physical, cognitive, and psychosocial functioning. The total score ranges from 0 to 84, with higher scores indicating greater fatigue impact. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Montreal Cognitive Assessment Score", "description": "Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates cognitive domains including attention, memory, language, visuospatial abilities, executive function, abstraction, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Short Form-36 Health Survey Score", "description": "Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36). The SF-36 evaluates eight domains of health-related quality of life: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Verbal Fluency Task Performance", "description": "Verbal fluency will be assessed using verbal fluency tasks. Performance will be evaluated based on the number of correct words generated within the specified time period. Higher scores indicate better verbal fluency performance. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Stroop Test Performance", "description": "Executive function, inhibitory control, and cognitive flexibility will be assessed using the Stroop test. Performance will be evaluated using test-specific measures such as response accuracy and/or completion time. Better performance is reflected by higher accuracy and/or shorter completion time, depending on the scoring method used. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Brain Metabolism", "description": "Brain metabolism will be assessed using positron emission tomography-computed tomography (PET-CT). Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Change in Heart Rate Variability", "description": "Autonomic nervous system activity will be assessed using heart rate variability (HRV) recorded under resting conditions. Time-domain, frequency-domain, and non-linear HRV indices will be evaluated to characterize changes in autonomic regulation.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Change in Endurance Capacity", "description": "Endurance capacity will be assessed using the Ekblom-Bak submaximal cycle ergometer test. Heart rate responses, perceived exertion, estimated maximal oxygen uptake, and internal load will be evaluated under standardized conditions.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Change in Handgrip Strength", "description": "Upper-limb muscle strength will be assessed using handgrip dynamometry. Participants will perform three maximal attempts, and the highest value will be used for analysis.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Change in Lower-Limb Neuromuscular Performance", "description": "Lower-limb neuromuscular performance will be assessed using the countermovement jump test performed on a force platform. Variables related to force and power production will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Tolerability of the tDCS Intervention", "description": "Tolerability of the tDCS intervention will be assessed during each stimulation session using session monitoring records and participant reports. Tolerability will be evaluated based on the number of completed tDCS sessions out of the 30 scheduled sessions and the participant's ability to complete each session without clinically relevant discomfort. A higher number of completed sessions indicates greater intervention tolerability", "time_frame": "During each tDCS session throughout the 30-session intervention period" }, { "type": "secondary", "measure": "Adverse Effects Related to tDCS", "description": "Adverse effects related to tDCS will be monitored and recorded at each stimulation session. Potential adverse effects include tingling, itching, headache, discomfort, burning sensation, dizziness, or transient erythema at the electrode site. The presence, type, and severity of adverse effects will be documented. Severity will be classified as mild, moderate, or severe.", "time_frame": "During each tDCS session throughout the 30-session intervention period" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in EuroQol 5-Dimension 5-Level Questionnaire Score", "description": "Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across five levels of severity. Higher scores or index values reflect better health status, depending on the scoring method used. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Modified Fatigue Impact Scale Score", "description": "Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS). The MFIS assesses the impact of fatigue on physical, cognitive, and psychosocial functioning. The total score ranges from 0 to 84, with higher scores indicating greater fatigue impact. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Montreal Cognitive Assessment Score", "description": "Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates cognitive domains including attention, memory, language, visuospatial abilities, executive function, abstraction, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Short Form-36 Health Survey Score", "description": "Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36). The SF-36 evaluates eight domains of health-related quality of life: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Verbal Fluency Task Performance", "description": "Verbal fluency will be assessed using verbal fluency tasks. Performance will be evaluated based on the number of correct words generated within the specified time period. Higher scores indicate better verbal fluency performance. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "primary", "measure": "Change in Stroop Test Performance", "description": "Executive function, inhibitory control, and cognitive flexibility will be assessed using the Stroop test. Performance will be evaluated using test-specific measures such as response accuracy and/or completion time. Better performance is reflected by higher accuracy and/or shorter completion time, depending on the scoring method used. Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Change in Brain Metabolism", "description": "Brain metabolism will be assessed using positron emission tomography-computed tomography (PET-CT). Changes from baseline to post-intervention will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Change in Heart Rate Variability", "description": "Autonomic nervous system activity will be assessed using heart rate variability (HRV) recorded under resting conditions. Time-domain, frequency-domain, and non-linear HRV indices will be evaluated to characterize changes in autonomic regulation.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Change in Endurance Capacity", "description": "Endurance capacity will be assessed using the Ekblom-Bak submaximal cycle ergometer test. Heart rate responses, perceived exertion, estimated maximal oxygen uptake, and internal load will be evaluated under standardized conditions.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Change in Handgrip Strength", "description": "Upper-limb muscle strength will be assessed using handgrip dynamometry. Participants will perform three maximal attempts, and the highest value will be used for analysis.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Change in Lower-Limb Neuromuscular Performance", "description": "Lower-limb neuromuscular performance will be assessed using the countermovement jump test performed on a force platform. Variables related to force and power production will be evaluated.", "time_frame": "Baseline and 3 days after completion of the 30-session tDCS intervention" }, { "type": "secondary", "measure": "Tolerability of the tDCS Intervention", "description": "Tolerability of the tDCS intervention will be assessed during each stimulation session using session monitoring records and participant reports. Tolerability will be evaluated based on the number of completed tDCS sessions out of the 30 scheduled sessions and the participant's ability to complete each session without clinically relevant discomfort. A higher number of completed sessions indicates greater intervention tolerability", "time_frame": "During each tDCS session throughout the 30-session intervention period" }, { "type": "secondary", "measure": "Adverse Effects Related to tDCS", "description": "Adverse effects related to tDCS will be monitored and recorded at each stimulation session. Potential adverse effects include tingling, itching, headache, discomfort, burning sensation, dizziness, or transient erythema at the electrode site. The presence, type, and severity of adverse effects will be documented. Severity will be classified as mild, moderate, or severe.", "time_frame": "During each tDCS session throughout the 30-session intervention period" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07709234", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07711444", "title": "The Efficacy of Long-Chain Fatty Acids, Eicosapentaenoic Acid (EPA) and Specialized Pro-Resolving Mediators (SPMs), in Treating Long COVID Neuropsychiatric Symptoms", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-07-21", "start_date": "2024-06-01", "completion_date": "2026-06-01", "primary_completion_date": "2025-12-01", "conditions_raw": [ "COVID - 19", "Depression - Major Depressive Disorder" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Eicosapentaenoic Acid", "Specialized Pro-Resolving Lipid Mediator" ], "sponsor": "National Science and Technology Council, Taiwan", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "Researchers conducted a 12-week, double-blind, randomized, placebo-controlled trial to assess the effectiveness of EPA or SPM treatments versus a placebo in managing Long COVID symptoms in adult patients. Researchers planned to enroll 240 eligible participants from various general and psychiatric hospitals in Taiwan. The focus was on evaluating the therapeutic impact and potential side effects of administering 3 g/day of EPA or 1.67 mg/day of SPMs on symptoms of depression in these patients. This consolidated approach aims to provide comprehensive insights into the efficacy of EPA and SPM treatments in Long COVID cases, addressing crucial mental health aspects.", "primary_outcomes": [ { "type": "primary", "measure": "Hamilton Depression Rating Scale (HAMD)", "description": "Adult depressive symptoms were assessed using the 21-item HAMD at baseline (week 0) and at weeks 1, 2, 4, 8, and 12.", "time_frame": "(week 0) and at weeks 1, 2, 4, 8, and 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Erythrocyte Omega-3 Polyunsaturated Fatty Acids", "description": "Peripheral blood samples were collected at baseline and at the end of the 12-week intervention period using EDTA-containing tubes for erythrocyte fatty acid analysis", "time_frame": "Week 0 and Week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Hamilton Depression Rating Scale (HAMD)", "description": "Adult depressive symptoms were assessed using the 21-item HAMD at baseline (week 0) and at weeks 1, 2, 4, 8, and 12.", "time_frame": "(week 0) and at weeks 1, 2, 4, 8, and 12" }, { "type": "secondary", "measure": "Erythrocyte Omega-3 Polyunsaturated Fatty Acids", "description": "Peripheral blood samples were collected at baseline and at the end of the 12-week intervention period using EDTA-containing tubes for erythrocyte fatty acid analysis", "time_frame": "Week 0 and Week 12" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other Gov" ], "enrollment": 54, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07711444", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07714213", "title": "Post-acute Infectious Syndrome - Aripiprazole Symptom Evaluation (PAIS-AriSE)", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2026-07-20", "start_date": "2026-10-01", "completion_date": "2028-12-31", "primary_completion_date": "2028-05-15", "conditions_raw": [ "Post-acute Infectious Syndrome (PAIS)", "Post-COVID-19 Condition (PCC or Long COVID)" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Aripiprazole" ], "sponsor": "Christiana Franke", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Post-acute infectious syndrome (PAIS), including post-COVID-19 condition (PCC or Long COVID), can develop after an infection and may cause persistent symptoms such as fatigue, problems with memory and concentration (\"brain fog\"), mood changes, and reduced quality of life. In some people, these symptoms continue for months or longer and can substantially affect daily activities. Currently, there are no approved treatments that specifically target these symptoms.\n\nAripiprazole is a medicine that is approved to treat certain psychiatric disorders. At low doses, it may affect brain signaling and immune processes that are thought to contribute to symptoms experienced by people with PAIS. Small observational studies have suggested that low-dose aripiprazole may improve symptoms such as fatigue and cognitive impairment in people with related conditions, but its effectiveness and safety have not yet been confirmed in a randomized controlled trial.\n\nThe purpose of this study is to evaluate whether low-dose aripiprazole is safe and more effective than placebo in improving fatigue and other neuropsychiatric symptoms in adults with PAIS.\n\nThis is a phase 2b, randomized, double-blind, placebo-controlled crossover trial. Approximately 138 participants with PAIS will be enrolled. Participants will be randomly assigned to one of two treatment sequences. One group will receive low-dose aripiprazole for 8 weeks followed by placebo for 8 weeks. The other group will receive placebo first, followed by low-dose aripiprazole. The two treatment periods will be separated by a 2-week washout period. Neither the participants nor the study team will know which treatment is being given during each treatment period.\n\nThe primary objective is to determine whether low-dose aripiprazole improves fatigue after the first 8-week treatment period compared with placebo. Fatigue will be assessed using the Chalder Fatigue Questionnaire. Secondary objectives include evaluating the effects of treatment on physical functioning, quality of life, memory and cognitive performance, mood, post-exertional malaise, illness-related anxiety and distress, and fatigue in participants who meet diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Safety will be assessed throughout the study by monitoring adverse events.\n\nThe results of this study may help determine whether low-dose aripiprazole is a safe and effective treatment option for people with PAIS", "primary_outcomes": [ { "type": "primary", "measure": "Intra-patient change in the Chalder Fatigue Scale (CFQ) by ≥ 3 points from baseline to week 9 in patients with PAIS.", "description": "The CFQ assesses the extent and severity of fatigue and has been used in multiple randomized controlled trials of behavioral interventions in patients with ME/CFS. Each of the 11 items is rated on a 4-point scale, resulting in a total score ranging from 0 (no symptoms) to 33 (maximum symptom severity). In this trial, intra-patient change in CFQ by ≥3 points from baseline to week 9 will be interpreted as meaningful improvement.", "time_frame": "9 weeks after first IMP intake" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Intra-patient change in CFQ by ≥3 points from baseline to week 9 in the subgroup fulfilling ME/CFS criteria.", "description": "@Studyteam: Please add a description of how the ME/CFS subgroup is defined in this trial.", "time_frame": "9 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in CFQ from baseline to week 19 and from week 9 to week 19.", "description": "The within-patient change in physical and mental fatigue, as measured by the CFQ, will be assessed from baseline to week 19 and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Fatigue Severity Score (FSS) from baseline to week 9 and to week 19 and from week 9 to week 19.", "description": "The FSS is a 9-item scale that assesses fatigue severity and its impact on a person's activities and lifestyle. Each item is rated on a 7-point scale (1 = strongly disagree; 7 = strongly agree), resulting in a total score ranging from 9 (no fatigue) to 63 (severe fatigue). The within-patient change in fatigue severity will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Bell Disability Scale from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The Bell Disability Scale is a standard assessment tool used to evaluate functional ability in adults with ME/CFS. It comprises 11 statements describing the patient's functional status, including symptom severity at rest and during activity, overall activity level, and the ability to work, travel, and perform self-care activities. Scores range from 0 (bedridden) to 100 (no symptoms and fully functional). The within-patient change in functional ability will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the PROMIS-29 questionnaire from baseline to week 9 and to week 19 and from week 9 to week 19.", "description": "The PROMIS-29 is a patient-reported outcome measure that assesses physical, mental, and social health. It can be used in both the general population and individuals with chronic health conditions. The within-patient changes in the health domains assessed by the PROMIS-29 will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Short Form 36 Health Survey - Physical Functioning (SF-36 PF) from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The Short Form 36 Health Survey (SF-36) is an established and widely used measure of health-related quality of life. The Physical Functioning (PF) domain assesses limitations in ten activities related to mobility and self-care, such as walking specified distances, carrying groceries, bathing, and dressing. Scores are weighted and transformed to a scale ranging from 0 (severe functional limitations) to 100 (no functional limitations). The within-patient change in SF-36 PF will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Multifactorial Memory Questionnaire (MMQ) subscale memory satisfaction from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The MMQ is a participant-reported outcome measure that assesses different aspects of subjective memory functioning. It comprises three subscales assessing memory satisfaction, perceived memory ability, and the use of memory strategies. The MMQ memory satisfaction subscale consists of 18 items rated on a 5-point Likert scale based on the participant's experiences during the previous two weeks. Scores range from 0 to 72, with higher scores indicating greater satisfaction with memory. A change of 13 points is considered clinically meaningful. The within-patient change in memory satisfaction will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Becks Depression Inventory (BDI-II) from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The BDI-II is a widely used self-report questionnaire that assesses the severity of depressive symptoms in individuals aged 13 years and older. It consists of 21 items, each assessing a specific symptom of depression. Each item is rated on a scale from 0 to 3, with higher total scores indicating greater severity of depressive symptoms. The within-patient change in the severity of depressive symptoms will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Post Exertional Malaise (PEM) questionnaire from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The PEM questionnaire assesses the frequency, severity, and duration of PEM. Frequency and severity scores each range from 0 to 20, with higher scores indicating more frequent and more severe PEM, respectively. Duration scores range from 0 to 6, with higher scores indicating longer-lasting PEM. The within-patient change in PEM frequency, severity, and duration will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Somatic Symptom Disorder-B Criteria Scale (SSD-12) from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The SSD-12 is a 12-item self-report questionnaire that assesses the psychological features associated with somatic symptom disorder according to the DSM-5 B criteria. It assesses cognitive, affective, and behavioral responses to somatic symptoms, with four items covering each domain. Each item is rated on a 5-point scale from 0 to 4, resulting in a total score ranging from 0 to 48. Higher scores indicate greater psychological distress and symptom-related thoughts, feelings, and behaviors associated with somatic symptoms. The within-patient change in psychological responses to somatic symptoms will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Difference in the occurrence of Adverse Events (AE) and Serious Adverse Events (SAE) between Aripiprazole and Placebo (IMP safety).", "description": "The occurrence of adverse reactions and other safety events, including but not limited to infections, endocrine disorders, and psychiatric complications, will be assessed based on AE, SAE, and SUSAR reporting.", "time_frame": "9 and 19 weeks after first IMP intake" } ], "outcome_measures": [ { "type": "primary", "measure": "Intra-patient change in the Chalder Fatigue Scale (CFQ) by ≥ 3 points from baseline to week 9 in patients with PAIS.", "description": "The CFQ assesses the extent and severity of fatigue and has been used in multiple randomized controlled trials of behavioral interventions in patients with ME/CFS. Each of the 11 items is rated on a 4-point scale, resulting in a total score ranging from 0 (no symptoms) to 33 (maximum symptom severity). In this trial, intra-patient change in CFQ by ≥3 points from baseline to week 9 will be interpreted as meaningful improvement.", "time_frame": "9 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in CFQ by ≥3 points from baseline to week 9 in the subgroup fulfilling ME/CFS criteria.", "description": "@Studyteam: Please add a description of how the ME/CFS subgroup is defined in this trial.", "time_frame": "9 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in CFQ from baseline to week 19 and from week 9 to week 19.", "description": "The within-patient change in physical and mental fatigue, as measured by the CFQ, will be assessed from baseline to week 19 and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Fatigue Severity Score (FSS) from baseline to week 9 and to week 19 and from week 9 to week 19.", "description": "The FSS is a 9-item scale that assesses fatigue severity and its impact on a person's activities and lifestyle. Each item is rated on a 7-point scale (1 = strongly disagree; 7 = strongly agree), resulting in a total score ranging from 9 (no fatigue) to 63 (severe fatigue). The within-patient change in fatigue severity will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Bell Disability Scale from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The Bell Disability Scale is a standard assessment tool used to evaluate functional ability in adults with ME/CFS. It comprises 11 statements describing the patient's functional status, including symptom severity at rest and during activity, overall activity level, and the ability to work, travel, and perform self-care activities. Scores range from 0 (bedridden) to 100 (no symptoms and fully functional). The within-patient change in functional ability will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the PROMIS-29 questionnaire from baseline to week 9 and to week 19 and from week 9 to week 19.", "description": "The PROMIS-29 is a patient-reported outcome measure that assesses physical, mental, and social health. It can be used in both the general population and individuals with chronic health conditions. The within-patient changes in the health domains assessed by the PROMIS-29 will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Short Form 36 Health Survey - Physical Functioning (SF-36 PF) from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The Short Form 36 Health Survey (SF-36) is an established and widely used measure of health-related quality of life. The Physical Functioning (PF) domain assesses limitations in ten activities related to mobility and self-care, such as walking specified distances, carrying groceries, bathing, and dressing. Scores are weighted and transformed to a scale ranging from 0 (severe functional limitations) to 100 (no functional limitations). The within-patient change in SF-36 PF will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Multifactorial Memory Questionnaire (MMQ) subscale memory satisfaction from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The MMQ is a participant-reported outcome measure that assesses different aspects of subjective memory functioning. It comprises three subscales assessing memory satisfaction, perceived memory ability, and the use of memory strategies. The MMQ memory satisfaction subscale consists of 18 items rated on a 5-point Likert scale based on the participant's experiences during the previous two weeks. Scores range from 0 to 72, with higher scores indicating greater satisfaction with memory. A change of 13 points is considered clinically meaningful. The within-patient change in memory satisfaction will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Becks Depression Inventory (BDI-II) from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The BDI-II is a widely used self-report questionnaire that assesses the severity of depressive symptoms in individuals aged 13 years and older. It consists of 21 items, each assessing a specific symptom of depression. Each item is rated on a scale from 0 to 3, with higher total scores indicating greater severity of depressive symptoms. The within-patient change in the severity of depressive symptoms will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Post Exertional Malaise (PEM) questionnaire from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The PEM questionnaire assesses the frequency, severity, and duration of PEM. Frequency and severity scores each range from 0 to 20, with higher scores indicating more frequent and more severe PEM, respectively. Duration scores range from 0 to 6, with higher scores indicating longer-lasting PEM. The within-patient change in PEM frequency, severity, and duration will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Intra-patient change in the Somatic Symptom Disorder-B Criteria Scale (SSD-12) from baseline to week 9 and to week 19 and from week 9 to week 19", "description": "The SSD-12 is a 12-item self-report questionnaire that assesses the psychological features associated with somatic symptom disorder according to the DSM-5 B criteria. It assesses cognitive, affective, and behavioral responses to somatic symptoms, with four items covering each domain. Each item is rated on a 5-point scale from 0 to 4, resulting in a total score ranging from 0 to 48. Higher scores indicate greater psychological distress and symptom-related thoughts, feelings, and behaviors associated with somatic symptoms. The within-patient change in psychological responses to somatic symptoms will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.", "time_frame": "9 and 19 weeks after first IMP intake" }, { "type": "secondary", "measure": "Difference in the occurrence of Adverse Events (AE) and Serious Adverse Events (SAE) between Aripiprazole and Placebo (IMP safety).", "description": "The occurrence of adverse reactions and other safety events, including but not limited to infections, endocrine disorders, and psychiatric complications, will be assessed based on AE, SAE, and SUSAR reporting.", "time_frame": "9 and 19 weeks after first IMP intake" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 138, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07714213", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05092516", "title": "Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-07-17", "start_date": "2022-06-07", "completion_date": "2026-09-15", "primary_completion_date": "2025-03-13", "conditions_raw": [ "Dysexecutive Syndrome", "Post-Acute Sequelae of COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Active Tdcs" ], "sponsor": "Massachusetts General Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.", "primary_outcomes": [ { "type": "primary", "measure": "Inhibitory Control", "description": "Performance during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.", "time_frame": "Baseline" }, { "type": "primary", "measure": "Inhibitory Control", "description": "Performance during the incongruent trials of the Eriksen Flanker Task were assessed approximately approximately 4-weeks after baseline. The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.", "time_frame": "Posttreatment (1 month follow-up)" }, { "type": "primary", "measure": "Processing Speed", "description": "Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention)", "time_frame": "Baseline" }, { "type": "primary", "measure": "Processing Speed", "description": "Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline.", "time_frame": "Posttreatment (1 month follow-up)" }, { "type": "primary", "measure": "EEG P300 Event-related Potential", "description": "EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.", "time_frame": "Baseline" }, { "type": "primary", "measure": "EEG P300 Event-related Potential", "description": "EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline. EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.", "time_frame": "Posttreatment (1 month follow-up)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Cognitive Flexibility", "description": "Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Cognitive Flexibility", "description": "Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.", "time_frame": "Posttreatment (1 month follow-up)" }, { "type": "secondary", "measure": "Working Memory", "description": "Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Working Memory", "description": "Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.", "time_frame": "Posttreatment (1 month follow-up)" }, { "type": "secondary", "measure": "Episodic Memory", "description": "Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Episodic Memory", "description": "Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.", "time_frame": "Posttreatment (1 month follow-up)" } ], "outcome_measures": [ { "type": "primary", "measure": "Inhibitory Control", "description": "Performance during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.", "time_frame": "Baseline" }, { "type": "primary", "measure": "Inhibitory Control", "description": "Performance during the incongruent trials of the Eriksen Flanker Task were assessed approximately approximately 4-weeks after baseline. The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.", "time_frame": "Posttreatment (1 month follow-up)" }, { "type": "primary", "measure": "Processing Speed", "description": "Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention)", "time_frame": "Baseline" }, { "type": "primary", "measure": "Processing Speed", "description": "Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline.", "time_frame": "Posttreatment (1 month follow-up)" }, { "type": "primary", "measure": "EEG P300 Event-related Potential", "description": "EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.", "time_frame": "Baseline" }, { "type": "primary", "measure": "EEG P300 Event-related Potential", "description": "EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline. EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.", "time_frame": "Posttreatment (1 month follow-up)" }, { "type": "secondary", "measure": "Cognitive Flexibility", "description": "Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Cognitive Flexibility", "description": "Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.", "time_frame": "Posttreatment (1 month follow-up)" }, { "type": "secondary", "measure": "Working Memory", "description": "Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Working Memory", "description": "Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.", "time_frame": "Posttreatment (1 month follow-up)" }, { "type": "secondary", "measure": "Episodic Memory", "description": "Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Episodic Memory", "description": "Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.", "time_frame": "Posttreatment (1 month follow-up)" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 31, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05092516", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05705648", "title": "Nutritional Management of Post COVID-19 Cognitive Symptoms", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-07-17", "start_date": "2023-10-01", "completion_date": "2027-03-01", "primary_completion_date": "2026-06-24", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Medium Chain Triglyceride Oil", "Safflower Oil" ], "sponsor": "University of Alberta", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to learn about in brain \"fog\" complaints associated with long-COVID in people aged 22-50-years. The main questions it aims to answer are:\n\n* the natural course of brain \"fog\" complaints\n* the effect, if any of supplemental dietary oil on brain \"fog\" complaints Participants will be asked to undergo some brain testing (X-rays and questions. Treatments they'll be given will be one of two supplemental oils to consume daily.\n\nResearchers will compare outcomes in the two different oil groups to see if it has any effect on brain \"fog\" complaints.", "primary_outcomes": [ { "type": "primary", "measure": "Cognigram(R)", "description": "computer-based cognitive test", "time_frame": "12-months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Montreal Cognitive Assessment", "description": "Cognitive test", "time_frame": "12-months" } ], "outcome_measures": [ { "type": "primary", "measure": "Cognigram(R)", "description": "computer-based cognitive test", "time_frame": "12-months" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment", "description": "Cognitive test", "time_frame": "12-months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 103, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05705648", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05877534", "title": "Effects of Individual Tailored Physical Exercise in Patients With POTS After COVID-19 - a Randomized Controlled Study", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-07-15", "start_date": "2023-05-25", "completion_date": "2026-11-01", "primary_completion_date": "2025-10-01", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome", "COVID-19", "Post COVID-19 Condition", "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Individual Tailored Exercise" ], "sponsor": "Karolinska Institutet", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Covid-19 has the potential to affect physical, cognitive and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. The term post COVID-19 condition (defined by WHO) is used to describe the wide range of prolonged symptoms following the infection. Patients may need specialized rehabilitation to be able to meet the complex symptoms and problems that may arise. A more specific syndrome that seems to occur more frequently than expected in the group of non-hospitalized patients with post COVID-19 condition is the postural orthostatic tachycardia syndrome (POTS).\n\nA randomized controlled design will be used to evaluate the effects of individual tailored physical exercise in patients with POTS after Covid-19.\n\nParticipants: Adults (\\>18 years) with post COVID-19 condition and diagnosed with POTS (n=60) will be included. Exclusion criteria: known pregnancy, cancer, already ongoing individual physical exercise (specific for POTS), or not able to perform measurements and/or intervention.\n\nProcedure and outcomes: The primary outcomes are objectively measured time in upright position and health-related quality of life. Secondary outcomes are: physical activity, physical capacity, work ability and disease specific symptoms measured with tests and questionnaires.\n\nPrior to randomization baseline measurements will be performed, aswell as after 16 weeks, 6 months and 12 months.\n\nIntervention: Participants randomized to intervention will receive standard care and undergo a individually designed physical exercise program during 16 weeks, supervised and guided by a physiotherapist. The intervention will consist of different exercises to enhance muscle strength and endurance. Progression will be according to a program (based on previous feasibility studie) but should be halted if post exertional malaise (PEM) or other problems occur.\n\nControls: Participants randomized to control will receive standard care during 16 weeks.\n\nMeasurements of both groups (control and intervention) will be repeated after completion of a period of 16 weeks.", "primary_outcomes": [ { "type": "primary", "measure": "Change in time in upright position and steps per day", "description": "Measured with two accelerometers, one attached to the chest and one to the lower limbs, to measure time (hours, minutes) in upright position", "time_frame": "through study completion, an average of 1 year" }, { "type": "primary", "measure": "Change in Health-Related Quality of Life (HRQoL)", "description": "Measured with EuroQualityOf Life 5 dimensions questionnaire (EQ-5D-5L), which is an instrument that evaluates the generic quality of life. EQ-5D includes a descriptive system, which comprises 5 dimensions of health: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. A descriptive index-score between 0-1, higher score indicates higher HRQoL. EQ-5D also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL.", "time_frame": "through study completion, an average of 1 year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in walking distance during 6 minute walk test", "description": "Change in walking distance measured in meters during 6 minutes walk test (6MWT)", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in oxygen saturation during 6 minute walk test", "description": "Change in the lowest oxygen saturation level measured in percentage (%) with pulse oximetry during 6 minute walk test", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in dyspnea during 6 minute walk test", "description": "Change in perceived dyspnea measured with Borg Category-Ratio scale (Borg CR-10) at the end of 6 minute walk test. Borg CR-10 ranging between 0-10. The higher the score, the higher the dyspnea.\n\ncalculated by subtracting the oxygen level at rest before the test with the lowest level during the test.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in leg fatigue during 6 minute walk test", "description": "Change in perceived leg fatigue measured with Borg CR-10 at the end of 6 minute walk test. Borg CR-10 ranging between 0-10. The higher the score, the higher the leg fatigue. test. Borg CR-10 ranging between 0-10. The higher the score, the higher the dyspnea.\n\ncalculated by subtracting the oxygen level at rest before the test with the lowest level during the test.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in exertion during 6 minute walk test", "description": "Change in perceived exertion measured with Borg Rating of Perceived Exertion (Borg RPE) at the end of 6 minutes walk test. Borg RPE ranging between 6-20. The higher the score, the higher the exertion.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in heart rate during 6 minute walk test", "description": "Change in the highest heart rate measured in beats per minute with pulseoxymeter during 6 minute walk test", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Self-reported POTS-symptoms", "description": "Measured with Malmö-POTS-questionnaire (MaPS), which is a self assessment tool examining common symptoms in POTS. MaPS consists of 12 items. Patients are asked to rate symptoms on a scale from 0-10 on each item. 0 i= no symptom and 10 = worst imaginable. Total score ranging from 0-120. Higher score indicates more POTS-symptoms.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Anxiety - Generalised Anxiety Disorder 7-item scale", "description": "Measured with Generalised Anxiety Disorder 7-item scale (GAD-7) which is a self assessment tool. Total score ranging from 0-21. Higher score indicates higher anxiety.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Depression - Patient Health Questionnaire-9", "description": "Measured with Patient Health Questionnaire-9 (PHQ-9). PHQ-9 which contains 9 items. Total score ranges from 0 to 27. Higher score indicate more severe depression symptoms", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Fatigue", "description": "Measured with Fatigue Severity Scale (FSS), which is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Total score ranging from 9-63. The higher the score, the more severe the fatigue is. Fatigue also measured with Mental Fatigue Scale (MFS), which is a 15-item scale that measures the severity of mental fatigue. Total score ranging from 0-44. The higher the score, the more severe the fatigue is.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Self-reported outcome measure of physical function", "description": "Measured with Patient Specific Functional Scale (PSFS), a questionnaire that can be used to quantify activity limitation and measure functional outcome for patients. Patients are asked to identify three to five important activities they are unable to perform or are having difficulty with because of their problem. In addition to identifying the activities, patients are asked to rate, on a scale ranging from 0-10, the current level of difficulty associated with each activity. The higher the score, the less difficulty to perform the activity", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in blood pressure during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in systolic and diastolic blood pressure after getting up to standing from the supine position", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in heart rate response during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in heart rate after getting up to standing from the supine position.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in oxygen saturation during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in oxygen saturation, measured with pulse oximetry, after getting up to standing from the supine position.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in respiratory rate during Active Standing Test", "description": "Change in respiratory rate, measured in number of breaths/min before and after the Active Standing Test", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in dyspnea during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in perceived dyspnea measured with Borg CR-10 scale after getting up to standing from the supine position.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in leg fatigue during Active Standing Test", "description": "Change in perceived leg fatigue measured with Borg CR-10 before, during and at the end of Active Standing Test.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in exertion during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in perceived exertion with Borg RPE scale after getting up to standing from the supine position.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Physical activity", "description": "Measured with Frändin/Grimby activity scale, which is a self-assessment scale about current levels of physical activity, ranging from 1 to 6. The higher the score, the higher the level of physical activity", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in orthostatic symptoms", "description": "Assessed with the Vanderbilt Orthostatic Symptom Scale (VOSS). After the Active standing test (AST) the participant uses a self-assessment questionnaire about orthostatic symptoms prominent during the Active standing test (performed according to a specific protocol with measurements of responses in systolic and diastolic blood pressure after getting up to standing from the supine position). The scale range from 0=no symptoms, to 10=worst imaginable symptoms. The scale includes 9 items regarding orthostatic symptoms and the higher the score, the higher level of symptoms during the orthostatic test.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in insomnia", "description": "Measured with Insomnia Severity Index (ISI), a 7-item questionnaire. Score between 0-28, with higher score indication a more severe insomnia.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Workability", "description": "Measured in percentage of full time work, ranging from 0-100%", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in muscle strength", "description": "Measured with the wireless microFET®2 Digital Handheld Dynamometer muscle tester. measurements of isometric muscle strength will be carried out on muscles in the lower extremity according to guidelines.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in post-exertional-Malaise (PEM)", "description": "Measured by the quiestionnaire; DePaul Symptom Questionnaire-Post Exertional Malaise Short-form (DSQ-PEM). DSQ-PEM is a 10 item questionnaire that includes scoring of frequency and severity of PEM and indicate if ME/CFS may be present. Higher score indicates more severe PEM.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in pharmacological treatment of POTS", "description": "Assessed by gathering information from the participants and from their medical journal of what type of pharmacological treatment they're in need of and the dose.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Compliance to intervention", "description": "Assessed by participant diaries during 16weeks", "time_frame": "through study completion, an average of 1 year" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in time in upright position and steps per day", "description": "Measured with two accelerometers, one attached to the chest and one to the lower limbs, to measure time (hours, minutes) in upright position", "time_frame": "through study completion, an average of 1 year" }, { "type": "primary", "measure": "Change in Health-Related Quality of Life (HRQoL)", "description": "Measured with EuroQualityOf Life 5 dimensions questionnaire (EQ-5D-5L), which is an instrument that evaluates the generic quality of life. EQ-5D includes a descriptive system, which comprises 5 dimensions of health: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. A descriptive index-score between 0-1, higher score indicates higher HRQoL. EQ-5D also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in walking distance during 6 minute walk test", "description": "Change in walking distance measured in meters during 6 minutes walk test (6MWT)", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in oxygen saturation during 6 minute walk test", "description": "Change in the lowest oxygen saturation level measured in percentage (%) with pulse oximetry during 6 minute walk test", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in dyspnea during 6 minute walk test", "description": "Change in perceived dyspnea measured with Borg Category-Ratio scale (Borg CR-10) at the end of 6 minute walk test. Borg CR-10 ranging between 0-10. The higher the score, the higher the dyspnea.\n\ncalculated by subtracting the oxygen level at rest before the test with the lowest level during the test.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in leg fatigue during 6 minute walk test", "description": "Change in perceived leg fatigue measured with Borg CR-10 at the end of 6 minute walk test. Borg CR-10 ranging between 0-10. The higher the score, the higher the leg fatigue. test. Borg CR-10 ranging between 0-10. The higher the score, the higher the dyspnea.\n\ncalculated by subtracting the oxygen level at rest before the test with the lowest level during the test.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in exertion during 6 minute walk test", "description": "Change in perceived exertion measured with Borg Rating of Perceived Exertion (Borg RPE) at the end of 6 minutes walk test. Borg RPE ranging between 6-20. The higher the score, the higher the exertion.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in heart rate during 6 minute walk test", "description": "Change in the highest heart rate measured in beats per minute with pulseoxymeter during 6 minute walk test", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Self-reported POTS-symptoms", "description": "Measured with Malmö-POTS-questionnaire (MaPS), which is a self assessment tool examining common symptoms in POTS. MaPS consists of 12 items. Patients are asked to rate symptoms on a scale from 0-10 on each item. 0 i= no symptom and 10 = worst imaginable. Total score ranging from 0-120. Higher score indicates more POTS-symptoms.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Anxiety - Generalised Anxiety Disorder 7-item scale", "description": "Measured with Generalised Anxiety Disorder 7-item scale (GAD-7) which is a self assessment tool. Total score ranging from 0-21. Higher score indicates higher anxiety.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Depression - Patient Health Questionnaire-9", "description": "Measured with Patient Health Questionnaire-9 (PHQ-9). PHQ-9 which contains 9 items. Total score ranges from 0 to 27. Higher score indicate more severe depression symptoms", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Fatigue", "description": "Measured with Fatigue Severity Scale (FSS), which is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Total score ranging from 9-63. The higher the score, the more severe the fatigue is. Fatigue also measured with Mental Fatigue Scale (MFS), which is a 15-item scale that measures the severity of mental fatigue. Total score ranging from 0-44. The higher the score, the more severe the fatigue is.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Self-reported outcome measure of physical function", "description": "Measured with Patient Specific Functional Scale (PSFS), a questionnaire that can be used to quantify activity limitation and measure functional outcome for patients. Patients are asked to identify three to five important activities they are unable to perform or are having difficulty with because of their problem. In addition to identifying the activities, patients are asked to rate, on a scale ranging from 0-10, the current level of difficulty associated with each activity. The higher the score, the less difficulty to perform the activity", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in blood pressure during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in systolic and diastolic blood pressure after getting up to standing from the supine position", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in heart rate response during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in heart rate after getting up to standing from the supine position.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in oxygen saturation during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in oxygen saturation, measured with pulse oximetry, after getting up to standing from the supine position.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in respiratory rate during Active Standing Test", "description": "Change in respiratory rate, measured in number of breaths/min before and after the Active Standing Test", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in dyspnea during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in perceived dyspnea measured with Borg CR-10 scale after getting up to standing from the supine position.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in leg fatigue during Active Standing Test", "description": "Change in perceived leg fatigue measured with Borg CR-10 before, during and at the end of Active Standing Test.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in exertion during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in perceived exertion with Borg RPE scale after getting up to standing from the supine position.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Physical activity", "description": "Measured with Frändin/Grimby activity scale, which is a self-assessment scale about current levels of physical activity, ranging from 1 to 6. The higher the score, the higher the level of physical activity", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in orthostatic symptoms", "description": "Assessed with the Vanderbilt Orthostatic Symptom Scale (VOSS). After the Active standing test (AST) the participant uses a self-assessment questionnaire about orthostatic symptoms prominent during the Active standing test (performed according to a specific protocol with measurements of responses in systolic and diastolic blood pressure after getting up to standing from the supine position). The scale range from 0=no symptoms, to 10=worst imaginable symptoms. The scale includes 9 items regarding orthostatic symptoms and the higher the score, the higher level of symptoms during the orthostatic test.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in insomnia", "description": "Measured with Insomnia Severity Index (ISI), a 7-item questionnaire. Score between 0-28, with higher score indication a more severe insomnia.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in Workability", "description": "Measured in percentage of full time work, ranging from 0-100%", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in muscle strength", "description": "Measured with the wireless microFET®2 Digital Handheld Dynamometer muscle tester. measurements of isometric muscle strength will be carried out on muscles in the lower extremity according to guidelines.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in post-exertional-Malaise (PEM)", "description": "Measured by the quiestionnaire; DePaul Symptom Questionnaire-Post Exertional Malaise Short-form (DSQ-PEM). DSQ-PEM is a 10 item questionnaire that includes scoring of frequency and severity of PEM and indicate if ME/CFS may be present. Higher score indicates more severe PEM.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Change in pharmacological treatment of POTS", "description": "Assessed by gathering information from the participants and from their medical journal of what type of pharmacological treatment they're in need of and the dose.", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Compliance to intervention", "description": "Assessed by participant diaries during 16weeks", "time_frame": "through study completion, an average of 1 year" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05877534", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06940609", "title": "Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-07-15", "start_date": "2025-07-07", "completion_date": "2029-06-30", "primary_completion_date": "2029-06-30", "conditions_raw": [ "Long COVID", "Long COVID Syndrome", "Long COVID-19 Syndrome", "PASC", "PASC Post Acute Sequelae of COVID 19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Accelerated Intermittent Theta Burst Stimulation" ], "sponsor": "University of New Mexico", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to test whether a type of rapid outpatient brain stimulation that uses magnetic fields, called accelerated intermittent theta burst stimulation (iTBS), can treat symptoms such as brain fog, depression, and anxiety in patients with Long COVID. The main questions it aims to answer are:\n\n* Is iTBS effective and feasible for reducing Long COVID symptoms? We will measure these symptoms using the Symptom Burden Questionnaire.\n* Are there changes in inflammatory brain chemicals associated with treatment with iTBS? We will be looking at levels of choline in the brain, which is thought to be related to inflammation.\n\nResearchers will compare sham versus active forms of iTBS to see if the active group has greater improvement in symptoms.\n\nParticipants will complete symptom surveys, cognitive tests, and magnetic resonance imaging scans at the beginning, middle, and end of treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Aim 1", "description": "Demonstrate that accelerated iTBS is effective and feasible for reducing neuro-PASC symptoms. Change in the score in the \"Cognitive Function/Brain Fog Symptoms\" score from the PACS: Post-acute COVID-19 Syndrome Questionnaire, where low scores are more severe symptoms compared to higher scores. Scale 1-Severly Unable to 4-Able. Higher scores show improvement in symptoms.", "time_frame": "From baseline to end of treatment at 2 weeks" }, { "type": "primary", "measure": "Aim 2", "description": "Identify neurometabolic and structural features associated with outcomes in MANIFEST. ADCcho in the thalamus measured using dMRS. The apparent diffusion coefficient of choline (ADCcho) is a measure of activity of microglia, higher values indicate higher levels of microglia. Decreased ADCcho means less microglia activation, and less inflammation.", "time_frame": "From baseline to end of treatment at 2 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Aim 1", "description": "Demonstrate that accelerated iTBS is effective and feasible for reducing neuro-PASC symptoms. Change in the score in the \"Cognitive Function/Brain Fog Symptoms\" score from the PACS: Post-acute COVID-19 Syndrome Questionnaire, where low scores are more severe symptoms compared to higher scores. Scale 1-Severly Unable to 4-Able. Higher scores show improvement in symptoms.", "time_frame": "From baseline to end of treatment at 2 weeks" }, { "type": "primary", "measure": "Aim 2", "description": "Identify neurometabolic and structural features associated with outcomes in MANIFEST. ADCcho in the thalamus measured using dMRS. The apparent diffusion coefficient of choline (ADCcho) is a measure of activity of microglia, higher values indicate higher levels of microglia. Decreased ADCcho means less microglia activation, and less inflammation.", "time_frame": "From baseline to end of treatment at 2 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06940609", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05421208", "title": "Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-07-15", "start_date": "2022-06-01", "completion_date": "2027-06-30", "primary_completion_date": "2026-07-13", "conditions_raw": [ "Post-acute COVID-19 Syndrome", "Postural Tachycardia Syndrome (POTS)", "Long COVID", "SARS CoV 2 Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Effect On Inflammation After Chronic Pns Stimulation" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists beyond the 3-month convalescence period after COVID-19 infections.\n\nThis syndrome affects mostly women (\\~80%), present with chronic tachycardia and Orthostatic intolerance symptoms without any identifiable cause. In addition, non-specific symptoms such as fatigue, headache, and \"brain fog\", commonly described in POTS patients are also present in this novel condition, recently named post-COVID-19 tachycardia syndrome, POTS variant.\n\nReduced Vagal activity and unresolved inflammation is post-COVID-19 POTS is hypothesized as the cause of Long COVID", "primary_outcomes": [ { "type": "primary", "measure": "IL-6 levels", "description": "Evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity. The primary endpoint is IL-6 levels", "time_frame": "Baseline to after 28 days of tVNS stimulation" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Orthostatic Symptoms Score", "description": "Standardized Orthostatic Symptoms Score COMPASS-31: Composite Autonomic Symptom Score EQ-5D: as a Quality of Life Measure in People with Dementia AD8 Dementia Scale: The AD8 was developed as a brief instrument to help discriminate between signs of normal aging and mild dementia.\n\nE-cog test: Everyday Cognition scales (ECog) , an informant-rated questionnaire designed to detect cognitive and functional decline.", "time_frame": "Baseline to after 28 days of tVNS stimulation" } ], "outcome_measures": [ { "type": "primary", "measure": "IL-6 levels", "description": "Evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity. The primary endpoint is IL-6 levels", "time_frame": "Baseline to after 28 days of tVNS stimulation" }, { "type": "secondary", "measure": "Orthostatic Symptoms Score", "description": "Standardized Orthostatic Symptoms Score COMPASS-31: Composite Autonomic Symptom Score EQ-5D: as a Quality of Life Measure in People with Dementia AD8 Dementia Scale: The AD8 was developed as a brief instrument to help discriminate between signs of normal aging and mild dementia.\n\nE-cog test: Everyday Cognition scales (ECog) , an informant-rated questionnaire designed to detect cognitive and functional decline.", "time_frame": "Baseline to after 28 days of tVNS stimulation" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05421208", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06086379", "title": "Cognitive Rehabilitation Therapy for COVID-19", "status": "ENROLLING_BY_INVITATION", "phase": "NA", "last_updated": "2026-07-15", "start_date": "2024-07-01", "completion_date": "2029-03-31", "primary_completion_date": "2027-06-30", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Compensatory Cognitive Training For Covid-19" ], "sponsor": "VA Office of Research and Development", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "Cognitive dysfunction, psychiatric symptoms, functional impairment, and disability following COVID-19 negatively impact Veterans' community functioning and quality of life, contribute to significant human suffering, and are costly to VHA. Rehabilitation is a critical priority for Veterans with long COVID. One promising treatment to improve functioning in Veterans with post-COVID-19 cognitive symptoms is Compensatory Cognitive Training (CCT). Previous studies have found that CCT is feasible, acceptable, and efficacious in Veteran populations with multiple sources of cognitive dysfunction. This randomized controlled trial aims to address important RR\\&D priorities by examining feasibility, acceptability, and preliminary efficacy of a COVID-19-specific rehabilitation intervention, CCT for long COVID (CCT-C) compared to a robust control condition. The proposed study has the potential to improve cognitive function, functional independence, and quality of life for Veterans with late or delayed effects of secondary conditions related to COVID-19 infections.", "primary_outcomes": [ { "type": "primary", "measure": "Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0)", "description": "Change in average total score", "time_frame": "baseline, 8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in objective cognitive performance z score", "description": "Change in composite z score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in functional capacity performance z score", "description": "Change in composite z score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire 9 (PHQ-9)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Generalized Anxiety Disorder 7 (GAD-7)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in PTSD Checklist for DSM-5 (PCL-5)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Cognitive Failures Questionnaire (CFQ)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Neuro-QOL: Applied Cognition General Concerns", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Neuro-QOL: Applied Cognition Executive Functioning", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Neuro-QOL: Fatigue", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in World Health Organization - Quality of Life (WHOQOL-BREF)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Insomnia Severity Index (ISI)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0)", "description": "Change in average total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in objective cognitive performance z score", "description": "Change in composite z score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in functional capacity performance z score", "description": "Change in composite z score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire 9 (PHQ-9)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Generalized Anxiety Disorder 7 (GAD-7)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in PTSD Checklist for DSM-5 (PCL-5)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Cognitive Failures Questionnaire (CFQ)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Neuro-QOL: Applied Cognition General Concerns", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Neuro-QOL: Applied Cognition Executive Functioning", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Neuro-QOL: Fatigue", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in World Health Organization - Quality of Life (WHOQOL-BREF)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" }, { "type": "secondary", "measure": "Change in Insomnia Severity Index (ISI)", "description": "Change in total score", "time_frame": "baseline, 8 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Fed" ], "enrollment": 70, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06086379", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06766825", "title": "Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC)", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2026-07-14", "start_date": "2025-02-07", "completion_date": "2026-09-10", "primary_completion_date": "2026-09-10", "conditions_raw": [ "Post COVID-19 Condition", "Long COVID Syndrome", "Persistent COVID-19", "Persistent COVID Condition", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Plitidepsin 1.5 Mg/Day" ], "sponsor": "Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The study aims to prove that plitidepsin could be an efficacious, safe, and well-tolerated therapy for PCC. To this end, we will perform a randomized, double-blind study comparing the clinical and laboratory benefits of plitidepsin vs. placebo in 90 subjects with moderate to severe functional disability. The study consists of an intervention period and a follow-up period, with a total of 135 +/-3 days approximately between both periods.\n\nDuring the intervention period, four treatment cycles will be administered, scheduled every 15 days (every 2 weeks), with intravenous (IV) infusion over three consecutive days. After completing the intervention period, a 90-day (+/-5) follow-up period will be conducted.\n\nSubjects in arm A will receive the plitidepsin 1.5 mg/day 1h-IV during the four treatment periods on Days 1 to 3, Days 15 to 17, Days 29 to 31 and Days 43 to 45. Subjects in arm B will receive 1h-IV placebo 1 vial /day during the first two treatment periods and will receive the plitidepsin 1.5 mg/day 1h-IV during the last two treatment periods. Subjects in arm C will receive 1h-IV placebo 1 vial/day during the four treatment periods.", "primary_outcomes": [ { "type": "primary", "measure": "Change in the overall health in patients from each group using patient reported outcomes measurement information system score (PROMIS-29®).", "description": "Difference between groups on the patient-reported outcomes measurement information system (PROMIS-29®) score health scale measured by T-Score; Each domain is scored on a 5-point scale, (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do), in case of the pain domain is on a 10-point scale; from no pain to the worse pain. on day 90 (±5) of the follow-up period\\* (after the intervention).", "time_frame": "On day 90 of follow-up period" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "To compare the safety/tolerability of Plitidepsin Vs placebo in terms of adverse events in patients with PCC.", "description": "The proportion of adverse events (AE, coded by MedDRA) comparing between groups at day 90 (±5) of the follow-up period, considering:\n\n1. All AEs.\n2. AEs grade 3 and 4 leading to discontinuation from the study.\n3. AEs of special interest (AESI): cardiac, liver, acute-infusional reactions.", "time_frame": "On day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare the incidence of Treatment-Emergent Adverse Events (TEAEs) between groups.", "description": "Percentage of TEAEs detected on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in the overall health in patients from each group using patient reported outcomes measurement information system score (PROMIS-29®).", "description": "Difference between groups on the PROMIS-29® health scale measured by T-Score on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. Each domain is scored on a 5-point scale, (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do), in case of the pain domain is on a 10-point scale; from no pain to the worse pain. on day 90 (±5) of the follow-up period\\* (after the intervention).", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare functional capacity changes in patients from each group using the post-COVID-19 Functional State (PCFS) scale.", "description": "Difference between groups in functional capacity on the PCFS scale on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare symptomatic changes in patients from each group using the Can Ruti Questionnaire.", "description": "Proportion of subjects with ≥10 points reduction in the Can Ruti Questionnaire scale on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in terms of Quality of Life (QoL) for each group.", "description": "Difference between groups according to the EuroQoL-5D questionnaire on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [psychomotor speed and executive function] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, measured using NeuScreen questionnaire to evaluate the psychomotor speed and executive function measured in seconds.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [depressive symptoms] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, using the PHQ-9 score questionnaire to evaluate the depressive symptoms, each question is scored on a 4-point scale, where (0) is the most positive answe and (3) is the worse condition.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [ anxiety symptoms] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, using the GAD-7 questionnaire to evaluate anxiety symptoms; Each question is scored as follows: 0 points: \"Not at all\", 1 point: \"Several days\", 2 points: \"More than half the days\", 3 points: \"Nearly every day\"", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [sleep quality] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, measured using PSQI to evaluate sleep quality; the scores for the seven components are then summed to yield a global PSQI score, which ranges from 0 to 21. A global score greater than 5 suggests poor sleep quality.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [disability] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, using WHODAS 2.0 questionnaire to evaluate disability: Each item is scored on a scale from 1 to 5, with higher scores indicating greater difficulty in functioning. The total score is calculated by summing the scores for all items, and it can be converted into a standardized score ranging from 0 to 100, where higher scores indicate greater disability.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in terms of physical activity in patients with PCC among the three arms.", "description": "Change from baseline in physical activity to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, assessed using the International Physical Activity Questionnaire (IPAQ).", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in terms of fatigue (Fatigue scale) in patients with PCC among the three treatment arms.", "description": "Change from baseline in physical activity to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, evaluated using the Fatigue Severity Scale (FSS): nine statements, of 7-point Likert scale, where (1- Strongly disagree) and (7-Strongly agree). Higher scores indicate greater fatigue severity.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in terms of fatigue (Five times sit to stant test) in patients with PCC among the three treatment arms.", "description": "Change from baseline in physical activity to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, evaluated using Five Times Sit-to-Stand Test (5xSTS), The score is the total time in seconds", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare the evolution of inflammation markers in patients with PCC among the three arms.", "description": "Change from baseline in inflammation markers on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare immune response markers: Antinuclear antibodies (ANAs) in patients with persistent COVID among the three treatment arms.", "description": "Change from baseline in Antinuclear antibodies (ANAs) to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in UI/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare immune response markers: antiphospholipid antibodies (Abs) in patients with persistent COVID among the three treatment arms.", "description": "Change from baseline in antiphospholipid antibodies (Abs),) to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in UI/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare immune response markers: antimitochondrial antibodies in patients with persistent COVID among the three treatment arms.", "description": "Change from baseline in antimitochondrial antibodies to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in UI/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare the SARS-CoV-2 RNA antigenemia (presence of viral components) in plasma with persistent COVID among the three treatment arms.", "description": "Change from baseline in viral components (SARS-CoV-2 RNA antigenemia) in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. The SARS-CoV-2 RNA is quantified in pg/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in Complement Activitation: Hemolytic Complement CH50 in patients with persistent COVID among the three treatment arms.", "description": "Change from baseline in Complement Activity: Hemolytic Complement CH50 to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in UI/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (prothrombin time (PT)), among the three treatment arms.", "description": "Change from baseline in prothrombin time (PT) ratio in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (activated partial thromboplastin time (aPTT)), among the three treatment arms.", "description": "Change from baseline in activated partial thromboplastin time (aPTT) in seconds, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (D-Dimer), among the three treatment arms.", "description": "Change from baseline in D-Dimer measured in ng/mL, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (Fibrinogen), among the three treatment arms.", "description": "Change from baseline in Fibrinogen measured in mg/dL, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (Antithrombin III (ATIII)), among the three treatment arms.", "description": "Change from baseline in Antithrombin III (ATIII) measured in %, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (Factor de Von willebrand), among the three treatment arms.", "description": "Change from baseline in Factor de Von Willebrand measured in %, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in hormonal components (Serotonin) among the three treatment arms.", "description": "Change from baseline in serotonin (UI) in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in hormonal components (Dopamine) among the three treatment arms.", "description": "Change from baseline in dopamine alterations in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in ug/24 h", "time_frame": "On day 10, day 30 and day 90 of follow-up period" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in the overall health in patients from each group using patient reported outcomes measurement information system score (PROMIS-29®).", "description": "Difference between groups on the patient-reported outcomes measurement information system (PROMIS-29®) score health scale measured by T-Score; Each domain is scored on a 5-point scale, (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do), in case of the pain domain is on a 10-point scale; from no pain to the worse pain. on day 90 (±5) of the follow-up period\\* (after the intervention).", "time_frame": "On day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare the safety/tolerability of Plitidepsin Vs placebo in terms of adverse events in patients with PCC.", "description": "The proportion of adverse events (AE, coded by MedDRA) comparing between groups at day 90 (±5) of the follow-up period, considering:\n\n1. All AEs.\n2. AEs grade 3 and 4 leading to discontinuation from the study.\n3. AEs of special interest (AESI): cardiac, liver, acute-infusional reactions.", "time_frame": "On day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare the incidence of Treatment-Emergent Adverse Events (TEAEs) between groups.", "description": "Percentage of TEAEs detected on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in the overall health in patients from each group using patient reported outcomes measurement information system score (PROMIS-29®).", "description": "Difference between groups on the PROMIS-29® health scale measured by T-Score on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. Each domain is scored on a 5-point scale, (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do), in case of the pain domain is on a 10-point scale; from no pain to the worse pain. on day 90 (±5) of the follow-up period\\* (after the intervention).", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare functional capacity changes in patients from each group using the post-COVID-19 Functional State (PCFS) scale.", "description": "Difference between groups in functional capacity on the PCFS scale on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare symptomatic changes in patients from each group using the Can Ruti Questionnaire.", "description": "Proportion of subjects with ≥10 points reduction in the Can Ruti Questionnaire scale on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in terms of Quality of Life (QoL) for each group.", "description": "Difference between groups according to the EuroQoL-5D questionnaire on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [psychomotor speed and executive function] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, measured using NeuScreen questionnaire to evaluate the psychomotor speed and executive function measured in seconds.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [depressive symptoms] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, using the PHQ-9 score questionnaire to evaluate the depressive symptoms, each question is scored on a 4-point scale, where (0) is the most positive answe and (3) is the worse condition.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [ anxiety symptoms] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, using the GAD-7 questionnaire to evaluate anxiety symptoms; Each question is scored as follows: 0 points: \"Not at all\", 1 point: \"Several days\", 2 points: \"More than half the days\", 3 points: \"Nearly every day\"", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [sleep quality] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, measured using PSQI to evaluate sleep quality; the scores for the seven components are then summed to yield a global PSQI score, which ranges from 0 to 21. A global score greater than 5 suggests poor sleep quality.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare neuropsychological symptomatology [disability] in patients with PCC among the three treatment arms.", "description": "Change from baseline\\*\\* in neuropsychological symptoms to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, using WHODAS 2.0 questionnaire to evaluate disability: Each item is scored on a scale from 1 to 5, with higher scores indicating greater difficulty in functioning. The total score is calculated by summing the scores for all items, and it can be converted into a standardized score ranging from 0 to 100, where higher scores indicate greater disability.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in terms of physical activity in patients with PCC among the three arms.", "description": "Change from baseline in physical activity to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, assessed using the International Physical Activity Questionnaire (IPAQ).", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in terms of fatigue (Fatigue scale) in patients with PCC among the three treatment arms.", "description": "Change from baseline in physical activity to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, evaluated using the Fatigue Severity Scale (FSS): nine statements, of 7-point Likert scale, where (1- Strongly disagree) and (7-Strongly agree). Higher scores indicate greater fatigue severity.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare changes in terms of fatigue (Five times sit to stant test) in patients with PCC among the three treatment arms.", "description": "Change from baseline in physical activity to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period, evaluated using Five Times Sit-to-Stand Test (5xSTS), The score is the total time in seconds", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare the evolution of inflammation markers in patients with PCC among the three arms.", "description": "Change from baseline in inflammation markers on day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare immune response markers: Antinuclear antibodies (ANAs) in patients with persistent COVID among the three treatment arms.", "description": "Change from baseline in Antinuclear antibodies (ANAs) to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in UI/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare immune response markers: antiphospholipid antibodies (Abs) in patients with persistent COVID among the three treatment arms.", "description": "Change from baseline in antiphospholipid antibodies (Abs),) to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in UI/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare immune response markers: antimitochondrial antibodies in patients with persistent COVID among the three treatment arms.", "description": "Change from baseline in antimitochondrial antibodies to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in UI/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare the SARS-CoV-2 RNA antigenemia (presence of viral components) in plasma with persistent COVID among the three treatment arms.", "description": "Change from baseline in viral components (SARS-CoV-2 RNA antigenemia) in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. The SARS-CoV-2 RNA is quantified in pg/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in Complement Activitation: Hemolytic Complement CH50 in patients with persistent COVID among the three treatment arms.", "description": "Change from baseline in Complement Activity: Hemolytic Complement CH50 to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in UI/mL.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (prothrombin time (PT)), among the three treatment arms.", "description": "Change from baseline in prothrombin time (PT) ratio in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (activated partial thromboplastin time (aPTT)), among the three treatment arms.", "description": "Change from baseline in activated partial thromboplastin time (aPTT) in seconds, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (D-Dimer), among the three treatment arms.", "description": "Change from baseline in D-Dimer measured in ng/mL, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (Fibrinogen), among the three treatment arms.", "description": "Change from baseline in Fibrinogen measured in mg/dL, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (Antithrombin III (ATIII)), among the three treatment arms.", "description": "Change from baseline in Antithrombin III (ATIII) measured in %, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in thromboinflammatory components (Factor de Von willebrand), among the three treatment arms.", "description": "Change from baseline in Factor de Von Willebrand measured in %, in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in hormonal components (Serotonin) among the three treatment arms.", "description": "Change from baseline in serotonin (UI) in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period.", "time_frame": "On day 10, day 30 and day 90 of follow-up period" }, { "type": "secondary", "measure": "To compare alterations in hormonal components (Dopamine) among the three treatment arms.", "description": "Change from baseline in dopamine alterations in plasma to day 10 (±2), day 30 (±2), and day 90 (±5) of the follow-up period. measured in ug/24 h", "time_frame": "On day 10, day 30 and day 90 of follow-up period" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 90, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06766825", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07224490", "title": "Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease", "status": "RECRUITING", "phase": "PHASE1", "last_updated": "2026-07-13", "start_date": "2026-03-10", "completion_date": "2030-05", "primary_completion_date": "2030-05", "conditions_raw": [ "Reproductive Disorder", "Neurodegeneration", "SARS-CoV 2", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Kisspeptin 112-121" ], "sponsor": "Stephanie B. Seminara, MD", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The objective of this protocol is to use a case-control paradigm to compare the response to an intravenous administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin.", "primary_outcomes": [ { "type": "primary", "measure": "Difference in mean luteinizing hormone (LH) amplitude between cases and controls", "description": "Difference between cases and controls of mean LH amplitude in response to kisspeptin", "time_frame": "Day of study visit (one to two hours)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Difference in mean luteinizing hormone (LH) amplitude between cases and controls", "description": "Difference between cases and controls of mean LH amplitude in response to kisspeptin", "time_frame": "Day of study visit (one to two hours)" } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07224490", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07697261", "title": "Fatigue in Long COVID", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-07-13", "start_date": "2026-11", "completion_date": "2028-12", "primary_completion_date": "2028-12", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Lightning Process", "Activity Pacing" ], "sponsor": "McMaster University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID affects about 6 in 100 people after a COVID-19 infection. It can cause ongoing problems like ongoing tiredness, muscle pain, and \"brain fog.\" We know very little about which treatments might be helpful for long COVID.\n\nThe goal of this trial is to compare two treatments for people with long COVID to try to manage their symptoms. The main question is to assess whether the Lightning Process is effective for people living with long COVID compared to activity pacing. Each person will be placed into one of the two groups randomly (by chance, like flipping a coin). Activity pacing helps people balance rest and daily activities. The Lightning Process teaches ways to change thought patterns and body responses to symptoms. We will include 100 adults with long COVID. Everything will be done online, including filling out surveys about health and daily life. The goal is to find out which approach helps people feel better and improve their daily activities.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue (Checklist Individual Strength-Fatigue)", "description": "The primary outcome will be the mean change in fatigue scores between Lightning Process and activity pacing group at 12 months post randomization. This will be assessed on the fatigue domain of the 8-item Checklist Individual Strength (CIS-fatigue) at 12 months follow-up. The CIS-fatigue domain consists of 8 items with a total score ranging from 8 to 56, with higher scores indicating more severe fatigue.", "time_frame": "12 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Respiratory function (Dyspnea-12)", "description": "Change in respiratory functioning will be assessed with the Dyspnea-12 (D-12) Scale which measures the current level of a patient's breathlessness severity, incorporating both physical and affective aspects, and does not depend on activity limitation. Each item scored from 0-3, for a total score range of 0-36. Higher scores indicate worse dyspnea.", "time_frame": "6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Post Exertional Malaise (De Paul Symptom Questionnaire)", "description": "Change in post exertional malaise (PEM) will be measured using a brief questionnaire derived from De Paul Symptom Questionnaire (DSQ). It is a 5-item self-report tool that evaluates common symptoms of long COVID, including worsening after physical or mental activity, recovery duration and activity intolerance. Each item is scored 0-4 on 5-point Likert scale. A score of ≥2 for frequency and ≥2 for severity on any item suggests PEM.", "time_frame": "Baseline, 6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Daily Pain (Brief Pain Inventory Short Form)", "description": "Change in pain will be assessed using Brief Pain Inventory short form (BPI-SF). This is a 9-item questionnaire used to evaluate the severity of a patient's pain and the impact of their pain on daily functioning. The BPI-SF evaluates pain severity at its worst, least, and average during the previous week, as well as current pain level, with 0 representing no pain and 10 the worst pain imaginable.", "time_frame": "6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Fatigue (Checklist Individual Strength-Fatigue)", "description": "Change in fatigue scores will be measured at 6 and 9 months post randomization. This will be assessed on the fatigue domain of the 8-item CIS-fatigue scale at 6 and 9 months follow-up.", "time_frame": "6 months and 9 months" }, { "type": "secondary", "measure": "Physical function (SF-12)", "description": "Change in physical functioning will be measured using Short Form Health Survey (SF-12) scale, a 12-item questionnaire that assesses physical and mental health status.", "time_frame": "Baseline, 6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Health related quality of life (EuroQol-5 Dimensions)", "description": "Health related quality of life will be measured using the EuroQol-5 Dimensions (EQ-5D) scale that provides a generic measure of health for clinical and economic appraisal. Its a continuous (scale 0-100). Higher scores relate to better health.", "time_frame": "Baseline, 6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Severity of somatic symptoms (Patient Health Questionnaire-15)", "description": "Change in somatic symptoms will be measured using Patient Health Questionnaire-15 (PHQ-15) that screens for somatization concerns and monitors symptom severity. Its a continuous (scale 0-30). Higher scores relate to greater somatic symptom severity.", "time_frame": "6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Functional impairment (Work and Social Adjustment Scale)", "description": "Change in functional impairment will be measured through Work and Social Adjustment Scale (WSAS) scale. Its a 5-item continuous scale (0-40) of functional impairment attributable to an identified problem. Higher scores relate to severely impaired.", "time_frame": "6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Adverse Events (AEs)", "description": "To ensure participant safety, adverse events (AEs) will be documented at each follow-up visit.", "time_frame": "Up to 12 months" }, { "type": "secondary", "measure": "Serious Adverse Events (SAEs)", "description": "To ensure participant safety, serious adverse events (SAEs) will be documented at each follow-up visit.", "time_frame": "Up to 12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue (Checklist Individual Strength-Fatigue)", "description": "The primary outcome will be the mean change in fatigue scores between Lightning Process and activity pacing group at 12 months post randomization. This will be assessed on the fatigue domain of the 8-item Checklist Individual Strength (CIS-fatigue) at 12 months follow-up. The CIS-fatigue domain consists of 8 items with a total score ranging from 8 to 56, with higher scores indicating more severe fatigue.", "time_frame": "12 months" }, { "type": "secondary", "measure": "Respiratory function (Dyspnea-12)", "description": "Change in respiratory functioning will be assessed with the Dyspnea-12 (D-12) Scale which measures the current level of a patient's breathlessness severity, incorporating both physical and affective aspects, and does not depend on activity limitation. Each item scored from 0-3, for a total score range of 0-36. Higher scores indicate worse dyspnea.", "time_frame": "6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Post Exertional Malaise (De Paul Symptom Questionnaire)", "description": "Change in post exertional malaise (PEM) will be measured using a brief questionnaire derived from De Paul Symptom Questionnaire (DSQ). It is a 5-item self-report tool that evaluates common symptoms of long COVID, including worsening after physical or mental activity, recovery duration and activity intolerance. Each item is scored 0-4 on 5-point Likert scale. A score of ≥2 for frequency and ≥2 for severity on any item suggests PEM.", "time_frame": "Baseline, 6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Daily Pain (Brief Pain Inventory Short Form)", "description": "Change in pain will be assessed using Brief Pain Inventory short form (BPI-SF). This is a 9-item questionnaire used to evaluate the severity of a patient's pain and the impact of their pain on daily functioning. The BPI-SF evaluates pain severity at its worst, least, and average during the previous week, as well as current pain level, with 0 representing no pain and 10 the worst pain imaginable.", "time_frame": "6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Fatigue (Checklist Individual Strength-Fatigue)", "description": "Change in fatigue scores will be measured at 6 and 9 months post randomization. This will be assessed on the fatigue domain of the 8-item CIS-fatigue scale at 6 and 9 months follow-up.", "time_frame": "6 months and 9 months" }, { "type": "secondary", "measure": "Physical function (SF-12)", "description": "Change in physical functioning will be measured using Short Form Health Survey (SF-12) scale, a 12-item questionnaire that assesses physical and mental health status.", "time_frame": "Baseline, 6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Health related quality of life (EuroQol-5 Dimensions)", "description": "Health related quality of life will be measured using the EuroQol-5 Dimensions (EQ-5D) scale that provides a generic measure of health for clinical and economic appraisal. Its a continuous (scale 0-100). Higher scores relate to better health.", "time_frame": "Baseline, 6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Severity of somatic symptoms (Patient Health Questionnaire-15)", "description": "Change in somatic symptoms will be measured using Patient Health Questionnaire-15 (PHQ-15) that screens for somatization concerns and monitors symptom severity. Its a continuous (scale 0-30). Higher scores relate to greater somatic symptom severity.", "time_frame": "6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Functional impairment (Work and Social Adjustment Scale)", "description": "Change in functional impairment will be measured through Work and Social Adjustment Scale (WSAS) scale. Its a 5-item continuous scale (0-40) of functional impairment attributable to an identified problem. Higher scores relate to severely impaired.", "time_frame": "6 months, 9 months, and 12 months" }, { "type": "secondary", "measure": "Adverse Events (AEs)", "description": "To ensure participant safety, adverse events (AEs) will be documented at each follow-up visit.", "time_frame": "Up to 12 months" }, { "type": "secondary", "measure": "Serious Adverse Events (SAEs)", "description": "To ensure participant safety, serious adverse events (SAEs) will be documented at each follow-up visit.", "time_frame": "Up to 12 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07697261", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07694232", "title": "A Pilot Randomized Controlled Trial of Homeopathic Treatment for Long COVID", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-07-09", "start_date": "2026-07-15", "completion_date": "2028-12-01", "primary_completion_date": "2028-07-01", "conditions_raw": [ "Long COVID", "Long COVID Symptoms" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Treatment A: Treatment By A Homeopath Prescribing A Specific Homeopathic Remedy For Long Covid", "A Course Of Individually Tailored Treatment By A Homeopath" ], "sponsor": "St. Mary's University, Twickenham", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "A small-scale test of the intervention, trial design and methods to explore the cumulative effectiveness of two commonly used prescribing strategies for patients with long COVID: Treatment A - prescribing a specific homeopathic remedy for long COVID, plus or minus Treatment B - a course of individually tailored treatment by a homeopath. Both interventions compared to usual care", "primary_outcomes": [ { "type": "primary", "measure": "Measure Your Own Medical Outcome Profile (MYMOP)", "description": "The participant chooses two symptoms that bother them the most. They also choose an activity of daily living that is limited or prevented by their problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale.", "time_frame": "monthly for 6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Wellbeing Health Survey Questionnaire (SF-36)", "description": "SF-36 consists of 36 items across eight health domains: physical functioning, role limitations due to physical and emotional problems, bodily pain, general health perceptions, vitality, social functioning, and mental health. Each item employs various response formats such as Likert scales, yes/no answers, and frequency ratings to capture the respondent's health status over the past four weeks. After completion, scores for each domain are calculated by summing item responses and transforming them on a 0-100 scale, where higher scores indicate better health.", "time_frame": "monthly for 6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Measure Your Own Medical Outcome Profile (MYMOP)", "description": "The participant chooses two symptoms that bother them the most. They also choose an activity of daily living that is limited or prevented by their problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale.", "time_frame": "monthly for 6 months" }, { "type": "secondary", "measure": "Wellbeing Health Survey Questionnaire (SF-36)", "description": "SF-36 consists of 36 items across eight health domains: physical functioning, role limitations due to physical and emotional problems, bodily pain, general health perceptions, vitality, social functioning, and mental health. Each item employs various response formats such as Likert scales, yes/no answers, and frequency ratings to capture the respondent's health status over the past four weeks. After completion, scores for each domain are calculated by summing item responses and transforming them on a 0-100 scale, where higher scores indicate better health.", "time_frame": "monthly for 6 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07694232", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06404060", "title": "RECOVER-ENERGIZE Platform Protocol_Appendix A (Exercise Intolerance)", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-07-08", "start_date": "2024-07-17", "completion_date": "2026-05-05", "primary_completion_date": "2026-03-10", "conditions_raw": [ "Long COVID", "Long Covid19", "Long Covid-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Personalized Cardiopulmonary Rehabilitation" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes.\n\nThis protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).\n\nThe focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Endurance Shuttle Walk Test (ESWT)", "description": "The ESWT consists of timed walking on a 10m course. The result is expressed as total walking time after an initial 2-minute warm-up. The ESWT is an outcome measure of exercise capacity.", "time_frame": "Baseline, week 12 (End of Intervention (EOI))" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in physical function, as measured by the PROMIS SF-Physical Function (PROMIS-PF)", "description": "The PROMIS Short Form v2.0 - Physical Function 8b (PROMIS-PF) consists of 8 items. The PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities.", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" }, { "type": "secondary", "measure": "Change in physical function, as measured by actigraphy", "description": "", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" }, { "type": "secondary", "measure": "Change in symptom frequency, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)", "description": "Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time.", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" }, { "type": "secondary", "measure": "Change in symptom severity, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)", "description": "Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" }, { "type": "secondary", "measure": "Change in symptom duration, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)", "description": "", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Endurance Shuttle Walk Test (ESWT)", "description": "The ESWT consists of timed walking on a 10m course. The result is expressed as total walking time after an initial 2-minute warm-up. The ESWT is an outcome measure of exercise capacity.", "time_frame": "Baseline, week 12 (End of Intervention (EOI))" }, { "type": "secondary", "measure": "Change in physical function, as measured by the PROMIS SF-Physical Function (PROMIS-PF)", "description": "The PROMIS Short Form v2.0 - Physical Function 8b (PROMIS-PF) consists of 8 items. The PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities.", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" }, { "type": "secondary", "measure": "Change in physical function, as measured by actigraphy", "description": "", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" }, { "type": "secondary", "measure": "Change in symptom frequency, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)", "description": "Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time.", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" }, { "type": "secondary", "measure": "Change in symptom severity, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)", "description": "Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" }, { "type": "secondary", "measure": "Change in symptom duration, as measured by the Modified DePaul Symptom Questionnaire - Post-Exertional Malaise (mDSQ-PEM)", "description": "", "time_frame": "Baseline, week 6 (middle of intervention), week 12 (EOI) and week 24 End of Study (EOS)" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 360, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06404060", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06404112", "title": "RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-07-08", "start_date": "2024-07-31", "completion_date": "2026-04-01", "primary_completion_date": "2026-02-26", "conditions_raw": [ "Long COVID", "Long COVID-19", "Sleep Disturbance" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Melatonin", "Tailored Lighting (Tl) Active" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices.\n\nThis platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).", "primary_outcomes": [ { "type": "primary", "measure": "Change in total score of the PROMIS 8b SD to assess sleep disturbance", "description": "The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate more sleep disturbance.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "primary", "measure": "Change in sleep onset variability, assessed using a wearable device", "description": "A wearable device will be used as an objective measure to assess sleep onset variability assessed for 7 days before randomization and 7 days before EOI", "time_frame": "Baseline, End of Intervention (Day 63)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in total score of the PROMIS 8a SRI to assess sleep-related impairment", "description": "The PROMIS 8a SRI form includes a total of 8 items that ask participants to reflect on their sleep-related daytime impairment over the past 7 days with questions rated not at all to very much. T-Scores range from 0 to 100, with \\> 55 1 SD above population mean.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in PROMIS 10a Fatigue score", "description": "The PROMIS 10a Fatigue is a 10-item questionnaire that assesses a participant's fatigue on a scale of 1 (not at all fatigued) to 5 (very much).", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in an objective neurocognitive battery score", "description": "", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in ECog2 measure", "description": "Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. It has been used for patients with mild cognitive impairment, Alzheimer's Disease, and dementia. It takes 5 minutes to complete.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in PASC Symptom Questionnaire responses", "description": "Participants will be asked to complete a questionnaire that asks about the presence of PASC symptoms at Baseline and at follow-up visits. This questionnaire includes symptoms that have been associated with PASC.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in total score from ISI (Insomnia Severity Index)", "description": "The ISI is a 7-item, self-report questionnaire that assesses the nature, severity, and impact of insomnia, on a 5-point Likert scale (eg, 0 = not at all, 4 = extremely; scores: from 0 to 28). The ISI asks patients to recall their insomnia symptoms over the past 2 weeks.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary", "description": "Sleep onset time will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary", "description": "Nocturnal sleep duration will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary", "description": "24-hour sleep duration will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary", "description": "Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker", "description": "Nocturnal sleep duration will be assessed by activity tracker", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker", "description": "24-hour sleep duration will be assessed by activity tracker", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker", "description": "Sleep Efficiency is the percentage of the sleep period spent asleep, as measured by activity tracker", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker", "description": "Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in total score of the PROMIS 8b SD to assess sleep disturbance", "description": "The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate more sleep disturbance.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "primary", "measure": "Change in sleep onset variability, assessed using a wearable device", "description": "A wearable device will be used as an objective measure to assess sleep onset variability assessed for 7 days before randomization and 7 days before EOI", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in total score of the PROMIS 8a SRI to assess sleep-related impairment", "description": "The PROMIS 8a SRI form includes a total of 8 items that ask participants to reflect on their sleep-related daytime impairment over the past 7 days with questions rated not at all to very much. T-Scores range from 0 to 100, with \\> 55 1 SD above population mean.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in PROMIS 10a Fatigue score", "description": "The PROMIS 10a Fatigue is a 10-item questionnaire that assesses a participant's fatigue on a scale of 1 (not at all fatigued) to 5 (very much).", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in an objective neurocognitive battery score", "description": "", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in ECog2 measure", "description": "Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. It has been used for patients with mild cognitive impairment, Alzheimer's Disease, and dementia. It takes 5 minutes to complete.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in PASC Symptom Questionnaire responses", "description": "Participants will be asked to complete a questionnaire that asks about the presence of PASC symptoms at Baseline and at follow-up visits. This questionnaire includes symptoms that have been associated with PASC.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in total score from ISI (Insomnia Severity Index)", "description": "The ISI is a 7-item, self-report questionnaire that assesses the nature, severity, and impact of insomnia, on a 5-point Likert scale (eg, 0 = not at all, 4 = extremely; scores: from 0 to 28). The ISI asks patients to recall their insomnia symptoms over the past 2 weeks.", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary", "description": "Sleep onset time will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary", "description": "Nocturnal sleep duration will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary", "description": "24-hour sleep duration will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary", "description": "Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker", "description": "Nocturnal sleep duration will be assessed by activity tracker", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker", "description": "24-hour sleep duration will be assessed by activity tracker", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker", "description": "Sleep Efficiency is the percentage of the sleep period spent asleep, as measured by activity tracker", "time_frame": "Baseline, End of Intervention (Day 63)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker", "description": "Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 63)" } ], "relevance_tags": [ "General", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 469, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06404112", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06586398", "title": "A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-07-06", "start_date": "2025-01-01", "completion_date": "2026-03-01", "primary_completion_date": "2026-03-01", "conditions_raw": [ "Long Covid-19", "PASC Post Acute Sequelae of COVID 19", "Brain Fog", "Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rtms" ], "sponsor": "University of California, Los Angeles", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a pilot randomized trial of rTMS for symptoms of fatigue and brain fog, and other neuropsychiatric symptoms of Long-COVID (Post-COVID, post-acute sequelae of COVID-19 infection, PASC). Twenty participants diagnosed with Long-COVID and recruited from the UCLA Long-COVID clinic will be randomized to receive active rTMS versus sham stimulation for 15 treatments followed by another 15 open-label rTMS treatments. Investigators will compare the safety and tolerability of rTMS vs Sham and examine within-group changes in symptoms of fatigue, sleep, pain, mood, and subjective and objective cognitive impairment. This project will provide information and pilot data for future larger clinical trials.", "primary_outcomes": [ { "type": "primary", "measure": "Tolerability as measured by Safteesi survey", "description": "Safteesi is an instrument that assesses any new symptom(s) that participants developed since starting the clinical study.", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." }, { "type": "primary", "measure": "Safety profile and adverse events", "description": "Study patients will be monitored weekly for the occurrence of adverse events.", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Subjective Cognitive impairment assessed by Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)", "description": "MISC is a brief 10-item survey that measures perceived cognitive function. The MISCI is normally distributed and has low rates of ceiling and floor effects, excellent internal consistency, and good construct validity in correlation with other measures.", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Fatigue assessed by Fatigue Severity Scale (FSS)", "description": "The FSS is a nine-item, self-report instrument designed to assess fatigue as a symptom of different chronic conditions and disorders. The scale addresses fatigue's effect on daily functioning and its relationship to motivation, physical activity, work, family, and social life. Participants will rate the ease with which they are fatigued and the degree to which the symptoms pose a problem.\n\nScoring uses a scale that ranges from 1 (completely disagree) to 7 (completely agree) to indicate agreement with the nine statements about fatigue.", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Physical and mental health assessed by PROMIS-29", "description": "The PROMIS-29 measures pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain.", "time_frame": "Baseline, through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Alzheimer's Disease Assessment Scale (ADAS-Cog)", "description": "Cognitive performance will be assessed by ADAS-Cog", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Fatigue assessed by VAS for Fatigue Questionnaire", "description": "VAS is a one-question self-report survey that asks \"How much fatigue are you having now?\" on a scale of 0 (no fatigue) to 10 (worst possible fatigue).", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "DKEFS CW", "description": "Verbally mediated processing speed and executive functioning will be assessed using the DKEFS Color Word Test.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Verbal Fluency test", "description": "The Verbal Fluency test will be used to assess global cognitive abilities.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "DKEFS Trailmaking A,B", "description": "Speed for attention, sequencing, mental flexibility, visual search, and motor functioning will be assessed by the DKEFS Trailmaking tests.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Test of Premorbid Functioning (TOPF)", "description": "TOPF will be used to estimate pre-morbid cognitive and memory functioning.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)", "description": "RBANS story memory subtest is used to assess immediate memory.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)", "description": "RBANS story recall subtest will be used to assess delayed memory", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Repeatable Battery for the Assessment of Neuropsychological (RBANS)", "description": "Processing speed, short-term visual memory, psychomotor speed, cognitive flexibility, concentration, and motivation will be assessed by RBANS Coding subtest.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "DKEFS CWI", "description": "Selective attention, cognitive flexibility, and processing speed will be assessed by the DKEFS Color Word Interference test.", "time_frame": "Baseline through study completion, an average of 12 weeks." } ], "outcome_measures": [ { "type": "primary", "measure": "Tolerability as measured by Safteesi survey", "description": "Safteesi is an instrument that assesses any new symptom(s) that participants developed since starting the clinical study.", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." }, { "type": "primary", "measure": "Safety profile and adverse events", "description": "Study patients will be monitored weekly for the occurrence of adverse events.", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Subjective Cognitive impairment assessed by Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)", "description": "MISC is a brief 10-item survey that measures perceived cognitive function. The MISCI is normally distributed and has low rates of ceiling and floor effects, excellent internal consistency, and good construct validity in correlation with other measures.", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Fatigue assessed by Fatigue Severity Scale (FSS)", "description": "The FSS is a nine-item, self-report instrument designed to assess fatigue as a symptom of different chronic conditions and disorders. The scale addresses fatigue's effect on daily functioning and its relationship to motivation, physical activity, work, family, and social life. Participants will rate the ease with which they are fatigued and the degree to which the symptoms pose a problem.\n\nScoring uses a scale that ranges from 1 (completely disagree) to 7 (completely agree) to indicate agreement with the nine statements about fatigue.", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Physical and mental health assessed by PROMIS-29", "description": "The PROMIS-29 measures pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain.", "time_frame": "Baseline, through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Alzheimer's Disease Assessment Scale (ADAS-Cog)", "description": "Cognitive performance will be assessed by ADAS-Cog", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Fatigue assessed by VAS for Fatigue Questionnaire", "description": "VAS is a one-question self-report survey that asks \"How much fatigue are you having now?\" on a scale of 0 (no fatigue) to 10 (worst possible fatigue).", "time_frame": "Baseline, after every 5th treatment, through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "DKEFS CW", "description": "Verbally mediated processing speed and executive functioning will be assessed using the DKEFS Color Word Test.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Verbal Fluency test", "description": "The Verbal Fluency test will be used to assess global cognitive abilities.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "DKEFS Trailmaking A,B", "description": "Speed for attention, sequencing, mental flexibility, visual search, and motor functioning will be assessed by the DKEFS Trailmaking tests.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Test of Premorbid Functioning (TOPF)", "description": "TOPF will be used to estimate pre-morbid cognitive and memory functioning.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)", "description": "RBANS story memory subtest is used to assess immediate memory.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)", "description": "RBANS story recall subtest will be used to assess delayed memory", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "Repeatable Battery for the Assessment of Neuropsychological (RBANS)", "description": "Processing speed, short-term visual memory, psychomotor speed, cognitive flexibility, concentration, and motivation will be assessed by RBANS Coding subtest.", "time_frame": "Baseline through study completion, an average of 12 weeks." }, { "type": "secondary", "measure": "DKEFS CWI", "description": "Selective attention, cognitive flexibility, and processing speed will be assessed by the DKEFS Color Word Interference test.", "time_frame": "Baseline through study completion, an average of 12 weeks." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 10, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06586398", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06231238", "title": "Balance Acceptance and Commitment Therapy for Long COVID", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-07-02", "start_date": "2024-06-04", "completion_date": "2026-08-01", "primary_completion_date": "2026-05-30", "conditions_raw": [ "Post-COVID-19 Syndrome", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Balance Acceptance And Commitment Therapy" ], "sponsor": "King's College London", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This randomised controlled trial aims to investigate the efficacy of a psychological intervention for long COVID (LC) / post-COVID-19 syndrome (PCS) called Balance Acceptance and Commitment Therapy (Balance ACT).\n\nThe primary objective of this trial is to investigate whether Balance-ACT improves quality of life over treatment as usual (i.e., self-help leaflet) in people with PCS/LC.", "primary_outcomes": [ { "type": "primary", "measure": "Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 14", "description": "", "time_frame": "Week 14" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "EuroQol 5 Dimension - 5 Levels (EQ-5D-5L)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Adult Service Use Schedule", "description": "", "time_frame": "Week 0 and 20" }, { "type": "secondary", "measure": "Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Modified Clinical Global Impressions Scale- Improvement (CGI-I)", "description": "", "time_frame": "Week 14 and 20" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Modified Patient Health Questionnaire-15 (PHQ-15)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Montreal cognitive assessment-telephone version (MoCA-T)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Perceived Deficits Questionnaire (PDQ)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Patient Health Questionnaire-8 (PHQ-8)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Generalised Anxiety Disorder-7 (GAD-7)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Work and social adjustment scale (WSAS)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Modified DePaul Post exertional malaise questionnaire", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Post Traumatic Stress Disorder Checklist for DSM 5 (PCL-5)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Nijmegen Questionnaire (NQ)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Dyspnoea-12", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Modified Medical Research Council Dyspnea Scale (mMRC)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Lung function (spirometry, Resting pulse oximetry; SpO2)", "description": "", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Muscle strength", "description": "Handgrip muscle strength: A handgrip dynamometer will be used to measure grip strength. The dynamometer will be placed in the participant's hand and the participant will be instructed to squeeze as hard as possible.", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Muscle fatigue", "description": "1. Handgrip volitional fatigue: A digital grip force transducer will be used to assess volitional handgrip fatigue.\n2. Quadriceps non-volitional fatigue: Quadriceps muscle endurance will be assessed non-volitionally using transcutaneous electrical stimulation.", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "1 minute sit-to-stand test", "description": "Participants will also be shown the Borg Rating of Perceived Exertion Scale and asked to rate their perceived breathlessness and leg fatigue prior to the start of the test, immediately after completion of the test, and following one minute of recovery.", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "4 metre gait speed", "description": "", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Short Physical Performance Battery (SPPB)", "description": "", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "International Physical Activity Questionnaire - Short Form (IPAQ-SF)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Heartrate variability", "description": "via electrocardiogram (ECG)", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Average Heart-rate", "description": "Average Heart-rate will be assessed from 5 minutes of a 10-minute resting 3 lead electrocardiogram (ECG). These short-term recordings provide a non-invasive measure of autonomic nervous system function.", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Cognitive and Behavioural Responses Questionnaire (CBRQ)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Comprehensive assessment of Acceptance and Commitment Therapy processes", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Quadricep Muscle Strength", "description": "Volitional Quadriceps MVC and assessment of quadriceps volitional activation by twitch interpolation using electrical stimulation.", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Post COVID Syndrome Recovery (Single Item)", "description": "A self-reported single item questionnaire \"Do you consider yourself recovered from long COVID?\"", "time_frame": "Week 7, 14 and 20" }, { "type": "secondary", "measure": "Treatment Satisfaction Questionnaire", "description": "", "time_frame": "Week 14" }, { "type": "secondary", "measure": "Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 20", "description": "", "time_frame": "Week 0, 7, and 20" }, { "type": "secondary", "measure": "Mental Component Summary (MCS) of the 36-item Short Form Health Survey (SF-36)", "description": "", "time_frame": "Week 0, 7, 14 and 20" } ], "outcome_measures": [ { "type": "primary", "measure": "Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 14", "description": "", "time_frame": "Week 14" }, { "type": "secondary", "measure": "EuroQol 5 Dimension - 5 Levels (EQ-5D-5L)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Adult Service Use Schedule", "description": "", "time_frame": "Week 0 and 20" }, { "type": "secondary", "measure": "Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Modified Clinical Global Impressions Scale- Improvement (CGI-I)", "description": "", "time_frame": "Week 14 and 20" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Modified Patient Health Questionnaire-15 (PHQ-15)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Montreal cognitive assessment-telephone version (MoCA-T)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Perceived Deficits Questionnaire (PDQ)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Patient Health Questionnaire-8 (PHQ-8)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Generalised Anxiety Disorder-7 (GAD-7)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Work and social adjustment scale (WSAS)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Modified DePaul Post exertional malaise questionnaire", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Post Traumatic Stress Disorder Checklist for DSM 5 (PCL-5)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Nijmegen Questionnaire (NQ)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Dyspnoea-12", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Modified Medical Research Council Dyspnea Scale (mMRC)", "description": "", "time_frame": "Week 0, 14 and 20" }, { "type": "secondary", "measure": "Lung function (spirometry, Resting pulse oximetry; SpO2)", "description": "", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Muscle strength", "description": "Handgrip muscle strength: A handgrip dynamometer will be used to measure grip strength. The dynamometer will be placed in the participant's hand and the participant will be instructed to squeeze as hard as possible.", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Muscle fatigue", "description": "1. Handgrip volitional fatigue: A digital grip force transducer will be used to assess volitional handgrip fatigue.\n2. Quadriceps non-volitional fatigue: Quadriceps muscle endurance will be assessed non-volitionally using transcutaneous electrical stimulation.", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "1 minute sit-to-stand test", "description": "Participants will also be shown the Borg Rating of Perceived Exertion Scale and asked to rate their perceived breathlessness and leg fatigue prior to the start of the test, immediately after completion of the test, and following one minute of recovery.", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "4 metre gait speed", "description": "", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Short Physical Performance Battery (SPPB)", "description": "", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "International Physical Activity Questionnaire - Short Form (IPAQ-SF)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Heartrate variability", "description": "via electrocardiogram (ECG)", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Average Heart-rate", "description": "Average Heart-rate will be assessed from 5 minutes of a 10-minute resting 3 lead electrocardiogram (ECG). These short-term recordings provide a non-invasive measure of autonomic nervous system function.", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Cognitive and Behavioural Responses Questionnaire (CBRQ)", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Comprehensive assessment of Acceptance and Commitment Therapy processes", "description": "", "time_frame": "Week 0, 7, 14 and 20" }, { "type": "secondary", "measure": "Quadricep Muscle Strength", "description": "Volitional Quadriceps MVC and assessment of quadriceps volitional activation by twitch interpolation using electrical stimulation.", "time_frame": "Week 0 and 14" }, { "type": "secondary", "measure": "Post COVID Syndrome Recovery (Single Item)", "description": "A self-reported single item questionnaire \"Do you consider yourself recovered from long COVID?\"", "time_frame": "Week 7, 14 and 20" }, { "type": "secondary", "measure": "Treatment Satisfaction Questionnaire", "description": "", "time_frame": "Week 14" }, { "type": "secondary", "measure": "Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 20", "description": "", "time_frame": "Week 0, 7, and 20" }, { "type": "secondary", "measure": "Mental Component Summary (MCS) of the 36-item Short Form Health Survey (SF-36)", "description": "", "time_frame": "Week 0, 7, 14 and 20" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 196, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06231238", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06907251", "title": "Dapagliflozin for Long COVID Syndrome", "status": "NOT_YET_RECRUITING", "phase": "PHASE3", "last_updated": "2026-07-01", "start_date": "2026-09-01", "completion_date": "2029-06-30", "primary_completion_date": "2028-06-30", "conditions_raw": [ "COVID - 19", "Long COVID Syndrome", "SARS CoV-2" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Dapagliflozin" ], "sponsor": "Ottawa Heart Institute Research Corporation", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a randomized, placebo-controlled study. Patients with long COVID will be randomized to receive dapagliflozin or placebo for 12 months.", "primary_outcomes": [ { "type": "primary", "measure": "6 month change in EQ-5D derived utility score.", "description": "The 6 month change in EQ-5D derived utility score will be compared between the dapagliflozin and placebo arms within a multiple regression model.", "time_frame": "6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Incident diabetes", "description": "New diagnosis of diabetes mellitus (fasting glucose \\>7.0 mmol/L. HbA!c \\>6.5%, new prescription of diabetes pharmacotherapy)", "time_frame": "12 months" }, { "type": "secondary", "measure": "Cardiovascular Event", "description": "Cardiovascular event - atrial fibrillation, ventricular tachycardia/fibrillation, acute coronary syndrome, heart failure, transient ischemic attack, stroke, cardiovascular death", "time_frame": "12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "6 month change in EQ-5D derived utility score.", "description": "The 6 month change in EQ-5D derived utility score will be compared between the dapagliflozin and placebo arms within a multiple regression model.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Incident diabetes", "description": "New diagnosis of diabetes mellitus (fasting glucose \\>7.0 mmol/L. HbA!c \\>6.5%, new prescription of diabetes pharmacotherapy)", "time_frame": "12 months" }, { "type": "secondary", "measure": "Cardiovascular Event", "description": "Cardiovascular event - atrial fibrillation, ventricular tachycardia/fibrillation, acute coronary syndrome, heart failure, transient ischemic attack, stroke, cardiovascular death", "time_frame": "12 months" } ], "relevance_tags": [ "General", "Phase 3", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 192, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06907251", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06082258", "title": "Education of Medical Staff to Post Acute Covid susTained sYmptoms", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2026-07-01", "start_date": "2024-11", "completion_date": "2026-05", "primary_completion_date": "2025-12", "conditions_raw": [ "Post-acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Training In The Management Of Functional Disorders", "Reimbursement Of 3 Long Consultations" ], "sponsor": "Assistance Publique - Hôpitaux de Paris", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Evaluation of the effectiveness of a training and support intervention for general practitioners treating patients with persistent symptoms after a COVID-19 episode on the patients'quality of life at 3 months.", "primary_outcomes": [ { "type": "primary", "measure": "Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 3 months compared to the PCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.", "time_frame": "3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 1 month compared to the PCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.", "time_frame": "1 month" }, { "type": "secondary", "measure": "Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 6 months compared to the PCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 1 month compared to the MCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The mental component summary (MCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better mental health functioning.", "time_frame": "1 month" }, { "type": "secondary", "measure": "Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 3 months compared to the MCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The mental component summary (MCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better mental health functioning.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 6 months compared to the MCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The mental component summary (MCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better mental health functioning.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Change of clinical global impression (CGI scores) of the patient at 1 month compared to the last available clinical evaluation", "description": "The CGI questionnaire is rated on a 7-point scale and score ranges range from 1 (very much improved) through to 7 (very much worse). Each component of the CGI is rated separately.\n\nThe following components will be considered: fatigue, pain, breathing difficulties, attention and concentration problems, other persistent symptoms.", "time_frame": "1 month" }, { "type": "secondary", "measure": "Change of clinical global impression (CGI scores) of the patient at 3 months compared to the last available clinical evaluation", "description": "The CGI questionnaire is rated on a 7-point scale and score ranges range from 1 (very much improved) through to 7 (very much worse). Each component of the CGI is rated separately.\n\nThe following components will be considered: fatigue, pain, breathing difficulties, attention and concentration problems, other persistent symptoms.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Change of clinical global impression (CGI scores) of the patient at 6 months compared to the last available clinical evaluation", "description": "The CGI questionnaire is rated on a 7-point scale and score ranges range from 1 (very much improved) through to 7 (very much worse). Each component of the CGI is rated separately.\n\nThe following components will be considered: fatigue, pain, breathing difficulties, attention and concentration problems, other persistent symptoms.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Frequency of patient care consultations at 1 month", "description": "Number of patient care consultations between inclusion and 1-month follow-up", "time_frame": "1 month" }, { "type": "secondary", "measure": "Frequency of patient care consultations at 3 months", "description": "Number of patient care consultations between inclusion and 3-month follow-up", "time_frame": "3 months" }, { "type": "secondary", "measure": "Frequency of patient care consultations at 6 months", "description": "Number of patient care consultations between inclusion and 6-month follow-up", "time_frame": "6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 3 months compared to the PCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 1 month compared to the PCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.", "time_frame": "1 month" }, { "type": "secondary", "measure": "Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 6 months compared to the PCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 1 month compared to the MCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The mental component summary (MCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better mental health functioning.", "time_frame": "1 month" }, { "type": "secondary", "measure": "Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 3 months compared to the MCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The mental component summary (MCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better mental health functioning.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 6 months compared to the MCS at the inclusion of the patient", "description": "Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The mental component summary (MCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better mental health functioning.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Change of clinical global impression (CGI scores) of the patient at 1 month compared to the last available clinical evaluation", "description": "The CGI questionnaire is rated on a 7-point scale and score ranges range from 1 (very much improved) through to 7 (very much worse). Each component of the CGI is rated separately.\n\nThe following components will be considered: fatigue, pain, breathing difficulties, attention and concentration problems, other persistent symptoms.", "time_frame": "1 month" }, { "type": "secondary", "measure": "Change of clinical global impression (CGI scores) of the patient at 3 months compared to the last available clinical evaluation", "description": "The CGI questionnaire is rated on a 7-point scale and score ranges range from 1 (very much improved) through to 7 (very much worse). Each component of the CGI is rated separately.\n\nThe following components will be considered: fatigue, pain, breathing difficulties, attention and concentration problems, other persistent symptoms.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Change of clinical global impression (CGI scores) of the patient at 6 months compared to the last available clinical evaluation", "description": "The CGI questionnaire is rated on a 7-point scale and score ranges range from 1 (very much improved) through to 7 (very much worse). Each component of the CGI is rated separately.\n\nThe following components will be considered: fatigue, pain, breathing difficulties, attention and concentration problems, other persistent symptoms.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Frequency of patient care consultations at 1 month", "description": "Number of patient care consultations between inclusion and 1-month follow-up", "time_frame": "1 month" }, { "type": "secondary", "measure": "Frequency of patient care consultations at 3 months", "description": "Number of patient care consultations between inclusion and 3-month follow-up", "time_frame": "3 months" }, { "type": "secondary", "measure": "Frequency of patient care consultations at 6 months", "description": "Number of patient care consultations between inclusion and 6-month follow-up", "time_frame": "6 months" } ], "relevance_tags": [ "General", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT06082258", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05977179", "title": "Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-06-23", "start_date": "2025-05-12", "completion_date": "2028-09-30", "primary_completion_date": "2028-06-30", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Dietary Intervention To Mitigate Post-Acute Covid-19 Syndrome" ], "sponsor": "University of Maryland, Baltimore", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The primary objective of this study is to conduct a 16-week randomized controlled trial aimed at investigating the effectiveness of the Whole-Diet Approach when following a healthy US-style diet rich in anti-inflammatory properties. The study will focus on evaluating its impact on reducing symptoms related to Post-Acute Sequelae of SARS-CoV-2 Infection (PACS) in adults aged 50 years and older.\n\nThe main research questions this study aims to answer are:\n\n1. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate fatigue symptoms in adults with PACS?\n2. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate declines in muscle function and physical performance in adults with PACS?\n\nAt the beginning of the study, eligible participants will be randomly assigned to either the Dietary Intervention Group, where they will receive personalized dietary plans and weekly sessions, or the Attention Control Group, where they will attend general health sessions on a weekly basis as well.\n\nThis research intends to shed light on the potential benefits of the Whole-Diet Approach and its role in ameliorating PACS-related symptoms among older adults. By comparing the outcomes of the two groups, we hope to gain valuable insights into the effectiveness of this dietary intervention in improving the quality of life for individuals dealing with PACS.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue will be assessed by the brief fatigue inventory (BFI)", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)" }, { "type": "primary", "measure": "Physical Function", "description": "Physical Function will be measured by the Short Physical Performance Battery(SPPB)", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue will be assessed by the brief fatigue inventory (BFI)", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)" }, { "type": "primary", "measure": "Physical Function", "description": "Physical Function will be measured by the Short Physical Performance Battery(SPPB)", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 56, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05977179", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06142253", "title": "Water-based Activity to Enhance Recovery in Long COVID-19", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-06-18", "start_date": "2024-12-01", "completion_date": "2026-12-31", "primary_completion_date": "2026-12-31", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Water+Ct" ], "sponsor": "VA Office of Research and Development", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "This two-year study will evaluate the feasibility and safety of an exercise + cognitive training program to improve neurological symptoms of long-COVID. This is a two-phased trial: 1) an exercise phase and 2) a cognitive training phase. The exercise phase will be an aquatic based exercise program. A combination exercise + memory training programs designed for persons with cognitive impairment have significantly improved memory more than other single intervention groups (exercise only, cognitive training only) and given the success of combination training programs with healthy adults, it is important to adapt these programs for persons with neurological symptoms of long-COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Feasibility of Intervention Measure", "description": "The FIM is a brief measure of the feasibility of an intervention.", "time_frame": "At the end of study completion, an average of 8 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Acceptability of Intervention Measure", "description": "The AIM is a brief measure that assesses the acceptability of an intervention.", "time_frame": "At the end of study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Fatigue Severity Scale", "description": "The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on a person. The FSS is a short questionnaire that requires a person to rate his/her level of fatigue using a scale of 1 (completely disagree) to 7 (completely agree). Scores range from 9 to 63 with higher scores indicating greater fatigue severity.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Mental Fatigue Scale", "description": "The Mental Fatigue Scale (MFS) is self-report scale that includes 15 questions which assess mental fatigue. Items are rated on a scale that ranges from 0 (normal function) to 3 (serious problems). Higher scores indicate greater symptom severity.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Digit Span", "description": "The Digit Span subt-test of the WAIS-IV assesses attention and working memory.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Digit Symbol Substitution Test", "description": "The Digit Symbol Substitution Test from the WAIS-III assesses attention, processing speed and executive function.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Stroop Color Word Test", "description": "The Stroop Color Word test assesses selection attention, cognitive inhibition, and processing speed.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Rey Auditory Verbal Learning Test", "description": "The Rey Auditory Verbal Learning Test; (RAVLT) assesses learning and memory.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in NIH Toolbox Cognitive Battery", "description": "The NIH Toolbox is a computerized battery of test that assesses neuropsychological function.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Hospital Anxiety and Depression Scale", "description": "The Hospital Anxiety and Depression Scale (HADS) is a 14-time self-rating scale to assess psychological distress in non-psychiatric patients. Items are rated on a 4-point Likert scale (range 0-3). The total score ranges from 0 to 42 with higher indicating greater severity.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in World Health Organization Disability assessment scale 2.0", "description": "The World Health Organization Disability assessment scale 2.0 (WHODAS 2.0) assesses multiple domains of function including: cognition, mobility, self-care, getting along, life activities (household and work) and participation.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Canadian Occupation Performance Measure", "description": "The Canadian Occupation Performance Measure (COPM) assesses an individual's perceived occupational performance in the areas of self-care, productivity, and leisure.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Blood labs", "description": "Standard blood labs include C-Reactive Protein, Interleukin-6, metabolic panel, and lipid panels", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Genetic Testing", "description": "Genetic testing includes assessment of APOE and BDNF genotypes.", "time_frame": "Baseline" } ], "outcome_measures": [ { "type": "primary", "measure": "Feasibility of Intervention Measure", "description": "The FIM is a brief measure of the feasibility of an intervention.", "time_frame": "At the end of study completion, an average of 8 months" }, { "type": "secondary", "measure": "Acceptability of Intervention Measure", "description": "The AIM is a brief measure that assesses the acceptability of an intervention.", "time_frame": "At the end of study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Fatigue Severity Scale", "description": "The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on a person. The FSS is a short questionnaire that requires a person to rate his/her level of fatigue using a scale of 1 (completely disagree) to 7 (completely agree). Scores range from 9 to 63 with higher scores indicating greater fatigue severity.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Mental Fatigue Scale", "description": "The Mental Fatigue Scale (MFS) is self-report scale that includes 15 questions which assess mental fatigue. Items are rated on a scale that ranges from 0 (normal function) to 3 (serious problems). Higher scores indicate greater symptom severity.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Digit Span", "description": "The Digit Span subt-test of the WAIS-IV assesses attention and working memory.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Digit Symbol Substitution Test", "description": "The Digit Symbol Substitution Test from the WAIS-III assesses attention, processing speed and executive function.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Stroop Color Word Test", "description": "The Stroop Color Word test assesses selection attention, cognitive inhibition, and processing speed.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Rey Auditory Verbal Learning Test", "description": "The Rey Auditory Verbal Learning Test; (RAVLT) assesses learning and memory.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in NIH Toolbox Cognitive Battery", "description": "The NIH Toolbox is a computerized battery of test that assesses neuropsychological function.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Hospital Anxiety and Depression Scale", "description": "The Hospital Anxiety and Depression Scale (HADS) is a 14-time self-rating scale to assess psychological distress in non-psychiatric patients. Items are rated on a 4-point Likert scale (range 0-3). The total score ranges from 0 to 42 with higher indicating greater severity.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in World Health Organization Disability assessment scale 2.0", "description": "The World Health Organization Disability assessment scale 2.0 (WHODAS 2.0) assesses multiple domains of function including: cognition, mobility, self-care, getting along, life activities (household and work) and participation.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Canadian Occupation Performance Measure", "description": "The Canadian Occupation Performance Measure (COPM) assesses an individual's perceived occupational performance in the areas of self-care, productivity, and leisure.", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Change in Blood labs", "description": "Standard blood labs include C-Reactive Protein, Interleukin-6, metabolic panel, and lipid panels", "time_frame": "Through study completion, an average of 8 months" }, { "type": "secondary", "measure": "Genetic Testing", "description": "Genetic testing includes assessment of APOE and BDNF genotypes.", "time_frame": "Baseline" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Fed" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06142253", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06974084", "title": "A Multi-Center, Individually-Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Superiority Trial to Evaluate the Efficacy of the Combination of Maraviroc and Atorvastatin for the Treatment of Subjects With Long COVID", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2026-06-18", "start_date": "2026-07-15", "completion_date": "2027-05", "primary_completion_date": "2026-12-01", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Maraviroc", "Atorvastatin, 10Mg, 20Mg, 40Mg" ], "sponsor": "HealthBio, Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The IMPACT Long Covid Treatment clinical study (IMPACT-LC) is testing two repurposed and previously approved drugs, Maraviroc and Atorvastatin, for the treatment of non-hospitalized subjects with Long COVID. The main goals of the clinical study are to determine if this combination drug therapy can improve neurocognitive and physical functions in Long Covid patients, such as fatigue severity, heart rate, blood pressure, digestion, breathing, dizziness, and cognitive function. A secondary goal is to determine if biomarker levels, measured by a diagnostic test, can improve during treatment. To qualify for the trial, a subject must be an adult ≥ 18 and ≤ 65 years of age and meets the WHO-defined post-COVID-19 condition and has one or more new-onset Long Covid symptom that persist ≥ 3 months after the diagnosis of acute COVID-19 infection. A total of 252 participants will take either two daily doses of two existing medications (Maraviroc and Atorvastatin together as separate tablets) or a placebo (pills with no active ingredient) for 16 weeks. Although these medications are not yet approved for Long Covid, they are FDA-approved for use in treating other health conditions.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue will be measured via PROMIS Fatigue v1.0. The PROMIS Fatigue 10a assesses fatigue severity in the previous week. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The instrument translates the total raw score into a T-score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population (SD=10).", "time_frame": "PROMIS Fatigue scores will be taken during screening (0-28 days before the first baseline) and at the EOT visit, week 12." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Improvement in dysautonomia symptoms as reflected by the Composite Autonomic Symptom Score (COMPASS-31)", "description": "To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on dysautonomia symptoms 12 weeks after treatment initiation in individuals with Long COVID.", "time_frame": "Scores will be determined at Visit 1 (Day 1) and EOT (week -12)" }, { "type": "secondary", "measure": "Improved Cognitive Function, measured by the PROMIS (Patient-Reported Outcomes Measurement Information System) Cognitive Function v.2.0 - Short Form 6a", "description": "The PROMIS (Patient-Reported Outcomes Measurement Information System) Cognitive Function v.2.0 - Short Form 6a is a 6-item sub-set scale of the PROMIS Cognitive Function item bank that assesses patient-perceived cognitive deficits. Each item has five response options ranging in value from one to five. The total raw score for a short form with all questions answered, is the sum of the values of the response to each question and ranges between 6 and 30. The raw score is translated in a T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10.", "time_frame": "Difference in T-score measured at Visit 1 (Day 1) and EOT (week-12)" }, { "type": "secondary", "measure": "To assess if maraviroc and atorvastatin decrease the Long Hauler Index (LHI) from baseline to week 12.", "description": "To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on the LHI 12 weeks after treatment initiation in individuals with Long COVID.", "time_frame": "LHI will be measured at Screening and EOT (week-12)" }, { "type": "secondary", "measure": "To assess the proportion of participants with a PROMIS Fatigue T-score improvement from baseline ≥5 points 12 weeks after treatment initiation.", "description": "In subjects with Long COVID complying with the key protocol criteria (evaluable participants) who received 12 weeks of study treatment:\n\n● Change in the proportion of subjects who improve their PROMIS T-score from baseline to week 12 in maraviroc/atorvastatin and placebo groups.", "time_frame": "From baseline Visit 1 (Day-1) and EOT (week-12)" }, { "type": "secondary", "measure": "To determine the safety profile of maraviroc and atorvastatin in patients treated for Long COVID-19", "description": "Participants report data will be compiled as follows:\n\nPercentage of participants reporting AEs from Dose 1 to 28 days after the last dose.\n\nPercentage of participants reporting SAEs from Dose 1 to 28 days after the last dose.\n\nPercentage of participants reporting AEs leading to discontinuation. Percentage of participants reporting SAEs leading to discontinuation.", "time_frame": "Adverse event collection will be done during every Visit (Day-1, Week-4, Week-8, Week-12, Week-16 (EOT) and EOS (28-42 Days after last dose)" }, { "type": "secondary", "measure": "To evaluate IncellKINE Biomarkers", "description": "To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on IncellKINE biomarker levels in individuals with Long COVID 12 weeks after treatment initiation.", "time_frame": "Screening and EOT (week-12)" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue will be measured via PROMIS Fatigue v1.0. The PROMIS Fatigue 10a assesses fatigue severity in the previous week. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The instrument translates the total raw score into a T-score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population (SD=10).", "time_frame": "PROMIS Fatigue scores will be taken during screening (0-28 days before the first baseline) and at the EOT visit, week 12." }, { "type": "secondary", "measure": "Improvement in dysautonomia symptoms as reflected by the Composite Autonomic Symptom Score (COMPASS-31)", "description": "To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on dysautonomia symptoms 12 weeks after treatment initiation in individuals with Long COVID.", "time_frame": "Scores will be determined at Visit 1 (Day 1) and EOT (week -12)" }, { "type": "secondary", "measure": "Improved Cognitive Function, measured by the PROMIS (Patient-Reported Outcomes Measurement Information System) Cognitive Function v.2.0 - Short Form 6a", "description": "The PROMIS (Patient-Reported Outcomes Measurement Information System) Cognitive Function v.2.0 - Short Form 6a is a 6-item sub-set scale of the PROMIS Cognitive Function item bank that assesses patient-perceived cognitive deficits. Each item has five response options ranging in value from one to five. The total raw score for a short form with all questions answered, is the sum of the values of the response to each question and ranges between 6 and 30. The raw score is translated in a T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10.", "time_frame": "Difference in T-score measured at Visit 1 (Day 1) and EOT (week-12)" }, { "type": "secondary", "measure": "To assess if maraviroc and atorvastatin decrease the Long Hauler Index (LHI) from baseline to week 12.", "description": "To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on the LHI 12 weeks after treatment initiation in individuals with Long COVID.", "time_frame": "LHI will be measured at Screening and EOT (week-12)" }, { "type": "secondary", "measure": "To assess the proportion of participants with a PROMIS Fatigue T-score improvement from baseline ≥5 points 12 weeks after treatment initiation.", "description": "In subjects with Long COVID complying with the key protocol criteria (evaluable participants) who received 12 weeks of study treatment:\n\n● Change in the proportion of subjects who improve their PROMIS T-score from baseline to week 12 in maraviroc/atorvastatin and placebo groups.", "time_frame": "From baseline Visit 1 (Day-1) and EOT (week-12)" }, { "type": "secondary", "measure": "To determine the safety profile of maraviroc and atorvastatin in patients treated for Long COVID-19", "description": "Participants report data will be compiled as follows:\n\nPercentage of participants reporting AEs from Dose 1 to 28 days after the last dose.\n\nPercentage of participants reporting SAEs from Dose 1 to 28 days after the last dose.\n\nPercentage of participants reporting AEs leading to discontinuation. Percentage of participants reporting SAEs leading to discontinuation.", "time_frame": "Adverse event collection will be done during every Visit (Day-1, Week-4, Week-8, Week-12, Week-16 (EOT) and EOS (28-42 Days after last dose)" }, { "type": "secondary", "measure": "To evaluate IncellKINE Biomarkers", "description": "To assess the effect of the combination of maraviroc and atorvastatin, compared with placebo, on IncellKINE biomarker levels in individuals with Long COVID 12 weeks after treatment initiation.", "time_frame": "Screening and EOT (week-12)" } ], "relevance_tags": [ "Repurposed", "Neurological / Autonomic", "Phase 2", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 252, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06974084", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05967052", "title": "Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation", "status": "TERMINATED", "phase": "PHASE2", "last_updated": "2026-06-17", "start_date": "2023-10-24", "completion_date": "2025-09-11", "primary_completion_date": "2025-09-11", "conditions_raw": [ "Chronic Fatigue Syndrome", "COVID-19, Long Haul" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Pregabalin", "Independent Walking Training", "Gradual Movement Therapy In The Ward", "Telerehabilitation", "Psychotherapy" ], "sponsor": "National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland", "sponsor_type": "NETWORK", "primary_purpose": "N/A", "brief_summary": "This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome).\n\nPatients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days).\n\nThere will be 4 outpatient visits to the research center and 12 telephone consultations.\n\nThe procedures and assessments performed as part of the study are listed in the study schedule.\n\nIt is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm).\n\nPatients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.", "primary_outcomes": [ { "type": "primary", "measure": "Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score", "description": "Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score", "time_frame": "3 months and 6 months" }, { "type": "primary", "measure": "Walking distance as a difference in score from the 6 Minute Walking Test", "description": "Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline", "time_frame": "3 months and 6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)", "description": "Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of the study", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the result obtained in the \"Beck Depression Inventory (BDIII)\" study", "description": "Change in the result obtained in the \"Beck Depression Inventory (BDIII)\" study in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)", "description": "Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI) in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i", "description": "Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of starting the study", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the result of the CCT test", "description": "Change in the result of the CCT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST)", "description": "Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST) in the 3rd and 6th month of the study compared to the result on the day of the study commencement.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the result of the RFFT test", "description": "Change in the result of the RFFT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the WAIS-R intelligence test result", "description": "Change in the WAIS-R intelligence test result in the 3rd and 6th month of the study in relation to the result on the day of the study commencement", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in reaction time expressed by the Stroop interference test", "description": "Change in reaction time expressed by the Stroop interference test in the 3rd and 6th month of the study compared to the result on the day of the study start.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the assessment of the quality of gait", "description": "Change in the assessment of the quality of gait in the 3rd and 6th month of the study in relation to the result on the day of the beginning of the study", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in walking speed", "description": "Change in walking speed in the 3rd and 6th month of the study in relation to the result on the day of the study.", "time_frame": "3 months and 6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score", "description": "Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score", "time_frame": "3 months and 6 months" }, { "type": "primary", "measure": "Walking distance as a difference in score from the 6 Minute Walking Test", "description": "Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)", "description": "Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of the study", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the result obtained in the \"Beck Depression Inventory (BDIII)\" study", "description": "Change in the result obtained in the \"Beck Depression Inventory (BDIII)\" study in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)", "description": "Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI) in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i", "description": "Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of starting the study", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the result of the CCT test", "description": "Change in the result of the CCT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST)", "description": "Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST) in the 3rd and 6th month of the study compared to the result on the day of the study commencement.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the result of the RFFT test", "description": "Change in the result of the RFFT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the WAIS-R intelligence test result", "description": "Change in the WAIS-R intelligence test result in the 3rd and 6th month of the study in relation to the result on the day of the study commencement", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in reaction time expressed by the Stroop interference test", "description": "Change in reaction time expressed by the Stroop interference test in the 3rd and 6th month of the study compared to the result on the day of the study start.", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in the assessment of the quality of gait", "description": "Change in the assessment of the quality of gait in the 3rd and 6th month of the study in relation to the result on the day of the beginning of the study", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Change in walking speed", "description": "Change in walking speed in the 3rd and 6th month of the study in relation to the result on the day of the study.", "time_frame": "3 months and 6 months" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Network" ], "enrollment": 23, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05967052", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07651371", "title": "Effects of a Physical Rehabilitation Program on Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-06-16", "start_date": "2021-01-05", "completion_date": "2024-12-15", "primary_completion_date": "2023-12-15", "conditions_raw": [ "Long Covid" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Physical Rehabilitation", "Treadmill Ergometer", "Pulley" ], "sponsor": "Universidade do Estado do Pará", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The objective of this clinical trial is to analyze the clinical, functional, and laboratory effects of a rehabilitation protocol designed for patients with long COVID; it may include any of the following: sex/gender, age groups, healthy volunteers. The main questions it aims to answer are:\n\nDoes handgrip strength improve after the intervention? Does the 6-minute walk test improve after the intervention? Participants must attend all 20 sessions of the physical rehabilitation program.", "primary_outcomes": [ { "type": "primary", "measure": "hand grip strength", "description": "Handgrip strength (HGS) was measured using a CROW model manual hydraulic dynamometer. The test was conducted in accordance with the recommendations of the American Society of Hand Therapists (ASTH).", "time_frame": "Through the end of the 20 sessions (up to 10 weeks)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "hand grip strength", "description": "Handgrip strength (HGS) was measured using a CROW model manual hydraulic dynamometer. The test was conducted in accordance with the recommendations of the American Society of Hand Therapists (ASTH).", "time_frame": "Through the end of the 20 sessions (up to 10 weeks)" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 74, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07651371", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07359482", "title": "sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19", "status": "RECRUITING", "phase": "PHASE3", "last_updated": "2026-06-09", "start_date": "2026-06-04", "completion_date": "2028-05-01", "primary_completion_date": "2027-12-31", "conditions_raw": [ "Post-COVID", "POST-Covid 19", "Post-COVID Conditions" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Fluvoxamine" ], "sponsor": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Fatigue, cognitive problems, post-exertional malaise (PEM) and postural orthostatic tachycardia syndrome (POTS) are common and debilitating symptoms after COVID-19. The pathophysiology of post-COVID is not well understood and there is no established biomedical treatment. Treatment options for post-COVID are thus much needed.\n\nA promising candidate intervention is fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), that may reduce post-COVID symptoms because of its regulatory effect on the (neuro) immune system, the hypothalamic-pituitary-adrenal (HPA) axis and the tryptophan system. The investigators will randomize 160 participants to either fluvoxamine or placebo for 12 weeks.\n\nThe investigators will use advanced functional neuroimaging techniques during cognitive challenge (optional substudy) and plasma biomarkers (inflammatory markers, cortisol, serotonin, IDO-2 activity), to facilitate identifying potential mechanistic pathways of post -COVID treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue severity", "description": "Fatigue scale of the Checklist Individual Strength (CIS-20R). This scale has a minimum score of 8 and a maximum score of 56. High score indicate worse outcome.", "time_frame": "week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue severity", "description": "Dutch-Flemish Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue short form 8a. A higher scores indicates worse outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Cognitive functioning", "description": "Dutch-Flemish Patient-Reported Outcome Measurement Information System (PROMIS) cognitive function 8a. Higher scores indicate better functioning.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Cognitive functioning", "description": "Concentration score on the Checklist Individual Strength (CIS-20R). This scale has a minimum score of 5 and a maximum score of 35. A higher score indicates worse outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "PEM", "description": "DePaul Symptom Questionnaire (DSQ) Post Exertional Malaise (PEM). Higher scores indicate worse outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "POTS (National Aeronautics and Space Administration (NASA) lean test", "description": "NASA lean test", "time_frame": "week 12" }, { "type": "secondary", "measure": "POTS", "description": "DePaul Symptom Questionnaire (DSQ) Postural Orthostatic Tachycardia Syndrome (POTS). Higher scores indicate worse outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Health-related Quality of Life", "description": "Dutch-Flemish Patient-Reported Outcome Measurement Information System (PROMIS) Profile-29. Higher scores indicate better outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Disability", "description": "Bell disability score. The minimum score is 0. The maximum score is 100. Higher scores indicate better outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Side effects", "description": "Antidepressant Side Effect Checklist-21 (ASEC-21). Higher scores indicate worse outcome.", "time_frame": "week 12" }, { "type": "secondary", "measure": "Side effects", "description": "Frequency, Intensity, Burden of Side Effects Rating scale (FIBSER scale). Higher scores indicate worse outcome.", "time_frame": "week 12" }, { "type": "secondary", "measure": "Brain Perfusion (optional MRI substudy)", "description": "Arterial Spin Labeling", "time_frame": "week 12" }, { "type": "secondary", "measure": "Brain functioning and connectivity (optional MRI substudy)", "description": "During resting-state and cognitive effort (challenging N-back (3-back vs. 0-back) on functional MRI", "time_frame": "week 12" }, { "type": "secondary", "measure": "Brain metabolites and neuroinflammation (optional MRI substudy)", "description": "Magnetic Resonance Spectroscopy", "time_frame": "week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue severity", "description": "Fatigue scale of the Checklist Individual Strength (CIS-20R). This scale has a minimum score of 8 and a maximum score of 56. High score indicate worse outcome.", "time_frame": "week 12" }, { "type": "secondary", "measure": "Fatigue severity", "description": "Dutch-Flemish Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue short form 8a. A higher scores indicates worse outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Cognitive functioning", "description": "Dutch-Flemish Patient-Reported Outcome Measurement Information System (PROMIS) cognitive function 8a. Higher scores indicate better functioning.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Cognitive functioning", "description": "Concentration score on the Checklist Individual Strength (CIS-20R). This scale has a minimum score of 5 and a maximum score of 35. A higher score indicates worse outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "PEM", "description": "DePaul Symptom Questionnaire (DSQ) Post Exertional Malaise (PEM). Higher scores indicate worse outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "POTS (National Aeronautics and Space Administration (NASA) lean test", "description": "NASA lean test", "time_frame": "week 12" }, { "type": "secondary", "measure": "POTS", "description": "DePaul Symptom Questionnaire (DSQ) Postural Orthostatic Tachycardia Syndrome (POTS). Higher scores indicate worse outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Health-related Quality of Life", "description": "Dutch-Flemish Patient-Reported Outcome Measurement Information System (PROMIS) Profile-29. Higher scores indicate better outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Disability", "description": "Bell disability score. The minimum score is 0. The maximum score is 100. Higher scores indicate better outcome.", "time_frame": "week 4, 8, 12" }, { "type": "secondary", "measure": "Side effects", "description": "Antidepressant Side Effect Checklist-21 (ASEC-21). Higher scores indicate worse outcome.", "time_frame": "week 12" }, { "type": "secondary", "measure": "Side effects", "description": "Frequency, Intensity, Burden of Side Effects Rating scale (FIBSER scale). Higher scores indicate worse outcome.", "time_frame": "week 12" }, { "type": "secondary", "measure": "Brain Perfusion (optional MRI substudy)", "description": "Arterial Spin Labeling", "time_frame": "week 12" }, { "type": "secondary", "measure": "Brain functioning and connectivity (optional MRI substudy)", "description": "During resting-state and cognitive effort (challenging N-back (3-back vs. 0-back) on functional MRI", "time_frame": "week 12" }, { "type": "secondary", "measure": "Brain metabolites and neuroinflammation (optional MRI substudy)", "description": "Magnetic Resonance Spectroscopy", "time_frame": "week 12" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Phase 3", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 160, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07359482", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06614309", "title": "Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-06-05", "start_date": "2024-09-24", "completion_date": "2026-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Acute Progressive Carbon Dioxide", "Acute Intermittent Hypoxia", "Training: Progressive Carbon Dioxide Ramping", "Training: Intermittent Hypoxic Exposure" ], "sponsor": "Mayo Clinic", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Change in cerebral blood flow", "description": "The intracranial middle cerebral arteries will be obtained (MCAv) will be imaged with a linear probe and duplex ultrasound system to simultaneously measure CBFv by pulse wave doppler (peak and mean flow)", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "primary", "measure": "Change in heart rate variability", "description": "Short- term HRV analysis of a 3-lead ECG recording (5 minute recording) will evaluate both time-domain parameters (mean heart rate, standard deviation of normal-to-normal (NN) intervals (SDNN) and root mean square of successive differences between NN intervals rMSSD) and frequency-domain parameters (total power, high frequency (HF) and low frequency (LF) and LF/HF ratio).", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "primary", "measure": "Change in brain fog scale", "description": "Questionnaire assessing of how much brain fog is affecting daily abilities", "time_frame": "Baseline, post-acute exposure and 14 days post training" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in fatigue functional assessment of chronic illness therapy-fatigue scale", "description": "Fatigue functional assessment of chronic illness therapy-fatigue scale (FACIT-Fatigue): assessment of how much fatigue is affecting daily abilities. Scores range from 0-52 for the FACIT with a higher score indicating higher levels of fatigue experienced.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in short form health survey (SF-36)", "description": "The Short Form (SF-36) Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in Trail making test", "description": "Trail making test: Consists of two parts. For part one, the subject will be presented with 25 numbered dots. The goal is to connect all 25 dots in numerical order quickly and accurately. The second part consists of 25 dots on the screen labelled with numbers and letters. The subject will then click the dots in sequential order by number followed by letter. For example, 1-A-2-B-3-C…, in the shortest amount of time possible while maintaining accuracy.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in rapid cognitive assessment tool (RCAT) score", "description": "The premise is to click spawning targets quickly and accurately. The assessment lasts one minute during which the game will add or reduce intensity based on real time performance. It is used to interpret psychological and psychomotor functions including hand-eye coordination, speed, response time, spatial awareness, situational awareness, and decision-making. Test takes one minute and score is calculate based on number of correct clicks.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in Task switching test performance", "description": "Task switching test will evaluate the individual's ability to switch between different tasks or operations. Participants are presented with a number between 1 and 9. The number will appear in one of two colors: purple or yellow. If the number is purple, the participant will answer with yes or no if the number is even. If yellow, the participants will answer with yes or no if the number is less than 5. Participants will see 40 numbers and their performance will be scored based on response time and accuracy.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in Rey Auditory Verbal Learning Test (AVLT) recall", "description": "Rey Auditory Verbal Learning Test (AVLT) will assess short term auditory recall. Subjects are read a list of 15 words and asked to repeat as many words as possible that they can remember back to the test administrator. They repeat this 5 times, then read a new list of 15 words to repeat back one time before returning to recall the first list of words.", "time_frame": "Baseline, post-acute exposure and 14 days post training" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in cerebral blood flow", "description": "The intracranial middle cerebral arteries will be obtained (MCAv) will be imaged with a linear probe and duplex ultrasound system to simultaneously measure CBFv by pulse wave doppler (peak and mean flow)", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "primary", "measure": "Change in heart rate variability", "description": "Short- term HRV analysis of a 3-lead ECG recording (5 minute recording) will evaluate both time-domain parameters (mean heart rate, standard deviation of normal-to-normal (NN) intervals (SDNN) and root mean square of successive differences between NN intervals rMSSD) and frequency-domain parameters (total power, high frequency (HF) and low frequency (LF) and LF/HF ratio).", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "primary", "measure": "Change in brain fog scale", "description": "Questionnaire assessing of how much brain fog is affecting daily abilities", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in fatigue functional assessment of chronic illness therapy-fatigue scale", "description": "Fatigue functional assessment of chronic illness therapy-fatigue scale (FACIT-Fatigue): assessment of how much fatigue is affecting daily abilities. Scores range from 0-52 for the FACIT with a higher score indicating higher levels of fatigue experienced.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in short form health survey (SF-36)", "description": "The Short Form (SF-36) Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in Trail making test", "description": "Trail making test: Consists of two parts. For part one, the subject will be presented with 25 numbered dots. The goal is to connect all 25 dots in numerical order quickly and accurately. The second part consists of 25 dots on the screen labelled with numbers and letters. The subject will then click the dots in sequential order by number followed by letter. For example, 1-A-2-B-3-C…, in the shortest amount of time possible while maintaining accuracy.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in rapid cognitive assessment tool (RCAT) score", "description": "The premise is to click spawning targets quickly and accurately. The assessment lasts one minute during which the game will add or reduce intensity based on real time performance. It is used to interpret psychological and psychomotor functions including hand-eye coordination, speed, response time, spatial awareness, situational awareness, and decision-making. Test takes one minute and score is calculate based on number of correct clicks.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in Task switching test performance", "description": "Task switching test will evaluate the individual's ability to switch between different tasks or operations. Participants are presented with a number between 1 and 9. The number will appear in one of two colors: purple or yellow. If the number is purple, the participant will answer with yes or no if the number is even. If yellow, the participants will answer with yes or no if the number is less than 5. Participants will see 40 numbers and their performance will be scored based on response time and accuracy.", "time_frame": "Baseline, post-acute exposure and 14 days post training" }, { "type": "secondary", "measure": "Change in Rey Auditory Verbal Learning Test (AVLT) recall", "description": "Rey Auditory Verbal Learning Test (AVLT) will assess short term auditory recall. Subjects are read a list of 15 words and asked to repeat as many words as possible that they can remember back to the test administrator. They repeat this 5 times, then read a new list of 15 words to repeat back one time before returning to recall the first list of words.", "time_frame": "Baseline, post-acute exposure and 14 days post training" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 45, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06614309", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07627815", "title": "Evaluating the Safety and Efficacy of PNMR as Treatment for Long COVID", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-06-04", "start_date": "2026-05-20", "completion_date": "2026-12-26", "primary_completion_date": "2026-08-26", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Paragon Novel Metabolic Regulator", "Dietary And Lifestyle Recommendations" ], "sponsor": "ParagonClinicals Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This will be a six-week, randomized, parallel, two group, open-label design. Patients will be treated with Paragon Novel Metabolic Regulator (PNMR) + standard of care (SOC) or SOC alone for 6 weeks for the treatment of Long COVID. All patients will also be provided with with Dietary \\& Lifestyle recommendations specifically designed to enhance immune system function and reduce viral proliferation.\n\nPatients will be assessed in the clinic at screening/baseline, 3 and 6 weeks while on treatment, and by telephone at 4 weeks post-treatment.\n\nAll patients will be asked to fill in a diary to record their daily treatment dosage when being treated with PNMR + SOC or with SOC alone. Primary objective: To evaluate the efficacy of PNMR + (SOC) vs. SOC in the treatment and management of patients with long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Change in distance walked on the 6-minute walk test (6MWT) after 6 weeks of treatment.", "description": "Patient baseline is first assessed at Day 0 upon screening, and then retested after 6 weeks of treatment.", "time_frame": "From enrollment to the end of treatment at 6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in distance walked on the 6MWT after 3 weeks of treatment.", "description": "", "time_frame": "From enrollment to the completion of 3 weeks initial treatment." }, { "type": "secondary", "measure": "Proportion of patients achieving an improvement of 30 meters or more on the 6MWT by 3 and 6 weeks on treatment.", "description": "", "time_frame": "From enrollment to measurements made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Time to achieving an improvement of 30 m or more on the 6MWT by 6 weeks on treatment.", "description": "", "time_frame": "From enrollment to measurements made at either 3 or 6 week if achieved" }, { "type": "secondary", "measure": "Change in patient-reported assessment of fatigue on a 100 mm visual analogue scale (VAS) at 3 and 6 weeks on treatment.", "description": "Fatigue Severity over the last 7 days, reported on a 100 mm Visual Analogue Scale: 0 - 100, higher score means a worse outcome", "time_frame": "From enrollment assessment to assessments made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Change in patient-reported assessment of brain fog duration at 3 and 6 weeks on treatment.", "description": "Brain Fog Duration seen over last 7 days: 0 - 7 days, higher score means a worse outcome", "time_frame": "From enrollment assessment to assessments made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Change in patient-reported assessment of brain fog severity on a 100 mm VAS at 3 and 6 weeks on treatment.", "description": "Brain Fog Severity over the last 7 days reported on a 100 mm Visual Analogue Scale: 0 - 100, higher score means a worse outcome", "time_frame": "From enrollment assessment to assessments made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Change in QoL as measured by the Medical Outcomes Study Short Form 36 (SF-36) at 3 and 6 weeks on treatment.", "description": "The SF-36 (Short Form 36) is a self-reported survey that measures 36 individual health-related indicators of Quality of Life (QOL). It asks the patient to rate their: General Health; General Health now compared to one week ago; along with more detailed evaluations of Physical Health, Role Limitations (Physical), Emotional Health, Role Limitations (Emotional), Social Functioning; and to rate other factors related to Pain, Energy, and Mood as compared to the week prior. Each question has a unique set of answers specific to the question. For some questions a higher score means a worse outcome, whereas for other questions a higher score means a better outcome. This method requires that the patient think through each answer individually.", "time_frame": "From enrollment measurement to measurements made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Health care utilization at 3 and 6 weeks on treatment.", "description": "Health care utilization at 3 and 6 weeks on treatment.\n\n* Physician visits\n* Clinic visits\n* Other health care professional visits and consultations\n* Prescription medication use for the management of flu or flu-like illness\n* Non-prescription medication use for the management of flu or flu-like illness", "time_frame": "Health care utilization measured at 3 and 6 weeks on treatment." } ], "outcome_measures": [ { "type": "primary", "measure": "Change in distance walked on the 6-minute walk test (6MWT) after 6 weeks of treatment.", "description": "Patient baseline is first assessed at Day 0 upon screening, and then retested after 6 weeks of treatment.", "time_frame": "From enrollment to the end of treatment at 6 weeks" }, { "type": "secondary", "measure": "Change in distance walked on the 6MWT after 3 weeks of treatment.", "description": "", "time_frame": "From enrollment to the completion of 3 weeks initial treatment." }, { "type": "secondary", "measure": "Proportion of patients achieving an improvement of 30 meters or more on the 6MWT by 3 and 6 weeks on treatment.", "description": "", "time_frame": "From enrollment to measurements made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Time to achieving an improvement of 30 m or more on the 6MWT by 6 weeks on treatment.", "description": "", "time_frame": "From enrollment to measurements made at either 3 or 6 week if achieved" }, { "type": "secondary", "measure": "Change in patient-reported assessment of fatigue on a 100 mm visual analogue scale (VAS) at 3 and 6 weeks on treatment.", "description": "Fatigue Severity over the last 7 days, reported on a 100 mm Visual Analogue Scale: 0 - 100, higher score means a worse outcome", "time_frame": "From enrollment assessment to assessments made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Change in patient-reported assessment of brain fog duration at 3 and 6 weeks on treatment.", "description": "Brain Fog Duration seen over last 7 days: 0 - 7 days, higher score means a worse outcome", "time_frame": "From enrollment assessment to assessments made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Change in patient-reported assessment of brain fog severity on a 100 mm VAS at 3 and 6 weeks on treatment.", "description": "Brain Fog Severity over the last 7 days reported on a 100 mm Visual Analogue Scale: 0 - 100, higher score means a worse outcome", "time_frame": "From enrollment assessment to assessments made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Change in QoL as measured by the Medical Outcomes Study Short Form 36 (SF-36) at 3 and 6 weeks on treatment.", "description": "The SF-36 (Short Form 36) is a self-reported survey that measures 36 individual health-related indicators of Quality of Life (QOL). It asks the patient to rate their: General Health; General Health now compared to one week ago; along with more detailed evaluations of Physical Health, Role Limitations (Physical), Emotional Health, Role Limitations (Emotional), Social Functioning; and to rate other factors related to Pain, Energy, and Mood as compared to the week prior. Each question has a unique set of answers specific to the question. For some questions a higher score means a worse outcome, whereas for other questions a higher score means a better outcome. This method requires that the patient think through each answer individually.", "time_frame": "From enrollment measurement to measurements made at 3 and 6 weeks" }, { "type": "secondary", "measure": "Health care utilization at 3 and 6 weeks on treatment.", "description": "Health care utilization at 3 and 6 weeks on treatment.\n\n* Physician visits\n* Clinic visits\n* Other health care professional visits and consultations\n* Prescription medication use for the management of flu or flu-like illness\n* Non-prescription medication use for the management of flu or flu-like illness", "time_frame": "Health care utilization measured at 3 and 6 weeks on treatment." } ], "relevance_tags": [ "Metabolic", "Immunomodulatory", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 82, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07627815", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06404099", "title": "RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-06-03", "start_date": "2024-08-12", "completion_date": "2026-04-20", "primary_completion_date": "2026-03-24", "conditions_raw": [ "Long COVID", "Long COVID-19", "Hypersomnia" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Modafinil", "Solriamfetol" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices.\n\nThis platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).", "primary_outcomes": [ { "type": "primary", "measure": "Change in total score of the PROMIS 8a SRI to assess sleep-related impairment", "description": "The PROMIS 8a SRI form includes a total of 8 items that ask participants to reflect on their sleep-related daytime impairment over the past 7 days with questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate greater sleep-related impairment.", "time_frame": "Baseline, End of Intervention (Day 77)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in total score of the PROMIS 8b SD to assess sleep disturbance", "description": "The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with \\> 55 1 SD above population mean.", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in PROMIS 10a Fatigue score", "description": "The PROMIS 10a Fatigue is a 10-item questionnaire that assesses a participant's fatigue on a scale of 1 (not at all fatigued) to 5 (very much).", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in an objective neurocognitive battery score", "description": "", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in ECog2 measure", "description": "Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. It has been used for patients with mild cognitive impairment, Alzheimer's Disease, and dementia. It takes 5 minutes to complete.", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in PASC Symptom Questionnaire responses", "description": "Participants will be asked to complete a questionnaire that asks about the presence of PASC symptoms at Baseline and at follow-up visits. This questionnaire includes symptoms that have been associated with PASC.", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in total score on the Insomnia Severity Index (ISI)", "description": "The ISI is a 7-item, self-report questionnaire that assesses the nature, severity, and impact of insomnia, on a 5-point Likert scale (eg, 0 = not at all, 4 = extremely; scores: from 0 to 28). The ISI asks patients to recall their insomnia symptoms over the past 2 weeks.", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary", "description": "Sleep onset time will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary", "description": "Nocturnal sleep duration will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary", "description": "24-hour sleep duration will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary", "description": "Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker", "description": "Nocturnal sleep duration will be assessed by activity tracker", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker", "description": "24-hour sleep duration will be assessed by activity tracker", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker", "description": "Sleep Efficiency is the percentage of the sleep period spent asleep, as measured by activity tracker", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker", "description": "Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in total score of the PROMIS 8a SRI to assess sleep-related impairment", "description": "The PROMIS 8a SRI form includes a total of 8 items that ask participants to reflect on their sleep-related daytime impairment over the past 7 days with questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate greater sleep-related impairment.", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in total score of the PROMIS 8b SD to assess sleep disturbance", "description": "The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with \\> 55 1 SD above population mean.", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in PROMIS 10a Fatigue score", "description": "The PROMIS 10a Fatigue is a 10-item questionnaire that assesses a participant's fatigue on a scale of 1 (not at all fatigued) to 5 (very much).", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in an objective neurocognitive battery score", "description": "", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in ECog2 measure", "description": "Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. It has been used for patients with mild cognitive impairment, Alzheimer's Disease, and dementia. It takes 5 minutes to complete.", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in PASC Symptom Questionnaire responses", "description": "Participants will be asked to complete a questionnaire that asks about the presence of PASC symptoms at Baseline and at follow-up visits. This questionnaire includes symptoms that have been associated with PASC.", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in total score on the Insomnia Severity Index (ISI)", "description": "The ISI is a 7-item, self-report questionnaire that assesses the nature, severity, and impact of insomnia, on a 5-point Likert scale (eg, 0 = not at all, 4 = extremely; scores: from 0 to 28). The ISI asks patients to recall their insomnia symptoms over the past 2 weeks.", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary", "description": "Sleep onset time will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary", "description": "Nocturnal sleep duration will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary", "description": "24-hour sleep duration will be assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary", "description": "Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker", "description": "Nocturnal sleep duration will be assessed by activity tracker", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker", "description": "24-hour sleep duration will be assessed by activity tracker", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker", "description": "Sleep Efficiency is the percentage of the sleep period spent asleep, as measured by activity tracker", "time_frame": "Baseline, End of Intervention (Day 77)" }, { "type": "secondary", "measure": "Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker", "description": "Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary", "time_frame": "Baseline, End of Intervention (Day 77)" } ], "relevance_tags": [ "General", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 361, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06404099", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06560554", "title": "Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID", "status": "ENROLLING_BY_INVITATION", "phase": "NA", "last_updated": "2026-06-03", "start_date": "2024-09-05", "completion_date": "2026-12-30", "primary_completion_date": "2025-09-30", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Fermented Foods" ], "sponsor": "Mayo Clinic", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to evaluate the effects of fermented foods on bacterial gut microbiome diversity of long-COVID subjects.", "primary_outcomes": [ { "type": "primary", "measure": "Gut Microbiome diversity", "description": "High-dimensional microbiome data representing taxonomic features of the microbiomes will be analyzed to decode the community structure and key components that are associated with the condition of interest", "time_frame": "At enrollment and completion of study (12 weeks)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptoms of depression and anxiety", "description": "Measured using the self-reported Hospital Anxiety and Depression Scale (HADS). Total questions: 14. Anxiety 7, Depression 7. Each item is rated on a 4-point scale from 0 \"absence\" to 3 \"extreme presence\". Total score is 21 per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; \\> 11: Abnormal", "time_frame": "At enrollment and completion of study (12 weeks)" }, { "type": "secondary", "measure": "Assessment of cognition", "description": "Measured using the Montreal Cognitive Assessment (MoCA-BLIND). Total questions:13. Memory 3 Attention 4 Language 3 Abstraction 2 Orientation 1. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal \\> 18 is considered normal cognition", "time_frame": "At enrollment and completion of study (12 weeks)" }, { "type": "secondary", "measure": "Assessment of quality of life", "description": "Measured using the self-reported EuroQol-5D-3L questionnaire. Total questions: 6. Mobility: 1, Self-Care: 1, Usual Activities: 1, Pain/discomfort: 1, Anxiety/depression: 1, Health State - Visual Analog Scale: 1. 3L - 3 levels of severity: no problems, some problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state.", "time_frame": "At enrollment and completion of study (12 weeks)" }, { "type": "secondary", "measure": "Assessment of post-traumatic stress (PTSD) symptoms", "description": "Measured using Impact of Events-revised (IES-r). Total questions: 22. Intrusion 7, Avoidance 8, Hyperarousal 7. Items are rated on a 5-point scale ranging from 0 (\"not at all\") to 4 (\"extremely\"). Total scores are summed with higher scores indicating greater distress with regards to a specific event.", "time_frame": "At enrollment and completion of the study (12 weeks)" } ], "outcome_measures": [ { "type": "primary", "measure": "Gut Microbiome diversity", "description": "High-dimensional microbiome data representing taxonomic features of the microbiomes will be analyzed to decode the community structure and key components that are associated with the condition of interest", "time_frame": "At enrollment and completion of study (12 weeks)" }, { "type": "secondary", "measure": "Symptoms of depression and anxiety", "description": "Measured using the self-reported Hospital Anxiety and Depression Scale (HADS). Total questions: 14. Anxiety 7, Depression 7. Each item is rated on a 4-point scale from 0 \"absence\" to 3 \"extreme presence\". Total score is 21 per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; \\> 11: Abnormal", "time_frame": "At enrollment and completion of study (12 weeks)" }, { "type": "secondary", "measure": "Assessment of cognition", "description": "Measured using the Montreal Cognitive Assessment (MoCA-BLIND). Total questions:13. Memory 3 Attention 4 Language 3 Abstraction 2 Orientation 1. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal \\> 18 is considered normal cognition", "time_frame": "At enrollment and completion of study (12 weeks)" }, { "type": "secondary", "measure": "Assessment of quality of life", "description": "Measured using the self-reported EuroQol-5D-3L questionnaire. Total questions: 6. Mobility: 1, Self-Care: 1, Usual Activities: 1, Pain/discomfort: 1, Anxiety/depression: 1, Health State - Visual Analog Scale: 1. 3L - 3 levels of severity: no problems, some problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state.", "time_frame": "At enrollment and completion of study (12 weeks)" }, { "type": "secondary", "measure": "Assessment of post-traumatic stress (PTSD) symptoms", "description": "Measured using Impact of Events-revised (IES-r). Total questions: 22. Intrusion 7, Avoidance 8, Hyperarousal 7. Items are rated on a 5-point scale ranging from 0 (\"not at all\") to 4 (\"extremely\"). Total scores are summed with higher scores indicating greater distress with regards to a specific event.", "time_frame": "At enrollment and completion of the study (12 weeks)" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06560554", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05676008", "title": "A Study of Positive Emotions With Long COVID-19", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-05-29", "start_date": "2023-01-12", "completion_date": "2027-04", "primary_completion_date": "2027-04", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Microdosing Of Mindfulness" ], "sponsor": "University of California, Davis", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is testing a new brief mindfulness practice for people suffering from long COVID-19 symptoms. People suffering from long COVID are particularly vulnerable to negative emotions, as they must also cope with the long-term uncertainty of physical and psychological stress beyond the acute infection. The goal of the study is to measure the ability of a brief mindfulness practice to promote a sense of well-being in people suffering from long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Well-being", "description": "14 items from the Mental Health Continuum Short Form", "time_frame": "1 month" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Perceived Stress", "description": "Perceived Stress Scale", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Anxiety symptoms", "description": "Generalized Anxiety Disorder scale", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Depressive symptoms", "description": "Beck Depression Inventory Short Form", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Physical health", "description": "Physical health symptoms - 11 items + 3 items of COVID symptoms", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Cardiac symptoms", "description": "Cardiac symptoms by the Kansas City Cardiomyopathy Questionnaire-12 items (KCCQ-12)", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Well-being", "description": "14 items from the Mental Health Continuum Short Form", "time_frame": "3 and 12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Well-being", "description": "14 items from the Mental Health Continuum Short Form", "time_frame": "1 month" }, { "type": "secondary", "measure": "Perceived Stress", "description": "Perceived Stress Scale", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Anxiety symptoms", "description": "Generalized Anxiety Disorder scale", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Depressive symptoms", "description": "Beck Depression Inventory Short Form", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Physical health", "description": "Physical health symptoms - 11 items + 3 items of COVID symptoms", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Cardiac symptoms", "description": "Cardiac symptoms by the Kansas City Cardiomyopathy Questionnaire-12 items (KCCQ-12)", "time_frame": "1, 3 and 12 months" }, { "type": "secondary", "measure": "Well-being", "description": "14 items from the Mental Health Continuum Short Form", "time_frame": "3 and 12 months" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 400, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05676008", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07559994", "title": "Diagnostic and Clinical Management of Non-Obstructive Myocardial Ischemia in Patients With Long Covid-19 Syndrome and New Onset Chest Pain", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-05-28", "start_date": "2021-09-02", "completion_date": "2026-06-30", "primary_completion_date": "2025-04-30", "conditions_raw": [ "Angina (Stable)", "INOCA (Ischemia With Non Obstructive Coronary Artery Disease)", "Long COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Coronary Functional Test" ], "sponsor": "Fundacion Investigacion Interhospitalaria Cardiovascular", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long Covid-19 INOCA is an investigator-initiated, prospective, randomized, sham-controlled, single center study. Its objective is to investigate the benefits of tailored medical therapy according to the results of the coronary functional testing (CFT) against the routine standard of care and the prevalence and endotypes of ischemia with non-obstructive coronary arteries (INOCA) in patients with long covid-19 syndrome (LCS) and new onset chest pain. All LCS patient with new onset of chest pain will be enrolled. Invasive coronary angiogram and epicardial physiological assessment will be performed to exclude significant epicardial coronary artery disease. Patients without significant epicardial coronary artery disease will undergo CFT which include Acetylcholine test and Coronary microvascular function test. Patients will be randomized into 2 groups: 1) tailored treatment group guided by the results of CFT (intervention) and 2) the routine standard of care group (sham). All patients will undergo the angina symptom and the quality-of-life (QoL) assessment at baseline, 3, and 12 months using the Seattle Angina Questionnaire (SAQ). In the sham group, patients and physicians will be blinded to the results of coronary functional testing for 3 months. Treatment of INOCA will be provided in both groups. The main hypothesis of the Long-Covid INOCA study states that, in LCS patients with chest pain, treatment guided by CFT will demonstrate better angina symptom control and improvement in quality of life (QoL) comparing to the routine standard of care.", "primary_outcomes": [ { "type": "primary", "measure": "The changes in angina symptom and quality of life assessed by Seattle Questionnaire of Angina score in the treatment guided group comparing to the standard of care group", "description": "The Seattle Angina Questionnaire (SAQ) measures 5 dimensions of coronary artery disease (physical limit, stability, frequency, satisfaction, disease perception) on a 0-100 scale, where higher scores indicate better health status. Scores are interpreted as: 0-24 (Poor), 25-49 (Fair), 50-74 (Good), 75-100 (Excellent).", "time_frame": "From the date of enrollment to the end of follow up period at 12 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The prevalence and type of INOCA in LCS patients with chest pain", "description": "INOCA can be diagnosed by Functional coronary testing if there is an evidence of vasomotor disorder (Epicardial or microvascular) from acetylcholine test and/or coronary microvascular dysfunction defined by coronary flow reserve less than 2.5 during hyperemia.", "time_frame": "From the date of enrollment to the last follow up period at 12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "The changes in angina symptom and quality of life assessed by Seattle Questionnaire of Angina score in the treatment guided group comparing to the standard of care group", "description": "The Seattle Angina Questionnaire (SAQ) measures 5 dimensions of coronary artery disease (physical limit, stability, frequency, satisfaction, disease perception) on a 0-100 scale, where higher scores indicate better health status. Scores are interpreted as: 0-24 (Poor), 25-49 (Fair), 50-74 (Good), 75-100 (Excellent).", "time_frame": "From the date of enrollment to the end of follow up period at 12 months" }, { "type": "secondary", "measure": "The prevalence and type of INOCA in LCS patients with chest pain", "description": "INOCA can be diagnosed by Functional coronary testing if there is an evidence of vasomotor disorder (Epicardial or microvascular) from acetylcholine test and/or coronary microvascular dysfunction defined by coronary flow reserve less than 2.5 during hyperemia.", "time_frame": "From the date of enrollment to the last follow up period at 12 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 108, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07559994", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07317401", "title": "Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to Improve Fatigue, Pain, and Quality of Life by Targeting Mitochondrial Dysfunction and Autonomic Nervous System Impairment", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-05-22", "start_date": "2026-06-01", "completion_date": "2029-01-01", "primary_completion_date": "2027-06-01", "conditions_raw": [ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Intermittent Hypoxia-Hyperoxia Treatment" ], "sponsor": "University of Aarhus", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is testing a new treatment for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and long-term symptoms after COVID-19. Both conditions cause extreme fatigue, muscle pain, \"brain fog,\" and trouble concentrating, which often get worse after physical or mental activity. Currently, no effective treatments are available.\n\nThe treatment being studied is called Intermittent Hypoxia-Hyperoxia Treatment (IHHT). It uses a machine called HypoxBreath to deliver short cycles of low oxygen (hypoxia) and high oxygen (hyperoxia) through a mask. Each session lasts 22-40 minutes and is carefully monitored to track oxygen levels, heart rate, and breathing. The therapy is customized for each patient to ensure comfort and effectiveness. IHHT is believed to help the body adapt to oxygen-related stress, improving energy production and reducing inflammation.\n\nIn this trial, 104 patients with ME/CFS will be randomly assigned to receive either IHHT or a placebo treatment with normal oxygen levels over eight weeks. The placebo group will follow a similar procedure without oxygen changes. An additional 20 healthy individuals will be recruited as a comparison group, but they will not undergo the treatment.\n\nParticipants will have medical check-ups before and after treatment to evaluate changes in fatigue, mental sharpness, pain, autonomic nervous system function, and overall quality of life. Blood samples and small skin biopsies will also be taken to study the biological processes behind ME/CFS and how the treatment works.\n\nThis research aims to find out if IHHT can improve the lives of people with ME/CFS or long-term COVID symptoms. The results could also provide new insights into the causes of these challenging conditions and guide future treatments.", "primary_outcomes": [ { "type": "primary", "measure": "Change in SF-36 Vitality Domain score from baseline to post-treatment", "description": "Change in the vitality domain of the 36-Item Short Form Health Survey (SF-36), assessing fatigue and energy-related quality of life.", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in health-related quality of life (SF-36 domains)", "description": "Assessment of additional SF-36 quality-of-life domains.", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" }, { "type": "secondary", "measure": "Change in fatigue severity (Fatigue Severity Scale, FSS)", "description": "Assessment of fatigue severity and functional impact using the Fatigue Severity Scale (FSS).", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" }, { "type": "secondary", "measure": "Change in functional capacity (FUNCAP-27)", "description": "Assessment of functional capacity using the FUNCAP-27 questionnaire.", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" }, { "type": "secondary", "measure": "Change in autonomic symptoms (COMPASS-31)", "description": "Assessment of autonomic symptom burden using the Composite Autonomic Symptom Score-31 (COMPASS-31).", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" }, { "type": "secondary", "measure": "Objective autonomic, neurophysiological, and functional performance measures", "description": "Objective assessments of autonomic function, sudomotor function, neurophysiology, tissue oxygenation, cognitive performance, and physical performance.", "time_frame": "Baseline and post-treatment (~8-10 weeks)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in SF-36 Vitality Domain score from baseline to post-treatment", "description": "Change in the vitality domain of the 36-Item Short Form Health Survey (SF-36), assessing fatigue and energy-related quality of life.", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" }, { "type": "secondary", "measure": "Change in health-related quality of life (SF-36 domains)", "description": "Assessment of additional SF-36 quality-of-life domains.", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" }, { "type": "secondary", "measure": "Change in fatigue severity (Fatigue Severity Scale, FSS)", "description": "Assessment of fatigue severity and functional impact using the Fatigue Severity Scale (FSS).", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" }, { "type": "secondary", "measure": "Change in functional capacity (FUNCAP-27)", "description": "Assessment of functional capacity using the FUNCAP-27 questionnaire.", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" }, { "type": "secondary", "measure": "Change in autonomic symptoms (COMPASS-31)", "description": "Assessment of autonomic symptom burden using the Composite Autonomic Symptom Score-31 (COMPASS-31).", "time_frame": "Baseline, post-treatment (~8-10 weeks), and 3-, 6-, and 12-month follow-up" }, { "type": "secondary", "measure": "Objective autonomic, neurophysiological, and functional performance measures", "description": "Objective assessments of autonomic function, sudomotor function, neurophysiology, tissue oxygenation, cognitive performance, and physical performance.", "time_frame": "Baseline and post-treatment (~8-10 weeks)" } ], "relevance_tags": [ "Metabolic", "Mitochondrial", "Neurological / Autonomic", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 104, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07317401", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07076862", "title": "Multiparametric [18F]F-AraG Imaging in Post-Acute Sequelae of COVID-19 (PASC)", "status": "RECRUITING", "phase": "EARLY_PHASE1", "last_updated": "2026-05-22", "start_date": "2025-12-04", "completion_date": "2029-12", "primary_completion_date": "2028-12", "conditions_raw": [ "PASC Post Acute Sequelae of COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "A.1 - [¹⁸F]F-Arag Pet/Ct", "A.2 - [¹⁸F]F-Arag Pet/Ct", "B.1 - [¹⁸F]F-Arag Pet/Ct", "B.2 - [¹⁸F]F-Arag Pet/Ct" ], "sponsor": "University of California, Davis", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study uses total-body \\[¹⁸F\\]F-AraG PET/CT imaging to investigate immune activation and vascular changes in individuals with post-acute sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Participants will undergo dynamic PET/CT imaging along with blood biomarker assessments and symptom evaluations. The study aims to characterize sites of immunological perturbation, correlate PET imaging findings with peripheral blood markers, and evaluate longitudinal changes in tissue-based immune activity in relation to symptom patterns over time. Data from this study will improve understanding of tissue-level immune dysregulation in PASC and support future clinical tools for assessing and managing this condition.", "primary_outcomes": [ { "type": "primary", "measure": "Quantification of [¹⁸F]F-AraG uptake kinetics in PASC and control participants", "description": "To assess immune activation in convalescent COVID-19, dynamic PET/CT scans will be analyzed to generate time-activity curves (TACs) in multiple tissues. Kinetic modeling will be applied to extract uptake parameters including SUV, SUVR, Vt, Ki, and k3. These values will be reported and statistically compared between PASC and control participants.", "time_frame": "Baseline Imaging Visit" }, { "type": "primary", "measure": "Correlation between [¹⁸F]F-AraG uptake parameters and blood-based markers of immune dysregulation", "description": "Spearman correlation tests and heat map clustering will be used to assess the association between PET-derived uptake measures and plasma biomarkers of inflammation and immune activation. Correlations will be examined in tissues showing significant uptake differences between study groups.", "time_frame": "Baseline imaging visit and baseline blood draw" }, { "type": "primary", "measure": "Longitudinal change in [¹⁸F]F-AraG uptake and correlation with PASC symptom scores", "description": "In a subset of participants, follow-up PET/CT imaging at 4 and 8 months will be used to assess within-subject change in kinetic uptake parameters. These changes will be compared to changes in symptom burden as measured by PHQ-15 symptom domain scores.", "time_frame": "Baseline, 4-month, and 8-month follow-up visits (subset of PASC participants only)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Feasibility of blood flow kinetic modeling using early [¹⁸F]F-AraG dynamic PET data", "description": "Early-phase TACs (\\< 5 min post-injection) will be fitted using the AATH model to estimate blood flow from the vascular phase of radiotracer distribution. Identifiability of kinetic parameters associated with vascular function will be evaluated. Mean values will be compared between study groups.", "time_frame": "Baseline imaging visit" }, { "type": "secondary", "measure": "Correlation between vascular imaging parameters and blood biomarkers of vascular dysfunction", "description": "Spearman correlations and heatmap analyses will be used to examine associations between PET-derived vascular parameters and plasma markers of vascular dysfunction.", "time_frame": "Baseline imaging visit and baseline blood draw" } ], "outcome_measures": [ { "type": "primary", "measure": "Quantification of [¹⁸F]F-AraG uptake kinetics in PASC and control participants", "description": "To assess immune activation in convalescent COVID-19, dynamic PET/CT scans will be analyzed to generate time-activity curves (TACs) in multiple tissues. Kinetic modeling will be applied to extract uptake parameters including SUV, SUVR, Vt, Ki, and k3. These values will be reported and statistically compared between PASC and control participants.", "time_frame": "Baseline Imaging Visit" }, { "type": "primary", "measure": "Correlation between [¹⁸F]F-AraG uptake parameters and blood-based markers of immune dysregulation", "description": "Spearman correlation tests and heat map clustering will be used to assess the association between PET-derived uptake measures and plasma biomarkers of inflammation and immune activation. Correlations will be examined in tissues showing significant uptake differences between study groups.", "time_frame": "Baseline imaging visit and baseline blood draw" }, { "type": "primary", "measure": "Longitudinal change in [¹⁸F]F-AraG uptake and correlation with PASC symptom scores", "description": "In a subset of participants, follow-up PET/CT imaging at 4 and 8 months will be used to assess within-subject change in kinetic uptake parameters. These changes will be compared to changes in symptom burden as measured by PHQ-15 symptom domain scores.", "time_frame": "Baseline, 4-month, and 8-month follow-up visits (subset of PASC participants only)" }, { "type": "secondary", "measure": "Feasibility of blood flow kinetic modeling using early [¹⁸F]F-AraG dynamic PET data", "description": "Early-phase TACs (\\< 5 min post-injection) will be fitted using the AATH model to estimate blood flow from the vascular phase of radiotracer distribution. Identifiability of kinetic parameters associated with vascular function will be evaluated. Mean values will be compared between study groups.", "time_frame": "Baseline imaging visit" }, { "type": "secondary", "measure": "Correlation between vascular imaging parameters and blood biomarkers of vascular dysfunction", "description": "Spearman correlations and heatmap analyses will be used to examine associations between PET-derived vascular parameters and plasma markers of vascular dysfunction.", "time_frame": "Baseline imaging visit and baseline blood draw" } ], "relevance_tags": [ "Immunomodulatory", "EARLY_Phase 1", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 51, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07076862", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07600320", "title": "Fareon Open Label Device Clinical Trial", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-05-20", "start_date": "2026-05-01", "completion_date": "2027-04-30", "primary_completion_date": "2027-04-30", "conditions_raw": [ "Cognitive Dysfunction", "Acquired Brain Injury", "Traumatic Brain Injury" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Fareon Device" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to assess the safety and feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to acquired brain injury, Long COVID, traumatic brain injury, myalgic encephalomyelitis (ME/CFS), and other neurodegenerative diagnoses including but not limited to Alzheimer's disease and to collect data on safety and efficacy to inform the design of larger clinical studies.", "primary_outcomes": [ { "type": "primary", "measure": "Proportion of participants who complete prescribed device sessions", "description": "Device Completion Rate: Proportion of enrolled participants who complete ≥80% of prescribed device sessions over the study period.", "time_frame": "Week 12 and Week 16" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "BrainCheck", "description": "BrainCheck is a computerized cognitive assessment battery evaluating attention, executive function, memory, and processing speed. Individual task scores are combined to generate a composite cognitive score that is normalized against age-adjusted reference populations. Composite score from 0-200. Higher scores indicate better cognitive performance. Change in composite score from baseline to Week 12 will be evaluated.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire assessing symptoms of anxiety and depression. Each item is scored from 0 to 3. The measure generates separate anxiety (HADS-A) and depression (HADS-D) subscale scores ranging from 0-21, and a total score ranging from 0-42. Higher scores indicate greater symptom severity.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "PROMIS Sleep Disturbance", "description": "The PROMIS Sleep Disturbance measure assesses perceived sleep quality and sleep-related impairment. Raw scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10 in the reference population. Higher scores indicate greater sleep disturbance.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "Neuro-QoL Cognitive Function (Short Form)", "description": "The Neuro-QoL Cognitive Function short form assesses perceived cognitive abilities in everyday life. Raw scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10 relative to the reference population. Higher scores indicate better perceived cognitive function.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "PROMIS Fatigue", "description": "The PROMIS Fatigue measure assesses fatigue severity and the impact of fatigue on daily functioning. Raw scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10 relative to the reference population. Higher scores indicate greater fatigue.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC)", "description": "The Patient Global Impression of Change (PGIC) is a single-item measure assessing participants' perception of overall change in their condition since starting treatment. Responses are rated on a 7-point Likert scale ranging from 1 (\"very much improved\") to 7 (\"very much worse\").", "time_frame": "Week 12 and Week 16" }, { "type": "secondary", "measure": "Functional Capacity Assessment (FUNCAP)", "description": "The Functional Capacity Assessment (FUNCAP-27) is a 27-item questionnaire assessing functional capacity across multiple domains of daily activity. Each item is scored on a 7-point scale from 0 to 6, where 0 indicates inability to perform the activity and 6 indicates no limitation. Item scores are summed to generate a total score ranging from 0 to 162, with higher scores indicating better functional capacity.", "time_frame": "Week 1 and Week 12 and Week 16" } ], "outcome_measures": [ { "type": "primary", "measure": "Proportion of participants who complete prescribed device sessions", "description": "Device Completion Rate: Proportion of enrolled participants who complete ≥80% of prescribed device sessions over the study period.", "time_frame": "Week 12 and Week 16" }, { "type": "secondary", "measure": "BrainCheck", "description": "BrainCheck is a computerized cognitive assessment battery evaluating attention, executive function, memory, and processing speed. Individual task scores are combined to generate a composite cognitive score that is normalized against age-adjusted reference populations. Composite score from 0-200. Higher scores indicate better cognitive performance. Change in composite score from baseline to Week 12 will be evaluated.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire assessing symptoms of anxiety and depression. Each item is scored from 0 to 3. The measure generates separate anxiety (HADS-A) and depression (HADS-D) subscale scores ranging from 0-21, and a total score ranging from 0-42. Higher scores indicate greater symptom severity.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "PROMIS Sleep Disturbance", "description": "The PROMIS Sleep Disturbance measure assesses perceived sleep quality and sleep-related impairment. Raw scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10 in the reference population. Higher scores indicate greater sleep disturbance.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "Neuro-QoL Cognitive Function (Short Form)", "description": "The Neuro-QoL Cognitive Function short form assesses perceived cognitive abilities in everyday life. Raw scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10 relative to the reference population. Higher scores indicate better perceived cognitive function.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "PROMIS Fatigue", "description": "The PROMIS Fatigue measure assesses fatigue severity and the impact of fatigue on daily functioning. Raw scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10 relative to the reference population. Higher scores indicate greater fatigue.", "time_frame": "Week 1 and Week 12" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC)", "description": "The Patient Global Impression of Change (PGIC) is a single-item measure assessing participants' perception of overall change in their condition since starting treatment. Responses are rated on a 7-point Likert scale ranging from 1 (\"very much improved\") to 7 (\"very much worse\").", "time_frame": "Week 12 and Week 16" }, { "type": "secondary", "measure": "Functional Capacity Assessment (FUNCAP)", "description": "The Functional Capacity Assessment (FUNCAP-27) is a 27-item questionnaire assessing functional capacity across multiple domains of daily activity. Each item is scored on a 7-point scale from 0 to 6, where 0 indicates inability to perform the activity and 6 indicates no limitation. Item scores are summed to generate a total score ranging from 0 to 162, with higher scores indicating better functional capacity.", "time_frame": "Week 1 and Week 12 and Week 16" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07600320", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07597902", "title": "SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2026-05-19", "start_date": "2026-06-01", "completion_date": "2028-06-30", "primary_completion_date": "2028-06-30", "conditions_raw": [ "Post-acute Sequelae of COVID-19", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Valacyclovir", "Celecoxib", "Paxlovid (Nirmatrelvir/Ritonavir)" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this research study is to test if the combination of three drugs, valacyclovir, celecoxib, and Paxlovid will decrease the symptoms of Long COVID in adults compared to a placebo (this does not contain the medications).", "primary_outcomes": [ { "type": "primary", "measure": "EQ-5D-5L Visual Analogue Scale (VAS)", "description": "The EQ VAS records the patient's self-rated health on a visual analogue scale where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0), with higher scores indicating better health state. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)", "description": "The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "General Symptom Questionnaire (GSQ-30)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a series of questions assessing presence and severity of depression symptoms. It evaluates each of the DSM-IV depression criteria and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Full scale from 0-27, with higher score indicating more severe symptoms.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD-7)", "description": "The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS)", "description": "A suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions that anyone can ask. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs.\n\nFull range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation). Higher score represents poorer health outcomes.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Neuro-QoL™ v2.0 Cognitive Function-Short Form", "description": "The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Single-item Sleep Quality Scale (SQS)", "description": "The SQS is a visual analog scale that instructs respondents to rate their overall quality of sleep over a 7-day recall period from 0 to 10. Scores of 0, 1, 4, 7, and 10 correspond to terrible, poor, fair, good, and excellent, respectively. Higher scores indicate better sleep quality.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" } ], "outcome_measures": [ { "type": "primary", "measure": "EQ-5D-5L Visual Analogue Scale (VAS)", "description": "The EQ VAS records the patient's self-rated health on a visual analogue scale where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0), with higher scores indicating better health state. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)", "description": "The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "General Symptom Questionnaire (GSQ-30)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a series of questions assessing presence and severity of depression symptoms. It evaluates each of the DSM-IV depression criteria and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Full scale from 0-27, with higher score indicating more severe symptoms.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD-7)", "description": "The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS)", "description": "A suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions that anyone can ask. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs.\n\nFull range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation). Higher score represents poorer health outcomes.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Neuro-QoL™ v2.0 Cognitive Function-Short Form", "description": "The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" }, { "type": "secondary", "measure": "Single-item Sleep Quality Scale (SQS)", "description": "The SQS is a visual analog scale that instructs respondents to rate their overall quality of sleep over a 7-day recall period from 0 to 10. Scores of 0, 1, 4, 7, and 10 correspond to terrible, poor, fair, good, and excellent, respectively. Higher scores indicate better sleep quality.", "time_frame": "Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, Week 20" } ], "relevance_tags": [ "Persistence / Antiviral", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 150, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07597902", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06960928", "title": "Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19", "status": "RECRUITING", "phase": "PHASE3", "last_updated": "2026-05-18", "start_date": "2025-04-18", "completion_date": "2027-05-31", "primary_completion_date": "2026-12-31", "conditions_raw": [ "Long COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Sirolimus (low-dose)" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The study is conducted in New York, New York at The Cohen Center for Recovery from Complex Chronic Illness at Mount Sinai.\n\nThis is an IND-exempt, off-label, multi-ascending, randomized, placebo-controlled clinical trial of sirolimus (also known as rapamycin) in adults with Long COVID. There are 2 arms: Sirolimus and Placebo.\n\nThis study aims to evaluate the efficacy of Sirolimus in adults with Long COVID. Efficacy will be evaluated by measuring patient-reported outcomes in response to Sirolimus.", "primary_outcomes": [ { "type": "primary", "measure": "European Quality of Life-Visual Analogue Scale (EQ-VAS)", "description": "The EQ VAS records the patient's self-rated health on a visual analogue scale where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0), with higher scores indicating better health state. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)", "description": "The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "General Symptom Questionnaire (GSQ-30)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a series of questions assessing presence and severity of depression symptoms. It evaluates each of the DSM-IV depression criteria and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Full scale from 0-27, with higher score indicating more severe symptoms.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD-7)", "description": "The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Neuro-QoL™ v2.0 Cognitive Function-Short Form", "description": "The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Single-item Sleep Quality Scale (SQS)", "description": "The SQS is a visual analog scale that instructs respondents to rate their overall quality of sleep over a 7-day recall period from 0 to 10. Scores of 0, 1, 4, 7, and 10 correspond to terrible, poor, fair, good, and excellent, respectively. Higher scores indicate better sleep quality.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)]" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "The Fatigue Severity Scale (FSS) uses a 7-point scale (1-7) to assess fatigue, with higher scores indicating greater severity, and a total score ranging from 9 to 63. Higher scores indicate more severe fatigue.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Fatigue Visual Analogue Scale [F-VAS])", "description": "The F-VAS consists of 18 items related to fatigue and energy in a visual analogue scale from 0 to 100. A higher score indicates more fatigue.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "DePaul Post-Exertional Malaise Questionnaire (DSQ)", "description": "The DSQ is designed to evaluate 54 classic ME/CFS symptoms, including fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments, and autonomic, neuroendocrine, and immune symptoms. Each symptom's frequency and intensity are rated on a 5-point scale (0-4). Frequency and severity scores are multiplied by 25, added together, and then divided by 2 to create a composite frequency/severity score for each symptom. These scores range from 0 to 100, with higher scores indicating a greater symptom burden.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Composite Autonomic Symptom Score 31(COMPASS-31)", "description": "The COMPASS-31 is a 31-question self-assessment instrument of autonomic symptoms and function that is up-to-date, broadly applicable, easy to administer in a short amount of time, and based on a scientific approach. The total score ranges from 0 to 100, with higher scores indicating greater autonomic dysfunction.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Pain (P-VAS)", "description": "Using a visual analogue scale, patients mark a point on a line representing a continuum from \"no pain\" to \"worst pain,\" with scores ranging from 0 to 100, where higher scores indicate greater pain.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)]" }, { "type": "secondary", "measure": "University of California-Los Angeles (UCLA) Loneliness Scale (3-item)", "description": "The UCLA Loneliness (3-item) Scale scores range from 3 to 9, with higher scores indicating greater perceived loneliness.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Adapted Berkman-Syme Social Network/Connection Index", "description": "This is a self-report questionnaire used to assess social integration and isolation, focusing on marital status, frequency of contact, and participation in social activities, particularly relevant for older adults. Each item is scored on a scale from 1-4 where higher values reflect greater frequency (e.g., 4 = \"5 or more times a week\"). For each respondent, a sum score is calculated by adding the scores of all five items, yielding a possible score range of 5-25. Higher sum scores reflect higher levels of social connection and lower social isolation.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" } ], "outcome_measures": [ { "type": "primary", "measure": "European Quality of Life-Visual Analogue Scale (EQ-VAS)", "description": "The EQ VAS records the patient's self-rated health on a visual analogue scale where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0), with higher scores indicating better health state. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)", "description": "The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "General Symptom Questionnaire (GSQ-30)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a series of questions assessing presence and severity of depression symptoms. It evaluates each of the DSM-IV depression criteria and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Full scale from 0-27, with higher score indicating more severe symptoms.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD-7)", "description": "The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Neuro-QoL™ v2.0 Cognitive Function-Short Form", "description": "The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Single-item Sleep Quality Scale (SQS)", "description": "The SQS is a visual analog scale that instructs respondents to rate their overall quality of sleep over a 7-day recall period from 0 to 10. Scores of 0, 1, 4, 7, and 10 correspond to terrible, poor, fair, good, and excellent, respectively. Higher scores indicate better sleep quality.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)]" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "The Fatigue Severity Scale (FSS) uses a 7-point scale (1-7) to assess fatigue, with higher scores indicating greater severity, and a total score ranging from 9 to 63. Higher scores indicate more severe fatigue.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Fatigue Visual Analogue Scale [F-VAS])", "description": "The F-VAS consists of 18 items related to fatigue and energy in a visual analogue scale from 0 to 100. A higher score indicates more fatigue.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "DePaul Post-Exertional Malaise Questionnaire (DSQ)", "description": "The DSQ is designed to evaluate 54 classic ME/CFS symptoms, including fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments, and autonomic, neuroendocrine, and immune symptoms. Each symptom's frequency and intensity are rated on a 5-point scale (0-4). Frequency and severity scores are multiplied by 25, added together, and then divided by 2 to create a composite frequency/severity score for each symptom. These scores range from 0 to 100, with higher scores indicating a greater symptom burden.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Composite Autonomic Symptom Score 31(COMPASS-31)", "description": "The COMPASS-31 is a 31-question self-assessment instrument of autonomic symptoms and function that is up-to-date, broadly applicable, easy to administer in a short amount of time, and based on a scientific approach. The total score ranges from 0 to 100, with higher scores indicating greater autonomic dysfunction.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Pain (P-VAS)", "description": "Using a visual analogue scale, patients mark a point on a line representing a continuum from \"no pain\" to \"worst pain,\" with scores ranging from 0 to 100, where higher scores indicate greater pain.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)]" }, { "type": "secondary", "measure": "University of California-Los Angeles (UCLA) Loneliness Scale (3-item)", "description": "The UCLA Loneliness (3-item) Scale scores range from 3 to 9, with higher scores indicating greater perceived loneliness.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" }, { "type": "secondary", "measure": "Adapted Berkman-Syme Social Network/Connection Index", "description": "This is a self-report questionnaire used to assess social integration and isolation, focusing on marital status, frequency of contact, and participation in social activities, particularly relevant for older adults. Each item is scored on a scale from 1-4 where higher values reflect greater frequency (e.g., 4 = \"5 or more times a week\"). For each respondent, a sum score is calculated by adding the scores of all five items, yielding a possible score range of 5-25. Higher sum scores reflect higher levels of social connection and lower social isolation.", "time_frame": "Baseline (Week 0) and Post-treatment (Week 12 and Week 24)" } ], "relevance_tags": [ "Immunomodulatory", "Repurposed", "Phase 3", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06960928", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05699538", "title": "Fatigability in Long COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-05-18", "start_date": "2023-07-31", "completion_date": "2025-09-30", "primary_completion_date": "2025-07-04", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Minimal-Dose Home-Based Resistance Exercise" ], "sponsor": "VA Office of Research and Development", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "The overall goal of this project is to advance the understanding of underlying mechanisms impacting performance fatigability and perceived fatigability in Veterans with post-COVID-19 fatigue and explore the safety and feasibility of a home-based \"minimal-dose\" resistance exercise program in this population. The central hypothesis is that declines in force capacity, skeletal muscle oxygen extraction, and affective responses to physical activity offer potential mechanisms through which fatigability is increased in Veterans with post-COVID-19 fatigue. Moreover, home-based resistance exercise delivered remotely may provide a safe and feasibility treatment option for targeting neuromuscular and neurobehavioral factors influencing fatigability severity in this population.", "primary_outcomes": [ { "type": "primary", "measure": "Performance fatigability", "description": "Performance fatigability will be assessed as change in maximal voluntary isometric contraction (MVIC) torque of the dominant leg. Change in MVIC torque from the initial MVIC contraction to the last MVIC contraction will be used to determine the Performance Fatigability index.", "time_frame": "baseline and week 8" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Rating of Perceived Fatigue (RPF)", "description": "Perceived fatigability will be assessed using a rating of perceived fatigue (RPF) scale.\n\n0=no fatigue at all; 10=absolutely exhausted higher the value=more fatigue", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Isometric and Isokinetic Knee Extensor Torque", "description": "Unilateral peak isometric and isokinetic knee extension torque (60º/s and 180º/s) will be obtained across five continuous repetitions using a dynamometer in a seated position per manufacturer guidelines (Biodex System 4).", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Skeletal muscle oxygen extraction", "description": "Skeletal muscle oxygen extraction of the dominant vastus lateralis will be assessed non-invasively using near-infrared spectroscopy (NIRS) (Artinis, Portamon, The Netherlands).", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Feeling Scale", "description": "Change's in affect during knee extensor performance fatigability testing will be assessed using the Feeling Scale. The Feeling Scale is an 11-point, single item, bipolar rating scale ranging from +5 to -5.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "9-item questionnaire assessing how fatigue interferes with certain activities and rates its severity according to a self-report scale. Items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. higher the value=more impact fatigue has", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Short Physical Performance Battery (SPPB)", "description": "SPPB will assess customary gait speed, side-by-side stand, semi-tandem stand, tandem stand, and 5-STS.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "30-second sit-to-stand", "description": "subjects will be asked to perform as many sit-to-stand repetitions in 30 seconds.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Six Minute Walk Test (6MWT)", "description": "Subjects will be asked to walk as far as possible in 6 minutes.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Motor Unit Firing Rate", "description": "motor unit shape and firing behavior of the dominant leg vastus lateralis will be extracted using surface electromyographic signals (sEMG) and specialized software (Trigno NeuroMap System, Delsys Inc., Natick, MA, USA).", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Muscle Activation", "description": "interpolated twitch technique will be applied to the femoral nerve using a constant-current, variable high-voltage stimulator (DS7R, Digitimer, Hertforshire, UK) to quantify muscle activation of the vastus lateralis.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "peak VO2", "description": "Peak VO2 will be assessed from cardiopulmonary exercise testing using the Modified Bruce Protocol.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Health-related quality of life (SF-36)", "description": "The 36-item short-form (SF-36) is a multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Pittsburgh Fatigability Scale", "description": "26-item scale chosen from four activity categories; social, sedentary, lifestyle or light-intensity, and moderate-to-high-intensity.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Short-form Depression, Anxiety, and Stress Scale (DASS-21)", "description": "The DASS is designed to measure the negative emotional states of depression, anxiety, and stress.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Physical Activity Level", "description": "Physical activity levels will be monitored objectively using ActiGraph activity monitors", "time_frame": "baseline and week 8" } ], "outcome_measures": [ { "type": "primary", "measure": "Performance fatigability", "description": "Performance fatigability will be assessed as change in maximal voluntary isometric contraction (MVIC) torque of the dominant leg. Change in MVIC torque from the initial MVIC contraction to the last MVIC contraction will be used to determine the Performance Fatigability index.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Rating of Perceived Fatigue (RPF)", "description": "Perceived fatigability will be assessed using a rating of perceived fatigue (RPF) scale.\n\n0=no fatigue at all; 10=absolutely exhausted higher the value=more fatigue", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Isometric and Isokinetic Knee Extensor Torque", "description": "Unilateral peak isometric and isokinetic knee extension torque (60º/s and 180º/s) will be obtained across five continuous repetitions using a dynamometer in a seated position per manufacturer guidelines (Biodex System 4).", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Skeletal muscle oxygen extraction", "description": "Skeletal muscle oxygen extraction of the dominant vastus lateralis will be assessed non-invasively using near-infrared spectroscopy (NIRS) (Artinis, Portamon, The Netherlands).", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Feeling Scale", "description": "Change's in affect during knee extensor performance fatigability testing will be assessed using the Feeling Scale. The Feeling Scale is an 11-point, single item, bipolar rating scale ranging from +5 to -5.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "9-item questionnaire assessing how fatigue interferes with certain activities and rates its severity according to a self-report scale. Items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. higher the value=more impact fatigue has", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Short Physical Performance Battery (SPPB)", "description": "SPPB will assess customary gait speed, side-by-side stand, semi-tandem stand, tandem stand, and 5-STS.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "30-second sit-to-stand", "description": "subjects will be asked to perform as many sit-to-stand repetitions in 30 seconds.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Six Minute Walk Test (6MWT)", "description": "Subjects will be asked to walk as far as possible in 6 minutes.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Motor Unit Firing Rate", "description": "motor unit shape and firing behavior of the dominant leg vastus lateralis will be extracted using surface electromyographic signals (sEMG) and specialized software (Trigno NeuroMap System, Delsys Inc., Natick, MA, USA).", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Muscle Activation", "description": "interpolated twitch technique will be applied to the femoral nerve using a constant-current, variable high-voltage stimulator (DS7R, Digitimer, Hertforshire, UK) to quantify muscle activation of the vastus lateralis.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "peak VO2", "description": "Peak VO2 will be assessed from cardiopulmonary exercise testing using the Modified Bruce Protocol.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Health-related quality of life (SF-36)", "description": "The 36-item short-form (SF-36) is a multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Pittsburgh Fatigability Scale", "description": "26-item scale chosen from four activity categories; social, sedentary, lifestyle or light-intensity, and moderate-to-high-intensity.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Short-form Depression, Anxiety, and Stress Scale (DASS-21)", "description": "The DASS is designed to measure the negative emotional states of depression, anxiety, and stress.", "time_frame": "baseline and week 8" }, { "type": "secondary", "measure": "Physical Activity Level", "description": "Physical activity levels will be monitored objectively using ActiGraph activity monitors", "time_frame": "baseline and week 8" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Fed" ], "enrollment": 21, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05699538", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06214455", "title": "Intermittent Fasting and a No-Sugar Diet for Long COVID Symptoms", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-05-14", "start_date": "2022-11-04", "completion_date": "2024-09-10", "primary_completion_date": "2024-07-01", "conditions_raw": [ "Long Covid19", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Low Sugar Diet And 10-12 Hour Eating Window", "Low Sugar Diet, 8 Hour Eating Window And Fasting" ], "sponsor": "Pacific Northwest University of Health Sciences", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This cross-over study will assess a no added sugar diet, a restricted daily eating window, and one or two full day water fasts to determine if there is an effect on self-reported symptoms of Long Covid (PASC).", "primary_outcomes": [ { "type": "primary", "measure": "Change in LC-Score, Per Treatment", "description": "This Outcome Measure is calculated by subtracting the Long COVID symptom severity score (LC-Score) before a treatment from the LC-Score after the treatment (i.e., score-after minus score-before). Negative values represent a reduction in number and severity of symptoms following treatment. LC-Scores are the sum of severity scores (0-4) for 28 common symptoms plus the count of 32 additional symptoms present. The maximum possible LC-Score is (28x4)+32 = 144.", "time_frame": "Before and after 4 weeks of Fasting treatment or TRE treatment" }, { "type": "primary", "measure": "Change in Number of Long COVID Symptoms, Per Treatment", "description": "This Outcome Measure is calculated by subtracting the Number of Long COVID symptoms (numLCsym) before a treatment from the numLCsym after the treatment (i.e., number-after minus number-before). Negative values represent a reduction in number of symptoms following treatment. The numLCsym is the count of 60 common symptoms.", "time_frame": "Before and after 4 weeks of Fasting treatment or TRE treatment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in LC-Score, Overall", "description": "This Outcome Measure is calculated by subtracting the Long COVID symptom severity score (LC-Score) at baseline from the LC-Score after the final treatment (i.e., score-after minus score-before). Negative values represent a reduction in number and severity of symptoms following treatment. LC-Scores are the sum of severity scores (0-4) for 28 common symptoms plus the count of 32 additional symptoms present. The maximum possible LC-Score is (28x4)+32 = 144.", "time_frame": "From enrollment to the end of the final treatment (10 weeks)" }, { "type": "secondary", "measure": "Change in Number of Long COVID Symptoms, Overall", "description": "This Outcome Measure is calculated by subtracting the Number of Long COVID symptoms (numLCsym) at baseline from the numLCsym after the final treatment (i.e., number-after minus number-before). Negative values represent a reduction in number of symptoms following treatment. The numLCsym is the count of 60 common symptoms.", "time_frame": "From enrollment to the end of the final treatment (10 weeks)" }, { "type": "secondary", "measure": "Serious Adverse Events", "description": "Adverse events were medically reviewed and categorized as Serious if appropriate", "time_frame": "During 4 weeks of Fasting treatment or during 6 weeks of TRE" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in LC-Score, Per Treatment", "description": "This Outcome Measure is calculated by subtracting the Long COVID symptom severity score (LC-Score) before a treatment from the LC-Score after the treatment (i.e., score-after minus score-before). Negative values represent a reduction in number and severity of symptoms following treatment. LC-Scores are the sum of severity scores (0-4) for 28 common symptoms plus the count of 32 additional symptoms present. The maximum possible LC-Score is (28x4)+32 = 144.", "time_frame": "Before and after 4 weeks of Fasting treatment or TRE treatment" }, { "type": "primary", "measure": "Change in Number of Long COVID Symptoms, Per Treatment", "description": "This Outcome Measure is calculated by subtracting the Number of Long COVID symptoms (numLCsym) before a treatment from the numLCsym after the treatment (i.e., number-after minus number-before). Negative values represent a reduction in number of symptoms following treatment. The numLCsym is the count of 60 common symptoms.", "time_frame": "Before and after 4 weeks of Fasting treatment or TRE treatment" }, { "type": "secondary", "measure": "Change in LC-Score, Overall", "description": "This Outcome Measure is calculated by subtracting the Long COVID symptom severity score (LC-Score) at baseline from the LC-Score after the final treatment (i.e., score-after minus score-before). Negative values represent a reduction in number and severity of symptoms following treatment. LC-Scores are the sum of severity scores (0-4) for 28 common symptoms plus the count of 32 additional symptoms present. The maximum possible LC-Score is (28x4)+32 = 144.", "time_frame": "From enrollment to the end of the final treatment (10 weeks)" }, { "type": "secondary", "measure": "Change in Number of Long COVID Symptoms, Overall", "description": "This Outcome Measure is calculated by subtracting the Number of Long COVID symptoms (numLCsym) at baseline from the numLCsym after the final treatment (i.e., number-after minus number-before). Negative values represent a reduction in number of symptoms following treatment. The numLCsym is the count of 60 common symptoms.", "time_frame": "From enrollment to the end of the final treatment (10 weeks)" }, { "type": "secondary", "measure": "Serious Adverse Events", "description": "Adverse events were medically reviewed and categorized as Serious if appropriate", "time_frame": "During 4 weeks of Fasting treatment or during 6 weeks of TRE" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 77, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06214455", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07567274", "title": "DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury", "status": "ENROLLING_BY_INVITATION", "phase": "PHASE2", "last_updated": "2026-05-13", "start_date": "2026-05-15", "completion_date": "2027-05", "primary_completion_date": "2026-07", "conditions_raw": [ "Tinnitus" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Dmso-Based Otic Solution With Betahistine, Dexamethasone, And Lidocaine", "N-Acetylcysteine (NAC)" ], "sponsor": "Leading Edge Clinic", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to test a compounded dimethyl sulfoxide (DMSO)-based dual-route therapy for adults with refractory subjective tinnitus linked to long-COVID (post-acute sequelae of SARS-CoV-2) or post-COVID-19 vaccine injury. Participants have bothersome tinnitus that has not improved with at least two prior standard treatments.\n\nAll participants will receive two study treatments for 30 days: a DMSO-based ear canal liquid and a DMSO-based transdermal cream applied to the skin around the ears and upper neck. The ear drops are used every 4 days, and the cream is applied once daily at bedtime. Both formulations are prepared by a licensed compounding pharmacy.\n\nThe main question is whether at least half of the participants achieve a 50% or greater reduction in their Tinnitus Handicap Inventory (THI) score from baseline to Day 30. Researchers will also look at changes in tinnitus loudness and annoyance, sleep and concentration, other symptoms such as vertigo, insomnia, headache, and fatigue, and any side effects.\n\nAfter an initial in-person ear, nose, and throat (ENT) evaluation, all study visits are conducted by telemedicine. Participants complete electronic questionnaires through a secure, HIPAA-compliant system over 12 months of follow-up.", "primary_outcomes": [ { "type": "primary", "measure": "Proportion of participants with at least 50% reduction in Tinnitus Handicap Inventory (THI) score", "description": "The Tinnitus Handicap Inventory (THI) is a 25-item validated questionnaire (total score 0-100) that measures tinnitus-related handicap. Responders are defined as participants with a reduction of at least 50% in total THI score from baseline to Day 30.", "time_frame": "Baseline to Day 30" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Tinnitus Handicap Inventory (THI) score over time", "description": "Change in total THI score from baseline to Day 30, Month 6, and Month 12. Higher scores indicate greater tinnitus-related handicap.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in tinnitus loudness on visual analog scale (VAS)", "description": "Participants rate tinnitus loudness on a 0-10 visual analog scale (0 = no tinnitus, 10 = worst imaginable). Change is calculated as follow-up minus baseline at each time point.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in tinnitus annoyance/distress on visual analog scale (VAS)", "description": "Participants rate how annoying or distressing their tinnitus is on a 0-10 visual analog scale (0 = not at all annoying, 10 = extremely annoying). Change is calculated as follow-up minus baseline.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in sleep interference due to tinnitus on visual analog scale (VAS)", "description": "Participants rate how much tinnitus interferes with sleep on a 0-10 visual analog scale (0 = no interference, 10 = extreme interference). Change is calculated as follow-up minus baseline.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in concentration difficulty due to tinnitus on visual analog scale (VAS)", "description": "Participants rate how much tinnitus interferes with concentration on a 0-10 visual analog scale (0 = no interference, 10 = extreme interference). Change is calculated as follow-up minus baseline.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC) in tinnitus symptoms", "description": "Participants rate overall change in their tinnitus on a 7-point Patient Global Impression of Change scale (1 = very much improved, 7 = very much worse). Outcomes will be summarized as the proportion reporting \"much improved\" or \"very much improved\" and as distribution across all categories.", "time_frame": "Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in concomitant symptom scores (vertigo, insomnia, headache, fatigue) on visual analog scales (VAS)", "description": "Participants rate vertigo, insomnia, headache, and fatigue on separate 0-10 visual analog scales (0 = no symptom, 10 = worst imaginable). Change in each symptom score from baseline to Day 30 will be summarized descriptively.", "time_frame": "Baseline to Day 30" }, { "type": "secondary", "measure": "Incidence of treatment-emergent adverse events", "description": "Number and proportion of participants experiencing treatment-emergent adverse events, including expected DMSO-related effects (e.g., garlic-like odor, transient warmth or flushing, skin irritation) and any serious or unexpected events. Events will be coded and summarized by severity and relationship to study treatment.", "time_frame": "From first dose through Day 30" }, { "type": "secondary", "measure": "Change in tympanic membrane temperature", "description": "In participants with local ENT follow-up, tympanic membrane temperature is measured at baseline and Day 30. Change in temperature will be summarized descriptively as an exploratory biomarker of local vascular and inflammatory effects.", "time_frame": "Baseline to Day 30 (where measured)" } ], "outcome_measures": [ { "type": "primary", "measure": "Proportion of participants with at least 50% reduction in Tinnitus Handicap Inventory (THI) score", "description": "The Tinnitus Handicap Inventory (THI) is a 25-item validated questionnaire (total score 0-100) that measures tinnitus-related handicap. Responders are defined as participants with a reduction of at least 50% in total THI score from baseline to Day 30.", "time_frame": "Baseline to Day 30" }, { "type": "secondary", "measure": "Change in Tinnitus Handicap Inventory (THI) score over time", "description": "Change in total THI score from baseline to Day 30, Month 6, and Month 12. Higher scores indicate greater tinnitus-related handicap.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in tinnitus loudness on visual analog scale (VAS)", "description": "Participants rate tinnitus loudness on a 0-10 visual analog scale (0 = no tinnitus, 10 = worst imaginable). Change is calculated as follow-up minus baseline at each time point.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in tinnitus annoyance/distress on visual analog scale (VAS)", "description": "Participants rate how annoying or distressing their tinnitus is on a 0-10 visual analog scale (0 = not at all annoying, 10 = extremely annoying). Change is calculated as follow-up minus baseline.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in sleep interference due to tinnitus on visual analog scale (VAS)", "description": "Participants rate how much tinnitus interferes with sleep on a 0-10 visual analog scale (0 = no interference, 10 = extreme interference). Change is calculated as follow-up minus baseline.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in concentration difficulty due to tinnitus on visual analog scale (VAS)", "description": "Participants rate how much tinnitus interferes with concentration on a 0-10 visual analog scale (0 = no interference, 10 = extreme interference). Change is calculated as follow-up minus baseline.", "time_frame": "Baseline to Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC) in tinnitus symptoms", "description": "Participants rate overall change in their tinnitus on a 7-point Patient Global Impression of Change scale (1 = very much improved, 7 = very much worse). Outcomes will be summarized as the proportion reporting \"much improved\" or \"very much improved\" and as distribution across all categories.", "time_frame": "Day 30, Month 6, and Month 12" }, { "type": "secondary", "measure": "Change in concomitant symptom scores (vertigo, insomnia, headache, fatigue) on visual analog scales (VAS)", "description": "Participants rate vertigo, insomnia, headache, and fatigue on separate 0-10 visual analog scales (0 = no symptom, 10 = worst imaginable). Change in each symptom score from baseline to Day 30 will be summarized descriptively.", "time_frame": "Baseline to Day 30" }, { "type": "secondary", "measure": "Incidence of treatment-emergent adverse events", "description": "Number and proportion of participants experiencing treatment-emergent adverse events, including expected DMSO-related effects (e.g., garlic-like odor, transient warmth or flushing, skin irritation) and any serious or unexpected events. Events will be coded and summarized by severity and relationship to study treatment.", "time_frame": "From first dose through Day 30" }, { "type": "secondary", "measure": "Change in tympanic membrane temperature", "description": "In participants with local ENT follow-up, tympanic membrane temperature is measured at baseline and Day 30. Change in temperature will be summarized descriptively as an exploratory biomarker of local vascular and inflammatory effects.", "time_frame": "Baseline to Day 30 (where measured)" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07567274", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06476496", "title": "Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-05-12", "start_date": "2024-06-21", "completion_date": "2025-06-23", "primary_completion_date": "2025-03-30", "conditions_raw": [ "Long COVID", "Pain" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Acupuncture" ], "sponsor": "University of Washington", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this preliminary study is to test methods and procedures to be used in a fully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, we will test the feasibility of conducting a 2-arm randomized clinical trial for evaluating the effectiveness of acupuncture for pain in patients with long COVID. Researchers will compare pain intensity and impact on general activities over 5 months in those who receive acupuncture treatment compared to patients who are receiving usual long COVID care.\n\nParticipants will complete 4 online surveys at weeks 0, 4, 8, and 20. These surveys include validated mental and physical health questionnaires. Participants who are randomly selected to receive the intervention will receive 8 acupuncture treatment sessions.", "primary_outcomes": [ { "type": "primary", "measure": "Pain, Enjoyment and General Activity (PEG)", "description": "The PEG is a widely used brief, three-item instrument that measures average pain intensity, enjoyment of life, and general activity in the past week, each rated on a 0 to 10 scale. Scores are calculated by averaging the scores of each of the three items. A higher score indicates worse pain impact.", "time_frame": "Baseline (Week 0), Mid-Point (Week 4), Post-Intervention (Week 8), and Final Follow-Up (Week 20)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS) Short Form", "description": "The Pain Catastrophizing Scale (PCS) - Short Form is a 6-item self-report measure of catastrophic thinking related to pain, including rumination, magnification, and helplessness. PCS is a commonly used measure of pain experience and catastrophizing. Each measure is scored on a scale of 0 to 4. The PCS-SF score is determined by the sum of all 6 items; scores range from 0 to 24. Higher scores indicate greater catastrophizing.", "time_frame": "Baseline (Week 0), Post-Intervention (Week 8) and Final Follow-Up (Week 20)" }, { "type": "secondary", "measure": "PROMIS-29", "description": "PROMIS® (Patient-Reported Outcomes Measurement Information System) is a collection of person-centered tools that assess and track physical, mental, and social health in both adults and children. The PROMIS-29 Questionnaire includes 4-item short forms that measure anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and social role participation, along with a single item for pain intensity.\n\nRaw scores were converted to T-scores (using an adult referent population), ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10 in the reference population. High scores indicate more of the concept being measured (e.g., for physical function and ability to participate in social activities, a higher score signifies greater function; for all other domains, a higher score indicates worse function). Pain intensity is a single item scored separately on a scale of 0 to 10, with higher scores representing worse pain.", "time_frame": "Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-up (Week 20)" }, { "type": "secondary", "measure": "PROMIS Cognitive Function", "description": "The PROMIS Cognitive Function scale complements the PROMIS-29 with questions relevant to participants with Long COVID comorbidities, such as \"brain fog.\" This scale measures patient-perceived cognitive deficits. Aspects include mental clarity, focus, verbal and nonverbal memory, verbal fluency, and perceived changes in cognitive functions. The scale consists of 8 items, each rated from 1 to 5 to generate a raw score; all 8 items must be answered for the scale to be scored. The T-score converts the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.", "time_frame": "Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-Up (Week 20)" }, { "type": "secondary", "measure": "UW Pain Related Self-Efficacy Scale (PRSE)", "description": "Pain-related self-efficacy is an individual's belief in their ability to accomplish important tasks and activities despite their pain. Identified subdomains include: Control/tolerance of/cope with symptoms, ability to manage the impact of pain on mood and psychological functioning, interpersonal relationships, and confidence to accomplish goals despite pain. The UW-PRSE was developed in a sample of adults living with chronic pain (mild to severe pain with average pain intensity of 3 or above on a scale from 0 to 10 for six months or longer and for at least half the days).\n\nThis study used the 6-item short form. Individual items are summed, and the total sum is then transformed to an IRT-based T-score. T-Scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. The mean score of the calibration sample included only individuals with chronic pain. A higher T-Score indicates higher self-efficacy.", "time_frame": "Weeks 0, 8, 20" } ], "outcome_measures": [ { "type": "primary", "measure": "Pain, Enjoyment and General Activity (PEG)", "description": "The PEG is a widely used brief, three-item instrument that measures average pain intensity, enjoyment of life, and general activity in the past week, each rated on a 0 to 10 scale. Scores are calculated by averaging the scores of each of the three items. A higher score indicates worse pain impact.", "time_frame": "Baseline (Week 0), Mid-Point (Week 4), Post-Intervention (Week 8), and Final Follow-Up (Week 20)" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS) Short Form", "description": "The Pain Catastrophizing Scale (PCS) - Short Form is a 6-item self-report measure of catastrophic thinking related to pain, including rumination, magnification, and helplessness. PCS is a commonly used measure of pain experience and catastrophizing. Each measure is scored on a scale of 0 to 4. The PCS-SF score is determined by the sum of all 6 items; scores range from 0 to 24. Higher scores indicate greater catastrophizing.", "time_frame": "Baseline (Week 0), Post-Intervention (Week 8) and Final Follow-Up (Week 20)" }, { "type": "secondary", "measure": "PROMIS-29", "description": "PROMIS® (Patient-Reported Outcomes Measurement Information System) is a collection of person-centered tools that assess and track physical, mental, and social health in both adults and children. The PROMIS-29 Questionnaire includes 4-item short forms that measure anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and social role participation, along with a single item for pain intensity.\n\nRaw scores were converted to T-scores (using an adult referent population), ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10 in the reference population. High scores indicate more of the concept being measured (e.g., for physical function and ability to participate in social activities, a higher score signifies greater function; for all other domains, a higher score indicates worse function). Pain intensity is a single item scored separately on a scale of 0 to 10, with higher scores representing worse pain.", "time_frame": "Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-up (Week 20)" }, { "type": "secondary", "measure": "PROMIS Cognitive Function", "description": "The PROMIS Cognitive Function scale complements the PROMIS-29 with questions relevant to participants with Long COVID comorbidities, such as \"brain fog.\" This scale measures patient-perceived cognitive deficits. Aspects include mental clarity, focus, verbal and nonverbal memory, verbal fluency, and perceived changes in cognitive functions. The scale consists of 8 items, each rated from 1 to 5 to generate a raw score; all 8 items must be answered for the scale to be scored. The T-score converts the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.", "time_frame": "Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-Up (Week 20)" }, { "type": "secondary", "measure": "UW Pain Related Self-Efficacy Scale (PRSE)", "description": "Pain-related self-efficacy is an individual's belief in their ability to accomplish important tasks and activities despite their pain. Identified subdomains include: Control/tolerance of/cope with symptoms, ability to manage the impact of pain on mood and psychological functioning, interpersonal relationships, and confidence to accomplish goals despite pain. The UW-PRSE was developed in a sample of adults living with chronic pain (mild to severe pain with average pain intensity of 3 or above on a scale from 0 to 10 for six months or longer and for at least half the days).\n\nThis study used the 6-item short form. Individual items are summed, and the total sum is then transformed to an IRT-based T-score. T-Scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. The mean score of the calibration sample included only individuals with chronic pain. A higher T-Score indicates higher self-efficacy.", "time_frame": "Weeks 0, 8, 20" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 93, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06476496", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07108036", "title": "A Study to Assess Anktiva in Patients With Long Covid-19.", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-05-11", "start_date": "2025-11-14", "completion_date": "2026-10", "primary_completion_date": "2026-10", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "N-803" ], "sponsor": "ImmunityBio, Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This study will test the safety and tolerability of Anktiva in patients with Long Covid. Eligible patients will receive up to 2 doses of Anktiva and have follow-up exams and tests.", "primary_outcomes": [ { "type": "primary", "measure": "Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of abnormal changes in safety laboratory tests (CBC and CMP).", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)" }, { "type": "primary", "measure": "Clinically important changes in vital signs.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in the ALC from Screening, INT1, FU1.3, INT2, FU2.3, FU2.4, FU2.5, and EOS.", "description": "", "time_frame": "Through the study treatment period (approximately 75 days)." }, { "type": "secondary", "measure": "Change in patient-reported outcomes (PROs) PROMIS-29 score from Baseline to FU2.5 (45 days following last NAI administration).", "description": "", "time_frame": "45 days following last NAI administration." }, { "type": "secondary", "measure": "Change in other assessments (eg, EuroQoL Quality of Life) from baseline, intervention 2, FU2.3 (2 weeks after last NAI administration), FU2.5, and EOS.", "description": "", "time_frame": "Through the study treatment period (approximately 75 days)." }, { "type": "secondary", "measure": "Proportion of participants with no detection of SARS-CoV-2 plasma remnants (ie viral detection by reverse transcriptase-polymerase chain reaction [RTPCR]) compared to baseline at FU2.5 and EOS.", "description": "", "time_frame": "Through the study treatment period (approximately 75 days)." }, { "type": "secondary", "measure": "Proportion of participants with reduced SARS-CoV-2 RNA in stool approximately 30 days post NAI administration.", "description": "", "time_frame": "30 days post NAI administration" } ], "outcome_measures": [ { "type": "primary", "measure": "Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.", "description": "", "time_frame": "Through 30 days post final study drug administration." }, { "type": "primary", "measure": "Incidence of abnormal changes in safety laboratory tests (CBC and CMP).", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)" }, { "type": "primary", "measure": "Clinically important changes in vital signs.", "description": "", "time_frame": "Through the end of the study treatment period (approximately 75 days)" }, { "type": "secondary", "measure": "Change in the ALC from Screening, INT1, FU1.3, INT2, FU2.3, FU2.4, FU2.5, and EOS.", "description": "", "time_frame": "Through the study treatment period (approximately 75 days)." }, { "type": "secondary", "measure": "Change in patient-reported outcomes (PROs) PROMIS-29 score from Baseline to FU2.5 (45 days following last NAI administration).", "description": "", "time_frame": "45 days following last NAI administration." }, { "type": "secondary", "measure": "Change in other assessments (eg, EuroQoL Quality of Life) from baseline, intervention 2, FU2.3 (2 weeks after last NAI administration), FU2.5, and EOS.", "description": "", "time_frame": "Through the study treatment period (approximately 75 days)." }, { "type": "secondary", "measure": "Proportion of participants with no detection of SARS-CoV-2 plasma remnants (ie viral detection by reverse transcriptase-polymerase chain reaction [RTPCR]) compared to baseline at FU2.5 and EOS.", "description": "", "time_frame": "Through the study treatment period (approximately 75 days)." }, { "type": "secondary", "measure": "Proportion of participants with reduced SARS-CoV-2 RNA in stool approximately 30 days post NAI administration.", "description": "", "time_frame": "30 days post NAI administration" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07108036", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05914649", "title": "NC Testing in LC & POTS", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-05-07", "start_date": "2024-09-19", "completion_date": "2030-12-31", "primary_completion_date": "2030-12-31", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome", "Post Acute Sequelae of SARS CoV 2 Infection" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Iv Normal Saline" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Patients with Postural Orthostatic Tachycardia Syndrome (POTS) and Post-Acute Sequelae of COVID (PASC, or \"Long COVID\") experience cognitive dysfunction. The investigators will test the hypothesis that 999 mL of IV saline will improve cognitive function in patients with POTS and Long COVID compared to placebo (50 mL of saline).", "primary_outcomes": [ { "type": "primary", "measure": "5RTI Reaction Time task (Standing)", "description": "5RTI Reaction Time Score (Standing) after 999 mL IV saline compared to 5RTI score after 50 mL IV saline measured in milliseconds (ms). The minimum score is 100 ms and the maximum score is 5100 ms. A longer time is a worse outcome.", "time_frame": "During Procedure (3 hours)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Reaction Time Test (Psychomotor Speed)", "description": "Reaction Time Test score after 1500mL IV saline compared to after 50mL IV saline measured in milliseconds. The minimum score is 100 ms and the maximum score is 5100 ms. A longer time is a worse outcome.", "time_frame": "During Procedure (3 hours)" }, { "type": "secondary", "measure": "Paired Associates Learning (Visual Episodic Memory)", "description": "Paired Associates Learning score after 999 mL IV saline compared to after 50 mL IV saline measured in arbitrary units. The minimum score is 0 and the maximum score is 70. A higher score is a worse outcome.", "time_frame": "During Procedure (3 hours)" }, { "type": "secondary", "measure": "Verbal Recognition Memory (Verbal memory)", "description": "Verbal Recognition Memory test score after 999 mL IV saline compared to after 50 mL IV saline. The range is 0-18. A higher score is a better outcome.", "time_frame": "During Procedure (3 hours)" }, { "type": "secondary", "measure": "Multitasking Test (Executive Function - Inhibition)", "description": "Multitasking Test Time after 999 mL IV saline compared to after 50 mL IV saline measured in ms. The range is 100 - 2000 ms. A longer time is a worse is a worse outcome.", "time_frame": "During Procedure (3 hours)" } ], "outcome_measures": [ { "type": "primary", "measure": "5RTI Reaction Time task (Standing)", "description": "5RTI Reaction Time Score (Standing) after 999 mL IV saline compared to 5RTI score after 50 mL IV saline measured in milliseconds (ms). The minimum score is 100 ms and the maximum score is 5100 ms. A longer time is a worse outcome.", "time_frame": "During Procedure (3 hours)" }, { "type": "secondary", "measure": "Reaction Time Test (Psychomotor Speed)", "description": "Reaction Time Test score after 1500mL IV saline compared to after 50mL IV saline measured in milliseconds. The minimum score is 100 ms and the maximum score is 5100 ms. A longer time is a worse outcome.", "time_frame": "During Procedure (3 hours)" }, { "type": "secondary", "measure": "Paired Associates Learning (Visual Episodic Memory)", "description": "Paired Associates Learning score after 999 mL IV saline compared to after 50 mL IV saline measured in arbitrary units. The minimum score is 0 and the maximum score is 70. A higher score is a worse outcome.", "time_frame": "During Procedure (3 hours)" }, { "type": "secondary", "measure": "Verbal Recognition Memory (Verbal memory)", "description": "Verbal Recognition Memory test score after 999 mL IV saline compared to after 50 mL IV saline. The range is 0-18. A higher score is a better outcome.", "time_frame": "During Procedure (3 hours)" }, { "type": "secondary", "measure": "Multitasking Test (Executive Function - Inhibition)", "description": "Multitasking Test Time after 999 mL IV saline compared to after 50 mL IV saline measured in ms. The range is 100 - 2000 ms. A longer time is a worse is a worse outcome.", "time_frame": "During Procedure (3 hours)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05914649", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06503913", "title": "Cognitive Muscular Therapy for Patients With Long-COVID and Breathing Pattern Disorder", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-05-06", "start_date": "2024-08-01", "completion_date": "2026-03-01", "primary_completion_date": "2026-03-01", "conditions_raw": [ "Long COVID", "Respiratory Disease" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cognitive Muscular Therapy", "Breathing Visualisation" ], "sponsor": "University of Salford", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of the study is to test a treatment known as \"Cognitive Muscular Therapy (CMT)\" for reducing breathlessness and improving autonomic function in patients with long-COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Nijmegen Questionnaire", "description": "Used to capture breathlessness symptoms associated with hyperventilation disorder. Score 0 - 60 (0 = no hyperventilation symptoms, 60 severe symptoms of hyperventilation).", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale", "description": "Used to capture breathlessness symptoms associated with long-COVID compared to pre-acute infection. Score 0 - 45 (0 = no long-COVID symptoms, 45 severe symptoms of long-COVID).", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in Dyspnea-12 questionnaire", "description": "Used to capture breathlessness symptoms. Score 0 - 36 (0 = no breathlessness symptoms, 36 severe breathlessness).", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in Self-evaluation of breathing questionnaire", "description": "Used to capture breathlessness symptoms associated with dysfunctional breathing. Score 0 - 75 (0 = no dysfunctional breathing symptoms, 60 severe symptoms of dysfunctional breathing).", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in Composite Autonomic Symptom Score", "description": "Used to capture symptoms associated with autonomic dysfunction. 31 questions rating the symptoms associated with autonomic dysfunction.", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in EQ-5D-5L", "description": "Used to capture an individual's quality of life through their ability to complete daily living activities. Each heading is rated from no problems through to unable to complete the task.", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in WHO Disability Assessment Schedule (12-item)", "description": "Used to capture an individual's ability to perform daily living activities. Each point is rated from No difficulty performing a task to extreme difficulty/cannot complete the task.", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Nijmegen Questionnaire", "description": "Used to capture breathlessness symptoms associated with hyperventilation disorder. Score 0 - 60 (0 = no hyperventilation symptoms, 60 severe symptoms of hyperventilation).", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale", "description": "Used to capture breathlessness symptoms associated with long-COVID compared to pre-acute infection. Score 0 - 45 (0 = no long-COVID symptoms, 45 severe symptoms of long-COVID).", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in Dyspnea-12 questionnaire", "description": "Used to capture breathlessness symptoms. Score 0 - 36 (0 = no breathlessness symptoms, 36 severe breathlessness).", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in Self-evaluation of breathing questionnaire", "description": "Used to capture breathlessness symptoms associated with dysfunctional breathing. Score 0 - 75 (0 = no dysfunctional breathing symptoms, 60 severe symptoms of dysfunctional breathing).", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in Composite Autonomic Symptom Score", "description": "Used to capture symptoms associated with autonomic dysfunction. 31 questions rating the symptoms associated with autonomic dysfunction.", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in EQ-5D-5L", "description": "Used to capture an individual's quality of life through their ability to complete daily living activities. Each heading is rated from no problems through to unable to complete the task.", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" }, { "type": "secondary", "measure": "Change in WHO Disability Assessment Schedule (12-item)", "description": "Used to capture an individual's ability to perform daily living activities. Each point is rated from No difficulty performing a task to extreme difficulty/cannot complete the task.", "time_frame": "Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 18, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06503913", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06170645", "title": "Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-05-06", "start_date": "2024-10-03", "completion_date": "2028-08", "primary_completion_date": "2028-02", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Apa Program", "Active Transcutaneous Vns" ], "sponsor": "Centre Hospitalier Universitaire de Saint Etienne", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue is enhanced by adapted physical activity (APA) programs. Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid benefit from a 4-6 week APA program, with 2 sessions per week. While most patients are improved by these exercise-training programs, for some the benefits remain very modest, and patients describe persistent fatigue. The literature unanimously describes the necessity of longer APA protocols (8-12 weeks, 2-3 sessions/week) for fatigue reduction in fibromyalgia and long Covid. However, it seems difficult to adhere to an optimal program as described in the literature for these fatigued patients. The investigators want to test a device that would both reduce fatigue and improve recovery between APA sessions, in order to gradually reach the recommendations for APA practice. Transcutaneous vagal nerve stimulation (tVNS) seems to be a promising approach. Thus, combining an APA intervention with a tVNS protocol could potentiate the expected and now well-known effect of exercise.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue evaluation assessed by autonomic nervous system activity", "description": "The root mean square of successive differences in heart rate (in milliseconds) will be measured from a nocturnal Holter ECG recording (Novacor, Paris, France) at the end of the 3-month APA and tVNS programme (month 3) and compared with pre-programme values (inclusion).", "time_frame": "Month : 0; 3" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "Subjective fatigue assessed by FSS, score from 9 to 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Medical Outcome Study Short Form questionnaire (MOS-SF 12)", "description": "Quality of life assessed by the MOS-SF 12 questionnaire , score from 0 to 100. A low score reflects a perception of poor health, loss of function and the presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Pittsburgh questionnaire", "description": "Quality of sleep assessed by Pittsburgh questionnaire (score 0 to 21). The 7 components of the score add up to give an overall score ranging from give an overall score ranging from 0 to 21 points, with 0 meaning that there are no difficulties, and 21 indicating major difficulties.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "6-minute walk test (6MWT)", "description": "Physical condition assessed by the walking distance covered in the 6MWT, walking distance in m.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Adult Physical Activity Questionnaire (APAQ)", "description": "Physical activity assessed by the APAQ, time spend to physical activity in hours/day.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Step count per day", "description": "Objective physical activity assessed by step count per day using a Garmin Vivofit 4 activity tracker.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Ratio of Low Frequency to High Frequency (LF/HF)", "description": "The autonomic balance (sympathetic/parasympathetic) will be analysed by measuring the LF/HF ratio on the basis of a nocturnal Holter ECG recording (Novacor, Paris, France).", "time_frame": "Month : 0; 6" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue evaluation assessed by autonomic nervous system activity", "description": "The root mean square of successive differences in heart rate (in milliseconds) will be measured from a nocturnal Holter ECG recording (Novacor, Paris, France) at the end of the 3-month APA and tVNS programme (month 3) and compared with pre-programme values (inclusion).", "time_frame": "Month : 0; 3" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "Subjective fatigue assessed by FSS, score from 9 to 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Medical Outcome Study Short Form questionnaire (MOS-SF 12)", "description": "Quality of life assessed by the MOS-SF 12 questionnaire , score from 0 to 100. A low score reflects a perception of poor health, loss of function and the presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Pittsburgh questionnaire", "description": "Quality of sleep assessed by Pittsburgh questionnaire (score 0 to 21). The 7 components of the score add up to give an overall score ranging from give an overall score ranging from 0 to 21 points, with 0 meaning that there are no difficulties, and 21 indicating major difficulties.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "6-minute walk test (6MWT)", "description": "Physical condition assessed by the walking distance covered in the 6MWT, walking distance in m.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Adult Physical Activity Questionnaire (APAQ)", "description": "Physical activity assessed by the APAQ, time spend to physical activity in hours/day.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Step count per day", "description": "Objective physical activity assessed by step count per day using a Garmin Vivofit 4 activity tracker.", "time_frame": "Month : 0; 6" }, { "type": "secondary", "measure": "Ratio of Low Frequency to High Frequency (LF/HF)", "description": "The autonomic balance (sympathetic/parasympathetic) will be analysed by measuring the LF/HF ratio on the basis of a nocturnal Holter ECG recording (Novacor, Paris, France).", "time_frame": "Month : 0; 6" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06170645", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05204550", "title": "Intranasal Heparin Treatment to Reduce Transmission Among Household Contacts of COVID 19 Positive Adults and Children", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-05-05", "start_date": "2023-01-30", "completion_date": "2026-04-01", "primary_completion_date": "2024-12-09", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Unfractionated Heparin" ], "sponsor": "Murdoch Childrens Research Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Coronavirus-induced disease 2019 (COVID-19) is an infection caused by a virus whose full name is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This is a new and rapidly-spreading infectious disease which carries a significant risk of death, has brought massive economic impact globally and has proved hard to contain through public health measures. While we currently have effective vaccines, they do not protect the whole community and the constant threat of new mutations means there is an urgent need to identify new approaches to reducing community spread of infection.\n\nHeparin is a naturally occurring sugar molecule which has been used for a century to treat a range of medical problems including heart attacks, strokes, and blood clots. It has also been investigated as a treatment for pneumonias. Recent research suggests it binds to the SARS-CoV-2 virus in such a way it may reduce the virus' ability to enter cells. This may be an important way to tackle the early stages of infection which occurs inside the nose. Therefore, this medication could be used amongst people with early COVID-19 infection and amongst their household contacts to reduce the rate of virus transmission during local outbreaks. If proven effective there are many other potential uses as primary prophylaxis for people working in high risk areas, for travel, for protection in high risk crowded environments such as nightclubs, or sporting events. Heparin is safe, inexpensive, available worldwide and if effective could be rapidly used across the world to slow progression of the current pandemic.\n\nFurther there are recent studies suggesting that the risk of brain complications as part of \"long COVID\", are directly related to the amount of virus in the nose. Reducing the viral load in the nose is thought to be effective in reducing these \"long COVID\" complications. This study will explore the effect of the intervention on viral load and long COVID.\n\nIn this study, researchers want to investigate this medicine in people who have been identified by a COVID-19 swab test to be in the early stages of infection(defined as the index case), and amongst their household contacts. Each participant would take the medicine or a dummy control solution by spray into their nose three times a day for 10 days. The study will investigate if there are fewer people who contract SARS-CoV-2 infection by day 10 amongst households who receive the medicine than households which receive the dummy control.", "primary_outcomes": [ { "type": "primary", "measure": "Number of household contacts (swab negative on day 1) testing positive for SARS-CoV-2 by PCR on either of three routine nasopharyngeal swabs on day 3,5 and 10 after enrolment or on nasopharyngeal swab in response to clinical symptoms in the first 14 days", "description": "household contacts who become COVID 19 positive at any time during study period", "time_frame": "14 days from randomisation" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Number of household contacts (swab negative on day 1 of study) becoming symptomatic of COVID-19 in next 28 days", "description": "household contacts who develop symptomatic COVID 19 defined as : fever (≥38°C) PLUS ≥1 respiratory symptom (sore throat, cough, shortness of breath); OR 2 respiratory symptoms (sore throat, cough, shortness of breath); OR 1 respiratory symptom (sore throat, cough, shortness of breath) PLUS ≥2 non-respiratory symptoms (chills, nausea, vomiting, diarrhea, headache, conjunctivitis, myalgia, arthralgia, loss of taste or smell, fatigue or general malaise).", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 3", "description": "proportion of COVID 19 positive participants becoming swab negative by day 3", "time_frame": "3 days from randomisation" }, { "type": "secondary", "measure": "total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 5", "description": "proportion of COVID 19 positive participants becoming swab negative by day 5", "time_frame": "5 days from randomisation" }, { "type": "secondary", "measure": "total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 10", "description": "proportion of COVID 19 positive participants becoming swab negative by day 10", "time_frame": "10 days from randomisation" }, { "type": "secondary", "measure": "Time to swab negative based on daily anterior nasal swab for index cases and household contacts combined who were swab positive on day 1.", "description": "mean time to swab negative in all COVID 19 positive participants", "time_frame": "10 days from randomisation" }, { "type": "secondary", "measure": "Quantitative replication sub genomic viral RNA at days 3 post randomisation.", "description": "The quantitative assay to generate these data will be the Q2 SARS-CoV-2 Viral Load Quantitation Assay, with lower limit of quantification of 500 copies/ml and upper limit of quantification of 500,000,000 copies/ml. Results below or above these limits will be included in the mean and the mean change from baseline, with imputed value 499 and 500,000,001, respectively. High viral load is defined as \\>106 copies/mL, low viral load is defined as ≤106 copies/mL, and undetectable viral load is defined as \\< 500 copies/ml", "time_frame": "3 days from randomisation" }, { "type": "secondary", "measure": "Quantitative replication sub genomic viral RNA at days 5 post randomisation.", "description": "The quantitative assay to generate these data will be the Q2 SARS-CoV-2 Viral Load Quantitation Assay, with lower limit of quantification of 500 copies/ml and upper limit of quantification of 500,000,000 copies/ml. Results below or above these limits will be included in the mean and the mean change from baseline, with imputed value 499 and 500,000,001, respectively. High viral load is defined as \\>106 copies/mL, low viral load is defined as ≤106 copies/mL, and undetectable viral load is defined as \\< 500 copies/ml", "time_frame": "5 days from randomisation" }, { "type": "secondary", "measure": "Quantitative replication sub genomic viral RNA at days 10 post randomisation.", "description": "The quantitative assay to generate these data will be the Q2 SARS-CoV-2 Viral Load Quantitation Assay, with lower limit of quantification of 500 copies/ml and upper limit of quantification of 500,000,000 copies/ml. Results below or above these limits will be included in the mean and the mean change from baseline, with imputed value 499 and 500,000,001, respectively. High viral load is defined as \\>106 copies/mL, low viral load is defined as ≤106 copies/mL, and undetectable viral load is defined as \\< 500 copies/ml", "time_frame": "10 days from randomisation" }, { "type": "secondary", "measure": "The number of participants who discontinue treatment prior to day 10 from randomisation", "description": "treatment tolerability", "time_frame": "10 days from randomisation" }, { "type": "secondary", "measure": "Number of index cases and household contacts swab positive on day 1, hospitalized with COVID-19 by day 28 from randomization", "description": "symptomatic progression of COVID 19", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "Number of household contacts swab negative on day 1, hospitalized with COVID-19 by day 28 from randomization", "description": "symptomatic progression of COVID 19", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "Maximum severity score of participants (index case and household contacts swab positive on day 1 compared to household contacts swab negative on day 1) during the study period as recorded by daily symptom diary up to day 28", "description": "A COVID-19 Composite Subjective Symptom Severity Score will be generated using the 11 common symptoms for COVID 19 infection listed at the Center for disease control website and a self-rated symptom severity assessment generated for each symptom on a daily basis using a Likert scale for each symptom (Scale 0-3: not present mild, moderate, severe).\n\nCommon symptoms:\n\n* Fever or chills\n* Cough\n* Shortness of breath or difficulty breathing\n* Fatigue\n* Muscle or body aches\n* Headache\n* New loss of taste or smell\n* Sore throat\n* Congestion or runny nose\n* Nausea or vomiting\n* Diarrhea\n\nIndex cases and household contacts will be asked to complete symptom severity checklists daily.\n\nAnalysis will utilise a summative score", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "time to symptom resolution analysis for index case and household contacts swab positive on day 1 compared to household contacts swab negative on day 1, during the study period as measured with daily symptom diary until on day 28", "description": "hazard ratio of time to sustained improvement or resolution of symptoms based on daily symptoms reports up to day 28 specific to the 11 common symptoms for COVID 19 infection listed at the Center for Disease Control website and a self-rated symptom severity assessment generated for each symptom on a daily basis using a Likert scale for each symptom (Scale 0-3: not present mild, moderate, severe).\n\nCommon symptoms:\n\n* Fever or chills\n* Cough\n* Shortness of breath or difficulty breathing\n* Fatigue\n* Muscle or body aches\n* Headache\n* New loss of taste or smell\n* Sore throat\n* Congestion or runny nose\n* Nausea or vomiting\n* Diarrhea\n\nIndex cases and household contacts will be asked to complete symptom severity checklists daily.", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "Number of participants with clinical symptoms of neurological long COVID at 6 months post initial positive COVID-19 test.", "description": "Telehealth self-rated symptom assessment using a Likert scale(0-3: absent, mild, moderate, severe). for each symptom Symptoms screened: fatigue, malaise, daytime tiredness, impaired concentration, brain fog, sleep disturbance, forgetfulness, confusion, Headache, dizziness, nausea, Hypo/anosmia , hypo/ageusia, Impaired walking, tingling feet or hands, burning feet or hands, numb feet or hands, impaired fine motor skills, muscle pain, Epilepsy, anxiety, depression. Cognition and mood will be assessed using the harmonised procedures developed by the Neuro-COVID Neuropsychology International Task force. Telephone - Montreal Cognitive Assessment,Patient's Assessment of Own Functioning, Wechsler Adult Intelligence Scale, Digit Span (Forward and Backward),Brief Visuospatial Memory Test - Revised,Hopkins Verbal Learning Test, Depression, Anxiety, Stress Scales", "time_frame": "6 months from randomisation" }, { "type": "secondary", "measure": "Number of participants with clinical symptoms of neurological long COVID at 12 months post initial positive COVID-19 test.", "description": "Telehealth self-rated symptom assessment using a Likert scale(0-3: absent, mild, moderate, severe). for each symptom Symptoms screened: fatigue, malaise, daytime tiredness, impaired concentration, brain fog, sleep disturbance, forgetfulness, confusion, Headache, dizziness, nausea, Hypo/anosmia , hypo/ageusia, Impaired walking, tingling feet or hands, burning feet or hands, numb feet or hands, impaired fine motor skills, muscle pain, Epilepsy, anxiety, depression. Cognition and mood will be assessed using the harmonised procedures developed by the Neuro-COVID Neuropsychology International Task force. Telephone - Montreal Cognitive Assessment,Patient's Assessment of Own Functioning, Wechsler Adult Intelligence Scale, Digit Span (Forward and Backward),Brief Visuospatial Memory Test - Revised,Hopkins Verbal Learning Test, Depression, Anxiety, Stress Scales", "time_frame": "12 months from randomisation" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of household contacts (swab negative on day 1) testing positive for SARS-CoV-2 by PCR on either of three routine nasopharyngeal swabs on day 3,5 and 10 after enrolment or on nasopharyngeal swab in response to clinical symptoms in the first 14 days", "description": "household contacts who become COVID 19 positive at any time during study period", "time_frame": "14 days from randomisation" }, { "type": "secondary", "measure": "Number of household contacts (swab negative on day 1 of study) becoming symptomatic of COVID-19 in next 28 days", "description": "household contacts who develop symptomatic COVID 19 defined as : fever (≥38°C) PLUS ≥1 respiratory symptom (sore throat, cough, shortness of breath); OR 2 respiratory symptoms (sore throat, cough, shortness of breath); OR 1 respiratory symptom (sore throat, cough, shortness of breath) PLUS ≥2 non-respiratory symptoms (chills, nausea, vomiting, diarrhea, headache, conjunctivitis, myalgia, arthralgia, loss of taste or smell, fatigue or general malaise).", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 3", "description": "proportion of COVID 19 positive participants becoming swab negative by day 3", "time_frame": "3 days from randomisation" }, { "type": "secondary", "measure": "total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 5", "description": "proportion of COVID 19 positive participants becoming swab negative by day 5", "time_frame": "5 days from randomisation" }, { "type": "secondary", "measure": "total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 10", "description": "proportion of COVID 19 positive participants becoming swab negative by day 10", "time_frame": "10 days from randomisation" }, { "type": "secondary", "measure": "Time to swab negative based on daily anterior nasal swab for index cases and household contacts combined who were swab positive on day 1.", "description": "mean time to swab negative in all COVID 19 positive participants", "time_frame": "10 days from randomisation" }, { "type": "secondary", "measure": "Quantitative replication sub genomic viral RNA at days 3 post randomisation.", "description": "The quantitative assay to generate these data will be the Q2 SARS-CoV-2 Viral Load Quantitation Assay, with lower limit of quantification of 500 copies/ml and upper limit of quantification of 500,000,000 copies/ml. Results below or above these limits will be included in the mean and the mean change from baseline, with imputed value 499 and 500,000,001, respectively. High viral load is defined as \\>106 copies/mL, low viral load is defined as ≤106 copies/mL, and undetectable viral load is defined as \\< 500 copies/ml", "time_frame": "3 days from randomisation" }, { "type": "secondary", "measure": "Quantitative replication sub genomic viral RNA at days 5 post randomisation.", "description": "The quantitative assay to generate these data will be the Q2 SARS-CoV-2 Viral Load Quantitation Assay, with lower limit of quantification of 500 copies/ml and upper limit of quantification of 500,000,000 copies/ml. Results below or above these limits will be included in the mean and the mean change from baseline, with imputed value 499 and 500,000,001, respectively. High viral load is defined as \\>106 copies/mL, low viral load is defined as ≤106 copies/mL, and undetectable viral load is defined as \\< 500 copies/ml", "time_frame": "5 days from randomisation" }, { "type": "secondary", "measure": "Quantitative replication sub genomic viral RNA at days 10 post randomisation.", "description": "The quantitative assay to generate these data will be the Q2 SARS-CoV-2 Viral Load Quantitation Assay, with lower limit of quantification of 500 copies/ml and upper limit of quantification of 500,000,000 copies/ml. Results below or above these limits will be included in the mean and the mean change from baseline, with imputed value 499 and 500,000,001, respectively. High viral load is defined as \\>106 copies/mL, low viral load is defined as ≤106 copies/mL, and undetectable viral load is defined as \\< 500 copies/ml", "time_frame": "10 days from randomisation" }, { "type": "secondary", "measure": "The number of participants who discontinue treatment prior to day 10 from randomisation", "description": "treatment tolerability", "time_frame": "10 days from randomisation" }, { "type": "secondary", "measure": "Number of index cases and household contacts swab positive on day 1, hospitalized with COVID-19 by day 28 from randomization", "description": "symptomatic progression of COVID 19", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "Number of household contacts swab negative on day 1, hospitalized with COVID-19 by day 28 from randomization", "description": "symptomatic progression of COVID 19", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "Maximum severity score of participants (index case and household contacts swab positive on day 1 compared to household contacts swab negative on day 1) during the study period as recorded by daily symptom diary up to day 28", "description": "A COVID-19 Composite Subjective Symptom Severity Score will be generated using the 11 common symptoms for COVID 19 infection listed at the Center for disease control website and a self-rated symptom severity assessment generated for each symptom on a daily basis using a Likert scale for each symptom (Scale 0-3: not present mild, moderate, severe).\n\nCommon symptoms:\n\n* Fever or chills\n* Cough\n* Shortness of breath or difficulty breathing\n* Fatigue\n* Muscle or body aches\n* Headache\n* New loss of taste or smell\n* Sore throat\n* Congestion or runny nose\n* Nausea or vomiting\n* Diarrhea\n\nIndex cases and household contacts will be asked to complete symptom severity checklists daily.\n\nAnalysis will utilise a summative score", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "time to symptom resolution analysis for index case and household contacts swab positive on day 1 compared to household contacts swab negative on day 1, during the study period as measured with daily symptom diary until on day 28", "description": "hazard ratio of time to sustained improvement or resolution of symptoms based on daily symptoms reports up to day 28 specific to the 11 common symptoms for COVID 19 infection listed at the Center for Disease Control website and a self-rated symptom severity assessment generated for each symptom on a daily basis using a Likert scale for each symptom (Scale 0-3: not present mild, moderate, severe).\n\nCommon symptoms:\n\n* Fever or chills\n* Cough\n* Shortness of breath or difficulty breathing\n* Fatigue\n* Muscle or body aches\n* Headache\n* New loss of taste or smell\n* Sore throat\n* Congestion or runny nose\n* Nausea or vomiting\n* Diarrhea\n\nIndex cases and household contacts will be asked to complete symptom severity checklists daily.", "time_frame": "28 days from randomisation" }, { "type": "secondary", "measure": "Number of participants with clinical symptoms of neurological long COVID at 6 months post initial positive COVID-19 test.", "description": "Telehealth self-rated symptom assessment using a Likert scale(0-3: absent, mild, moderate, severe). for each symptom Symptoms screened: fatigue, malaise, daytime tiredness, impaired concentration, brain fog, sleep disturbance, forgetfulness, confusion, Headache, dizziness, nausea, Hypo/anosmia , hypo/ageusia, Impaired walking, tingling feet or hands, burning feet or hands, numb feet or hands, impaired fine motor skills, muscle pain, Epilepsy, anxiety, depression. Cognition and mood will be assessed using the harmonised procedures developed by the Neuro-COVID Neuropsychology International Task force. Telephone - Montreal Cognitive Assessment,Patient's Assessment of Own Functioning, Wechsler Adult Intelligence Scale, Digit Span (Forward and Backward),Brief Visuospatial Memory Test - Revised,Hopkins Verbal Learning Test, Depression, Anxiety, Stress Scales", "time_frame": "6 months from randomisation" }, { "type": "secondary", "measure": "Number of participants with clinical symptoms of neurological long COVID at 12 months post initial positive COVID-19 test.", "description": "Telehealth self-rated symptom assessment using a Likert scale(0-3: absent, mild, moderate, severe). for each symptom Symptoms screened: fatigue, malaise, daytime tiredness, impaired concentration, brain fog, sleep disturbance, forgetfulness, confusion, Headache, dizziness, nausea, Hypo/anosmia , hypo/ageusia, Impaired walking, tingling feet or hands, burning feet or hands, numb feet or hands, impaired fine motor skills, muscle pain, Epilepsy, anxiety, depression. Cognition and mood will be assessed using the harmonised procedures developed by the Neuro-COVID Neuropsychology International Task force. Telephone - Montreal Cognitive Assessment,Patient's Assessment of Own Functioning, Wechsler Adult Intelligence Scale, Digit Span (Forward and Backward),Brief Visuospatial Memory Test - Revised,Hopkins Verbal Learning Test, Depression, Anxiety, Stress Scales", "time_frame": "12 months from randomisation" } ], "relevance_tags": [ "General", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 506, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05204550", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06223971", "title": "Long COVID-19 [11C]CPPC Study", "status": "COMPLETED", "phase": "EARLY_PHASE1", "last_updated": "2026-04-30", "start_date": "2024-08-06", "completion_date": "2026-03-31", "primary_completion_date": "2025-04-30", "conditions_raw": [ "COVID Long-Haul" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "[11C]Cppc Injection" ], "sponsor": "Johns Hopkins University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this study is to evaluate the safety of using the \\[5-cyano-N-(4-(4-\\[11C\\]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide\\] (\\[11C\\]CPPC) radiotracer in positron emission tomography (PET) imaging of people with history of COVID-19 infection, with and without symptoms. The investigators are also interested to see whether use of this radiotracer reveals imaging differences between patients with history of COVID-19 infection and still exhibiting symptoms or healthy patients with history of COVID-19 infection but exhibiting no current symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "To assess the safety and tolerability of one dose level of [11C]CPPC when administered intravenously.", "description": "Safety and tolerability will be determined by evaluation of spontaneously reported adverse events, clinical laboratory test results, physical, cognitive and neurologic exams and imaging (PET).", "time_frame": "Baseline and up to 2 days follow-up after scan" }, { "type": "primary", "measure": "Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete blood count (CBC) test.", "description": "Safety of use of \\[11C\\]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-Covid and healthy participants with history of COVID-19 infection. Safety will be assessed by monitoring of the complete blood count (CBC) for a change from baseline that is outside of the normal range.", "time_frame": "Baseline and up to 2 days follow-up after scan" }, { "type": "primary", "measure": "Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete metabolic panel (CMP) test.", "description": "Safety of use of \\[11C\\]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-COVID and healthy participants with history of COVID-19 infection. Safety will be assessed by a change in the CMP from baseline that is outside of the normal range", "time_frame": "Baseline and up to 2 days follow-up after scan" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Biodistribution of [11C]CPPC by PET imaging", "description": "Image analysis of PET imaging obtained of patients and healthy participants. The PET compartmental model fits will be applied to the regional time activity curves (TACs) will be first assessed visually before the relative goodness of fit will be assessed using the statistical F test.", "time_frame": "1 day" }, { "type": "secondary", "measure": "Cognitive function as assessed by the NIH Toolbox Cognition Battery (NIHTB-CB)", "description": "NIH Toolbox Cognition Battery (NIHTB-CB), which is an iPad-based instrument assessing five cognitive sub-domains: Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory. Score range 59 - 140, higher score means better cognition.", "time_frame": "1 day" }, { "type": "secondary", "measure": "Neuro-psychological assessment as assessed by the The Rey-Osterrieth complex figure test (ROCF)", "description": "The Rey-Osterrieth complex figure test (ROCF) is a neuro-psychological assessment in which participants are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall). Scoring of drawings is based on the 36-point scoring system (0 being the worst score and 36 the best).", "time_frame": "1 day" }, { "type": "secondary", "measure": "Global cognitive function as assessed by the Mini-Mental State Exam (MMSE)", "description": "The MMSE is a measure of global cognitive function, scores range from 0-30, a lower score indicates greater cognitive impairment.", "time_frame": "1 day" }, { "type": "secondary", "measure": "Dementia as assessed by the Clinical Dementia Rating (CDR) scale", "description": "The Clinical Dementia Rating Dementia Staging Instrument minimum score = 0, maximum score = 18. Low scores indicate less problems.", "time_frame": "1 day" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS) score", "description": "Scoring for the Hospital Anxiety and Depression scale is 0-21; Normal (0-7); Borderline Abnormal Case (8-10); and Abnormal Case (11-21) higher score indicates worse outcome.", "time_frame": "1 day" } ], "outcome_measures": [ { "type": "primary", "measure": "To assess the safety and tolerability of one dose level of [11C]CPPC when administered intravenously.", "description": "Safety and tolerability will be determined by evaluation of spontaneously reported adverse events, clinical laboratory test results, physical, cognitive and neurologic exams and imaging (PET).", "time_frame": "Baseline and up to 2 days follow-up after scan" }, { "type": "primary", "measure": "Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete blood count (CBC) test.", "description": "Safety of use of \\[11C\\]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-Covid and healthy participants with history of COVID-19 infection. Safety will be assessed by monitoring of the complete blood count (CBC) for a change from baseline that is outside of the normal range.", "time_frame": "Baseline and up to 2 days follow-up after scan" }, { "type": "primary", "measure": "Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete metabolic panel (CMP) test.", "description": "Safety of use of \\[11C\\]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-COVID and healthy participants with history of COVID-19 infection. Safety will be assessed by a change in the CMP from baseline that is outside of the normal range", "time_frame": "Baseline and up to 2 days follow-up after scan" }, { "type": "secondary", "measure": "Biodistribution of [11C]CPPC by PET imaging", "description": "Image analysis of PET imaging obtained of patients and healthy participants. The PET compartmental model fits will be applied to the regional time activity curves (TACs) will be first assessed visually before the relative goodness of fit will be assessed using the statistical F test.", "time_frame": "1 day" }, { "type": "secondary", "measure": "Cognitive function as assessed by the NIH Toolbox Cognition Battery (NIHTB-CB)", "description": "NIH Toolbox Cognition Battery (NIHTB-CB), which is an iPad-based instrument assessing five cognitive sub-domains: Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory. Score range 59 - 140, higher score means better cognition.", "time_frame": "1 day" }, { "type": "secondary", "measure": "Neuro-psychological assessment as assessed by the The Rey-Osterrieth complex figure test (ROCF)", "description": "The Rey-Osterrieth complex figure test (ROCF) is a neuro-psychological assessment in which participants are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall). Scoring of drawings is based on the 36-point scoring system (0 being the worst score and 36 the best).", "time_frame": "1 day" }, { "type": "secondary", "measure": "Global cognitive function as assessed by the Mini-Mental State Exam (MMSE)", "description": "The MMSE is a measure of global cognitive function, scores range from 0-30, a lower score indicates greater cognitive impairment.", "time_frame": "1 day" }, { "type": "secondary", "measure": "Dementia as assessed by the Clinical Dementia Rating (CDR) scale", "description": "The Clinical Dementia Rating Dementia Staging Instrument minimum score = 0, maximum score = 18. Low scores indicate less problems.", "time_frame": "1 day" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS) score", "description": "Scoring for the Hospital Anxiety and Depression scale is 0-21; Normal (0-7); Borderline Abnormal Case (8-10); and Abnormal Case (11-21) higher score indicates worse outcome.", "time_frame": "1 day" } ], "relevance_tags": [ "General", "EARLY_Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 6, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06223971", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05846126", "title": "Digital Multimodal Rehabilitation for People With Post-acute COVID-19 Syndrome.", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-04-30", "start_date": "2023-05-05", "completion_date": "2024-12-31", "primary_completion_date": "2024-12-20", "conditions_raw": [ "Post-COVID Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rehabcovid_Telematic", "Rehabcovid_Immersivevr" ], "sponsor": "Consorci Sanitari de Terrassa", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Although most infected people survive the infection, many have persistent sequelae or symptoms, which cause disability or decreased quality of life. The World Health Organization has called on countries to prioritize the rehabilitation of the consequences of COVID-19 in both the medium and long term, as this chronicity is expected to impact the health public and the economy in the coming years.\n\nRehabCOVID (also referred to as RehabNautilus) is born from the need to provide solutions to persistent cognitive impairment symptoms of people who have suffered from COVID-19. Thus, we will offer people with long COVID that accomplish inclusion/exclusion criteria to participate in a randomized clinical trial to evaluate the effectiveness of cognitive stimulation therapy combined with physical exercise and mindfulness. The current project is a single-blind randomized control study, where we will compare two combined interventions with a control group that will encompass different functional, structural, and biochemical changes and interactions in the brain. We will study the effects that this combined intervention produces in the brain. We expect to gain more insight into the specific neuroplasticity mechanisms of cognitive persistent COVID symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Differences between groups in scores of global cognition", "description": "Global cognition was assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of selective attention, inhibition, and processing speed", "description": "Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word \"red\" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of Visual scanning and processing speed", "description": "Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of Executive functioning and cognitive flexibility", "description": "Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of auditory attention", "description": "Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of working memory_DSB", "description": "Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of Perceptual Reasoning", "description": "Perceptual Reasoning is measured with Matrices from the WAIS-IV. Participants are presented with a pattern or design with one missing piece and are asked to select the correct piece from a set of options to complete the pattern. Higher scores on the Perceptual Reasoning Index mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of sustained attention and impulsivity", "description": "Conners Continuous Performance Test - 2nd edition (CPT-II) is task-oriented computerised assessment of attention-related problems. Participants are presented with a repetitive array of visual stimuli on a computer screen for 14 min. Participants are instructed to press the space bar every time a letter other than \"X\" appears and to not press the space bar when \"X\" appears. The rate of stimulus presentation varies according to 1, 2, and 4 s intervals throughout the task. Measures: Correct Detection (Higher rates indicate better outcome), Reaction times (Lower scores indicate better outcome), Omission errors (Lower rates indicate better outcome), and Commission errors (Lower rates indicate better outcome).", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of processing speed", "description": "The Digit Symbol Coding subtest from the WAIS-III is a neuropsychological assessment instrument for the detection of brain dysfunction in children and adults. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of verbal memory and learning", "description": "Verbal memory and learning are measured with the Rey Auditory Verbal Learning Test (RAVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by a recall of list A. Delayed recall and recognition are also tested. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of phonetic fluency", "description": "Phonetic fluency is measured with the FAS test. It consists of saying words that start with a certain letter, as many words as possible must be mentioned during a specific time of 1 minute. The standard administration of the test provides three letters, the most used are the letters F, A, and S. Higher scores indicate better performance.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of semantic verbal fluency", "description": "Semantic verbal fluency is measured with the ANIMAL test. It consists of generating the name of as many species of animals as possible within 1min. Higher scores indicate better performance.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of memory and everyday forgetfulness", "description": "Memory and everyday forgetfulness are measured with The Memory Failures of Everyday-MFE Questionnaire is a self-reported test that allows an assessment of memory and everyday forgetfulness. It is a unifactorial questionnaire and consists of 30 items. The total score results from the sum of the scores in each item, from 1 to 30. The MFE can assess the current situation of the patients and their evolution long-term or changes due to treatment. Scores \\<8 represent an optimal memory function. Lower scores indicate better outcomes.", "time_frame": "Before the intervention and 12 weeks later" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Differences between groups in scores of anxiety", "description": "Anxiety is measured with the 7-item Generalized Anxiety Disorder Scale (GAD-7), a Likert-type scale with questions ranging from \"not at all\" (0 points) to \"nearly every day\" (3 points). The maximum score is 24. Higher scores mean a worse outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of depression", "description": "Depression is measured with the Patient Health Questionnaire-9 (PHQ-9) which scores each of the 9 DSM-IV criteria as \"not at all\" (0 points) to \"nearly every day\" (3 points). Higher scores mean a worse outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of Mindfulness levels", "description": "Mindfulness levels are measured with The Mindful Attention Awareness Scale (MAAS) assesses an individual's level of mindfulness, including attention, awareness, and non-judgment. The 15-item self-report questionnaire uses a 6-point Likert scale to measure an individual's general tendency to be aware of and attentive to their current experience. Scores on the MAAS range from 15 to 90, with higher scores indicating greater levels of mindfulness. A higher score suggests better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of Fatigue", "description": "Fatigue is measured with the Chalder Fatigue Scale, an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales. Seven items represent physical fatigue (items 1-7) and 4 represent mental fatigue (items 8-11). Each item \" less than usual\" (0) to \" much more than usual\" (3). The ratings of items are added together to calculate the total score (range=0-33). High scores represent high levels of fatigue.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of psychological flexibility", "description": "Psychological flexibility is measured with the Acceptance and Action Questionnaire, a 7-point Likert scale, ranging from 1 (\"never true\") to 7 (\"always true\"), indicating how frequently they experience the described behavior or feeling in their daily lives. The scale has 9 items and the total score ranges from 9 to 63, with higher scores indicating greater levels of psychological flexibility (better outcome).", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in Functionality", "description": "Functionality is measured with a 12-item World Health Organization Disability Assessment Schedule-II (WHODAS-II). Patients are asked to state the level of difficulty experienced, considering how they usually do the activity. The scale scores each item as \"none\" (1) to \"cannot do\" (5). The total score is calculated with an SPSS syntax, and the range varies from 0 to 100, with higher scores reflecting more significant disability.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of Sleep Quality", "description": "Sleep Quality is measured with The Pittsburgh Sleep Quality Index (PSQI). This test presents 24 items, although only 19 are taken into account for the correction. This test is divided into 7 dimensions, namely, sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, hypnotic drugs, and daytime dysfunction. Higher scores indicate worse sleep quality.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of Quality of Life", "description": "Quality of Life is measured with EuroQol a self-completion questionnaire, which consists of five questions: covering mobility, hygiene, activities, pain, and anxiety. The descriptive system divides each of the 5 dimensions into three levels of response: the absence of a problem, some problem, and extreme problem. Lower scores indicate better outcomes. In addition, the questionnaire has a plus scale where the participants rated their health state on a scale of 0-100. In this scale, higher scores indicate better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of performed physical activity", "description": "Performed physical activity is measured with The International Physical Activity Questionnaire (IPAQ) is a questionnaire composed of 7 questionsin order to assessthe frequency, duration, and intensity (vigorous or moderate) of the performed physical activity, walking, and sitting time during a business day for the last 7 days. Later, from the minutes obtained from the participant's answers, the METS (metabolic equivalent tasks) conversion is performed, allowing a classification, depending on the energy consumption obtained for each activity, into three categories (low, medium, high). Higher score indicate better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in White Matter integrity", "description": "White matter integrity: tractography measured by MRI", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in brain Volumetry", "description": "Grey and white matter volume measured by MRI", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in Resting-state connectivity", "description": "Resting state brain activity using fMRI", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in rate of expression analysis of Sirt-1 levels", "description": "Sirt-1 levels are measured with the Sirtuin-1 ELISA Kit", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in rate of expression analysis of different microRNAs", "description": "microRNAs are measured with TaqMan miRNA qRT-PCR", "time_frame": "Before the intervention and 12 weeks later" } ], "outcome_measures": [ { "type": "primary", "measure": "Differences between groups in scores of global cognition", "description": "Global cognition was assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of selective attention, inhibition, and processing speed", "description": "Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word \"red\" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of Visual scanning and processing speed", "description": "Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of Executive functioning and cognitive flexibility", "description": "Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of auditory attention", "description": "Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of working memory_DSB", "description": "Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of Perceptual Reasoning", "description": "Perceptual Reasoning is measured with Matrices from the WAIS-IV. Participants are presented with a pattern or design with one missing piece and are asked to select the correct piece from a set of options to complete the pattern. Higher scores on the Perceptual Reasoning Index mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of sustained attention and impulsivity", "description": "Conners Continuous Performance Test - 2nd edition (CPT-II) is task-oriented computerised assessment of attention-related problems. Participants are presented with a repetitive array of visual stimuli on a computer screen for 14 min. Participants are instructed to press the space bar every time a letter other than \"X\" appears and to not press the space bar when \"X\" appears. The rate of stimulus presentation varies according to 1, 2, and 4 s intervals throughout the task. Measures: Correct Detection (Higher rates indicate better outcome), Reaction times (Lower scores indicate better outcome), Omission errors (Lower rates indicate better outcome), and Commission errors (Lower rates indicate better outcome).", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of processing speed", "description": "The Digit Symbol Coding subtest from the WAIS-III is a neuropsychological assessment instrument for the detection of brain dysfunction in children and adults. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of verbal memory and learning", "description": "Verbal memory and learning are measured with the Rey Auditory Verbal Learning Test (RAVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by a recall of list A. Delayed recall and recognition are also tested. Higher scores mean a better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of phonetic fluency", "description": "Phonetic fluency is measured with the FAS test. It consists of saying words that start with a certain letter, as many words as possible must be mentioned during a specific time of 1 minute. The standard administration of the test provides three letters, the most used are the letters F, A, and S. Higher scores indicate better performance.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of semantic verbal fluency", "description": "Semantic verbal fluency is measured with the ANIMAL test. It consists of generating the name of as many species of animals as possible within 1min. Higher scores indicate better performance.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "primary", "measure": "Differences between groups in scores of memory and everyday forgetfulness", "description": "Memory and everyday forgetfulness are measured with The Memory Failures of Everyday-MFE Questionnaire is a self-reported test that allows an assessment of memory and everyday forgetfulness. It is a unifactorial questionnaire and consists of 30 items. The total score results from the sum of the scores in each item, from 1 to 30. The MFE can assess the current situation of the patients and their evolution long-term or changes due to treatment. Scores \\<8 represent an optimal memory function. Lower scores indicate better outcomes.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of anxiety", "description": "Anxiety is measured with the 7-item Generalized Anxiety Disorder Scale (GAD-7), a Likert-type scale with questions ranging from \"not at all\" (0 points) to \"nearly every day\" (3 points). The maximum score is 24. Higher scores mean a worse outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of depression", "description": "Depression is measured with the Patient Health Questionnaire-9 (PHQ-9) which scores each of the 9 DSM-IV criteria as \"not at all\" (0 points) to \"nearly every day\" (3 points). Higher scores mean a worse outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of Mindfulness levels", "description": "Mindfulness levels are measured with The Mindful Attention Awareness Scale (MAAS) assesses an individual's level of mindfulness, including attention, awareness, and non-judgment. The 15-item self-report questionnaire uses a 6-point Likert scale to measure an individual's general tendency to be aware of and attentive to their current experience. Scores on the MAAS range from 15 to 90, with higher scores indicating greater levels of mindfulness. A higher score suggests better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of Fatigue", "description": "Fatigue is measured with the Chalder Fatigue Scale, an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales. Seven items represent physical fatigue (items 1-7) and 4 represent mental fatigue (items 8-11). Each item \" less than usual\" (0) to \" much more than usual\" (3). The ratings of items are added together to calculate the total score (range=0-33). High scores represent high levels of fatigue.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of psychological flexibility", "description": "Psychological flexibility is measured with the Acceptance and Action Questionnaire, a 7-point Likert scale, ranging from 1 (\"never true\") to 7 (\"always true\"), indicating how frequently they experience the described behavior or feeling in their daily lives. The scale has 9 items and the total score ranges from 9 to 63, with higher scores indicating greater levels of psychological flexibility (better outcome).", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in Functionality", "description": "Functionality is measured with a 12-item World Health Organization Disability Assessment Schedule-II (WHODAS-II). Patients are asked to state the level of difficulty experienced, considering how they usually do the activity. The scale scores each item as \"none\" (1) to \"cannot do\" (5). The total score is calculated with an SPSS syntax, and the range varies from 0 to 100, with higher scores reflecting more significant disability.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of Sleep Quality", "description": "Sleep Quality is measured with The Pittsburgh Sleep Quality Index (PSQI). This test presents 24 items, although only 19 are taken into account for the correction. This test is divided into 7 dimensions, namely, sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, hypnotic drugs, and daytime dysfunction. Higher scores indicate worse sleep quality.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of Quality of Life", "description": "Quality of Life is measured with EuroQol a self-completion questionnaire, which consists of five questions: covering mobility, hygiene, activities, pain, and anxiety. The descriptive system divides each of the 5 dimensions into three levels of response: the absence of a problem, some problem, and extreme problem. Lower scores indicate better outcomes. In addition, the questionnaire has a plus scale where the participants rated their health state on a scale of 0-100. In this scale, higher scores indicate better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in scores of performed physical activity", "description": "Performed physical activity is measured with The International Physical Activity Questionnaire (IPAQ) is a questionnaire composed of 7 questionsin order to assessthe frequency, duration, and intensity (vigorous or moderate) of the performed physical activity, walking, and sitting time during a business day for the last 7 days. Later, from the minutes obtained from the participant's answers, the METS (metabolic equivalent tasks) conversion is performed, allowing a classification, depending on the energy consumption obtained for each activity, into three categories (low, medium, high). Higher score indicate better outcome.", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in White Matter integrity", "description": "White matter integrity: tractography measured by MRI", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in brain Volumetry", "description": "Grey and white matter volume measured by MRI", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in Resting-state connectivity", "description": "Resting state brain activity using fMRI", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in rate of expression analysis of Sirt-1 levels", "description": "Sirt-1 levels are measured with the Sirtuin-1 ELISA Kit", "time_frame": "Before the intervention and 12 weeks later" }, { "type": "secondary", "measure": "Differences between groups in rate of expression analysis of different microRNAs", "description": "microRNAs are measured with TaqMan miRNA qRT-PCR", "time_frame": "Before the intervention and 12 weeks later" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 172, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05846126", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05890534", "title": "Pycnogenol® in Post-COVID-19 Condition", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2026-04-29", "start_date": "2023-06-07", "completion_date": "2025-01-31", "primary_completion_date": "2024-11-05", "conditions_raw": [ "Post COVID-19 Condition", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Pycnogenol®" ], "sponsor": "University of Zurich", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "To determine the effect of Pycnogenol® versus placebo on patient-reported health status in people with post COVID-19 condition.", "primary_outcomes": [ { "type": "primary", "measure": "Health status (EQ-VAS)", "description": "EQ-Visual Analogue Scale (EQ-VAS also known as \"Feeling thermometer\") assessed daily over 7 consecutive days prior to the baseline and at the end of the follow-up 2 visit (i.e., study end after 12 weeks). The scale ranges from 0-100 with 0 representing worst health status and 100 representing best health status.", "time_frame": "Change from baseline to 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Post COVID-19 symptoms", "description": "Symptoms (present/not present) and symptom severity (5- point Likert scale: 1=not bad at all, 2=mild, 3=moderate, 4=severe, 5=very severe) will be assessed using a self-administered online questionnaire. Symptoms will also be recorded in a paper diary and completed on a weekly basis.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Fatigue", "description": "Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). 13-item questionnaire with a 7-day recall period assessed at baseline and after 12 weeks. The level of fatigue is measured on a 5-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). Individual item scores are summed, with lower scores indicating more severe fatigue.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Dyspnea", "description": "Symptom domain of the Chronic Respiratory Questionnaire (CRQ) assessed at baseline and after 12 weeks. The questionnaire contains 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Montreal Cognitive Assessment (MoCA) assessed at baseline and after 12 weeks. The cut-off score \\< 26 for cognitive impairment will be used in this study.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Anxiety and depression", "description": "Hospital, Anxiety and Depression Scale (HADS) assessed at baseline and after 12 weeks. Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Health-related quality of life (EQ-5D-5L)", "description": "The EQ-5D-5L assesses the 5 dimensions mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The EQ-5D-5L scores each dimension on five levels of severity ranging from 1 = \"no problems\" to 5 = \"extreme problems. The instrument will be used at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Functional exercise capacity", "description": "A 30 second Sit-to-Stand (STS) will be performed at baseline and after 12 weeks. The number of repetitions that the participant completes the full sit-to-stand movement on a chair during 30 seconds. A familiarisation test will be done at the screening visit to rule out potential learning effects.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Physical activity", "description": "Physical activity measured with an accelerometer (ActiGraph wGT3X-BT, Pensacola, FL, USA), which is worn at the right hip over 8 consecutive days prior to the baseline and 12 week study visit. Number of daily steps and time spent in different intensity domains (min per day) will be analysed.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Soluble Thrombomodulin (sTM)", "description": "Blood biomarker of endothelial health measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "von Willebrand Factor antigen (VWF:Ag)", "description": "Blood biomarker of endothelial health measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Syndecan-1", "description": "Blood biomarker of endothelial health measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Circulating Cascular Cell Adhesion Molecule-1 (sVCAM 1)", "description": "Blood biomarker of endothelial health measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "C-reative protein (CRP)", "description": "Marker of inflammation (serum) measured at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Interleukine 6 (IL 6)", "description": "Marker of inflammation measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "sCD40L", "description": "Marker of coagulation and platelet function measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "sP selectin", "description": "Adhesion molecule measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "D-Dimer", "description": "Marker of coagulation and platelet function measured in citrate blood at baseline and after 12 weeks by certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Activated partial thromboplastin time (aPTT)", "description": "Marker of coagulation and platelet function measured in citrate blood at baseline and after 12 weeks by certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "International normalized ratio (INR) blood test", "description": "Marker of coagulation and platelet function measured in citrate blood at baseline and after 12 weeks by certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Total antioxidant capacity (TAC)", "description": "Marker of oxidative stress measured in blood plasma at baseline and after 12 weeks. TAC will be measured using the well-established Ferric Reduction Capability of Plasma (FRAP) method using a commercially available kit.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Aspartate aminotransferase (ASAT)", "description": "Marker of liver function measured in blood serum at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Alanine aminotransferase (ALAT)", "description": "Livery enzyme measured in blood serum at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Gamma glutamyltransferase (γ-GT)", "description": "Livery enzyme measured in blood serum at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Creatinine", "description": "Creatinine including clearance measured in blood serum at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Health status (EQ-VAS)", "description": "EQ-Visual Analogue Scale (EQ-VAS also known as \"Feeling thermometer\") assessed daily over 7 consecutive days prior to the baseline and at the end of the follow-up 2 visit (i.e., study end after 12 weeks). The scale ranges from 0-100 with 0 representing worst health status and 100 representing best health status.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Post COVID-19 symptoms", "description": "Symptoms (present/not present) and symptom severity (5- point Likert scale: 1=not bad at all, 2=mild, 3=moderate, 4=severe, 5=very severe) will be assessed using a self-administered online questionnaire. Symptoms will also be recorded in a paper diary and completed on a weekly basis.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Fatigue", "description": "Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). 13-item questionnaire with a 7-day recall period assessed at baseline and after 12 weeks. The level of fatigue is measured on a 5-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). Individual item scores are summed, with lower scores indicating more severe fatigue.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Dyspnea", "description": "Symptom domain of the Chronic Respiratory Questionnaire (CRQ) assessed at baseline and after 12 weeks. The questionnaire contains 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Montreal Cognitive Assessment (MoCA) assessed at baseline and after 12 weeks. The cut-off score \\< 26 for cognitive impairment will be used in this study.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Anxiety and depression", "description": "Hospital, Anxiety and Depression Scale (HADS) assessed at baseline and after 12 weeks. Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Health-related quality of life (EQ-5D-5L)", "description": "The EQ-5D-5L assesses the 5 dimensions mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The EQ-5D-5L scores each dimension on five levels of severity ranging from 1 = \"no problems\" to 5 = \"extreme problems. The instrument will be used at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Functional exercise capacity", "description": "A 30 second Sit-to-Stand (STS) will be performed at baseline and after 12 weeks. The number of repetitions that the participant completes the full sit-to-stand movement on a chair during 30 seconds. A familiarisation test will be done at the screening visit to rule out potential learning effects.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Physical activity", "description": "Physical activity measured with an accelerometer (ActiGraph wGT3X-BT, Pensacola, FL, USA), which is worn at the right hip over 8 consecutive days prior to the baseline and 12 week study visit. Number of daily steps and time spent in different intensity domains (min per day) will be analysed.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Soluble Thrombomodulin (sTM)", "description": "Blood biomarker of endothelial health measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "von Willebrand Factor antigen (VWF:Ag)", "description": "Blood biomarker of endothelial health measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Syndecan-1", "description": "Blood biomarker of endothelial health measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Circulating Cascular Cell Adhesion Molecule-1 (sVCAM 1)", "description": "Blood biomarker of endothelial health measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "C-reative protein (CRP)", "description": "Marker of inflammation (serum) measured at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Interleukine 6 (IL 6)", "description": "Marker of inflammation measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "sCD40L", "description": "Marker of coagulation and platelet function measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "sP selectin", "description": "Adhesion molecule measured with Enzyme-linked Immunosorbent Assay (ELISA) or Luminex (bead-based immunoassay) at baseline and after 12 weeks.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "D-Dimer", "description": "Marker of coagulation and platelet function measured in citrate blood at baseline and after 12 weeks by certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Activated partial thromboplastin time (aPTT)", "description": "Marker of coagulation and platelet function measured in citrate blood at baseline and after 12 weeks by certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "International normalized ratio (INR) blood test", "description": "Marker of coagulation and platelet function measured in citrate blood at baseline and after 12 weeks by certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Total antioxidant capacity (TAC)", "description": "Marker of oxidative stress measured in blood plasma at baseline and after 12 weeks. TAC will be measured using the well-established Ferric Reduction Capability of Plasma (FRAP) method using a commercially available kit.", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Aspartate aminotransferase (ASAT)", "description": "Marker of liver function measured in blood serum at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Alanine aminotransferase (ALAT)", "description": "Livery enzyme measured in blood serum at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Gamma glutamyltransferase (γ-GT)", "description": "Livery enzyme measured in blood serum at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" }, { "type": "secondary", "measure": "Creatinine", "description": "Creatinine including clearance measured in blood serum at baseline and after 12 weeks by a certified laboratory (Analytica, Zurich, Switzerland).", "time_frame": "Change from baseline to 12 weeks" } ], "relevance_tags": [ "General", "Phase 3", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 153, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05890534", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07553897", "title": "Tele-exercise Training Program for Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-04-28", "start_date": "2021-10-12", "completion_date": "2023-11-22", "primary_completion_date": "2023-11-08", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Telehealth Exercise Training Program" ], "sponsor": "Tri-Service General Hospital (TSGH)", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Patients with long coronavirus disease (COVID-19) experience multisystem symptoms and reduced quality of life (QOL). Proactive interventions are needed to enhance health outcomes.To investigate the effects of a 12-week tele-exercise training program on long COVID symptoms, cardiorespiratory fitness, and QOL.", "primary_outcomes": [ { "type": "primary", "measure": "Long COVID Symptoms", "description": "Common long COVID symptoms, based on the participants' subjective reports, include fatigue, shortness of breath, cough, chest pain, palpitations, brain fog, headaches, sleep disturbances, dizziness, changes in taste or smell, and depression or anxiety; these were assessed by a physician using a checklist with a binary response (present or absent).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Cardiorespiratory Fitness - Peak Oxygen Uptake (VO₂peak)", "description": "Participants will undergo cardiopulmonary exercise testing using a motorized cycle ergometer with an incremental ramp protocol (10 W/min). The test will continue until participants report physical exhaustion or reach maximal exercise capacity, defined by respiratory exchange ratio criteria. Peak oxygen uptake (VO₂peak, mL/kg/min) will be estimated from maximal cardiac output and oxygen utilization and identified when oxygen consumption plateaus despite increasing exercise intensity.\n\nUnit of Measure: mL/kg/min", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Cardiorespiratory Fitness - Peak Workload", "description": "During cardiopulmonary exercise testing, peak workload (watts) will be recorded as the highest workload achieved on the cycle ergometer. This reflects participants' ability to tolerate increasing exercise intensity.\n\nUnit of Measure: watts", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Cardiorespiratory Fitness - Anaerobic Threshold", "description": "Anaerobic threshold (AT, mL/kg/min) will be determined during cardiopulmonary exercise testing as the point at which energy production begins to shift from aerobic to anaerobic metabolism.\n\nUnit of Measure: mL/kg/min", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Health-Related Quality of Life", "description": "The brief World Health Organization Quality of Life questionnaire includes 26 standardized items covering four domains: physical, psychological, social, and environmental. It also contains two general items assessing overall quality of life and general health. The Taiwanese version adds two culturally specific items related to social respect/acceptance and eating/food.\n\nAll items are rated on a 5-point Likert scale, where higher scores reflect better quality of life. Scores for each domain are calculated by averaging the item scores within that domain and then multiplying by 4, yielding a final score range from 4 to 20.", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Safety and adverse events", "description": "Adverse events were monitored throughout the 12-week intervention. They were defined as any unfavorable or unintended signs, symptoms, or medical conditions occurring during the study that were considered related or possibly related to the intervention and required medical attention, discontinuation of exercise, or modification of the intervention.\n\nMild and transient exercise-related responses, such as expected fatigue or delayed-onset muscle soreness that resolved without medical intervention, were not classified as adverse events, in accordance with standard exercise guidelines.", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Long COVID Symptoms", "description": "Common long COVID symptoms, based on the participants' subjective reports, include fatigue, shortness of breath, cough, chest pain, palpitations, brain fog, headaches, sleep disturbances, dizziness, changes in taste or smell, and depression or anxiety; these were assessed by a physician using a checklist with a binary response (present or absent).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Cardiorespiratory Fitness - Peak Oxygen Uptake (VO₂peak)", "description": "Participants will undergo cardiopulmonary exercise testing using a motorized cycle ergometer with an incremental ramp protocol (10 W/min). The test will continue until participants report physical exhaustion or reach maximal exercise capacity, defined by respiratory exchange ratio criteria. Peak oxygen uptake (VO₂peak, mL/kg/min) will be estimated from maximal cardiac output and oxygen utilization and identified when oxygen consumption plateaus despite increasing exercise intensity.\n\nUnit of Measure: mL/kg/min", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Cardiorespiratory Fitness - Peak Workload", "description": "During cardiopulmonary exercise testing, peak workload (watts) will be recorded as the highest workload achieved on the cycle ergometer. This reflects participants' ability to tolerate increasing exercise intensity.\n\nUnit of Measure: watts", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Cardiorespiratory Fitness - Anaerobic Threshold", "description": "Anaerobic threshold (AT, mL/kg/min) will be determined during cardiopulmonary exercise testing as the point at which energy production begins to shift from aerobic to anaerobic metabolism.\n\nUnit of Measure: mL/kg/min", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Health-Related Quality of Life", "description": "The brief World Health Organization Quality of Life questionnaire includes 26 standardized items covering four domains: physical, psychological, social, and environmental. It also contains two general items assessing overall quality of life and general health. The Taiwanese version adds two culturally specific items related to social respect/acceptance and eating/food.\n\nAll items are rated on a 5-point Likert scale, where higher scores reflect better quality of life. Scores for each domain are calculated by averaging the item scores within that domain and then multiplying by 4, yielding a final score range from 4 to 20.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Safety and adverse events", "description": "Adverse events were monitored throughout the 12-week intervention. They were defined as any unfavorable or unintended signs, symptoms, or medical conditions occurring during the study that were considered related or possibly related to the intervention and required medical attention, discontinuation of exercise, or modification of the intervention.\n\nMild and transient exercise-related responses, such as expected fatigue or delayed-onset muscle soreness that resolved without medical intervention, were not classified as adverse events, in accordance with standard exercise guidelines.", "time_frame": "12 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07553897", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04510194", "title": "COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2026-04-24", "start_date": "2021-01-01", "completion_date": "2022-12-14", "primary_completion_date": "2022-12-14", "conditions_raw": [ "Covid19", "SARS-CoV Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Metformin", "Fluvoxamine", "Ivermectin" ], "sponsor": "University of Minnesota", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "1. The purpose of this trial is to conduct a 2x3 factorial randomized trials, which efficiently allows the parallel conduct of three randomized trials to understand whether metformin, ivermectin, or fluvoxamine, is superior to placebo for preventing Covid-19 disease progression in non-hospitalized adults with SARS- CoV-2 infection.\n2. To understand if the active treatment arms are superior to placebo in improving viral load, serologic markers associated with Covid-19, and gut microbiome in non-hospitalized adults with SARS-CoV-2 infection.\n3. To understand if any of the active treatment arms prevent long-covid syndrome, PASC (post-acute sequelae of SARS-CoV-2 infection).", "primary_outcomes": [ { "type": "primary", "measure": "Clinical Progression to Severe Covid", "description": "Clinical progression, defined as Emergency department visit for any COVID-19 related symptom (including hospitalization or death) or decrease in O2 saturation (\\<=93% on room air, or need for supplemental oxygen to maintain an O2 saturation \\<=93%)", "time_frame": "14 Days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Clinical Progression to Severe Covid", "description": "Emergency department visit for any COVID-19 related symptom (including hospitalization or death), active relative to placebo", "time_frame": "14 days" }, { "type": "secondary", "measure": "Progression", "description": "Count of participants with clinical progression to Hospitalization, Death", "time_frame": "28 days" }, { "type": "secondary", "measure": "Maximum Symptom Severity", "description": "Defined by adding the symptom score for each individual symptom on the \"Daily Symptom Scale Recommended by FDA For Industry.\" Each symptom on the scale had an answer option ranging from 0 to 3. They corresponded to 0= no symptom; 1=mild symptom; 2=moderate symptom; 3=severe symptom. The range for the total score is 0 to 42 (14 symptoms x 3). The data presented here are the unadjusted mean (SD) for the total symptom score on Day 14.", "time_frame": "14 days" }, { "type": "secondary", "measure": "Clinical Deterioration: Hospital and Vent >3days", "description": "Progression to Hospitalization or Ventilation by Day 28", "time_frame": "28 days" }, { "type": "secondary", "measure": "Laboratory Outcome Study", "description": "Count of participants with no detectable viral load on Day 10.", "time_frame": "Day5-Day10" }, { "type": "secondary", "measure": "All-cause Study Medicine Discontinuation", "description": "Study drug discontinuation (total interrupted - total restarted), per treatment allocation. Per treatment allocation means that these counts are not per randomized comparison.", "time_frame": "14 days" }, { "type": "secondary", "measure": "Long Covid", "description": "Proportion of participants with long-covid syndrome, PASC (post-acute sequelae of SARS-CoV-2 infection)", "time_frame": "Day 300" } ], "outcome_measures": [ { "type": "primary", "measure": "Clinical Progression to Severe Covid", "description": "Clinical progression, defined as Emergency department visit for any COVID-19 related symptom (including hospitalization or death) or decrease in O2 saturation (\\<=93% on room air, or need for supplemental oxygen to maintain an O2 saturation \\<=93%)", "time_frame": "14 Days" }, { "type": "secondary", "measure": "Clinical Progression to Severe Covid", "description": "Emergency department visit for any COVID-19 related symptom (including hospitalization or death), active relative to placebo", "time_frame": "14 days" }, { "type": "secondary", "measure": "Progression", "description": "Count of participants with clinical progression to Hospitalization, Death", "time_frame": "28 days" }, { "type": "secondary", "measure": "Maximum Symptom Severity", "description": "Defined by adding the symptom score for each individual symptom on the \"Daily Symptom Scale Recommended by FDA For Industry.\" Each symptom on the scale had an answer option ranging from 0 to 3. They corresponded to 0= no symptom; 1=mild symptom; 2=moderate symptom; 3=severe symptom. The range for the total score is 0 to 42 (14 symptoms x 3). The data presented here are the unadjusted mean (SD) for the total symptom score on Day 14.", "time_frame": "14 days" }, { "type": "secondary", "measure": "Clinical Deterioration: Hospital and Vent >3days", "description": "Progression to Hospitalization or Ventilation by Day 28", "time_frame": "28 days" }, { "type": "secondary", "measure": "Laboratory Outcome Study", "description": "Count of participants with no detectable viral load on Day 10.", "time_frame": "Day5-Day10" }, { "type": "secondary", "measure": "All-cause Study Medicine Discontinuation", "description": "Study drug discontinuation (total interrupted - total restarted), per treatment allocation. Per treatment allocation means that these counts are not per randomized comparison.", "time_frame": "14 days" }, { "type": "secondary", "measure": "Long Covid", "description": "Proportion of participants with long-covid syndrome, PASC (post-acute sequelae of SARS-CoV-2 infection)", "time_frame": "Day 300" } ], "relevance_tags": [ "General", "Phase 3", "Very Large (1000+ participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 1323, "enrollment_type": "ACTUAL", "size_category": "Very Large (1000+ participants)", "link": "https://clinicaltrials.gov/study/NCT04510194", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07216040", "title": "Harnessing Optimism and Perseverance in the Face of Long COVID-Español", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-04-23", "start_date": "2026-05", "completion_date": "2026-08-31", "primary_completion_date": "2026-08-31", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Hope-Lc~Espanol" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The Harnessing Optimism and Perseverance in the Face of Long COVID (HOPE-LC) program, created by Drs. Eric Watson and Amelia Hicks, is a group therapy model designed to foster resilience, adjustment, and coping skills for those living with chronic Long COVID. HOPE-LC\\~Español provides a culturally and linguistically adapted version for Spanish-speaking individuals in Queens, developed with input from Spanish-speaking clinicians, Long COVID experts, and people with lived experience. Partnering with H+H/Elmhurst and H+H/Queens, the project aims to recruit 25 participants and evaluate program feasibility and preliminary efficacy.", "primary_outcomes": [ { "type": "primary", "measure": "Recruitment rate", "description": "Number of eligible participants screened and enrolled by referral source", "time_frame": "Throughout the study period, 12 weeks" }, { "type": "primary", "measure": "Retention rate", "description": "Number of participants completing the intervention (defined as attending at least 8 of 12 sessions)", "time_frame": "Throughout the study period, 12 weeks" }, { "type": "primary", "measure": "Number of sessions participants attended", "description": "Feasibility measured via participant attendance", "time_frame": "Throughout the study period, 12 weeks" }, { "type": "primary", "measure": "Number of completed surveys", "description": "Feasibility measured via number of surveys completed from participant follow-up and study procedures.", "time_frame": "Throughout the study period, 12 weeks" }, { "type": "primary", "measure": "Patient Satisfaction", "description": "Post-treatment survey assessing participant satisfaction with HOPE-LC\\~Español. Items are on a 5-point Likert Scale evaluated agreement to statements about their experience in the program (e.g., feeling heard, learning practical strategies, and willingness to recommend the program). The total score range is 5 - 40, with higher ratings indicating greater satisfaction.", "time_frame": "Post-treatment (Week 12)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "DePaul Symptom Questionnaire", "description": "The DePaul Symptom Questionnaire (DSQ) is a validated tool to assess symptoms, frequency and severity of various symptoms of fatigue and other neurological impairment. Total score range 0-100, with higher scores indicating greater symptom severity and functional impairment.", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Brief Illness Perception Questionnaire (BIPQ)", "description": "The BIPQ assesses cognitive and emotional representations of illness in 8 items + 1 open-ended causal item. Total score range is 0-80, higher scores mean a more negative perception of illness.", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Valued Based Living Questionnaire (VLQ)", "description": "Assesses alignment between personal values and daily actions. Two ratings per domain: (1) Importance (1-10) and (2) Consistency with actions (1-10). Total score range is between 4-40. Higher consistency scores reflect greater valued living (better outcome); lower scores reflect minimal valued living (worse outcome).", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)", "description": "The C19-YRSm is a 17-item self-report scale designed to assess the impact of post-COVID symptoms. Items are rated on a scale from 0 (none of this symptom) to 3 (extremely severe level or impact). The scale includes four subscales:\n\nSymptom Severity (Questions 1-10; score range: 0-30) Functional Disability (Questions 11-15; score range: 0-15) Other Symptoms (Question 16; score range: 0-25) Overall Health (Question 17; score range: 0-10)\n\nFull scale from 0-80. Higher scores indicate greater symptom severity and functional impairment.", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire-8 Item (PHQ-8)", "description": "Patient health questionnaire-8 (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-8 is an 8-item instrument. Each question is rated on a scale of 0 to 3, total score scale from 0 - 24. Lower scores indicate minimal depression (better outcome) and higher scores indicate severe depression (worse outcome).", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-7 Item (GAD-7)", "description": "This is a 7-item measure that asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 (\"not at all\") to 3 (\"nearly every day\"). Total scores range from 0-21, with higher scores indicating greater severity of generalized anxiety symptoms.", "time_frame": "Baseline; 6 weeks, 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Recruitment rate", "description": "Number of eligible participants screened and enrolled by referral source", "time_frame": "Throughout the study period, 12 weeks" }, { "type": "primary", "measure": "Retention rate", "description": "Number of participants completing the intervention (defined as attending at least 8 of 12 sessions)", "time_frame": "Throughout the study period, 12 weeks" }, { "type": "primary", "measure": "Number of sessions participants attended", "description": "Feasibility measured via participant attendance", "time_frame": "Throughout the study period, 12 weeks" }, { "type": "primary", "measure": "Number of completed surveys", "description": "Feasibility measured via number of surveys completed from participant follow-up and study procedures.", "time_frame": "Throughout the study period, 12 weeks" }, { "type": "primary", "measure": "Patient Satisfaction", "description": "Post-treatment survey assessing participant satisfaction with HOPE-LC\\~Español. Items are on a 5-point Likert Scale evaluated agreement to statements about their experience in the program (e.g., feeling heard, learning practical strategies, and willingness to recommend the program). The total score range is 5 - 40, with higher ratings indicating greater satisfaction.", "time_frame": "Post-treatment (Week 12)" }, { "type": "secondary", "measure": "DePaul Symptom Questionnaire", "description": "The DePaul Symptom Questionnaire (DSQ) is a validated tool to assess symptoms, frequency and severity of various symptoms of fatigue and other neurological impairment. Total score range 0-100, with higher scores indicating greater symptom severity and functional impairment.", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Brief Illness Perception Questionnaire (BIPQ)", "description": "The BIPQ assesses cognitive and emotional representations of illness in 8 items + 1 open-ended causal item. Total score range is 0-80, higher scores mean a more negative perception of illness.", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Valued Based Living Questionnaire (VLQ)", "description": "Assesses alignment between personal values and daily actions. Two ratings per domain: (1) Importance (1-10) and (2) Consistency with actions (1-10). Total score range is between 4-40. Higher consistency scores reflect greater valued living (better outcome); lower scores reflect minimal valued living (worse outcome).", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)", "description": "The C19-YRSm is a 17-item self-report scale designed to assess the impact of post-COVID symptoms. Items are rated on a scale from 0 (none of this symptom) to 3 (extremely severe level or impact). The scale includes four subscales:\n\nSymptom Severity (Questions 1-10; score range: 0-30) Functional Disability (Questions 11-15; score range: 0-15) Other Symptoms (Question 16; score range: 0-25) Overall Health (Question 17; score range: 0-10)\n\nFull scale from 0-80. Higher scores indicate greater symptom severity and functional impairment.", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire-8 Item (PHQ-8)", "description": "Patient health questionnaire-8 (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-8 is an 8-item instrument. Each question is rated on a scale of 0 to 3, total score scale from 0 - 24. Lower scores indicate minimal depression (better outcome) and higher scores indicate severe depression (worse outcome).", "time_frame": "Baseline; 6 weeks, 12 weeks" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-7 Item (GAD-7)", "description": "This is a 7-item measure that asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 (\"not at all\") to 3 (\"nearly every day\"). Total scores range from 0-21, with higher scores indicating greater severity of generalized anxiety symptoms.", "time_frame": "Baseline; 6 weeks, 12 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 25, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07216040", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06597396", "title": "Study to Investigate the Efficacy of Abrocitinib in Adult Participants With Severe Fatigue From Post COVID Condition/Long COVID", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2026-04-20", "start_date": "2024-12-27", "completion_date": "2026-09-30", "primary_completion_date": "2026-03-27", "conditions_raw": [ "Post-COVID Condition", "Fatigue Symptom" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Abrocitinib" ], "sponsor": "Beth Israel Deaconess Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The primary purpose of this phase 2a study is to compare the efficacy of abrocitinib to placebo in improving severe fatigue in non-hospitalized adults with symptomatic Post-COVID Condition (PCC) (also called Long COVID). We are also interested in learning if abrocitinib is effective in improving overall health status in people suffering from severe fatigue from PCC. Eligible participants with a confirmed history of COVID19 infection who also have PCC according to the World Health Organization definition, will be randomized to receive abrocitinib at a dose of 50 mg, 100 mg, or placebo by mouth daily for 12 weeks (84 days).", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale", "description": "To compare the efficacy of abrocitinib to placebo in improving severe fatigue in adults with symptomatic PCC", "time_frame": "Baseline to Day 84" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from baseline for EQ(EuroQol)-5D-5L values and visual analog scale (VAS) score to Day 84", "description": "To compare efficacy of abrocitinib to placebo in improving health status in adults with symptomatic PCC", "time_frame": "Baseline to Day 84" }, { "type": "secondary", "measure": "Change from baseline in PASC Symptom PRO (patient reported outcome) Instrument score to Day 84", "description": "To compare efficacy of abrocitinib to placebo in improving health status adults with symptomatic PCC", "time_frame": "Baseline to Day 84" }, { "type": "secondary", "measure": "Safety-related clinical laboratory test abnormalities and related adverse events", "description": "To describe the safety and tolerability of abrocitinib compared to placebo in the treatment of PCC in adults with symptomatic PCC", "time_frame": "Baseline to Day 84" }, { "type": "secondary", "measure": "The difference in blood high sensitivity C-reactive protein (HSCRP) from baseline visit to Day 84", "description": "To compare the effect of abrocitinib to placebo for the treatment of symptomatic PCC in reducing HSCRP values", "time_frame": "Baseline to Day 84" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale", "description": "To compare the efficacy of abrocitinib to placebo in improving severe fatigue in adults with symptomatic PCC", "time_frame": "Baseline to Day 84" }, { "type": "secondary", "measure": "Change from baseline for EQ(EuroQol)-5D-5L values and visual analog scale (VAS) score to Day 84", "description": "To compare efficacy of abrocitinib to placebo in improving health status in adults with symptomatic PCC", "time_frame": "Baseline to Day 84" }, { "type": "secondary", "measure": "Change from baseline in PASC Symptom PRO (patient reported outcome) Instrument score to Day 84", "description": "To compare efficacy of abrocitinib to placebo in improving health status adults with symptomatic PCC", "time_frame": "Baseline to Day 84" }, { "type": "secondary", "measure": "Safety-related clinical laboratory test abnormalities and related adverse events", "description": "To describe the safety and tolerability of abrocitinib compared to placebo in the treatment of PCC in adults with symptomatic PCC", "time_frame": "Baseline to Day 84" }, { "type": "secondary", "measure": "The difference in blood high sensitivity C-reactive protein (HSCRP) from baseline visit to Day 84", "description": "To compare the effect of abrocitinib to placebo for the treatment of symptomatic PCC in reducing HSCRP values", "time_frame": "Baseline to Day 84" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 46, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06597396", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06637800", "title": "Prospective, Open-label Study of Seraph 100 in Patients With Prolonged COVID (PC)", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2026-04-20", "start_date": "2025-02-15", "completion_date": "2025-04", "primary_completion_date": "2025-04", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Seraph® 100 Microbind® Affinity Blood Filter" ], "sponsor": "ExThera Medical Corporation", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This study will use a prospective, open, single-arm design, in which a group of 100 patients with a diagnosis of prolonged COVID, previously selected according to inclusion and exclusion criteria, and who have undergone informed consent process and have signed the informed consent form, undergo two hemoperfusion procedures with the Seraph 100 filter, on consecutive days. They are then evaluated at day 3 and 4 weeks, to complete the safety and effectiveness assessment.", "primary_outcomes": [ { "type": "primary", "measure": "Assessment of Technical Procedure Success", "description": "Procedural Success is defined as:\n\n1. Device use as originally intended, and\n2. No device procedure related serious adverse events (SAEs)", "time_frame": "Procedure Stop Time" }, { "type": "primary", "measure": "Assessment of Device Success", "description": "Seraph 100 Device Success", "time_frame": "3, 7 and 28 days" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Assessment of Technical Procedure Success", "description": "Procedural Success is defined as:\n\n1. Device use as originally intended, and\n2. No device procedure related serious adverse events (SAEs)", "time_frame": "Procedure Stop Time" }, { "type": "primary", "measure": "Assessment of Device Success", "description": "Seraph 100 Device Success", "time_frame": "3, 7 and 28 days" } ], "relevance_tags": [ "General", "NA", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT06637800", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06095297", "title": "Long COVID Brain Fog: Cognitive Rehabilitation Trial", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-04-13", "start_date": "2024-04-25", "completion_date": "2027-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Long COVID", "Brain Fog", "Cognitive Impairment", "Cognitive Dysfunction", "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Processing Speed Training", "In-Lab Instrumental Activities Of Daily Living Training", "In-Lab Brain Health Training", "Transfer Package", "Follow Up Phone Calls", "Vocational Rehabilitation", "Peer Mentoring", "Reaction Time Training", "Trans-Auricular Vagus Nerve Stimulation: High Intensity", "Trans-Auricular Vagus Nerve Stimulation: Low Intensity" ], "sponsor": "University of Alabama at Birmingham", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will compare two approaches to cognitive rehabilitation in adults with long COVID with persistent, mild to moderate, cognitive impairment. One approach will feature (A) web-based computer \"games\" that trains how quickly individuals process information that they receive through their senses; (B) in-lab training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation (VNS), i.e., trans-auricular VNS (taVNS). Component B will include work-related tasks. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will feature (A) web-based computer \"games\" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, healthy nutrition, and healthy sleep, (C) procedures designed to promote integration of these lifestyle changes into everyday life, and (D) taVNS. This approach is termed Brain Fitness Training (BFT).\n\nA subset of participants, who qualify for and and desire vocational rehabilitation (VR), will receive VR from the Alabama Department of Rehabilitation Services (ADRS) in addition to CICT or BFT. ADRS VR will include career counseling, prescription of on-the-job accommodations, and guidance on return-to-work. Those in the CICT + VR group will also receive on-the-job coaching from a peer mentor for a month after completing training.\n\nCICT, with or without VR, will involve 30 hours of training. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life and improving skills essential to work; the set of the latter procedures is termed the Transfer Package. ta-VNS will administered for 10 minutes before gaming and in-lab target behavior training. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life.\n\nBFT, with or without VR, will involve 30 hours of training following the same schedule as for CICT. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors (healthy sleep, nutrition and relaxation habits) and the procedures designed to promote transfer of behavior change to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life.\n\nParticipants will be randomly assigned to the interventions. Randomization will be stratified by whether participants qualify for and desire VR from ADRS or not. If yes, participants will be randomized in equal numbers to CICT + VR or BFT + VR. If no, participants will be randomized in equal numbers to CICT or BFT.\n\nTesting will happen one month before treatment, one day before treatment, one day afterwards, and 6-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Another important outcome measure will be whether or not participants were able to return back to work or had significant improvements in their work activities.", "primary_outcomes": [ { "type": "primary", "measure": "Canadian Occupational Performance Measure (COPM)", "description": "The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview which is commonly used to measure the real-world outcome of rehabilitation procedures that span both motor and cognitive functions after stroke. The Performance Scale assesses how well a participant performs five activities in their daily life, i.e., outside the lab, that are important to the participant. Activities, for this purpose, will be restricted to those with an important cognitive component ,i.e., IADL. The 10-point response scale ranges from 1 (not able to do the activity at all) to 10 (able to do the activity extremely well). Performance Scale scores from the participant will be the primary outcome.", "time_frame": "Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Canadian Occupational Performance Measure (COPM)", "description": "The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview which is commonly used to measure the real-world outcome of rehabilitation procedures that span both motor and cognitive functions after stroke. The Performance Scale assesses how well a participant performs five activities in their daily life, i.e., outside the lab, that are important to the participant. Activities, for this purpose, will be restricted to those with an important cognitive component ,i.e., IADL. The 10-point response scale ranges from 1 (not able to do the activity at all) to 10 (able to do the activity extremely well). Performance Scale scores from the participant will be the primary outcome.", "time_frame": "Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06095297", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06871293", "title": "Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-04-13", "start_date": "2025-10-30", "completion_date": "2027-01-01", "primary_completion_date": "2026-12-31", "conditions_raw": [ "Long COVID-19 Syndrome", "COVID 19", "Noncommunicable Disease", "Hypertension", "Diabetes Mellitus", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Functional And Cognitive Rehabilitation Strategy", "Evidence-Based Informational Support" ], "sponsor": "Fundación Cardioinfantil Instituto de Cardiología", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to evaluate the impact of a functional and cognitive rehabilitation strategy compared to evidence-based informational messages, on functional capacity, cognitive abilities, quality of life, and disease progression in adults with chronic non-communicable diseases (NCDs) and Long Covid-19.\n\nResearchers will compare a structured rehabilitation program to informational support through evidence-based messages to determine if rehabilitation leads to better functional and cognitive outcomes in patients with Long Covid-19.\n\nParticipants will be randomly assigned to one of two groups:\n\n1. Functional and cognitive rehabilitation: Attending weekly in-person sessions for 8 weeks, including supervised physical and cognitive exercises.\n2. Informational support: Receiving weekly evidence-based educational messages for 8 weeks.\n\nParticipants will undergo assessments at baseline, post-intervention, and six months later, including a six-minute walk test, handgrip strength measurement, and questionnaires on disability, anxiety, depression, fatigue, dyspnea, cognitive function, and quality of life.", "primary_outcomes": [ { "type": "primary", "measure": "Composite Change in Functional Capacity, Cognitive Function, Health-Related Quality of Life, and Strength", "description": "The primary outcome is a composite measure evaluating the aggregated change across four key functional and cognitive scales:\n\n* Functional Capacity with six-minute walk test.\n* Cognitive Function with Montreal Cognitive Assessment, MoCA. The minimum score is 0 points, which would indicate very severe cognitive impairment, since the maximum total score is 30 points. Normally, a score of 26 or higher is considered within the normal range, although the range may vary depending on factors such as the patient's age and educational level. A score below 26 could suggest possible cognitive impairment, and the lower the score, the more indicative it may be of severe cognitive problems.\n* Health-Related Quality of Life with EuroQol 5 Dimensions 5 Levels, EQ-5D-5L. Maximum value: 1 This value corresponds to the best possible health state. Minimum value: -0.594 This value corresponds to the worst possible.\n* Handgrip Strength with hydraulic dynamometer.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Functional Capacity", "description": "Distance covered in six minutes will be measured and compared to baseline values. Additional tests include the four-step climb power test and the 30-second sit-to-stand test, evaluating lower body strength and endurance.\n\nGreater distance indicates better functional capacity. Lower values may indicate physical dysfunction or a chronic illness.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Change in Cognitive Function", "description": "Montreal Cognitive Assessment scores will be used to assess changes in memory, visuospatial abilities, executive function, attention, language, and orientation.\n\nThe minimum score is 0 points, which would indicate very severe cognitive impairment, since the maximum total score is 30 points. Normally, a score of 26 or higher is considered within the normal range, although the range may vary depending on factors such as the patient's age and educational level. A score below 26 could suggest possible cognitive impairment, and the lower the score, the more indicative it may be of severe cognitive problems.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Change in Health-Related Quality of Life", "description": "Changes in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression will be evaluated using EuroQol 5 Dimensions 5 Levels.\n\nMaximum value: 1 This value corresponds to the best possible health state. Minimum value: -0.594 This value corresponds to the worst possible.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Change in Health-Related Quality of Life, Visual Analogue Scale", "description": "In addition to the score based on the 5 dimensions, the VAS scale from 0 to 100, where: 0 represents the worst imaginable health and 100 represents perfect health.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Change in Handgrip Strength, Hydraulic Dynamometer", "description": "Bilateral handgrip strength will be measured according to the American Society of Hand Therapists guidelines. Changes in dominant and non-dominant hand strength will be assessed.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Incidence of Chronic Disease Decompensation Events", "description": "Participants will report new medical visits, hospital admissions, medication adjustments, or cardiovascular events related to their underlying chronic condition.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Additional Functional and Clinical Assessments", "description": "Complementary assessments will be conducted at baseline, post-intervention, and six-month follow-up, including:\n\n* WHO Disability Assessment Schedule 0-24: No significant disability 25-49: Mild to moderate disability 50-74: Moderate to severe disability 75-100: Severe or extreme disability\n* Hospital Anxiety and Depression Scale 0-7 points: Normal, no signs of anxiety or depression. 8-10 points: Possible signs of anxiety or depression, follow-up is needed. 11-21 points: Indicative of clinically significant symptoms of anxiety or depression, suggesting a more detailed evaluation is needed.\n* Fatigue Severity Scale\n\n 1 - 3: Low fatigue 4 - 5: Moderate fatigue 6 - 7: Severe fatigue\n* Medical Research Council Dyspnea Scale Level 1: No difficulty breathing during normal activities. Level 2: Dyspnea with moderate physical activities. Level 3: Dyspnea with everyday physical activities. Level 4: Dyspnea with minimal exertion. Level 5: Dyspnea at rest, indicating sever", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." } ], "outcome_measures": [ { "type": "primary", "measure": "Composite Change in Functional Capacity, Cognitive Function, Health-Related Quality of Life, and Strength", "description": "The primary outcome is a composite measure evaluating the aggregated change across four key functional and cognitive scales:\n\n* Functional Capacity with six-minute walk test.\n* Cognitive Function with Montreal Cognitive Assessment, MoCA. The minimum score is 0 points, which would indicate very severe cognitive impairment, since the maximum total score is 30 points. Normally, a score of 26 or higher is considered within the normal range, although the range may vary depending on factors such as the patient's age and educational level. A score below 26 could suggest possible cognitive impairment, and the lower the score, the more indicative it may be of severe cognitive problems.\n* Health-Related Quality of Life with EuroQol 5 Dimensions 5 Levels, EQ-5D-5L. Maximum value: 1 This value corresponds to the best possible health state. Minimum value: -0.594 This value corresponds to the worst possible.\n* Handgrip Strength with hydraulic dynamometer.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Change in Functional Capacity", "description": "Distance covered in six minutes will be measured and compared to baseline values. Additional tests include the four-step climb power test and the 30-second sit-to-stand test, evaluating lower body strength and endurance.\n\nGreater distance indicates better functional capacity. Lower values may indicate physical dysfunction or a chronic illness.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Change in Cognitive Function", "description": "Montreal Cognitive Assessment scores will be used to assess changes in memory, visuospatial abilities, executive function, attention, language, and orientation.\n\nThe minimum score is 0 points, which would indicate very severe cognitive impairment, since the maximum total score is 30 points. Normally, a score of 26 or higher is considered within the normal range, although the range may vary depending on factors such as the patient's age and educational level. A score below 26 could suggest possible cognitive impairment, and the lower the score, the more indicative it may be of severe cognitive problems.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Change in Health-Related Quality of Life", "description": "Changes in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression will be evaluated using EuroQol 5 Dimensions 5 Levels.\n\nMaximum value: 1 This value corresponds to the best possible health state. Minimum value: -0.594 This value corresponds to the worst possible.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Change in Health-Related Quality of Life, Visual Analogue Scale", "description": "In addition to the score based on the 5 dimensions, the VAS scale from 0 to 100, where: 0 represents the worst imaginable health and 100 represents perfect health.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Change in Handgrip Strength, Hydraulic Dynamometer", "description": "Bilateral handgrip strength will be measured according to the American Society of Hand Therapists guidelines. Changes in dominant and non-dominant hand strength will be assessed.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Incidence of Chronic Disease Decompensation Events", "description": "Participants will report new medical visits, hospital admissions, medication adjustments, or cardiovascular events related to their underlying chronic condition.", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." }, { "type": "secondary", "measure": "Additional Functional and Clinical Assessments", "description": "Complementary assessments will be conducted at baseline, post-intervention, and six-month follow-up, including:\n\n* WHO Disability Assessment Schedule 0-24: No significant disability 25-49: Mild to moderate disability 50-74: Moderate to severe disability 75-100: Severe or extreme disability\n* Hospital Anxiety and Depression Scale 0-7 points: Normal, no signs of anxiety or depression. 8-10 points: Possible signs of anxiety or depression, follow-up is needed. 11-21 points: Indicative of clinically significant symptoms of anxiety or depression, suggesting a more detailed evaluation is needed.\n* Fatigue Severity Scale\n\n 1 - 3: Low fatigue 4 - 5: Moderate fatigue 6 - 7: Severe fatigue\n* Medical Research Council Dyspnea Scale Level 1: No difficulty breathing during normal activities. Level 2: Dyspnea with moderate physical activities. Level 3: Dyspnea with everyday physical activities. Level 4: Dyspnea with minimal exertion. Level 5: Dyspnea at rest, indicating sever", "time_frame": "Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 374, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06871293", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06128967", "title": "A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2026-04-13", "start_date": "2023-10-18", "completion_date": "2025-08-01", "primary_completion_date": "2025-07-01", "conditions_raw": [ "Long COVID-19 Syndrome", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Fluvoxamine Maleate 100 Mg", "Metformin" ], "sponsor": "Cardresearch", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "IRB approval date 14-APR-2024 and public at https://plataformabrasil.saude.gov.br/login.jsf since IURB approval\n\nLong COVID is a multi-systemic condition comprising often severe and persistent symptoms (longer than 12 weeks) that follow a known episode of COVID-19 and cannot be explained by another medical condition. This condition is observed in up to 15% of all individuals after an acute episode of COVID-19, even in those who had a mild and oligosymptomatic SARS-CoV-2 infection. Around 40% of these patients present symptoms that significantly compromise their daily activities.\n\nThere is increasing evidence that LONG COVID is accompanied by dysregulated, persistent and uncontrolled inflammation, often accompanied by the development of an autoreactive immune response, including autoantibodies. Symptoms can last months or years, particularly in cases of chronic fatigue syndrome, with significant proportions of individuals having significant chronic impairment, preventing the performance of work and social activities.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement on Fatigue Severity Score Scale (FSS)", "description": "Improvement on Fatigue Severity Score Scale (FSS)", "time_frame": "Day 60 after randomization" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Improvement on Fatigue Severity Score Scale (FSS)", "description": "Improvement on Fatigue Severity Score Scale (FSS)", "time_frame": "Day 30 after randomization" }, { "type": "secondary", "measure": "Improvement on Fatigue Severity Score Scale (FSS)", "description": "Improvement on Fatigue Severity Score Scale (FSS)", "time_frame": "Day 30 post Study Drug Termination (Day 90 after randomization)" }, { "type": "secondary", "measure": "Reduction on any cause hospitalization", "description": "Reduction on any cause hospitalization", "time_frame": "Day 60 after randomization" }, { "type": "secondary", "measure": "Safety of metformin", "description": "Safety of metformin (intention to treat analysis)", "time_frame": "Since randomization up to Day 60 (last IMP dose)" }, { "type": "secondary", "measure": "Safety of Fluvoxamine", "description": "Safety of Fluvoxamine (intention to treat analysis)", "time_frame": "Since randomization up to Day 60 (last IMP dose)" }, { "type": "secondary", "measure": "Death of any cause", "description": "Occurrence of Death of any cause", "time_frame": "Since randomization up to Day 60 (last IMP dose)" } ], "outcome_measures": [ { "type": "primary", "measure": "Improvement on Fatigue Severity Score Scale (FSS)", "description": "Improvement on Fatigue Severity Score Scale (FSS)", "time_frame": "Day 60 after randomization" }, { "type": "secondary", "measure": "Improvement on Fatigue Severity Score Scale (FSS)", "description": "Improvement on Fatigue Severity Score Scale (FSS)", "time_frame": "Day 30 after randomization" }, { "type": "secondary", "measure": "Improvement on Fatigue Severity Score Scale (FSS)", "description": "Improvement on Fatigue Severity Score Scale (FSS)", "time_frame": "Day 30 post Study Drug Termination (Day 90 after randomization)" }, { "type": "secondary", "measure": "Reduction on any cause hospitalization", "description": "Reduction on any cause hospitalization", "time_frame": "Day 60 after randomization" }, { "type": "secondary", "measure": "Safety of metformin", "description": "Safety of metformin (intention to treat analysis)", "time_frame": "Since randomization up to Day 60 (last IMP dose)" }, { "type": "secondary", "measure": "Safety of Fluvoxamine", "description": "Safety of Fluvoxamine (intention to treat analysis)", "time_frame": "Since randomization up to Day 60 (last IMP dose)" }, { "type": "secondary", "measure": "Death of any cause", "description": "Occurrence of Death of any cause", "time_frame": "Since randomization up to Day 60 (last IMP dose)" } ], "relevance_tags": [ "Immunomodulatory", "Anti-inflammatory", "Phase 3", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 399, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06128967", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06503874", "title": "Improving Attention in Individuals With Long COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-04-02", "start_date": "2024-03-22", "completion_date": "2026-03-13", "primary_completion_date": "2026-03-13", "conditions_raw": [ "Long Covid" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Attention Training", "Music Group" ], "sponsor": "Shirley Ryan AbilityLab", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is to find out if the Attention Processing Training program is a potential treatment for brain fog symptoms, reported by people with Long-Covid. Also investigating the feasibility of completing this program virtually.", "primary_outcomes": [ { "type": "primary", "measure": "Number of participants who successfully completed at least 80% of the study tasks sessions", "description": "Recording the number of participants who completed at least 80% of the study sessions out of the number of all participants who enrolled in the study.", "time_frame": "2 years" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change of scores in objective attention tests (i.e, CPT 3), pre- and post -intervention", "description": "The Conners Continuous Performance Test Third Edition™ (Conners CPT 3™)", "time_frame": "2 year" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of participants who successfully completed at least 80% of the study tasks sessions", "description": "Recording the number of participants who completed at least 80% of the study sessions out of the number of all participants who enrolled in the study.", "time_frame": "2 years" }, { "type": "secondary", "measure": "Change of scores in objective attention tests (i.e, CPT 3), pre- and post -intervention", "description": "The Conners Continuous Performance Test Third Edition™ (Conners CPT 3™)", "time_frame": "2 year" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 58, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06503874", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06161688", "title": "Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2026-04-02", "start_date": "2024-04-09", "completion_date": "2026-12-31", "primary_completion_date": "2024-12-20", "conditions_raw": [ "Long COVID", "Post Acute Sequelae of COVID-19", "Post-Acute COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ensitrelvir" ], "sponsor": "Timothy Henrich", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be susceptible to antiviral therapy that blocks viral replication, which has the potential to alleviate long COVID symptoms. This trial will study the safety and efficacy of Ensitrelvir (S-217622), an antiviral, to treat individuals with Long COVID in an adult population.", "primary_outcomes": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at 10 post-\\[ADD\\]. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.", "time_frame": "Day 10" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 30 post-randomization. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.", "time_frame": "Day 30" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 10 post-randomization. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 30 post-randomization. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.", "time_frame": "Day 30" }, { "type": "secondary", "measure": "Quality of Life (Global Health Score) on a 100-point Visual-Analogue Scale", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in the baseline adjusted mean Quality of Life 100-point Visual-Analogue-Scale at Day 10 post-randomization. 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Quality of Life Score (5-Item EuroQol EQ-5D-5L) Index Value Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score at Day 10 post-randomization. 5-Item EuroQol EQ-5D-5L questions assess pain/difficulty in day-to-day activities over the past week. The 5-Item EuroQol EQ-5D-5L produces a score that typically ranges from 0 - 1, with a higher score indicating better quality of life.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Duke Activity Status Index (DASI)", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean DASI at Day 10 post-randomization. The Duke Activity Status Index is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points, which is linearly correlated with a patient's VO2 max and METs, as measured from cardiopulmonary exercise testing (CPET). It inquires about a person's ability to perform self-care, walk, climb stairs, run, do house and yard work, engage in sexual intercourse, and perform moderate recreational activities. A higher score indicates higher functional capacity.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Orthostatic Hypotension Questionnaire (OHQ) Composite Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean OHQ composite score at Day 10 post-randomization.\n\nThe Orthostatic Hypotension Questionnaire (OHQ) was developed as a psychometric tool to capture patients' experience quantifying symptomatic burden and functional limitations caused by neurogenic orthostatic hypotension\n\nThe OHQ composite score range is 0 -10 with a higher score indicating higher burden.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) Questionnaire", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean WHO-DAS 2.0 score at Day 10 post-randomization. The World Health Organization Disability Assessment Schedule 2.0 questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. The range is scored from 0-48, with a higher score indicating a higher level of disability.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC)", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on the Patient Global Impression of Change (PGIC) scale at Day 10 post-randomization. The self-reported PGIC reflects a patient's belief about the efficacy of treatment. We used a modified PGIC scale which has been used to study pain syndromes and has been employed in other Long COVID clinical trials. It is a common data element developed by the National Institutes of Mental Health. The PGIC ranges from 0 (Much better) to 10 (Much Worse). A score of 5 indicates no change.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Everyday Cognition Form (ECog-41)", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean ECog-41 score at Day 10 post-randomization. The ECog-41 is an instrument that measures the decline in everyday cognitive and functional abilities that map to six cognitive domains, adapted specifically to describe change in abilities since having COVID. A summary ECog-41 score is calculated scored with a range of 1-4, with a higher score indicating greater cognitive impairment.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "6 Minute Walking Test (6MWT)", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean distance walked on the 6MWT at Day 10 post-randomization. The 6MWT requires an individual to walk at their normal pace for 6 minutes on a marked track (for example, a hallway). Vital signs are assessed, and the total distance covered is the primary outcome of interest. A larger distance is regarded as better.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Active Stand Test", "description": "The active standing test is a non-invasive tool to assess orthostatic hypotension (OH) and postural orthostatic tachycardia syndrome (POTS). In short, blood pressure and heart rate measurements were obtained after 5 minutes of resting supine and 1, 3, 5, and 10 minutes of continuous standing. A positive active stand test is defined as: those with a decline \\>20 mmHg in systolic or \\> 10 mmHg in diastolic blood pressure in at least two consecutive measurements, or those with an increase in heart rate \\> 30 bpm on two consecutive measurements. Here we evaluate positive active stand tests as a binary outcome (yes, no), comparing the difference in proportion of participants with a positive active stand test at baseline and day 10 between the group treated with Ensitrelvir versus placebo.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Neurocognition Index (NCI) Score From the CNS-VS", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean NCI standard score from the CNS-VS at Day 10 post-randomization The CNS Vital Signs is a a computer-based neurocognitive assessment comprised of seven tests: verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention and the continuous performance test. The battery gives a summary neurocognition index (NCI) score averaging five domain scores (Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility) and representing a global score of neurocognition. NCI scores are normalized scores (mean 100, standard deviation 15) that are age matched relative to other people in a normative sample. A higher score indicates better cognitive function.", "time_frame": "Day 10" } ], "outcome_measures": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at 10 post-\\[ADD\\]. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 30 post-randomization. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.", "time_frame": "Day 30" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 10 post-randomization. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 30 post-randomization. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.", "time_frame": "Day 30" }, { "type": "secondary", "measure": "Quality of Life (Global Health Score) on a 100-point Visual-Analogue Scale", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in the baseline adjusted mean Quality of Life 100-point Visual-Analogue-Scale at Day 10 post-randomization. 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Quality of Life Score (5-Item EuroQol EQ-5D-5L) Index Value Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score at Day 10 post-randomization. 5-Item EuroQol EQ-5D-5L questions assess pain/difficulty in day-to-day activities over the past week. The 5-Item EuroQol EQ-5D-5L produces a score that typically ranges from 0 - 1, with a higher score indicating better quality of life.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Duke Activity Status Index (DASI)", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean DASI at Day 10 post-randomization. The Duke Activity Status Index is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points, which is linearly correlated with a patient's VO2 max and METs, as measured from cardiopulmonary exercise testing (CPET). It inquires about a person's ability to perform self-care, walk, climb stairs, run, do house and yard work, engage in sexual intercourse, and perform moderate recreational activities. A higher score indicates higher functional capacity.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Orthostatic Hypotension Questionnaire (OHQ) Composite Score", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean OHQ composite score at Day 10 post-randomization.\n\nThe Orthostatic Hypotension Questionnaire (OHQ) was developed as a psychometric tool to capture patients' experience quantifying symptomatic burden and functional limitations caused by neurogenic orthostatic hypotension\n\nThe OHQ composite score range is 0 -10 with a higher score indicating higher burden.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) Questionnaire", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean WHO-DAS 2.0 score at Day 10 post-randomization. The World Health Organization Disability Assessment Schedule 2.0 questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. The range is scored from 0-48, with a higher score indicating a higher level of disability.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC)", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo on the Patient Global Impression of Change (PGIC) scale at Day 10 post-randomization. The self-reported PGIC reflects a patient's belief about the efficacy of treatment. We used a modified PGIC scale which has been used to study pain syndromes and has been employed in other Long COVID clinical trials. It is a common data element developed by the National Institutes of Mental Health. The PGIC ranges from 0 (Much better) to 10 (Much Worse). A score of 5 indicates no change.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Everyday Cognition Form (ECog-41)", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean ECog-41 score at Day 10 post-randomization. The ECog-41 is an instrument that measures the decline in everyday cognitive and functional abilities that map to six cognitive domains, adapted specifically to describe change in abilities since having COVID. A summary ECog-41 score is calculated scored with a range of 1-4, with a higher score indicating greater cognitive impairment.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "6 Minute Walking Test (6MWT)", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean distance walked on the 6MWT at Day 10 post-randomization. The 6MWT requires an individual to walk at their normal pace for 6 minutes on a marked track (for example, a hallway). Vital signs are assessed, and the total distance covered is the primary outcome of interest. A larger distance is regarded as better.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Active Stand Test", "description": "The active standing test is a non-invasive tool to assess orthostatic hypotension (OH) and postural orthostatic tachycardia syndrome (POTS). In short, blood pressure and heart rate measurements were obtained after 5 minutes of resting supine and 1, 3, 5, and 10 minutes of continuous standing. A positive active stand test is defined as: those with a decline \\>20 mmHg in systolic or \\> 10 mmHg in diastolic blood pressure in at least two consecutive measurements, or those with an increase in heart rate \\> 30 bpm on two consecutive measurements. Here we evaluate positive active stand tests as a binary outcome (yes, no), comparing the difference in proportion of participants with a positive active stand test at baseline and day 10 between the group treated with Ensitrelvir versus placebo.", "time_frame": "Day 10" }, { "type": "secondary", "measure": "Neurocognition Index (NCI) Score From the CNS-VS", "description": "This measure will evaluate whether there is a difference between treatment with Ensitrelvir versus placebo in baseline adjusted mean NCI standard score from the CNS-VS at Day 10 post-randomization The CNS Vital Signs is a a computer-based neurocognitive assessment comprised of seven tests: verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention and the continuous performance test. The battery gives a summary neurocognition index (NCI) score averaging five domain scores (Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility) and representing a global score of neurocognition. NCI scores are normalized scores (mean 100, standard deviation 15) that are age matched relative to other people in a normative sample. A higher score indicates better cognitive function.", "time_frame": "Day 10" } ], "relevance_tags": [ "Persistence / Antiviral", "Anti-inflammatory", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06161688", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05855369", "title": "Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID)", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-04-02", "start_date": "2023-10-02", "completion_date": "2028-05-31", "primary_completion_date": "2028-05-31", "conditions_raw": [ "Smell Dysfunction", "Olfactory Disorder", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Trigeminal Nerve Stimulation", "Active Smell Training" ], "sponsor": "Medical University of South Carolina", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. This study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions, attend three in-person study visits at the MUSC Department of Psychiatry and Behavioral Sciences, and complete electronic questionnaires over the 12-week trial, and again at the six-month timepoint. Participants in this trial may benefit directly with an improvement in sense of smell. However, participation may also help society more generally, as this study will provide new information about long COVID-related smell loss and its treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Psychophysical Olfactory Function from Baseline to 4 and 12 Weeks", "description": "Sniffin' Sticks (Bughardt Messtechnik, Wedel Germany) will be used to determine odor threshold (T), odor discrimination (D), and odor identification (I), each on 16-point scales, and summed for a total TDI score. Higher scores indicate better function.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Perceived Intensity of Odorants from Baseline to 4 and 12 Weeks", "description": "Perceived intensity on 100-mm visual analog scales with anchor points: 0=\"imperceptible\" to 100=\"extremely intense\" will be rated for suprathreshold concentrations of PEA, vanilla, eugenol, and eucalyptus.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Perceived Hedonics of Odorants from Baseline to 4 and 12 Weeks", "description": "Perceived hedonics on 100-mm visual analog scales with anchor points: 0=\"extremely unpleasant\" to 100=\"extremely pleasant\".", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Olfactory-related Quality of Life from Baseline to 4 and 12 Weeks", "description": "The Modified Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) consists of 17 negative statements (rated on a scale from 0 to 3; total score ranging from 0 to 51), with lower scores indicating better olfactory-related quality of life.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Impact of Olfactory Loss from Baseline to 4 and 12 Weeks", "description": "The Impact of Olfactory Loss Visual Analog Scale (IOL-VAS) consists of 9 separate items assessing the impact of olfactory loss upon mood, food enjoyment, social interactions, safety, hygiene, sex, cooking, appetite, and weight changes, rated from 0 (no impact) to 10 (biggest impact possible).", "time_frame": "2 times: 4 weeks, 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Long COVID Symptoms from Baseline to 4 and 12 Weeks", "description": "53 long COVID symptoms (scored from 0-53 reflecting the number of different symptoms experienced) and the impact of those symptoms (scored from 0=no impact to 10=maximal impact) will be obtained.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Sustained Attention from Baseline to 4 and 12 Weeks", "description": "The Sustained Attention to Response Task (SART) is a computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target (often the digit 3) presented amongst a background of frequent non-targets (0-2, 4-9).", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Cognitive Function from Baseline to 4 and 12 Weeks", "description": "The NIH Toolbox Cognitive Battery is a widely used assessment for detecting cognitive impairment. This test assesses short-term memory, executable performance, attention, and focus.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Mood State from Baseline to 4 and 12 Weeks", "description": "The Profile of Mood States Short Form (POMS-SF) is a psychological rating scale used to assess transient, distinct mood states across six different dimensions including Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, and Confusion or Bewilderment.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Sleep Quality from Baseline to 4 and 12 Weeks", "description": "The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Scores greater than 5 are indicative of a sleep disturbance.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Excessive Daytime Sleepiness from Baseline to 4 and 12 Weeks", "description": "The Epworth Sleepiness Scale (ESS) is a measure intended to assess daytime sleepiness. Items consist of 8 different activities which are rated according to how likely it would be to doze off or fall asleep if engaged in that activity. A score of 10 or more is indicative excessive daytime sleepiness.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Symptoms of Depression from Baseline to 4 and 12 Weeks", "description": "The Patient Health Questionnaire-9 (PHQ-9) is a self-administered 9-item questionnaire to screen for the presence and severity of depression. Items are rated on a 3pt scale ranging from 0=\"Not at all\" to 3=\"Nearly every day\". Total score ranges from 0-27 and is used to classify depression severity: 0-4=None/Minimal; 5-9=Mild; 10-14=Moderate; 15-19=Moderately Severe; 20-27=Severe.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Symptoms of Anxiety from Baseline to 4 and 12 Weeks", "description": "The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item questionnaire to screen for presence and severity of anxiety disorder. Items are rated on a 3pt scale ranging from 0=\"Not at all\" to 3=\"Nearly every day\". Total score ranges from 0 to 21 and is used to classify anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety).", "time_frame": "2 times: 4 weeks, 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Psychophysical Olfactory Function from Baseline to 4 and 12 Weeks", "description": "Sniffin' Sticks (Bughardt Messtechnik, Wedel Germany) will be used to determine odor threshold (T), odor discrimination (D), and odor identification (I), each on 16-point scales, and summed for a total TDI score. Higher scores indicate better function.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Perceived Intensity of Odorants from Baseline to 4 and 12 Weeks", "description": "Perceived intensity on 100-mm visual analog scales with anchor points: 0=\"imperceptible\" to 100=\"extremely intense\" will be rated for suprathreshold concentrations of PEA, vanilla, eugenol, and eucalyptus.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Perceived Hedonics of Odorants from Baseline to 4 and 12 Weeks", "description": "Perceived hedonics on 100-mm visual analog scales with anchor points: 0=\"extremely unpleasant\" to 100=\"extremely pleasant\".", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Olfactory-related Quality of Life from Baseline to 4 and 12 Weeks", "description": "The Modified Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) consists of 17 negative statements (rated on a scale from 0 to 3; total score ranging from 0 to 51), with lower scores indicating better olfactory-related quality of life.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Impact of Olfactory Loss from Baseline to 4 and 12 Weeks", "description": "The Impact of Olfactory Loss Visual Analog Scale (IOL-VAS) consists of 9 separate items assessing the impact of olfactory loss upon mood, food enjoyment, social interactions, safety, hygiene, sex, cooking, appetite, and weight changes, rated from 0 (no impact) to 10 (biggest impact possible).", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Long COVID Symptoms from Baseline to 4 and 12 Weeks", "description": "53 long COVID symptoms (scored from 0-53 reflecting the number of different symptoms experienced) and the impact of those symptoms (scored from 0=no impact to 10=maximal impact) will be obtained.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Sustained Attention from Baseline to 4 and 12 Weeks", "description": "The Sustained Attention to Response Task (SART) is a computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target (often the digit 3) presented amongst a background of frequent non-targets (0-2, 4-9).", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Cognitive Function from Baseline to 4 and 12 Weeks", "description": "The NIH Toolbox Cognitive Battery is a widely used assessment for detecting cognitive impairment. This test assesses short-term memory, executable performance, attention, and focus.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Mood State from Baseline to 4 and 12 Weeks", "description": "The Profile of Mood States Short Form (POMS-SF) is a psychological rating scale used to assess transient, distinct mood states across six different dimensions including Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, and Confusion or Bewilderment.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Sleep Quality from Baseline to 4 and 12 Weeks", "description": "The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Scores greater than 5 are indicative of a sleep disturbance.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Excessive Daytime Sleepiness from Baseline to 4 and 12 Weeks", "description": "The Epworth Sleepiness Scale (ESS) is a measure intended to assess daytime sleepiness. Items consist of 8 different activities which are rated according to how likely it would be to doze off or fall asleep if engaged in that activity. A score of 10 or more is indicative excessive daytime sleepiness.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Symptoms of Depression from Baseline to 4 and 12 Weeks", "description": "The Patient Health Questionnaire-9 (PHQ-9) is a self-administered 9-item questionnaire to screen for the presence and severity of depression. Items are rated on a 3pt scale ranging from 0=\"Not at all\" to 3=\"Nearly every day\". Total score ranges from 0-27 and is used to classify depression severity: 0-4=None/Minimal; 5-9=Mild; 10-14=Moderate; 15-19=Moderately Severe; 20-27=Severe.", "time_frame": "2 times: 4 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change in Symptoms of Anxiety from Baseline to 4 and 12 Weeks", "description": "The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item questionnaire to screen for presence and severity of anxiety disorder. Items are rated on a 3pt scale ranging from 0=\"Not at all\" to 3=\"Nearly every day\". Total score ranges from 0 to 21 and is used to classify anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety).", "time_frame": "2 times: 4 weeks, 12 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 145, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05855369", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06171152", "title": "Study of Liraglutide (A Weight Loss Drug) in High Risk Obese Participants With Cognitive and Memory Issues", "status": "SUSPENDED", "phase": "EARLY_PHASE1", "last_updated": "2026-03-30", "start_date": "2024-01-26", "completion_date": "2027-10-01", "primary_completion_date": "2027-06-01", "conditions_raw": [ "Multiple Sclerosis", "Long COVID", "Long Covid19", "Obese", "Obesity", "Obesity, Morbid", "Acute Leukemia in Remission" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Liraglutide Pen Injector [Saxenda]", "Medication Diary" ], "sponsor": "University of Chicago", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is for people who have multiple sclerosis, acute leukemia (in remission), or long-COVID and a Body Mass Index over 27 and may struggle with cognitive issues such as remembering information, concentrating, or making decisions that affect everyday life.\n\nBy doing this study, researchers hope to learn how liraglutide (Saxenda®), a weight loss drug, affects levels of a certain disease marker in the body called Brain Derived Neurotrophic Factor (BDNF). Participation in this research will last about 21 weeks.", "primary_outcomes": [ { "type": "primary", "measure": "Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks", "description": "Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels after reaching the goal dose of GLP-1 agonist (8 weeks).", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 4 Weeks", "description": "Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels at 4 weeks.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 12 Weeks", "description": "Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels at 12 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 21 Weeks", "description": "Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels at discontinuation of study drug (21 weeks).", "time_frame": "21 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks", "description": "Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels after reaching the goal dose of GLP-1 agonist (8 weeks).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 4 Weeks", "description": "Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels at 4 weeks.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 12 Weeks", "description": "Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels at 12 weeks.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 21 Weeks", "description": "Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels at discontinuation of study drug (21 weeks).", "time_frame": "21 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "EARLY_Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06171152", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07454395", "title": "Is Swimming a More Tolerable Form of Movement for Individuals With Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome?", "status": "SUSPENDED", "phase": "NA", "last_updated": "2026-03-30", "start_date": "2026-02-20", "completion_date": "2027-06", "primary_completion_date": "2027-01", "conditions_raw": [ "ME/CFS", "Long COVID", "Post- COVID-19 Syndrome", "POTS - Postural Orthostatic Tachycardia Syndrome", "Fibromyalgia", "Overtraining Syndrome", "Post-Viral Fatigue Syndrome", "Mast Cell Activation Syndrome" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Swimming", "Cycling" ], "sponsor": "Simon Fraser University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Individuals with ME/CFS experience profound exercise intolerance and post-exertional malaise. This remote (app-based) pilot study explores whether light, fully self-paced, swimming may be a tolerable form of movement for people with ME/CFS and related conditions, due to the distinct physiological effects of water immersion. The horizontal posture and hydrostatic pressure of water supports venous return and reduces orthostatic stress, while cool water exposure may influence autonomic and inflammatory responses. We are recruiting adults with mild-to-moderate ME/CFS and related conditions for this study examining short-term symptom and autonomic responses to gentle swimming. Participants will choose their own intensity and duration and may stop at any time. A light cycling session is available as an optional comparator for those who feel comfortable doing so. \\[Note: this is not an exercise training or rehabilitation study, and participation is only intended for individuals who can tolerate some gentle activity and can be in public spaces without triggering post-exertional malaise. You should be comfortable with swimming, but flotation or other assistive devices are welcome\\]", "primary_outcomes": [ { "type": "primary", "measure": "Symptoms", "description": "Daily symptoms will be recorded in the Visible app each evening as part of the evening check-in. All available symptoms listed on the app will be evaluated (44 items, rated 0-3, with 0=none, and 3= severe). The total score will be the sum of all 44 items.", "time_frame": "From enrollment until minimally three days post final exercise session (11~15 days total)" }, { "type": "primary", "measure": "Heart Rate Variability", "description": "HRV will be collected each morning upon waking, and in the seated-upright position, through the Visible application. This is assessed with lnRMSSD plotted on a 0-100 scale. Analyses will focus on changes in HRV from baseline to 24, 48, and 72 hours post-swim session compared to post-bike session.", "time_frame": "From enrollment until minimially three days after one or both exercise sessions (11~15 days total)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Time to recovery", "description": "The time to recovery from each exercise session will be assessed. This will be defined as the number of days it takes for the readiness scores to reach at least a 4 out of 5 on the Visible App.", "time_frame": "From enrollment to the post-exercise recovery periods from days ~9-11 and ~13-15." }, { "type": "secondary", "measure": "Exercise Load", "description": "The intensity and duration of the exercise sessions will be determined as the duration of the exercise in minutes multiplied by the rating of perceived exertion for the session (sRPE) on a Borg 0-10 scale.", "time_frame": "Exercise days ~8 and ~12." }, { "type": "secondary", "measure": "Severity of ME/CFS", "description": "The functional capacity 27 scale will be used to assess the functional severity of each participant's condition. The scale has 27 statements, that are ranked from on a likert scale of 0-6, with 0 being \"unable to perform that activity\", and 6 being \"unproblematic - does not affect other activities.\" The average score from all 27 statements is used as the overall score. Only participants with a score ≥3.0 and \\<5.8 will be included in the study (representing mild-to-moderate ME/CFS).", "time_frame": "Baseline" } ], "outcome_measures": [ { "type": "primary", "measure": "Symptoms", "description": "Daily symptoms will be recorded in the Visible app each evening as part of the evening check-in. All available symptoms listed on the app will be evaluated (44 items, rated 0-3, with 0=none, and 3= severe). The total score will be the sum of all 44 items.", "time_frame": "From enrollment until minimally three days post final exercise session (11~15 days total)" }, { "type": "primary", "measure": "Heart Rate Variability", "description": "HRV will be collected each morning upon waking, and in the seated-upright position, through the Visible application. This is assessed with lnRMSSD plotted on a 0-100 scale. Analyses will focus on changes in HRV from baseline to 24, 48, and 72 hours post-swim session compared to post-bike session.", "time_frame": "From enrollment until minimially three days after one or both exercise sessions (11~15 days total)" }, { "type": "secondary", "measure": "Time to recovery", "description": "The time to recovery from each exercise session will be assessed. This will be defined as the number of days it takes for the readiness scores to reach at least a 4 out of 5 on the Visible App.", "time_frame": "From enrollment to the post-exercise recovery periods from days ~9-11 and ~13-15." }, { "type": "secondary", "measure": "Exercise Load", "description": "The intensity and duration of the exercise sessions will be determined as the duration of the exercise in minutes multiplied by the rating of perceived exertion for the session (sRPE) on a Borg 0-10 scale.", "time_frame": "Exercise days ~8 and ~12." }, { "type": "secondary", "measure": "Severity of ME/CFS", "description": "The functional capacity 27 scale will be used to assess the functional severity of each participant's condition. The scale has 27 statements, that are ranked from on a likert scale of 0-6, with 0 being \"unable to perform that activity\", and 6 being \"unproblematic - does not affect other activities.\" The average score from all 27 statements is used as the overall score. Only participants with a score ≥3.0 and \\<5.8 will be included in the study (representing mild-to-moderate ME/CFS).", "time_frame": "Baseline" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07454395", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05212610", "title": "Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2026-03-27", "start_date": "2022-03-21", "completion_date": "2025-03-07", "primary_completion_date": "2025-03-07", "conditions_raw": [ "COVID-19", "Corona Virus Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Pfizer-Biontech Mrna Covid-19 Vaccine", "Moderna Mrna Covid-19 Vaccine" ], "sponsor": "University of Michigan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will evaluate the safety of administering an additional dose of an mRNA COVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19 vaccine to individuals with a personal history of allergic reaction. In addition, this study will evaluate the safety of administering an initial or additional dose or bivalent booster of an mRNA COVID-19 vaccine to individuals experiencing an adverse reaction to a natural COVID-19 infection (\"long COVID\").\n\nEligible participants enrolled in this trial will receive an initial or additional dose of either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna COVID-19 bivalent vaccine. Participants will also be required to have 1-2 in person visits along with phone call follow up visits.\n\nWe hypothesize that individuals who have had adverse reactions to a previous dose of an mRNA COVID-19 vaccine will tolerate an additional dose of the primary mRNA vaccine or bivalent booster, as indicated, and those with a personal history of allergic reaction will tolerate an initial dose of an mRNA COVID-19 vaccine. We also hypothesize that those individuals experiencing an adverse reaction will tolerate an initial or additional dose of a primary mRNA COVID-19 bivalent vaccine, as indicated.\n\nThe study hypothesizes that individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.", "primary_outcomes": [ { "type": "primary", "measure": "Participants Who Had a Reaction to an Initial or Additional Dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA Vaccine, or Who Had Long COVID", "description": "Results reflect the number of participants who had previously received the Pfizer-BioNTech, the Moderna mRNA COVID-19 vaccine, or both, and who had experienced an adverse reaction (AR). An AR would be any symptom reported or objective finding during the 30-minute observation, or any symptom reported at the 7 day follow up. ARs were graded using the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, which utilized the following grades:\n\nGrade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life-threatening Grade 5 = Death", "time_frame": "up to approximately 7 days after the vaccine is given" }, { "type": "primary", "measure": "Number of Participants With Treatment-related Allergic Reaction Adverse Events", "description": "The safety of administering an initial or additional dose will be determined by using the grading of systemic allergic reactions will be based on a scale of 1 (mild reaction) to 5 (severe reaction, including death) according to criteria set forth in the Consortium of Food Allergy Research (CoFAR) grading scale (version 3.0) modified for adults as well as the Brighton Collaboration to grade the diagnostic certainty of anaphylaxis. Results reflect the number of participants who received an initial dose or were revaccinated during the trial, and experienced related acute allergic reaction adverse event, and what the CoFAR severity for the events was. Events were deemed to be allergic if symptoms were consistent with an IgE-reaction and symptom onset began within 1 hour of vaccination.", "time_frame": "up to approximately 7 days after the vaccine is given" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Number of Non-allergic Clinical Adverse Reactions", "description": "Results reflect the number of participants who experienced a non-allergic clinical adverse reaction (AR). A non-allergic clinical AR was determined by non-allergic symptomatology and time frame from when the participant received a vaccine. Nonallergic ARs were symptoms that were inconsistent with an IgE-mechanism or had an onset greater than 1 hour following vaccination. ARs were graded using the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, which utilized the following grades: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life-threatening Grade 5 = Death", "time_frame": "up to approximately 7 days after the vaccine is given" } ], "outcome_measures": [ { "type": "primary", "measure": "Participants Who Had a Reaction to an Initial or Additional Dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA Vaccine, or Who Had Long COVID", "description": "Results reflect the number of participants who had previously received the Pfizer-BioNTech, the Moderna mRNA COVID-19 vaccine, or both, and who had experienced an adverse reaction (AR). An AR would be any symptom reported or objective finding during the 30-minute observation, or any symptom reported at the 7 day follow up. ARs were graded using the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, which utilized the following grades:\n\nGrade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life-threatening Grade 5 = Death", "time_frame": "up to approximately 7 days after the vaccine is given" }, { "type": "primary", "measure": "Number of Participants With Treatment-related Allergic Reaction Adverse Events", "description": "The safety of administering an initial or additional dose will be determined by using the grading of systemic allergic reactions will be based on a scale of 1 (mild reaction) to 5 (severe reaction, including death) according to criteria set forth in the Consortium of Food Allergy Research (CoFAR) grading scale (version 3.0) modified for adults as well as the Brighton Collaboration to grade the diagnostic certainty of anaphylaxis. Results reflect the number of participants who received an initial dose or were revaccinated during the trial, and experienced related acute allergic reaction adverse event, and what the CoFAR severity for the events was. Events were deemed to be allergic if symptoms were consistent with an IgE-reaction and symptom onset began within 1 hour of vaccination.", "time_frame": "up to approximately 7 days after the vaccine is given" }, { "type": "secondary", "measure": "Number of Non-allergic Clinical Adverse Reactions", "description": "Results reflect the number of participants who experienced a non-allergic clinical adverse reaction (AR). A non-allergic clinical AR was determined by non-allergic symptomatology and time frame from when the participant received a vaccine. Nonallergic ARs were symptoms that were inconsistent with an IgE-mechanism or had an onset greater than 1 hour following vaccination. ARs were graded using the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, which utilized the following grades: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life-threatening Grade 5 = Death", "time_frame": "up to approximately 7 days after the vaccine is given" } ], "relevance_tags": [ "General", "Phase 4", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 137, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05212610", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05965726", "title": "RECOVER-VITAL: Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-03-27", "start_date": "2023-07-26", "completion_date": "2025-03-13", "primary_completion_date": "2024-12-05", "conditions_raw": [ "Long COVID-19", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Paxlovid (Nirmatrelvir/Ritonavir)", "Ritonavir" ], "sponsor": "Kanecia Obie Zimmerman", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is an appendix of master protocol (NCT05595369) designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This sub-study is a prospective, multi-center, double-blind, randomized, controlled trial evaluating nirmatrelvir/ritonavir (Paxlovid) in two dosing durations for the treatment of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The study is evaluating potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Percentage of Participants Who Improved in Cognitive Dysfunction Symptom Cluster, as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive 8a Function T-score", "description": "PROMIS Cognitive 8a is a questionnaire assessing self-reported cognitive impairments over the past 7 days using 8 items. It assesses the frequency that respondents experienced cognitive impairments on a scale ranging from 5 (never) to 1 (very often; several times a day). The total raw score is transformed into a T-score, with higher scores representing better cognitive function. The T-scores are interpreted in relation to a US reference population and are scaled to have mean = 50 and SD = 10 in the reference population. The primary endpoint for the cognitive dysfunction symptom cluster is improvement of at least 5 T-score points on the PROMIS-cognitive 8a as measured at Day 90 compared to baseline.", "time_frame": "Baseline, Day 90" }, { "type": "primary", "measure": "Percentage of Participants Who Improved in Autonomic Dysfunction Symptom Cluster, as Measured by the Orthostatic Hypotension Questionnaire (OHQ)", "description": "The Orthostatic Hypotension Questionnaire (OHQ) is a patient reported outcome designed to assess the severity and impact of orthostatic hypotension (OH), a condition characterized by a sudden drop in blood pressure when standing. The OHQ consists of two main components: the Orthostatic Hypotension Symptom Assessment (OHSA) and the Orthostatic Hypotension Daily Activity Scale (OHDAS). The OHSA consists of 6 items measuring severity on a scale ranging from 0 (none) to 10 (worst possible). The OHDAS assesses the extent to which OH interferes with daily life on a scale ranging from 0 (no interference) to 10 (total interference). The primary endpoint for the autonomic dysfunction symptom cluster is improvement as defined by at least a 1-point decrease in the response to OHQ question 1 at Day 90 compared to baseline.", "time_frame": "Baseline, Day 90" }, { "type": "primary", "measure": "Percentage of Participants Who Improved in Exercise Intolerance Symptom Cluster, as Measured by the Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM)", "description": "The Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM) is a patient-reported outcome designed to assess the frequency and severity of symptoms worsening after physical or mental exertion. The first 10 items of DSQ-PEM assess frequency and severity of the following 5 exercise-related impairments. These items were modified for the current study to use a 7-day instead of 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The primary endpoint for the exercise symptom cluster is improvement in PEM, defined as having no symptoms of moderate or greater severity with 50% or more frequency as determined by the DSQ-PEM short form at Day 90.", "time_frame": "Baseline, Day 90" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Percentage of Participants Who Improved in Cognitive Dysfunction Symptom Cluster, as Measured by a Neurocognitive Battery", "description": "The Neurocognitive battery is a performance measure used to assess various elements related to cognition. The neurocognitive battery consists of a cognitive assessment sequence of the following: WHO/UCLA Auditory Verbal Learning Test (WHO/UCLA AVLT) and Symbol Digit Modalities Test (SDMT). The major secondary endpoint for the cognitive dysfunction symptom cluster is a binary endpoint defined as an increase by at least 1 point in either or both of the AVLT delayed recall Z-score and/or SDMT number of correct substitutions Z-score, and no decrease exceeding 0.15 in either of these measures, at Day 90 compared to baseline.", "time_frame": "Baseline, Day 90" }, { "type": "secondary", "measure": "Percentage of Participants Who Improved in Autonomic Dysfunction Symptom Cluster, as Measured by the Active Stand Test", "description": "The active stand test is performed to assess presence of orthostatic intolerance, orthostatic hypotension, and postural orthostatic tachycardia syndrome. The participant's blood pressure and heart rate are recorded after 5 minutes of lying and then at minutes 1, 3, 5, and 10 after standing. Changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate beats per minute (HR BPM) are assessed from lying to standing for 10 minutes. The major secondary endpoint for the autonomic dysfunction cluster is a binary endpoint defined as improvement in change from lying to standing in at least one of HR, DBP, or DBP from baseline to Day 90 (defined as an increase of at least 10mmHg in SBP, an increase of at least 5mmHg on DBP, or a decrease of at least 10 BPM on HR) and no worsening in any of HR, DBP, or DBP from baseline to Day 90 (defined as any decrease in SBP or DBP, or any increase in HR.", "time_frame": "Baseline, Day 90" }, { "type": "secondary", "measure": "Percentage of Participants Who Improved in Exercise Intolerance Symptom Cluster, as Measured by the Endurance Shuttle Walk Test (ESWT)", "description": "The endurance shuttle walk test (ESWT) is a performance measure that consists of timed walking on a 10 meter course. The major secondary endpoint for the exercise intolerance symptom cluster is defined as an increase of at least 3 minutes in walk time at Day 90 compared to baseline.", "time_frame": "Baseline, Day 90" }, { "type": "secondary", "measure": "Total Number of SAEs (Serious Adverse Events)", "description": "", "time_frame": "Up to 190 days" }, { "type": "secondary", "measure": "Number of Participants Experiencing One or More SAEs (Serious Adverse Events)", "description": "", "time_frame": "Up to 190 days" }, { "type": "secondary", "measure": "Number of Participants Experiencing AEs (Adverse Events) or SAEs (Serious Adverse Events) Leading to Treatment Discontinuation", "description": "", "time_frame": "Up to 25 days" }, { "type": "secondary", "measure": "Number of Participants With an Event of Special Interest (ESI)", "description": "", "time_frame": "Up to 190 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Percentage of Participants Who Improved in Cognitive Dysfunction Symptom Cluster, as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive 8a Function T-score", "description": "PROMIS Cognitive 8a is a questionnaire assessing self-reported cognitive impairments over the past 7 days using 8 items. It assesses the frequency that respondents experienced cognitive impairments on a scale ranging from 5 (never) to 1 (very often; several times a day). The total raw score is transformed into a T-score, with higher scores representing better cognitive function. The T-scores are interpreted in relation to a US reference population and are scaled to have mean = 50 and SD = 10 in the reference population. The primary endpoint for the cognitive dysfunction symptom cluster is improvement of at least 5 T-score points on the PROMIS-cognitive 8a as measured at Day 90 compared to baseline.", "time_frame": "Baseline, Day 90" }, { "type": "primary", "measure": "Percentage of Participants Who Improved in Autonomic Dysfunction Symptom Cluster, as Measured by the Orthostatic Hypotension Questionnaire (OHQ)", "description": "The Orthostatic Hypotension Questionnaire (OHQ) is a patient reported outcome designed to assess the severity and impact of orthostatic hypotension (OH), a condition characterized by a sudden drop in blood pressure when standing. The OHQ consists of two main components: the Orthostatic Hypotension Symptom Assessment (OHSA) and the Orthostatic Hypotension Daily Activity Scale (OHDAS). The OHSA consists of 6 items measuring severity on a scale ranging from 0 (none) to 10 (worst possible). The OHDAS assesses the extent to which OH interferes with daily life on a scale ranging from 0 (no interference) to 10 (total interference). The primary endpoint for the autonomic dysfunction symptom cluster is improvement as defined by at least a 1-point decrease in the response to OHQ question 1 at Day 90 compared to baseline.", "time_frame": "Baseline, Day 90" }, { "type": "primary", "measure": "Percentage of Participants Who Improved in Exercise Intolerance Symptom Cluster, as Measured by the Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM)", "description": "The Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM) is a patient-reported outcome designed to assess the frequency and severity of symptoms worsening after physical or mental exertion. The first 10 items of DSQ-PEM assess frequency and severity of the following 5 exercise-related impairments. These items were modified for the current study to use a 7-day instead of 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The primary endpoint for the exercise symptom cluster is improvement in PEM, defined as having no symptoms of moderate or greater severity with 50% or more frequency as determined by the DSQ-PEM short form at Day 90.", "time_frame": "Baseline, Day 90" }, { "type": "secondary", "measure": "Percentage of Participants Who Improved in Cognitive Dysfunction Symptom Cluster, as Measured by a Neurocognitive Battery", "description": "The Neurocognitive battery is a performance measure used to assess various elements related to cognition. The neurocognitive battery consists of a cognitive assessment sequence of the following: WHO/UCLA Auditory Verbal Learning Test (WHO/UCLA AVLT) and Symbol Digit Modalities Test (SDMT). The major secondary endpoint for the cognitive dysfunction symptom cluster is a binary endpoint defined as an increase by at least 1 point in either or both of the AVLT delayed recall Z-score and/or SDMT number of correct substitutions Z-score, and no decrease exceeding 0.15 in either of these measures, at Day 90 compared to baseline.", "time_frame": "Baseline, Day 90" }, { "type": "secondary", "measure": "Percentage of Participants Who Improved in Autonomic Dysfunction Symptom Cluster, as Measured by the Active Stand Test", "description": "The active stand test is performed to assess presence of orthostatic intolerance, orthostatic hypotension, and postural orthostatic tachycardia syndrome. The participant's blood pressure and heart rate are recorded after 5 minutes of lying and then at minutes 1, 3, 5, and 10 after standing. Changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate beats per minute (HR BPM) are assessed from lying to standing for 10 minutes. The major secondary endpoint for the autonomic dysfunction cluster is a binary endpoint defined as improvement in change from lying to standing in at least one of HR, DBP, or DBP from baseline to Day 90 (defined as an increase of at least 10mmHg in SBP, an increase of at least 5mmHg on DBP, or a decrease of at least 10 BPM on HR) and no worsening in any of HR, DBP, or DBP from baseline to Day 90 (defined as any decrease in SBP or DBP, or any increase in HR.", "time_frame": "Baseline, Day 90" }, { "type": "secondary", "measure": "Percentage of Participants Who Improved in Exercise Intolerance Symptom Cluster, as Measured by the Endurance Shuttle Walk Test (ESWT)", "description": "The endurance shuttle walk test (ESWT) is a performance measure that consists of timed walking on a 10 meter course. The major secondary endpoint for the exercise intolerance symptom cluster is defined as an increase of at least 3 minutes in walk time at Day 90 compared to baseline.", "time_frame": "Baseline, Day 90" }, { "type": "secondary", "measure": "Total Number of SAEs (Serious Adverse Events)", "description": "", "time_frame": "Up to 190 days" }, { "type": "secondary", "measure": "Number of Participants Experiencing One or More SAEs (Serious Adverse Events)", "description": "", "time_frame": "Up to 190 days" }, { "type": "secondary", "measure": "Number of Participants Experiencing AEs (Adverse Events) or SAEs (Serious Adverse Events) Leading to Treatment Discontinuation", "description": "", "time_frame": "Up to 25 days" }, { "type": "secondary", "measure": "Number of Participants With an Event of Special Interest (ESI)", "description": "", "time_frame": "Up to 190 days" } ], "relevance_tags": [ "Immunomodulatory", "Persistence / Antiviral", "Anti-inflammatory", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 964, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05965726", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07492953", "title": "Using Enhanced External Counterpulsation to Recover Cardiovascular Function for Patient of Chronic Diseases", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-03-25", "start_date": "2023-12-25", "completion_date": "2024-06-24", "primary_completion_date": "2024-06-24", "conditions_raw": [ "Long COVID Symptoms" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Enhanced External Counterpulsation" ], "sponsor": "National Defense Medical Center, Taiwan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to learn whether enhanced external counterpulsation (EECP) therapy can improve cardiopulmonary function and symptoms in adults with long COVID. It will also evaluate the safety and feasibility of two different EECP treatment schedules.\n\nThe main questions it aims to answer are:\n\n* Does EECP therapy improve functional exercise capacity and cardiopulmonary performance in patients with long COVID?\n* Do different EECP treatment schedules (standard vs. accelerated sessions) lead to different improvements in symptoms, quality of life, and physiological outcomes?\n* What side effects or medical problems occur during EECP therapy?\n\nResearchers will compare two EECP treatment schedules to determine whether a shorter, accelerated program provides similar benefits to the standard schedule.\n\nParticipants will:\n\n* Receive EECP therapy either 1 hour per day (5 days per week for 7 weeks) or 2 hours per day (5 days per week for about 4 weeks), both totaling 35 hours of treatment\n* Visit the cardiopulmonary rehabilitation clinic regularly for supervised treatment sessions\n* Complete physical performance tests (such as the Six-Minute Walk Test and cardiopulmonary exercise testing)\n* Have blood pressure and heart rate measured\n* Complete questionnaires about symptoms, physical function, sleep quality, and quality of life", "primary_outcomes": [ { "type": "primary", "measure": "Peak oxygen uptake (Peak VO₂)", "description": "Peak oxygen uptake was measured during symptom-limited cardiopulmonary exercise testing (CPET) performed on a cycle ergometer using a ramp protocol (0 W initial workload with increments of 10-15 W per minute). Breath-by-breath gas exchange was continuously recorded using a metabolic cart. Peak VO₂ was defined as the highest 30-second averaged oxygen uptake during the test and expressed in mL·kg-¹·min-¹. Continuous ECG and pulse oximetry monitoring were performed during the test. Exercise was terminated at volitional fatigue or standardized safety criteria.", "time_frame": "Baseline and within 1 week after completion of the 35-hour EECP intervention (approximately 4-7 weeks)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The Six-Minute Walk Test (6MWT)", "description": "The Six-Minute Walk Test (6MWT) was used to assess aerobic capacity and endurance. Participants were instructed to walk at their maximal comfortable pace back-and-forth along a 30-meter corridor for 6 minutes, and the total distance walked (in meters) was recorded. One practice trial was done at baseline to familiarize patients, followed by a measured 6MWT at baseline and again within one week after completing EECP. Standard encouragement and stopping criteria were applied.", "time_frame": "Baseline and again within one week after completing EECP" }, { "type": "secondary", "measure": "Blood Pressure and Heart Rate", "description": "Resting blood pressure (BP) (systolic and diastolic) and resting heart rate were measured after 5 minutes seated, at baseline and post-intervention. We also tracked any change in these vital signs immediately before and after individual EECP sessions to monitor acute effects. For analysis, we focused on the baseline vs post-intervention resting BP and HR changes.", "time_frame": "Baseline and weekly, immediately before and after each EECP session, throughout the treatment period." }, { "type": "secondary", "measure": "PROMIS Physical Health score", "description": "Physical health status was assessed using the PROMIS Adult Health Profile short form. The Physical Health domain includes items related to fatigue, pain, and physical functioning. Scores were calculated using a summed short-form scale ranging from 4 to 20, with higher scores indicating better physical health.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "PROMIS Mental Health Score", "description": "Mental health status was assessed using the PROMIS Adult Health Profile short form. The Mental Health domain includes items related to depression, anxiety, and social role functioning. Scores were calculated using a summed short-form scale ranging from 4 to 20, with higher scores indicating better mental health.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "PROMIS Sleep Disturbance Domain", "description": "Sleep disturbance was evaluated using the PROMIS Sleep Disturbance domain. This measure assesses perceived sleep quality and sleep-related problems, with higher scores indicating greater sleep disturbance.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "Seattle Angina Questionnaire-7 (SAQ-7) summary score", "description": "Cardiovascular health status was assessed using the Seattle Angina Questionnaire-7 (SAQ-7), a validated instrument evaluating angina frequency, physical limitation, and disease-specific quality of life related to coronary artery disease. Scores range from 0 to 100, with higher scores indicating fewer angina symptoms and better quality of life.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "COPD Assessment Test (CAT) score", "description": "Respiratory symptom burden was measured using the COPD Assessment Test (CAT), an 8-item questionnaire evaluating symptoms such as cough, dyspnea, chest tightness, and energy level. Total scores range from 0 to 40, with lower scores indicating fewer respiratory symptoms.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "Rose Dyspnea Scale (RDS)", "description": "Breathlessness severity was evaluated using the Rose Dyspnea Scale (RDS), a 4-item scale assessing dyspnea during physical activities. Scores range from 0 to 4, with higher grades indicating more severe dyspnea.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI) global score", "description": "Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire measuring sleep quality and disturbances over the previous month. The instrument includes seven components that generate a global score ranging from 0 to 21. Higher scores indicate worse sleep quality, and a global score greater than 5 indicates poor sleep quality.", "time_frame": "Baseline and within 1 week after completion of the intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Peak oxygen uptake (Peak VO₂)", "description": "Peak oxygen uptake was measured during symptom-limited cardiopulmonary exercise testing (CPET) performed on a cycle ergometer using a ramp protocol (0 W initial workload with increments of 10-15 W per minute). Breath-by-breath gas exchange was continuously recorded using a metabolic cart. Peak VO₂ was defined as the highest 30-second averaged oxygen uptake during the test and expressed in mL·kg-¹·min-¹. Continuous ECG and pulse oximetry monitoring were performed during the test. Exercise was terminated at volitional fatigue or standardized safety criteria.", "time_frame": "Baseline and within 1 week after completion of the 35-hour EECP intervention (approximately 4-7 weeks)." }, { "type": "secondary", "measure": "The Six-Minute Walk Test (6MWT)", "description": "The Six-Minute Walk Test (6MWT) was used to assess aerobic capacity and endurance. Participants were instructed to walk at their maximal comfortable pace back-and-forth along a 30-meter corridor for 6 minutes, and the total distance walked (in meters) was recorded. One practice trial was done at baseline to familiarize patients, followed by a measured 6MWT at baseline and again within one week after completing EECP. Standard encouragement and stopping criteria were applied.", "time_frame": "Baseline and again within one week after completing EECP" }, { "type": "secondary", "measure": "Blood Pressure and Heart Rate", "description": "Resting blood pressure (BP) (systolic and diastolic) and resting heart rate were measured after 5 minutes seated, at baseline and post-intervention. We also tracked any change in these vital signs immediately before and after individual EECP sessions to monitor acute effects. For analysis, we focused on the baseline vs post-intervention resting BP and HR changes.", "time_frame": "Baseline and weekly, immediately before and after each EECP session, throughout the treatment period." }, { "type": "secondary", "measure": "PROMIS Physical Health score", "description": "Physical health status was assessed using the PROMIS Adult Health Profile short form. The Physical Health domain includes items related to fatigue, pain, and physical functioning. Scores were calculated using a summed short-form scale ranging from 4 to 20, with higher scores indicating better physical health.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "PROMIS Mental Health Score", "description": "Mental health status was assessed using the PROMIS Adult Health Profile short form. The Mental Health domain includes items related to depression, anxiety, and social role functioning. Scores were calculated using a summed short-form scale ranging from 4 to 20, with higher scores indicating better mental health.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "PROMIS Sleep Disturbance Domain", "description": "Sleep disturbance was evaluated using the PROMIS Sleep Disturbance domain. This measure assesses perceived sleep quality and sleep-related problems, with higher scores indicating greater sleep disturbance.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "Seattle Angina Questionnaire-7 (SAQ-7) summary score", "description": "Cardiovascular health status was assessed using the Seattle Angina Questionnaire-7 (SAQ-7), a validated instrument evaluating angina frequency, physical limitation, and disease-specific quality of life related to coronary artery disease. Scores range from 0 to 100, with higher scores indicating fewer angina symptoms and better quality of life.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "COPD Assessment Test (CAT) score", "description": "Respiratory symptom burden was measured using the COPD Assessment Test (CAT), an 8-item questionnaire evaluating symptoms such as cough, dyspnea, chest tightness, and energy level. Total scores range from 0 to 40, with lower scores indicating fewer respiratory symptoms.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "Rose Dyspnea Scale (RDS)", "description": "Breathlessness severity was evaluated using the Rose Dyspnea Scale (RDS), a 4-item scale assessing dyspnea during physical activities. Scores range from 0 to 4, with higher grades indicating more severe dyspnea.", "time_frame": "Baseline and within 1 week after completion of the intervention" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI) global score", "description": "Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire measuring sleep quality and disturbances over the previous month. The instrument includes seven components that generate a global score ranging from 0 to 21. Higher scores indicate worse sleep quality, and a global score greater than 5 indicates poor sleep quality.", "time_frame": "Baseline and within 1 week after completion of the intervention" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 10, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07492953", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05764538", "title": "DAOIB for the Treatment of Brain Fog", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-03-19", "start_date": "2023-02-27", "completion_date": "2026-06", "primary_completion_date": "2026-06", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Daoib" ], "sponsor": "Chang Gung Memorial Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB treatment will be beneficial in improving the cognitive function, mood symptoms, global functioning and quality of life in long-COVID patients with cognitive impairments.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24", "description": "Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)", "time_frame": "week 0, 8, 16, 24" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24", "description": "Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24", "time_frame": "week 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24", "description": "The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best)", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline in Quality of life score at week 8, 16 and 24", "description": "Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health.", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline of 17-item Hamilton Rating Scale for Depression", "description": "Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured every 8 weeks", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline of Hamilton Anxiety Rating Scale", "description": "Assessment of anxiety symptoms. The Hamilton Anxiety Rating Scale will be measured every 8 weeks", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline of Perceived Stress Scale", "description": "Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured every 8 weeks", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline in the score of a battery of additional cognitive tests", "description": "The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing)", "time_frame": "week 0, 8, 16, 24" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24", "description": "Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24", "description": "Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24", "time_frame": "week 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24", "description": "The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best)", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline in Quality of life score at week 8, 16 and 24", "description": "Quality of life will be assessed by Medical Outcomes Study Short-Form-36 (SF-36). The SF-36 consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health.", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline of 17-item Hamilton Rating Scale for Depression", "description": "Assessment of depressive symptoms. The 17-item Hamilton Rating Scale for Depression will be measured every 8 weeks", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline of Hamilton Anxiety Rating Scale", "description": "Assessment of anxiety symptoms. The Hamilton Anxiety Rating Scale will be measured every 8 weeks", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline of Perceived Stress Scale", "description": "Assessment of stress and anxiety symptoms. The Perceived Stress Scale will be measured every 8 weeks", "time_frame": "week 0, 8, 16, 24" }, { "type": "secondary", "measure": "Change from baseline in the score of a battery of additional cognitive tests", "description": "The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing)", "time_frame": "week 0, 8, 16, 24" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05764538", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06511050", "title": "Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome", "status": "RECRUITING", "phase": "PHASE1", "last_updated": "2026-03-13", "start_date": "2024-10-09", "completion_date": "2026-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Long Covid", "Post-treatment Lyme Disease Syndrome", "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Lumbrokinase" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:\n\n* Long Covid (LC)\n* Post-treatment Lyme disease syndrome (PTLDS)\n* Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)", "primary_outcomes": [ { "type": "primary", "measure": "EuroQol Visual Analogue Scale Score (EQ-VAS)", "description": "The EQ VAS is a visual analogue scale that allows individuals to rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health), providing a quantitative measure of health as judged by the patient.", "time_frame": "Up to 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "10-Meter Walk Test", "description": "The scoring for the 10-meter walk test involves recording the time it takes to walk 10 meters and then calculating walking speed in meters per second (m/s). The test typically measures the time it takes to walk the middle 6 meters of a 10-meter walk, allowing for acceleration and deceleration.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Root mean square of successive differences between normal heartbeats (RMSSD)", "description": "The RMSSD is obtained by first calculating each successive time difference between heartbeats in ms. Then, each of the values is squared and the result is averaged before the square root of the total is obtained. This is a measure of parasympathetic nervous system function. Higher RMSSD values generally indicate greater parasympathetic activity and a more resilient heart.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "BrainCheck Cognitive Assessment Battery", "description": "The BrainCheck software is an advanced digital cognitive assessment completed on a computer or tablet. Scores within one standard deviation of the mean are considered normal, while scores outside this range may suggest cognitive impairment.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "General Symptom Questionnaire (GSQ-30)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Medical Research Council Breathlessness Scale (MRC)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)", "description": "The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) is a tool used to identify and classify pain, particularly neuropathic pain, based on a patient's reported symptoms and signs of nerve damage. A score of 12 or more on the LANSS is generally considered indicative of neuropathic pain.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-2)", "description": "A PHQ-2 score ranges from 0 to 6, with 3 being the optimal cut-off point for depression screening. A score of 3 or higher indicates a high probability of major depressive disorder. A score of 2 or higher may be preferred in situations where clinicians want to ensure that few cases of depression are missed.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD-7)", "description": "The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Neuro-QoL™ v2.0 Cognitive Function-Short Form", "description": "The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "The Fatigue Severity Scale (FSS) uses a 7-point scale (1-7) to assess fatigue, with higher scores indicating greater severity, and a total score ranging from 9 to 63. Higher scores indicate more severe fatigue.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "DePaul Post-Exertional Malaise Questionnaire (DSQ)", "description": "The DSQ is designed to evaluate 54 classic ME/CFS symptoms, including fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments, and autonomic, neuroendocrine, and immune symptoms. Each symptom's frequency and intensity are rated on a 5-point scale (0-4). Frequency and severity scores are multiplied by 25, added together, and then divided by 2 to create a composite frequency/severity score for each symptom. These scores range from 0 to 100, with higher scores indicating a greater symptom burden.", "time_frame": "Up to 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "EuroQol Visual Analogue Scale Score (EQ-VAS)", "description": "The EQ VAS is a visual analogue scale that allows individuals to rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health), providing a quantitative measure of health as judged by the patient.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "10-Meter Walk Test", "description": "The scoring for the 10-meter walk test involves recording the time it takes to walk 10 meters and then calculating walking speed in meters per second (m/s). The test typically measures the time it takes to walk the middle 6 meters of a 10-meter walk, allowing for acceleration and deceleration.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Root mean square of successive differences between normal heartbeats (RMSSD)", "description": "The RMSSD is obtained by first calculating each successive time difference between heartbeats in ms. Then, each of the values is squared and the result is averaged before the square root of the total is obtained. This is a measure of parasympathetic nervous system function. Higher RMSSD values generally indicate greater parasympathetic activity and a more resilient heart.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "BrainCheck Cognitive Assessment Battery", "description": "The BrainCheck software is an advanced digital cognitive assessment completed on a computer or tablet. Scores within one standard deviation of the mean are considered normal, while scores outside this range may suggest cognitive impairment.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "General Symptom Questionnaire (GSQ-30)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Medical Research Council Breathlessness Scale (MRC)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)", "description": "The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) is a tool used to identify and classify pain, particularly neuropathic pain, based on a patient's reported symptoms and signs of nerve damage. A score of 12 or more on the LANSS is generally considered indicative of neuropathic pain.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-2)", "description": "A PHQ-2 score ranges from 0 to 6, with 3 being the optimal cut-off point for depression screening. A score of 3 or higher indicates a high probability of major depressive disorder. A score of 2 or higher may be preferred in situations where clinicians want to ensure that few cases of depression are missed.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD-7)", "description": "The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Neuro-QoL™ v2.0 Cognitive Function-Short Form", "description": "The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "The Fatigue Severity Scale (FSS) uses a 7-point scale (1-7) to assess fatigue, with higher scores indicating greater severity, and a total score ranging from 9 to 63. Higher scores indicate more severe fatigue.", "time_frame": "Up to 12 weeks" }, { "type": "secondary", "measure": "DePaul Post-Exertional Malaise Questionnaire (DSQ)", "description": "The DSQ is designed to evaluate 54 classic ME/CFS symptoms, including fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments, and autonomic, neuroendocrine, and immune symptoms. Each symptom's frequency and intensity are rated on a 5-point scale (0-4). Frequency and severity scores are multiplied by 25, added together, and then divided by 2 to create a composite frequency/severity score for each symptom. These scores range from 0 to 100, with higher scores indicating a greater symptom burden.", "time_frame": "Up to 12 weeks" } ], "relevance_tags": [ "General", "Phase 1", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06511050", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06511063", "title": "Antiviral Clinical Trial for Long Covid-19", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-03-13", "start_date": "2024-10-01", "completion_date": "2026-12", "primary_completion_date": "2026-11", "conditions_raw": [ "Long Covid" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Tenofovir Disoproxil/Emtricitabine", "Selzentry" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The trial will test if two repurposed HIV antivirals can reduce symptom burden in adult participants with Long Covid compared to placebo. Viral infection and viral reactivation have been documented in Long Covid.\n\nParticipants will be randomly allocated to receive antivirals, Truvada (tenofovir disoproxil/emtricitabine, TDF/FTC, Group 1) or Selzentry (Group 2), or a placebo (pill) (Group 3), taken daily for 90 days.", "primary_outcomes": [ { "type": "primary", "measure": "EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale", "description": "The EQ-5D-5L is a standardized measure of health status that consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each with 5 levels of severity, and a visual analogue scale (VAS) where individuals rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health).", "time_frame": "at Screening, Day 60, Day 90, and Day 180" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)", "description": "The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "General Symptom Questionnaire (GSQ-30)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a series of questions assessing presence and severity of depression symptoms. It evaluates each of the DSM-IV depression criteria and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Full scale from 0-27, with higher score indicating more severe symptoms.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD-7)", "description": "The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Neuro-QoL™ v2.0 Cognitive Function-Short Form", "description": "The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Single-item Sleep Quality Scale (SQS)", "description": "The SQS is a visual analog scale that instructs respondents to rate their overall quality of sleep over a 7-day recall period from 0 to 10. Scores of 0, 1, 4, 7, and 10 correspond to terrible, poor, fair, good, and excellent, respectively. Higher scores indicate better sleep quality.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale (FSS) uses a 7-point scale (1-7) to assess fatigue, with higher scores indicating greater severity, and a total score ranging from 9 to 63. Higher scores indicate more severe fatigue.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Fatigue Visual Analogue Scale (F-VAS)", "description": "The F-VAS consists of 18 items related to fatigue and energy in a visual analogue scale from 0 to 100. A higher score indicates more fatigue.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "DePaul Post-Exertional Malaise Questionnaire (DSQ)", "description": "The DSQ is designed to evaluate 54 classic ME/CFS symptoms, including fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments, and autonomic, neuroendocrine, and immune symptoms. Each symptom's frequency and intensity are rated on a 5-point scale (0-4). Frequency and severity scores are multiplied by 25, added together, and then divided by 2 to create a composite frequency/severity score for each symptom. These scores range from 0 to 100, with higher scores indicating a greater symptom burden.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Composite Autonomic Symptom Score 31(COMPASS-31)", "description": "The COMPASS-31 is a 31-question self-assessment instrument of autonomic symptoms and function that is up-to-date, broadly applicable, easy to administer in a short amount of time, and based on a scientific approach. The total score ranges from 0 to 100, with higher scores indicating greater autonomic dysfunction.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Pain Visual Analogue Scale (P-VAS)", "description": "Using a visual analogue scale, patients mark a point on a line representing a continuum from \"no pain\" to \"worst pain,\" with scores ranging from 0 to 100, where higher scores indicate greater pain.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" } ], "outcome_measures": [ { "type": "primary", "measure": "EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale", "description": "The EQ-5D-5L is a standardized measure of health status that consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each with 5 levels of severity, and a visual analogue scale (VAS) where individuals rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health).", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)", "description": "The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "General Symptom Questionnaire (GSQ-30)", "description": "The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a series of questions assessing presence and severity of depression symptoms. It evaluates each of the DSM-IV depression criteria and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Full scale from 0-27, with higher score indicating more severe symptoms.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD-7)", "description": "The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 (\"Not at all\") to 3 (\"Nearly every day\"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Neuro-QoL™ v2.0 Cognitive Function-Short Form", "description": "The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Single-item Sleep Quality Scale (SQS)", "description": "The SQS is a visual analog scale that instructs respondents to rate their overall quality of sleep over a 7-day recall period from 0 to 10. Scores of 0, 1, 4, 7, and 10 correspond to terrible, poor, fair, good, and excellent, respectively. Higher scores indicate better sleep quality.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale (FSS) uses a 7-point scale (1-7) to assess fatigue, with higher scores indicating greater severity, and a total score ranging from 9 to 63. Higher scores indicate more severe fatigue.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Fatigue Visual Analogue Scale (F-VAS)", "description": "The F-VAS consists of 18 items related to fatigue and energy in a visual analogue scale from 0 to 100. A higher score indicates more fatigue.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "DePaul Post-Exertional Malaise Questionnaire (DSQ)", "description": "The DSQ is designed to evaluate 54 classic ME/CFS symptoms, including fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments, and autonomic, neuroendocrine, and immune symptoms. Each symptom's frequency and intensity are rated on a 5-point scale (0-4). Frequency and severity scores are multiplied by 25, added together, and then divided by 2 to create a composite frequency/severity score for each symptom. These scores range from 0 to 100, with higher scores indicating a greater symptom burden.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Composite Autonomic Symptom Score 31(COMPASS-31)", "description": "The COMPASS-31 is a 31-question self-assessment instrument of autonomic symptoms and function that is up-to-date, broadly applicable, easy to administer in a short amount of time, and based on a scientific approach. The total score ranges from 0 to 100, with higher scores indicating greater autonomic dysfunction.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" }, { "type": "secondary", "measure": "Pain Visual Analogue Scale (P-VAS)", "description": "Using a visual analogue scale, patients mark a point on a line representing a continuum from \"no pain\" to \"worst pain,\" with scores ranging from 0 to 100, where higher scores indicate greater pain.", "time_frame": "at Screening, Day 60, Day 90, and Day 180" } ], "relevance_tags": [ "Repurposed", "Persistence / Antiviral", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 90, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06511063", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06437223", "title": "Study of Xiflam™ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID (LC)", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-03-06", "start_date": "2024-03-12", "completion_date": "2025-09-30", "primary_completion_date": "2025-09-30", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Tonabersat" ], "sponsor": "Inflammx Therapeutics Inc", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The primary objective of this study is to evaluate the safety and efficacy of Xiflam versus Placebo in patients who present with signs and symptoms of Long COVID.\n\nXiflam (n=10) or placebo (n=5) will be administered orally once a day (QD) for 12 weeks.", "primary_outcomes": [ { "type": "primary", "measure": "Primary Endpoint", "description": "Primary outcomes are change from baseline for signs and symptoms measured by a Visual Analogue Scale (VAS) instrument. Reporting done by the patient on a 0-100 scale. Scale measures severity from none (0) to severe (100) for multiple signs and symptoms, for the different systems involved in this disease state (see below)\n\n1. General health\n2. Neurological signs/symptoms\n3. Ocular signs/symptoms\n4. Respiratory signs/symptoms\n5. Gastrointestinal signs/symptoms\n6. Cardiovascular signs/symptoms\n7. Musculoskeletal signs/symptoms\n8. Dermatological signs/symptoms\n9. Mental Health signs/symptoms\n10. Miscellaneous signs/symptoms which may not be captured above.\n\nSince Long COVID is a multi-system disease, patients will only score on the severity scale of the signs/symptoms which are of clinical significance to that particular patient.", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Secondary Endpoint", "description": "Complete Blood Count (CBC) including biomarkers of inflammation Physical Examination including electrocardiogram (EKG)\n\nChange in laboratory values including inflammatory markers, e.g., C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), Antinuclear Antibody (ANA)", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Primary Endpoint", "description": "Primary outcomes are change from baseline for signs and symptoms measured by a Visual Analogue Scale (VAS) instrument. Reporting done by the patient on a 0-100 scale. Scale measures severity from none (0) to severe (100) for multiple signs and symptoms, for the different systems involved in this disease state (see below)\n\n1. General health\n2. Neurological signs/symptoms\n3. Ocular signs/symptoms\n4. Respiratory signs/symptoms\n5. Gastrointestinal signs/symptoms\n6. Cardiovascular signs/symptoms\n7. Musculoskeletal signs/symptoms\n8. Dermatological signs/symptoms\n9. Mental Health signs/symptoms\n10. Miscellaneous signs/symptoms which may not be captured above.\n\nSince Long COVID is a multi-system disease, patients will only score on the severity scale of the signs/symptoms which are of clinical significance to that particular patient.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Secondary Endpoint", "description": "Complete Blood Count (CBC) including biomarkers of inflammation Physical Examination including electrocardiogram (EKG)\n\nChange in laboratory values including inflammatory markers, e.g., C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), Antinuclear Antibody (ANA)", "time_frame": "12 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 16, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06437223", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06452095", "title": "Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hyperbaric Oxygen Therapy for the Treatment of Post COVID Condition", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-02-23", "start_date": "2026-01-01", "completion_date": "2029-12-31", "primary_completion_date": "2029-12-31", "conditions_raw": [ "Long COVID", "Post Acute Sequelae of COVID-19", "Post-COVID-19 Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Hyperbaric Oxygen Therapy (HBOT)" ], "sponsor": "University Health Network, Toronto", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The RECLAIM study platform will be used to explore whether the use of Hyperbaric Oxygen therapy (HBOT) improves the symptoms of post covid cognitive dysfunction.\n\nHyperbaric oxygen therapy is a well-established medical treatment. HBOT promotes healing by delivering a high concentration of oxygen into the body. This high level of oxygen has a number of known benefits, such as growth of new blood vessels, as well as regulating immune and inflammation responses. It helps protect the brain and other nervous tissue from inflammation. HBOT may also have antiviral effects.\n\nCollectively, it has the potential to target the underlying mechanisms believed to play a critical role in the development of Long COVID.\n\nMany individuals with Long COVID complain of fatigue, brain fog, muscle aches and other symptoms. There is evidence to suggest that these symptoms may be a problem with the blood vessels, resulting in abnormal delivery of oxygen to tissues. Thus, our group is investigating whether HBOT improves post-COVID cognitive dysfunction.", "primary_outcomes": [ { "type": "primary", "measure": "Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit", "description": "On-line survey tool", "time_frame": "Baseline/Start of intervention to two months" }, { "type": "primary", "measure": "Verbal paired associates [VPA] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit", "description": "On-line survey tool", "time_frame": "Baseline/Start of intervention to two months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptoms scale", "description": "Three point Likert scale assessing how bothersome symptoms are on a weekly basis for two months then monthly until end of study, as reported by the participant: to provide a granular, detailed picture of the symptom trajectory.", "time_frame": "Baseline/start of intervention weekly to 2 months, then once monthly to 6 months." }, { "type": "secondary", "measure": "Symptom Checklist", "description": "Symptom Checklist (adapted from the De Paul Symptom Questionnaire (DSQ2), the World Health Organization Global COVID-19 Clinical Platform's Post COVID-19 CRF and the Symptom Burden Questionnaire for Long COVID): to track symptom trajectory.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Six Minute Walking Test (6MWT) with oximetry", "description": "Subjects walk as far as they can in six minutes while receiving maximum encouragement. It is simple to execute, inexpensive, standardized and gives a tangible measure of functional exercise capacity. It has been validated in many different populations. The 6MWT will be conducted according to American Thoracic Society standards.", "time_frame": "Baseline/start of intervention and 2 months." }, { "type": "secondary", "measure": "SF-36", "description": "The self-administered SF-36 evaluates eight health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning-emotional, and mental health. Previous studies have used this instrument in many different populations and it takes approximately 15 minutes to complete.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "TestMyBrain cognitive testing", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test battery includes:\n\nTMB Verbal Paired Associates (Concrete), TMB Digit Span - Backward, TMB Digit Span - Forward, TMB Choice Reaction Time, TMB Simple Reaction Time, TMB Gradual Onset Continuous Performance Task. The test battery will take about 20 minutes to complete and will assess: verbal, episodic and working memory, attention, processing speed, basic psychomotor response speed, and cognitive control.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Post COVID19 functional status scale", "description": "The post-COVID-19 functional status (PCFS) scale focuses on relevant aspects of daily life during follow-up after the infection. The scale is intended to help users become aware of current functional limitations in COVID-19 patients, whether or not as a result of the specific infection, and to objectively determine this degree of disability. The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle. The PCFS demonstrates good construct validity.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Reintegration to Normal Living Index (RNLI)", "description": "This short self-administered assessment tool will determine the degree to which participants reintegrate into normal social activities such as recreation, mobility in the community and interaction in family and other relationships. This tool has been validated in community living adults with mobility limitations.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "The Fatigue Scale", "description": "The Fatigue Scale was adapted from the De Paul Symptom Questionnaire (DSQ2)'s 38 questions assessing medical history of Myalgic Encephalitis/Chronic Fatigue Syndrome (ME/CFS), comorbidities, medications, impact on quality of life and daily activities, etc.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Brief Fatigue inventory", "description": "The self-administered Brief Fatigue Inventory is composed of 9 items evaluated on a 10-point scale, assessing severity of fatigue and impact of fatigue on daily life. It takes approximately 2-3 minutes to complete.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "The self-administered DPEMQ is comprised of three sections assessing post-exertional malaise (PEM): (i) onset and triggers of PEM (9 questions), (ii) consequences and symptoms (14 questions), (iii) duration, recovery and pacing (7 questions).", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - General Anxiety Assessment Form (GAD-7)", "description": "The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. It is an easy-to-use, self-administered patient questionnaire that can be completed in minutes.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a validated, multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It incorporates Diagnostic and Statistical Manual 1V (DSM-IV) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The PHQ-9 is brief and useful in clinical practice.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Dyspnea", "description": "Assessed using the Borg Dyspnea scale. This short assessment tool assesses perceived shortness of breath on exertion using a 10 point scale as assessed by the patient.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Blood samples", "description": "Blood samples will be used in correlative studies using advanced multi-omic and machine learning techniques to better understand our results so as to identify phenotypes that will benefit from specific therapies", "time_frame": "Baseline/start of intervention and 2 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit", "description": "On-line survey tool", "time_frame": "Baseline/Start of intervention to two months" }, { "type": "primary", "measure": "Verbal paired associates [VPA] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit", "description": "On-line survey tool", "time_frame": "Baseline/Start of intervention to two months" }, { "type": "secondary", "measure": "Symptoms scale", "description": "Three point Likert scale assessing how bothersome symptoms are on a weekly basis for two months then monthly until end of study, as reported by the participant: to provide a granular, detailed picture of the symptom trajectory.", "time_frame": "Baseline/start of intervention weekly to 2 months, then once monthly to 6 months." }, { "type": "secondary", "measure": "Symptom Checklist", "description": "Symptom Checklist (adapted from the De Paul Symptom Questionnaire (DSQ2), the World Health Organization Global COVID-19 Clinical Platform's Post COVID-19 CRF and the Symptom Burden Questionnaire for Long COVID): to track symptom trajectory.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Six Minute Walking Test (6MWT) with oximetry", "description": "Subjects walk as far as they can in six minutes while receiving maximum encouragement. It is simple to execute, inexpensive, standardized and gives a tangible measure of functional exercise capacity. It has been validated in many different populations. The 6MWT will be conducted according to American Thoracic Society standards.", "time_frame": "Baseline/start of intervention and 2 months." }, { "type": "secondary", "measure": "SF-36", "description": "The self-administered SF-36 evaluates eight health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning-emotional, and mental health. Previous studies have used this instrument in many different populations and it takes approximately 15 minutes to complete.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "TestMyBrain cognitive testing", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test battery includes:\n\nTMB Verbal Paired Associates (Concrete), TMB Digit Span - Backward, TMB Digit Span - Forward, TMB Choice Reaction Time, TMB Simple Reaction Time, TMB Gradual Onset Continuous Performance Task. The test battery will take about 20 minutes to complete and will assess: verbal, episodic and working memory, attention, processing speed, basic psychomotor response speed, and cognitive control.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Post COVID19 functional status scale", "description": "The post-COVID-19 functional status (PCFS) scale focuses on relevant aspects of daily life during follow-up after the infection. The scale is intended to help users become aware of current functional limitations in COVID-19 patients, whether or not as a result of the specific infection, and to objectively determine this degree of disability. The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle. The PCFS demonstrates good construct validity.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Reintegration to Normal Living Index (RNLI)", "description": "This short self-administered assessment tool will determine the degree to which participants reintegrate into normal social activities such as recreation, mobility in the community and interaction in family and other relationships. This tool has been validated in community living adults with mobility limitations.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "The Fatigue Scale", "description": "The Fatigue Scale was adapted from the De Paul Symptom Questionnaire (DSQ2)'s 38 questions assessing medical history of Myalgic Encephalitis/Chronic Fatigue Syndrome (ME/CFS), comorbidities, medications, impact on quality of life and daily activities, etc.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Brief Fatigue inventory", "description": "The self-administered Brief Fatigue Inventory is composed of 9 items evaluated on a 10-point scale, assessing severity of fatigue and impact of fatigue on daily life. It takes approximately 2-3 minutes to complete.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "The self-administered DPEMQ is comprised of three sections assessing post-exertional malaise (PEM): (i) onset and triggers of PEM (9 questions), (ii) consequences and symptoms (14 questions), (iii) duration, recovery and pacing (7 questions).", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - General Anxiety Assessment Form (GAD-7)", "description": "The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. It is an easy-to-use, self-administered patient questionnaire that can be completed in minutes.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a validated, multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It incorporates Diagnostic and Statistical Manual 1V (DSM-IV) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The PHQ-9 is brief and useful in clinical practice.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Dyspnea", "description": "Assessed using the Borg Dyspnea scale. This short assessment tool assesses perceived shortness of breath on exertion using a 10 point scale as assessed by the patient.", "time_frame": "Baseline/start of intervention to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Blood samples", "description": "Blood samples will be used in correlative studies using advanced multi-omic and machine learning techniques to better understand our results so as to identify phenotypes that will benefit from specific therapies", "time_frame": "Baseline/start of intervention and 2 months" } ], "relevance_tags": [ "Immunomodulatory", "Persistence / Antiviral", "Neurological / Autonomic", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06452095", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05513560", "title": "RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-02-23", "start_date": "2023-05-31", "completion_date": "2025-12-31", "primary_completion_date": "2025-03-31", "conditions_raw": [ "Long COVID", "Post COVID Condition", "Post Acute Sequelae of COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ibudilast", "Pentoxifylline" ], "sponsor": "University Health Network, Toronto", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The researchers propose to develop a Canada-wide, adaptive randomized clinical platform trial to assess the effectiveness of various interventions in patients with lingering symptoms of COVID-19 (\"Long COVID\"). Participants will be randomized initially to 1 of 3 arms, including placebo (control) and 2 interventions. Because this is an adaptive trial, arms can be dropped if found to be ineffective and new arms can be added.\n\nInterventions will last for 2 months and participants will be followed for an additional 4 months (6 months total). Approximately 800-1000 patients with Long COVID will be recruited across Canada. Results from this trial will accelerate the availability of high-quality, real-time evidence and solutions to enable Canada to improve the clinical care of patients with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "SF-36 physical component score (PCS)", "description": "mean change in the SF-36 (v.1) physical component score (PCS)", "time_frame": "from baseline to two months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptoms scale", "description": "Three point Likert scale assessing how bothersome symptoms are on a weekly basis for two months then monthly until end of study, as reported by the participant: to provide a granular, detailed picture of the symptom trajectory.", "time_frame": "Baseline/Randomization weekly to 2 months, then once monthly to 6 months." }, { "type": "secondary", "measure": "Symptom Checklist", "description": "Symptom Checklist (adapted from the De Paul Symptom Questionnaire (DSQ2), the World Health Organization Global COVID-19 Clinical Platform's Post COVID-19 CRF and the Symptom Burden Questionnaire for Long COVID): to track symptom trajectory.", "time_frame": "Baseline/Randomization weekly to 2 months, then once monthly to 6 months." }, { "type": "secondary", "measure": "Six Minute Walking Test (6MWT) with oximetry", "description": "Subjects walk as far as they can in six minutes while receiving maximum encouragement. It is simple to execute, inexpensive, standardized and gives a tangible measure of functional exercise capacity. It has been validated in many different populations. The 6MWT will be conducted according to American Thoracic Society standards.", "time_frame": "Baseline/Randomization and 2 months" }, { "type": "secondary", "measure": "TestMyBrain cognitive testing", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test battery will take about 20 minutes to complete and will assess: verbal, episodic and working memory, attention, processing speed, basic psychomotor response speed, and cognitive control.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Post COVID19 functional status scale", "description": "The post-COVID-19 functional status (PCFS) scale focuses on relevant aspects of daily life during follow-up after the infection. The scale is intended to help users become aware of current functional limitations in COVID-19 patients, whether or not as a result of the specific infection, and to objectively determine this degree of disability. The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle. The PCFS demonstrates good construct validity.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Reintegration to Normal Living Index (RNLI)", "description": "This short self-administered assessment tool will determine the degree to which participants reintegrate into normal social activities such as recreation, mobility in the community and interaction in family and other relationships. This tool has been validated in community living adults with mobility limitations.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Fatigue Scale", "description": "The Fatigue Scale was adapted from the De Paul Symptom Questionnaire (DSQ2)'s 38 questions assessing medical history of Myalgic Encephalitis/Chronic Fatigue Syndrome (ME/CFS), comorbidities, medications, impact on quality of life and daily activities, etc.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Brief Fatigue inventory", "description": "The self-administered Brief Fatigue Inventory is composed of 9 items evaluated on a 10-point scale, assessing severity of fatigue and impact of fatigue on daily life. It takes approximately 2-3 minutes to complete.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "The self-administered DPEMQ is comprised of three sections assessing post-exertional malaise (PEM): (i) onset and triggers of PEM (9 questions), (ii) consequences and symptoms (14 questions), (iii) duration, recovery and pacing (7 questions).", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - Post-traumatic Stress Disorder Checklist (PCL-5)", "description": "The PCL-5 is a validated, reliable, 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual 5 (DSM-5) symptoms of Post-Traumatic Stress Disorder (PTSD). It takes approximately 5-10 minutes to complete.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - General Anxiety Assessment Form (GAD-7)", "description": "The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. It is an easy-to-use, self-administered patient questionnaire that can be completed in minutes.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a validated, multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It incorporates Diagnostic and Statistical Manual 1V (DSM-IV) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The PHQ-9 is brief and useful in clinical practice.\n\nThe PHQ-9 is completed by the patient in minutes and is rapidly scored by the clinician. The PHQ-9 can also be administered repeatedly, which can reflect improvement or worsening of depression in response to treatment.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health Composite score (MCS) of the SF-36", "description": "The self-administered SF-36 evaluates eight health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning-emotional, and mental health. Previous studies have used this instrument in many different populations and it takes approximately 15 minutes to complete.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Dyspnea", "description": "Assessed using the Borg Dyspnea scale. This short assessment tool assesses perceived shortness of breath on exertion using a 10 point scale as assessed by the patient.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Blood samples", "description": "Blood samples will be used in correlative studies using advanced multi-omic and machine learning methods to better understand our results so as to identify phenotypes that will benefit from specific therapies", "time_frame": "Baseline/Randomization and 2 months" } ], "outcome_measures": [ { "type": "primary", "measure": "SF-36 physical component score (PCS)", "description": "mean change in the SF-36 (v.1) physical component score (PCS)", "time_frame": "from baseline to two months" }, { "type": "secondary", "measure": "Symptoms scale", "description": "Three point Likert scale assessing how bothersome symptoms are on a weekly basis for two months then monthly until end of study, as reported by the participant: to provide a granular, detailed picture of the symptom trajectory.", "time_frame": "Baseline/Randomization weekly to 2 months, then once monthly to 6 months." }, { "type": "secondary", "measure": "Symptom Checklist", "description": "Symptom Checklist (adapted from the De Paul Symptom Questionnaire (DSQ2), the World Health Organization Global COVID-19 Clinical Platform's Post COVID-19 CRF and the Symptom Burden Questionnaire for Long COVID): to track symptom trajectory.", "time_frame": "Baseline/Randomization weekly to 2 months, then once monthly to 6 months." }, { "type": "secondary", "measure": "Six Minute Walking Test (6MWT) with oximetry", "description": "Subjects walk as far as they can in six minutes while receiving maximum encouragement. It is simple to execute, inexpensive, standardized and gives a tangible measure of functional exercise capacity. It has been validated in many different populations. The 6MWT will be conducted according to American Thoracic Society standards.", "time_frame": "Baseline/Randomization and 2 months" }, { "type": "secondary", "measure": "TestMyBrain cognitive testing", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test battery will take about 20 minutes to complete and will assess: verbal, episodic and working memory, attention, processing speed, basic psychomotor response speed, and cognitive control.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Post COVID19 functional status scale", "description": "The post-COVID-19 functional status (PCFS) scale focuses on relevant aspects of daily life during follow-up after the infection. The scale is intended to help users become aware of current functional limitations in COVID-19 patients, whether or not as a result of the specific infection, and to objectively determine this degree of disability. The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle. The PCFS demonstrates good construct validity.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Reintegration to Normal Living Index (RNLI)", "description": "This short self-administered assessment tool will determine the degree to which participants reintegrate into normal social activities such as recreation, mobility in the community and interaction in family and other relationships. This tool has been validated in community living adults with mobility limitations.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Fatigue Scale", "description": "The Fatigue Scale was adapted from the De Paul Symptom Questionnaire (DSQ2)'s 38 questions assessing medical history of Myalgic Encephalitis/Chronic Fatigue Syndrome (ME/CFS), comorbidities, medications, impact on quality of life and daily activities, etc.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Brief Fatigue inventory", "description": "The self-administered Brief Fatigue Inventory is composed of 9 items evaluated on a 10-point scale, assessing severity of fatigue and impact of fatigue on daily life. It takes approximately 2-3 minutes to complete.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "The self-administered DPEMQ is comprised of three sections assessing post-exertional malaise (PEM): (i) onset and triggers of PEM (9 questions), (ii) consequences and symptoms (14 questions), (iii) duration, recovery and pacing (7 questions).", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - Post-traumatic Stress Disorder Checklist (PCL-5)", "description": "The PCL-5 is a validated, reliable, 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual 5 (DSM-5) symptoms of Post-Traumatic Stress Disorder (PTSD). It takes approximately 5-10 minutes to complete.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - General Anxiety Assessment Form (GAD-7)", "description": "The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. It is an easy-to-use, self-administered patient questionnaire that can be completed in minutes.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health - Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a validated, multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It incorporates Diagnostic and Statistical Manual 1V (DSM-IV) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The PHQ-9 is brief and useful in clinical practice.\n\nThe PHQ-9 is completed by the patient in minutes and is rapidly scored by the clinician. The PHQ-9 can also be administered repeatedly, which can reflect improvement or worsening of depression in response to treatment.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Mental Health Composite score (MCS) of the SF-36", "description": "The self-administered SF-36 evaluates eight health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning-emotional, and mental health. Previous studies have used this instrument in many different populations and it takes approximately 15 minutes to complete.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Dyspnea", "description": "Assessed using the Borg Dyspnea scale. This short assessment tool assesses perceived shortness of breath on exertion using a 10 point scale as assessed by the patient.", "time_frame": "Baseline/Randomization to 1, 2 months 3 and 6 months" }, { "type": "secondary", "measure": "Blood samples", "description": "Blood samples will be used in correlative studies using advanced multi-omic and machine learning methods to better understand our results so as to identify phenotypes that will benefit from specific therapies", "time_frame": "Baseline/Randomization and 2 months" } ], "relevance_tags": [ "General", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 460, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05513560", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05911906", "title": "An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2026-02-20", "start_date": "2024-10-08", "completion_date": "2025-09-17", "primary_completion_date": "2025-09-17", "conditions_raw": [ "SARS-CoV-2 Infection", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Remdesivir" ], "sponsor": "University of Derby", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Following an infection with Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV2), one in ten people will experience persisting symptoms, or develop symptoms which can last for months and even years. These symptoms affect people in different ways and have been demonstrated to broadly impact physical, mental, and cognitive health. This is called Long COVID. Currently, there are no treatments available to address the issues that patients experience but anti-viral medications have been suggested as being potentially effective. This study will recruit patients that have confirmed long COVID and participants will undertake a series of tests to determine their symptoms and the impact that their condition has had on their bodily systems. The total duration of each participant's involvement is approximately 8 weeks, and this will involve 13 visits (15 visits if taking part in Exeter) at the closest study location (Derby or Exeter). Initial assessments are conducted over three separate visits and then all participants will be scheduled to receive five consecutive days of a medication that has been identified as having the potential to reduce the impact of Long COVID. Following a period of 28 days, participants will be invited to repeat the same tests that were conducted before receiving the medication so that it can be determined how well the drug has worked. In this study we are specifically collecting information to understand how feasible this medication could be to help patients improve their condition and this will help us to determine how likely this drug is able to be used within the wider Long COVID community.\n\nThe medication that will be used within this study is an existing anti-viral medication (Remdesivir). If we find patients are able to tolerate the treatment and the research tasks we will use this information to conduct a larger trial to determine how well this drug can be used to reduce the impact of Long COVID in a greater number of patients.", "primary_outcomes": [ { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "To ascertain screening and recruitment rates (overall and by different recruitment pathways).", "time_frame": "55 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Retention and dropout rate (due to the treatment and/or trial demands, overall and by centre):", "time_frame": "55 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Adherence to treatment regimen (attendance to 5 days of IMP).", "time_frame": "22 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Completeness of study assessments (CPET, Bloods and PET/CT if in Exeter).", "time_frame": "55 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Completeness of all data collection activities including baseline and +28 days after treatment.", "time_frame": "55 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Acceptability of outcome measurements (measured by completion rates).", "time_frame": "55 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Quality of life, functional status and symptom burden (Pre and Post Intervention Patient Reported Outcome Measures)", "time_frame": "52 days" }, { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Tolerance to physical stimulus: exercise tolerance and reduced post exertional symptom exacerbation following incremental exercise.", "time_frame": "52 days" }, { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Physiological function, physical function, cognitive function, and emotional status and/or capacity.", "time_frame": "52 days" }, { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Biomarker and inflammatory profiles", "time_frame": "52 days" }, { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Exeter patients only - Microvascular function: whole body FDG uptake using PET/CT methods.", "time_frame": "55 days" }, { "type": "secondary", "measure": "To determine the clinical safety and tolerance parameters of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "AE/SAE/AR/SAR/SUSAR", "time_frame": "55 days" } ], "outcome_measures": [ { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "To ascertain screening and recruitment rates (overall and by different recruitment pathways).", "time_frame": "55 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Retention and dropout rate (due to the treatment and/or trial demands, overall and by centre):", "time_frame": "55 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Adherence to treatment regimen (attendance to 5 days of IMP).", "time_frame": "22 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Completeness of study assessments (CPET, Bloods and PET/CT if in Exeter).", "time_frame": "55 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Completeness of all data collection activities including baseline and +28 days after treatment.", "time_frame": "55 days" }, { "type": "primary", "measure": "To assess the feasibility of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "Acceptability of outcome measurements (measured by completion rates).", "time_frame": "55 days" }, { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Quality of life, functional status and symptom burden (Pre and Post Intervention Patient Reported Outcome Measures)", "time_frame": "52 days" }, { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Tolerance to physical stimulus: exercise tolerance and reduced post exertional symptom exacerbation following incremental exercise.", "time_frame": "52 days" }, { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Physiological function, physical function, cognitive function, and emotional status and/or capacity.", "time_frame": "52 days" }, { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Biomarker and inflammatory profiles", "time_frame": "52 days" }, { "type": "secondary", "measure": "To identify the most clinically relevant primary outcome for the definitive study", "description": "Exeter patients only - Microvascular function: whole body FDG uptake using PET/CT methods.", "time_frame": "55 days" }, { "type": "secondary", "measure": "To determine the clinical safety and tolerance parameters of the use of Remdesivir in the treatment of patients with Long COVID.", "description": "AE/SAE/AR/SAR/SUSAR", "time_frame": "55 days" } ], "relevance_tags": [ "Persistence / Antiviral", "Neurological / Autonomic", "Phase 4", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 73, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05911906", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06391489", "title": "HOBSCOTCH for People With Post Acute COVID-19 Syndrome (PACS)", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-02-20", "start_date": "2024-05-14", "completion_date": "2026-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Post Acute COVID 19 Syndrome", "Memory Impairment", "Memory Dysfunction", "Cognitive Dysfunction" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Hobscotch-Pacs" ], "sponsor": "Dartmouth-Hitchcock Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Post Acute Covid Syndrome (PACS).\n\nThe main questions it aims to answer are:\n\nCan the current HOBSCOTCH program be adapted for people with PACS?\n\nWill people with PACS experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?\n\nParticipants will be asked to:\n\n* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PACS sessions with a one-on-one certified HOBSCOTCH-PACS coach\n* complete a brief clinical questionnaire about their diagnosis of PACS\n* complete seven questionnaires before and after the HOBSCOTCH-PACS sessions about their quality of life, memory and thinking processes (objective and subjective cognition), about their physical and mental health and about autonomic symptoms associated with their diagnosis of PACS\n* keep a short daily diary (using a smart phone app or on paper) about their PACS symptoms and use of the self-management strategies taught in the HOBSCOTCH-PACS program\n* complete two brief surveys to assess satisfaction with their experience after the entire HOBSCOTCH-PACS program", "primary_outcomes": [ { "type": "primary", "measure": "Change in overall quality of life as measured by comparing PROMIS-10 Global Health scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "PROMIS Global-10 is a validated 10-question survey and part of the Patient-Reported Outcomes Measurement Information System (PROMIS) used to assess health care-related quality of life. Measures include overall health, pain, fatigue, social health, mental health, and physical health. 9 of the items are scored on a Likert Scale of 1 - 5 with 5 representing the best health care-related quality of life; higher scores are associated with better quality of life. One item related to pain is measured on a scale of 1 - 10 with 10 being the worst possible pain.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "primary", "measure": "Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "The Cognitive Function sub-scale of the Neuro-QOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in objective cognition as measured by comparing Symbol-Digit Modalities Test scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "The Symbol Digit Modalities Test (SDMT) is a validated tool that measures cognitive processing speed. It requires a person to substitute a number (1 - 9), either orally or written, for randomized presentations of geometric figures over 90 seconds. Scores range between 0 and 100 with a lower score representing poorer performance.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in objective cognition as measured by comparing California Verbal Learning Test-III scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "The California Verbal Learning Test-III is a validated verbal learning and memory assessment. It consists of a 16-word, list-recall task with up to five learning/recall trials. Higher scores of recall over time are associated with better performance.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in objective cognition as measured by comparing Montreal Cognitive Assessment (MOCA) scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "The Montreal Cognitive Assessment (MOCA) is a validated 30 item test that helps healthcare professionals detect cognitive impairments. The test examines seven domains (aspects) of cognitive function with a total of 11 different exercises and tasks including: executive and visuospatial function, naming, attention, language, abstraction, delayed recall, orientation.\n\nScores range from 0 - 30 with higher scores indicating less cognitive impairment.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in self-reported autonomic symptoms as measured by comparing COMPASS-31 scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "COMPASS 31 is an abbreviated quantitative measure of autonomic symptoms based on the 169-item Autonomic Symptom Profile (ASP) and its validated 84-question scoring instrument, the Composite Autonomic Symptom Score (COMPASS). The six domain scores sum to a total COMPASS 31 score of 0 to 100, and a higher COMPASS 31 score indicates more severe autonomic symptoms.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in subjective physical and mental health as measured by comparing PROMIS-29+2 scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "PROMIS-29+2 is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It assesses pain intensity and seven health domains: physical functioning, fatigue, pain interference, depression, anxiety, social participation, and sleep disturbance in addition to two (+2) subjective cognition questions. The test is scored on a 5-point Likert scale, except for one question on subjective pain that uses a scale of 1 - 10. The domains are scored separately and compared to a mean score. Scores below 1 SD above the mean do not represent a problem for the person, or perhaps a mild concern. Between 1 and 2 SD reflect a moderate concern or interference in day to day function. Scores worse than 2SD beyond the mean score are considered to reflect poorer subjective physical or mental health.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in participants' self-reports of mood as measured by comparing scores on the PHQ-8 pre- and post-HOBSCOTCH-PACS intervention.", "description": "The PHQ-8 is a self-reported, standardized set of 8 questions used to assess the presence and severity of depression symptoms. It is a shortened version of the PHQ-9, omitting the last question about suicidal thoughts or self-harm. The items are scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Higher scores are consistent with greater symptoms of poor mood or depression.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in participants' self-reports of anxiety as measured by comparing scores on the GAD-7 pre- and post-HOBSCOTCH-PACS intervention.", "description": "The Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for measuring symptoms of generalized anxiety disorder (GAD). The seven items are scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Higher scores suggest greater symptoms of anxiety.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Changes in brain fog symptoms as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.", "description": "Participants will self-report their brain fog symptoms using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Changes in autonomic symptom frequency as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.", "description": "Participants will self-report their autonomic symptom frequency using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Changes in participants' use of memory strategies as measured by a daily self-reported diary compared at baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention.", "description": "Participants will self-report their use of the memory strategies they learn in the HOBSCOTCH-PACS program using a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in a paper log.", "time_frame": "Recorded daily and compared between baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention." }, { "type": "secondary", "measure": "Changes in participants' self-reports of wellbeing as measured by comparing daily reports of well-being at baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention.", "description": "Participants will self-report daily well-being information on a single item Likert-scale of well-being throughout the entire study by use of a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in paper log.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Evaluation of participants' engagement and compliance in HOBSCOTCH-PACS by measuring completed HOBSCOTCH sessions and use of smart phone app/daily diary from baseline (pre-HOBSCOTCH-PACS) through post-HOBSCOTCH-PACS intervention.", "description": "Participants' completed HOBSCOTCH-PACS sessions and smart phone app/daily diary logs will be assessed and recorded weekly. Greater number of sessions and daily diary records indicate better engagement and compliance.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Evaluation of participant satisfaction with the HOBSCOTCH-PACS intervention as measured by Satisfaction for PTE Participants as measured by analyzing a Participant Satisfaction Survey at the end of the study.", "description": "The Participant Satisfaction Survey has been developed through the original HOBSCOTH Institute at Dartmouth and is used in clinical practice for program evaluation and quality improvement. It contains 9 items scored on a 5-point Likert scale with a higher score indicating greater satisfaction with the program. Four open-ended questions exist for participants to express likes, dislikes, areas for improvement and additional comments.", "time_frame": "After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment." }, { "type": "secondary", "measure": "Evaluation of participants' perception of shared-decision making during HOBSCOTCH-PACS intervention as measured by CollaboRATE score.", "description": "CollaboRATE is a brief patient survey focused on shared decision making. It employs a 3-item assessment of patient perception of how much effort was made to hear, understand and incorporate their concerns into the program. The items are measured on a 10-point Likert scale in which 0 indicates that no effort was made and 9 indicates every effort was made. Higher scores indicate a greater degree or positive impression of patient perception of shared decision making.", "time_frame": "After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment." } ], "outcome_measures": [ { "type": "primary", "measure": "Change in overall quality of life as measured by comparing PROMIS-10 Global Health scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "PROMIS Global-10 is a validated 10-question survey and part of the Patient-Reported Outcomes Measurement Information System (PROMIS) used to assess health care-related quality of life. Measures include overall health, pain, fatigue, social health, mental health, and physical health. 9 of the items are scored on a Likert Scale of 1 - 5 with 5 representing the best health care-related quality of life; higher scores are associated with better quality of life. One item related to pain is measured on a scale of 1 - 10 with 10 being the worst possible pain.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "primary", "measure": "Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "The Cognitive Function sub-scale of the Neuro-QOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in objective cognition as measured by comparing Symbol-Digit Modalities Test scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "The Symbol Digit Modalities Test (SDMT) is a validated tool that measures cognitive processing speed. It requires a person to substitute a number (1 - 9), either orally or written, for randomized presentations of geometric figures over 90 seconds. Scores range between 0 and 100 with a lower score representing poorer performance.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in objective cognition as measured by comparing California Verbal Learning Test-III scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "The California Verbal Learning Test-III is a validated verbal learning and memory assessment. It consists of a 16-word, list-recall task with up to five learning/recall trials. Higher scores of recall over time are associated with better performance.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in objective cognition as measured by comparing Montreal Cognitive Assessment (MOCA) scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "The Montreal Cognitive Assessment (MOCA) is a validated 30 item test that helps healthcare professionals detect cognitive impairments. The test examines seven domains (aspects) of cognitive function with a total of 11 different exercises and tasks including: executive and visuospatial function, naming, attention, language, abstraction, delayed recall, orientation.\n\nScores range from 0 - 30 with higher scores indicating less cognitive impairment.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in self-reported autonomic symptoms as measured by comparing COMPASS-31 scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "COMPASS 31 is an abbreviated quantitative measure of autonomic symptoms based on the 169-item Autonomic Symptom Profile (ASP) and its validated 84-question scoring instrument, the Composite Autonomic Symptom Score (COMPASS). The six domain scores sum to a total COMPASS 31 score of 0 to 100, and a higher COMPASS 31 score indicates more severe autonomic symptoms.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in subjective physical and mental health as measured by comparing PROMIS-29+2 scores pre- and post-HOBSCOTCH-PACS intervention.", "description": "PROMIS-29+2 is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It assesses pain intensity and seven health domains: physical functioning, fatigue, pain interference, depression, anxiety, social participation, and sleep disturbance in addition to two (+2) subjective cognition questions. The test is scored on a 5-point Likert scale, except for one question on subjective pain that uses a scale of 1 - 10. The domains are scored separately and compared to a mean score. Scores below 1 SD above the mean do not represent a problem for the person, or perhaps a mild concern. Between 1 and 2 SD reflect a moderate concern or interference in day to day function. Scores worse than 2SD beyond the mean score are considered to reflect poorer subjective physical or mental health.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in participants' self-reports of mood as measured by comparing scores on the PHQ-8 pre- and post-HOBSCOTCH-PACS intervention.", "description": "The PHQ-8 is a self-reported, standardized set of 8 questions used to assess the presence and severity of depression symptoms. It is a shortened version of the PHQ-9, omitting the last question about suicidal thoughts or self-harm. The items are scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Higher scores are consistent with greater symptoms of poor mood or depression.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Change in participants' self-reports of anxiety as measured by comparing scores on the GAD-7 pre- and post-HOBSCOTCH-PACS intervention.", "description": "The Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for measuring symptoms of generalized anxiety disorder (GAD). The seven items are scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Higher scores suggest greater symptoms of anxiety.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Changes in brain fog symptoms as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.", "description": "Participants will self-report their brain fog symptoms using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Changes in autonomic symptom frequency as measured by comparing daily self-reported symptoms pre- and post-HOBSCOTCH-PACS intervention.", "description": "Participants will self-report their autonomic symptom frequency using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Changes in participants' use of memory strategies as measured by a daily self-reported diary compared at baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention.", "description": "Participants will self-report their use of the memory strategies they learn in the HOBSCOTCH-PACS program using a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in a paper log.", "time_frame": "Recorded daily and compared between baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention." }, { "type": "secondary", "measure": "Changes in participants' self-reports of wellbeing as measured by comparing daily reports of well-being at baseline/pre-HOBSCOTCH-PACS and post-HOBSCOTCH-PACS intervention.", "description": "Participants will self-report daily well-being information on a single item Likert-scale of well-being throughout the entire study by use of a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in paper log.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Evaluation of participants' engagement and compliance in HOBSCOTCH-PACS by measuring completed HOBSCOTCH sessions and use of smart phone app/daily diary from baseline (pre-HOBSCOTCH-PACS) through post-HOBSCOTCH-PACS intervention.", "description": "Participants' completed HOBSCOTCH-PACS sessions and smart phone app/daily diary logs will be assessed and recorded weekly. Greater number of sessions and daily diary records indicate better engagement and compliance.", "time_frame": "Baseline (pre-HOBSCOTCH-PACS) and post-HOBSCOTCH-PACS, approximately 9 weeks later." }, { "type": "secondary", "measure": "Evaluation of participant satisfaction with the HOBSCOTCH-PACS intervention as measured by Satisfaction for PTE Participants as measured by analyzing a Participant Satisfaction Survey at the end of the study.", "description": "The Participant Satisfaction Survey has been developed through the original HOBSCOTH Institute at Dartmouth and is used in clinical practice for program evaluation and quality improvement. It contains 9 items scored on a 5-point Likert scale with a higher score indicating greater satisfaction with the program. Four open-ended questions exist for participants to express likes, dislikes, areas for improvement and additional comments.", "time_frame": "After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment." }, { "type": "secondary", "measure": "Evaluation of participants' perception of shared-decision making during HOBSCOTCH-PACS intervention as measured by CollaboRATE score.", "description": "CollaboRATE is a brief patient survey focused on shared decision making. It employs a 3-item assessment of patient perception of how much effort was made to hear, understand and incorporate their concerns into the program. The items are measured on a 10-point Likert scale in which 0 indicates that no effort was made and 9 indicates every effort was made. Higher scores indicate a greater degree or positive impression of patient perception of shared decision making.", "time_frame": "After completion of the HOBSCOTCH-PACS intervention and all post-HOBSCOTCH-PACS assessments, approximately 9 weeks after enrollment." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 10, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06391489", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06305806", "title": "RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-02-20", "start_date": "2024-03-11", "completion_date": "2025-12-17", "primary_completion_date": "2025-10-13", "conditions_raw": [ "Long COVID", "Long Covid19", "Long Covid-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ivabradine", "Coordinated Care" ], "sponsor": "Kanecia Obie Zimmerman", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.\n\nThis protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score", "description": "The OHQ / OIQ is a measure of orthostatic intolerance and includes a 6-item symptom assessment (OHSA) and the 4-item Daily Activity Scale (OHDAS). Each item is scored from 0 (none/no interference) to 10 (worst possible/complete interference), describing the preceding week. The OHSA composite score is the average of the first 6 non-zero items and the OHDAS composite score is the average of the last 4 non-zero items. The OHQ/OIQ composite score is the average of the OHSA and OHDAS composite scores. The OHQ/OIQ scales at post-baseline are calculated using only those items that were included in the baseline scores.", "time_frame": "Baseline to End of Intervention (3 months)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Composite Autonomic Symptoms Score 31 (COMPASS-31)", "description": "The COMPASS-31 is a patient reported outcome that measures autonomic symptoms across multiple domains commonly seen in patients with PASC. Scores range from 0-100 with higher values representing severe symptoms.", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Change in Malmo POTS Symptom Score", "description": "The Malmo POTS symptom score assesses symptom burden in postural orthostatic tachycardia syndrome (POTS). It is a self-rating, 12-item score (0-10 per item, total range 0-120) based on patients' own perception of symptoms through visual analogue scale assessment. Higher scores represent more pronounced symptoms.", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Change in heart rate (HR)", "description": "measured during Active Stand Test", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Change in 6-min Walk Test", "description": "Normal walking speed will be measured using a standard 6 minute walk", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Change in PROMIS-29 + 2 Questionnaire", "description": "The PROMIS-29 consists of 29 items that assess general domains of health and functioning, including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.\n\nThe PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Scores will be reported as T scores ranging from 0 to 100, with a score of 60 being 1 standard deviation above the mean. Higher scores indicate worse overall health.", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Characterize the safety and tolerability of study intervention for treatment of PASC", "description": "Adverse events, including serious adverse events (SAEs) and events of special interest (ESIs). Proportion of participants who experience individual SAEs and the proportion who experience any one or more SAEs. Incidence of SAEs leading to discontinuation. Incidence of ESIs.", "time_frame": "Baseline to Follow-up (6 months)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score", "description": "The OHQ / OIQ is a measure of orthostatic intolerance and includes a 6-item symptom assessment (OHSA) and the 4-item Daily Activity Scale (OHDAS). Each item is scored from 0 (none/no interference) to 10 (worst possible/complete interference), describing the preceding week. The OHSA composite score is the average of the first 6 non-zero items and the OHDAS composite score is the average of the last 4 non-zero items. The OHQ/OIQ composite score is the average of the OHSA and OHDAS composite scores. The OHQ/OIQ scales at post-baseline are calculated using only those items that were included in the baseline scores.", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Change in Composite Autonomic Symptoms Score 31 (COMPASS-31)", "description": "The COMPASS-31 is a patient reported outcome that measures autonomic symptoms across multiple domains commonly seen in patients with PASC. Scores range from 0-100 with higher values representing severe symptoms.", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Change in Malmo POTS Symptom Score", "description": "The Malmo POTS symptom score assesses symptom burden in postural orthostatic tachycardia syndrome (POTS). It is a self-rating, 12-item score (0-10 per item, total range 0-120) based on patients' own perception of symptoms through visual analogue scale assessment. Higher scores represent more pronounced symptoms.", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Change in heart rate (HR)", "description": "measured during Active Stand Test", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Change in 6-min Walk Test", "description": "Normal walking speed will be measured using a standard 6 minute walk", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Change in PROMIS-29 + 2 Questionnaire", "description": "The PROMIS-29 consists of 29 items that assess general domains of health and functioning, including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.\n\nThe PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Scores will be reported as T scores ranging from 0 to 100, with a score of 60 being 1 standard deviation above the mean. Higher scores indicate worse overall health.", "time_frame": "Baseline to End of Intervention (3 months)" }, { "type": "secondary", "measure": "Characterize the safety and tolerability of study intervention for treatment of PASC", "description": "Adverse events, including serious adverse events (SAEs) and events of special interest (ESIs). Proportion of participants who experience individual SAEs and the proportion who experience any one or more SAEs. Incidence of SAEs leading to discontinuation. Incidence of ESIs.", "time_frame": "Baseline to Follow-up (6 months)" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 181, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06305806", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07418567", "title": "A Fasting Pilot Study for Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-02-18", "start_date": "2025-05-01", "completion_date": "2025-12-01", "primary_completion_date": "2025-11-01", "conditions_raw": [ "Long COVID Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Prolonged Fasting" ], "sponsor": "Université de Sherbrooke", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Background Long COVID (LC) is a chronic multisystemic condition which substantially impact the quality of life. Despite the staggering burden of LC, there is still no effective treatment.\n\nBecause fasting promotes anti-inflammatory and antioxidant responses, which are involved in the pathophysiology of LC, we hypothesized that it might improve daily functioning and health-related quality of life in patients with LC.\n\nThe aim of this single center, one arm, prospective pilot clinical trial will be to assess the feasibility and acceptability of prolonged fasting for LC. The main questions aims to answers are;\n\n1. Does in-home prolonged fasting (7 days) is feasible and acceptable for patients with LC\n2. Is there a clinical benefit associated with fasting is LC patients\n\nParticipants (adults 18 year and older) will be asked to\n\n1. Fast for 7 days\n2. Have in-person visit at baseline (day 0) and at day 9 for checkups and tests\n3. Answer difference questionnnaires about their perceived health during and after fasting", "primary_outcomes": [ { "type": "primary", "measure": "Feasibility and Acceptability", "description": "Retention rates will be used to measure feasibility and response to Likert-like questions for measuring acceptability", "time_frame": "From baseline (day 0) to end of follow up day 30" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Mean changes from baseline to one month post-fasting on the SF 36 physical component score questionnaire", "description": "The SF 36 questionnaire is a validated scale for assessment and monitoring of patients with LC. The 36-item scale includes 8 subscales : role functioning-physical, body pain, general health, vitality, social functioning, role functioning-emotional, and mental health.", "time_frame": "From baseline (day 0) to the end of follow up at day 30" } ], "outcome_measures": [ { "type": "primary", "measure": "Feasibility and Acceptability", "description": "Retention rates will be used to measure feasibility and response to Likert-like questions for measuring acceptability", "time_frame": "From baseline (day 0) to end of follow up day 30" }, { "type": "secondary", "measure": "Mean changes from baseline to one month post-fasting on the SF 36 physical component score questionnaire", "description": "The SF 36 questionnaire is a validated scale for assessment and monitoring of patients with LC. The 36-item scale includes 8 subscales : role functioning-physical, body pain, general health, vitality, social functioning, role functioning-emotional, and mental health.", "time_frame": "From baseline (day 0) to the end of follow up at day 30" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 25, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07418567", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06045338", "title": "Mind Body Intervention for Long COVID-19", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-02-18", "start_date": "2023-11-09", "completion_date": "2026-12", "primary_completion_date": "2026-09", "conditions_raw": [ "Long COVID", "Post-Acute Sequelae of COVID-19", "COVID Long-Haul" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Mind Body Intervention #1" ], "sponsor": "Beth Israel Deaconess Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with Long COVID. The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates individual somatic complaints and improves daily functioning, relative to usual care and the active control", "primary_outcomes": [ { "type": "primary", "measure": "Somatic Symptom Score-8 (SSS-8)", "description": "Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints. Range of 0-32, with higher scores indicating higher levels of discomfort.", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Short Form Brief Pain Inventory (BPI)", "description": "Used to gauge pain intensity, and pain interference with daily function over the duration of the study", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "Consists of statements relating to a patient's general level of fatigue and fatigue with specific activities. Range of 7-63, with higher scores indicating a higher degree of fatigue.", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "The Multidimensional Dyspnea Profile (MDP)", "description": "A survey that assesses perceived physical aspects of dyspnea and associated emotional effects. Each of the rating scales within the MDP is designed to measure a separate construct, though each can be grouped between the two above mentioned domains.", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder form 7 (GAD-7)", "description": "Self-report instrument assessing general anxiety over the last two weeks. Each of the 7 item is a statement concerning an anxiety trait, respondents then rate how often that statement is true. Responses range from 0 (not at all) to 3 (nearly every day).", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)", "description": "a standardized assessment of health-related quality of life", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "End of study measurements", "description": "Participants' subjective experience of the program upon completion", "time_frame": "13 weeks" }, { "type": "secondary", "measure": "Pain Anxiety Symptom Score-20 (Pass-20)", "description": "Anxiety from pain determined from 20 item survey, with each item being scored from 1-5 in terms of frequency", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "Patient Reported Outcomes Measurement Information System Survey for Cognitive Function (PROMIS SF v2.0 cognitive function 8a)", "description": "Cognition assessment", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Somatic Symptom Score-8 (SSS-8)", "description": "Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints. Range of 0-32, with higher scores indicating higher levels of discomfort.", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "Short Form Brief Pain Inventory (BPI)", "description": "Used to gauge pain intensity, and pain interference with daily function over the duration of the study", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "Consists of statements relating to a patient's general level of fatigue and fatigue with specific activities. Range of 7-63, with higher scores indicating a higher degree of fatigue.", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "The Multidimensional Dyspnea Profile (MDP)", "description": "A survey that assesses perceived physical aspects of dyspnea and associated emotional effects. Each of the rating scales within the MDP is designed to measure a separate construct, though each can be grouped between the two above mentioned domains.", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder form 7 (GAD-7)", "description": "Self-report instrument assessing general anxiety over the last two weeks. Each of the 7 item is a statement concerning an anxiety trait, respondents then rate how often that statement is true. Responses range from 0 (not at all) to 3 (nearly every day).", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)", "description": "a standardized assessment of health-related quality of life", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "End of study measurements", "description": "Participants' subjective experience of the program upon completion", "time_frame": "13 weeks" }, { "type": "secondary", "measure": "Pain Anxiety Symptom Score-20 (Pass-20)", "description": "Anxiety from pain determined from 20 item survey, with each item being scored from 1-5 in terms of frequency", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" }, { "type": "secondary", "measure": "Patient Reported Outcomes Measurement Information System Survey for Cognitive Function (PROMIS SF v2.0 cognitive function 8a)", "description": "Cognition assessment", "time_frame": "Baseline, 4 weeks, 8 weeks, 13 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 180, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06045338", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05445921", "title": "Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2026-02-12", "start_date": "2022-09-01", "completion_date": "2022-12-12", "primary_completion_date": "2022-12-12", "conditions_raw": [ "Anosmia", "Hyposmia", "Parosmia", "Olfactory Disorder" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Stellate Ganglion Block" ], "sponsor": "Washington University School of Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic olfactory dysfunction from the COVID-19 pandemic is a growing public health crisis with up to 1.2 million people in the Unites States affected. Olfactory dysfunction impacts one's quality of life significantly by decreasing the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to perform certain jobs. Olfactory dysfunction is also an independent predictor of anxiety, depression, and even mortality. While the pandemic has increased the interest by the scientific community in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Furthermore, patients impacted by \"long COVID,\" or chronic symptoms after an acute COVID-19 infection, experience impairments other than olfactory and gustatory dysfunction, such as chronic dyspnea, impaired memory and concentration, and severe fatigue. These symptoms have been hypothesized to be a result of sympathetic positive feedback loops and dysautonomia. Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous system. Studies prior to the COVID-19 pandemic have supported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, and recent news reports and a published case series have described a dramatic benefit in both olfactory function and other long COVID symptoms in patients receiving stellate ganglion blocks. Therefore, we propose a single cohort prospective study to generate pilot data on the efficacy and safety of sequential stellate ganglion blocks for the treatment of COVID-19-induced olfactory dysfunction and other long COVID symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Clinical Global Impression - Improvement (CGI-I) Score", "description": "Participants will be asked about their change in olfactory dysfunction on a 7-point Likert scale from much better to much worse.", "time_frame": "5-10 days post SGB #1 and 1 month" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "University of Pennsylvania Smell Identification Test (UPSIT)", "description": "Participants will complete the 40-item scratch and sniff UPSIT and mean change will be assessed.\n\nThe UPSIT has a minimum score of 0 and maximum score of 40 with lower scores indicating a greater degree of impairment. An UPSIT score of \\>33 for men and \\>34 for women is considered normosmic, and the minimal clinically important difference is a change of 4 points.", "time_frame": "baseline, 5-10 days, and 1 month" }, { "type": "secondary", "measure": "Olfactory Dysfunction Outcomes Rating (ODOR)", "description": "Participants will be asked to complete the ODOR, which is a patient-reported outcome measure assessing physical problems, functional limitations, and emotional consequences of olfactory dysfunction.\n\nThe ODOR has a minimum score of 0 and a maximum score of 112 with higher scores indicating a greater degree of impairment and limitation. The minimal clinically important difference is a change of 15 points.", "time_frame": "baseline, 5-10 days post SGB #1, and 1 month" }, { "type": "secondary", "measure": "Clinical Global Impression - Severity (CGI-S) Score", "description": "Participants will be asked about the severity of their olfactory dysfunction (and gustatory dysfunction) on a 5-point Likert scale from no smell loss to severe smell loss.", "time_frame": "baseline, 5-10 days, and 1 month" } ], "outcome_measures": [ { "type": "primary", "measure": "Clinical Global Impression - Improvement (CGI-I) Score", "description": "Participants will be asked about their change in olfactory dysfunction on a 7-point Likert scale from much better to much worse.", "time_frame": "5-10 days post SGB #1 and 1 month" }, { "type": "secondary", "measure": "University of Pennsylvania Smell Identification Test (UPSIT)", "description": "Participants will complete the 40-item scratch and sniff UPSIT and mean change will be assessed.\n\nThe UPSIT has a minimum score of 0 and maximum score of 40 with lower scores indicating a greater degree of impairment. An UPSIT score of \\>33 for men and \\>34 for women is considered normosmic, and the minimal clinically important difference is a change of 4 points.", "time_frame": "baseline, 5-10 days, and 1 month" }, { "type": "secondary", "measure": "Olfactory Dysfunction Outcomes Rating (ODOR)", "description": "Participants will be asked to complete the ODOR, which is a patient-reported outcome measure assessing physical problems, functional limitations, and emotional consequences of olfactory dysfunction.\n\nThe ODOR has a minimum score of 0 and a maximum score of 112 with higher scores indicating a greater degree of impairment and limitation. The minimal clinically important difference is a change of 15 points.", "time_frame": "baseline, 5-10 days post SGB #1, and 1 month" }, { "type": "secondary", "measure": "Clinical Global Impression - Severity (CGI-S) Score", "description": "Participants will be asked about the severity of their olfactory dysfunction (and gustatory dysfunction) on a 5-point Likert scale from no smell loss to severe smell loss.", "time_frame": "baseline, 5-10 days, and 1 month" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05445921", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06980636", "title": "A Trial of Shengmai Liquid for Long COVID Fatigue.", "status": "RECRUITING", "phase": "PHASE4", "last_updated": "2026-02-09", "start_date": "2025-12-01", "completion_date": "2026-11-30", "primary_completion_date": "2026-10-30", "conditions_raw": [ "Long COVID Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Shengmai Liquid" ], "sponsor": "Beijing University of Chinese Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to learn if Shengmai liquid works to treat Long Covid fatigue. It will also learn about the safety of Shengmai liquid. The main questions it aims to answer are:\n\n* Dose the Shengmai liquid will reduce the level of fatigue in the participants and reduce the fatigue scale score of the participants?\n* Dose the Shengmai liquid will reduce the level of anxiety and depression in the participants and improve the sleep quality and quality of life of the participants Researchers will compare Shengmai oral liquid to a placebo (a look-alike substance that contains no drug) to see if Shengmai liquid works to treat Long Covid fatigue.\n\nParticipants will:\n\n* Take Shengmai liquid or a placebo every day for 8 weeks.\n* Visit the clinic once every 4 weeks for check up and test. There are a total of two telephone follow-ups, one follow-up 15 days after the treatment starts and another follow-up 30 days after the treatment ends.\n* Participants' medication responses and scale scores will be recorded.", "primary_outcomes": [ { "type": "primary", "measure": "The degree of improvement in patient fatigue, measured using the Modified Fatigue Impact Scale (MFIS)", "description": "MFIS is a standardized questionnaire reflecting physical and mental fatigue, consisting of 21 questions. Each question has five options (none at all, a little, sometimes, often, almost always), with a total score range of 0 to 84. The higher the score, the higher the degree of chronic fatigue.", "time_frame": "From enrollment to the end of follow up at 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Traditional Chinese Medicine Syndrome Score Scale", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 week" }, { "type": "secondary", "measure": "Improvement in depression, assessed using the 17-item Hamilton Depression Scale", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "secondary", "measure": "Improvement in anxiety, assessed using the Hamilton Anxiety Scale (HAMA)", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "secondary", "measure": "Improvement in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI)", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 week" }, { "type": "secondary", "measure": "Improvement in quality of life, assessed using the World Health Organization Quality of Life Scale", "description": "measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "secondary", "measure": "six minute walk test（6MWT）", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "The degree of improvement in patient fatigue, measured using the Modified Fatigue Impact Scale (MFIS)", "description": "MFIS is a standardized questionnaire reflecting physical and mental fatigue, consisting of 21 questions. Each question has five options (none at all, a little, sometimes, often, almost always), with a total score range of 0 to 84. The higher the score, the higher the degree of chronic fatigue.", "time_frame": "From enrollment to the end of follow up at 12 weeks" }, { "type": "secondary", "measure": "Traditional Chinese Medicine Syndrome Score Scale", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 week" }, { "type": "secondary", "measure": "Improvement in depression, assessed using the 17-item Hamilton Depression Scale", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "secondary", "measure": "Improvement in anxiety, assessed using the Hamilton Anxiety Scale (HAMA)", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "secondary", "measure": "Improvement in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI)", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 week" }, { "type": "secondary", "measure": "Improvement in quality of life, assessed using the World Health Organization Quality of Life Scale", "description": "measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "secondary", "measure": "six minute walk test（6MWT）", "description": "Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.", "time_frame": "From enrollment to the end of treatment at 8 weeks" } ], "relevance_tags": [ "General", "Phase 4", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06980636", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07397130", "title": "Inspiratory Muscle Pressure and Diaphragmatic Strength in Women With Long COVID-19: A Pressure Biofeedback-Guided Training Study", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-02-09", "start_date": "2024-07-01", "completion_date": "2025-10-01", "primary_completion_date": "2025-08-01", "conditions_raw": [ "Long COVID-19 Syndrome", "Post COVID Syndrome Long Covid", "Post COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Pressure Biofeedback Unit" ], "sponsor": "RSUP Persahabatan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "COVID-19 is an infectious disease that can cause long-term health problems even after the acute infection has resolved. Many people who have recovered from COVID-19 continue to experience breathing difficulties, fatigue, and reduced physical capacity. These ongoing problems are often related to decreased lung function and weakness of the breathing muscles, especially the diaphragm, which plays a major role in breathing.\n\nIn women after COVID-19, respiratory muscle weakness may result from inflammation during infection, prolonged bed rest, and increased effort required to breathe. This can lead to reduced inspiratory strength, shortness of breath, and limitations in daily activities. Respiratory rehabilitation is therefore important to help restore breathing muscle strength and improve overall respiratory function.\n\nOne rehabilitation approach is indirect diaphragmatic muscle training using pressure biofeedback. This method provides visual or tactile feedback during breathing exercises to help patients activate and strengthen the diaphragm more effectively. Pressure biofeedback has been used as part of post-COVID-19 rehabilitation in Indonesia, but its effectiveness in improving inspiratory strength and diaphragmatic function, particularly in women after COVID-19, has not been fully evaluated.\n\nThe purpose of this study is to examine the relationship between improvements in maximal inspiratory pressure and improvements in diaphragmatic strength in women recovering from COVID-19 who perform indirect diaphragmatic muscle training using pressure biofeedback. The study hypothesizes that indirect diaphragmatic training guided by pressure biofeedback can improve diaphragmatic strength and increase maximal inspiratory pressure in women after COVID-19.", "primary_outcomes": [ { "type": "primary", "measure": "Diaphragmatic Muscle Strength", "description": "Diaphragmatic muscle strength is assessed using ultrasonographic evaluation of diaphragmatic movement and thickness during respiration to determine diaphragmatic function.", "time_frame": "Baseline and after completion of the intervention period (at 4 weeks)" }, { "type": "primary", "measure": "Maximal Inspiratory Pressure (MIP)", "description": "Maximal inspiratory pressure is measured to assess inspiratory muscle strength. MIP is evaluated using a pressure manometer during a maximal inspiratory effort and reflects the functional strength of the diaphragm and other inspiratory muscles.", "time_frame": "Baseline and after completion of the intervention period (at 4 weeks)" }, { "type": "primary", "measure": "Maximal Expiratory Pressure (MEP)", "description": "Maximal expiratory pressure is measured to assess expiratory muscle strength. MEP is evaluated using a pressure manometer during a maximal expiratory effort and reflects the strength of the abdominal and expiratory respiratory muscles.", "time_frame": "Baseline and after completion of the intervention period (at 4 weeks)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Diaphragmatic Muscle Strength", "description": "Diaphragmatic muscle strength is assessed using ultrasonographic evaluation of diaphragmatic movement and thickness during respiration to determine diaphragmatic function.", "time_frame": "Baseline and after completion of the intervention period (at 4 weeks)" }, { "type": "primary", "measure": "Maximal Inspiratory Pressure (MIP)", "description": "Maximal inspiratory pressure is measured to assess inspiratory muscle strength. MIP is evaluated using a pressure manometer during a maximal inspiratory effort and reflects the functional strength of the diaphragm and other inspiratory muscles.", "time_frame": "Baseline and after completion of the intervention period (at 4 weeks)" }, { "type": "primary", "measure": "Maximal Expiratory Pressure (MEP)", "description": "Maximal expiratory pressure is measured to assess expiratory muscle strength. MEP is evaluated using a pressure manometer during a maximal expiratory effort and reflects the strength of the abdominal and expiratory respiratory muscles.", "time_frame": "Baseline and after completion of the intervention period (at 4 weeks)" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07397130", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07397910", "title": "Clinical Trial on a Natural Compound to Improve Chronic Inflammation After SARS-CoV-2 Infection", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-02-09", "start_date": "2026-02-23", "completion_date": "2026-08-03", "primary_completion_date": "2026-07-06", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Experimental Product", "Physical Exercise", "No Physical Exercise" ], "sponsor": "Universidad Católica San Antonio de Murcia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "A controlled, randomized clinical trial is proposed to demonstrate the effectiveness of the experimental product in controlling hepato-pulmonary inflammation and neurovascular encephalic inflammation, which may constitute the etiopathogenic basis of persistent COVID. In addition, an individualized training program will be implemented for each participant in order to improve chronic symptoms and, consequently, their quality of life.", "primary_outcomes": [ { "type": "primary", "measure": "Immunoinflammatory profile", "description": "Antibody assay for molecular biomarkers of the brain-liver-lung axis, blood-brain barrier, immunometabolic pathways, and immune-inflammatory and immuno-angiogenic cardiac remodeling.", "time_frame": "Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 120 days of product intake." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Clinical signs", "description": "The number of clinical manifestations, the type of manifestation, intensity according to the visual analog scale from 0 to 10, and duration of the symptomps. The clinical manifestations will be those felt by the subject.", "time_frame": "It will be recorded twice, before starting the consumption of the product and before the end of consumption (120 days)" }, { "type": "secondary", "measure": "Short Form 12 Health Survey", "description": "Measured by SF-12 questionnaire. Scale 0-100%", "time_frame": "It will be measured twice, once at baseline and at the end of the study after 120 days of consumption." }, { "type": "secondary", "measure": "Sleep quality", "description": "Measured by Pittsburgh test", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Sleep efficiency", "description": "Measured by accelerometry, with Actigraph wGT3X-BT", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Fatigue", "description": "Measured with Fatigue Severity Scale (FSS). Rated on a 7-point Likert scale (1=strongly disagree, 7=strongly agree), a mean score of \\\\(\\\\ge 4\\\\) typically indicates a moderate to high level of fatigue.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Dyspnea", "description": "It will be measured with Modified Medical Research Council (mMRC)", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Depression", "description": "It will be measured with Beck Depression Inventory (BDI). Scores are calculated by adding up the responses to 21 items, with a range from 0 to 63, and scores are interpreted by severity levels: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe).", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Anxiety", "description": "It will be measured with the State-Trait Anxiety Inventory (STAI). The STAI (State-Trait Anxiety Inventory) assesses transient (state) and stable (trait) anxiety using 40 items (20 per subscale) with a Likert-type score from 0 to 3. The total score per subscale ranges from 0 to 60, with higher scores indicating greater anxiety.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression", "description": "Measured with Hospital Anxiety and Depression Scale (HADS). It is a self-administered instrument with 14 items (7 for anxiety, 7 for depression) that is scored from 0 to 3, with a maximum total of 21 points per subscale. A score of 7 or less indicates normality, 8-10 indicates a borderline case, and 11 or above indicates a probable case of anxiety or depression.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Stress level", "description": "Perceived stress scale (PSS). Measures stress levels over the past month on a scale of 0 to 56. The higher the score, the greater the perceived stress. Typical interpretive ranges include low stress (0-13), moderate stress (14-26), and high stress (27-40+).", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Cardiorespiratory fitness.", "description": "A submaximal test will be performed.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "The Rate of Force Development", "description": "The Rate of Force Development (RFD) measures the speed at which the neuromuscular system generates maximum force in a short period of time (typically in the first 100-200 ms). It is a key indicator of explosive strength and power, vital in fast movements, jumps, sprints, and climbing.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Maximum Voluntary Isometric Contraction", "description": "Maximum Voluntary Isometric Contraction (MVIC) is the gold standard for measuring muscle strength, involving maximum contraction without joint movement (isometric). It is used to evaluate muscle activation using electromyography, comparing the percentage of effort against the muscle's maximum possible strength.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Body composition", "description": "It is a control variable. Measured by bioimpedance.", "time_frame": "The test will be measured at baseline and after 16 weeks of consumption." }, { "type": "secondary", "measure": "Liver safety variables", "description": "It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)", "time_frame": "Hematological samples were taken before (day 0) and after consumption of the product (day 120) both in the control group and in the experimental group." }, { "type": "secondary", "measure": "Adverse events", "description": "It will be evaluated only at the end of the study.", "time_frame": "After 16 weeks of consumption." } ], "outcome_measures": [ { "type": "primary", "measure": "Immunoinflammatory profile", "description": "Antibody assay for molecular biomarkers of the brain-liver-lung axis, blood-brain barrier, immunometabolic pathways, and immune-inflammatory and immuno-angiogenic cardiac remodeling.", "time_frame": "Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 120 days of product intake." }, { "type": "secondary", "measure": "Clinical signs", "description": "The number of clinical manifestations, the type of manifestation, intensity according to the visual analog scale from 0 to 10, and duration of the symptomps. The clinical manifestations will be those felt by the subject.", "time_frame": "It will be recorded twice, before starting the consumption of the product and before the end of consumption (120 days)" }, { "type": "secondary", "measure": "Short Form 12 Health Survey", "description": "Measured by SF-12 questionnaire. Scale 0-100%", "time_frame": "It will be measured twice, once at baseline and at the end of the study after 120 days of consumption." }, { "type": "secondary", "measure": "Sleep quality", "description": "Measured by Pittsburgh test", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Sleep efficiency", "description": "Measured by accelerometry, with Actigraph wGT3X-BT", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Fatigue", "description": "Measured with Fatigue Severity Scale (FSS). Rated on a 7-point Likert scale (1=strongly disagree, 7=strongly agree), a mean score of \\\\(\\\\ge 4\\\\) typically indicates a moderate to high level of fatigue.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Dyspnea", "description": "It will be measured with Modified Medical Research Council (mMRC)", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Depression", "description": "It will be measured with Beck Depression Inventory (BDI). Scores are calculated by adding up the responses to 21 items, with a range from 0 to 63, and scores are interpreted by severity levels: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe).", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Anxiety", "description": "It will be measured with the State-Trait Anxiety Inventory (STAI). The STAI (State-Trait Anxiety Inventory) assesses transient (state) and stable (trait) anxiety using 40 items (20 per subscale) with a Likert-type score from 0 to 3. The total score per subscale ranges from 0 to 60, with higher scores indicating greater anxiety.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression", "description": "Measured with Hospital Anxiety and Depression Scale (HADS). It is a self-administered instrument with 14 items (7 for anxiety, 7 for depression) that is scored from 0 to 3, with a maximum total of 21 points per subscale. A score of 7 or less indicates normality, 8-10 indicates a borderline case, and 11 or above indicates a probable case of anxiety or depression.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Stress level", "description": "Perceived stress scale (PSS). Measures stress levels over the past month on a scale of 0 to 56. The higher the score, the greater the perceived stress. Typical interpretive ranges include low stress (0-13), moderate stress (14-26), and high stress (27-40+).", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Cardiorespiratory fitness.", "description": "A submaximal test will be performed.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "The Rate of Force Development", "description": "The Rate of Force Development (RFD) measures the speed at which the neuromuscular system generates maximum force in a short period of time (typically in the first 100-200 ms). It is a key indicator of explosive strength and power, vital in fast movements, jumps, sprints, and climbing.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Maximum Voluntary Isometric Contraction", "description": "Maximum Voluntary Isometric Contraction (MVIC) is the gold standard for measuring muscle strength, involving maximum contraction without joint movement (isometric). It is used to evaluate muscle activation using electromyography, comparing the percentage of effort against the muscle's maximum possible strength.", "time_frame": "Progress will be measured after 120 days of consumption." }, { "type": "secondary", "measure": "Body composition", "description": "It is a control variable. Measured by bioimpedance.", "time_frame": "The test will be measured at baseline and after 16 weeks of consumption." }, { "type": "secondary", "measure": "Liver safety variables", "description": "It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)", "time_frame": "Hematological samples were taken before (day 0) and after consumption of the product (day 120) both in the control group and in the experimental group." }, { "type": "secondary", "measure": "Adverse events", "description": "It will be evaluated only at the end of the study.", "time_frame": "After 16 weeks of consumption." } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07397910", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07374562", "title": "Stellate Ganglion Block for Long COVID Symptoms: A Randomized Controlled Trial", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-02-09", "start_date": "2026-02-05", "completion_date": "2027-02", "primary_completion_date": "2027-02", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Stellate Ganglion Block" ], "sponsor": "Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This single-center, randomized, controlled, single-blind clinical trial evaluates whether a stellate ganglion block (SGB) using bupivacaine can improve persistent symptoms in adults with long COVID. Participants are assigned in a 1:1 ratio to receive either an ultrasound-guided right-sided SGB or a placebo saline injection delivered to the sternocleidomastoid muscle. After the intervention, participants are followed for 26 weeks with scheduled evaluations that include symptom questionnaires and functional tests.\n\nThe study assesses changes in functional status, fatigue, cognitive complaints, quality of life, dyspnea, lower-limb endurance, and orthostatic tolerance over time. Safety is monitored throughout all follow-up visits. Approximately 40 participants meeting predefined eligibility criteria will be enrolled. This trial seeks to determine whether a single stellate ganglion block has an effect on persistent long-COVID symptoms compared with placebo.The results will help determine the therapeutic value of SGB in the management of long COVID and inform future research and clinical practice.", "primary_outcomes": [ { "type": "primary", "measure": "Post-COVID-19 Functional Status Scale (PCFS)", "description": "The PCFS measures limitations in daily functioning related to persistent post-COVID-19 symptoms. Scores range from 0 (no functional limitation) to 4 (severe functional limitation). Assesses changes in functional status over time.", "time_frame": "4 weeks after the intervention" }, { "type": "primary", "measure": "Fatigue Severity Scale (FSS)", "description": "The FSS is a validated 9-item questionnaire assessing the impact of fatigue on daily activities, motivation, and functioning. Each item is scored from 1 to 7; higher scores indicate greater fatigue severity. Clinically significant change is defined as ≥0.45 points.", "time_frame": "4 weeks after the intervention" }, { "type": "primary", "measure": "Brain Fog Scale (BFS)", "description": "The BFS is a 23-item questionnaire evaluating cognitive symptoms associated with Long COVID, including mental fatigue, cognitive clarity, logical thinking, and concentration. Total scores range from 0 to 92, with higher scores indicating more severe cognitive impairment.", "time_frame": "4 weeks after the intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Health-Related Quality of Life (SF-36)", "description": "The SF-36 is a validated 36-item questionnaire assessing eight domains of health-related quality of life, including physical functioning, limitations due to physical or emotional problems, pain, general health, vitality, social functioning, and mental health. Higher scores reflect better perceived health and functioning.", "time_frame": "4 weeks after the intervention" }, { "type": "secondary", "measure": "Dyspnea Severity (mMRC Scale)", "description": "The modified Medical Research Council (mMRC) Dyspnea Scale is a 0-4 grading system that assesses the degree to which breathlessness limits daily activities. Higher grades indicate greater functional limitation due to dyspnea. It is the only validated French-language scale measuring dyspnea in daily activities.", "time_frame": "4 weeks after the intervention" }, { "type": "secondary", "measure": "Lower-Limb Muscle Endurance (1-Minute Sit-to-Stand Test)", "description": "The 1-Minute Sit-to-Stand Test (1STST) measures lower-limb muscular endurance by counting the number of sit-to-stand repetitions a participant completes in one minute from a standard chair without armrests. It is reliable, sensitive, and well-tolerated in populations with impaired physical capacity. Higher counts indicate better endurance.", "time_frame": "4 weeks after the intervention" }, { "type": "secondary", "measure": "Orthostatic Intolerance (NASA Lean Test)", "description": "The NASA Lean Test assesses orthostatic intolerance by measuring heart rate and blood pressure changes during 10 minutes of standing with the back supported against a wall. Results help identify symptoms such as dizziness, palpitations, or light-headedness related to positional changes. If a participant cannot complete 10 minutes, the test is still considered valid.", "time_frame": "4 weeks after the intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Post-COVID-19 Functional Status Scale (PCFS)", "description": "The PCFS measures limitations in daily functioning related to persistent post-COVID-19 symptoms. Scores range from 0 (no functional limitation) to 4 (severe functional limitation). Assesses changes in functional status over time.", "time_frame": "4 weeks after the intervention" }, { "type": "primary", "measure": "Fatigue Severity Scale (FSS)", "description": "The FSS is a validated 9-item questionnaire assessing the impact of fatigue on daily activities, motivation, and functioning. Each item is scored from 1 to 7; higher scores indicate greater fatigue severity. Clinically significant change is defined as ≥0.45 points.", "time_frame": "4 weeks after the intervention" }, { "type": "primary", "measure": "Brain Fog Scale (BFS)", "description": "The BFS is a 23-item questionnaire evaluating cognitive symptoms associated with Long COVID, including mental fatigue, cognitive clarity, logical thinking, and concentration. Total scores range from 0 to 92, with higher scores indicating more severe cognitive impairment.", "time_frame": "4 weeks after the intervention" }, { "type": "secondary", "measure": "Health-Related Quality of Life (SF-36)", "description": "The SF-36 is a validated 36-item questionnaire assessing eight domains of health-related quality of life, including physical functioning, limitations due to physical or emotional problems, pain, general health, vitality, social functioning, and mental health. Higher scores reflect better perceived health and functioning.", "time_frame": "4 weeks after the intervention" }, { "type": "secondary", "measure": "Dyspnea Severity (mMRC Scale)", "description": "The modified Medical Research Council (mMRC) Dyspnea Scale is a 0-4 grading system that assesses the degree to which breathlessness limits daily activities. Higher grades indicate greater functional limitation due to dyspnea. It is the only validated French-language scale measuring dyspnea in daily activities.", "time_frame": "4 weeks after the intervention" }, { "type": "secondary", "measure": "Lower-Limb Muscle Endurance (1-Minute Sit-to-Stand Test)", "description": "The 1-Minute Sit-to-Stand Test (1STST) measures lower-limb muscular endurance by counting the number of sit-to-stand repetitions a participant completes in one minute from a standard chair without armrests. It is reliable, sensitive, and well-tolerated in populations with impaired physical capacity. Higher counts indicate better endurance.", "time_frame": "4 weeks after the intervention" }, { "type": "secondary", "measure": "Orthostatic Intolerance (NASA Lean Test)", "description": "The NASA Lean Test assesses orthostatic intolerance by measuring heart rate and blood pressure changes during 10 minutes of standing with the back supported against a wall. Results help identify symptoms such as dizziness, palpitations, or light-headedness related to positional changes. If a participant cannot complete 10 minutes, the test is still considered valid.", "time_frame": "4 weeks after the intervention" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07374562", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06739668", "title": "Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-02-02", "start_date": "2024-12-19", "completion_date": "2025-12-01", "primary_completion_date": "2025-12-01", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Cognitive Dysfunction" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Pascal Device" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to assess the feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to PASC, and to collect data on safety and efficacy to inform the design of larger clinical studies. A prospective randomized controlled study of 30 participants with PASC and moderate to severe cognitive dysfunction. Total study duration will be 8 weeks, including 4 weeks of treatment and 4 weeks of untreated follow up.", "primary_outcomes": [ { "type": "primary", "measure": "Proportion of Successfully Completed Treatments", "description": "Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments.", "time_frame": "End of treatment, 4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Device comfort", "description": "Comfort will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater comfort.", "time_frame": "End of treatment, 4 weeks" }, { "type": "secondary", "measure": "Device ease of use", "description": "Ease of use will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater ease of use.", "time_frame": "End of treatment, 4 weeks" }, { "type": "secondary", "measure": "Clarity of instructions", "description": "Clarity of instructions will be assessed using a 5-point Likert scale, full scale from 1-5 with high scores indicating greater clarity of instructions.", "time_frame": "End of treatment, 4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Proportion of Successfully Completed Treatments", "description": "Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments.", "time_frame": "End of treatment, 4 weeks" }, { "type": "secondary", "measure": "Device comfort", "description": "Comfort will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater comfort.", "time_frame": "End of treatment, 4 weeks" }, { "type": "secondary", "measure": "Device ease of use", "description": "Ease of use will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater ease of use.", "time_frame": "End of treatment, 4 weeks" }, { "type": "secondary", "measure": "Clarity of instructions", "description": "Clarity of instructions will be assessed using a 5-point Likert scale, full scale from 1-5 with high scores indicating greater clarity of instructions.", "time_frame": "End of treatment, 4 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06739668", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04591210", "title": "The COVID-RASi Trial (COVID-19)", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2026-01-28", "start_date": "2021-01-27", "completion_date": "2024-12-30", "primary_completion_date": "2024-12-30", "conditions_raw": [ "COVID-19", "Cardiovascular Diseases" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Angiotensin Converting Enzyme Inhibitor", "Angiotensin Ii Receptor Blockers" ], "sponsor": "Ottawa Heart Institute Research Corporation", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The COVID-RASi study is an international randomized clinical trial that will evaluate the potential benefit of angiotensin modulators on clinical outcomes, in COVID-19 patients. The purpose of this study is to determine if renin-angiotensin system inhibitors (RASi), with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), has a beneficial effect in patients with COVID-19 infections, by reducing ICU admission, ventilator requirement or death. We would also like to determine if there are differences between ACEi and ARB therapeutic treatments. With the increasing potential of long COVID symptoms, at the 1 year follow up, a primary endpoint will be the quality of life of study participants, as assessed by ongoing symptoms and/or the standardized questionnaires.", "primary_outcomes": [ { "type": "primary", "measure": "Death", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "Mechanical ventilation", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "ICU admission", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "Major Adverse Cardiac Events (MACE)", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "Hospitalizations", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "Quality of life of study participants", "description": "Assessed by ongoing symptoms and standardized questionnaires, scale to assess overall health 1-100, 100 is the best, higher score means better outcome", "time_frame": "1 year" }, { "type": "primary", "measure": "Quality of life of study participants", "description": "Assessed by ongoing symptoms and standardized questionnaires- scale to assess overall health 1-100, 100 is the best, higher score means better outcome", "time_frame": "1 year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Days alive and out of hospital", "description": "", "time_frame": "30 days" }, { "type": "secondary", "measure": "Days alive and out of hospital", "description": "", "time_frame": "180 days" }, { "type": "secondary", "measure": "Cardiovascular mortality", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "All cause hospitalization", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "Percent of patients require intensive care", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "Percent of patients requiring ventilation", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "Percent of patients requiring dialysis", "description": "", "time_frame": "1 year" } ], "outcome_measures": [ { "type": "primary", "measure": "Death", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "Mechanical ventilation", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "ICU admission", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "Major Adverse Cardiac Events (MACE)", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "Hospitalizations", "description": "Within first 28 days post randomization", "time_frame": "28 days" }, { "type": "primary", "measure": "Quality of life of study participants", "description": "Assessed by ongoing symptoms and standardized questionnaires, scale to assess overall health 1-100, 100 is the best, higher score means better outcome", "time_frame": "1 year" }, { "type": "primary", "measure": "Quality of life of study participants", "description": "Assessed by ongoing symptoms and standardized questionnaires- scale to assess overall health 1-100, 100 is the best, higher score means better outcome", "time_frame": "1 year" }, { "type": "secondary", "measure": "Days alive and out of hospital", "description": "", "time_frame": "30 days" }, { "type": "secondary", "measure": "Days alive and out of hospital", "description": "", "time_frame": "180 days" }, { "type": "secondary", "measure": "Cardiovascular mortality", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "All cause hospitalization", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "Percent of patients require intensive care", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "Percent of patients requiring ventilation", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "Percent of patients requiring dialysis", "description": "", "time_frame": "1 year" } ], "relevance_tags": [ "General", "Phase 3", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 372, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT04591210", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05697640", "title": "Study to Investigate Improvement in Physical Function in SF-36 With Vericiguat Compared With Placebo in Participants With Post-COVID-19 Syndrome", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2026-01-28", "start_date": "2023-06-22", "completion_date": "2026-12-31", "primary_completion_date": "2026-04-01", "conditions_raw": [ "Post-COVID ME/CFS" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Vericiguat Oral Tablet" ], "sponsor": "Charite University, Berlin, Germany", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to evaluate the therapeutic value of an approved drug (Vericiguat) in patients with post-COVID-19 syndrome, who suffer from profound tiredness or fatigue, regardless of bed rest.The main questions it aims to answer are: • Does Vericiguat relieve fatigue and/or other symptoms associated with post-COVID-19 syndrome? • What are the side effects of Vericiguat in this patient population; and how common are they?\n\nParticipants will be asked to participate for approx. 18 weeks. After screening, participants will receive assigned intervention of either 10 weeks of treatment with Vericiguat or matching placebo tablet, followed by 30 day follow-up period. Every participant will undergo trial, cardiovascular safety, and monitoring assessments.\n\nThe results of this study will provide information on whether Vericiguat can alleviate PCS-related symptoms as well as insights into the pathophysiological processes of PCS, which in turn can help to develop therapies.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)", "description": "The Short Form 36 Health Survey (SF-36) is an established and widely used health-related quality of life measure. The Physical Function (PF) domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change of 10 points in SF-36-PF from baseline to week ten is considered clinically meaningful.", "time_frame": "10 weeks after first IMP intake" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Difference in responder rate in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36) comparing Vericiguat with placebo", "description": "Occurrence of responders in patients that receive Vericiguat compared with placebo. Responders are defined as an intra-patient 10-point increase in SF-36-PF from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in other sub-domains of the Short Form 36 Health Survey Questionnaire (SF-36) comparing Vericiguat with placebo", "description": "Intra-patient change in other SF-36 subdomains from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in fatigue as measured by the Fatigue Severity Score (FSS)", "description": "The Fatigue Severity Scale (FSS) is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle. Answers are scored on a seven-point scale (1 = strongly disagree; 7 = strongly agree). Thus, the minimum score is 9 (no fatigue), and the highest is 63 (heavy fatigue). Intra-patient change in fatigue severity from baseline to week 10 will be documented as indexed by the FSS.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in severity of muscle pain and headache as measured by the Canadian Consensus Criteria (CCC) symptom score", "description": "The Canadian Consensus Criteria (CCC) Symptom Score quantifies ME/CFS symptoms. Its score ranges from 1 (no symptoms) to 10 (extreme symptoms). Intra-patient change in muscle pain and headache from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in symptoms of myalgic encephalomyelitis (ME)/ chronic fatigue syndrome (CFS) as measured by Canadian Consensus Criteria (CCC) Symptom Score", "description": "Intra-patient change in ME/CFS symptoms from baseline to week 10 will be documented as indexed by the CCC Symptom Score.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in functional disability as measured by the Bell disability scale", "description": "The Bell disability scale is a standard assessment in ME/CFS that evaluates functional ability in adult ME/CFS patients. Eleven statements describe patient status such as level of symptoms at rest, level of symptoms with exercise, activity level, and ability to perform work, travel and self care. Its score ranges from 0 (bedridden) to 100 (no symptoms). Intra-patient change in Bell score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)", "description": "The Composite Autonomic Symptom Score (COMPASS-31) is a refined, internally consistent, and markedly abbreviated quantitative measure of autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, applies a much-simplified scoring algorithm, and is suitable for widespread use in autonomic research and practice. It evaluates six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The score ranges from 0 (no symptoms) to 100 (strong autonomic dysfunction). Intra-patient change in autonomic dysfunction from baseline to week ten will be documented as indexed by the COMPASS-31.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in disease severity based on self- reported symptoms as measured by the Munich Berlin Symptom Questionnaire (MBSQ)", "description": "The Munich Berlin Symptom Questionnaire (MBSQ) is a questionnaire for ME/CFS that captures the IOM and CCC diagnostic criteria as well as a total of 44 symptoms from 8 domains on a scale of 0 - 4 for frequency and severity. From this, a score for total symptom severity ranging from 0 (not present) to 352 (very severe) is calculated. Intra-patient change in MBSQ score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in disease severity based on self- reported symptoms as measured by the Munich Long Covid Symptom Questionnaire (MLCSQ)", "description": "The Munich Long Covid Symptom Questionnaire (MLCSQ) is a long covid questionnaire that measures a total of 83 symptoms from 13 domains on a scale of 1-3 for frequency and severity. This results in a score for total symptom severity ranging from 83 (mild) to 496 (severe). Intra-patient change in MLCSQ score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in post exertional malaise (PEM) frequency, strength and severity as measured by the PEM questionnaire", "description": "The PEM questionnaire determines frequency (from 0 to 20 points, higher scores equate to greater frequency), severity (from 0 to 20 points, higher scores equate to greater severity), and length (from 0 to 6 points, higher scores equate to longer duration) of PEM. Intra-patient change in PEM score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in muscle fatigue measured by the repetitive hand grip strength test (HGS)", "description": "Intra-patient change in hand grip strength (HGS) from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in orthostatic intolerance measured by the passive standing test", "description": "Intra-patient change in blood pressure, sitting and standing heart rate, and delta heart rate from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement of endothelial cell function as assessed using EndoPAT", "description": "Intra-patient change in vascular regulation as indexed by the reactive hyperemia index (RHI) from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in cognitive function measured by the Symbol Digit Modalities Test (SDMT)", "description": "The Symbol Digit Modalities Test (SDMT) is a screening instrument commonly used to assess neurological dysfunction. It detects cognitive impairment as well as changes in cognitive functioning over time and in response to treatment. The scores range between 0 and 110 (higher scores equate to greater cognitive functioning). Intra-patient change in cognitive score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in ET-1 serum levels", "description": "Intra-patient change in ET-1 level from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Difference of occurring AE and SAE comparing Vericiguat with placebo (IMP safety).", "description": "Occurrence of IMP side and adverse effects, assessed with AE, SAE and SUSAR reports", "time_frame": "10 weeks after first IMP intake" } ], "outcome_measures": [ { "type": "primary", "measure": "Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)", "description": "The Short Form 36 Health Survey (SF-36) is an established and widely used health-related quality of life measure. The Physical Function (PF) domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change of 10 points in SF-36-PF from baseline to week ten is considered clinically meaningful.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Difference in responder rate in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36) comparing Vericiguat with placebo", "description": "Occurrence of responders in patients that receive Vericiguat compared with placebo. Responders are defined as an intra-patient 10-point increase in SF-36-PF from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in other sub-domains of the Short Form 36 Health Survey Questionnaire (SF-36) comparing Vericiguat with placebo", "description": "Intra-patient change in other SF-36 subdomains from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in fatigue as measured by the Fatigue Severity Score (FSS)", "description": "The Fatigue Severity Scale (FSS) is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle. Answers are scored on a seven-point scale (1 = strongly disagree; 7 = strongly agree). Thus, the minimum score is 9 (no fatigue), and the highest is 63 (heavy fatigue). Intra-patient change in fatigue severity from baseline to week 10 will be documented as indexed by the FSS.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in severity of muscle pain and headache as measured by the Canadian Consensus Criteria (CCC) symptom score", "description": "The Canadian Consensus Criteria (CCC) Symptom Score quantifies ME/CFS symptoms. Its score ranges from 1 (no symptoms) to 10 (extreme symptoms). Intra-patient change in muscle pain and headache from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in symptoms of myalgic encephalomyelitis (ME)/ chronic fatigue syndrome (CFS) as measured by Canadian Consensus Criteria (CCC) Symptom Score", "description": "Intra-patient change in ME/CFS symptoms from baseline to week 10 will be documented as indexed by the CCC Symptom Score.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in functional disability as measured by the Bell disability scale", "description": "The Bell disability scale is a standard assessment in ME/CFS that evaluates functional ability in adult ME/CFS patients. Eleven statements describe patient status such as level of symptoms at rest, level of symptoms with exercise, activity level, and ability to perform work, travel and self care. Its score ranges from 0 (bedridden) to 100 (no symptoms). Intra-patient change in Bell score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)", "description": "The Composite Autonomic Symptom Score (COMPASS-31) is a refined, internally consistent, and markedly abbreviated quantitative measure of autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, applies a much-simplified scoring algorithm, and is suitable for widespread use in autonomic research and practice. It evaluates six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The score ranges from 0 (no symptoms) to 100 (strong autonomic dysfunction). Intra-patient change in autonomic dysfunction from baseline to week ten will be documented as indexed by the COMPASS-31.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in disease severity based on self- reported symptoms as measured by the Munich Berlin Symptom Questionnaire (MBSQ)", "description": "The Munich Berlin Symptom Questionnaire (MBSQ) is a questionnaire for ME/CFS that captures the IOM and CCC diagnostic criteria as well as a total of 44 symptoms from 8 domains on a scale of 0 - 4 for frequency and severity. From this, a score for total symptom severity ranging from 0 (not present) to 352 (very severe) is calculated. Intra-patient change in MBSQ score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in disease severity based on self- reported symptoms as measured by the Munich Long Covid Symptom Questionnaire (MLCSQ)", "description": "The Munich Long Covid Symptom Questionnaire (MLCSQ) is a long covid questionnaire that measures a total of 83 symptoms from 13 domains on a scale of 1-3 for frequency and severity. This results in a score for total symptom severity ranging from 83 (mild) to 496 (severe). Intra-patient change in MLCSQ score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in post exertional malaise (PEM) frequency, strength and severity as measured by the PEM questionnaire", "description": "The PEM questionnaire determines frequency (from 0 to 20 points, higher scores equate to greater frequency), severity (from 0 to 20 points, higher scores equate to greater severity), and length (from 0 to 6 points, higher scores equate to longer duration) of PEM. Intra-patient change in PEM score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in muscle fatigue measured by the repetitive hand grip strength test (HGS)", "description": "Intra-patient change in hand grip strength (HGS) from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in orthostatic intolerance measured by the passive standing test", "description": "Intra-patient change in blood pressure, sitting and standing heart rate, and delta heart rate from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement of endothelial cell function as assessed using EndoPAT", "description": "Intra-patient change in vascular regulation as indexed by the reactive hyperemia index (RHI) from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in cognitive function measured by the Symbol Digit Modalities Test (SDMT)", "description": "The Symbol Digit Modalities Test (SDMT) is a screening instrument commonly used to assess neurological dysfunction. It detects cognitive impairment as well as changes in cognitive functioning over time and in response to treatment. The scores range between 0 and 110 (higher scores equate to greater cognitive functioning). Intra-patient change in cognitive score from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Improvement in ET-1 serum levels", "description": "Intra-patient change in ET-1 level from baseline to week ten.", "time_frame": "10 weeks after first IMP intake" }, { "type": "secondary", "measure": "Difference of occurring AE and SAE comparing Vericiguat with placebo (IMP safety).", "description": "Occurrence of IMP side and adverse effects, assessed with AE, SAE and SUSAR reports", "time_frame": "10 weeks after first IMP intake" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 104, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05697640", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06055244", "title": "Amantadine Therapy for Cognitive Impairment in Long COVID", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-01-27", "start_date": "2023-12-07", "completion_date": "2025-12-29", "primary_completion_date": "2025-12-11", "conditions_raw": [ "Long COVID", "Post-COVID19 Condition", "Post-Acute COVID19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Amantadine" ], "sponsor": "Ohio State University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will look at the effects of amantadine on cognitive function in persons with Long COVID. It will also collect specimens to study possible causes of cognitive symptoms in Long COVID, and whether any lab tests can predict who will respond better to amantadine.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement in cognitive symptoms", "description": "Improvement in scores on self-assessment of overall cognitive functioning", "time_frame": "4 months" }, { "type": "primary", "measure": "Improvement on objective cognitive testing", "description": "Subjects will be administered battery of cognitive tests to determine if there is a change in objective cognitive function", "time_frame": "4 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Mood symptoms", "description": "Subjects will be administered anxiety and depression questionnaires to determine if there is improvement in mood symptoms.", "time_frame": "4 months" }, { "type": "secondary", "measure": "Medication tolerability", "description": "Subjects will complete a questionnaire addressing tolerability of amantadine and side effects experienced", "time_frame": "4 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Improvement in cognitive symptoms", "description": "Improvement in scores on self-assessment of overall cognitive functioning", "time_frame": "4 months" }, { "type": "primary", "measure": "Improvement on objective cognitive testing", "description": "Subjects will be administered battery of cognitive tests to determine if there is a change in objective cognitive function", "time_frame": "4 months" }, { "type": "secondary", "measure": "Mood symptoms", "description": "Subjects will be administered anxiety and depression questionnaires to determine if there is improvement in mood symptoms.", "time_frame": "4 months" }, { "type": "secondary", "measure": "Medication tolerability", "description": "Subjects will complete a questionnaire addressing tolerability of amantadine and side effects experienced", "time_frame": "4 months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 64, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06055244", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07189936", "title": "Effect of 2-HOBA in Persistent Immune Activation in Long COVID POTS", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-01-22", "start_date": "2025-12-18", "completion_date": "2029-06-30", "primary_completion_date": "2028-06-30", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Postural Tachycardia Syndrome (POTS)", "SARS CoV 2 Infection", "Long COVID19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "To Measure Levels Of Circulating Monocyte/ T Cell Doublets At Baseline", "To Measure Levels Of Circulating Monocyte/ T Cell Doublets After 28 Days Of 2 Hoba Treatment", "To Measure Splanchnic Venous Capacitance After 28 Days Of Treatment With 2Hoba", "To Measure Orthostatic Tachycardia After 28 Days Of Treatment With 2Hoba" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID is defined by a range of symptoms affecting multiple organs that persist for more than three months following an acute SARS-CoV-2 infection. Approximately 7% of individuals who recover from SARS-Cov-2 infection develop Long COVID.\n\nLong COVID Postural Orthostatic Tachycardia Syndrome (LCPOTS) symptoms include fatigue, exercise intolerance, orthostatic intolerance, syncope, and heightened orthostatic tachycardia.\n\nResearch has found that decreased parasympathetic activity in LCPOTS increases the production of highly immunogenic neoantigens Isolevuglandins (IsoLG-adducts). IsoLG-adducts induce formation of circulating monocyte/T cell complexes(doublets) leading to the persistent and unresolved immune response that continues after the initial infection.\n\nThe purpose of the this research, is to study the effects of 2-hydroxybenzylamine (2-HOBA), an Iso-LG-adduct scavenger, its effects in immune markers and compare it with Placebo", "primary_outcomes": [ { "type": "primary", "measure": "Effect IsoLG-adducts (2-HOBA) measured by levels of monocyte/T cell doublets in LCPOTS.", "description": "The effect of 28-day treatment with Iso-LG-adduct scavenger, 2-hydroxybenzylamine (2-HOBA) versus placebo on circulating monocyte/ T cell doublets, and inflammatory cytokines and compare it to the placebo", "time_frame": "Baseline (Day 0) to after 28 days of treatment" }, { "type": "primary", "measure": "Changes in Splanchnic venous capacitance before and after 28 days of treatment", "description": "Changes in Splanchnic venous capacitance at 30 mins Head up tilt, before and after 28 days of treatment and compare it with 2-HOBA group with placebo group", "time_frame": "Day 0- Day 28 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Measure the effects of 2- HOBA on Orthostatic Tachycardia at HUT", "description": "To see the effects of IsoLG-adducts (2-HOBA) on Orthostatic Tachycardia in LCPOTS subjects at 30 mins Head up Tilt (HUT) and compare it with Placebo group", "time_frame": "Baseline (Day0) to after 28 days of study medication" } ], "outcome_measures": [ { "type": "primary", "measure": "Effect IsoLG-adducts (2-HOBA) measured by levels of monocyte/T cell doublets in LCPOTS.", "description": "The effect of 28-day treatment with Iso-LG-adduct scavenger, 2-hydroxybenzylamine (2-HOBA) versus placebo on circulating monocyte/ T cell doublets, and inflammatory cytokines and compare it to the placebo", "time_frame": "Baseline (Day 0) to after 28 days of treatment" }, { "type": "primary", "measure": "Changes in Splanchnic venous capacitance before and after 28 days of treatment", "description": "Changes in Splanchnic venous capacitance at 30 mins Head up tilt, before and after 28 days of treatment and compare it with 2-HOBA group with placebo group", "time_frame": "Day 0- Day 28 days" }, { "type": "secondary", "measure": "Measure the effects of 2- HOBA on Orthostatic Tachycardia at HUT", "description": "To see the effects of IsoLG-adducts (2-HOBA) on Orthostatic Tachycardia in LCPOTS subjects at 30 mins Head up Tilt (HUT) and compare it with Placebo group", "time_frame": "Baseline (Day0) to after 28 days of study medication" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07189936", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06404086", "title": "RECOVER-SLEEP: Platform Protocol", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-01-22", "start_date": "2024-07-31", "completion_date": "2025-12-31", "primary_completion_date": "2025-12-31", "conditions_raw": [ "Long COVID", "Long COVID-19", "Hypersomnia", "Sleep Disturbance" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Modafinil", "Solriamfetol", "Melatonin", "Tailored Lighting (Tl) Active" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices.\n\nThis platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).", "primary_outcomes": [ { "type": "primary", "measure": "Total number of participants enrolled in each Appendix", "description": "Total number of participants enrolled in each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT#.", "time_frame": "12 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Total number of participants enrolled in each Appendix", "description": "Total number of participants enrolled in each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT#.", "time_frame": "12 months" } ], "relevance_tags": [ "General", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 830, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06404086", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07355751", "title": "The Effect of Acupuncture Treatment on Cognitive Functions and Brain Networks for Long COVID", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-01-21", "start_date": "2026-05", "completion_date": "2027-12", "primary_completion_date": "2027-12", "conditions_raw": [ "Long Covid" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Acupuncture" ], "sponsor": "Tingting Luo", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Background of study:\n\nLong COVID(LC) is a prevalent sequalae of SARS-CoV-2 infection and can affect multiple organ systems. Cognitive dysfunction is one of the most common symptoms in LC with 22% prevalence. It can persist for years and significantly reduce patients' quality of life. Brain network is the neural basis underlying human cognitive processes. Diffusion tensor imaging (DTI) and functional magnetic resonance imaging(fMRI) research has revealed that alterations of network characteristics were associated with cognitive impairments across attention, memory, executive function and language in LC. Currently, there is no accepted therapy for cognitive impairment in LC. Acupuncture, as a Traditional Chinese Medicine therapy, has potential to improve cognitive deficits for LC. However, research focusing on the impact of acupuncture on cognitive functions in LC is rare. Additionally, no one has evaluated the mechanism of acupuncture improving cognitive functions in LC.\n\nObjective of the study:\n\nThis study aims to assess the effect of acupuncture treatment on cognitive function and explore the central mechanism of acupuncture therapy in improving cognitive function for LC using cognitive assessments, DTI and resting-state fMRI.\n\nStudy design:\n\nA prospective, three-armed, randomized controlled trial with DTI and rs-fMRI. Adults with LC will be randomly assigned to acupuncture, sham acupuncture, or waitlist control group in a 1:1:1 ratio, receiving 8-week intervention or waiting. Cognitive function and topological attributes of brain networks will be examined at baseline and 8th week.\n\nStudy population:\n\nPatients fulfilling World Health Organization (WHO) criteria for LC will be included in this study.", "primary_outcomes": [ { "type": "primary", "measure": "Change of Addenbrooke's Cognitive Examination-III total score from baseline to the end of 8 weeks", "description": "Addenbrooke's Cognitive Examination-III is a cognitive screening tool, and the total score assess general cognitive function. The total score ranges from 0 to 100. Higher score indicates better general cognitive function", "time_frame": "Baseline and 8 weeks" }, { "type": "primary", "measure": "Change of Phonemic Fluency Test score from baseline to the end of 8 weeks", "description": "Phonemic fluency test measures the number of correct words produced under restricted search conditions of phonemic(letter F) . Higher score indicates better language.", "time_frame": "Baseline and 8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes of Digit Span Test scores from baseline to the end of 8 weeks", "description": "Digit Span Test consists of forward and backward subtests, that respectively assess attention and executive function through measuring the number of correct digit sequences. The minimum score is 0 , and the maximum scores are respectively 10 and 9 for forward and backward subtests. Higher scores indicate better attention and executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Symbol Digit Modality Test score from baseline to the end of 8 weeks", "description": "Symbol Digit Modality Test assesses attention through measuring the number of correct responses within 90 seconds. The minimum score is 0, and the maximum score is 110. Higher score indicates better attention.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Trail Making Test scores from baseline to the end of 8 weeks", "description": "Trail Making Test includes Part A(TMT-A) and Part B(TMT-B), that respectively evaluates attention and executive function via measuring the time in seconds required for completing each part of the test. Higher scores indicate worse attention and executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Rey Auditory Verbal Learning Test scores from baseline to the end of 8 weeks", "description": "Rey Auditory Verbal Learning Test evaluates different aspects of verbal memory through measuring total learning, repetitions, delayed recall, retroactive interference, and proactive interference. Higher scores for total learning and delayed recall indicate better memory, while higher scores for repetitions, retroactive interference, and proactive interference indicate worse memory.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Rey-Osterrieth Complex Figure Test scores from baseline to the end of 8 weeks", "description": "Rey-Osterrieth Complex Figure Test evaluates visuospatial construction ability through measuring the accuracy of copy, and evaluates visual memory via measuring the accuracies of immediate and delayed recalls. Higher scores indicate better visuospatial construction and visual memory.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Stroop Test scores from baseline to the end of 8 weeks", "description": "Stroop test consists of Stroop word test(Part A), Stroop color test(Part B) and Stroop color word test(Part C), that assess executive function through measuring the time in second required to complete each part and the number of errors for each part. Higher score for each part indicates worse executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Category Fluency Test Score from baseline to the end of 8 weeks.", "description": "Category Fluency Test assesses language through measuring the number of correct words produced under restricted search condition of category(animals). Higher score for each subtest indicates better language.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Action Fluency Test Score from baseline to the end of 8 weeks", "description": "Action Fluency Test evaluates language via measures the number of correct words produced under restricted search condition of action(kitchen actions). Higher score for each subtest indicates better language", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Boston Naming Test score from baseline to the end of 8 weeks", "description": "Boston Naming Test includes 30 items and evaluates language through measuring the total of correct responses. The minimum score is 0, and the maximum score is 30. Higher score indicates better language.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change in Fatigue Severity Scale score from baseline to the end of 8 weeks", "description": "Fatigue Severity Scale is a self-report questionnaire consisting of 9 items which are devised to evaluate the impact of fatigue on daily functioning, severity of fatigue. The minimum score is 9,and the maximum score is 63. Higher score indicate greater severity of fatigue and impact of fatigue on daily functioning.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of the Generalized Anxiety Disorde-7 score from baseline to the end of 8 weeks", "description": "Generalized Anxiety Disorde-7 is a self-report questionnaire with 7 items, that assesses the level of anxiety in the past two week. The minimum score is 0, and the maximum score is 21. Higher score indicates greater severity of anxiety.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Hamilton Depression Scale score from baseline to the end of 8 weeks", "description": "Hamilton Depression Scale is the most commonly used instrument for the assessment of depression in clinical practice. It includes 24 items and assesses the level of depression through measuring factors of Anxiety/Somatization, Weight, Cognitive Impairment, Diurnal Variation, Retardation, Sleep Disturbance, and Hopelessness. The total score range is 0 to 76. Higher total score indicates greater level of depression.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of the MOS Item Short From Health Survey subscores from baseline to the end of 8 weeks", "description": "The MOS Item Short From Health Survey is a self-report instrument with 36 items, that assesses quality of life through measuring subscales of Physical Function, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Higher subscores indicate better quality of life.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change in clustering coefficient of brain network from baseline to the end of 8 weeks", "description": "Clustering coefficient is the average of clustering coefficients across all nodes in a network. Higher value indicates greater density and complexity of the entire network.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in characteristic path length of brain network from baseline to the end of 8 weeks", "description": "Characteristic path length the average of shortest path length (the minimum number of edges required to connect one node to another node) across any pair of nodes in the network. Lower value indicates higher speed of information transmission in the network.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in global efficiency of brain network from baseline to the end of 8 weeks", "description": "Global efficiency is the mean of inverse of the shortest path length between all pairs of nodes in a network. Higher value reflects better functional integration of the network", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in local efficiency of brain network from baseline to the end of 8 weeks.", "description": "Local efficiency is the mean of the local efficiency across all nodes in whole network. Higher value suggests greater stability of a local network when the local network is interrupted.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in normalized clustering coefficient from baseline to the end of 8 weeks.", "description": "Normalized clustering coefficient is the ratio of culstring coefficient of network to the culstring coefficient of random network. Higher value indicates greater local modularization and specialization.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in normalized characteristic path length from baseline to the end of 8 weeks", "description": "Normalized characteristic path length is the ratio of characteristic path length of network to characteristic path length of a random network. (the Lp of a random network). Higher value indicates lower global integration effeciency of network.", "time_frame": "Baselien and 8 weeks" }, { "type": "secondary", "measure": "The change in small-worldness of brain network from baseline to the end of 8 weeks.", "description": "Small-worldness is the ratio of normalized clustering coefficient to normalized characteristic path length. Higher value indicates greater the balance between local specification and global integration of information transmission.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in degree centrality of brain network from baseline to the end of 8 weeks", "description": "Degree centrality is the number of direct connections attached to a node. Higher value indicates greater the information transmission between a node and other network nodes.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in nodal efficiency of brain network from baseline to the end of 8 weeks", "description": "Nodal efficiency is the average of the inverse of shortest path length between a given node and all other nodes. Higher value indicates greater efficiency of information transmission between a node and other nodes", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in betweenness centrality of brain network from baseline to the end of 8 weeks", "description": "Betweenness centrality is the number of times a given node lies on one of the paths between all pairs of nodes in a network. Higher value represents greater influence of a node on the overall flow of information in the network.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in closeness centrality of brain network from baselien to the end of 8 weeks", "description": "Closeness centrality is the reciprocal of the sum of the shortest path lengths from that node to all other nodes. Higher value reflects greater closeness a node to all other nodes in a network", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in nodal clustering coefficient of brain network from baseline to the end of 8 weeks", "description": "Nodal clustering coefficient is the number of a node's neighbors (nodes directly connecting the node) that are also connected. Higher value indicates greater cliquishness of the subnetwork where the node is located.", "time_frame": "Baseline and8 weeks" }, { "type": "secondary", "measure": "The change in nodal local efficiency of brain network from baseline to the end of 8 weeks", "description": "Nodal local efficiency is inverse of shortest path length between all node pairs in the sub-network formed by a given node and its neighbors. Higher value represents greater between the efficiency of information transmission between the node and its neighbors.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in nodal shortest path length of brain network from baseline to the end of 8 weeks", "description": "Nodal shortest path length is the average of the shortest path length from a single node to all other nodes in a network. Lower value indicates greater efficiency of information transmission of the node", "time_frame": "Baseline and 8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of Addenbrooke's Cognitive Examination-III total score from baseline to the end of 8 weeks", "description": "Addenbrooke's Cognitive Examination-III is a cognitive screening tool, and the total score assess general cognitive function. The total score ranges from 0 to 100. Higher score indicates better general cognitive function", "time_frame": "Baseline and 8 weeks" }, { "type": "primary", "measure": "Change of Phonemic Fluency Test score from baseline to the end of 8 weeks", "description": "Phonemic fluency test measures the number of correct words produced under restricted search conditions of phonemic(letter F) . Higher score indicates better language.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Digit Span Test scores from baseline to the end of 8 weeks", "description": "Digit Span Test consists of forward and backward subtests, that respectively assess attention and executive function through measuring the number of correct digit sequences. The minimum score is 0 , and the maximum scores are respectively 10 and 9 for forward and backward subtests. Higher scores indicate better attention and executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Symbol Digit Modality Test score from baseline to the end of 8 weeks", "description": "Symbol Digit Modality Test assesses attention through measuring the number of correct responses within 90 seconds. The minimum score is 0, and the maximum score is 110. Higher score indicates better attention.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Trail Making Test scores from baseline to the end of 8 weeks", "description": "Trail Making Test includes Part A(TMT-A) and Part B(TMT-B), that respectively evaluates attention and executive function via measuring the time in seconds required for completing each part of the test. Higher scores indicate worse attention and executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Rey Auditory Verbal Learning Test scores from baseline to the end of 8 weeks", "description": "Rey Auditory Verbal Learning Test evaluates different aspects of verbal memory through measuring total learning, repetitions, delayed recall, retroactive interference, and proactive interference. Higher scores for total learning and delayed recall indicate better memory, while higher scores for repetitions, retroactive interference, and proactive interference indicate worse memory.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Rey-Osterrieth Complex Figure Test scores from baseline to the end of 8 weeks", "description": "Rey-Osterrieth Complex Figure Test evaluates visuospatial construction ability through measuring the accuracy of copy, and evaluates visual memory via measuring the accuracies of immediate and delayed recalls. Higher scores indicate better visuospatial construction and visual memory.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Stroop Test scores from baseline to the end of 8 weeks", "description": "Stroop test consists of Stroop word test(Part A), Stroop color test(Part B) and Stroop color word test(Part C), that assess executive function through measuring the time in second required to complete each part and the number of errors for each part. Higher score for each part indicates worse executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Category Fluency Test Score from baseline to the end of 8 weeks.", "description": "Category Fluency Test assesses language through measuring the number of correct words produced under restricted search condition of category(animals). Higher score for each subtest indicates better language.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Action Fluency Test Score from baseline to the end of 8 weeks", "description": "Action Fluency Test evaluates language via measures the number of correct words produced under restricted search condition of action(kitchen actions). Higher score for each subtest indicates better language", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Boston Naming Test score from baseline to the end of 8 weeks", "description": "Boston Naming Test includes 30 items and evaluates language through measuring the total of correct responses. The minimum score is 0, and the maximum score is 30. Higher score indicates better language.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change in Fatigue Severity Scale score from baseline to the end of 8 weeks", "description": "Fatigue Severity Scale is a self-report questionnaire consisting of 9 items which are devised to evaluate the impact of fatigue on daily functioning, severity of fatigue. The minimum score is 9,and the maximum score is 63. Higher score indicate greater severity of fatigue and impact of fatigue on daily functioning.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of the Generalized Anxiety Disorde-7 score from baseline to the end of 8 weeks", "description": "Generalized Anxiety Disorde-7 is a self-report questionnaire with 7 items, that assesses the level of anxiety in the past two week. The minimum score is 0, and the maximum score is 21. Higher score indicates greater severity of anxiety.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Hamilton Depression Scale score from baseline to the end of 8 weeks", "description": "Hamilton Depression Scale is the most commonly used instrument for the assessment of depression in clinical practice. It includes 24 items and assesses the level of depression through measuring factors of Anxiety/Somatization, Weight, Cognitive Impairment, Diurnal Variation, Retardation, Sleep Disturbance, and Hopelessness. The total score range is 0 to 76. Higher total score indicates greater level of depression.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of the MOS Item Short From Health Survey subscores from baseline to the end of 8 weeks", "description": "The MOS Item Short From Health Survey is a self-report instrument with 36 items, that assesses quality of life through measuring subscales of Physical Function, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Higher subscores indicate better quality of life.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change in clustering coefficient of brain network from baseline to the end of 8 weeks", "description": "Clustering coefficient is the average of clustering coefficients across all nodes in a network. Higher value indicates greater density and complexity of the entire network.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in characteristic path length of brain network from baseline to the end of 8 weeks", "description": "Characteristic path length the average of shortest path length (the minimum number of edges required to connect one node to another node) across any pair of nodes in the network. Lower value indicates higher speed of information transmission in the network.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in global efficiency of brain network from baseline to the end of 8 weeks", "description": "Global efficiency is the mean of inverse of the shortest path length between all pairs of nodes in a network. Higher value reflects better functional integration of the network", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in local efficiency of brain network from baseline to the end of 8 weeks.", "description": "Local efficiency is the mean of the local efficiency across all nodes in whole network. Higher value suggests greater stability of a local network when the local network is interrupted.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in normalized clustering coefficient from baseline to the end of 8 weeks.", "description": "Normalized clustering coefficient is the ratio of culstring coefficient of network to the culstring coefficient of random network. Higher value indicates greater local modularization and specialization.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in normalized characteristic path length from baseline to the end of 8 weeks", "description": "Normalized characteristic path length is the ratio of characteristic path length of network to characteristic path length of a random network. (the Lp of a random network). Higher value indicates lower global integration effeciency of network.", "time_frame": "Baselien and 8 weeks" }, { "type": "secondary", "measure": "The change in small-worldness of brain network from baseline to the end of 8 weeks.", "description": "Small-worldness is the ratio of normalized clustering coefficient to normalized characteristic path length. Higher value indicates greater the balance between local specification and global integration of information transmission.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in degree centrality of brain network from baseline to the end of 8 weeks", "description": "Degree centrality is the number of direct connections attached to a node. Higher value indicates greater the information transmission between a node and other network nodes.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in nodal efficiency of brain network from baseline to the end of 8 weeks", "description": "Nodal efficiency is the average of the inverse of shortest path length between a given node and all other nodes. Higher value indicates greater efficiency of information transmission between a node and other nodes", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in betweenness centrality of brain network from baseline to the end of 8 weeks", "description": "Betweenness centrality is the number of times a given node lies on one of the paths between all pairs of nodes in a network. Higher value represents greater influence of a node on the overall flow of information in the network.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in closeness centrality of brain network from baselien to the end of 8 weeks", "description": "Closeness centrality is the reciprocal of the sum of the shortest path lengths from that node to all other nodes. Higher value reflects greater closeness a node to all other nodes in a network", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in nodal clustering coefficient of brain network from baseline to the end of 8 weeks", "description": "Nodal clustering coefficient is the number of a node's neighbors (nodes directly connecting the node) that are also connected. Higher value indicates greater cliquishness of the subnetwork where the node is located.", "time_frame": "Baseline and8 weeks" }, { "type": "secondary", "measure": "The change in nodal local efficiency of brain network from baseline to the end of 8 weeks", "description": "Nodal local efficiency is inverse of shortest path length between all node pairs in the sub-network formed by a given node and its neighbors. Higher value represents greater between the efficiency of information transmission between the node and its neighbors.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in nodal shortest path length of brain network from baseline to the end of 8 weeks", "description": "Nodal shortest path length is the average of the shortest path length from a single node to all other nodes in a network. Lower value indicates greater efficiency of information transmission of the node", "time_frame": "Baseline and 8 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 108, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07355751", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06156202", "title": "Evaluating a Comprehensive Multimodal Outpatient Rehabilitation Program for PASC Program to Improve Functioning of Persons Suffering From Post-COVID-19 Syndrome: A Randomized Controlled Trial", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-01-20", "start_date": "2023-11-15", "completion_date": "2025-11-30", "primary_completion_date": "2025-11-30", "conditions_raw": [ "Post-Acute COVID-19", "Post-Acute COVID-19 Syndrome", "Post-Acute COVID-19 Infection", "Long COVID", "Long Covid19", "Dyspnea", "Orthostasis", "Cognitive Impairment" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Comprehensive Rehabilitation" ], "sponsor": "University of Pennsylvania", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "About 10-20% of persons who contract SARS CoV-2 will experience persistent post-acute sequelae of SARSCoV-2 infection (referred here as PASC). While treatments offered at emerging outpatient COVID recovery clinics are being informed by previous similar diseases, the need is great for a better understanding of the unique needs of this growing population and for tested, efficacious rehabilitation programs to address them. We provide both here.The targeted six-week program will be comprised of a core set of therapies, including individually titrated stretching and flexibility, strengthening of accessory breathing muscles and diaphragm, resistance and aerobic conditioning, and vestibular rehabilitation, supplemented by neuropsychological and cognitive remediation tailored to patients' needs.", "primary_outcomes": [ { "type": "primary", "measure": "Six minute walk test", "description": "", "time_frame": "At week 1 and week 8" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Six minute walk test", "description": "", "time_frame": "At week 1 and week 8" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 125, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06156202", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05710770", "title": "Immunoadsorption in Patients With Chronic Fatigue Syndrome Including Patients With Post-COVID-19 CFS", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-01-16", "start_date": "2023-10-01", "completion_date": "2025-10-08", "primary_completion_date": "2025-08-04", "conditions_raw": [ "ME/CFS", "Post-COVID ME/CFS" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Immunoadsorption" ], "sponsor": "Charite University, Berlin, Germany", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to learn about the effectiveness of repeated immunoadsorption intervention in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS).\n\nThe main questions it aims to answer are: (1) Does repeated immunoadsorption relieve fatigue and/or other symptoms associated with CFS and PACS-CFS? (2) Is repeated immunoadsorption safe and tolerable in this patient population? What are the side effects of repeated immunoadsorption, and how common are they?\n\nParticipants will be asked to participate for approx. 32 weeks (8 months). After screening, participants will receive assigned intervention of either five immunoadsorption treatments (with Ig adsorber) every other day over 10 days or matching sham treatments (without Ig adsorber), followed by a 6-month follow-up period with three ambulatory visits. Every participant will undergo trial outcome, safety, and monitoring assessments.\n\nThe results of this study will provide information on whether repeated immunoadsorption can alleviate symptoms associated with CFS and PACS-CFS, as well as insights into the pathophysiological processes in this condition, which in turn can help to develop new and effective therapies.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale", "description": "The Chalder Fatigue Scale measures the extent and severity of tiredness and has been used in multiple randomized trials of behavioral interventions in patients with ME/CFS. Each of the 11 items is answered on a 4-point scale with an overall score ranging from 0 (asymptomatic) to 33 (maximum symptomology). Intra-patient change in physical and mental fatigue from baseline to month three will be documented as indexed by the Chalder Fatigue Scale.", "time_frame": "3 months after completion of immunoadsorption or sham apheresis" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Sustained improvement quantified by the Chalder Fatigue Scale", "description": "Intra-patient change in physical and mental fatigue from baseline to follow-up points will be documented.", "time_frame": "10 days, 1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Verification of safety and tolerability of immunoadsorption in this patient population", "description": "Number of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuation due to TEAEs", "time_frame": "1 day, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in severity of symptoms of chronic fatigue syndrome (CFS) as measured by the Fluge score", "description": "The Fluge score uses a visual analogue scale ranging from 1 to 10 (1 = no symptom, 10 = very severe symptom) to assess 32 self-reported CFS symptoms including fatigue, pain, cognitive, and other CFS-related symptoms. Intra-patient change in Fluge score from baseline to follow-up points will be documented.", "time_frame": "1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in physical function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)", "description": "The Short Form 36 Health Survey (SF-36) is an established and widely used health-related quality of life measure. The Physical Function (PF) domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change in SF-36-PF from baseline to follow-up points will be documented.", "time_frame": "1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in functional disability as measured by the Bell disability scale", "description": "The Bell disability scale is a standard assessment in ME/CFS that evaluates functional ability in adult ME/CFS patients. Eleven statements describe patient status such as level of symptoms at rest, level of symptoms with exercise, activity level, and ability to perform work, travel and self care. Its score ranges from 0 (bedridden) to 100 (no symptoms). Intra-patient change in Bell score from baseline to follow-up points will be documented.", "time_frame": "1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in fatigue quantified by post exertional malaise (PEM) questionnaire", "description": "The PEM questionnaire determines frequency (from 0 to 20 points, higher scores equate to greater frequency), severity (from 0 to 20 points, higher scores equate to greater severity), and length (from 0 to 6 points, higher scores equate to longer duration) of PEM. Intra-patient change in PEM score from baseline to follow-up points will be documented.", "time_frame": "1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in muscle fatigue measured by the repetitive hand grip strength test (HGS)", "description": "Intra-patient change in hand grip strength (HGS) from baseline to follow-up points.", "time_frame": "10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)", "description": "The Composite Autonomic Symptom Score (COMPASS-31) is a refined, internally consistent, and markedly abbreviated quantitative measure of autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, applies a much-simplified scoring algorithm, and is suitable for widespread use in autonomic research and practice. It evaluates six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The score ranges from 0 (no symptoms) to 100 (strong autonomic dysfunction). Intra-patient change in autonomic dysfunction from baseline to follow-up points will be documented as indexed by the COMPASS-31.", "time_frame": "10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in symptoms of autonomic dysfunction by measuring blood pressure and heart rate regulation with the Schellong Test", "description": "The Schellong Test is a test for circulatory function. The patient is required to stand for 10 to 20 min, during which time the blood pressure is measured continuously. A fall of systolic pressure of 20 mm Hg or more indicates poor circulatory function. Intra-patient change in Schellong Test from baseline to follow-up points will be documented.", "time_frame": "10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in neurocognitive functions as measured by the Montreal Cognitive Assessment (MoCA)", "description": "MoCA is a sensitive and validated cognitive screening tool to test subjects quickly and accurately for mild cognitive impairment, irrespective of etiology. A person can gain a maximum of 30 points, and professionals consider a score of 26 or above to be normal. A score of 25 points or less may indicate some degree of cognitive impairment (18-25 = mild cognitive impairment, 10-17 = moderate cognitive impairment, fewer than 10 points = severe cognitive impairment). Intra-patient change in neurocognitive functions at month 3 and at month 6 (if required by the investigator) after IA completion compared to baseline.", "time_frame": "3 months and 6 months (only if requested by the investigator) after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in neurocognitive functions as measured by the symbol digit modalities test (SDMT)", "description": "The SDMT (oral version) detects cognitive impairment in less than five minutes and will be used to assess change in cognitive function over time. SDMT is a validated and established measure of cognition in multiple sclerosis capturing impairments such as processing speed and working memory, visual search and scanning and oculomotor functioning. Patients are provided a sheet with nine symbols, each paired with a number on top of the page. The remainder of the page consists of a randomized, sequential assortment of these symbols. Participants are asked to verbally respond with the number that corresponds with each symbol. The final score is the correct number of substitutions in 90 s (range 0 to 110, higher score = higher neurocognitive function). Intra-patient change in neurocognitive functions at month 3 and at month 6 (if required by the investigator) after IA completion compared to baseline.", "time_frame": "3 months and 6 months (only if requested by the investigator) after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in quality of life (QoL) as measured by the PROMIS questionnaire", "description": "PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS measures can be used with the general population and with individuals living with chronic conditions. Intra-patient change in PROMIS score from baseline to follow-up points will be documented.", "time_frame": "3 months and optional 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Changes in biomarkers of autoimmune activity", "description": "Intra-patient changes in biomarkers of autoimmune activity (autoantibody titers against neurotransmitter receptors; among others ß2-adeno-receptor- and muscarine- receptor-antibodies) in blood and optional in cerebrospinal fluid at month 3 after IA completion compared to baseline.", "time_frame": "3 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Changes in biomarkers of inflammation", "description": "Intra-patient change in biomarkers of inflammation (CRP, ferritin, MBL, white blood cell count, complement factors, cytokines, immunoglobulin level and subtype) in blood at month 3 and 6 after IA completion compared to baseline.", "time_frame": "3 months and 6 months after completion of immunoadsorption or sham apheresis" } ], "outcome_measures": [ { "type": "primary", "measure": "Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale", "description": "The Chalder Fatigue Scale measures the extent and severity of tiredness and has been used in multiple randomized trials of behavioral interventions in patients with ME/CFS. Each of the 11 items is answered on a 4-point scale with an overall score ranging from 0 (asymptomatic) to 33 (maximum symptomology). Intra-patient change in physical and mental fatigue from baseline to month three will be documented as indexed by the Chalder Fatigue Scale.", "time_frame": "3 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Sustained improvement quantified by the Chalder Fatigue Scale", "description": "Intra-patient change in physical and mental fatigue from baseline to follow-up points will be documented.", "time_frame": "10 days, 1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Verification of safety and tolerability of immunoadsorption in this patient population", "description": "Number of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuation due to TEAEs", "time_frame": "1 day, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in severity of symptoms of chronic fatigue syndrome (CFS) as measured by the Fluge score", "description": "The Fluge score uses a visual analogue scale ranging from 1 to 10 (1 = no symptom, 10 = very severe symptom) to assess 32 self-reported CFS symptoms including fatigue, pain, cognitive, and other CFS-related symptoms. Intra-patient change in Fluge score from baseline to follow-up points will be documented.", "time_frame": "1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in physical function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)", "description": "The Short Form 36 Health Survey (SF-36) is an established and widely used health-related quality of life measure. The Physical Function (PF) domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change in SF-36-PF from baseline to follow-up points will be documented.", "time_frame": "1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in functional disability as measured by the Bell disability scale", "description": "The Bell disability scale is a standard assessment in ME/CFS that evaluates functional ability in adult ME/CFS patients. Eleven statements describe patient status such as level of symptoms at rest, level of symptoms with exercise, activity level, and ability to perform work, travel and self care. Its score ranges from 0 (bedridden) to 100 (no symptoms). Intra-patient change in Bell score from baseline to follow-up points will be documented.", "time_frame": "1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in fatigue quantified by post exertional malaise (PEM) questionnaire", "description": "The PEM questionnaire determines frequency (from 0 to 20 points, higher scores equate to greater frequency), severity (from 0 to 20 points, higher scores equate to greater severity), and length (from 0 to 6 points, higher scores equate to longer duration) of PEM. Intra-patient change in PEM score from baseline to follow-up points will be documented.", "time_frame": "1 month, 3 months, and 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in muscle fatigue measured by the repetitive hand grip strength test (HGS)", "description": "Intra-patient change in hand grip strength (HGS) from baseline to follow-up points.", "time_frame": "10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)", "description": "The Composite Autonomic Symptom Score (COMPASS-31) is a refined, internally consistent, and markedly abbreviated quantitative measure of autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, applies a much-simplified scoring algorithm, and is suitable for widespread use in autonomic research and practice. It evaluates six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The score ranges from 0 (no symptoms) to 100 (strong autonomic dysfunction). Intra-patient change in autonomic dysfunction from baseline to follow-up points will be documented as indexed by the COMPASS-31.", "time_frame": "10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in symptoms of autonomic dysfunction by measuring blood pressure and heart rate regulation with the Schellong Test", "description": "The Schellong Test is a test for circulatory function. The patient is required to stand for 10 to 20 min, during which time the blood pressure is measured continuously. A fall of systolic pressure of 20 mm Hg or more indicates poor circulatory function. Intra-patient change in Schellong Test from baseline to follow-up points will be documented.", "time_frame": "10 days, 3 months, and optional 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in neurocognitive functions as measured by the Montreal Cognitive Assessment (MoCA)", "description": "MoCA is a sensitive and validated cognitive screening tool to test subjects quickly and accurately for mild cognitive impairment, irrespective of etiology. A person can gain a maximum of 30 points, and professionals consider a score of 26 or above to be normal. A score of 25 points or less may indicate some degree of cognitive impairment (18-25 = mild cognitive impairment, 10-17 = moderate cognitive impairment, fewer than 10 points = severe cognitive impairment). Intra-patient change in neurocognitive functions at month 3 and at month 6 (if required by the investigator) after IA completion compared to baseline.", "time_frame": "3 months and 6 months (only if requested by the investigator) after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in neurocognitive functions as measured by the symbol digit modalities test (SDMT)", "description": "The SDMT (oral version) detects cognitive impairment in less than five minutes and will be used to assess change in cognitive function over time. SDMT is a validated and established measure of cognition in multiple sclerosis capturing impairments such as processing speed and working memory, visual search and scanning and oculomotor functioning. Patients are provided a sheet with nine symbols, each paired with a number on top of the page. The remainder of the page consists of a randomized, sequential assortment of these symbols. Participants are asked to verbally respond with the number that corresponds with each symbol. The final score is the correct number of substitutions in 90 s (range 0 to 110, higher score = higher neurocognitive function). Intra-patient change in neurocognitive functions at month 3 and at month 6 (if required by the investigator) after IA completion compared to baseline.", "time_frame": "3 months and 6 months (only if requested by the investigator) after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Improvement in quality of life (QoL) as measured by the PROMIS questionnaire", "description": "PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS measures can be used with the general population and with individuals living with chronic conditions. Intra-patient change in PROMIS score from baseline to follow-up points will be documented.", "time_frame": "3 months and optional 6 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Changes in biomarkers of autoimmune activity", "description": "Intra-patient changes in biomarkers of autoimmune activity (autoantibody titers against neurotransmitter receptors; among others ß2-adeno-receptor- and muscarine- receptor-antibodies) in blood and optional in cerebrospinal fluid at month 3 after IA completion compared to baseline.", "time_frame": "3 months after completion of immunoadsorption or sham apheresis" }, { "type": "secondary", "measure": "Changes in biomarkers of inflammation", "description": "Intra-patient change in biomarkers of inflammation (CRP, ferritin, MBL, white blood cell count, complement factors, cytokines, immunoglobulin level and subtype) in blood at month 3 and 6 after IA completion compared to baseline.", "time_frame": "3 months and 6 months after completion of immunoadsorption or sham apheresis" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 66, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05710770", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06492590", "title": "Long COVID-19 Intervention (COVIDL/MIQoL)", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-01-16", "start_date": "2025-01-17", "completion_date": "2025-11-30", "primary_completion_date": "2025-09-30", "conditions_raw": [ "Long COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Multicomponent Intervention" ], "sponsor": "Consorci Sanitari de Terrassa", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to assess the effectiveness of a multicomponent intervention in individuals with Long COVID. The main questions it aims to answer are:\n\n* Does the intervention increase quality of life, mental well-being, resilience, and physical condition in individuals with Long COVID?\n* Does the intervention decrease anxiety, depressed mood, and fatigue in individuals with Long COVID? The researchers will compare the multicomponent intervention with a control (non-intervention) group.\n\nParticipants will:\n\n• Participate in a multicomponent intervention for 9 weeks (2 sessions each week, one of psycho-education and one of physical rehabilitation).", "primary_outcomes": [ { "type": "primary", "measure": "Improved quality of life", "description": "Changes in level of quality of life using the EuroQol 5D-5L scale (EQ-5D-5L). Values range from 0 to 1 (full health). Higher scores, better outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Improve well-being", "description": "Changes in level of well-being using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Values range from 14 to 70 . Higher scores, better outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" }, { "type": "secondary", "measure": "Decreased anxiety and depression", "description": "Changes in level of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Anxiety values range from 0 to 15 . Higher scores, worse outcome. Depression values range from 0 to 12. Higher scores, worse outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" }, { "type": "secondary", "measure": "Increased resilience", "description": "Changes in level of resilience using the Connor-Davidson Resilience Scale (CD-RISC). Values range from 0 to 40 . Higher scores, better outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" }, { "type": "secondary", "measure": "Improve physical activity", "description": "Changes in level of physical activity using the International Physical Activity Questionnaire (IPAQ). In each category a maximum of 21 hours of activity are permitted a week (3 hours X 7 days) To calculate MET minutes a week multiply the MET value given (r walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. Higher scores, better outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" }, { "type": "secondary", "measure": "Decreased fatigue", "description": "Changes in level of fatigue scale using the Chalder Fatigue Scale (CFS). Values range from 0 to 42 . Higher scores, worse outcome.", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" } ], "outcome_measures": [ { "type": "primary", "measure": "Improved quality of life", "description": "Changes in level of quality of life using the EuroQol 5D-5L scale (EQ-5D-5L). Values range from 0 to 1 (full health). Higher scores, better outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" }, { "type": "secondary", "measure": "Improve well-being", "description": "Changes in level of well-being using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Values range from 14 to 70 . Higher scores, better outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" }, { "type": "secondary", "measure": "Decreased anxiety and depression", "description": "Changes in level of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Anxiety values range from 0 to 15 . Higher scores, worse outcome. Depression values range from 0 to 12. Higher scores, worse outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" }, { "type": "secondary", "measure": "Increased resilience", "description": "Changes in level of resilience using the Connor-Davidson Resilience Scale (CD-RISC). Values range from 0 to 40 . Higher scores, better outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" }, { "type": "secondary", "measure": "Improve physical activity", "description": "Changes in level of physical activity using the International Physical Activity Questionnaire (IPAQ). In each category a maximum of 21 hours of activity are permitted a week (3 hours X 7 days) To calculate MET minutes a week multiply the MET value given (r walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. Higher scores, better outcome", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" }, { "type": "secondary", "measure": "Decreased fatigue", "description": "Changes in level of fatigue scale using the Chalder Fatigue Scale (CFS). Values range from 0 to 42 . Higher scores, worse outcome.", "time_frame": "Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 74, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06492590", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07343856", "title": "Long COVID Diagnostic Reactivity Assesment Test", "status": "ENROLLING_BY_INVITATION", "phase": "NA", "last_updated": "2026-01-15", "start_date": "2025-12-05", "completion_date": "2027-01-01", "primary_completion_date": "2026-12-30", "conditions_raw": [ "Long COVID", "Post-Acute Sequelae of SARS-CoV-2 Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Electrodiagnostic Bioelectrical Assessment" ], "sponsor": "Oncology Center,Ministry Of Heath,Uzbekistan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is a diagnostic clinical investigation designed to evaluate bioelectrical response patterns assessed by electro-acupuncture-based medicament testing.\n\nThe method is used to identify individual bioelectrical reactivity associated with the presence and persistence of pathological factors and to assess patient-specific responses to tested medicinal substances.\n\nThe study involves a single-session, non-invasive diagnostic procedure without administration of pharmacological treatment. The primary objective is the methodological evaluation of the diagnostic approach and the characterization of the detected bioelectrical response patterns in the studied population.", "primary_outcomes": [ { "type": "primary", "measure": "Number of Participants With Bioelectrical Response Patterns Consistent With Viral Persistence", "description": "Non-invasive diagnostic assessment using electroacupuncture-based medicament testing to identify bioelectrical response patterns consistent with viral antigen persistence in participants with post-viral conditions.", "time_frame": "At enrollment (single diagnostic session)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Distribution of Bioelectrical Reactivity Patterns During Medicament Testing", "description": "", "time_frame": "Baseline(Day 1)" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of Participants With Bioelectrical Response Patterns Consistent With Viral Persistence", "description": "Non-invasive diagnostic assessment using electroacupuncture-based medicament testing to identify bioelectrical response patterns consistent with viral antigen persistence in participants with post-viral conditions.", "time_frame": "At enrollment (single diagnostic session)" }, { "type": "secondary", "measure": "Distribution of Bioelectrical Reactivity Patterns During Medicament Testing", "description": "", "time_frame": "Baseline(Day 1)" } ], "relevance_tags": [ "Persistence / Antiviral", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07343856", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05675995", "title": "Qigong for Post Acute Sequelae of COVID-19 Infection", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-01-13", "start_date": "2023-01-04", "completion_date": "2024-05-15", "primary_completion_date": "2024-05-15", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Qigong" ], "sponsor": "University of California, Davis", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to conduct a pilot feasibility study of a combination of external and internal qigong on health-related quality of life in individuals with prolonged symptoms following COVID-19 infection.", "primary_outcomes": [ { "type": "primary", "measure": "Changes in physical and mental health", "description": "Changes in PROMIS-29 summary scores from before to after intervention in all participants", "time_frame": "8 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Changes in physical and mental health", "description": "Changes in PROMIS-29 summary scores from before to after intervention in all participants", "time_frame": "8 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05675995", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05926505", "title": "Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-01-08", "start_date": "2023-09-06", "completion_date": "2028-03", "primary_completion_date": "2028-03", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Post-Acute COVID-19", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Anakinra 149 Mg/Ml Prefilled Syringe [Kineret]" ], "sponsor": "Hellenic Institute for the Study of Sepsis", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The PRECISION is a proof-of-concept, phase II randomized clinical trial aiming to evaluate the efficacy and safety of anakinra in patients with Post-Acute COVID Syndrome (PACS) of the pro-inflammatory respiratory phenotype. Improvement is measured by a composite endpoint, namely, the \"Score of PACS progression reversal\"", "primary_outcomes": [ { "type": "primary", "measure": "Score of PACS progression reversal", "description": "A positive score is defined differently for patients enrolled in the study because of Condition 1 or Condition 2. For patients enrolled in Condition 1, a positive score comprises at least two of the following: 1. At least 20% improvement of restrictive lung disease from baseline 2.No need for hospitalization οr admission to the Emergency Department 3. No increase of the degree of lung fibrosis score in lung HRCT For patients enrolled in Condition 2, a positive score comprises at least two of the following: 1. At least 20% decrease of the total score in lung HRCT OR Improved exercise capacity in the 6min walk test. 2.No need for hospitalization οr admission to the Emergency Department. 3.No increase of the degree of lung fibrosis score in lung HRCT.\n\nThe proportion of patients achieving the above composite endpoint compared to placebo at week 4 will be the primary study endpoint.", "time_frame": "Through study completion,an average of 2 years" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo).", "description": "The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo).", "time_frame": "Through study completion,an average of 2 years" }, { "type": "secondary", "measure": "Changes of concentration of cytokines produced by stimulated PBMCs at week 4 between the two arms of treatment.", "description": "Changes of concentration of cytokines produced by stimulated PBMCs at week 4 between the two arms of treatment.", "time_frame": "Through study completion,an average of 2 years" }, { "type": "secondary", "measure": "Change of each component of the score for the primary outcome at week 4 between the two arms of treatment.", "description": "Change of each component of the score for the primary outcome at week 4 between the two arms of treatment. Post-acute COVID-19 syndrome (PACS) score. The higher the score, the worst the patients' outcome. PACS score ranges between 0-16.", "time_frame": "Through study completion,an average of 2 years" }, { "type": "secondary", "measure": "At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment.", "description": "At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment.", "time_frame": "Through study completion,an average of 2 years" }, { "type": "secondary", "measure": "At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment.", "description": "At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment", "time_frame": "Through study completion,an average of 2 years" } ], "outcome_measures": [ { "type": "primary", "measure": "Score of PACS progression reversal", "description": "A positive score is defined differently for patients enrolled in the study because of Condition 1 or Condition 2. For patients enrolled in Condition 1, a positive score comprises at least two of the following: 1. At least 20% improvement of restrictive lung disease from baseline 2.No need for hospitalization οr admission to the Emergency Department 3. No increase of the degree of lung fibrosis score in lung HRCT For patients enrolled in Condition 2, a positive score comprises at least two of the following: 1. At least 20% decrease of the total score in lung HRCT OR Improved exercise capacity in the 6min walk test. 2.No need for hospitalization οr admission to the Emergency Department. 3.No increase of the degree of lung fibrosis score in lung HRCT.\n\nThe proportion of patients achieving the above composite endpoint compared to placebo at week 4 will be the primary study endpoint.", "time_frame": "Through study completion,an average of 2 years" }, { "type": "secondary", "measure": "The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo).", "description": "The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo).", "time_frame": "Through study completion,an average of 2 years" }, { "type": "secondary", "measure": "Changes of concentration of cytokines produced by stimulated PBMCs at week 4 between the two arms of treatment.", "description": "Changes of concentration of cytokines produced by stimulated PBMCs at week 4 between the two arms of treatment.", "time_frame": "Through study completion,an average of 2 years" }, { "type": "secondary", "measure": "Change of each component of the score for the primary outcome at week 4 between the two arms of treatment.", "description": "Change of each component of the score for the primary outcome at week 4 between the two arms of treatment. Post-acute COVID-19 syndrome (PACS) score. The higher the score, the worst the patients' outcome. PACS score ranges between 0-16.", "time_frame": "Through study completion,an average of 2 years" }, { "type": "secondary", "measure": "At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment.", "description": "At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment.", "time_frame": "Through study completion,an average of 2 years" }, { "type": "secondary", "measure": "At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment.", "description": "At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment", "time_frame": "Through study completion,an average of 2 years" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 182, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05926505", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06330376", "title": "Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD)", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-01-08", "start_date": "2024-03-01", "completion_date": "2025-08-15", "primary_completion_date": "2025-08-15", "conditions_raw": [ "Post-Acute Sequelae of COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Specific Db Program/Diaphragmatic Manipulation Program" ], "sponsor": "University of Minnesota", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Diaphragm is the principal muscle of inspiration. Diaphragmatic dysfunction is seen in many conditions including following intubation, lung disease, prolonged ventilation, neuromuscular disease, phrenic nerve injury. The possible mechanisms of diaphragmatic dysfunction in patients with COVID19 are critical illness myopathy, ventilator-induced diaphragm dysfunction, iatrogenic phrenic nerve injury particularly secondary to line placement, post-infectious inflammatory neuropathy of the phrenic nerve, or possibly direct neuromuscular involvement of the SARS- CoV-2 virus given expression of the angiotensin- converting enzyme 2 (ACE2) receptor in the peripheral nervous system and skeletal muscle. The use of diaphragmatic ultrasound has been widely used to assess diaphragmatic function is well known in patients following prolonged mechanical ventilation. Prolonged mechanical ventilation leads to contractile dysfunction of respiratory muscles, in particular the diaphragm, causing a so-called ventilator-induced diaphragm dysfunction. The latter is defined as a loss of diaphragm force-generating capacity specifically related to the use of mechanical ventilation. However, the use of diaphragmatic Ultrasound to assess its function in Long COVID patients has not been noted and is a gap in the work up of these patients.\n\nThe purpose of this study is to address Diaphragmatic Dysfunctional (DD) breathing seen in patients with Post-Acute Sequelae of COVID-19 (PASC), which results in shortness of breath/chest tightness and subsequent fatigue. Targeting shortness of breath and subsequent fatigue as a central symptom of PASC will alleviate long term sequelae for the patients with PASC. DD will be addressed by a unique intervention of physical therapy. The goal of this prospective randomized clinical study will be to evaluate the comparative treatment effect of DB on markers, specifically fatigue, dyspnea, 6 min walk test, depression/anxiety, and quality of life (QoL).", "primary_outcomes": [ { "type": "primary", "measure": "6-minute walk test (6MWT)", "description": "It is a simple test that requires no specialized equipment or advanced training for physicians and assesses the submaximal level of functional capacity of an individual while walking on a flat, hard surface in a period of 6 min. It is used to assess the response to a medical therapy, and in cardiac/pulmonary rehabilitation.", "time_frame": "6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "PHQ9: Patient health questionnaire 9", "description": "measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.", "time_frame": "6 months" }, { "type": "secondary", "measure": "GAD7: Generalized anxiety disorder 7-item", "description": "measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.", "time_frame": "6 months" }, { "type": "secondary", "measure": "PROMIS score: Patient-Reported Outcomes Measurement Information System", "description": "is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Administration of these scales is a standard of care in our post-COVID clinic.", "time_frame": "6 months" }, { "type": "secondary", "measure": "QoL scale: Quality of life scale", "description": "measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.", "time_frame": "6 months" }, { "type": "secondary", "measure": "FACIT fatigue scale 's Fatigue score", "description": "Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (FACIT) FACIT fatigue scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) 18 The FACIT Fatigue Scale is one of many different FACIT scales that are part of a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness referred to as The FACIT Measurement System.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Modified Borg dyspnea scale", "description": "The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT).", "time_frame": "6 months" }, { "type": "secondary", "measure": "RR; respiratory rate with 6 min walk test", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "PR: pulse rate with 6 min walk test", "description": "", "time_frame": "6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "6-minute walk test (6MWT)", "description": "It is a simple test that requires no specialized equipment or advanced training for physicians and assesses the submaximal level of functional capacity of an individual while walking on a flat, hard surface in a period of 6 min. It is used to assess the response to a medical therapy, and in cardiac/pulmonary rehabilitation.", "time_frame": "6 months" }, { "type": "secondary", "measure": "PHQ9: Patient health questionnaire 9", "description": "measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.", "time_frame": "6 months" }, { "type": "secondary", "measure": "GAD7: Generalized anxiety disorder 7-item", "description": "measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.", "time_frame": "6 months" }, { "type": "secondary", "measure": "PROMIS score: Patient-Reported Outcomes Measurement Information System", "description": "is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Administration of these scales is a standard of care in our post-COVID clinic.", "time_frame": "6 months" }, { "type": "secondary", "measure": "QoL scale: Quality of life scale", "description": "measures of depression, anxiety, and physical/mental/and social health, respectively, and will serve as covariates in our analysis.", "time_frame": "6 months" }, { "type": "secondary", "measure": "FACIT fatigue scale 's Fatigue score", "description": "Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (FACIT) FACIT fatigue scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) 18 The FACIT Fatigue Scale is one of many different FACIT scales that are part of a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness referred to as The FACIT Measurement System.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Modified Borg dyspnea scale", "description": "The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT).", "time_frame": "6 months" }, { "type": "secondary", "measure": "RR; respiratory rate with 6 min walk test", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "PR: pulse rate with 6 min walk test", "description": "", "time_frame": "6 months" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 16, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06330376", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07190105", "title": "Vagal Approaches on Long COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-01-07", "start_date": "2025-10-27", "completion_date": "2025-12-11", "primary_completion_date": "2025-12-11", "conditions_raw": [ "Long COVID Symptoms" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Sonocea Sonic Augmentation Technology", "Truvaga Electrical Vagus Nerve Stimulator" ], "sponsor": "Leidos Life Sciences", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to explore whether two general wellness products, alone or combined, can support individuals experiencing Long COVID symptoms. Both wellness products stimulate the vagus nerve - a nerve that helps regulate stress, relaxation, mood, breathing, heart rate, inflammation, and digestion.\n\nThe investigators will use a Fitbit to track participants' health measurements including, but not limited to, activity, heart rate, and heart rate variability, and participants will be asked to complete surveys about their experience. This information will be collected into a repository where participants can share their experiences with Long COVID symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Patient Health Questionnaire-8 (PHQ-8)", "description": "The PHQ-8 is a gold-standard screening tool for major depressive disorder, endorsed by the CDC and WHO, with strong criterion validity and sensitivity to clinical change.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "Generalized Anxiety Disorder-7 (GAD-7)", "description": "The GAD-7 captures both somatic and cognitive components of generalized anxiety. Extensively used in both clinical and epidemiological contexts, the GAD-7 shows excellent internal consistency (α \\> 0.90) and convergent validity with clinician-administered diagnostic tools.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "PTSD Checklist for DSM-5 Short Form (Abbreviated PCL-5)", "description": "The Abbreviated PCL-5 captures re-experiencing, avoidance, hyperarousal, and mood alterations. The Abbreviated PCL-5 is validated across diverse populations and is widely used in both military and civilian trauma research. It is recommended by the National Center for PTSD.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "Symptom Burden Questionnaire - Long COVID (SBQ-LC)", "description": "The SBQ-LC measures the intensity and impact of Long COVID symptoms, offering key insight into the ongoing symptom burden experienced. The SBQ-LC demonstrates strong psychometric properties with high internal consistency across subscales and good convergent validity with established measures of symptom severity and functional impairment. It has been validated across diverse Long COVID populations in multiple clinical settings.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "Body Perception Questionnaire (BPQ)", "description": "The BPQ assesses self-reported autonomic reactivity and has been used in a range of international neural, behavioral, and clinical studies and translated into several languages. It has been corroborated with sensor-based measures of autonomic function.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "Benefits Scale", "description": "The Benefits Scale assesses biobehavioral state, including the ability to quiet thoughts, awareness of bodily rhythms, breathing, muscular relaxation, physical pain levels, and emotional states such as peacefulness, relaxation, anxiety, irritability, feeling overwhelmed, worry about the future, and vulnerability.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Sleep Metrics", "description": "The investigators will use the sleep categories of accumulated minutes of deep sleep, REM sleep, light sleep, and wakefulness during the night to provide us with sleep architecture.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Resting Heart Rate", "description": "Monitoring resting heart rate will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are effective in lowering the elevated resting heart rate often observed in Long COVID patients via parasympathetic stimulation.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Steps", "description": "Monitoring steps will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are associated with an increase in average daily steps, which may indicate enhanced functional capacity or reduced fatigue.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Breathing Rate", "description": "This measurement captures a user's average breaths per minute during sleep.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Heart Rate Variability (HRV)", "description": "Heart rate variability (HRV) is a widely recognized biomarker for autonomic nervous system regulation. Long COVID is commonly associated with reduced HRV, reflecting autonomic nervous system dysregulation. Lower HRV in these patients has been linked to greater symptom burden.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Cardio Score (VO2 Max)", "description": "Tracking changes in estimated aerobic capacity can help evaluate whether approaches are improving cardiovascular function and exercise tolerance over time.", "time_frame": "Weekly" }, { "type": "primary", "measure": "SpO2", "description": "SpO2 measures blood oxygen saturation levels, indicating how well oxygen is being transported throughout the body.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Active Zone Minutes", "description": "Active Zone Minutes are a measure of time spent in elevated heart rate zones, including Fat Burn, Cardio, and Peak zones.", "time_frame": "Weekly" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Patient Health Questionnaire-8 (PHQ-8)", "description": "The PHQ-8 is a gold-standard screening tool for major depressive disorder, endorsed by the CDC and WHO, with strong criterion validity and sensitivity to clinical change.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "Generalized Anxiety Disorder-7 (GAD-7)", "description": "The GAD-7 captures both somatic and cognitive components of generalized anxiety. Extensively used in both clinical and epidemiological contexts, the GAD-7 shows excellent internal consistency (α \\> 0.90) and convergent validity with clinician-administered diagnostic tools.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "PTSD Checklist for DSM-5 Short Form (Abbreviated PCL-5)", "description": "The Abbreviated PCL-5 captures re-experiencing, avoidance, hyperarousal, and mood alterations. The Abbreviated PCL-5 is validated across diverse populations and is widely used in both military and civilian trauma research. It is recommended by the National Center for PTSD.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "Symptom Burden Questionnaire - Long COVID (SBQ-LC)", "description": "The SBQ-LC measures the intensity and impact of Long COVID symptoms, offering key insight into the ongoing symptom burden experienced. The SBQ-LC demonstrates strong psychometric properties with high internal consistency across subscales and good convergent validity with established measures of symptom severity and functional impairment. It has been validated across diverse Long COVID populations in multiple clinical settings.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "Body Perception Questionnaire (BPQ)", "description": "The BPQ assesses self-reported autonomic reactivity and has been used in a range of international neural, behavioral, and clinical studies and translated into several languages. It has been corroborated with sensor-based measures of autonomic function.", "time_frame": "Week 0, Week 4 and Week 8" }, { "type": "primary", "measure": "Benefits Scale", "description": "The Benefits Scale assesses biobehavioral state, including the ability to quiet thoughts, awareness of bodily rhythms, breathing, muscular relaxation, physical pain levels, and emotional states such as peacefulness, relaxation, anxiety, irritability, feeling overwhelmed, worry about the future, and vulnerability.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Sleep Metrics", "description": "The investigators will use the sleep categories of accumulated minutes of deep sleep, REM sleep, light sleep, and wakefulness during the night to provide us with sleep architecture.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Resting Heart Rate", "description": "Monitoring resting heart rate will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are effective in lowering the elevated resting heart rate often observed in Long COVID patients via parasympathetic stimulation.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Steps", "description": "Monitoring steps will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are associated with an increase in average daily steps, which may indicate enhanced functional capacity or reduced fatigue.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Breathing Rate", "description": "This measurement captures a user's average breaths per minute during sleep.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Heart Rate Variability (HRV)", "description": "Heart rate variability (HRV) is a widely recognized biomarker for autonomic nervous system regulation. Long COVID is commonly associated with reduced HRV, reflecting autonomic nervous system dysregulation. Lower HRV in these patients has been linked to greater symptom burden.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Cardio Score (VO2 Max)", "description": "Tracking changes in estimated aerobic capacity can help evaluate whether approaches are improving cardiovascular function and exercise tolerance over time.", "time_frame": "Weekly" }, { "type": "primary", "measure": "SpO2", "description": "SpO2 measures blood oxygen saturation levels, indicating how well oxygen is being transported throughout the body.", "time_frame": "Weekly" }, { "type": "primary", "measure": "Active Zone Minutes", "description": "Active Zone Minutes are a measure of time spent in elevated heart rate zones, including Fat Burn, Cardio, and Peak zones.", "time_frame": "Weekly" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 546, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT07190105", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06189066", "title": "Long COVID Ultrasound Trial", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-01-07", "start_date": "2024-01-03", "completion_date": "2025-07-24", "primary_completion_date": "2024-07-24", "conditions_raw": [ "Long Covid" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Splenic Ultrasound" ], "sponsor": "SecondWave Systems Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The research objective is to assess the safety and potential efficacy of spleen ultrasound stimulation as an intervention for Long COVID in a pilot study.\n\nSpecific Aims include:\n\n* Measure Long COVID disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation.\n* Measure molecular correlates of Long COVID disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation.\n* Track adverse events throughout the study to assess safety of the ultrasound intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Within-arm change in the endurance shuttle walk test (ESWT) from baseline to the completion of an up-to 8-week intervention period.", "description": "ESWT is a standardized, externally controlled, constant-paced walking test for the assessment of endurance capacity. Improvement in this outcome will be determined by an increase of distance walked and/or increase in time walked before failure to maintain the controlled walking pace.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Within-arm change in the Chalder fatigue scale (CFQ-11; Likert score) from baseline to the completion of an up-to 8-week intervention period.", "description": "CFQ-11 is a is a self-administered questionnaire for measuring the extent and severity of fatigue.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Track adverse events throughout the study to assess the safety of the ultrasound intervention.", "description": "", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Within-arm change in the endurance shuttle walk test (ESWT) from baseline to the completion of an up-to 8-week intervention period.", "description": "ESWT is a standardized, externally controlled, constant-paced walking test for the assessment of endurance capacity. Improvement in this outcome will be determined by an increase of distance walked and/or increase in time walked before failure to maintain the controlled walking pace.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Within-arm change in the Chalder fatigue scale (CFQ-11; Likert score) from baseline to the completion of an up-to 8-week intervention period.", "description": "CFQ-11 is a is a self-administered questionnaire for measuring the extent and severity of fatigue.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Track adverse events throughout the study to assess the safety of the ultrasound intervention.", "description": "", "time_frame": "8 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 15, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06189066", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05999435", "title": "Study of LAU-7b for the Treatment of Long COVID in Adults", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-01-06", "start_date": "2023-11-15", "completion_date": "2024-11-30", "primary_completion_date": "2024-08-05", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Lau-7B For 3 Cycles" ], "sponsor": "Laurent Pharmaceuticals Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "ESSOR is a double-blind, placebo-controlled study of the orally-administered antiviral and inflammation-controlling LAU-7b for the treatment of adults with Long COVID and moderate to severe symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12", "description": "The SF-36 questionnaire consists of 36 items grouped in eight health domains, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, that can be aggregated to two summary scales, physical component summary (PCS ) and mental component summary (MCS). The PCS summarizes the physical status and constitutes the primary outcome variable. Each health domain score consists of the sum scores of the assigned questions. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, ie, severe disability) to 100 (no health restrictions). A higher score means a better physical status. The calculation process for the PCS has been previously described by Taft et al. 2001.", "time_frame": "Week 0 and 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Safety of LAU-7b, Overview", "description": "Number of participants with adverse events. The safety was assessed through the monitoring of adverse events including laboratory test abnormalities, serious adverse events and adverse events leading to study treatment discontinuation. Treatment-emergent adverse event is defined as any adverse event with onset date on or after the first dose of study drug and on or before the Week 12 in person follow-up or until early termination or death, whichever occurred first.", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGI-C)", "description": "The PGI-C is a single item questionnaire that asks: \"Overall, how would you rate the change in your ability to perform usual daily activities since you started the study?\".\n\nThese are the 7-point scale options: 1) \"very much better\", 2) \"much better\", 3) \"minimally better\", 4) \"no change\", 5) \"minimally worse\", 6) \"much worse\", or 7) \"very much worse\".\n\nHigher scores indicate a change for the worse and lower scores indicate a change for the better.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Participants With Marked Improvement in PGI-C", "description": "Marked improvement includes \"Very much improved\" and Much improved\". The PGI-C is a single item questionnaire that asks: \"Overall, how would you rate the change in your ability to perform usual daily activities since you started the study?\".\n\nThese are the 7-point scale options: 1) \"very much better\", 2) \"much better\", 3) \"minimally better\", 4) \"no change\", 5) \"minimally worse\", 6) \"much worse\", or 7) \"very much worse\".\n\nHigher scores indicate a change for the worse and lower scores indicate a change for the better.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale", "description": "This instrument was developed to characterize fatigue, in cancer and used in other conditions with a phenotype of fatigue. It is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The recall period is 7 days and the response scale employs a 5-point Likert-type scale. The final total score is the sum of the responses for all 13 items and can range from 0 to 52. A higher score means less fatigue.", "time_frame": "Weeks 0, 4, 8 and 12" }, { "type": "secondary", "measure": "Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ)", "description": "This instrument was developed to characterize and evaluate the debilitation caused by a physical exertion, whether a usual daily activity or a leisure activity. It is a 10-item questionnaire that assess both the nature of post-exertional malaise (PEM) and duration of symptom. In this study, the presence or not of PEM (based on frequency and severity of 5 PEM items) is determined by the questionnaire. The endpoint of the study is the proportion of participants with PEM at baseline and Week 12, compared between treatment groups.", "time_frame": "Weeks 0 and 12" }, { "type": "secondary", "measure": "Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8", "description": "The SF-36 questionnaire consists of 36 items grouped in eight health domains, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, that can be aggregated to two summary scales, physical component summary (PCS ) and mental component summary (MCS). The PCS summarizes the physical status and constitutes the primary outcome variable. Each health domain score consists of the sum scores of the assigned questions. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, ie, severe disability) to 100 (no health restrictions). A higher score means a better physical status. The calculation process for the PCS has been previously described by Taft et al. 2001. The analysis is performed jointly with the primary outcome measure (Week 12). A positive change from baseline value means improvement, negative value means worsening.", "time_frame": "Weeks 0, 4 and 8" }, { "type": "secondary", "measure": "Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36)", "description": "The SF-36 questionnaire consists of 36 items grouped in eight health domains, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, that can be aggregated to two summary scales, physical component summary (PCS ) and mental component summary (MCS). Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, ie, severe disability) to 100 (no health restrictions). A higher score means a better outcome. The study endpoint is the change from baseline in score, a positive change from baseline value means improvement and a negative value means worsening outcome. For sake of conciseness, only Week 12 comparisons are presented.", "time_frame": "Weeks 0, 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection.", "description": "This will be assessed by a single question with either yes or no as answer: \"Do you judge that you have regained the daily usual activity level you had prior to being infected by COVID-19 back in Month xxxx? By daily usual activity we mean work, leisure, physical exercise...etc.\"", "time_frame": "From Week 0 through Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects Achieving >=25% (>=50% and >=75% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.", "description": "The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome. A sum of the burdensome category is calculated for each visit and is the endpoint being evaluated for improvement since burdensome symptoms are those with highest impact on daily usual activity level.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects Achieving >=50% (>=25% and >=75% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.", "description": "The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome. A sum of the burdensome category is calculated for each visit and is the endpoint being evaluated for improvement since burdensome symptoms are those with highest impact on daily usual activity level.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects Achieving >=75% (>=25% and >=50% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.", "description": "The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome. A sum of the burdensome category is calculated for each visit and is the endpoint being evaluated for improvement since burdensome symptoms are those with highest impact on daily usual activity level.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score", "description": "EQ-5D-5L is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). Higher values indicate worse outcomes, while lower indicate better outcomes. The subscales are combined to compute a total score index, adjusted for a standard value of general population in a country/region and averaged to produce the mean and SD. The Summary index value range is from 0 to 1, where 1 is considered the best possible health and 0 is the worst possible health. For the change in score, a positive number indicates that the scores improved from baseline.", "time_frame": "Weeks 0, 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks.", "description": "The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome.\n\nRelief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change)", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Time to Relief of the First Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks, Among Those Symptoms Present at Baseline.", "description": "The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (brain fog or memory fog) and mental health symptoms. Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom. 0 and 1 are deemed not burdensome, 2 and 3 are burdensome. This will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. Relief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change). A longer time is worse than a short time to resolution.", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms.", "description": "The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome.\n\nThis will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. Relief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change). A higher proportion is better than a lower proportion.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core).", "description": "This will be assessed through periodic inventory of all the Long COVID symptoms, performed at each visit, relative to the baseline inventory. A lower total number is better than a higher total number.", "time_frame": "Weeks 0, 4, 8 and 12, as well as the longer term visit at Week 24" }, { "type": "secondary", "measure": "Proportion of Subjects With Long COVID-related Unplanned Medical Visits", "description": "This will be assessed by probing the subjects at each visit. Long COVID-related unplanned medical visits includes visits to practitioner's office, urgent care visits, emergency room \\<24h, or hospitalization \\>24 hours.\n\nA higher proportion is worse than a lower proportion", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Proportion of Subjects Deceased From Any Cause Through Week 12.", "description": "This will be assessed by probing the subjects at each visit, including caretakers or relatives if the subjects cannot be reached at a given visit.\n\nA higher proportion is worse than a lower proportion", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Proportion of Subjects With Significant Cardiovascular Events", "description": "A significant cardiovascular event is one that results in at least an acute care visit, a hospitalization or an event-related death.\n\nA higher proportion is worse than a lower proportion", "time_frame": "From Week 0 to Week 12 and including up to the long-term follow-up at Week 24" } ], "outcome_measures": [ { "type": "primary", "measure": "Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12", "description": "The SF-36 questionnaire consists of 36 items grouped in eight health domains, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, that can be aggregated to two summary scales, physical component summary (PCS ) and mental component summary (MCS). The PCS summarizes the physical status and constitutes the primary outcome variable. Each health domain score consists of the sum scores of the assigned questions. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, ie, severe disability) to 100 (no health restrictions). A higher score means a better physical status. The calculation process for the PCS has been previously described by Taft et al. 2001.", "time_frame": "Week 0 and 12" }, { "type": "secondary", "measure": "Safety of LAU-7b, Overview", "description": "Number of participants with adverse events. The safety was assessed through the monitoring of adverse events including laboratory test abnormalities, serious adverse events and adverse events leading to study treatment discontinuation. Treatment-emergent adverse event is defined as any adverse event with onset date on or after the first dose of study drug and on or before the Week 12 in person follow-up or until early termination or death, whichever occurred first.", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGI-C)", "description": "The PGI-C is a single item questionnaire that asks: \"Overall, how would you rate the change in your ability to perform usual daily activities since you started the study?\".\n\nThese are the 7-point scale options: 1) \"very much better\", 2) \"much better\", 3) \"minimally better\", 4) \"no change\", 5) \"minimally worse\", 6) \"much worse\", or 7) \"very much worse\".\n\nHigher scores indicate a change for the worse and lower scores indicate a change for the better.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Participants With Marked Improvement in PGI-C", "description": "Marked improvement includes \"Very much improved\" and Much improved\". The PGI-C is a single item questionnaire that asks: \"Overall, how would you rate the change in your ability to perform usual daily activities since you started the study?\".\n\nThese are the 7-point scale options: 1) \"very much better\", 2) \"much better\", 3) \"minimally better\", 4) \"no change\", 5) \"minimally worse\", 6) \"much worse\", or 7) \"very much worse\".\n\nHigher scores indicate a change for the worse and lower scores indicate a change for the better.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale", "description": "This instrument was developed to characterize fatigue, in cancer and used in other conditions with a phenotype of fatigue. It is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The recall period is 7 days and the response scale employs a 5-point Likert-type scale. The final total score is the sum of the responses for all 13 items and can range from 0 to 52. A higher score means less fatigue.", "time_frame": "Weeks 0, 4, 8 and 12" }, { "type": "secondary", "measure": "Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ)", "description": "This instrument was developed to characterize and evaluate the debilitation caused by a physical exertion, whether a usual daily activity or a leisure activity. It is a 10-item questionnaire that assess both the nature of post-exertional malaise (PEM) and duration of symptom. In this study, the presence or not of PEM (based on frequency and severity of 5 PEM items) is determined by the questionnaire. The endpoint of the study is the proportion of participants with PEM at baseline and Week 12, compared between treatment groups.", "time_frame": "Weeks 0 and 12" }, { "type": "secondary", "measure": "Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8", "description": "The SF-36 questionnaire consists of 36 items grouped in eight health domains, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, that can be aggregated to two summary scales, physical component summary (PCS ) and mental component summary (MCS). The PCS summarizes the physical status and constitutes the primary outcome variable. Each health domain score consists of the sum scores of the assigned questions. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, ie, severe disability) to 100 (no health restrictions). A higher score means a better physical status. The calculation process for the PCS has been previously described by Taft et al. 2001. The analysis is performed jointly with the primary outcome measure (Week 12). A positive change from baseline value means improvement, negative value means worsening.", "time_frame": "Weeks 0, 4 and 8" }, { "type": "secondary", "measure": "Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36)", "description": "The SF-36 questionnaire consists of 36 items grouped in eight health domains, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, that can be aggregated to two summary scales, physical component summary (PCS ) and mental component summary (MCS). Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, ie, severe disability) to 100 (no health restrictions). A higher score means a better outcome. The study endpoint is the change from baseline in score, a positive change from baseline value means improvement and a negative value means worsening outcome. For sake of conciseness, only Week 12 comparisons are presented.", "time_frame": "Weeks 0, 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection.", "description": "This will be assessed by a single question with either yes or no as answer: \"Do you judge that you have regained the daily usual activity level you had prior to being infected by COVID-19 back in Month xxxx? By daily usual activity we mean work, leisure, physical exercise...etc.\"", "time_frame": "From Week 0 through Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects Achieving >=25% (>=50% and >=75% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.", "description": "The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome. A sum of the burdensome category is calculated for each visit and is the endpoint being evaluated for improvement since burdensome symptoms are those with highest impact on daily usual activity level.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects Achieving >=50% (>=25% and >=75% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.", "description": "The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome. A sum of the burdensome category is calculated for each visit and is the endpoint being evaluated for improvement since burdensome symptoms are those with highest impact on daily usual activity level.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects Achieving >=75% (>=25% and >=50% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.", "description": "The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome. A sum of the burdensome category is calculated for each visit and is the endpoint being evaluated for improvement since burdensome symptoms are those with highest impact on daily usual activity level.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score", "description": "EQ-5D-5L is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). Higher values indicate worse outcomes, while lower indicate better outcomes. The subscales are combined to compute a total score index, adjusted for a standard value of general population in a country/region and averaged to produce the mean and SD. The Summary index value range is from 0 to 1, where 1 is considered the best possible health and 0 is the worst possible health. For the change in score, a positive number indicates that the scores improved from baseline.", "time_frame": "Weeks 0, 4, 8 and 12" }, { "type": "secondary", "measure": "Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks.", "description": "The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome.\n\nRelief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change)", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Time to Relief of the First Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks, Among Those Symptoms Present at Baseline.", "description": "The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (brain fog or memory fog) and mental health symptoms. Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom. 0 and 1 are deemed not burdensome, 2 and 3 are burdensome. This will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. Relief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change). A longer time is worse than a short time to resolution.", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms.", "description": "The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.\n\nEach symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.\n\n0 and 1 are deemed not burdensome, 2 and 3 are burdensome.\n\nThis will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. Relief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change). A higher proportion is better than a lower proportion.", "time_frame": "Weeks 4, 8 and 12" }, { "type": "secondary", "measure": "Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core).", "description": "This will be assessed through periodic inventory of all the Long COVID symptoms, performed at each visit, relative to the baseline inventory. A lower total number is better than a higher total number.", "time_frame": "Weeks 0, 4, 8 and 12, as well as the longer term visit at Week 24" }, { "type": "secondary", "measure": "Proportion of Subjects With Long COVID-related Unplanned Medical Visits", "description": "This will be assessed by probing the subjects at each visit. Long COVID-related unplanned medical visits includes visits to practitioner's office, urgent care visits, emergency room \\<24h, or hospitalization \\>24 hours.\n\nA higher proportion is worse than a lower proportion", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Proportion of Subjects Deceased From Any Cause Through Week 12.", "description": "This will be assessed by probing the subjects at each visit, including caretakers or relatives if the subjects cannot be reached at a given visit.\n\nA higher proportion is worse than a lower proportion", "time_frame": "From Week 0 to Week 12" }, { "type": "secondary", "measure": "Proportion of Subjects With Significant Cardiovascular Events", "description": "A significant cardiovascular event is one that results in at least an acute care visit, a hospitalization or an event-related death.\n\nA higher proportion is worse than a lower proportion", "time_frame": "From Week 0 to Week 12 and including up to the long-term follow-up at Week 24" } ], "relevance_tags": [ "Persistence / Antiviral", "Anti-inflammatory", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 272, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05999435", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07316127", "title": "Immunoadsorption in Autoimmune Long COVID", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-01-05", "start_date": "2026-01-01", "completion_date": "2028-03-12", "primary_completion_date": "2027-12-12", "conditions_raw": [ "Long COVID", "Long COVID Syndrome", "Long COVID-19 Syndrome", "Post COVID Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Immunoadsorption" ], "sponsor": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Some people continue to have serious symptoms long after COVID-19, such as extreme fatigue and feeling worse after activity. In some patients, this may happen because the immune system is attacking the body by mistake.\n\nThis study will test a treatment called immunoadsorption, which filters the blood to remove harmful antibodies. People with long COVID who have these antibodies will be randomly assigned to receive either the real treatment or a placebo. The main goal is to see whether fatigue improves after one month, and whether other symptoms and daily functioning improve over six months.\n\nThis research will help us find out if this treatment can benefit the group of long COVID patients with immune-related disease.", "primary_outcomes": [ { "type": "primary", "measure": "Change in fatigue measured by the Fatigue Assessment Scale (FAS)", "description": "Score range 10-50 (10 items, Likert scale 1-5). Higher scores indicate more severe fatigue (worse). The difference in scores from baseline will be measured (MCID of 4 points) as the primary outcome.", "time_frame": "At baseline and 28 days after start treatment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in health related quality of life using the 36-Item Short Form Health Survey (SF-36)", "description": "Eight domains scored from 0-100. Domain scores are commonly summarized into the Physical Component Summary (PCS) and Mental Component Summary (MCS) (norm-based, mean 50, SD 10). Higher scores indicate better health-related quality of life and functioning.", "time_frame": "At baseline and days 28, 60, 90, and 180" }, { "type": "secondary", "measure": "Change in cognitive functioning using the Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form 8a (PROMIS Cognitive Function Short Form 8a)", "description": "Raw scores are converted to T-scores (20-80), with a population mean of 50 (SD 10). Higher scores indicate better cognitive functioning. Change in score will be measured (MCID 3-5).", "time_frame": "At baseline and days 28, 60, 90, and 180" }, { "type": "secondary", "measure": "Change in autonomic symptoms using the Composite Autonomic Symptom Score-31 (COMPASS-31)", "description": "0-100 weighted total score across six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor symptoms. Higher scores indicate greater autonomic symptom burden.", "time_frame": "At baseline and days 28, 60, 90, and 180" }, { "type": "secondary", "measure": "Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) related to the intervention", "description": "All AEs and SAEs will be recorded, graded according to CTCAE v5.0, and assessed for relatedness to the study treatment. Specific attention will be given to complications of extracorporeal procedures (e.g., hypotension, bleeding, allergic reactions, infection, and vascular access issues)", "time_frame": "From first study intervention through day 180" }, { "type": "secondary", "measure": "Repeated Handgrip Strength", "description": "Handgrip strength will be assessed using a calibrated handheld dynamometer at four standardized measurement points in accordance with the American Society of Hand Therapists (ASHT) guidelines. Grip strength will be recorded in kilograms (kg). Higher grip strength reflects better muscle function.", "time_frame": "At baseline and days 28, 60, 90, and 180" }, { "type": "secondary", "measure": "Orthostatic intolerance using the NASA lean test", "description": "The NASA Lean Test is a standardized active standing test used to assess orthostatic intolerance. Participants rest in a supine position followed by an active standing phase while leaning against a wall to minimize skeletal muscle pumping. Heart rate and blood pressure are measured at predefined intervals during standing. Abnormal heart rate and/or blood pressure responses during the test indicate orthostatic intolerance.", "time_frame": "At baseline and days 28 and 180" }, { "type": "secondary", "measure": "Efficacy treatment by measuring immunoglobuline titers", "description": "Immunoglobulin G titers will be measured in blood samples using standardized laboratory assays and reported as concentrations (g/L).", "time_frame": "At baseline (prior to treatment initiation), during treatment, and at days 28 and 180 after treatment initiation." }, { "type": "secondary", "measure": "Autoantibody score using an in-house Luminex assay", "description": "For this assay, IgG will be isolated from patient serum samples obtained during screening and analyzed using a Luminex-based multiplex immunoassay targeting a panel of 15 validated autoantigens. A weighted scoring system is applied to the resulting autoantibody signals.", "time_frame": "At screening and on days 28, 60, 90, and 180" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in fatigue measured by the Fatigue Assessment Scale (FAS)", "description": "Score range 10-50 (10 items, Likert scale 1-5). Higher scores indicate more severe fatigue (worse). The difference in scores from baseline will be measured (MCID of 4 points) as the primary outcome.", "time_frame": "At baseline and 28 days after start treatment" }, { "type": "secondary", "measure": "Change in health related quality of life using the 36-Item Short Form Health Survey (SF-36)", "description": "Eight domains scored from 0-100. Domain scores are commonly summarized into the Physical Component Summary (PCS) and Mental Component Summary (MCS) (norm-based, mean 50, SD 10). Higher scores indicate better health-related quality of life and functioning.", "time_frame": "At baseline and days 28, 60, 90, and 180" }, { "type": "secondary", "measure": "Change in cognitive functioning using the Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form 8a (PROMIS Cognitive Function Short Form 8a)", "description": "Raw scores are converted to T-scores (20-80), with a population mean of 50 (SD 10). Higher scores indicate better cognitive functioning. Change in score will be measured (MCID 3-5).", "time_frame": "At baseline and days 28, 60, 90, and 180" }, { "type": "secondary", "measure": "Change in autonomic symptoms using the Composite Autonomic Symptom Score-31 (COMPASS-31)", "description": "0-100 weighted total score across six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor symptoms. Higher scores indicate greater autonomic symptom burden.", "time_frame": "At baseline and days 28, 60, 90, and 180" }, { "type": "secondary", "measure": "Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) related to the intervention", "description": "All AEs and SAEs will be recorded, graded according to CTCAE v5.0, and assessed for relatedness to the study treatment. Specific attention will be given to complications of extracorporeal procedures (e.g., hypotension, bleeding, allergic reactions, infection, and vascular access issues)", "time_frame": "From first study intervention through day 180" }, { "type": "secondary", "measure": "Repeated Handgrip Strength", "description": "Handgrip strength will be assessed using a calibrated handheld dynamometer at four standardized measurement points in accordance with the American Society of Hand Therapists (ASHT) guidelines. Grip strength will be recorded in kilograms (kg). Higher grip strength reflects better muscle function.", "time_frame": "At baseline and days 28, 60, 90, and 180" }, { "type": "secondary", "measure": "Orthostatic intolerance using the NASA lean test", "description": "The NASA Lean Test is a standardized active standing test used to assess orthostatic intolerance. Participants rest in a supine position followed by an active standing phase while leaning against a wall to minimize skeletal muscle pumping. Heart rate and blood pressure are measured at predefined intervals during standing. Abnormal heart rate and/or blood pressure responses during the test indicate orthostatic intolerance.", "time_frame": "At baseline and days 28 and 180" }, { "type": "secondary", "measure": "Efficacy treatment by measuring immunoglobuline titers", "description": "Immunoglobulin G titers will be measured in blood samples using standardized laboratory assays and reported as concentrations (g/L).", "time_frame": "At baseline (prior to treatment initiation), during treatment, and at days 28 and 180 after treatment initiation." }, { "type": "secondary", "measure": "Autoantibody score using an in-house Luminex assay", "description": "For this assay, IgG will be isolated from patient serum samples obtained during screening and analyzed using a Luminex-based multiplex immunoassay targeting a panel of 15 validated autoantigens. A weighted scoring system is applied to the resulting autoantibody signals.", "time_frame": "At screening and on days 28, 60, 90, and 180" } ], "relevance_tags": [ "Immunomodulatory", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 70, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07316127", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07312357", "title": "Whole-Body Electrostimulation for Functional Recovery in Post-COVID Syndrome", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-12-31", "start_date": "2026-03", "completion_date": "2026-12", "primary_completion_date": "2026-09", "conditions_raw": [ "Post COVID Syndrome Long Covid", "Post COVID Syndrome", "Long COVID Fatigue", "Long Covid" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Whole-Body Electromyostimulation Suit" ], "sponsor": "Universidad Rey Juan Carlos", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Post-COVID syndrome is a condition that affects some people after recovering from the acute phase of COVID-19. Common symptoms include persistent fatigue, reduced physical capacity, and difficulties performing everyday activities, which can significantly impact quality of life and independence. At present, there is limited scientific evidence on effective rehabilitation strategies for this population.\n\nThe purpose of this study is to evaluate whether the use of a whole-body electrostimulation suit can improve fatigue, physical performance, and functional independence in people with post-COVID syndrome. Whole-body electrostimulation is a non-pharmacological technique that uses low-frequency electrical impulses to activate multiple muscle groups simultaneously and has shown potential benefits in other clinical populations.\n\nThis is a randomized, double-blind, controlled pilot clinical trial. Participants will be randomly assigned to either an experimental group, which will receive active whole-body electrostimulation during functional activities, or a control group, which will follow the same sessions using the electrostimulation suit with minimal stimulation (placebo condition). Neither participants nor outcome assessors will know which group each participant belongs to.\n\nThe intervention will consist of 12 supervised sessions conducted once per week. Outcomes will be assessed before and after the intervention, with an additional follow-up assessment three months later. The main outcomes include fatigue levels, functional capacity, physical performance, and independence in activities of daily living. Safety and tolerance to the intervention will be monitored throughout the study.\n\nThe results of this study may help to determine the feasibility and potential effectiveness of whole-body electrostimulation as a rehabilitation tool for people with post-COVID syndrome and provide preliminary data for future larger-scale clinical trials.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity", "description": "Fatigue will be assessed using the Chalder Fatigue Scale (CFQ-11), a validated self-report questionnaire that evaluates physical and mental fatigue. Higher scores indicate greater fatigue severity.", "time_frame": "Baseline, immediately post-intervention (12 weeks), and 3-month follow-up" }, { "type": "primary", "measure": "Handgrip Muscle Strength", "description": "Handgrip strength will be measured using a hand-held dynamometer as an objective indicator of overall muscle strength. Measurements will be performed following standardized procedures.", "time_frame": "Baseline, immediately post-intervention (12 weeks), and 3-month follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Independence in Activities of Daily Living", "description": "Independence in activities of daily living will be assessed using the Activities of Daily Living Questionnaire (ADLQ), a self-report instrument that evaluates functional independence across daily activities. Lower scores indicate greater functional independence.", "time_frame": "Baseline, immediately post-intervention (12 weeks), and 3-month follow-up" }, { "type": "secondary", "measure": "Functional Capacity", "description": "Functional capacity will be evaluated using the Six-Minute Walk Test (6MWT), which measures the maximum distance walked in six minutes as an indicator of aerobic capacity and functional exercise tolerance.", "time_frame": "Baseline, immediately post-intervention (12 weeks), and 3-month follow-up" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity", "description": "Fatigue will be assessed using the Chalder Fatigue Scale (CFQ-11), a validated self-report questionnaire that evaluates physical and mental fatigue. Higher scores indicate greater fatigue severity.", "time_frame": "Baseline, immediately post-intervention (12 weeks), and 3-month follow-up" }, { "type": "primary", "measure": "Handgrip Muscle Strength", "description": "Handgrip strength will be measured using a hand-held dynamometer as an objective indicator of overall muscle strength. Measurements will be performed following standardized procedures.", "time_frame": "Baseline, immediately post-intervention (12 weeks), and 3-month follow-up" }, { "type": "secondary", "measure": "Independence in Activities of Daily Living", "description": "Independence in activities of daily living will be assessed using the Activities of Daily Living Questionnaire (ADLQ), a self-report instrument that evaluates functional independence across daily activities. Lower scores indicate greater functional independence.", "time_frame": "Baseline, immediately post-intervention (12 weeks), and 3-month follow-up" }, { "type": "secondary", "measure": "Functional Capacity", "description": "Functional capacity will be evaluated using the Six-Minute Walk Test (6MWT), which measures the maximum distance walked in six minutes as an indicator of aerobic capacity and functional exercise tolerance.", "time_frame": "Baseline, immediately post-intervention (12 weeks), and 3-month follow-up" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07312357", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07128082", "title": "The Long COVID Treatment Trial", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2025-12-23", "start_date": "2025-10-30", "completion_date": "2026-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Tirzepatide" ], "sponsor": "Scripps Translational Science Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this study is to determine whether a medicine called tirzepatide, also called Zepbound, can reduce symptoms of Long COVID. A randomized control trial will allow us to measure the effect of the treatment by having half of the participants take the medication and half take a placebo that has no medication. Participants will take the medication (or placebo) they are given and complete study surveys for 12 months. All of the study tasks are done remotely from the comfort of a participants home.", "primary_outcomes": [ { "type": "primary", "measure": "Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS)", "description": "The average difference in Fatigue Severity Scale (minimum score 9, maximum score 63, with higher scores indicating worse fatigue) between treatment and control groups of adults with Long COVID at month 3 or month 12 after study start", "time_frame": "12 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Secondary Outcome: Changes in overall health, measured by European Quality of Life 5 day, 5 level (EQ-5D-5L) scores", "description": "EQ-5D-5L is a quality of life survey with a minimum score of 5 and a maximum score of 25, with a higher score indicating worse quality of life.", "time_frame": "12 months" }, { "type": "secondary", "measure": "Secondary Outcome: Presence of and changes in post-exertional malaise, a condition that occurs in subsets of Long COVID and IACIs, measured by DePaul Symptom Questionnaire Post Exertional Malaise (DSQ-PEM)", "description": "DSQ-PEM evaluates the presence or absence of PEM and myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS)", "time_frame": "12 month" }, { "type": "secondary", "measure": "Secondary Outcome: Changes in functional capacity as measured by Functional Capacity (FUNCAP) survey", "description": "The 27-question version of FUNCAP has a minimum score of 0 and a maximum score of 162, with a lower score indicating lower functional capacity.", "time_frame": "12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS)", "description": "The average difference in Fatigue Severity Scale (minimum score 9, maximum score 63, with higher scores indicating worse fatigue) between treatment and control groups of adults with Long COVID at month 3 or month 12 after study start", "time_frame": "12 months" }, { "type": "secondary", "measure": "Secondary Outcome: Changes in overall health, measured by European Quality of Life 5 day, 5 level (EQ-5D-5L) scores", "description": "EQ-5D-5L is a quality of life survey with a minimum score of 5 and a maximum score of 25, with a higher score indicating worse quality of life.", "time_frame": "12 months" }, { "type": "secondary", "measure": "Secondary Outcome: Presence of and changes in post-exertional malaise, a condition that occurs in subsets of Long COVID and IACIs, measured by DePaul Symptom Questionnaire Post Exertional Malaise (DSQ-PEM)", "description": "DSQ-PEM evaluates the presence or absence of PEM and myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS)", "time_frame": "12 month" }, { "type": "secondary", "measure": "Secondary Outcome: Changes in functional capacity as measured by Functional Capacity (FUNCAP) survey", "description": "The 27-question version of FUNCAP has a minimum score of 0 and a maximum score of 162, with a lower score indicating lower functional capacity.", "time_frame": "12 months" } ], "relevance_tags": [ "General", "Phase 2", "Very Large (1000+ participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 1000, "enrollment_type": "ACTUAL", "size_category": "Very Large (1000+ participants)", "link": "https://clinicaltrials.gov/study/NCT07128082", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06974058", "title": "Study to Investigate the Health Benefits of a Quercetin/Curcumin-Based Supplement for Mild to Moderate Long COVID-19 Symptoms", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-12-19", "start_date": "2025-07-22", "completion_date": "2025-12-14", "primary_completion_date": "2025-11-18", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Nasafytol®" ], "sponsor": "Liaquat University of Medical & Health Sciences", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This pragmatic clinical study aims to evaluate the efficacy and tolerance of a combined quercetin/curcumin supplement in adults experiencing mild to moderate symptoms of Long COVID-19. Participants will receive the combined quercetin/curcumin supplement for 2 months. The primary outcome is the improvement in overall symptom burden, while secondary outcomes include changes in quality of life, the need for NSAIDs, and inflammatory markers. The study seeks to provide real-world evidence of the potential benefits of this combined supplement in managing Long COVID-19 symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Overall Symptom Burden", "description": "Assessment of overall symptom burden using the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS). Improvement will be defined as either a ≥2-point reduction in any single symptom domain or a ≥10% reduction in the total C19-YRS symptom burden score from baseline.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Functional Status and Quality of Life (SF-36 Scores)", "description": "Assessment of quality of life using the SF-36 Health Survey, which evaluates eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, and emotional well-being. It provides two summary scores: physical and mental health components.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in the Need for Prescribed Medications or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)", "description": "Monitoring the frequency and dosage of prescribed medications or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) used for symptom relief. This will be recorded using a participant-maintained medication log.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Pain Severity and Pain Interference (Brief Pain Inventory - Short Form)", "description": "The Brief Pain Inventory - Short Form (BPI-SF) is a validated, self-reported questionnaire that assesses the severity of pain and the impact of pain on daily functioning. The instrument includes items measuring pain intensity (worst, least, average, and current pain) and pain interference with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Scores range from 0 to 10, with higher scores indicating greater pain severity or interference.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Fatigue Severity (Fatigue Severity Scale)", "description": "The Fatigue Severity Scale (FSS) is a 9-item, self-administered questionnaire designed to assess the severity of fatigue and its impact on daily activities and functioning. Each item is rated on a 7-point Likert scale, with higher scores indicating greater fatigue severity.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Anxiety and Depression Symptoms (Hospital Anxiety and Depression Scale)", "description": "The Hospital Anxiety and Depression Scale (HADS) is a validated, 14-item self-report instrument used to assess symptoms of anxiety and depression. It consists of two subscales (anxiety and depression), each with 7 items. Subscale scores range from 0 to 21, with higher scores indicating greater symptom severity.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Sleep Quality (Pittsburgh Sleep Quality Index)", "description": "The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire that assesses sleep quality and sleep disturbances over a 1-month interval. It consists of 19 items generating seven component scores and a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Cognitive Function (PROMIS Cognitive Function - Short Form 8a)", "description": "The PROMIS® Cognitive Function - Short Form 8a is a validated, patient-reported outcome measure assessing perceived cognitive abilities, including memory, attention, and mental clarity. The instrument consists of 8 items and is scored using standardized T-scores, with higher scores indicating better cognitive function.", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Overall Symptom Burden", "description": "Assessment of overall symptom burden using the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS). Improvement will be defined as either a ≥2-point reduction in any single symptom domain or a ≥10% reduction in the total C19-YRS symptom burden score from baseline.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Functional Status and Quality of Life (SF-36 Scores)", "description": "Assessment of quality of life using the SF-36 Health Survey, which evaluates eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, and emotional well-being. It provides two summary scores: physical and mental health components.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in the Need for Prescribed Medications or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)", "description": "Monitoring the frequency and dosage of prescribed medications or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) used for symptom relief. This will be recorded using a participant-maintained medication log.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Pain Severity and Pain Interference (Brief Pain Inventory - Short Form)", "description": "The Brief Pain Inventory - Short Form (BPI-SF) is a validated, self-reported questionnaire that assesses the severity of pain and the impact of pain on daily functioning. The instrument includes items measuring pain intensity (worst, least, average, and current pain) and pain interference with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Scores range from 0 to 10, with higher scores indicating greater pain severity or interference.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Fatigue Severity (Fatigue Severity Scale)", "description": "The Fatigue Severity Scale (FSS) is a 9-item, self-administered questionnaire designed to assess the severity of fatigue and its impact on daily activities and functioning. Each item is rated on a 7-point Likert scale, with higher scores indicating greater fatigue severity.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Anxiety and Depression Symptoms (Hospital Anxiety and Depression Scale)", "description": "The Hospital Anxiety and Depression Scale (HADS) is a validated, 14-item self-report instrument used to assess symptoms of anxiety and depression. It consists of two subscales (anxiety and depression), each with 7 items. Subscale scores range from 0 to 21, with higher scores indicating greater symptom severity.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Sleep Quality (Pittsburgh Sleep Quality Index)", "description": "The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire that assesses sleep quality and sleep disturbances over a 1-month interval. It consists of 19 items generating seven component scores and a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Cognitive Function (PROMIS Cognitive Function - Short Form 8a)", "description": "The PROMIS® Cognitive Function - Short Form 8a is a validated, patient-reported outcome measure assessing perceived cognitive abilities, including memory, attention, and mental clarity. The instrument consists of 8 items and is scored using standardized T-scores, with higher scores indicating better cognitive function.", "time_frame": "8 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 15, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06974058", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07278206", "title": "Brain Stimulation in Long COVID", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-12-19", "start_date": "2025-11-17", "completion_date": "2029-05-12", "primary_completion_date": "2028-11-17", "conditions_raw": [ "Long COVID", "PASC Post Acute Sequelae of COVID 19", "Post COVID-19 Condition (PCC)" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Repetitive Transcranial Magnetic Stimulation" ], "sponsor": "Amsterdam UMC, location VUmc", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Cognitive problems and severe fatigue are two frequently occurring symptoms in long COVID, also known as Post-Covid Condition or Post-Acute Sequelae of COVID-19 (PASC), and their causes are currently unknown. Previous studies have shown reduced blood flow and increased inflammation in the brains of people with PASC. These brain processes are related to fatigue and cognitive problems. In other conditions, these disrupted brain processes have been treated safely and successfully with non-invasive brain stimulation. This may offer an effective treatment for people with PASC.\n\nThe main goal of this clinical trial is to see whether non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS) can reduce fatigue in adults with PASC who also have trouble concentrating. rTMS uses short magnetic pulses on the scalp to gently stimulate a small brain area.\n\nIn this study, 66 adults with PASC will be included, recruited through the Post-COVID Network Netherlands. Participants will be randomly assigned to receive either active rTMS or sham (placebo) rTMS. Sham rTMS feels and looks similar to the active treatment, but it does not generate effective magnetic pulses. The brain area that will be targeted is personalized using a brain scan (MRI) during a planning task. All participants will receive 24 rTMS sessions over six weeks (four per week).\n\nFatigue will be measured within two weeks before and two weeks after treatment to determine whether active rTMS works better than sham. We will also look at cognition, brain connectivity and blood flow, signs of (neuro)inflammation, daily activity using an activity watch, and questionnaires about quality of life, mood, and sleep. Follow-up on cognition and questionnaires will take place 3 and 6 months after the end of the treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue as measured by the 8-item fatigue subscale of the Checklist Individual Strength (CIS). The subscale is scored on a 7-point Likert scale, adding up to a total score between 8 and 56. A score of 35 or higher indicates the presence of severe fatigue.", "time_frame": "Fatigue will be measured within two weeks before and within two weeks after treatment, and at 3 and 6 months follow-up." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Objective cognitive functioning", "description": "Objective cognitive functioning will be measured using a composite score that combines the T-scores from multiple cognitive tests: (1) Stroop Test (information processing and interference sensitivity), (2) Trail Making Test A/B (various domains of executive function), (3) D2 Test (selective and sustained attention, concentration, and processing speed), and (4) 15-Word Test (memory).\n\nThese scores will be combined into a composite score by taking the mean of the individual T-scores, which are corrected for age, sex, and education and will provide a comprehensive assessment of objective cognitive functioning. The final composite score will not include any individual test units but will provide an overall score reflecting performance across multiple cognitive domains.", "time_frame": "Objective cognitive functioning will be measured two weeks before and two weeks after treatment and at 3 and 6 months follow-up after treatment." }, { "type": "secondary", "measure": "Arterial Spin Labeling (ASL)", "description": "We will measure blood-brain barrier integrity and perfusion using ASL.", "time_frame": "Neuroimaging will be performed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Magnetic Resonance Spectroscopy (MRS)", "description": "Neuroinflammation and neuronal injury will be measured using MRS (metabolites for inflammation include choline, creatine and myo-inositol, and for neuronal injury N-acetyl-aspartate, glutamate and lactate).", "time_frame": "Neuroimaging will be performed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Functional Magnetic Resonance Imaging (fMRI)", "description": "Participants will undergo a 10-minute resting-state scan, during which they are instructed to relax and remain awake while looking at a visual fixation cross for the entirety of the scan. After the resting-state scan, participants will complete the Tower of London task to measure task-based activity.", "time_frame": "Neuroimaging will be performed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Actigraphy", "description": "Participants will wear an Actiwatch to monitor actigraphy for a continuous period of five days. Participants will be instructed to wear the actiwatch continuously during the measurement days and to maintain their usual daily routines. Actigraphy data will provide objective measures of day and nighttime activity.", "time_frame": "Continuous period of eight days two weeks before and directly after treatment" }, { "type": "secondary", "measure": "Short physical performance battery (SPPB)", "description": "The short physical performance battery (SPPB) will be performed to measure physical performance through three components: gait speed, balance, and repeated chair stands. The SPPB score is a composite of three physical tasks (gait speed, balance, and repeated chair stands) combined into a single score, ranging from 0-12. Higher scores mean better physical performance.", "time_frame": "Physical performance will be measured within two weeks before and within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Simple Reaction Time (SRT)", "description": "Reaction time will be assessed using a Simple Reaction Time (SRT) task, where participants are instructed to press the spacebar as quickly as possible when red circles appears on the screen. The task consists of 25 trials, with a randomized interval between each trial. The primary outcome will be the mean reaction time, with secondary analysis of the coefficient of variation (CV) across trials.", "time_frame": "Participants will complete the SRT within two weeks before, within two weeks after treatment and three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Effort-based decision task", "description": "An effort-based decision task will be assessed to measure reward sensitivity. In this task, participants will either accept or reject offers in which they could exert physical effort (ticking boxes on screen, 5 levels) to gain rewards (money, 5 levels).", "time_frame": "The effort-based decision task will be completed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Neurofilament light (NF-L)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Neurofilament light (NF-L) will be quantified to reflect neuronal injury.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Brain-Derived Tau (BD-Tau)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Brain-Derived Tau (BD-Tau) will be quantified to reflect neuronal injury.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Interleukin-6 (IL-6)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis.Interleukin-6 (IL-6) will be quantified to measure (neuro)inflammation.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Interleukin-1 (IL-1)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Interleukin-1 (IL-1) will be quantified to measure (neuro)inflammation.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Glial Fibrillary Acidic Protein (GFAP)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Glial Fibrillary Acidic Protein (GFAP) will be quantified to measure astrocytic activity", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Tumor Necrosis Factor-alpha (TNF-α)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Tumor Necrosis Factor-alpha (TNF-α) will be quantified to measure (neuro)inflammation.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Eotaxin-1/CCL11", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Eotaxin-1/CCL11 will be quantified to measure (neuro)inflammation.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Brain-derived neurotrophic factor (BDNF)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Brain-derived neurotrophic factor (BDNF) will be quantified as a brain plasticity marker.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Checklist Individuele Spankracht (CIS)", "description": "The Checklist Individuele Spankracht (CIS) measures subjective fatigue and related behavior. Score ranges from 20-140, with higher scores indicating worse outcomes.", "time_frame": "Survey will be completed within two weeks before and within two weeks after treatment, and three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Cognitive Failures Questionnaire (CFQ)", "description": "The Cognitive Failures Questionnaire (CFQ) measures subjective cognition. Score ranges from 0-100, with higher scores indicating worse outcomes (greater cognitive failures).", "time_frame": "Survey will be completed within two weeks before and within two weeks after treatment, and three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Illness Perception Questionnaire (IPQ)-short form", "description": "The Illness Perception Questionnaire (IPQ)-short form assesses various dimensions of an individual's illness perception, including its perceived consequences, timeline, controllability, and emotional representation. The responses to each question are evaluated individually, as no composite score is generated. Higher scores on each question indicate worse perceptions.", "time_frame": "Survey will be completed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)", "description": "The PROMIS-29 will measure a multi-domain scale that measures physical function, fatigue, pain interference, anxiety, depression, sleep disturbance, and ability to participate in social roles. The PROMIS-Cognitive function 8a will assess subjective cognitive function.\n\nFor most PROMIS instruments, a score of 50 represents the average for the general U.S. population, with a standard deviation of 10. Higher T-scores reflect more of the concept being measured (e.g., higher cognitive function). For example, a T-score of 60 is one standard deviation above average (better than average) and a T-score of 40 is one standard deviation below average (worse than average).", "time_frame": "Survey will be completed within two weeks before treatment, weekly during treatment and within two weeks after treatment." }, { "type": "secondary", "measure": "Patient Health Questionnaire 9 (PHQ-9)", "description": "The Patient Health Questionnaire 9 (PHQ-9) measures the severity of depressive symptoms, including mood and sleep. The score ranges from 0 to 27, with higher scores indicating worse outcomes. It includes a question specifically about suicidality (Item 9), which will be used to monitor thoughts of self-harm or suicide throughout the study.", "time_frame": "Survey will be completed within two weeks before treatment, weekly during treatment, within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "DePaul Symptom Questionnaire (DSQ)- post-exterional malaise and postural orthostatic tachycardia syndrome related questions", "description": "Using the DePaul Symptom Questionnaire (DSQ) the severity of symptoms related to post-exertional malaise and postural orthostatic tachycardia syndrome will be assessed. Higher scores indicate worse outcomes (more severe symptoms).", "time_frame": "Survey will be completed within two weeks before treatment, within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Bell Chronic Fatigue Syndrome Disability Scale", "description": "The Bell chronic fatigue syndrome disability scale consists of one question that measures the degree of disability, focusing on the impact of the illness on daily functioning. A higher score means a greater degree of disability.", "time_frame": "Survey will be completed within two weeks before treatment, within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "The insomnia severity index (ISI) evaluates the severity of insomnia symptoms, including difficulty falling asleep, staying asleep, and daytime impairment due to sleep problems. The score ranges from 0 to 28, with higher scores indicating worse outcomes.", "time_frame": "Survey will be completed within two weeks before treatment, within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Jacobson Fatigue Catastrophizing Scale (J-FCS)", "description": "The Jacobson Fatigue Catastrophizing Scale (J-FCS) assesses how individuals catastrophize or worry about their fatigue, including thoughts and feelings that amplify the experience of fatigue. The score ranges from 10 to 50, with higher scores indicating a higher degree of catastrophic thinking.", "time_frame": "Survey will be completed within two weeks before treatment and within two weeks after treatment." }, { "type": "secondary", "measure": "Self-Efficacy Scale 28 (SES-28)", "description": "The Self-Efficacy Scale 28 (SES-28) consists of a 7-item questionnaire measuring self-efficacy and coping of difficult or stressful situations. The score ranges from 7 to 28, with higher scores reflecting a higher degree of self-efficacy.", "time_frame": "Survey will be completed within two weeks before treatment and within two weeks after treatment." }, { "type": "secondary", "measure": "Cognitive and Behavioral Responses to Symptoms Questionnaire (CBRQ)", "description": "The Cognitive and Behavioral Responses to Symptoms Questionnaire (CBRQ) 16-item questionnaire is used to assess fear avoidance, damage beliefs, and all-or-nothing behavior. Items are scored on a 5-point scale, with higher scores indicating a stronger presence of the specific cognitive or behavioral response.", "time_frame": "Survey will be completed within two weeks before treatment and within two weeks after treatment." }, { "type": "secondary", "measure": "Treatment Inventory of Costs in Patients (TIC-P) - Work Absenteeism/Productivity Subscale", "description": "The Treatment Inventory of Costs in Patients (TIC-P) - Work Absenteeism/Productivity Subscale assesses the impact of illness on work attendance and productivity. It does not provide a single score but instead measures whether the individual is currently working, whether they are required to stay home from work due to their condition, and how many days of work are missed due to illness. This information helps evaluate the effect of illness on work performance and productivity.", "time_frame": "Survey will be completed within two weeks before treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Multimodal Evaluation of Sensory Sensitivity (MESSY) - multisensory, visual and auditory sensitivity subscales", "description": "The Multimodal Evaluation of Sensory Sensitivity (MESSY) - multisensory, visual and auditory sensitivity subscales assess sensory sensitivity across these three sensory modalities. Every item is measured on a 1 to 5 point scale. A higher score indicates a higher sensory sensitivity severity.", "time_frame": "Survey will be completed within two weeks before treatment, within two weeks after treatment and three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Credibility Expectancy Questionnaire (CEQ)", "description": "The Credibility Expectancy Questionnaire (CEQ) assesses the credibility and expectations of patients regarding the intervention, measuring how much they believe in its potential effectiveness. It consists of three questions regarding credibility and three questions regarding expectancy, each question rated or converted to a 9 point Likert scale. A higher score means higher treatment credibility and expectancy.", "time_frame": "Survey will be completed within two weeks before treatment." } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue as measured by the 8-item fatigue subscale of the Checklist Individual Strength (CIS). The subscale is scored on a 7-point Likert scale, adding up to a total score between 8 and 56. A score of 35 or higher indicates the presence of severe fatigue.", "time_frame": "Fatigue will be measured within two weeks before and within two weeks after treatment, and at 3 and 6 months follow-up." }, { "type": "secondary", "measure": "Objective cognitive functioning", "description": "Objective cognitive functioning will be measured using a composite score that combines the T-scores from multiple cognitive tests: (1) Stroop Test (information processing and interference sensitivity), (2) Trail Making Test A/B (various domains of executive function), (3) D2 Test (selective and sustained attention, concentration, and processing speed), and (4) 15-Word Test (memory).\n\nThese scores will be combined into a composite score by taking the mean of the individual T-scores, which are corrected for age, sex, and education and will provide a comprehensive assessment of objective cognitive functioning. The final composite score will not include any individual test units but will provide an overall score reflecting performance across multiple cognitive domains.", "time_frame": "Objective cognitive functioning will be measured two weeks before and two weeks after treatment and at 3 and 6 months follow-up after treatment." }, { "type": "secondary", "measure": "Arterial Spin Labeling (ASL)", "description": "We will measure blood-brain barrier integrity and perfusion using ASL.", "time_frame": "Neuroimaging will be performed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Magnetic Resonance Spectroscopy (MRS)", "description": "Neuroinflammation and neuronal injury will be measured using MRS (metabolites for inflammation include choline, creatine and myo-inositol, and for neuronal injury N-acetyl-aspartate, glutamate and lactate).", "time_frame": "Neuroimaging will be performed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Functional Magnetic Resonance Imaging (fMRI)", "description": "Participants will undergo a 10-minute resting-state scan, during which they are instructed to relax and remain awake while looking at a visual fixation cross for the entirety of the scan. After the resting-state scan, participants will complete the Tower of London task to measure task-based activity.", "time_frame": "Neuroimaging will be performed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Actigraphy", "description": "Participants will wear an Actiwatch to monitor actigraphy for a continuous period of five days. Participants will be instructed to wear the actiwatch continuously during the measurement days and to maintain their usual daily routines. Actigraphy data will provide objective measures of day and nighttime activity.", "time_frame": "Continuous period of eight days two weeks before and directly after treatment" }, { "type": "secondary", "measure": "Short physical performance battery (SPPB)", "description": "The short physical performance battery (SPPB) will be performed to measure physical performance through three components: gait speed, balance, and repeated chair stands. The SPPB score is a composite of three physical tasks (gait speed, balance, and repeated chair stands) combined into a single score, ranging from 0-12. Higher scores mean better physical performance.", "time_frame": "Physical performance will be measured within two weeks before and within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Simple Reaction Time (SRT)", "description": "Reaction time will be assessed using a Simple Reaction Time (SRT) task, where participants are instructed to press the spacebar as quickly as possible when red circles appears on the screen. The task consists of 25 trials, with a randomized interval between each trial. The primary outcome will be the mean reaction time, with secondary analysis of the coefficient of variation (CV) across trials.", "time_frame": "Participants will complete the SRT within two weeks before, within two weeks after treatment and three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Effort-based decision task", "description": "An effort-based decision task will be assessed to measure reward sensitivity. In this task, participants will either accept or reject offers in which they could exert physical effort (ticking boxes on screen, 5 levels) to gain rewards (money, 5 levels).", "time_frame": "The effort-based decision task will be completed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Neurofilament light (NF-L)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Neurofilament light (NF-L) will be quantified to reflect neuronal injury.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Brain-Derived Tau (BD-Tau)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Brain-Derived Tau (BD-Tau) will be quantified to reflect neuronal injury.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Interleukin-6 (IL-6)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis.Interleukin-6 (IL-6) will be quantified to measure (neuro)inflammation.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Interleukin-1 (IL-1)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Interleukin-1 (IL-1) will be quantified to measure (neuro)inflammation.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Glial Fibrillary Acidic Protein (GFAP)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Glial Fibrillary Acidic Protein (GFAP) will be quantified to measure astrocytic activity", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Tumor Necrosis Factor-alpha (TNF-α)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Tumor Necrosis Factor-alpha (TNF-α) will be quantified to measure (neuro)inflammation.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Eotaxin-1/CCL11", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Eotaxin-1/CCL11 will be quantified to measure (neuro)inflammation.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Brain-derived neurotrophic factor (BDNF)", "description": "Blood will be drawn from the antecubital vein into EDTA tubes, placed on ice, centrifuged, and plasma stored at -80°C until analysis. Brain-derived neurotrophic factor (BDNF) will be quantified as a brain plasticity marker.", "time_frame": "Blood samples will be collected within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Checklist Individuele Spankracht (CIS)", "description": "The Checklist Individuele Spankracht (CIS) measures subjective fatigue and related behavior. Score ranges from 20-140, with higher scores indicating worse outcomes.", "time_frame": "Survey will be completed within two weeks before and within two weeks after treatment, and three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Cognitive Failures Questionnaire (CFQ)", "description": "The Cognitive Failures Questionnaire (CFQ) measures subjective cognition. Score ranges from 0-100, with higher scores indicating worse outcomes (greater cognitive failures).", "time_frame": "Survey will be completed within two weeks before and within two weeks after treatment, and three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Illness Perception Questionnaire (IPQ)-short form", "description": "The Illness Perception Questionnaire (IPQ)-short form assesses various dimensions of an individual's illness perception, including its perceived consequences, timeline, controllability, and emotional representation. The responses to each question are evaluated individually, as no composite score is generated. Higher scores on each question indicate worse perceptions.", "time_frame": "Survey will be completed within two weeks before and within two weeks after treatment." }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)", "description": "The PROMIS-29 will measure a multi-domain scale that measures physical function, fatigue, pain interference, anxiety, depression, sleep disturbance, and ability to participate in social roles. The PROMIS-Cognitive function 8a will assess subjective cognitive function.\n\nFor most PROMIS instruments, a score of 50 represents the average for the general U.S. population, with a standard deviation of 10. Higher T-scores reflect more of the concept being measured (e.g., higher cognitive function). For example, a T-score of 60 is one standard deviation above average (better than average) and a T-score of 40 is one standard deviation below average (worse than average).", "time_frame": "Survey will be completed within two weeks before treatment, weekly during treatment and within two weeks after treatment." }, { "type": "secondary", "measure": "Patient Health Questionnaire 9 (PHQ-9)", "description": "The Patient Health Questionnaire 9 (PHQ-9) measures the severity of depressive symptoms, including mood and sleep. The score ranges from 0 to 27, with higher scores indicating worse outcomes. It includes a question specifically about suicidality (Item 9), which will be used to monitor thoughts of self-harm or suicide throughout the study.", "time_frame": "Survey will be completed within two weeks before treatment, weekly during treatment, within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "DePaul Symptom Questionnaire (DSQ)- post-exterional malaise and postural orthostatic tachycardia syndrome related questions", "description": "Using the DePaul Symptom Questionnaire (DSQ) the severity of symptoms related to post-exertional malaise and postural orthostatic tachycardia syndrome will be assessed. Higher scores indicate worse outcomes (more severe symptoms).", "time_frame": "Survey will be completed within two weeks before treatment, within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Bell Chronic Fatigue Syndrome Disability Scale", "description": "The Bell chronic fatigue syndrome disability scale consists of one question that measures the degree of disability, focusing on the impact of the illness on daily functioning. A higher score means a greater degree of disability.", "time_frame": "Survey will be completed within two weeks before treatment, within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "The insomnia severity index (ISI) evaluates the severity of insomnia symptoms, including difficulty falling asleep, staying asleep, and daytime impairment due to sleep problems. The score ranges from 0 to 28, with higher scores indicating worse outcomes.", "time_frame": "Survey will be completed within two weeks before treatment, within two weeks after treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Jacobson Fatigue Catastrophizing Scale (J-FCS)", "description": "The Jacobson Fatigue Catastrophizing Scale (J-FCS) assesses how individuals catastrophize or worry about their fatigue, including thoughts and feelings that amplify the experience of fatigue. The score ranges from 10 to 50, with higher scores indicating a higher degree of catastrophic thinking.", "time_frame": "Survey will be completed within two weeks before treatment and within two weeks after treatment." }, { "type": "secondary", "measure": "Self-Efficacy Scale 28 (SES-28)", "description": "The Self-Efficacy Scale 28 (SES-28) consists of a 7-item questionnaire measuring self-efficacy and coping of difficult or stressful situations. The score ranges from 7 to 28, with higher scores reflecting a higher degree of self-efficacy.", "time_frame": "Survey will be completed within two weeks before treatment and within two weeks after treatment." }, { "type": "secondary", "measure": "Cognitive and Behavioral Responses to Symptoms Questionnaire (CBRQ)", "description": "The Cognitive and Behavioral Responses to Symptoms Questionnaire (CBRQ) 16-item questionnaire is used to assess fear avoidance, damage beliefs, and all-or-nothing behavior. Items are scored on a 5-point scale, with higher scores indicating a stronger presence of the specific cognitive or behavioral response.", "time_frame": "Survey will be completed within two weeks before treatment and within two weeks after treatment." }, { "type": "secondary", "measure": "Treatment Inventory of Costs in Patients (TIC-P) - Work Absenteeism/Productivity Subscale", "description": "The Treatment Inventory of Costs in Patients (TIC-P) - Work Absenteeism/Productivity Subscale assesses the impact of illness on work attendance and productivity. It does not provide a single score but instead measures whether the individual is currently working, whether they are required to stay home from work due to their condition, and how many days of work are missed due to illness. This information helps evaluate the effect of illness on work performance and productivity.", "time_frame": "Survey will be completed within two weeks before treatment and at three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Multimodal Evaluation of Sensory Sensitivity (MESSY) - multisensory, visual and auditory sensitivity subscales", "description": "The Multimodal Evaluation of Sensory Sensitivity (MESSY) - multisensory, visual and auditory sensitivity subscales assess sensory sensitivity across these three sensory modalities. Every item is measured on a 1 to 5 point scale. A higher score indicates a higher sensory sensitivity severity.", "time_frame": "Survey will be completed within two weeks before treatment, within two weeks after treatment and three and six months after treatment (follow-up)." }, { "type": "secondary", "measure": "Credibility Expectancy Questionnaire (CEQ)", "description": "The Credibility Expectancy Questionnaire (CEQ) assesses the credibility and expectations of patients regarding the intervention, measuring how much they believe in its potential effectiveness. It consists of three questions regarding credibility and three questions regarding expectancy, each question rated or converted to a 9 point Likert scale. A higher score means higher treatment credibility and expectancy.", "time_frame": "Survey will be completed within two weeks before treatment." } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 66, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07278206", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07285707", "title": "Acupuncture and Chinese Herbal Medicine for Long COVID", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-12-16", "start_date": "2025-09-10", "completion_date": "2026-12-31", "primary_completion_date": "2026-12-31", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Acupuncture" ], "sponsor": "Southern California University of Health Sciences", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "List of the Hypothesis:\n\nPrimary hypothesis: A flexible acupuncture and Chinese herbal medicine protocol will be feasible, acceptable, and useful for the treatment of long COVID.\n\nSecondary hypothesis: Long COVID patients receiving acupuncture treatment or acupuncture treatment and Chinese herbal supplements over an 8-week period will see improvements in their symptoms, function, and quality of life measurements.\n\nSpecific Aims of This Research (Purpose of the study):\n\nTo study the feasibility, acceptability and utility of an acupuncture and Chinese herbal supplement treatment protocol for patients with long COVID and preliminarily assess the effects of treatment.\n\nCurrently Available Research on This Subject:\n\nStudies indicate that acupuncture can effectively treat symptoms that are similar to those often seen in long COVID patients. Additionally, recent studies and clinical evidence suggest that there is substantial potential for acupuncture in the treatment of long COVID. Acupuncture may be beneficial because it can address many symptoms simultaneously with a single intervention, whereas symptom clusters can be difficult to manage with pharmaceuticals due to the need for multiple pharmaceutical agents.\n\nSummary of the research protocol/methodology:\n\nFive patients will receive acupuncture treatment, and five patients will receive acupuncture and Chinese herbal medicine. Each participant will receive 16 acupuncture treatments over the course of eight weeks (i.e., twice per week). Each treatment session will last for 30 minutes. Follow-up will occur at 12 weeks (i.e., four weeks after the final treatment session).\n\nSignificance of this research to the health and welfare of general public:\n\nThere is currently not a single, specific treatment for long COVID. If acupuncture treatment alone and/or acupuncture and Chinese herbal medicine combined are feasible, acceptable, and efficacious in the improvement of long COVID symptoms, it will offer patients additional treatment options, which may help some patients to avoid pharmaceutical treatment side effects or polypharmacy challenges.", "primary_outcomes": [ { "type": "primary", "measure": "Feasibility of Implementing a Combined Acupuncture and Chinese Herbal Medicine Intervention for long COVID", "description": "Feasibility will be measured through a feasibility assessment questionnaire which will evaluate recruitment, retention, and adherence metrics across the 12-week intervention and the final follow-up. Feasibility indicators will be summarized as proportions and descriptive statistics to evaluate the practicality of the study procedures and protocol implementation.", "time_frame": "From enrollment to the final follow-up at 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient-Reported Acceptability of the Study Procedures and Treatments", "description": "Acceptability will be evaluated using a participant satisfaction questionnaire administered at the end of the 12-week intervention. The survey includes Likert-scale items (1 = very dissatisfied to 5 = very satisfied) assessing participants' comfort with study procedures, satisfaction with the acupuncture and herbal treatment, and willingness to recommend participation to others. Mean scores will be calculated; higher scores indicate greater acceptability and satisfaction with the study protocol and treatment experience", "time_frame": "Week 12 (final follow-up)." }, { "type": "secondary", "measure": "Clinician-Reported Acceptability of the Study Protocol", "description": "Clinician acceptability will be measured through a self-administered survey at the end of the 12-week intervention. The survey uses a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied) to assess satisfaction with the clinical feasibility, workflow, and perceived patient benefit of the combined acupuncture and herbal medicine protocol. Scores will be averaged, and higher scores indicate greater clinician-reported acceptability.", "time_frame": "Week 12 (final follow-up)." }, { "type": "secondary", "measure": "Change in Health-Related Quality of Life Measured by PROMIS-29 v2.1", "description": "Quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.1) at baseline, mid-intervention, and post-intervention. The PROMIS-29 measures physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and social participation. Each domain produces a standardized T-score (mean = 50, SD = 10). Higher scores represent better functioning for positive domains and greater symptom burden for negative domains. Changes from baseline to Week 12 will reflect improvements or declines in overall quality of life.", "time_frame": "Baseline, Week 4, Week 8, and Week 12." }, { "type": "secondary", "measure": "Change in Symptom Burden Measured by the Symptom Burden Questionnaire for Long COVID (SBQ™-LC)", "description": "Symptom burden will be assessed using the Symptom Burden Questionnaire for Long COVID (SBQ™-LC). At baseline, participants complete all domains; at Weeks 8 and 12, they complete up to four domains corresponding to their most bothersome baseline symptoms, as well as the mandatory Mental Health and Well-Being domain. Each item is rated from 0 (no symptom) to 10 (worst possible symptom). Higher scores indicate greater symptom severity. Domain and total scores will be compared across time points to evaluate changes in symptom burden.", "time_frame": "Baseline, Week 8, and Week 12." }, { "type": "secondary", "measure": "Change in Whole Health Person Index (WHPI)", "description": "Overall well-being will be measured using the Whole Health Person Index (WHPI), a 0-100 scale that assesses physical, emotional, and social wellness. Higher scores indicate better overall health and life balance. The change in WHPI from baseline to Week 12 will be used to evaluate perceived improvements in general well-being associated with the intervention.", "time_frame": "Baseline, Week 8, and Week 12." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Complete blood count", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes complete blood count (CBC) with differential. Changes in this marker will indicate biological trends in inflammation.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Incidence and Severity of Adverse Events Associated with Acupuncture and Herbal Medicine", "description": "Safety will be monitored throughout the 12-week study by documenting adverse events (AEs) and serious adverse events (SAEs) related to acupuncture or herbal supplementation. Each event will be recorded in Qualtrics using the Adverse Event Form and graded as mild, moderate, or severe per Institutional Review Board (IRB) and Common Terminology Criteria for Adverse Events (CTCAE v5.0) guidelines. Frequency and type of AEs will be summarized descriptively as counts and percentages.", "time_frame": "Throughout the 12-week study period" }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Comprehensive metabolic panel", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes complete comprehensive metabolic panel (CMP). Changes in this marker will indicate biological trends in inflammation and metabolic function.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - C-reactive protein", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes C-reactive protein (CRP). Changes in this marker will indicate biological trends in inflammation.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Erythrocyte sedimentation rate", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes erythrocyte sedimentation rate (ESR). Changes in this marker will indicate biological trends in inflammation.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Tumor necrosis factor-alpha", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes tumor necrosis factor-alpha. Changes in this marker will indicate biological trends in inflammation and metabolic function.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - thyroid panel", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes thyroid panel. Changes in this marker will indicate biological trends in metabolic function.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Vitamin D levels.", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Tests include vitamin D levels. Changes in these markers will indicate biological trends in inflammation and metabolic function.", "time_frame": "Baseline and Week 8." } ], "outcome_measures": [ { "type": "primary", "measure": "Feasibility of Implementing a Combined Acupuncture and Chinese Herbal Medicine Intervention for long COVID", "description": "Feasibility will be measured through a feasibility assessment questionnaire which will evaluate recruitment, retention, and adherence metrics across the 12-week intervention and the final follow-up. Feasibility indicators will be summarized as proportions and descriptive statistics to evaluate the practicality of the study procedures and protocol implementation.", "time_frame": "From enrollment to the final follow-up at 12 weeks" }, { "type": "secondary", "measure": "Patient-Reported Acceptability of the Study Procedures and Treatments", "description": "Acceptability will be evaluated using a participant satisfaction questionnaire administered at the end of the 12-week intervention. The survey includes Likert-scale items (1 = very dissatisfied to 5 = very satisfied) assessing participants' comfort with study procedures, satisfaction with the acupuncture and herbal treatment, and willingness to recommend participation to others. Mean scores will be calculated; higher scores indicate greater acceptability and satisfaction with the study protocol and treatment experience", "time_frame": "Week 12 (final follow-up)." }, { "type": "secondary", "measure": "Clinician-Reported Acceptability of the Study Protocol", "description": "Clinician acceptability will be measured through a self-administered survey at the end of the 12-week intervention. The survey uses a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied) to assess satisfaction with the clinical feasibility, workflow, and perceived patient benefit of the combined acupuncture and herbal medicine protocol. Scores will be averaged, and higher scores indicate greater clinician-reported acceptability.", "time_frame": "Week 12 (final follow-up)." }, { "type": "secondary", "measure": "Change in Health-Related Quality of Life Measured by PROMIS-29 v2.1", "description": "Quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.1) at baseline, mid-intervention, and post-intervention. The PROMIS-29 measures physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and social participation. Each domain produces a standardized T-score (mean = 50, SD = 10). Higher scores represent better functioning for positive domains and greater symptom burden for negative domains. Changes from baseline to Week 12 will reflect improvements or declines in overall quality of life.", "time_frame": "Baseline, Week 4, Week 8, and Week 12." }, { "type": "secondary", "measure": "Change in Symptom Burden Measured by the Symptom Burden Questionnaire for Long COVID (SBQ™-LC)", "description": "Symptom burden will be assessed using the Symptom Burden Questionnaire for Long COVID (SBQ™-LC). At baseline, participants complete all domains; at Weeks 8 and 12, they complete up to four domains corresponding to their most bothersome baseline symptoms, as well as the mandatory Mental Health and Well-Being domain. Each item is rated from 0 (no symptom) to 10 (worst possible symptom). Higher scores indicate greater symptom severity. Domain and total scores will be compared across time points to evaluate changes in symptom burden.", "time_frame": "Baseline, Week 8, and Week 12." }, { "type": "secondary", "measure": "Change in Whole Health Person Index (WHPI)", "description": "Overall well-being will be measured using the Whole Health Person Index (WHPI), a 0-100 scale that assesses physical, emotional, and social wellness. Higher scores indicate better overall health and life balance. The change in WHPI from baseline to Week 12 will be used to evaluate perceived improvements in general well-being associated with the intervention.", "time_frame": "Baseline, Week 8, and Week 12." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Complete blood count", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes complete blood count (CBC) with differential. Changes in this marker will indicate biological trends in inflammation.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Incidence and Severity of Adverse Events Associated with Acupuncture and Herbal Medicine", "description": "Safety will be monitored throughout the 12-week study by documenting adverse events (AEs) and serious adverse events (SAEs) related to acupuncture or herbal supplementation. Each event will be recorded in Qualtrics using the Adverse Event Form and graded as mild, moderate, or severe per Institutional Review Board (IRB) and Common Terminology Criteria for Adverse Events (CTCAE v5.0) guidelines. Frequency and type of AEs will be summarized descriptively as counts and percentages.", "time_frame": "Throughout the 12-week study period" }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Comprehensive metabolic panel", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes complete comprehensive metabolic panel (CMP). Changes in this marker will indicate biological trends in inflammation and metabolic function.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - C-reactive protein", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes C-reactive protein (CRP). Changes in this marker will indicate biological trends in inflammation.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Erythrocyte sedimentation rate", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes erythrocyte sedimentation rate (ESR). Changes in this marker will indicate biological trends in inflammation.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Tumor necrosis factor-alpha", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes tumor necrosis factor-alpha. Changes in this marker will indicate biological trends in inflammation and metabolic function.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - thyroid panel", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes thyroid panel. Changes in this marker will indicate biological trends in metabolic function.", "time_frame": "Baseline and Week 8." }, { "type": "secondary", "measure": "Change in Laboratory Biomarkers - Vitamin D levels.", "description": "Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Tests include vitamin D levels. Changes in these markers will indicate biological trends in inflammation and metabolic function.", "time_frame": "Baseline and Week 8." } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 10, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07285707", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04948203", "title": "Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID Fibrosis", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2025-12-15", "start_date": "2021-07-09", "completion_date": "2026-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Pulmonary Fibrosis", "COVID-19 Pneumonia", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Sirolimus (low-dose)" ], "sponsor": "University of Chicago", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The primary purpose of this study is to determine whether the drug sirolimus reduces the likelihood of developing of pulmonary fibrosis in patients who are hospitalized with COVID-19 pneumonia.", "primary_outcomes": [ { "type": "primary", "measure": "Prevalence of Pulmonary Fibrosis as evidenced by CT scan", "description": "Number of patients with \\>10% pulmonary fibrosis on chest CT", "time_frame": "12 Weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "10% Threshold for Pulmonary Fibrosis evidenced by CT scan", "description": "Number of patients with \\>10% pulmonary fibrosis on chest CT", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Qualitative Fibrotic markers on chest CT", "description": "Number of patients with the presence or absence of chest CT imaging markers of fibrosis", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Quantitative Fibrosis Score on chest CT", "description": "Quantitative Fibrosis Score on chest CT", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Duration of Increased Supplemental Oxygen from Baseline", "description": "Number of days over which the participant requires supplemental oxygen in excess over baseline supplemental oxygen requirement.", "time_frame": "84 Days" }, { "type": "secondary", "measure": "Pulmonary Function Test impairment", "description": "Number of subjects with the presence of abnormal indices of lung function tests", "time_frame": "12 Weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Prevalence of Pulmonary Fibrosis as evidenced by CT scan", "description": "Number of patients with \\>10% pulmonary fibrosis on chest CT", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "10% Threshold for Pulmonary Fibrosis evidenced by CT scan", "description": "Number of patients with \\>10% pulmonary fibrosis on chest CT", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Qualitative Fibrotic markers on chest CT", "description": "Number of patients with the presence or absence of chest CT imaging markers of fibrosis", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Quantitative Fibrosis Score on chest CT", "description": "Quantitative Fibrosis Score on chest CT", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Duration of Increased Supplemental Oxygen from Baseline", "description": "Number of days over which the participant requires supplemental oxygen in excess over baseline supplemental oxygen requirement.", "time_frame": "84 Days" }, { "type": "secondary", "measure": "Pulmonary Function Test impairment", "description": "Number of subjects with the presence of abnormal indices of lung function tests", "time_frame": "12 Weeks" } ], "relevance_tags": [ "Immunomodulatory", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04948203", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07278388", "title": "Neural Mechanisms of Fatigue in Post-Acute Sequela of SARS-CoV-2", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-12-12", "start_date": "2025-07-16", "completion_date": "2029-12-31", "primary_completion_date": "2029-12-31", "conditions_raw": [ "PASC Post Acute Sequelae of COVID 19", "Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Physical Fatigue" ], "sponsor": "Hugo W. Moser Research Institute at Kennedy Krieger, Inc.", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This proposal aims to understand the neurobiological mechanisms of fatigue in individuals with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). This knowledge will eventually provide candidate mechanisms to target with pharmacological intervention and inform rehabilitative care for those individuals suffering from symptoms of fatigue in PASC.", "primary_outcomes": [ { "type": "primary", "measure": "Comparison between PASC and HC - difference in mean Assessment Error", "description": "The difference between the level of effort rated by participants, and their average grip force exerted on a grip force dynamometer. Compared between PASC and HC.", "time_frame": "Baseline, during experimental protocol." }, { "type": "primary", "measure": "Comparing between PASC and HC - difference in BBB permeability", "description": "Collected from and MRI sequence designed to measure BBB permeability.", "time_frame": "Baseline, during MRI acquisition." }, { "type": "primary", "measure": "Comparing between PASC and HC - Regions of the brain that are sensitive to Assessment error as a function of disease state", "description": "We will examine an fMRI contrast, at the time of effort assessment, between HC and PASC groups. This contrast will examine percent signal change in brain activity.", "time_frame": "Baseline, during experimental protocol." }, { "type": "primary", "measure": "The modulatory effect of BBB permeability on the relationship between Neural Activity and Effort Assessment", "description": "We will create a structural equation model that includes BBB permeability, fMRI activity, effort assessment behavior, and disease state (PASC/HC).", "time_frame": "Baseline, during experimental protocol and MRI aquisition." }, { "type": "primary", "measure": "Comparing between PASC and HC - Difference in momentary subjective fatigue ratings", "description": "Measures of subjective fatigue will be collected on self report scale that ranges from 'not fatigued at all' to 'very fatigued'.", "time_frame": "Baseline and during fatiguing exertions in the experimental protocol." }, { "type": "primary", "measure": "Comparing between PASC and HC - Difference in Mean Acceptance Rate of Risky Effort Options between rested/baseline and fatigue choices", "description": "Proportion of decisions in which inviduals choice to accept a risky effort opitions over a sure effort option.", "time_frame": "Baseline and during fatiguing exertions in the experimental protocol." }, { "type": "primary", "measure": "Comparing between PASC and HC - Regions of the brain encoding a difference in effort cost between rested/baseline and fatigue choices", "description": "We will examine a contrast between chosen effort value pre versus post fatigue, between the HC and PASC groups. This contrast will examine percent signal change in brain activity.", "time_frame": "Baseline and during fatiguing exertions in the experimental protocol." }, { "type": "primary", "measure": "The modulatory effect of BBB permeability on the relationship between Neural Activity and change effort-based decision-making", "description": "We will create a structural equation model that includes BBB permeability, fMRI activity, change in effort-based decision-making, and disease state (PASC/HC).", "time_frame": "Baseline, fatigueing exertion, and during experimental protocol and MRI aquisition" }, { "type": "primary", "measure": "Comparing between PASC and HC - Difference in mean assessment error as a function of time", "description": "The difference between the level of effort rated by participants, and their average grip force exerted on a grip force dynamometer. Compared between PASC and HC.", "time_frame": "Data collections at months 0, 3, 6, 12" }, { "type": "primary", "measure": "Comparing between PASC and HC - Difference in momentary subjective fatigue ratings as a function of time", "description": "Measures of subjective fatigue will be collected on self report scale that ranges from 'not fatigued at all' to 'very fatigued'.", "time_frame": "Data collections at months 0, 3, 6, 12" }, { "type": "primary", "measure": "Comparing between PASC and HC - difference in BBB permeability as a function of time", "description": "Collected from and MRI sequence designed to measure BBB permeability.", "time_frame": "Data collections at months 0, 3, 6, 12" }, { "type": "primary", "measure": "Comparing between PASC and HC - Regions of the brain that are sensitive to Assessment error as a function of disease state and time", "description": "We will examine a contrast, at the time of effort assessment, between HC and PASC groups, and use time as a covariate. This contrast will examine percent signal change in brain activity.", "time_frame": "Data collections at months 0, 3, 6, 12" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Comparison between PASC and HC - difference in mean Assessment Error", "description": "The difference between the level of effort rated by participants, and their average grip force exerted on a grip force dynamometer. Compared between PASC and HC.", "time_frame": "Baseline, during experimental protocol." }, { "type": "primary", "measure": "Comparing between PASC and HC - difference in BBB permeability", "description": "Collected from and MRI sequence designed to measure BBB permeability.", "time_frame": "Baseline, during MRI acquisition." }, { "type": "primary", "measure": "Comparing between PASC and HC - Regions of the brain that are sensitive to Assessment error as a function of disease state", "description": "We will examine an fMRI contrast, at the time of effort assessment, between HC and PASC groups. This contrast will examine percent signal change in brain activity.", "time_frame": "Baseline, during experimental protocol." }, { "type": "primary", "measure": "The modulatory effect of BBB permeability on the relationship between Neural Activity and Effort Assessment", "description": "We will create a structural equation model that includes BBB permeability, fMRI activity, effort assessment behavior, and disease state (PASC/HC).", "time_frame": "Baseline, during experimental protocol and MRI aquisition." }, { "type": "primary", "measure": "Comparing between PASC and HC - Difference in momentary subjective fatigue ratings", "description": "Measures of subjective fatigue will be collected on self report scale that ranges from 'not fatigued at all' to 'very fatigued'.", "time_frame": "Baseline and during fatiguing exertions in the experimental protocol." }, { "type": "primary", "measure": "Comparing between PASC and HC - Difference in Mean Acceptance Rate of Risky Effort Options between rested/baseline and fatigue choices", "description": "Proportion of decisions in which inviduals choice to accept a risky effort opitions over a sure effort option.", "time_frame": "Baseline and during fatiguing exertions in the experimental protocol." }, { "type": "primary", "measure": "Comparing between PASC and HC - Regions of the brain encoding a difference in effort cost between rested/baseline and fatigue choices", "description": "We will examine a contrast between chosen effort value pre versus post fatigue, between the HC and PASC groups. This contrast will examine percent signal change in brain activity.", "time_frame": "Baseline and during fatiguing exertions in the experimental protocol." }, { "type": "primary", "measure": "The modulatory effect of BBB permeability on the relationship between Neural Activity and change effort-based decision-making", "description": "We will create a structural equation model that includes BBB permeability, fMRI activity, change in effort-based decision-making, and disease state (PASC/HC).", "time_frame": "Baseline, fatigueing exertion, and during experimental protocol and MRI aquisition" }, { "type": "primary", "measure": "Comparing between PASC and HC - Difference in mean assessment error as a function of time", "description": "The difference between the level of effort rated by participants, and their average grip force exerted on a grip force dynamometer. Compared between PASC and HC.", "time_frame": "Data collections at months 0, 3, 6, 12" }, { "type": "primary", "measure": "Comparing between PASC and HC - Difference in momentary subjective fatigue ratings as a function of time", "description": "Measures of subjective fatigue will be collected on self report scale that ranges from 'not fatigued at all' to 'very fatigued'.", "time_frame": "Data collections at months 0, 3, 6, 12" }, { "type": "primary", "measure": "Comparing between PASC and HC - difference in BBB permeability as a function of time", "description": "Collected from and MRI sequence designed to measure BBB permeability.", "time_frame": "Data collections at months 0, 3, 6, 12" }, { "type": "primary", "measure": "Comparing between PASC and HC - Regions of the brain that are sensitive to Assessment error as a function of disease state and time", "description": "We will examine a contrast, at the time of effort assessment, between HC and PASC groups, and use time as a covariate. This contrast will examine percent signal change in brain activity.", "time_frame": "Data collections at months 0, 3, 6, 12" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 200, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT07278388", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07254377", "title": "Design and Validation of Innovative Strategies Based on Dual-Task Approach", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-12-11", "start_date": "2025-11-01", "completion_date": "2027-02-28", "primary_completion_date": "2026-03-30", "conditions_raw": [ "Stroke", "Multiple Sclerosis", "Parkinson Disease", "Dual Task Exercises", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Dual Task Exercise", "Physical Therapy" ], "sponsor": "I.R.C.C.S. Fondazione Santa Lucia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "People affected by Stroke, Multiple Sclerosis (MS), and Parkinson's disease (PD) share severe and complex disabilities. Widespread neuro-inflammatory processes represent an important pathogenetic component in all three conditions. The potential overlap with neurological complications of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection has further contributed to the worsening of functional impairment. Since pharmacological therapies have limited or negligible effects in these disorders, neurorehabilitation plays a crucial role in restoring and maintaining adequate functional abilities. In this context, dual-task strategies have attracted growing interest, but their effectiveness has not been adequately assessed in the above neurological conditions-and not at all in individuals with long-term sequelae of SARS-CoV-2 infection.\n\nBased on these premises, the objectives of this research project are:\n\n* to design rehabilitation strategies using the dual-task approach in its various forms (dual motor task, dual cognitive task, and combined motor-cognitive task) and to conduct feasibility tests in small groups of individuals affected by stroke, MS, PD, or long-term Coronavirus Disease 2019 (COVID-19) sequelae;\n* to apply the strategies found to be effective in larger trials involving participants with stroke, MS, or PD, with or without a history of SARS-CoV-2 infection;\n* to compare the outcomes of dual-task strategies with those obtained through conventional rehabilitation approaches.\n\nThe activities planned within the project will be distributed among the four participating operating units (OUs). OU1 (Santa Lucia Foundation) will be responsible for:\n\n1. designing and validating dual-task rehabilitation strategies covering the three possible combinations of motor and cognitive activities (dual motor task, dual cognitive task, and combined motor-cognitive task);\n2. assessing the feasibility of these strategies through a pilot study involving small groups of individuals with the aforementioned neurological conditions, including those with long-term outcomes of SARS-CoV-2 infection, and selecting the most suitable approaches.\n\nAll four OUs will participate in the selection and enrollment of subjects for the trial phase.\n\nOUs 1, 3, and 4 (Collaborators to the project) will conduct the activities planned for the experimental trial, including:\n\n1. baseline assessment of enrolled participants using validated instruments to measure various motor and cognitive functions;\n2. implementation of rehabilitation strategies based on the dual-task approach, making use of newly emerging technological devices;\n3. follow-up assessments at the end of the treatment period and again three months later.\n\nAssessments will focus on motor functions such as gait and balance, cognitive functions, mood, the occurrence of domestic accidents, and the measurement of circulating biomarkers of neuroinflammation and neurodegeneration.\n\nData collected throughout the different phases of the study will be compiled into a single database, and statistical analyses will be performed by researchers from OU1.\n\nThe interpretation of results will be carried out collaboratively by members of all OUs, and findings will be disseminated through participation in conferences and congresses, as well as through publications in peer-reviewed international indexed journals.", "primary_outcomes": [ { "type": "primary", "measure": "6-Minute Walking Test", "description": "The 6-Minute Walking Test is a standardized assessment of functional walking capacity in which the patient is instructed to walk back and forth along a predefined path for six minutes. The total distance covered during this time reflects the individual's aerobic endurance, mobility, and overall functional performance. The test is simple, well tolerated, and widely used in both clinical and research settings. The minimum score is about 300m and denotes a very low funcional motility, while higher distance covered (\\> 600 m) is a sign of good walking ability.", "time_frame": "Baseline (Day 1), end of treatment (Day 56), follow -up (146)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Montreal Cognitive Assessment", "description": "The Montreal Cognitive Assessment is a widely used screening tool designed to evaluate global cognitive function. It assesses multiple domains, including attention, executive functions, memory, language, visuospatial abilities, abstraction, and orientation. The test is quick to administer, sensitive to mild cognitive impairment, and commonly applied in both clinical practice and research settings. The maximum score is 30, 25 is a cut off for normal cognitive functioning, with higher score denoting better performance.", "time_frame": "Baseline (Day 1), End of Treatment (Day 56), 3-Month Follow-up (Day 146)" } ], "outcome_measures": [ { "type": "primary", "measure": "6-Minute Walking Test", "description": "The 6-Minute Walking Test is a standardized assessment of functional walking capacity in which the patient is instructed to walk back and forth along a predefined path for six minutes. The total distance covered during this time reflects the individual's aerobic endurance, mobility, and overall functional performance. The test is simple, well tolerated, and widely used in both clinical and research settings. The minimum score is about 300m and denotes a very low funcional motility, while higher distance covered (\\> 600 m) is a sign of good walking ability.", "time_frame": "Baseline (Day 1), end of treatment (Day 56), follow -up (146)" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment", "description": "The Montreal Cognitive Assessment is a widely used screening tool designed to evaluate global cognitive function. It assesses multiple domains, including attention, executive functions, memory, language, visuospatial abilities, abstraction, and orientation. The test is quick to administer, sensitive to mild cognitive impairment, and commonly applied in both clinical practice and research settings. The maximum score is 30, 25 is a cut off for normal cognitive functioning, with higher score denoting better performance.", "time_frame": "Baseline (Day 1), End of Treatment (Day 56), 3-Month Follow-up (Day 146)" } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 48, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07254377", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06695910", "title": "Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA).", "status": "RECRUITING", "phase": "PHASE4", "last_updated": "2025-12-11", "start_date": "2024-11-06", "completion_date": "2027-07-01", "primary_completion_date": "2027-05-01", "conditions_raw": [ "Brain Fog", "Cognitive Health" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Monoglyceride Eicosapentaenoic Acid", "Sunflower Oil" ], "sponsor": "Samuel Fortin", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "A growing body of studies shows that omega-3s act directly in molecular signaling pathways that reduce inflammation and are thought to have a positive effect on cognitive health. Brain fog is a term that has been popularized in the medical world in the wake of the COVID-19 pandemic. A significant proportion of patients with long COVID reported having cognitive sequelae that were like fogginess. It is defined as a cognitive impairment with characteristic symptoms including problems with concentration, attention and memory, confusion, difficulty understanding what others are saying, reduced mental acuity and mental fatigue. These are episodes of reduced cognitive capacity that are not representative of the person's normal state. This condition can be caused by various factors such as stress, lack of sleep, overwork, depression, hormonal changes due to pregnancy or menopause in women, head injuries, migraine, certain diseases or viral infections, certain medications as well as substance abuse (alcohol and/or street drugs). In this study, we want to test whether omega-3 monoglycerides (MAG-EPA) can modulate the cognitive health of people with brain fog.", "primary_outcomes": [ { "type": "primary", "measure": "Cognitive health assessment with the Brain Fog Scale (BFS)", "description": "* Evaluate the brain fog of all subjects using the Brain Fog Scale (BFS) before the start of treatment, then every 14 days over a period of 98 days (BFS 1 to 8) in phase 1 or a period of 154 days in phase 2 (BFS 1 to 12).\n* For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the score of each individual factor (Factor 1: mental fatigue; Factor 2: impaired cognitive acuity; Factor 3: confusion) with that obtained at the pre-treatment BFS measures (BFS 1 and 2).\n* For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the total score with that obtained at the pre-treatment BFS measures (BFS 1 and 2).", "time_frame": "Phase 1: Every two (2) weeks over a period of fourteen (14) weeks in total.Phase 2: Every two (2) weeks over a period of twenty-two (22) weeks in total." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Omega-3 intake assessment by Omega-3 index analysis", "description": "Measure the subjects' omega-3 index four times during the study (Day 0, Day 28, Day 56 and Day 84 in Phase 1; Day 0, Day 56, Day 112 and Day 140 in Phase 2) to validate if the level of omega-3 index correlates with BFS scores and that the subjects in the test group adhere to the treatment. This measurement is also used to check that subjects in the placebo group are not supplemented with omega-3 during the study. Blinded personnel and subjects will not have access to the results of omega-3 index testing.", "time_frame": "At 0, 4, 8 and 12 weeks in phase 1; At 0, 8, 16 and 20 weeks after the start of the study in Phase 2." }, { "type": "secondary", "measure": "Demographic data analysis", "description": "Demographic data such as age, gender, body mass index (BMI), substance use habits (alcohol, tobacco), sports habits, sleep habits as well as daily time spent using electronics will be collected to draw a detailed portrait of the studied population. These data will allow to correct for potential confounding variables in the event of an imbalance between the groups.", "time_frame": "From week 0 to 12 in Phase 1; From week 0 to 20 in Phase 2." }, { "type": "secondary", "measure": "Adverse Event reporting", "description": "Evaluate adverse events potentially related to MAG-EPA throughout the supplementation period as well as during the withdrawal period.", "time_frame": "From week 2 to 12 in Phase 1; From week 2 to week 20 in Phase 2." } ], "outcome_measures": [ { "type": "primary", "measure": "Cognitive health assessment with the Brain Fog Scale (BFS)", "description": "* Evaluate the brain fog of all subjects using the Brain Fog Scale (BFS) before the start of treatment, then every 14 days over a period of 98 days (BFS 1 to 8) in phase 1 or a period of 154 days in phase 2 (BFS 1 to 12).\n* For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the score of each individual factor (Factor 1: mental fatigue; Factor 2: impaired cognitive acuity; Factor 3: confusion) with that obtained at the pre-treatment BFS measures (BFS 1 and 2).\n* For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the total score with that obtained at the pre-treatment BFS measures (BFS 1 and 2).", "time_frame": "Phase 1: Every two (2) weeks over a period of fourteen (14) weeks in total.Phase 2: Every two (2) weeks over a period of twenty-two (22) weeks in total." }, { "type": "secondary", "measure": "Omega-3 intake assessment by Omega-3 index analysis", "description": "Measure the subjects' omega-3 index four times during the study (Day 0, Day 28, Day 56 and Day 84 in Phase 1; Day 0, Day 56, Day 112 and Day 140 in Phase 2) to validate if the level of omega-3 index correlates with BFS scores and that the subjects in the test group adhere to the treatment. This measurement is also used to check that subjects in the placebo group are not supplemented with omega-3 during the study. Blinded personnel and subjects will not have access to the results of omega-3 index testing.", "time_frame": "At 0, 4, 8 and 12 weeks in phase 1; At 0, 8, 16 and 20 weeks after the start of the study in Phase 2." }, { "type": "secondary", "measure": "Demographic data analysis", "description": "Demographic data such as age, gender, body mass index (BMI), substance use habits (alcohol, tobacco), sports habits, sleep habits as well as daily time spent using electronics will be collected to draw a detailed portrait of the studied population. These data will allow to correct for potential confounding variables in the event of an imbalance between the groups.", "time_frame": "From week 0 to 12 in Phase 1; From week 0 to 20 in Phase 2." }, { "type": "secondary", "measure": "Adverse Event reporting", "description": "Evaluate adverse events potentially related to MAG-EPA throughout the supplementation period as well as during the withdrawal period.", "time_frame": "From week 2 to 12 in Phase 1; From week 2 to week 20 in Phase 2." } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "Phase 4", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 48, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06695910", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05619653", "title": "Myocardial Protection in Patients With Post-acute Inflammatory Cardiac Involvement Due to COVID-19", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE3", "last_updated": "2025-12-09", "start_date": "2022-12-12", "completion_date": "2026-03-31", "primary_completion_date": "2025-08-08", "conditions_raw": [ "COVID-19 Associated Cardiac Involvement", "Remodeling, Left Ventricle", "Remodeling, Vascular", "Left Ventricular Dysfunction", "Exercise Intolerance", "Vascular Inflammation", "Microvascular Angina", "Long COVID", "Myocarditis, Pericarditis" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Prednisolone", "Losartan" ], "sponsor": "Valentina Puentmann", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID or Postacute sequelae of COVID-19 infection (PASC) are increasingly recognised complications, defined by lingering symptoms, not present prior to the infection, typically persisting for more than 4 weeks. Cardiac symptoms due to post-acute inflammatory cardiac involvement affect a broad segment of people, who were previously well and may have had only mild acute illness (PASC-cardiovascular syndrome, PASC-CVS). Symptoms may be contiguous with the acute illness, however, more commonly they occur after a delay. Symptoms related to the cardiovascular system include exertional dyspnoea, exercise intolerance chest tightness, pulling or burning chest pain, and palpitations (POTS, exertional tachycardia).\n\nPathophysiologically, Long COVID relates to small vessel disease (endothelial dysfunction) vascular dysfunction and consequent tissue organ hypoperfusion due to ongoing immune dysregulation. Active organs with high oxygen dependency are most affected (heart, brain, kidneys, muscles, etc.). Thus, cardiac symptoms are often accompanied by manifestations of other organ systems, including fatigue, brain fog, kidney problems, myalgias, skin and joint manifestations, etc, now commonly referred to as the Long COVID or PASC syndrome.\n\nPhenotypically, PostCOVID Heart involvement is characterised by chronic perivascular and myopericardial inflammation. We and others have shown changes using sensitive cardiac MRI imaging that relate to cardiac symptoms (Puntmann et al, Nature Medicine 2022; Puntmann et al, JAMA Cardiol 2020; Summary of studies included in 2022 ACC PostCOVID Expert Consensus Taskforce Development Statement, JACC 2022, references below).\n\nEarly intervention with immunosuppression and antiremodelling therapy may reduce symptoms and development of myocardial impairment, by minimising the disease activity and inducing disease remission. Low-dose maintenance therapy may help to maintain the disease activity at the lowest possible level. The benefits of early initiations of antiremodelling therapy to reduce symptoms of exercise intolerance are well recognised, but not commonly employed outside the classical cardiology contexts, such as heart failure or hypertension. As most patients with inflammatory heart disease only have mild or no structural abnormalities, they are left untreated (standard of care).\n\nThe aim of this study is to examine the efficacy of a combined immunosuppressive / antiremodelling therapy in patients with PASC symptoms and inflammatory cardiac involvement determined by CMR, to reduce the symptoms and inflammatory myocardial injury and thereby stop the progression to reduced LVEF, HF and death.", "primary_outcomes": [ { "type": "primary", "measure": "Left ventricular ejection fraction", "description": "absolute change of LVEF from baseline", "time_frame": "16 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Scar burden by late gadolinium enhancement (LGE)", "description": "mean LGE extent (%) and change thereof from baseline", "time_frame": "16 weeks" }, { "type": "secondary", "measure": "Cardiopulmonary exercise testing (CPET)", "description": "Achieved Work rate, VO2max, VCO2 max, RER, AT and Slope and change thereof compared to baseline", "time_frame": "16 weeks" }, { "type": "secondary", "measure": "Mean T1 and T2 mapping", "description": "Mean T1 and T2 mapping values (ms) and absolute change thereof compared to baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "LV Volume (ml/m2) and LV mass (g/m2)", "description": "Average LV Volume (ml/m2) and average LV mass (g/m2) and change there of measures from baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "LV strain %", "description": "absolute change of measures from baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "Aortic stiffness (PWV)", "description": "absolute change of measures from baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "Aortic wall imaging (LGE)", "description": "absolute change of measures from baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "Average Symptom Score (Modified CCS, NYHA, MRC Dyspnea Score, LC Questionnaire (Sudre et al, NM 2020)", "description": "change thereof compared to baseline", "time_frame": "at all available time points compared to baseline" }, { "type": "secondary", "measure": "HF and MACE Endpoints", "description": "proportion of patients with endpoints", "time_frame": "1 year" }, { "type": "secondary", "measure": "Quality of Life assessment", "description": "Quality of Life assessment (RAND 36-Item health survey V2.0)", "time_frame": "at all available time points compared to baseline" }, { "type": "secondary", "measure": "Compliance and Tolerance of Therapy", "description": "Compliance and Tolerance of Therapy", "time_frame": "at all available time points compared to baseline" }, { "type": "secondary", "measure": "Assessment of Treatment Response", "description": "Number of responders achieving partial or full recovery by imaging markers", "time_frame": "16 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Left ventricular ejection fraction", "description": "absolute change of LVEF from baseline", "time_frame": "16 weeks" }, { "type": "secondary", "measure": "Scar burden by late gadolinium enhancement (LGE)", "description": "mean LGE extent (%) and change thereof from baseline", "time_frame": "16 weeks" }, { "type": "secondary", "measure": "Cardiopulmonary exercise testing (CPET)", "description": "Achieved Work rate, VO2max, VCO2 max, RER, AT and Slope and change thereof compared to baseline", "time_frame": "16 weeks" }, { "type": "secondary", "measure": "Mean T1 and T2 mapping", "description": "Mean T1 and T2 mapping values (ms) and absolute change thereof compared to baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "LV Volume (ml/m2) and LV mass (g/m2)", "description": "Average LV Volume (ml/m2) and average LV mass (g/m2) and change there of measures from baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "LV strain %", "description": "absolute change of measures from baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "Aortic stiffness (PWV)", "description": "absolute change of measures from baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "Aortic wall imaging (LGE)", "description": "absolute change of measures from baseline", "time_frame": "16 Weeks" }, { "type": "secondary", "measure": "Average Symptom Score (Modified CCS, NYHA, MRC Dyspnea Score, LC Questionnaire (Sudre et al, NM 2020)", "description": "change thereof compared to baseline", "time_frame": "at all available time points compared to baseline" }, { "type": "secondary", "measure": "HF and MACE Endpoints", "description": "proportion of patients with endpoints", "time_frame": "1 year" }, { "type": "secondary", "measure": "Quality of Life assessment", "description": "Quality of Life assessment (RAND 36-Item health survey V2.0)", "time_frame": "at all available time points compared to baseline" }, { "type": "secondary", "measure": "Compliance and Tolerance of Therapy", "description": "Compliance and Tolerance of Therapy", "time_frame": "at all available time points compared to baseline" }, { "type": "secondary", "measure": "Assessment of Treatment Response", "description": "Number of responders achieving partial or full recovery by imaging markers", "time_frame": "16 weeks" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Anti-inflammatory", "Phase 3", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 279, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05619653", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05566483", "title": "Physiology of Long COVID-19 and the Impact of Cardiopulmonary Rehabilitation on Quality-of-Life and Functional Capacity", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-12-04", "start_date": "2023-03-01", "completion_date": "2027-10-31", "primary_completion_date": "2027-10-31", "conditions_raw": [ "Post-acute Sequelae of SARS-CoV-2 Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Exercise" ], "sponsor": "University of Colorado, Denver", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The primary objectives of this study are to determine whether exercise training is an effective strategy for treatment of Long COVID and characterize the cardiorespiratory and autonomic physiology in these patients to precisely characterize mechanisms contributing to this syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Characterizing the impact of exercise training (cardiac rehabilitation) on functional capacity among patients with Long COVID", "description": "functional capacity as determined by VO2max", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Characterizing the impact of exercise training (cardiac rehabilitation) on HRqOL among patients with Long COVID", "description": "Health-related quality of life (HRqOL) from SF-36 form; all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "orthostatic challenge", "description": "Heart rate during orthostatic challenge", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Characterizing the impact of exercise training (cardiac rehabilitation) on functional capacity among patients with Long COVID", "description": "functional capacity as determined by VO2max", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Characterizing the impact of exercise training (cardiac rehabilitation) on HRqOL among patients with Long COVID", "description": "Health-related quality of life (HRqOL) from SF-36 form; all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "orthostatic challenge", "description": "Heart rate during orthostatic challenge", "time_frame": "12 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05566483", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05595369", "title": "RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2025-12-02", "start_date": "2023-07-26", "completion_date": "2025-03-13", "primary_completion_date": "2024-08-06", "conditions_raw": [ "Long COVID", "Long Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Paxlovid (Nirmatrelvir/Ritonavir)" ], "sponsor": "Kanecia Obie Zimmerman", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, double-blind, randomized, controlled platform trial with different interventions organized as appendices to the protocol. Each appendix (or sub-study) evaluates potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection, viral reactivation, and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Total Number of Participants Enrolled in Each Appendix", "description": "Appendix-specific outcome measure data will be reported under the associated NCT ID.", "time_frame": "90 days" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Total Number of Participants Enrolled in Each Appendix", "description": "Appendix-specific outcome measure data will be reported under the associated NCT ID.", "time_frame": "90 days" } ], "relevance_tags": [ "Immunomodulatory", "Persistence / Antiviral", "Anti-inflammatory", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 963, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05595369", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07110714", "title": "Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-12-02", "start_date": "2025-12-01", "completion_date": "2027-10-31", "primary_completion_date": "2027-01-31", "conditions_raw": [ "Post COVID-19 Condition", "Post COVID-19 Condition (PCC)", "Post COVID-19", "Post COVID-19 Syndrome", "Long COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cold Water Hydrotherapy" ], "sponsor": "Eggensberger OHG", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This randomized controlled study evaluates the effects of cold water hydrotherapy in patients with Post-COVID Syndrome. The primary aim is to assess changes in quality of life compared to an usual care setting without hydrotherapy treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Health-related quality of life by Short Form-12 Health Survey (SF-12)", "description": "Change in the Short Form-12 physical and mental component summary scores (minimum score = 0; maximum score = 100; higher scores indicate higher health-related quality of life)", "time_frame": "From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue severity by Fatigue Severity Scale", "description": "Change in Fatigue Severity Scale score (minimum score = 9; maximum score = 63; higher scores indicate greater fatigue severity)", "time_frame": "From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)" }, { "type": "secondary", "measure": "Sleep quality by Pittsburgh Sleep Quality Index", "description": "Change in Pittsburgh Sleep Quality Index score (minimum score = 0; maximum score = 21; higher scores indicate poorer sleep quality)", "time_frame": "From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)" }, { "type": "secondary", "measure": "Health status by EuroQol-5 Dimensions-5 Levels", "description": "Change in EuroQol-5 Dimensions-5 Levels questionnaire score (score represented by a 5-digit code; each digit represents one dimension, ranging from 1 to 5; higher digits indicate poorer health state)", "time_frame": "From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)" }, { "type": "secondary", "measure": "Autonomic function (heart rate variability by photoplethysmography)", "description": "Change in heart rate variability (root mean square of successive differences) measured by Kyto 2935 via photoplethysmography", "time_frame": "Daily during the 3-week program (Visit 1 to Visit 2)" }, { "type": "secondary", "measure": "Resting blood pressure (systolic and diastolic)", "description": "Change in morning resting systolic and diastolic blood pressure", "time_frame": "Daily during first 3 weeks of rehabilitation (Visit 1 to Visit 2)" }, { "type": "secondary", "measure": "Post-COVID work-absence days", "description": "Number of days of work absence due to Post-COVID-19 symptoms during the past 12-weeks", "time_frame": "From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)" }, { "type": "secondary", "measure": "Long-term quality of life by Short Form-12 Health Survey", "description": "Change in Short Form-12 scores at follow-up (minimum score = 0; maximum score = 100; higher scores indicate higher health-related quality of life)", "time_frame": "From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)" }, { "type": "secondary", "measure": "Long-term fatigue by Fatigue Severity Scale", "description": "Change in Fatigue Severity Scale score at follow-up (minimum score = 9; maximum score = 63; higher scores indicate greater fatigue severity)", "time_frame": "From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)" }, { "type": "secondary", "measure": "Adherence to hydrotherapy", "description": "Proportion of prescribed hydrotherapy applications in the intervention group performed, as recorded in diary or app.\n\nShort-term Adherence: During the 3-week intervention phase, patients are considered \"adherent\" if they perform atleast one hydrotherapy session per day on at least 75% of study days. The investigators will compare health improvements between high-adherence and low-adherence participants.\n\nLong-term Adherence and Effects: Over the 3- and 6-month follow-up, \"adherent\" patients are those who continue self administered hydrotherapy at least four times per week on at least 75% of follow-up weeks. The investigators will assess whether these patients sustain greater gains in quality of life.", "time_frame": "During the 3-week intervention phase (up to Visit 2) and over the 6-month follow-up period (to Visit 4)" }, { "type": "secondary", "measure": "Adverse events recording", "description": "Number and severity of adverse events related to Kneipp hydrotherapy", "time_frame": "From start of intervention (Visit 1) through end of study (Visit 4, 6-month follow-up)" }, { "type": "secondary", "measure": "Long-term heart rate variability changes (HRV)", "description": "Change in heart rate variability parameters (root mean square of successive differences) measured by photoplethysmography. At follow-up visits patients will measure HRV for 7 consecutive days", "time_frame": "From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)" }, { "type": "secondary", "measure": "Post-exertional malaise severity", "description": "Change in Post-Exertional Malaise score measured by the DePaul Symptom Questionnaire-Post-Exertional Malaise", "time_frame": "From baseline (Visit 1) to 6-month (Visit 4) follow-up" }, { "type": "secondary", "measure": "Daily well-being documentation", "description": "Self-reported daily well-being recorded via digital diary on a scale from 0 to 100", "time_frame": "Daily throughout the intervention and 6 months follow-up phase (Visit 1 to Visit 4)" } ], "outcome_measures": [ { "type": "primary", "measure": "Health-related quality of life by Short Form-12 Health Survey (SF-12)", "description": "Change in the Short Form-12 physical and mental component summary scores (minimum score = 0; maximum score = 100; higher scores indicate higher health-related quality of life)", "time_frame": "From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)" }, { "type": "secondary", "measure": "Fatigue severity by Fatigue Severity Scale", "description": "Change in Fatigue Severity Scale score (minimum score = 9; maximum score = 63; higher scores indicate greater fatigue severity)", "time_frame": "From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)" }, { "type": "secondary", "measure": "Sleep quality by Pittsburgh Sleep Quality Index", "description": "Change in Pittsburgh Sleep Quality Index score (minimum score = 0; maximum score = 21; higher scores indicate poorer sleep quality)", "time_frame": "From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)" }, { "type": "secondary", "measure": "Health status by EuroQol-5 Dimensions-5 Levels", "description": "Change in EuroQol-5 Dimensions-5 Levels questionnaire score (score represented by a 5-digit code; each digit represents one dimension, ranging from 1 to 5; higher digits indicate poorer health state)", "time_frame": "From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)" }, { "type": "secondary", "measure": "Autonomic function (heart rate variability by photoplethysmography)", "description": "Change in heart rate variability (root mean square of successive differences) measured by Kyto 2935 via photoplethysmography", "time_frame": "Daily during the 3-week program (Visit 1 to Visit 2)" }, { "type": "secondary", "measure": "Resting blood pressure (systolic and diastolic)", "description": "Change in morning resting systolic and diastolic blood pressure", "time_frame": "Daily during first 3 weeks of rehabilitation (Visit 1 to Visit 2)" }, { "type": "secondary", "measure": "Post-COVID work-absence days", "description": "Number of days of work absence due to Post-COVID-19 symptoms during the past 12-weeks", "time_frame": "From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)" }, { "type": "secondary", "measure": "Long-term quality of life by Short Form-12 Health Survey", "description": "Change in Short Form-12 scores at follow-up (minimum score = 0; maximum score = 100; higher scores indicate higher health-related quality of life)", "time_frame": "From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)" }, { "type": "secondary", "measure": "Long-term fatigue by Fatigue Severity Scale", "description": "Change in Fatigue Severity Scale score at follow-up (minimum score = 9; maximum score = 63; higher scores indicate greater fatigue severity)", "time_frame": "From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)" }, { "type": "secondary", "measure": "Adherence to hydrotherapy", "description": "Proportion of prescribed hydrotherapy applications in the intervention group performed, as recorded in diary or app.\n\nShort-term Adherence: During the 3-week intervention phase, patients are considered \"adherent\" if they perform atleast one hydrotherapy session per day on at least 75% of study days. The investigators will compare health improvements between high-adherence and low-adherence participants.\n\nLong-term Adherence and Effects: Over the 3- and 6-month follow-up, \"adherent\" patients are those who continue self administered hydrotherapy at least four times per week on at least 75% of follow-up weeks. The investigators will assess whether these patients sustain greater gains in quality of life.", "time_frame": "During the 3-week intervention phase (up to Visit 2) and over the 6-month follow-up period (to Visit 4)" }, { "type": "secondary", "measure": "Adverse events recording", "description": "Number and severity of adverse events related to Kneipp hydrotherapy", "time_frame": "From start of intervention (Visit 1) through end of study (Visit 4, 6-month follow-up)" }, { "type": "secondary", "measure": "Long-term heart rate variability changes (HRV)", "description": "Change in heart rate variability parameters (root mean square of successive differences) measured by photoplethysmography. At follow-up visits patients will measure HRV for 7 consecutive days", "time_frame": "From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)" }, { "type": "secondary", "measure": "Post-exertional malaise severity", "description": "Change in Post-Exertional Malaise score measured by the DePaul Symptom Questionnaire-Post-Exertional Malaise", "time_frame": "From baseline (Visit 1) to 6-month (Visit 4) follow-up" }, { "type": "secondary", "measure": "Daily well-being documentation", "description": "Self-reported daily well-being recorded via digital diary on a scale from 0 to 100", "time_frame": "Daily throughout the intervention and 6 months follow-up phase (Visit 1 to Visit 4)" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07110714", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05852873", "title": "PAxlovid loNg cOvid-19 pRevention triAl With recruitMent In the Community in Norway", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE3", "last_updated": "2025-11-21", "start_date": "2023-05-12", "completion_date": "2027-06-11", "primary_completion_date": "2025-09-09", "conditions_raw": [ "Post COVID-19 Condition, Unspecified", "SARS-CoV2 Infection", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Paxlovid (Nirmatrelvir/Ritonavir)" ], "sponsor": "Haukeland University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to compare treatment with oral Paxlovid (nirmatrelvir/ritonavir) and placebo for acute COVID-19 as an intervention to prevent long-COVID (post-COVID-19 condition) in adults aged 18-64 years old.\n\nThe main question it aims to answer is:\n\nDoes treatment with Paxlovid for acute COVID-19 reduce the prevalence of long-COVID compared to placebo.\n\nParticipants with acute COVID-19, documented with positive lateral flow test or PCR, within the last 5 days will be randomised to take either Paxlovid or placebo. All participants will receive standard of care in addition. Participants will respond to electronic questionnaires at 14 time points during follow-up. The primary outcome is presence of long-COVID symptoms at 3 months follow-up.\n\nResearchers will compare participants who received Paxlovid and placebo to see if Paxlovid treatment can prevent the occurrence of long-COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Symptoms of long-COVID", "description": "a dichotomous variable for presence of any of the three most important long-COVID symptoms: (i) fatigue, (ii) dyspnea and (iii) cognitive symptoms (defined as memory and/or concentration problems).", "time_frame": "Change in symptoms from baseline to 3, 6 and 12 months follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptoms individually and grouped by organ system", "description": "All individual symptoms separately, and grouped by systems (systemic symptoms, chest-symptoms, cognitive, other neuropsychiatric symptoms).", "time_frame": "Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up" }, { "type": "secondary", "measure": "Graded responses for symptoms and symptom constellations", "description": "Graded responses for separate symptoms and symptom constellations, including an ordinal variable graded 0-3 for the presence of the 3 symptoms in the primary outcome.", "time_frame": "Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up" }, { "type": "secondary", "measure": "Risk factors for long-COVID", "description": "Analysis of patient characteristics and other factors that may affect the occurrence of long-COVID", "time_frame": "Up to 24 months" }, { "type": "secondary", "measure": "Severity of acute disease", "description": "Severity of acute disease using an 8-step scale (1 - no limitation of activities, 2 - limitations of activities, not hospitalised, 3 - hospitalised not requiring specific treatment, 4 - hospitalised, requiring medical treatment, but not supplemental oxygen, 5 - need of supplemental oxygen, 6 - need of non-invasive ventilatory support (CPAP, BiPAP), 7 - need ov invasive ventilation, 8 - death", "time_frame": "28 days" }, { "type": "secondary", "measure": "Hospitalisation", "description": "Hospitalisation - binary outcome", "time_frame": "28 days" }, { "type": "secondary", "measure": "Severe adverse events", "description": "Severe adverse events", "time_frame": "Up to 24 months" }, { "type": "secondary", "measure": "Absence from work", "description": "Absence from work, full or partial sick leave", "time_frame": "Up to 24 months" }, { "type": "secondary", "measure": "Societal costs", "description": "Societal cost / economic analysis, including estimated cost of absence from work/school, hospitalizations, deaths, QALYs lost according to EQ-5D-5L, and more", "time_frame": "Up to 24 months" }, { "type": "secondary", "measure": "Symptoms of long-COVID", "description": "a dichotomous variable for presence of any of the three most important long-COVID symptoms: (i) fatigue, (ii) dyspnea and (iii) cognitive symptoms (defined as memory and/or concentration problems).", "time_frame": "Change in symptoms from baseline to 3, 6 and 12 months follow-up" } ], "outcome_measures": [ { "type": "primary", "measure": "Symptoms of long-COVID", "description": "a dichotomous variable for presence of any of the three most important long-COVID symptoms: (i) fatigue, (ii) dyspnea and (iii) cognitive symptoms (defined as memory and/or concentration problems).", "time_frame": "Change in symptoms from baseline to 3, 6 and 12 months follow-up" }, { "type": "secondary", "measure": "Symptoms individually and grouped by organ system", "description": "All individual symptoms separately, and grouped by systems (systemic symptoms, chest-symptoms, cognitive, other neuropsychiatric symptoms).", "time_frame": "Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up" }, { "type": "secondary", "measure": "Graded responses for symptoms and symptom constellations", "description": "Graded responses for separate symptoms and symptom constellations, including an ordinal variable graded 0-3 for the presence of the 3 symptoms in the primary outcome.", "time_frame": "Change in symptoms from baseline to 3, 6, 12 and 24 months follow-up" }, { "type": "secondary", "measure": "Risk factors for long-COVID", "description": "Analysis of patient characteristics and other factors that may affect the occurrence of long-COVID", "time_frame": "Up to 24 months" }, { "type": "secondary", "measure": "Severity of acute disease", "description": "Severity of acute disease using an 8-step scale (1 - no limitation of activities, 2 - limitations of activities, not hospitalised, 3 - hospitalised not requiring specific treatment, 4 - hospitalised, requiring medical treatment, but not supplemental oxygen, 5 - need of supplemental oxygen, 6 - need of non-invasive ventilatory support (CPAP, BiPAP), 7 - need ov invasive ventilation, 8 - death", "time_frame": "28 days" }, { "type": "secondary", "measure": "Hospitalisation", "description": "Hospitalisation - binary outcome", "time_frame": "28 days" }, { "type": "secondary", "measure": "Severe adverse events", "description": "Severe adverse events", "time_frame": "Up to 24 months" }, { "type": "secondary", "measure": "Absence from work", "description": "Absence from work, full or partial sick leave", "time_frame": "Up to 24 months" }, { "type": "secondary", "measure": "Societal costs", "description": "Societal cost / economic analysis, including estimated cost of absence from work/school, hospitalizations, deaths, QALYs lost according to EQ-5D-5L, and more", "time_frame": "Up to 24 months" }, { "type": "secondary", "measure": "Symptoms of long-COVID", "description": "a dichotomous variable for presence of any of the three most important long-COVID symptoms: (i) fatigue, (ii) dyspnea and (iii) cognitive symptoms (defined as memory and/or concentration problems).", "time_frame": "Change in symptoms from baseline to 3, 6 and 12 months follow-up" } ], "relevance_tags": [ "Persistence / Antiviral", "Phase 3", "Very Large (1000+ participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 2000, "enrollment_type": "ESTIMATED", "size_category": "Very Large (1000+ participants)", "link": "https://clinicaltrials.gov/study/NCT05852873", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06404047", "title": "RECOVER-ENERGIZE Platform Protocol", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-11-14", "start_date": "2024-07-17", "completion_date": "2025-10-30", "primary_completion_date": "2025-10-30", "conditions_raw": [ "Long COVID", "Long Covid19", "Long Covid-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Personalized Cardiopulmonary Rehabilitation", "Structured Pacing" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes.\n\nThis protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).\n\nThe focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.", "primary_outcomes": [ { "type": "primary", "measure": "Total number of participants enrolled in each Appendix", "description": "Total number of participants enrolled in each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT#", "time_frame": "6 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Total number of participants enrolled in each Appendix", "description": "Total number of participants enrolled in each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT#", "time_frame": "6 months" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 660, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06404047", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05931497", "title": "Sauna for Long Covid", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-11-13", "start_date": "2026-08-01", "completion_date": "2026-12-01", "primary_completion_date": "2026-09-30", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Whole Body Hyperthermia" ], "sponsor": "Massachusetts General Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Research suggests that Whole Body Hyperthermia in a sauna-like environment can reduce symptoms related to post-acute sequelae of SARS-CoV-2 (PASC), or Long Covid. The investigators aim to study the feasibility and treatment effect of this procedure for patients experiencing Long Covid symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF)", "description": "provides a more in depth assessment of fatigue as compared to the PROMIS 29 and consists of 7 items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week. Uses a range of 7-35, higher scores indicate higher fatigue.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS-29)", "description": "assesses seven health domains (i.e., physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. There is no total score, and scores range from 4-10 for each health domain (with 4 items for each of the 7 health domains). Scores are transformed into t scores with higher scores indicating better health.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ)", "description": "a well-established, brief self-administered 9-item depression screening and monitoring tool. Uses a range of 0-27 with higher scores indicating greater depressive symptoms.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "The Perceived Stress Scale (PSS)", "description": "consists of 10 items and measures the frequency with which perceived stressful life situations are experienced. Scores can range from 0 to 40 with higher scores indicating higher perceived stress.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System Cognitive Abilities", "description": "items target positive self-assessments of cognitive functioning with a total of 8 items. Raw scores can range from 8 to 40. The raw score is then converted to a t-score and higher scores indicate better perceived cognitive functioning.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System Cognitive Concerns", "description": "items are worded negatively and express concerns in the same areas as in the Patient-Reported Outcomes Measurement Information System Cognitive Abilities with a total of 8 items. Raw scores can range from 8 to 40. The raw score is then converted to a t-score and higher scores indicate greater cognitive concerns.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Positive and Negative Affective Schedule (PANAS)", "description": "consists of two 10-item mood scales to measure positive and negative affect. Raw scores range from 10 to 50. Higher scores indicate more of a positive affect.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "The Composite Autonomic Symptom Score (COMPASS-31)", "description": "consists of 31 items and measures autonomic and neurodegenerative system symptoms. Total scores range from 0 to 100 with greater scores indicating greater autonomic dysfunction.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)", "description": "13-item questionnaire designed to assess the severity of fatigue and its impact on daily functioning and quality of life. Respondents rate items on a 5-point scale, with higher scores indicating less fatigue. Total scores can range between 0 and 52.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Long-COVID Symptom Tool (Long-COVID ST)", "description": "assess the symptoms of long COVID-19 created from patients' lived experience that measures 10 different physiological domains. Scores can range from 0 to 53 with higher scores indicating greater severity of symptoms.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Long-COVID Impact Tool (Long-COVID IT)", "description": "assess the symptoms of long COVID-19 created from patients' lived experience that measures 10 different physiological domains. The scale also measures the impact from these symptoms. Scores can range from 0 to 60 with higher scores indicating greater life impact.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "The Patient Reported Outcome Measurement Information System Fatigue-Short Form v1.0 -Fatigue 7a (PROMIS F-SF)", "description": "provides a more in depth assessment of fatigue as compared to the PROMIS 29 and consists of 7 items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week. Uses a range of 7-35, higher scores indicate higher fatigue.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS-29)", "description": "assesses seven health domains (i.e., physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. There is no total score, and scores range from 4-10 for each health domain (with 4 items for each of the 7 health domains). Scores are transformed into t scores with higher scores indicating better health.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ)", "description": "a well-established, brief self-administered 9-item depression screening and monitoring tool. Uses a range of 0-27 with higher scores indicating greater depressive symptoms.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "The Perceived Stress Scale (PSS)", "description": "consists of 10 items and measures the frequency with which perceived stressful life situations are experienced. Scores can range from 0 to 40 with higher scores indicating higher perceived stress.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System Cognitive Abilities", "description": "items target positive self-assessments of cognitive functioning with a total of 8 items. Raw scores can range from 8 to 40. The raw score is then converted to a t-score and higher scores indicate better perceived cognitive functioning.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System Cognitive Concerns", "description": "items are worded negatively and express concerns in the same areas as in the Patient-Reported Outcomes Measurement Information System Cognitive Abilities with a total of 8 items. Raw scores can range from 8 to 40. The raw score is then converted to a t-score and higher scores indicate greater cognitive concerns.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Positive and Negative Affective Schedule (PANAS)", "description": "consists of two 10-item mood scales to measure positive and negative affect. Raw scores range from 10 to 50. Higher scores indicate more of a positive affect.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "The Composite Autonomic Symptom Score (COMPASS-31)", "description": "consists of 31 items and measures autonomic and neurodegenerative system symptoms. Total scores range from 0 to 100 with greater scores indicating greater autonomic dysfunction.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)", "description": "13-item questionnaire designed to assess the severity of fatigue and its impact on daily functioning and quality of life. Respondents rate items on a 5-point scale, with higher scores indicating less fatigue. Total scores can range between 0 and 52.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Long-COVID Symptom Tool (Long-COVID ST)", "description": "assess the symptoms of long COVID-19 created from patients' lived experience that measures 10 different physiological domains. Scores can range from 0 to 53 with higher scores indicating greater severity of symptoms.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" }, { "type": "secondary", "measure": "Long-COVID Impact Tool (Long-COVID IT)", "description": "assess the symptoms of long COVID-19 created from patients' lived experience that measures 10 different physiological domains. The scale also measures the impact from these symptoms. Scores can range from 0 to 60 with higher scores indicating greater life impact.", "time_frame": "2-weeks (primary endpoint) follow up at 6 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 21, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05931497", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06253806", "title": "Stellate Ganglion Block for COVID-induced Parosmia", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2025-11-10", "start_date": "2023-10-25", "completion_date": "2024-09-16", "primary_completion_date": "2024-09-16", "conditions_raw": [ "COVID-19-Induced Parosmia" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Stellate Ganglion Block" ], "sponsor": "Washington University School of Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic olfactory dysfunction, both hyposmia and parosmia, from the COVID-19 pandemic is a growing public health crisis with up to 1.2 million people in the United States affected. Olfactory dysfunction impacts one's quality of life significantly by decreasing the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to perform certain jobs. Olfactory loss is also an independent predictor of anxiety, depression, and even mortality. Recent research by our group (unpublished data) and suggests that parosmias, moreso than hyposmias, can result in increased rates of anxiety, depression, and even suicidal ideation. While the pandemic has increased the interest by the scientific community in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Persistent symptoms after an acute COVID-19 infection, or \"Long COVID\" symptoms, have been hypothesized to be a result of sympathetic positive feedback loops and dysautonomia. Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous system. Studies prior to the COVID-19 pandemic have supported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, and recent news reports and a published case series have described a dramatic benefit in both olfactory function and other long COVID symptoms in patients receiving stellate ganglion blocks. A previous pilot study using stellate ganglion blocks of 20 participants with persistent COVID-19 olfactory dysfunction resulted modest improvements in subjective olfactory function, smell identification, and olfactory-specific quality-of-life, but it lacked a control group. Therefore, we propose a double-blinded, placebo-controlled randomized clinical trial assessing the efficacy of a stellate ganglion block versus saline injection in a total of up to 140 participants with persistent COVID-19-associated olfactory dysfunction.", "primary_outcomes": [ { "type": "primary", "measure": "Parosmia Olfactory Dysfunction Outcomes Rating", "description": "The primary outcome of the study is to determine the efficacy of a stellate ganglion block (SGB) in improving parosmia-related quality of life compared to a saline injection placebo.\n\nThe instrument contains 28 total items with each scored on a 5-point Likert scale from 0 (no difficulty) to 4 (complete difficulty or very frequent bother).\n\nHigher total scores indicate a greater degree of dysfunction and limitation. The minimal clinically important difference (MCID) for DisODOR being 15 points.", "time_frame": "1-mo outcome and 3-mo outcome" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Clinical Global Impression - Severity Scale (CGI-S) Smell Loss", "description": "The Clinical Global Impression - Improvement Scale (CGI-I) for smell loss (parosmia) is used to measure the overall response to treatment by assessing changes in the clinical condition compared to before the stellate ganglion block. It uses a 7-point Likert scale with the following response options: (1) Much better now than before, (2) Moderately better now than before, (3) Slightly better now than before, (4) About the same, (5) Slightly worse now than before, (6) Moderately worse now than before, and (7) Much worse now than before. Participants who report \"slightly better now than before\" or greater improvement are classified as responders.", "time_frame": "1-mo and 3-mo" }, { "type": "secondary", "measure": "Long-COVID Questionnaire", "description": "At each follow-up visit, participants are asked to rank their overall improvement in each of the 11 symptoms compared to their symptoms prior to their first SGB. The improvement options are based on the CGI-I 7-point Likert scale.\n\nTotal scores range from 0-77, with higher scores being worse and lower scores being better.", "time_frame": "1 month, 3 months" }, { "type": "secondary", "measure": "Olfaction Catastrophizing Scale (OCS)", "description": "Participants will be asked to complete the OCS, which measures the negative mental response to smell dysfunction loss. Multiple thoughts/feelings will be assessed on a 5-point Likert scale with a maximum score of 52.\n\nParticipants will complete the OCS at each study visit to assess the degree of olfactory-related catastrophizing over time.", "time_frame": "1 month, 3 months" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "Participants will be asked to complete the HADS, which screens for both anxiety and depression in the general population. It consists of 7 questions for anxiety and 7 questions for depression each ranked on a 4-point Likert Scale. A score of 0-7 is considered normal, 8-10 is borderline abnormal anxiety or depression, and a score of 11-21 corresponds with screening positive for anxiety or depression.", "time_frame": "1 month, 3 months" }, { "type": "secondary", "measure": "Patient Satisfaction With Treatment", "description": "Participants will be asked at 1 month \"Overall, how satisfied were you with the stellate ganglion block treatment for your parosmia?\" with possible answer choices: 1) Completely dissatisfied, 2) Mostly dissatisfied, 3) Somewhat dissatisfied, 4) Neither satisfied or dissatisfied, 5) Somewhat satisfied, 6) Mostly satisfied, 7) Completely satisfied.", "time_frame": "1 mo, 3-mo" }, { "type": "secondary", "measure": "Assessment of the Blind", "description": "Immediately after the injection, participants will be asked \"Which intervention do you think you received?\" with answer choices of 1) Mepivacaine (active medication) or 2) Saline (placebo).\n\nIt is performed immediately after the initial injection during the first visit, just prior to discharge.", "time_frame": "during first visit" } ], "outcome_measures": [ { "type": "primary", "measure": "Parosmia Olfactory Dysfunction Outcomes Rating", "description": "The primary outcome of the study is to determine the efficacy of a stellate ganglion block (SGB) in improving parosmia-related quality of life compared to a saline injection placebo.\n\nThe instrument contains 28 total items with each scored on a 5-point Likert scale from 0 (no difficulty) to 4 (complete difficulty or very frequent bother).\n\nHigher total scores indicate a greater degree of dysfunction and limitation. The minimal clinically important difference (MCID) for DisODOR being 15 points.", "time_frame": "1-mo outcome and 3-mo outcome" }, { "type": "secondary", "measure": "Clinical Global Impression - Severity Scale (CGI-S) Smell Loss", "description": "The Clinical Global Impression - Improvement Scale (CGI-I) for smell loss (parosmia) is used to measure the overall response to treatment by assessing changes in the clinical condition compared to before the stellate ganglion block. It uses a 7-point Likert scale with the following response options: (1) Much better now than before, (2) Moderately better now than before, (3) Slightly better now than before, (4) About the same, (5) Slightly worse now than before, (6) Moderately worse now than before, and (7) Much worse now than before. Participants who report \"slightly better now than before\" or greater improvement are classified as responders.", "time_frame": "1-mo and 3-mo" }, { "type": "secondary", "measure": "Long-COVID Questionnaire", "description": "At each follow-up visit, participants are asked to rank their overall improvement in each of the 11 symptoms compared to their symptoms prior to their first SGB. The improvement options are based on the CGI-I 7-point Likert scale.\n\nTotal scores range from 0-77, with higher scores being worse and lower scores being better.", "time_frame": "1 month, 3 months" }, { "type": "secondary", "measure": "Olfaction Catastrophizing Scale (OCS)", "description": "Participants will be asked to complete the OCS, which measures the negative mental response to smell dysfunction loss. Multiple thoughts/feelings will be assessed on a 5-point Likert scale with a maximum score of 52.\n\nParticipants will complete the OCS at each study visit to assess the degree of olfactory-related catastrophizing over time.", "time_frame": "1 month, 3 months" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "Participants will be asked to complete the HADS, which screens for both anxiety and depression in the general population. It consists of 7 questions for anxiety and 7 questions for depression each ranked on a 4-point Likert Scale. A score of 0-7 is considered normal, 8-10 is borderline abnormal anxiety or depression, and a score of 11-21 corresponds with screening positive for anxiety or depression.", "time_frame": "1 month, 3 months" }, { "type": "secondary", "measure": "Patient Satisfaction With Treatment", "description": "Participants will be asked at 1 month \"Overall, how satisfied were you with the stellate ganglion block treatment for your parosmia?\" with possible answer choices: 1) Completely dissatisfied, 2) Mostly dissatisfied, 3) Somewhat dissatisfied, 4) Neither satisfied or dissatisfied, 5) Somewhat satisfied, 6) Mostly satisfied, 7) Completely satisfied.", "time_frame": "1 mo, 3-mo" }, { "type": "secondary", "measure": "Assessment of the Blind", "description": "Immediately after the injection, participants will be asked \"Which intervention do you think you received?\" with answer choices of 1) Mepivacaine (active medication) or 2) Saline (placebo).\n\nIt is performed immediately after the initial injection during the first visit, just prior to discharge.", "time_frame": "during first visit" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 48, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06253806", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05877508", "title": "Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19)", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2025-10-28", "start_date": "2023-08-01", "completion_date": "2026-07-31", "primary_completion_date": "2024-07-29", "conditions_raw": [ "Long COVID", "Post-Acute Sequela of COVID-19", "Post-Acute COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Aer002" ], "sponsor": "Michael Peluso, MD", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be able to be targeted by SARS-CoV-2 monoclonal antibodies (mAbs). This trial will study the safety and efficacy of AER002 to treat individuals with Long COVID in an adult population.", "primary_outcomes": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 90 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.", "time_frame": "Day 90" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 30 and Day 180 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.", "time_frame": "Day 30 and Day 180" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 90 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 30 and Day 180 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.", "time_frame": "Day 30 and Day 180" }, { "type": "secondary", "measure": "Quality of Life (Global Health Score) 100-point Visual-Analogue Scale", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in the baseline adjusted mean Quality of Life 100-point Visual-Analogue-Scale at Day 90 post-infusion. 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score at Day 90 post-infusion. 5-Item EuroQol EQ-5D-5L questions assess pain/difficulty in day-to-day activities over the past week. The 5-Item EuroQol EQ-5D-5L produces a score that typically ranges from 0 - 1, with a higher score indicating better quality of life.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Duke Activity Status Index (DASI)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean DASI at Day 90 post-infusion. The Duke Activity Status Index is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points, which is linearly correlated with a patient's VO2 max and METs, as measured from cardiopulmonary exercise testing (CPET). It inquires about a person's ability to perform self-care, walk, climb stairs, run, do house and yard work, engage in sexual intercourse, and perform moderate recreational activities. A higher score indicates higher functional capacity.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Composite Autonomic Symptom Score-31 (COMPASS-31)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean COMPASS-31 score at Day 90 post-infusion. COMPASS-31 asks 31 questions related to autonomic dysfunction. The answer to each question generates a numeric score for the question, which is then summed at the end of the questionnaire. A total score out of 100 is generated summarizing orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, urinary, pupillomotor, temperature intolerance, and sexual impairment. The total score ranges from 0 to 100 and a higher score indicates more severe autonomic dysfunction.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean WHO-DAS 2.0 score at Day 90 post-infusion. The World Health Organization Disability Assessment Schedule 2.0 questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. The range is scored from 0-48, with a higher score indicating a higher level of disability.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC) Scale", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the Patient Global Impression of Change (PGIC) scale at Day 90 post-infusion. The self-reported PGIC reflects a patient's belief about the efficacy of treatment. We used a modified PGIC scale which has been used to study pain syndromes and has been employed in other Long COVID clinical trials. It is a common data element developed by the National Institutes of Mental Health. The PGIC ranges from 0 (Much better) to 10 (Much Worse). A score of 5 indicates no change.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Everyday Cognition Form (ECog-39)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean ECog-39 score at Day 90 post-infusion. The ECog-39 is an instrument that measures the decline in everyday cognitive and functional abilities that map to six cognitive domains, adapted specifically to describe change in abilities since having COVID. A summary ECog-39 score is calculated scored with a range of 1-4, with a higher score indicating greater cognitive impairment.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "6 Minute Walking Test (6MWT)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean distance walked on the 6MWT at Day 90 post-infusion. The 6MWT requires an individual to walk at their normal pace for 6 minutes on a marked track (for example, a hallway). Vital signs are assessed, and the total distance covered is the primary outcome of interest.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Active Stand Test", "description": "The active standing test is a non-invasive tool to assess orthostatic hypotension (OH) and postural orthostatic tachycardia syndrome (POTS). In short, blood pressure and heart rate measurements were obtained after 5 minutes of resting supine and 1, 3, 5, and 10 minutes of continuous standing. Abnormal active standing test results were defined as those with a decline of \\>20 mmHg in systolic or \\> 10 mmHg in diastolic blood pressure in at least two consecutive measurements, or those with an increase in heart rate \\> 30 bpm on two consecutive measurements.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Neurocognition Index (NCI) Standard Score From the CNS-VS", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean NCI standard score from the CNS-VS at Day 90 post-infusion. The CNS Vital Signs is a a computer-based neurocognitive assessment comprised of seven tests: verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention and the continuous performance test. The battery gives a summary neurocognition index (NCI) score averaging five domain scores (Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility) and representing a global score of neurocognition. NCI scores are normalized scores (mean 100, standard deviation 15) that are age matched relative to other people in a normative sample. A higher score indicates better cognitive function.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "C-Reactive Protein (CRP)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean CRP concentration (mg/L) at Day 90 post-infusion.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Erythrocyte Sedimentation Rate (ESR)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean ESR at Day 90 post-infusion.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "D-Dimer", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean D-Dimer at Day 90 post-infusion.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Fibrinogen", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean fibrinogen concentration (mg/dL) at Day 90 post-infusion.", "time_frame": "Day 90" } ], "outcome_measures": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 90 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 30 and Day 180 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.", "time_frame": "Day 30 and Day 180" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 90 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Mental Health Summary Score at Day 30 and Day 180 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse mental health.", "time_frame": "Day 30 and Day 180" }, { "type": "secondary", "measure": "Quality of Life (Global Health Score) 100-point Visual-Analogue Scale", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in the baseline adjusted mean Quality of Life 100-point Visual-Analogue-Scale at Day 90 post-infusion. 0 represents the worst health a person can imagine and 100 represents the best health a person can imagine.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score at Day 90 post-infusion. 5-Item EuroQol EQ-5D-5L questions assess pain/difficulty in day-to-day activities over the past week. The 5-Item EuroQol EQ-5D-5L produces a score that typically ranges from 0 - 1, with a higher score indicating better quality of life.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Duke Activity Status Index (DASI)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean DASI at Day 90 post-infusion. The Duke Activity Status Index is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points, which is linearly correlated with a patient's VO2 max and METs, as measured from cardiopulmonary exercise testing (CPET). It inquires about a person's ability to perform self-care, walk, climb stairs, run, do house and yard work, engage in sexual intercourse, and perform moderate recreational activities. A higher score indicates higher functional capacity.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Composite Autonomic Symptom Score-31 (COMPASS-31)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean COMPASS-31 score at Day 90 post-infusion. COMPASS-31 asks 31 questions related to autonomic dysfunction. The answer to each question generates a numeric score for the question, which is then summed at the end of the questionnaire. A total score out of 100 is generated summarizing orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, urinary, pupillomotor, temperature intolerance, and sexual impairment. The total score ranges from 0 to 100 and a higher score indicates more severe autonomic dysfunction.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean WHO-DAS 2.0 score at Day 90 post-infusion. The World Health Organization Disability Assessment Schedule 2.0 questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. The range is scored from 0-48, with a higher score indicating a higher level of disability.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC) Scale", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo on the Patient Global Impression of Change (PGIC) scale at Day 90 post-infusion. The self-reported PGIC reflects a patient's belief about the efficacy of treatment. We used a modified PGIC scale which has been used to study pain syndromes and has been employed in other Long COVID clinical trials. It is a common data element developed by the National Institutes of Mental Health. The PGIC ranges from 0 (Much better) to 10 (Much Worse). A score of 5 indicates no change.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Everyday Cognition Form (ECog-39)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean ECog-39 score at Day 90 post-infusion. The ECog-39 is an instrument that measures the decline in everyday cognitive and functional abilities that map to six cognitive domains, adapted specifically to describe change in abilities since having COVID. A summary ECog-39 score is calculated scored with a range of 1-4, with a higher score indicating greater cognitive impairment.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "6 Minute Walking Test (6MWT)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean distance walked on the 6MWT at Day 90 post-infusion. The 6MWT requires an individual to walk at their normal pace for 6 minutes on a marked track (for example, a hallway). Vital signs are assessed, and the total distance covered is the primary outcome of interest.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Active Stand Test", "description": "The active standing test is a non-invasive tool to assess orthostatic hypotension (OH) and postural orthostatic tachycardia syndrome (POTS). In short, blood pressure and heart rate measurements were obtained after 5 minutes of resting supine and 1, 3, 5, and 10 minutes of continuous standing. Abnormal active standing test results were defined as those with a decline of \\>20 mmHg in systolic or \\> 10 mmHg in diastolic blood pressure in at least two consecutive measurements, or those with an increase in heart rate \\> 30 bpm on two consecutive measurements.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Neurocognition Index (NCI) Standard Score From the CNS-VS", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean NCI standard score from the CNS-VS at Day 90 post-infusion. The CNS Vital Signs is a a computer-based neurocognitive assessment comprised of seven tests: verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention and the continuous performance test. The battery gives a summary neurocognition index (NCI) score averaging five domain scores (Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention, and Cognitive Flexibility) and representing a global score of neurocognition. NCI scores are normalized scores (mean 100, standard deviation 15) that are age matched relative to other people in a normative sample. A higher score indicates better cognitive function.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "C-Reactive Protein (CRP)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean CRP concentration (mg/L) at Day 90 post-infusion.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Erythrocyte Sedimentation Rate (ESR)", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean ESR at Day 90 post-infusion.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "D-Dimer", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean D-Dimer at Day 90 post-infusion.", "time_frame": "Day 90" }, { "type": "secondary", "measure": "Fibrinogen", "description": "This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean fibrinogen concentration (mg/dL) at Day 90 post-infusion.", "time_frame": "Day 90" } ], "relevance_tags": [ "Persistence / Antiviral", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 36, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05877508", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05918978", "title": "Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS", "status": "TERMINATED", "phase": "PHASE2", "last_updated": "2025-10-23", "start_date": "2023-06-20", "completion_date": "2024-08-15", "primary_completion_date": "2024-08-15", "conditions_raw": [ "Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Efgartigimod" ], "sponsor": "argenx", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic.", "primary_outcomes": [ { "type": "primary", "measure": "Number of Participants With TEAEs, TESAEs and TEAESIs", "description": "An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. An adverse event of special interest (AESI) was an AE of scientific and medical concern specific to the sponsor's product or program. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration.", "time_frame": "From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change From Baseline to Weeks 24 and 48 in the COMPASS 31 (2-week Recall Version)", "description": "Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Change From Baseline to Weeks 24 and 48 in the MaPS", "description": "The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a numerical rating scale ranging from 0 (no symptoms) to 10 (very pronounced symptoms). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Percentage of Participants With Improved PGI-S at Weeks 24 and 48", "description": "The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An \"improved PGI-S\" was defined by a change from baseline of -3, -2 and -1.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Percentage of Participants With Improved PGI-C at Weeks 24 and 48", "description": "The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of an overall change in their symptoms from start of study drug. It was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An \"improved PGI-C\" was defined by a change from baseline of 1, 2 and 3.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Change From Baseline to Weeks 24 and 48 in the PROMIS Fatigue Short Form 8a", "description": "The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Change From Baseline to Weeks 24 and 48 in the PROMIS Cognitive Function Short Form 6a", "description": "PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Percent Change From Baseline in Total IgG Levels at Weeks 24 and 48", "description": "Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Serum Concentration of Efgartigimod", "description": "Serum samples were collected at specified timepoints to determine the concentration of efgartigimod.", "time_frame": "Pre-dose at Baseline (Day 1) and Weeks 1, 4, 12 and 24" }, { "type": "secondary", "measure": "Number of Participants With ADAs Against Efgartigimod", "description": "Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline.", "time_frame": "From the first dose of study drug (Day 1) up to Week 48" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of Participants With TEAEs, TESAEs and TEAESIs", "description": "An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. An adverse event of special interest (AESI) was an AE of scientific and medical concern specific to the sponsor's product or program. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration.", "time_frame": "From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days" }, { "type": "secondary", "measure": "Change From Baseline to Weeks 24 and 48 in the COMPASS 31 (2-week Recall Version)", "description": "Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Change From Baseline to Weeks 24 and 48 in the MaPS", "description": "The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a numerical rating scale ranging from 0 (no symptoms) to 10 (very pronounced symptoms). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Percentage of Participants With Improved PGI-S at Weeks 24 and 48", "description": "The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An \"improved PGI-S\" was defined by a change from baseline of -3, -2 and -1.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Percentage of Participants With Improved PGI-C at Weeks 24 and 48", "description": "The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of an overall change in their symptoms from start of study drug. It was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An \"improved PGI-C\" was defined by a change from baseline of 1, 2 and 3.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Change From Baseline to Weeks 24 and 48 in the PROMIS Fatigue Short Form 8a", "description": "The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Change From Baseline to Weeks 24 and 48 in the PROMIS Cognitive Function Short Form 6a", "description": "PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Percent Change From Baseline in Total IgG Levels at Weeks 24 and 48", "description": "Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory.", "time_frame": "Baseline (Day 1) and Weeks 24 and 48" }, { "type": "secondary", "measure": "Serum Concentration of Efgartigimod", "description": "Serum samples were collected at specified timepoints to determine the concentration of efgartigimod.", "time_frame": "Pre-dose at Baseline (Day 1) and Weeks 1, 4, 12 and 24" }, { "type": "secondary", "measure": "Number of Participants With ADAs Against Efgartigimod", "description": "Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline.", "time_frame": "From the first dose of study drug (Day 1) up to Week 48" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 33, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05918978", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06366724", "title": "LIFT: Life Improvement Trial", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2025-10-22", "start_date": "2024-09-10", "completion_date": "2026-11", "primary_completion_date": "2026-09", "conditions_raw": [ "ME/CFS", "Long COVID", "PASC" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Pyridostigmine", "Low-Dose Naltrexone (LDN)" ], "sponsor": "Brigham and Women's Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-70 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance (OI). Long COVID (LC) subjects will also be included if they meet CCC and have OI.\n\nThis double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily.\n\nThe trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial.\n\nThe time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete.\n\nThe LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition.", "primary_outcomes": [ { "type": "primary", "measure": "Functional Capacity", "description": "Change in the total FUNCAP55 questionnaire score\n\nThe FUNCAP55 is a questionnaire developed to assess the functional capacity of patients. Each question is answered on a 6-point scale. The greater the score, the better the functioning.", "time_frame": "15 weeks" }, { "type": "primary", "measure": "Physiologic Response - Oxygen Uptake Efficiency Slope (OUES)", "description": "Changes in % of predicted oxygen uptake efficiency slope (OUES) between baseline and follow-up measured during a non-invasive cardiopulmonary exercise test (CPET)", "time_frame": "13 weeks" }, { "type": "primary", "measure": "Physiologic Response - Oxygen Utilization (VO2)", "description": "Changes in % of predicted extrapolated peak oxygen utilization (extrapolated max VO2) between baseline and follow-up measured during a submaximum CPET", "time_frame": "13 weeks" }, { "type": "primary", "measure": "Physiologic Response - Heart Rate Recovery (HRR)", "description": "Changes in 1-min heart rate recovery (HRR) in beats per minute (bpm) between baseline and follow-up measured during a submaximum CPET", "time_frame": "13 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "Change in DePaul Symptom Questionnaire-1 (DSQ1) score\n\nThe questionnaire lists 5 symptoms that are scored based on frequency and severity. Each question is answered on a 4-point scale. The greater the score, the greater the frequency and severity of the symptom.", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "PROMIS-29-Pain", "description": "Change in PROMIS-29 questionnaire score\n\nReflected as combination of the \"pain interference\" (0 to 5) and \"pain intensity\" (0 to 10) sections of the questionnaire will be secondary outcomes. The greater the score, the greater the pain experienced.", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Daily Activity", "description": "Change in daily steps (steps/day) measured using Garmin Vivosmart 5", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Heart Rate Variability", "description": "Change in heart rate variability (HRV) defined as the specific change in time (ms) between successive heart beats. All collected via Garmin VivoSmart5", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Blood Oxygen", "description": "Change in blood oxygen saturation (%) measured with Garmin VivoSmart 5", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Resting Heart Rate", "description": "Change in resting heart rate (bpm) using Garmin VivoSmart 5", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "DANA Brain Vital-Simple Reaction Time (SRT)", "description": "Change in time (ms) required to recognize the presence of an object and tap the object", "time_frame": "15 Weeks" }, { "type": "secondary", "measure": "DANA Brain Vital-Procedural Reaction Time (PRT)", "description": "Change in time (ms) required to recognize 1 of 4 numbers and tap 1 of 2 buttons", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "DANA Brain Vital-Memory Search (MS)", "description": "Change in time (ms) required to recognize letters that have previously been memorized", "time_frame": "15 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Functional Capacity", "description": "Change in the total FUNCAP55 questionnaire score\n\nThe FUNCAP55 is a questionnaire developed to assess the functional capacity of patients. Each question is answered on a 6-point scale. The greater the score, the better the functioning.", "time_frame": "15 weeks" }, { "type": "primary", "measure": "Physiologic Response - Oxygen Uptake Efficiency Slope (OUES)", "description": "Changes in % of predicted oxygen uptake efficiency slope (OUES) between baseline and follow-up measured during a non-invasive cardiopulmonary exercise test (CPET)", "time_frame": "13 weeks" }, { "type": "primary", "measure": "Physiologic Response - Oxygen Utilization (VO2)", "description": "Changes in % of predicted extrapolated peak oxygen utilization (extrapolated max VO2) between baseline and follow-up measured during a submaximum CPET", "time_frame": "13 weeks" }, { "type": "primary", "measure": "Physiologic Response - Heart Rate Recovery (HRR)", "description": "Changes in 1-min heart rate recovery (HRR) in beats per minute (bpm) between baseline and follow-up measured during a submaximum CPET", "time_frame": "13 weeks" }, { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "Change in DePaul Symptom Questionnaire-1 (DSQ1) score\n\nThe questionnaire lists 5 symptoms that are scored based on frequency and severity. Each question is answered on a 4-point scale. The greater the score, the greater the frequency and severity of the symptom.", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "PROMIS-29-Pain", "description": "Change in PROMIS-29 questionnaire score\n\nReflected as combination of the \"pain interference\" (0 to 5) and \"pain intensity\" (0 to 10) sections of the questionnaire will be secondary outcomes. The greater the score, the greater the pain experienced.", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Daily Activity", "description": "Change in daily steps (steps/day) measured using Garmin Vivosmart 5", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Heart Rate Variability", "description": "Change in heart rate variability (HRV) defined as the specific change in time (ms) between successive heart beats. All collected via Garmin VivoSmart5", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Blood Oxygen", "description": "Change in blood oxygen saturation (%) measured with Garmin VivoSmart 5", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Resting Heart Rate", "description": "Change in resting heart rate (bpm) using Garmin VivoSmart 5", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "DANA Brain Vital-Simple Reaction Time (SRT)", "description": "Change in time (ms) required to recognize the presence of an object and tap the object", "time_frame": "15 Weeks" }, { "type": "secondary", "measure": "DANA Brain Vital-Procedural Reaction Time (PRT)", "description": "Change in time (ms) required to recognize 1 of 4 numbers and tap 1 of 2 buttons", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "DANA Brain Vital-Memory Search (MS)", "description": "Change in time (ms) required to recognize letters that have previously been memorized", "time_frame": "15 weeks" } ], "relevance_tags": [ "Immunomodulatory", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 160, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06366724", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06840873", "title": "Tele-Rehabilitative Exercise Training Program in Nurses With Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-10-07", "start_date": "2023-11-02", "completion_date": "2024-11-01", "primary_completion_date": "2024-06-30", "conditions_raw": [ "Cardiorespiratory Fitness", "Exercise", "Long COVID", "Nurses", "Quality of Life (QOL)", "Fatigue", "Stress", "Tele-rehabilitation" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Wearable Device", "Healthy Consulation" ], "sponsor": "Shang-Lin Chiang", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID can cause a decline in cardiorespiratory fitness, resulting in fatigue and negative impacts on individuals' quality of life (QoL), particularly in nurses who play a crucial role in public health. Combining with reduced cardiorespiratory fitness and suffering from a spectrum of long-COVID symptoms might substantially exaggertate fatigue, perceived stress, and reduce willingness to work for hospital nurses. Therefore, this study aimed to evaluate the effectiveness of tele-rehabilitative exercise on fatigue, perceived stress, symptom severity of long COVID, and QoL in this population.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue (score)", "description": "The Chinese version of the Fatigue Severity Scale (CFSS) (Wang et al., 2016) assesses the severity of fatigue in the participants. The scale is a self-administered questionnaire. The scale evaluates the severity of fatigue symptoms and their impact on daily activities over the past two weeks. It consists of 9 items, rated on a 7-point scale, with scores ranging from 1 to 7, where 1 indicates strong disagreement and 7 indicates strong agreement. The minimum score is 9, and the maximum score is 63. Higher scores indicate more severe fatigue, with a total score of 36 (inclusive) or higher indicating severe fatigue.", "time_frame": "10 minutes" }, { "type": "primary", "measure": "O2 pulse in ml/beat", "description": "It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Aerobic capacity (VO2 max in ml/kg/min )", "description": "Maximal VO2 during testing, also means aerobic capacity", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Working load in watt", "description": "Maximal Working load during testing", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Heart rate recovery in beat/min", "description": "Heart rate recovery is measured by recording your heart rate immediately after stopping exercise, and then at intervals (e.g., 1 minute and 2 minutes) after the exercise ends, which reflects autonomic nervous system function.", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Anaerobic threshold (AT in ml/kg/min)", "description": "The point during exercise at which lactate (a byproduct of anaerobic metabolism) starts to accumulate in the blood faster than it can be removed. This indicates a shift from primarily aerobic energy production to more anaerobic energy production.", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Severity of long COVID symptoms (scores)", "description": "This study uses the Chinese version of the Post-COVID-19 Functional Status Scale (PCFS) translated by Liao and Cheng (2023), which was originally developed by Frederikus A. Klok. It assesses changes in daily living, work and study activities, social activities, and overall functional status over the past week (Klok et al., 2020). The scale consists of two parts: the functional status scale and the symptom checklist. The first part, the functional status scale, is divided into five levels from 0 to 4. The second part, the post-infection symptom checklist, checks for specific symptoms that appear after COVID-19 infection. It is divided into five levels. This checklist evaluates respiratory, cardiovascular, gastrointestinal, neurological, psychological, and musculoskeletal symptoms.", "time_frame": "10 minutes" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Quality of life (scores)", "description": "The indicator of quality of life in this study will use Taiwan Concise Version of the World Health Organization Quality of Life Questionnaire (WHOQOL) to evaluate. The Taiwan version development team led by Yao Kaiping developed a brief version of the questionnaire (WHOQOL-BREF) based on WHOQOL-100. The questionnaire includes 1 question measuring the overall quality of life, 1 question measuring general health, and 7 questions measuring the physical domain. , 6 questions measure the psychological domain (psychological domain), 3 questions measure the social relationship domain (social relationships domain), and 8 questions measure the environment domain (environment domain), and add 1 local question to the social relationship and environment domains, totaling 28 questions. The item is a 5-point scale, with higher scores indicating a higher quality of life. The total score ranges from 25 to 140.", "time_frame": "baseline, 4, and 8 weeks" }, { "type": "secondary", "measure": "Perceived stress (scores)", "description": "The Chinese version of the Perceived Stress Scale (PSS) measures the perception of stress (Chiu, 2012). The original scale was developed by Cohen et al. (Cohen et al., 1983). The Chinese version has shown good reliability and validity in a study of nurses in Taiwan, with a Cronbach's alpha of 0.73. The scale is a self-administered questionnaire that measures the level of perceived stress in the past month. It consists of 14 items, all rated using a Likert scale with five response options: \"Never,\" \"Occasionally,\" \"Sometimes,\" \"Often,\" and \"Always\" (0-4 points). Seven of the items (4, 5, 6, 7, 9, 10, 13) are positive questions that need to be reverse-scored. The total score ranges from 0 to 56, with higher scores indicating higher perceived stress. A score of 0-28 is considered within the normal stress range, 29-37 indicates high stress, and 38-56 suggests the need to seek external support.", "time_frame": "baseline, 4, and 8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue (score)", "description": "The Chinese version of the Fatigue Severity Scale (CFSS) (Wang et al., 2016) assesses the severity of fatigue in the participants. The scale is a self-administered questionnaire. The scale evaluates the severity of fatigue symptoms and their impact on daily activities over the past two weeks. It consists of 9 items, rated on a 7-point scale, with scores ranging from 1 to 7, where 1 indicates strong disagreement and 7 indicates strong agreement. The minimum score is 9, and the maximum score is 63. Higher scores indicate more severe fatigue, with a total score of 36 (inclusive) or higher indicating severe fatigue.", "time_frame": "10 minutes" }, { "type": "primary", "measure": "O2 pulse in ml/beat", "description": "It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Aerobic capacity (VO2 max in ml/kg/min )", "description": "Maximal VO2 during testing, also means aerobic capacity", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Working load in watt", "description": "Maximal Working load during testing", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Heart rate recovery in beat/min", "description": "Heart rate recovery is measured by recording your heart rate immediately after stopping exercise, and then at intervals (e.g., 1 minute and 2 minutes) after the exercise ends, which reflects autonomic nervous system function.", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Anaerobic threshold (AT in ml/kg/min)", "description": "The point during exercise at which lactate (a byproduct of anaerobic metabolism) starts to accumulate in the blood faster than it can be removed. This indicates a shift from primarily aerobic energy production to more anaerobic energy production.", "time_frame": "30 minutes" }, { "type": "primary", "measure": "Severity of long COVID symptoms (scores)", "description": "This study uses the Chinese version of the Post-COVID-19 Functional Status Scale (PCFS) translated by Liao and Cheng (2023), which was originally developed by Frederikus A. Klok. It assesses changes in daily living, work and study activities, social activities, and overall functional status over the past week (Klok et al., 2020). The scale consists of two parts: the functional status scale and the symptom checklist. The first part, the functional status scale, is divided into five levels from 0 to 4. The second part, the post-infection symptom checklist, checks for specific symptoms that appear after COVID-19 infection. It is divided into five levels. This checklist evaluates respiratory, cardiovascular, gastrointestinal, neurological, psychological, and musculoskeletal symptoms.", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Quality of life (scores)", "description": "The indicator of quality of life in this study will use Taiwan Concise Version of the World Health Organization Quality of Life Questionnaire (WHOQOL) to evaluate. The Taiwan version development team led by Yao Kaiping developed a brief version of the questionnaire (WHOQOL-BREF) based on WHOQOL-100. The questionnaire includes 1 question measuring the overall quality of life, 1 question measuring general health, and 7 questions measuring the physical domain. , 6 questions measure the psychological domain (psychological domain), 3 questions measure the social relationship domain (social relationships domain), and 8 questions measure the environment domain (environment domain), and add 1 local question to the social relationship and environment domains, totaling 28 questions. The item is a 5-point scale, with higher scores indicating a higher quality of life. The total score ranges from 25 to 140.", "time_frame": "baseline, 4, and 8 weeks" }, { "type": "secondary", "measure": "Perceived stress (scores)", "description": "The Chinese version of the Perceived Stress Scale (PSS) measures the perception of stress (Chiu, 2012). The original scale was developed by Cohen et al. (Cohen et al., 1983). The Chinese version has shown good reliability and validity in a study of nurses in Taiwan, with a Cronbach's alpha of 0.73. The scale is a self-administered questionnaire that measures the level of perceived stress in the past month. It consists of 14 items, all rated using a Likert scale with five response options: \"Never,\" \"Occasionally,\" \"Sometimes,\" \"Often,\" and \"Always\" (0-4 points). Seven of the items (4, 5, 6, 7, 9, 10, 13) are positive questions that need to be reverse-scored. The total score ranges from 0 to 56, with higher scores indicating higher perceived stress. A score of 0-28 is considered within the normal stress range, 29-37 indicates high stress, and 38-56 suggests the need to seek external support.", "time_frame": "baseline, 4, and 8 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 68, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06840873", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07184398", "title": "Use of a Cysteine-rich Whey Protein Isolate in Post COVID-19 Cognitive Impairment", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-09-24", "start_date": "2024-07-01", "completion_date": "2025-01-01", "primary_completion_date": "2024-09-30", "conditions_raw": [ "COVID-19 (SARS-CoV-2 Infection)" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Intervention With Consolidated Cysteine (Immunocal) 20 G Per Day", "Cognitive Rehabilitation Workshops" ], "sponsor": "Universidad Libre seccional Cali", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Abstract Background: Post-COVID-19 cognitive impairment (PCCI), characterized by deficits in attention, memory, and executive functioning, remains a major challenge among patients with long COVID. Oxidative stress is a key contributor to this condition. Cysteine-rich whey protein isolate (CRWPI), such as Immunocal®, enhances intracellular glutathione production and may offer neuroprotective benefits.\n\nObjective: To evaluate the efficacy of Immunocal® supplementation on cognitive function, particularly attention and memory, and functional performance in individuals with ICCP.\n\nMethods: A randomized, controlled, parallel-group trial was conducted in Cali, Colombia, with 120 adults recovering from COVID-19 with mild to moderate cognitive impairment. Participants were randomly assigned to three groups: (1) immune® supplementation (CRWPI) (20 g/day), (2) neuropsychological rehabilitation, or (3) no intervention (control), for 12 weeks. Cognitive outcomes were assessed using the Montreal Cognitive Assessment (MoCA) and the NEUROPSI attention and memory test. Physical endurance was measured using the 30-second foot test (STST). Clinical symptoms evaluated through a medical assessment form, before and after the intervention, were also taken into account. Results: Both the Immunocal® and neurorehabilitation groups showed statistically significant improvements in all attention subdomains and memory types compared to the control. Immunocal® produced greater gains in divided attention and working memory, suggesting a specific advantage in cognitive domains sensitive to oxidative stress. STST performance was also significantly improved in the Immunocal® group. No significant improvements were seen in the control group.\n\nConclusion: Immunocal® supplementation significantly improves cognitive performance, comparable to structured neurorehabilitation, in individuals with ICCP. It also shows potential to improve physical endurance, clinical symptoms, and reduce fatigue. These findings support the integration of Immunocal® as a non-pharmacological intervention for cognitive dysfunction related to long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Cognitive Function", "description": "Cognitive performance will be assessed using a standardized neuropsychological test battery evaluating memory, attention, and executive function. Scores will be compared from baseline to the end of the intervention period.", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Functional Capacity (Sit-to-Stand Test)", "description": "Functional capacity will be measured by the 30-second sit-to-stand test. The number of repetitions completed will be compared between baseline and study completion.", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Cognitive Function", "description": "Cognitive performance will be assessed using a standardized neuropsychological test battery evaluating memory, attention, and executive function. Scores will be compared from baseline to the end of the intervention period.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in Functional Capacity (Sit-to-Stand Test)", "description": "Functional capacity will be measured by the 30-second sit-to-stand test. The number of repetitions completed will be compared between baseline and study completion.", "time_frame": "12 weeks" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07184398", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07184385", "title": "A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition", "status": "NOT_YET_RECRUITING", "phase": "PHASE3", "last_updated": "2025-09-23", "start_date": "2026-03-31", "completion_date": "2027-09-30", "primary_completion_date": "2027-06-30", "conditions_raw": [ "Long COVID", "Post-COVID-19 Condition", "Post-COVID Syndrome", "Post-COVID Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Regenecyte" ], "sponsor": "StemCyte, Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "REGENECYTE (HPC, Cord Blood) for treatment in patients with post-COVID.", "primary_outcomes": [ { "type": "primary", "measure": "The change of efficacy", "description": "Change of efficacy evaluation", "time_frame": "Week" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Treatment-emergent adverse events (TEAEs)", "description": "Incidence of treatment-emergent adverse events (TEAEs)", "time_frame": "Week" } ], "outcome_measures": [ { "type": "primary", "measure": "The change of efficacy", "description": "Change of efficacy evaluation", "time_frame": "Week" }, { "type": "secondary", "measure": "Treatment-emergent adverse events (TEAEs)", "description": "Incidence of treatment-emergent adverse events (TEAEs)", "time_frame": "Week" } ], "relevance_tags": [ "General", "Phase 3", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07184385", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05398692", "title": "Long COVID-19 Rehabilitation & Recovery Research Program", "status": "TERMINATED", "phase": "NA", "last_updated": "2025-09-22", "start_date": "2022-02-02", "completion_date": "2023-12-31", "primary_completion_date": "2023-12-31", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "On Site Exercise Rehabilitation" ], "sponsor": "Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of the study is to assess the physiologic, immunologic, and mental health effects of an exercise and pulmonary rehabilitation program on patients with Long COVID-19 (LC).", "primary_outcomes": [ { "type": "primary", "measure": "Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program.", "description": "Cardopulmonary - Exercise Outcomes.", "time_frame": "10 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Short Form (SF-36)", "description": "Quality of Life - 36 Item Short Form Survey. 8 subdomains - Potential scores 0 to 100 (100 being best) in each domain.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "Change in a Fatigue Score - 9 questions -1 (strongly disagree) to 7 (strongly agree). Total score from 7 to 54. Lower numbers are better.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "General Anxiety Disorder Screener (GAD-7)", "description": "Change in Anxiety scores - 7 questions. 0-Not at all to 3 Nearly Every Day - Scores from 0-21. Lower numbers are better.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Pittsburg Sleep Quality Score (PSQI)", "description": "Change in Sleep Quality Index - Scores from 0 to 42. Lower scores are better. A score \\> 5 indicates poor sleep quality.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Modified Medical Research Council Dyspnea Scale (mMRC)", "description": "Score ranges from 0 to 4. Lower scores are better.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Modified DePaul Assessment for Post-Exertional Malaise (DSQ-PEM)", "description": "Questions 6-10 Specific to PEM. All questions are Yes/No, No is best.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "Change in Depression scores - 9 questions that are scored from 0-3. Total scores 0-27. Lower scores are better.", "time_frame": "10 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program.", "description": "Cardopulmonary - Exercise Outcomes.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Short Form (SF-36)", "description": "Quality of Life - 36 Item Short Form Survey. 8 subdomains - Potential scores 0 to 100 (100 being best) in each domain.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "Change in a Fatigue Score - 9 questions -1 (strongly disagree) to 7 (strongly agree). Total score from 7 to 54. Lower numbers are better.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "General Anxiety Disorder Screener (GAD-7)", "description": "Change in Anxiety scores - 7 questions. 0-Not at all to 3 Nearly Every Day - Scores from 0-21. Lower numbers are better.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Pittsburg Sleep Quality Score (PSQI)", "description": "Change in Sleep Quality Index - Scores from 0 to 42. Lower scores are better. A score \\> 5 indicates poor sleep quality.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Modified Medical Research Council Dyspnea Scale (mMRC)", "description": "Score ranges from 0 to 4. Lower scores are better.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Modified DePaul Assessment for Post-Exertional Malaise (DSQ-PEM)", "description": "Questions 6-10 Specific to PEM. All questions are Yes/No, No is best.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "Change in Depression scores - 9 questions that are scored from 0-3. Total scores 0-27. Lower scores are better.", "time_frame": "10 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 21, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05398692", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06928506", "title": "Effect of Hi-OxSR for the Treatment of Post COVID Condition", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-09-15", "start_date": "2025-08-01", "completion_date": "2028-12", "primary_completion_date": "2027-12", "conditions_raw": [ "Long COVID", "Post COVID-19 Condition", "Post Acute Sequelae of COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Hi-Oxsr Device", "Hi-Ox Device" ], "sponsor": "University Health Network, Toronto", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The RECLAIM study platform will be used to explore whether the use of the Hi-OxSR device improves the symptoms of post covid cognitive dysfunction. Carbon dioxide (CO2) has been proposed as a potential treatment for persistent immune activation as there is evidence that CO2 has antioxidant, anti-inflammatory, and anti-cytokine effects. We conducted a pilot study assessing the open label use of re-breathing CO2 (using Hi-OxSR) twice a day for 14 days, for the treatment of post-COVID cognitive dysfunction. Significant improvements were found in multiple cognitive assessments using TestMyBrain cognitive tests and brain fog (MSNQ) and fatigue scores. This phase 2 clinical trial seeks to build on current findings to determine the optimal effective dose of treatment (i.e. length of use, oxygen concentration, without or without CO2 rebreathing) and the safety of using Hi-OxSR in this patient population.", "primary_outcomes": [ { "type": "primary", "measure": "Simple reaction time (SRT) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test will take about 5 minutes to complete and will assess reaction time.", "time_frame": "Baseline/Start of intervention to two months" }, { "type": "primary", "measure": "Verbal paired associates (VPA) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test will take about 5 minutes to complete and will assess memory.", "time_frame": "Baseline/Start of intervention to two months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "All cognitive performance tasks (measured by the TESTMYBRAIN.org (TMB) neuropsychology toolkit", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test battery will take about 20 minutes to complete and will assess: verbal, episodic and working memory, attention, processing speed, basic psychomotor response speed, and cognitive control.", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Brain Fog Questionnaire", "description": "(Adapted from MSNQ) This is a self-administered 15-item questionnaire that assesses neurocognitive function. It takes approximately less than 5 minutes to complete", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Brief Fatigue Inventory", "description": "The self-administered Brief Fatigue Inventory is composed of 9 items evaluated on a 10-point scale, assessing severity of fatigue and impact of fatigue on daily life. It takes approximately 2-3 minutes to complete.", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Short Form (SF)-36", "description": "Mental health related quality of life, measured by the Mental Composite Score (MCS), and physical health-related quality of life, measured by the Physical Component Score (PCS) of the SF-36 (v.1)", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Safety, adverse events and serious adverse events", "description": "Safety of the Hi-OxSR device will be reported through Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period.", "time_frame": "Baseline/start of intervention to 6 months" }, { "type": "secondary", "measure": "Symptom Checklist", "description": "Symptom Checklist (adapted from the De Paul Symptom Questionnaire (DSQ2), the World Health Organization Global COVID-19 Clinical Platform's Post COVID-19 case report form (CRF) and the Symptom Burden Questionnaire for Long COVID): to track symptom trajectory.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "The DePaul Symptom Post-Exertional Malaise Short Form DSQ-PEM", "description": "The self-administered DSQ-PEM is comprised of two sections assessing post-exertional malaise (PEM): (i) frequency and severity of PEM (5 questions), (ii) consequences, symptoms and recovery (5 questions).", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Dyspnea", "description": "Assessed using the Borg Dyspnea scale. This short assessment tool assesses perceived shortness of breath on exertion using a 10 point scale as assessed by the patient.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Mental Health - General Anxiety Assessment Form (GAD-7)", "description": "The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. It is an easy-to-use, self-administered patient questionnaire that can be completed in minutes.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Mental Health - Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a validated, multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It incorporates Diagnostic and Statistical Manual IV (DSM-IV) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The PHQ-9 is brief and useful in clinical practice.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Mental Health -Post-traumatic Stress Disorder Checklist (PCL-5)", "description": "The PCL-5 is a validated, reliable, 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual 5 (DSM-5) symptoms of Post-Traumatic Stress Disorder (PTSD). It takes approximately 5-10 minutes to complete.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Reintegration to Normal Living Index (RNLI)", "description": "This short self-administered assessment tool will determine the degree to which participants reintegrate into normal social activities such as recreation, mobility in the community and interaction in family and other relationships. This tool has been validated in community living adults with mobility limitations.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Blood samples", "description": "Blood samples will be used in correlative studies using advanced multi-omic and machine learning methods to better understand our results so as to identify phenotypes that will benefit from specific therapies", "time_frame": "Baseline/start of intervention and 2 months" }, { "type": "secondary", "measure": "Fatigue Scale (adapted from the De Paul Symptom Questionnaire (DSQ2)", "description": "The Fatigue Scale was adapted from the De Paul Symptom Questionnaire (DSQ2)'s 38 questions assessing medical history of Myalgia encephalomyelitis/chronic fatigue syndrome (ME/CFS), comorbidities, medications, impact on quality of life and daily activities, etc.", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Simple reaction time (SRT) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test will take about 5 minutes to complete and will assess reaction time.", "time_frame": "Baseline/Start of intervention to two months" }, { "type": "primary", "measure": "Verbal paired associates (VPA) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test will take about 5 minutes to complete and will assess memory.", "time_frame": "Baseline/Start of intervention to two months" }, { "type": "secondary", "measure": "All cognitive performance tasks (measured by the TESTMYBRAIN.org (TMB) neuropsychology toolkit", "description": "TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test battery will take about 20 minutes to complete and will assess: verbal, episodic and working memory, attention, processing speed, basic psychomotor response speed, and cognitive control.", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Brain Fog Questionnaire", "description": "(Adapted from MSNQ) This is a self-administered 15-item questionnaire that assesses neurocognitive function. It takes approximately less than 5 minutes to complete", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Brief Fatigue Inventory", "description": "The self-administered Brief Fatigue Inventory is composed of 9 items evaluated on a 10-point scale, assessing severity of fatigue and impact of fatigue on daily life. It takes approximately 2-3 minutes to complete.", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Short Form (SF)-36", "description": "Mental health related quality of life, measured by the Mental Composite Score (MCS), and physical health-related quality of life, measured by the Physical Component Score (PCS) of the SF-36 (v.1)", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Safety, adverse events and serious adverse events", "description": "Safety of the Hi-OxSR device will be reported through Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period.", "time_frame": "Baseline/start of intervention to 6 months" }, { "type": "secondary", "measure": "Symptom Checklist", "description": "Symptom Checklist (adapted from the De Paul Symptom Questionnaire (DSQ2), the World Health Organization Global COVID-19 Clinical Platform's Post COVID-19 case report form (CRF) and the Symptom Burden Questionnaire for Long COVID): to track symptom trajectory.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "The DePaul Symptom Post-Exertional Malaise Short Form DSQ-PEM", "description": "The self-administered DSQ-PEM is comprised of two sections assessing post-exertional malaise (PEM): (i) frequency and severity of PEM (5 questions), (ii) consequences, symptoms and recovery (5 questions).", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" }, { "type": "secondary", "measure": "Dyspnea", "description": "Assessed using the Borg Dyspnea scale. This short assessment tool assesses perceived shortness of breath on exertion using a 10 point scale as assessed by the patient.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Mental Health - General Anxiety Assessment Form (GAD-7)", "description": "The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. It is an easy-to-use, self-administered patient questionnaire that can be completed in minutes.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Mental Health - Patient Health Questionnaire (PHQ-9)", "description": "The PHQ-9 is a validated, multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It incorporates Diagnostic and Statistical Manual IV (DSM-IV) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The PHQ-9 is brief and useful in clinical practice.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Mental Health -Post-traumatic Stress Disorder Checklist (PCL-5)", "description": "The PCL-5 is a validated, reliable, 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual 5 (DSM-5) symptoms of Post-Traumatic Stress Disorder (PTSD). It takes approximately 5-10 minutes to complete.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Reintegration to Normal Living Index (RNLI)", "description": "This short self-administered assessment tool will determine the degree to which participants reintegrate into normal social activities such as recreation, mobility in the community and interaction in family and other relationships. This tool has been validated in community living adults with mobility limitations.", "time_frame": "Baseline/start of intervention to 2 and 6 months" }, { "type": "secondary", "measure": "Blood samples", "description": "Blood samples will be used in correlative studies using advanced multi-omic and machine learning methods to better understand our results so as to identify phenotypes that will benefit from specific therapies", "time_frame": "Baseline/start of intervention and 2 months" }, { "type": "secondary", "measure": "Fatigue Scale (adapted from the De Paul Symptom Questionnaire (DSQ2)", "description": "The Fatigue Scale was adapted from the De Paul Symptom Questionnaire (DSQ2)'s 38 questions assessing medical history of Myalgia encephalomyelitis/chronic fatigue syndrome (ME/CFS), comorbidities, medications, impact on quality of life and daily activities, etc.", "time_frame": "Baseline/start of intervention to 2 weeks, 1, 2 and 6 months" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06928506", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07163130", "title": "Tragus Stimulation for POTS Treatment", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-09-09", "start_date": "2025-09-01", "completion_date": "2027-01-31", "primary_completion_date": "2026-12-31", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Transcutaneous Auricular Vagus Nerve Stimulation" ], "sponsor": "Aristotle University Of Thessaloniki", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural Tachycardia Syndrome (POTS) is a form of dysautonomia characterized by an abnormal cardiovascular response to orthostatic challenges. Individuals afflicted with POTS typically exhibit a heart rate increase of more than 30 beats per minute (bpm) within 10 minutes of assuming an upright posture from a supine or sitting position. This abnormal response is often accompanied by symptoms, such as orthostatic intolerance, dizziness, weakness, fatigue, and, in certain instances, syncope. Lately, there is revived interest in POTS, as it has been quite frequently reported as a manifestation of autonomic dysfunction among patients with long COVID. POTS primarily affects the younger demographic, particularly women, and its pathophysiology appears to be multifactorial, involving autonomic neuropathy, hyperadrenergic state, and inadequate blood volume regulation. Diagnostic criteria commonly include a sustained heart rate increase without significant orthostatic hypotension. The pathophysiological mechanisms of POTS are complex and not fully elucidated. Management strategies encompass lifestyle modifications, exercise programs, and pharmacotherapy, but their efficacy is modest.\n\nTranscutaneous auricular vagus nerve stimulation (tVNS) is an emerging therapeutic modality in cardiovascular diseases. tVNS has been shown to exert antiadrenergic and anti-inflammatory effects in humans. Recently, tVNS has been tested in experimental and human POTS, leading to improved autonomic function, reduction of anti-autonomic autoantibodies and inflammatory cytokines. However, the exact patient characteristics that would identify a patient likely to respond to tVNS as well as further mechanistic and clinical endpoints with tVNS have not been explored.\n\nThe aim of this study is to assess and characterize in detail the effect of tVNS in patients with POTS. This is a prospective crossover study in patients with POTS. The expected study duration is approximately 15 months from the time the first subject is enrolled to study termination. Patient enrollment is planned to take place at 3-4 major centers in Greece.", "primary_outcomes": [ { "type": "primary", "measure": "Difference in Heart Rate change during the posture test, between the 2 treatment periods (on-treatment versus off-treatment).", "description": "Difference in Heart Rate change during the posture test, between the 2 treatment periods (active versus sham). The Heart rate change will be calculated as Standing Heart rate minus Supine Heart rate, the former being defined as the maximal heart rate recorded during a 10-minute period from erection from the supine to the standing position and the latter as the heart rate immediately before standing (the patient will remain at the supine position in a quiet room for at least 5 minutes before rising to the standing position).", "time_frame": "Through study completion, up to 16 months from study start date" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Autonomic symptoms assessed using the Malmo POTS Score questionnaire", "description": "", "time_frame": "Through study completion, up to 16 months from study start date" } ], "outcome_measures": [ { "type": "primary", "measure": "Difference in Heart Rate change during the posture test, between the 2 treatment periods (on-treatment versus off-treatment).", "description": "Difference in Heart Rate change during the posture test, between the 2 treatment periods (active versus sham). The Heart rate change will be calculated as Standing Heart rate minus Supine Heart rate, the former being defined as the maximal heart rate recorded during a 10-minute period from erection from the supine to the standing position and the latter as the heart rate immediately before standing (the patient will remain at the supine position in a quiet room for at least 5 minutes before rising to the standing position).", "time_frame": "Through study completion, up to 16 months from study start date" }, { "type": "secondary", "measure": "Autonomic symptoms assessed using the Malmo POTS Score questionnaire", "description": "", "time_frame": "Through study completion, up to 16 months from study start date" } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 24, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07163130", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05576662", "title": "Paxlovid for Treatment of Long Covid", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2025-09-04", "start_date": "2022-11-08", "completion_date": "2023-09-12", "primary_completion_date": "2023-08-14", "conditions_raw": [ "Post-acute Sequelae of SARS-CoV-2 Infection", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Paxlovid (Nirmatrelvir/Ritonavir)", "Ritonavir" ], "sponsor": "Stanford University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to compare whether being treated with nirmatrelvir plus ritonavir for 15 days works better than being treated with placebo plus ritonavir to reduce severe symptoms of Long Covid.\n\nParticipants will have 5 planned visits to the study clinic over 15 weeks and will take the drug (or placebo) for the first 15 days.\n\nThis study uses the term post-acute sequelae of SARS-CoV-2 (PASC), which is another name for \"Long Covid.\"", "primary_outcomes": [ { "type": "primary", "measure": "Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score", "description": "This measure was to evaluate whether there is a difference between treatment with Paxlovid versus placebo on any of the 6 core symptoms of PASC at week 10 (adjusting for patients' baseline levels). Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).", "time_frame": "Week 10" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score", "description": "This measure was to evaluate whether there is a difference between treatment with Paxlovid versus placebo on any of the 6 core symptoms of PASC at week 10 (adjusting for patients' baseline levels). Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).", "time_frame": "Day 15" }, { "type": "secondary", "measure": "Number of Participants Reporting Relief of at Least One Core Symptom for 2 Weeks", "description": "Relief defined as reduction of severity from moderate to none, or severe to mild/none (≥ 2-point Likert score change). Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.", "time_frame": "Baseline through week 10, assessed at week 10" }, { "type": "secondary", "measure": "Number of Participants With Overall Alleviation for 2 Weeks", "description": "Overall alleviation defined as both:\n\n1. Any core symptom(s) that are none/mild (Likert 0 or 1) at baseline are none at 10 weeks, and\n2. Any core symptom(s) that are moderate/severe (Likert 2 or 3) at baseline are none/mild at 10 weeks.\n\nLikert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.", "time_frame": "Baseline through week 10, assessed at week 10" }, { "type": "secondary", "measure": "Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom", "description": "This outcome was to assess the severity of the most bothersome symptom experienced by participants. Each symptom was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms) using the Core Symptoms Severity Scale.", "time_frame": "Assessed at weeks 5, 10, and 15" }, { "type": "secondary", "measure": "Time to Relief of the 6 Core Symptoms", "description": "Relief defined as reduction of severity from moderate to none, or severe to mild/none for 2 consecutive weeks (≥ 2-point Likert score change). Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.", "time_frame": "Up to 15 weeks" }, { "type": "secondary", "measure": "Time to Relief of the Most Bothersome Symptom", "description": "Relief defined as reduction of severity from moderate to none, or severe to mild/none for 2 consecutive weeks (≥ 2-point Likert score change). Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.", "time_frame": "Up to 15 weeks" }, { "type": "secondary", "measure": "Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function T-Score", "description": "The PROMIS-Physical Function Short Form (SF) assesses difficulty level performing activities of daily living such as doing chores, climbing stairs, walking, and running errands. The assessment consists of 4 items (questions) with each item scored on 5-point Likert scale (higher scores correspond to better physical function). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher physical function T-score indicates better physical function.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in PROMIS Fatigue T-Score", "description": "The PROMIS Fatigue Score assesses level of fatigue and its interference on daily activities. The assessment consists of 7 items (questions) with each item scored on 5-point Likert scale (higher scores correspond to more fatigue). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher fatigue T-score indicates greater fatigue.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in PROMIS Dyspnea-Severity T-Score", "description": "The PROMIS-Fatigue Dyspnea-Severity Short Form assesses shortness of breath and its interference on daily activities. The assessment consists of 5 items (questions) scored on 4-point Likert scale with a 7-day recall period (higher scores correspond to worse symptoms). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher Dyspnea-Severity T-score indicates worse symptoms.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in PROMIS Cognitive Function Abilities T-Score", "description": "The PROMIS-Cognitive Function Abilities Short Form assesses brain fog and its interference on daily activities. The assessment consists of 4 items scored on 5-point Likert scale with a 7-day recall period (higher scores indicate better cognitive function). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher Cognitive Function T-score indicates better cognitive function.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in Orthostatic Vitals Test", "description": "This outcome measures the difference in supine to standing systolic blood pressure (SBP) and diastolic blood pressure (DBP).", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in Heart Rate", "description": "This outcome measures the difference in supine to standing heart rate.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in 1-minute Sit-to-stand Test", "description": "Number of times participant is able to go from sitting (in an armless chair) to standing in 1 minute (sit to stand cycles).", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Patient Global Impression of Severity (PGIS) Scale Score", "description": "The PGIS reflects a participant's perception about the overall severity of their disease symptoms, rated from 1 to 6 (1 = not present; 2 = very mild; 3 = mild; 4 = moderate; 5 = severe; 6 = extremely severe).", "time_frame": "Day 15, and weeks 5, 10, and 15" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC) Scale Score", "description": "The PGIC reflects a participant's perception about the overall efficacy of treatment and their overall status since the start of the treatment, rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).", "time_frame": "Day 15, and weeks 5, 10, and 15" }, { "type": "secondary", "measure": "Summative Severity Score for All Core Symptoms", "description": "Core Symptoms Severity Scale Scores for each of the 6 core symptoms were summed to create a summative score. Each core symptom is assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Summative score range: 0 to 18 (high scores correspond to greater severity).", "time_frame": "Weeks 5, 10, and 15" }, { "type": "secondary", "measure": "Percentage of Weeks 1-15 With Mild or no Symptoms", "description": "Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) is assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).", "time_frame": "15 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of Participants With No, Mild, Moderate, or Severe Symptoms at Week 10 According to the Core Symptoms Severity Scale Score", "description": "This measure was to evaluate whether there is a difference between treatment with Paxlovid versus placebo on any of the 6 core symptoms of PASC at week 10 (adjusting for patients' baseline levels). Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).", "time_frame": "Week 10" }, { "type": "secondary", "measure": "Number of Participants With No, Mild, Moderate, or Severe Symptoms at Day 15 According to the Core Symptoms Severity Scale Score", "description": "This measure was to evaluate whether there is a difference between treatment with Paxlovid versus placebo on any of the 6 core symptoms of PASC at week 10 (adjusting for patients' baseline levels). Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).", "time_frame": "Day 15" }, { "type": "secondary", "measure": "Number of Participants Reporting Relief of at Least One Core Symptom for 2 Weeks", "description": "Relief defined as reduction of severity from moderate to none, or severe to mild/none (≥ 2-point Likert score change). Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.", "time_frame": "Baseline through week 10, assessed at week 10" }, { "type": "secondary", "measure": "Number of Participants With Overall Alleviation for 2 Weeks", "description": "Overall alleviation defined as both:\n\n1. Any core symptom(s) that are none/mild (Likert 0 or 1) at baseline are none at 10 weeks, and\n2. Any core symptom(s) that are moderate/severe (Likert 2 or 3) at baseline are none/mild at 10 weeks.\n\nLikert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.", "time_frame": "Baseline through week 10, assessed at week 10" }, { "type": "secondary", "measure": "Number of Participants With No, Mild, Moderate, or Severe Symptoms of Their Most Bothersome Symptom", "description": "This outcome was to assess the severity of the most bothersome symptom experienced by participants. Each symptom was assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms) using the Core Symptoms Severity Scale.", "time_frame": "Assessed at weeks 5, 10, and 15" }, { "type": "secondary", "measure": "Time to Relief of the 6 Core Symptoms", "description": "Relief defined as reduction of severity from moderate to none, or severe to mild/none for 2 consecutive weeks (≥ 2-point Likert score change). Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.", "time_frame": "Up to 15 weeks" }, { "type": "secondary", "measure": "Time to Relief of the Most Bothersome Symptom", "description": "Relief defined as reduction of severity from moderate to none, or severe to mild/none for 2 consecutive weeks (≥ 2-point Likert score change). Likert score range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms.", "time_frame": "Up to 15 weeks" }, { "type": "secondary", "measure": "Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function T-Score", "description": "The PROMIS-Physical Function Short Form (SF) assesses difficulty level performing activities of daily living such as doing chores, climbing stairs, walking, and running errands. The assessment consists of 4 items (questions) with each item scored on 5-point Likert scale (higher scores correspond to better physical function). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher physical function T-score indicates better physical function.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in PROMIS Fatigue T-Score", "description": "The PROMIS Fatigue Score assesses level of fatigue and its interference on daily activities. The assessment consists of 7 items (questions) with each item scored on 5-point Likert scale (higher scores correspond to more fatigue). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher fatigue T-score indicates greater fatigue.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in PROMIS Dyspnea-Severity T-Score", "description": "The PROMIS-Fatigue Dyspnea-Severity Short Form assesses shortness of breath and its interference on daily activities. The assessment consists of 5 items (questions) scored on 4-point Likert scale with a 7-day recall period (higher scores correspond to worse symptoms). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher Dyspnea-Severity T-score indicates worse symptoms.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in PROMIS Cognitive Function Abilities T-Score", "description": "The PROMIS-Cognitive Function Abilities Short Form assesses brain fog and its interference on daily activities. The assessment consists of 4 items scored on 5-point Likert scale with a 7-day recall period (higher scores indicate better cognitive function). Scores are computed to a T-score metric, where 50 represents the mean for US general adult population and 10 is the standard deviation. A higher Cognitive Function T-score indicates better cognitive function.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in Orthostatic Vitals Test", "description": "This outcome measures the difference in supine to standing systolic blood pressure (SBP) and diastolic blood pressure (DBP).", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in Heart Rate", "description": "This outcome measures the difference in supine to standing heart rate.", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Change in 1-minute Sit-to-stand Test", "description": "Number of times participant is able to go from sitting (in an armless chair) to standing in 1 minute (sit to stand cycles).", "time_frame": "Baseline and week 10" }, { "type": "secondary", "measure": "Patient Global Impression of Severity (PGIS) Scale Score", "description": "The PGIS reflects a participant's perception about the overall severity of their disease symptoms, rated from 1 to 6 (1 = not present; 2 = very mild; 3 = mild; 4 = moderate; 5 = severe; 6 = extremely severe).", "time_frame": "Day 15, and weeks 5, 10, and 15" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC) Scale Score", "description": "The PGIC reflects a participant's perception about the overall efficacy of treatment and their overall status since the start of the treatment, rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).", "time_frame": "Day 15, and weeks 5, 10, and 15" }, { "type": "secondary", "measure": "Summative Severity Score for All Core Symptoms", "description": "Core Symptoms Severity Scale Scores for each of the 6 core symptoms were summed to create a summative score. Each core symptom is assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Summative score range: 0 to 18 (high scores correspond to greater severity).", "time_frame": "Weeks 5, 10, and 15" }, { "type": "secondary", "measure": "Percentage of Weeks 1-15 With Mild or no Symptoms", "description": "Each symptom (fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms) is assessed on a 4-point Likert scale (range: 0 to 3; 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).", "time_frame": "15 weeks" } ], "relevance_tags": [ "Persistence / Antiviral", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 168, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05576662", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07154199", "title": "Transcranial Ultrasound Stimulation for Cognitive Function Modulation in Patients With Post COVID-19 Brain Fog", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-09-04", "start_date": "2023-01-06", "completion_date": "2027-12", "primary_completion_date": "2027-12", "conditions_raw": [ "COVID-19", "Brain Fog", "Long COVID", "Transcranial Ultrasound Stimulation" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Real Transcranial Ultrasound Stimulation" ], "sponsor": "Xuanwu Hospital, Beijing", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to investigate whether a specific brain region mediates the cognitive deficit in long COVID brain fog, and whether targeted modulation of this region can improve cognition.\n\nIn observational study, the objective was to identify potential intervention targets for patients with long COVID brain fog. A total of 120 patients with long COVID were enrolled. Brain fog (BF) severity was quantified using the Brain Fog Assessment (BFA). Participants completed a continuous random-dot motion (cRDM) task during 128-channel electroencephalography (EEG) and underwent structural MRI and standardized neuropsychological testing.\n\nIn interventional study, 40 participants with persistent BF symptoms were enrolled for transcranial ultrasound stimulation (TUS). On Day 1, participants completed the BFA and provided demographic data, then performed the baseline cRDM task; 20 minutes later, structural MRI and baseline resting-state MRI were acquired. On Day 2, participants received 60 seconds of TUS (active or sham) according to randomized allocation. Twenty minutes post-stimulation, an 8-minute resting-state MRI scan was obtained, followed immediately by the follow-up cRDM task.", "primary_outcomes": [ { "type": "primary", "measure": "false alarm rate change", "description": "false alarm rate change", "time_frame": "Day 1, Day 2" }, { "type": "primary", "measure": "accuracy change", "description": "accuracy change", "time_frame": "Day 1, Day 2" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "false alarm rate", "description": "false alarm rate", "time_frame": "Day 1" }, { "type": "secondary", "measure": "accuracy", "description": "accuracy", "time_frame": "Day 1" }, { "type": "secondary", "measure": "cRDM modeling metrics", "description": "cRDM modeling metrics", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Neural activation pattern of EEG", "description": "Neural activation pattern of EEG", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Brain structure indicator of MRI", "description": "Brain structure indicator of MRI", "time_frame": "Day 1" }, { "type": "secondary", "measure": "resting-state functional connectivity change in MRI", "description": "resting-state functional connectivity change in MRI", "time_frame": "Day 1, Day 2" } ], "outcome_measures": [ { "type": "primary", "measure": "false alarm rate change", "description": "false alarm rate change", "time_frame": "Day 1, Day 2" }, { "type": "primary", "measure": "accuracy change", "description": "accuracy change", "time_frame": "Day 1, Day 2" }, { "type": "secondary", "measure": "false alarm rate", "description": "false alarm rate", "time_frame": "Day 1" }, { "type": "secondary", "measure": "accuracy", "description": "accuracy", "time_frame": "Day 1" }, { "type": "secondary", "measure": "cRDM modeling metrics", "description": "cRDM modeling metrics", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Neural activation pattern of EEG", "description": "Neural activation pattern of EEG", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Brain structure indicator of MRI", "description": "Brain structure indicator of MRI", "time_frame": "Day 1" }, { "type": "secondary", "measure": "resting-state functional connectivity change in MRI", "description": "resting-state functional connectivity change in MRI", "time_frame": "Day 1, Day 2" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07154199", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06620406", "title": "Synbiotic Therapy for NP-PASC", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-08-26", "start_date": "2024-12-09", "completion_date": "2025-08-06", "primary_completion_date": "2025-08-06", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Long COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Synbiotic Ivs-1", "Maltodextrin" ], "sponsor": "Columbia University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Gut microbiome dysbiosis has been noted in patients with Post-acute sequelae (PASC) of Severe Acute Respiratory Syndrome-CoronaVirus -2 (SARS-CoV-2). A study performed at Columbia found that plasma levels of the short chain fatty acid (SCFA), butyric acid, remained lower in people with Neuropsychiatric PASC (NP-PASC) than in people with PASC after SAR-CoV-2 infection. Synbiotics improve SCFA levels and are well-tolerated in the general population but have not been studied among people with PASC in the United States. The purpose of this pilot study is to characterize changes in plasma SCFA levels and gut microbiome after treatment with synbiotics and placebo in people with NP-PASC. The intervention will be a mixture of the prebiotic resistant starch and the probiotic Bifidobacterium adolescentis in-vivo selection 1 strain (iVS-1). The placebo will be Maltodextrin.", "primary_outcomes": [ { "type": "primary", "measure": "Difference in plasma short chain fatty acid (SCFA) levels between study arms", "description": "SCFA levels will be measured from plasma samples and compared between the intervention group and the placebo group. In-group differences will also be measured between baseline and 4 weeks.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Difference in gut microbiota between study arms", "description": "Bacterial flora will be measured from rectal swab samples and compared between the intervention group and the placebo group. In-group differences will also be measured between baseline and 4 weeks.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Difference in other biomarkers between study arms", "description": "Additional biomarkers, such as serotonin and inflammatory cytokines, measured from the plasma samples and rectal swabs, whose concentration will be compared between the intervention group and the placebo group, and in-group differences between timepoints. Additional biomarkers include, but are not limited to, inflammatory cytokines and serotonin.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Difference in clinical profiles between study arms", "description": "Survey data will be compared between the intervention group and the placebo group, and in-group differences between timepoints. Survey data includes, but is not limited to, medication, COVID History, Vaccine History, and Medical History.", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Number of participants enrolled per week and agree to take the intervention", "description": "This measures the feasibility and acceptability of the study drug.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Number of participants who successfully take the intervention", "description": "This measures the feasibility and acceptability of the study drug.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Difference in NP-PASC symptoms between study arms", "description": "NP-PASC symptom severity differences as assessed by the NeuroScreen app between the baseline and the 4 week timepoint, and differences between the intervention and the placebo group.", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Difference in plasma short chain fatty acid (SCFA) levels between study arms", "description": "SCFA levels will be measured from plasma samples and compared between the intervention group and the placebo group. In-group differences will also be measured between baseline and 4 weeks.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Difference in gut microbiota between study arms", "description": "Bacterial flora will be measured from rectal swab samples and compared between the intervention group and the placebo group. In-group differences will also be measured between baseline and 4 weeks.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Difference in other biomarkers between study arms", "description": "Additional biomarkers, such as serotonin and inflammatory cytokines, measured from the plasma samples and rectal swabs, whose concentration will be compared between the intervention group and the placebo group, and in-group differences between timepoints. Additional biomarkers include, but are not limited to, inflammatory cytokines and serotonin.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Difference in clinical profiles between study arms", "description": "Survey data will be compared between the intervention group and the placebo group, and in-group differences between timepoints. Survey data includes, but is not limited to, medication, COVID History, Vaccine History, and Medical History.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Number of participants enrolled per week and agree to take the intervention", "description": "This measures the feasibility and acceptability of the study drug.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Number of participants who successfully take the intervention", "description": "This measures the feasibility and acceptability of the study drug.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Difference in NP-PASC symptoms between study arms", "description": "NP-PASC symptom severity differences as assessed by the NeuroScreen app between the baseline and the 4 week timepoint, and differences between the intervention and the placebo group.", "time_frame": "4 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 36, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06620406", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06234462", "title": "A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid", "status": "WITHDRAWN", "phase": "PHASE2", "last_updated": "2025-08-26", "start_date": "2025-06", "completion_date": "2025-10-01", "primary_completion_date": "2025-09-01", "conditions_raw": [ "Long COVID", "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Amantadine", "Physical, Occupational, Speech Therapy", "Provider Counseling", "Medications For Symptoms Management" ], "sponsor": "University of Texas Southwestern Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Purpose: To decrease symptom burden, improve cognitive function, improve endurance, and decrease fatigue in subjects with post-acute sequelae of COVID-19 (PASC) or \"long-hauler\" COVID using amantadine. If amantadine use is determined to be efficacious in this population, the findings of this study will be used towards a subsequent randomized control trial.", "primary_outcomes": [ { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Repeatable Battery for the Assessment of Neuropsychological Status (R BANS) Self-reported percent back to normal, FAS, Trails A\\&B, and Digit\n\nVigilance Test (DVT)", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Cognitive Subscale of Modified Fatigue Impact Scale (MFIS)", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Self-reported percent back to normal", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "FAS Test", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Trails A \\& B", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Digit Vigilance Test", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Measures of endurance and strength", "description": "6 Minute Walk Test (6MWT)", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of endurance and strength", "description": "30 second sit-to-stand", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of endurance and strength", "description": "grip strength\n\ngrip strength", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of endurance and strength", "description": "Physical Function subsection of PROMIS-29", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of fatigue", "description": "Physical Subscale of the Modified Fatigue Impact Scale\n\n(MFIS), and fatigue subsection of PROMIS-29.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of anxiety and depression", "description": "Patient Health Questionnaire-9 (PHQ-9)", "time_frame": "4-6 weeks" }, { "type": "secondary", "measure": "Measures of anxiety and depression", "description": "Generalized Anxiety DIsorder-7 (GAD-7) questionnaires", "time_frame": "4-6 weeks" }, { "type": "secondary", "measure": "Measures of anxiety and depression", "description": "anxiety and depression sections of the PROMIS-29", "time_frame": "4-6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Repeatable Battery for the Assessment of Neuropsychological Status (R BANS) Self-reported percent back to normal, FAS, Trails A\\&B, and Digit\n\nVigilance Test (DVT)", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Cognitive Subscale of Modified Fatigue Impact Scale (MFIS)", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Self-reported percent back to normal", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "FAS Test", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Trails A \\& B", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Measures of cognitive functioning", "description": "Digit Vigilance Test", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of endurance and strength", "description": "6 Minute Walk Test (6MWT)", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of endurance and strength", "description": "30 second sit-to-stand", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of endurance and strength", "description": "grip strength\n\ngrip strength", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of endurance and strength", "description": "Physical Function subsection of PROMIS-29", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of fatigue", "description": "Physical Subscale of the Modified Fatigue Impact Scale\n\n(MFIS), and fatigue subsection of PROMIS-29.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measures of anxiety and depression", "description": "Patient Health Questionnaire-9 (PHQ-9)", "time_frame": "4-6 weeks" }, { "type": "secondary", "measure": "Measures of anxiety and depression", "description": "Generalized Anxiety DIsorder-7 (GAD-7) questionnaires", "time_frame": "4-6 weeks" }, { "type": "secondary", "measure": "Measures of anxiety and depression", "description": "anxiety and depression sections of the PROMIS-29", "time_frame": "4-6 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT06234462", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05813873", "title": "The Use of Incentive Spirometry in Adult Patients Hospitalised in a Rehabilitation Center With Long-covid Syndrome", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-08-14", "start_date": "2022-12-21", "completion_date": "2026-12-31", "primary_completion_date": "2025-12-23", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Triflow" ], "sponsor": "European University Cyprus", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of this clinical trial is to investigate the efficacy of Triflow in the rehabilitation of patients with long covid syndrome hospitalised in a rehabilitation center. Participants will be divided into 2 groups and follow their exercise regime until the day they are discharged from the rehabilitation center. The intervention group will participate in a rehabilitation program which includes upper and lower limbs exercises, cycle ergometer, walking and the use of triflow. The control group will participate in the same program but without the Triflow.", "primary_outcomes": [ { "type": "primary", "measure": "Barthel Index", "description": "Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living.", "time_frame": "on admission day" }, { "type": "primary", "measure": "Barthel Index", "description": "Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living.", "time_frame": "on discharge day" }, { "type": "primary", "measure": "Dyspnoea (Medical Research Council Dyspnoea Scale)", "description": "Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is", "time_frame": "on admission day" }, { "type": "primary", "measure": "Dyspnoea (Medical Research Council Dyspnoea Scale)", "description": "Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is", "time_frame": "on discharge day" }, { "type": "primary", "measure": "Peak Flow Meter", "description": "Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is", "time_frame": "on admission day" }, { "type": "primary", "measure": "Peak Flow Meter", "description": "Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is", "time_frame": "on discharge day" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Number of hospitalisation days", "description": "Number of days participants stay in the rehabilitation center", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Muscle strength (Hand Grip)", "description": "Assess muscle strength for the upper extremities via hand-held dynamometer", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Muscle strength (Hand Grip)", "description": "Assess muscle strength for the upper extremities via hand-held dynamometer", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Muscle strength and endurance (30 seconds Sit to stand)", "description": "Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Muscle strength and endurance (30 seconds Sit to stand)", "description": "Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Balance (Berg Balance)", "description": "Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls.", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Balance (Berg Balance)", "description": "Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls.", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Cardiorespiratory fitness (Six minutes walking test)", "description": "Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness.", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Cardiorespiratory fitness (Six minutes walking test)", "description": "Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness.", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Quality of life (EQ-5D-5L)", "description": "Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health)", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Quality of life (EQ-5D-5L)", "description": "Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health)", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Fatigue (Multidimensional fatigue inventory)", "description": "Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true)", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Fatigue (Multidimensional fatigue inventory)", "description": "Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true)", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Timed up and Go", "description": "Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Timed up and Go", "description": "Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility", "time_frame": "on discharge day" } ], "outcome_measures": [ { "type": "primary", "measure": "Barthel Index", "description": "Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living.", "time_frame": "on admission day" }, { "type": "primary", "measure": "Barthel Index", "description": "Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living.", "time_frame": "on discharge day" }, { "type": "primary", "measure": "Dyspnoea (Medical Research Council Dyspnoea Scale)", "description": "Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is", "time_frame": "on admission day" }, { "type": "primary", "measure": "Dyspnoea (Medical Research Council Dyspnoea Scale)", "description": "Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is", "time_frame": "on discharge day" }, { "type": "primary", "measure": "Peak Flow Meter", "description": "Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is", "time_frame": "on admission day" }, { "type": "primary", "measure": "Peak Flow Meter", "description": "Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Number of hospitalisation days", "description": "Number of days participants stay in the rehabilitation center", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Muscle strength (Hand Grip)", "description": "Assess muscle strength for the upper extremities via hand-held dynamometer", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Muscle strength (Hand Grip)", "description": "Assess muscle strength for the upper extremities via hand-held dynamometer", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Muscle strength and endurance (30 seconds Sit to stand)", "description": "Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Muscle strength and endurance (30 seconds Sit to stand)", "description": "Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Balance (Berg Balance)", "description": "Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls.", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Balance (Berg Balance)", "description": "Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls.", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Cardiorespiratory fitness (Six minutes walking test)", "description": "Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness.", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Cardiorespiratory fitness (Six minutes walking test)", "description": "Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness.", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Quality of life (EQ-5D-5L)", "description": "Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health)", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Quality of life (EQ-5D-5L)", "description": "Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health)", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Fatigue (Multidimensional fatigue inventory)", "description": "Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true)", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Fatigue (Multidimensional fatigue inventory)", "description": "Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true)", "time_frame": "on discharge day" }, { "type": "secondary", "measure": "Timed up and Go", "description": "Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility", "time_frame": "on admission day" }, { "type": "secondary", "measure": "Timed up and Go", "description": "Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility", "time_frame": "on discharge day" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 70, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05813873", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06968104", "title": "Vagus Nerve Stimulation to the Ear to Improve Symptoms in Post-COVID-19 and ME/CFS", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-08-08", "start_date": "2025-07-18", "completion_date": "2026-10", "primary_completion_date": "2026-10", "conditions_raw": [ "Post-COVID / Long-COVID", "ME/CFS" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Transcutaneous Vagus Nerve Stimulation" ], "sponsor": "University of Luxembourg", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is testing whether a gentle electrical stimulation of a nerve in the ear, called the vagus nerve, can help reduce fatigue and improve symptoms in people with Post-COVID Syndrome or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The treatment, known as transcutaneous auricular vagus nerve stimulation (taVNS), is non-invasive and can be done at home using a small device.\n\nParticipants will try two different types of stimulation, called Intervention A and Intervention B, to see which may be more effective. Each intervention lasts 4 weeks and will be separated by a break of at least 4 weeks.\n\nParticipants will use the device at home twice a day for 30 minutes. Fatigue, quality of life, sleep, and daily activity will be tracked through surveys and wearable devices. All parts of the study-including check-ins and data collection-will be done remotely.\n\nThe goal is to learn whether this type of at-home nerve stimulation can safely improve symptoms in people with Post-COVID Syndrome or ME/CFS.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue", "description": "Reduction in fatigue measured by the Fatigue Severity and Chalder Fatigue Scales. The FSS is a 9-item scale that measures the severity of fatigue and how much it affects the person's activities and lifestyle in patients with a variety of disorders. The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity. More common way of scoring: mean of all the scores with minimum score being 1 and maximum score being 7. The Chalder Fatigue Scale consists of 11 items scored on a 4-point Likert scale (0 to 3). Higher total scores reflect a greater degree of fatigue.", "time_frame": "From baseline to end of treatment at 4 weeks." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient Health (Quality of life)", "description": "Improvements in quality of life, assessed by the Short Form Health Survey (SF-36). The SF-36 is a 36-item scale constructed to survey health status and quality of life (Ware \\& Sherbourne, 1992). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Greater scores indicate greater functioning.", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Patient Health (Ability)", "description": "Assessment of functional ability/disability using the Bell CFIDS disability scale (Bell Score). Scores from 0 to 100, lower score indicating greater disability.", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM)", "description": "PEM measured by the DePaul Symptom Questionnaire - Post-Exertional-Malaise Subscale (DSQ-PEM)", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Autonomic Function", "description": "Autonomic function evaluated through Heart Rate Variability (HRV)", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Sleep Quality", "description": "Assessed by the Pittsburgh Sleep Quality Index (PSQI) and daily E-Diary entries.", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Sleepiness", "description": "Measured by the Epworth Sleepiness Scale (ESS). Scores from 0 to 24:\n\n0-5 lower normal daytime sleepiness 6-10 normal daytime sleepiness 11-12 mild daytime symptoms 13-15 moderate daytime symptoms 16-24 severe daytime symptoms", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Depression and Anxiety", "description": "Evaluated using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 questions that can be scored from 0 to 3. Seven questions relate to anxiety (indicated by an 'A') and 7 questions relate to depression (as shown by a 'D'). 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); 11-21 = Abnormal (case).", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Patients Activity", "description": "monitored through actigraphy (i.e. step count)", "time_frame": "From baseline to end of treatment at 4 weeks." } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue", "description": "Reduction in fatigue measured by the Fatigue Severity and Chalder Fatigue Scales. The FSS is a 9-item scale that measures the severity of fatigue and how much it affects the person's activities and lifestyle in patients with a variety of disorders. The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity. More common way of scoring: mean of all the scores with minimum score being 1 and maximum score being 7. The Chalder Fatigue Scale consists of 11 items scored on a 4-point Likert scale (0 to 3). Higher total scores reflect a greater degree of fatigue.", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Patient Health (Quality of life)", "description": "Improvements in quality of life, assessed by the Short Form Health Survey (SF-36). The SF-36 is a 36-item scale constructed to survey health status and quality of life (Ware \\& Sherbourne, 1992). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Greater scores indicate greater functioning.", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Patient Health (Ability)", "description": "Assessment of functional ability/disability using the Bell CFIDS disability scale (Bell Score). Scores from 0 to 100, lower score indicating greater disability.", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM)", "description": "PEM measured by the DePaul Symptom Questionnaire - Post-Exertional-Malaise Subscale (DSQ-PEM)", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Autonomic Function", "description": "Autonomic function evaluated through Heart Rate Variability (HRV)", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Sleep Quality", "description": "Assessed by the Pittsburgh Sleep Quality Index (PSQI) and daily E-Diary entries.", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Sleepiness", "description": "Measured by the Epworth Sleepiness Scale (ESS). Scores from 0 to 24:\n\n0-5 lower normal daytime sleepiness 6-10 normal daytime sleepiness 11-12 mild daytime symptoms 13-15 moderate daytime symptoms 16-24 severe daytime symptoms", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Depression and Anxiety", "description": "Evaluated using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 questions that can be scored from 0 to 3. Seven questions relate to anxiety (indicated by an 'A') and 7 questions relate to depression (as shown by a 'D'). 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); 11-21 = Abnormal (case).", "time_frame": "From baseline to end of treatment at 4 weeks." }, { "type": "secondary", "measure": "Patients Activity", "description": "monitored through actigraphy (i.e. step count)", "time_frame": "From baseline to end of treatment at 4 weeks." } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 48, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06968104", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04828668", "title": "Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-08-07", "start_date": "2021-04-02", "completion_date": "2022-02-14", "primary_completion_date": "2022-01-31", "conditions_raw": [ "Covid 19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Targeted Wellness Formula C™ Sublingual Drops - 1200Mg - 30 Ml" ], "sponsor": "Endourage, LLC", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or \"PACS\".", "primary_outcomes": [ { "type": "primary", "measure": "Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.", "description": "PROMIS® is a set of patient-centered instruments used to measure various patient reported outcomes.\n\nMeasures are scored on the T-score metric of which 50 is the mean of a relevant baseline population with 10 being the standard deviation of that population.\n\nA score of 40 is one stndard deviation less than and a score of 60 is one standard deviation greater than the mean of the baseline or reference population.\n\nHigh scores suggest more of what is being measured (e.g., more fatigue, more shortness of breath) and a lower score suggest improvement in symptoms or complaints assessed depending on symptom or complaint being measured.", "time_frame": "56-days (designated time points)" }, { "type": "primary", "measure": "PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)", "description": "This scale evaluates various aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Scale associated with subjective responses range 1-7 (from no change or a one through a great deal better and considerable improvement that has made all the difference or a seven), higher ratings indicate improved sympomtoms (responders) versus those reporting lower scores suggesting no change or a worsening of their condition (non-responders).", "time_frame": "56-days (designated time points)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Study product related adverse events and side effects.", "description": "Daily diary entries and clinical interview at scheduled visit; the number of participants with treatment related events as measured by grading scale of the Common Terminology Criteria for Adverse Events (CTCAE), grade 1-IV (one through four) and using descriptor terms, mild, moderate, severe. Additionally, any adverse event meeting serious adverse event criteria will be collected and reported. Frequency summary tables of all adverse events/serious adverse events will be tabulated and reported.", "time_frame": "56-days (designated time points)" } ], "outcome_measures": [ { "type": "primary", "measure": "Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.", "description": "PROMIS® is a set of patient-centered instruments used to measure various patient reported outcomes.\n\nMeasures are scored on the T-score metric of which 50 is the mean of a relevant baseline population with 10 being the standard deviation of that population.\n\nA score of 40 is one stndard deviation less than and a score of 60 is one standard deviation greater than the mean of the baseline or reference population.\n\nHigh scores suggest more of what is being measured (e.g., more fatigue, more shortness of breath) and a lower score suggest improvement in symptoms or complaints assessed depending on symptom or complaint being measured.", "time_frame": "56-days (designated time points)" }, { "type": "primary", "measure": "PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)", "description": "This scale evaluates various aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Scale associated with subjective responses range 1-7 (from no change or a one through a great deal better and considerable improvement that has made all the difference or a seven), higher ratings indicate improved sympomtoms (responders) versus those reporting lower scores suggesting no change or a worsening of their condition (non-responders).", "time_frame": "56-days (designated time points)" }, { "type": "secondary", "measure": "Study product related adverse events and side effects.", "description": "Daily diary entries and clinical interview at scheduled visit; the number of participants with treatment related events as measured by grading scale of the Common Terminology Criteria for Adverse Events (CTCAE), grade 1-IV (one through four) and using descriptor terms, mild, moderate, severe. Additionally, any adverse event meeting serious adverse event criteria will be collected and reported. Frequency summary tables of all adverse events/serious adverse events will be tabulated and reported.", "time_frame": "56-days (designated time points)" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 32, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04828668", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05836402", "title": "Long COVID-19 Syndrome Lifestyle Intervention Study", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-08-07", "start_date": "2023-09-14", "completion_date": "2025-08-04", "primary_completion_date": "2025-08-04", "conditions_raw": [ "Long COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Low Carbohydrate Diet Intervention" ], "sponsor": "University of Southern California", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Rationale: Hyper-inflammatory responses seen in acute COVID-19 are also a feature of long covid, a condition of long-term consequences that are persisting or appearing after initial infection and recovery from acute COVID-19. Long-standing, often disabling symptoms are common in long covid and can be highly varied. Common symptoms include fatigue, brain fog, muscle and chest pain, migraines, shortness of breath, anosmia, muscle weakness, and cognitive dysfunction. 35% of post-COVID patients were found to have decreased kidney function at 6 months post-discharge. In this study, we will evaluate the effect of dietary interventions in long covid patients. The dietary interventions are aimed at lowering blood glucose levels, and raising blood BHB levels. The dietary plan will recommend a low-carbohydrate diet including the avoidance of foods containing sugars and starch, while simultaneously increasing the consumption of healthy fats and sources of protein. The dietary interventions are supported by the consumption of a medical food that delivers exogenous BHB in order to raise blood BHB levels without the necessity of adhering to a strict ketogenic diet which would be difficult to implement and typically requires strict medical supervision.\n\nIntervention: Dietary intervention with Ketocitra versus control arm (no intervention) in a 1:1 ratio Objectives: The hypothesis of this study is that low-carbohydrate dietary interventions leading to lowering of blood glucose and raising of blood BHB in addition to standard therapy will lead to faster recovery and amelioration of symptoms in long covid compared to those treated with standard therapy alone.\n\nStudy population: Subjects with a history of COVID-19 at least 2 months ago and with at least 2 neurological and/or symptoms that are typical for long covid that either started at COVID-19 infection and are ongoing at time of study entry Study methodology: Prospective and interventional randomized controlled pilot study Study arms: Dietary intervention (including medical food) arm versus control arm Study endpoints: The primary endpoint is the feasibility, safety and tolerability of dietary intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Feasibility of dietary intervention:", "description": "Questionnaire on diet feasibility (Appendix F). Exit Questionnaire. Scale 1-5 (1= worse outcome; 5=better outcome)", "time_frame": "One month" }, { "type": "primary", "measure": "Safety signals for electrolytes", "description": "calcium, sodium, potassium, carbon dioxide, chloride,", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Safety signals for kidney function", "description": "BUN and creatinine", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Safety signals for liver function", "description": "Alkaline Phosphatase, ALT, AST, bilirubin, \\& total protein, glucose", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Cardiovascular risk", "description": "Fasting lipid panel: total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Improved uric acid metabolism", "description": "Serum Uric Acid", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "kidney function: proteinuria", "description": "urinalysis and urine protein to creatinine ratio", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Safety and tolerability of dietary intervention:", "description": "Questionnaire on parameters of safety and tolerability (Appendix E) 0-10 (Scale 0= best outcome to 10=worse outcome)", "time_frame": "30 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs Measurement of change in body weight", "description": "● body weight", "time_frame": "At start and at day 30" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs Measurement of aerobic capacity:", "description": "6-minute walk test", "time_frame": "At start and at day 30" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: Measures of inflammation", "description": "● C-reactive protein (CRP)", "time_frame": "At start and at day 30" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: stability of kidney function", "description": "● Measurement of serum creatinine/eGFR, proteinuria/cystatin C into the CKD-EPI equation", "time_frame": "At start and at day 30" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: respiratory health review of systems", "description": "* Breathing: cough, shortness of breath, lung or chest pain, sleep\n* Pain\n* Fatigue: tired/low energy\n* Memory, Thinking, \\& Communication: lack of concentration/focus, forgetfulness (short/long), expressive aphasia\n* Sleep\n* Ear, Nose, \\& Throat: change or loss of taste/smell/appetite/weight, sinus symptoms (face pain, nasal congestion)\n* Stomach \\& Digestion: nausea/vomiting/diarrhea\n* Muscles \\& Joints: body aches (muscle), neuropathy (numbness or tingling)\n* Mental Health \\& Wellbeing: depression, anxiety or feelings of overwhelm\n* Skin: skin changes (rash, swelling)\n* Eye: visual disturbances\n* Fever/Chills\n* Headache\n* Any changes in urine (color, amount, frequency, appearance, pain)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: neurological and mental health review of systems", "description": "Pain, Fatigue, Memory, Thinking, \\& Communication: lack of concentration/focus, forgetfulness (short/long), expressive aphasia, Headache, depression, anxiety or feelings of overwhelm, neuropathy (numbness or tingling), visual disturbances, change or loss of taste/smell, Sleep. sinus symptoms (face pain, nasal congestion)\n\n:appetite/weight, sinus symptoms (face pain, nasal congestion)\n\n* Stomach \\& Digestion: nausea/vomiting/diarrhea\n* Muscles \\& Joints: body aches (muscle),\n* Skin: skin changes (rash, swelling)\n* Fever/Chills\n* Any changes in urine (color, amount, frequency, appearance, pain)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: Gastrointestinal review of systems", "description": "appetite/weight changes; Stomach \\& Digestion: nausea/vomiting/diarrhea\n\n* Muscles \\& Joints: body aches (muscle),\n* Skin: skin changes (rash, swelling)\n* Fever/Chills\n* Any changes in urine (color, amount, frequency, appearance, pain)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: musculoskeletal review of systems", "description": "● Muscles \\& Joints: such as body aches (muscle)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: urinary tract review of systems", "description": "Any changes in urine (color, amount, frequency, appearance, pain)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: infectious diseases review of systems", "description": "● Fever/Chills/ Skin changes/rashes", "time_frame": "One month" }, { "type": "secondary", "measure": "Quality of Life Changes", "description": "Short-Form Health Survey 12 (SF-12v2) 30", "time_frame": "One month" } ], "outcome_measures": [ { "type": "primary", "measure": "Feasibility of dietary intervention:", "description": "Questionnaire on diet feasibility (Appendix F). Exit Questionnaire. Scale 1-5 (1= worse outcome; 5=better outcome)", "time_frame": "One month" }, { "type": "primary", "measure": "Safety signals for electrolytes", "description": "calcium, sodium, potassium, carbon dioxide, chloride,", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Safety signals for kidney function", "description": "BUN and creatinine", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Safety signals for liver function", "description": "Alkaline Phosphatase, ALT, AST, bilirubin, \\& total protein, glucose", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Cardiovascular risk", "description": "Fasting lipid panel: total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Improved uric acid metabolism", "description": "Serum Uric Acid", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "kidney function: proteinuria", "description": "urinalysis and urine protein to creatinine ratio", "time_frame": "At start and at day 30" }, { "type": "primary", "measure": "Safety and tolerability of dietary intervention:", "description": "Questionnaire on parameters of safety and tolerability (Appendix E) 0-10 (Scale 0= best outcome to 10=worse outcome)", "time_frame": "30 days" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs Measurement of change in body weight", "description": "● body weight", "time_frame": "At start and at day 30" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs Measurement of aerobic capacity:", "description": "6-minute walk test", "time_frame": "At start and at day 30" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: Measures of inflammation", "description": "● C-reactive protein (CRP)", "time_frame": "At start and at day 30" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: stability of kidney function", "description": "● Measurement of serum creatinine/eGFR, proteinuria/cystatin C into the CKD-EPI equation", "time_frame": "At start and at day 30" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: respiratory health review of systems", "description": "* Breathing: cough, shortness of breath, lung or chest pain, sleep\n* Pain\n* Fatigue: tired/low energy\n* Memory, Thinking, \\& Communication: lack of concentration/focus, forgetfulness (short/long), expressive aphasia\n* Sleep\n* Ear, Nose, \\& Throat: change or loss of taste/smell/appetite/weight, sinus symptoms (face pain, nasal congestion)\n* Stomach \\& Digestion: nausea/vomiting/diarrhea\n* Muscles \\& Joints: body aches (muscle), neuropathy (numbness or tingling)\n* Mental Health \\& Wellbeing: depression, anxiety or feelings of overwhelm\n* Skin: skin changes (rash, swelling)\n* Eye: visual disturbances\n* Fever/Chills\n* Headache\n* Any changes in urine (color, amount, frequency, appearance, pain)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: neurological and mental health review of systems", "description": "Pain, Fatigue, Memory, Thinking, \\& Communication: lack of concentration/focus, forgetfulness (short/long), expressive aphasia, Headache, depression, anxiety or feelings of overwhelm, neuropathy (numbness or tingling), visual disturbances, change or loss of taste/smell, Sleep. sinus symptoms (face pain, nasal congestion)\n\n:appetite/weight, sinus symptoms (face pain, nasal congestion)\n\n* Stomach \\& Digestion: nausea/vomiting/diarrhea\n* Muscles \\& Joints: body aches (muscle),\n* Skin: skin changes (rash, swelling)\n* Fever/Chills\n* Any changes in urine (color, amount, frequency, appearance, pain)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: Gastrointestinal review of systems", "description": "appetite/weight changes; Stomach \\& Digestion: nausea/vomiting/diarrhea\n\n* Muscles \\& Joints: body aches (muscle),\n* Skin: skin changes (rash, swelling)\n* Fever/Chills\n* Any changes in urine (color, amount, frequency, appearance, pain)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: musculoskeletal review of systems", "description": "● Muscles \\& Joints: such as body aches (muscle)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: urinary tract review of systems", "description": "Any changes in urine (color, amount, frequency, appearance, pain)", "time_frame": "One month" }, { "type": "secondary", "measure": "Improvement of long-COVID syndrome signs: infectious diseases review of systems", "description": "● Fever/Chills/ Skin changes/rashes", "time_frame": "One month" }, { "type": "secondary", "measure": "Quality of Life Changes", "description": "Short-Form Health Survey 12 (SF-12v2) 30", "time_frame": "One month" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 14, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05836402", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05167227", "title": "Does a Technology Enabled Multi-disciplinary Team-based Care Model for the Management of Long COVID and Other Fatiguing Illnesses Improve Clinical Care of Patients and Represent a Sustainable Approach Within a Federally Qualified Health Center?", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-08-06", "start_date": "2021-11-30", "completion_date": "2025-11-28", "primary_completion_date": "2024-11-20", "conditions_raw": [ "SARS-CoV-2 Acute Respiratory Disease", "Myalgic Encephalomyelitis", "Chronic Fatigue Syndrome", "Post-acute Sequelae of SARS-COV-2 Infection", "Post COVID-19 Condition" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Extension For Community Healthcare Outcomes" ], "sponsor": "Family Health Centers of San Diego", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The primary objective of the present research is to determine the effectiveness of Family Health Center of San Diego's Long COVID and Fatiguing Illness Recovery Program (LC\\&FIRP) on clinician- and patient-level outcomes. LC\\&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with Long COVID, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI). Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC\\&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings.", "primary_outcomes": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient symptom checklist with associated severity for those present", "description": "Patient baseline and quarterly surveys, None, Mild, Moderate, Severe", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present, has patient experienced this in the past month", "description": "Patient baseline and quarterly surveys, Yes/No", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present, how long has patient experienced this symptom", "description": "Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present, did patient have this symptom before the patient tested positive for COVID-19?", "description": "Patient baseline and quarterly surveys, Yes/No", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present, during the past month how often have the patient had this symptom?", "description": "Patient baseline and quarterly surveys with use of Likert scale", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present during the past month, how bad was this symptom?", "description": "Patient baseline and quarterly surveys with use of Likert scale", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "For symptoms present, do any of them get worse for at least 24 hours after engaging in activities (physical or mental) that patient was used to doing with no problems?", "description": "Patient baseline and quarterly surveys with Yes/No/Not Applicable/Don't Know", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If fatigue, tiredness, or exhaustion is present, doesn't patient describe it as feeling it come on all of a sudden, or slowly over time", "description": "Patient baseline and quarterly surveys with All of sudden, Slowly over time, Not applicable, Don't know", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If fatigue present, what month and year did the fatiguing illness begin?", "description": "Patient baseline and quarterly surveys, estimated month and year", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "When fatigued, does rest make patient's fatigue better?", "description": "Patient baseline and quarterly surveys, Yes a lot, Yes a little, No not very much, Not applicable, Don't know", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities?", "description": "Patient baseline and quarterly surveys, Yes, No, Not applicable, Don't know", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Patient's medical history check-list", "description": "Patient baseline survey, Yes, No, Unsure", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient's dietary restrictions", "description": "Patient baseline survey, No, Vegan, Vegetarian, Ketogenic, Gluten-free, Dairy-free, Intermittent fasting, Other", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient's food allergies or other food intolerances", "description": "Patient baseline survey, Yes/No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Has patient's employment been impacted due to contracting COVID-19?", "description": "Patient baseline survey, Yes, No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient's frequency to complete 150-minutes per week of moderate-intensity physical activity (like a brisk walk, slow biking, gardening, or ballroom dancing) prior to contracting COVID-19", "description": "Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient's frequency to complete 150-minutes per week of vigorous-intensity physical activity (like running, swimming laps, competitive sports, or fast bicycling) prior to contracting COVID-19", "description": "Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Did patient receive a COVID-19 PCR (nasal swab) test", "description": "Patient baseline survey, Yes/No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Did patient receive a COVID-19 antibody test", "description": "Patient baseline survey, Yes/No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient symptom onset", "description": "Patient baseline survey, Date", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient reported medications used for COVID-19 symptoms", "description": "Patient baseline survey, free text", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient reported prescribed supplementary oxygen support", "description": "Patient baseline survey, Yes/No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient reported admittance to hospital due to COVID-19", "description": "Patient baseline and quarterly surveys, Yes/No", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Do any of the following activities exacerbate patients symptoms: Physical exertion, Diet Changes, Big Meal, Dehydration, Weather changes (hot and humid), Tight clothing, Stress or anxiety, Pre Menstrual period, Menstrual period, Alcohol consumption", "description": "Patient baseline and quarterly surveys, Yes/No", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Does patient feel fully recovered from COVID-19", "description": "Patient quarterly surveys, Yes/No", "time_frame": "During 9 months of follow-up" }, { "type": "secondary", "measure": "Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing)", "description": "Patient quarterly surveys, free text", "time_frame": "During 9 months of follow-up" }, { "type": "secondary", "measure": "Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling)", "description": "Patient quarterly surveys, free text", "time_frame": "During 9 months of follow-up" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ)-2", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ)-9 (if applicable)", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "PROMIS Dyspnea Functional Limitations and Severity Short Forms", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "PROMIS Applied Cognition Abilities and General Concerns Short Forms", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD)-7", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "2-minute step test", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "30 sec sit to stand test", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Grip strength", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Functional Gait Assessment", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Balance tasks", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Post-exertional malaise follow-up", "description": "Follow-up Physical Therapy appointment with patient, Not at all, A little bit, Somewhat, Quite a bit, Very much", "time_frame": "Per Physical Therapy encounter after PT assessment" } ], "outcome_measures": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS)-29", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Patient symptom checklist with associated severity for those present", "description": "Patient baseline and quarterly surveys, None, Mild, Moderate, Severe", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present, has patient experienced this in the past month", "description": "Patient baseline and quarterly surveys, Yes/No", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present, how long has patient experienced this symptom", "description": "Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present, did patient have this symptom before the patient tested positive for COVID-19?", "description": "Patient baseline and quarterly surveys, Yes/No", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present, during the past month how often have the patient had this symptom?", "description": "Patient baseline and quarterly surveys with use of Likert scale", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If symptom is present during the past month, how bad was this symptom?", "description": "Patient baseline and quarterly surveys with use of Likert scale", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "For symptoms present, do any of them get worse for at least 24 hours after engaging in activities (physical or mental) that patient was used to doing with no problems?", "description": "Patient baseline and quarterly surveys with Yes/No/Not Applicable/Don't Know", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If fatigue, tiredness, or exhaustion is present, doesn't patient describe it as feeling it come on all of a sudden, or slowly over time", "description": "Patient baseline and quarterly surveys with All of sudden, Slowly over time, Not applicable, Don't know", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "If fatigue present, what month and year did the fatiguing illness begin?", "description": "Patient baseline and quarterly surveys, estimated month and year", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "When fatigued, does rest make patient's fatigue better?", "description": "Patient baseline and quarterly surveys, Yes a lot, Yes a little, No not very much, Not applicable, Don't know", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities?", "description": "Patient baseline and quarterly surveys, Yes, No, Not applicable, Don't know", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Patient's medical history check-list", "description": "Patient baseline survey, Yes, No, Unsure", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient's dietary restrictions", "description": "Patient baseline survey, No, Vegan, Vegetarian, Ketogenic, Gluten-free, Dairy-free, Intermittent fasting, Other", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient's food allergies or other food intolerances", "description": "Patient baseline survey, Yes/No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Has patient's employment been impacted due to contracting COVID-19?", "description": "Patient baseline survey, Yes, No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient's frequency to complete 150-minutes per week of moderate-intensity physical activity (like a brisk walk, slow biking, gardening, or ballroom dancing) prior to contracting COVID-19", "description": "Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient's frequency to complete 150-minutes per week of vigorous-intensity physical activity (like running, swimming laps, competitive sports, or fast bicycling) prior to contracting COVID-19", "description": "Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Did patient receive a COVID-19 PCR (nasal swab) test", "description": "Patient baseline survey, Yes/No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Did patient receive a COVID-19 antibody test", "description": "Patient baseline survey, Yes/No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient symptom onset", "description": "Patient baseline survey, Date", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient reported medications used for COVID-19 symptoms", "description": "Patient baseline survey, free text", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient reported prescribed supplementary oxygen support", "description": "Patient baseline survey, Yes/No", "time_frame": "Through study referral period, an average of 12 weeks" }, { "type": "secondary", "measure": "Patient reported admittance to hospital due to COVID-19", "description": "Patient baseline and quarterly surveys, Yes/No", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Do any of the following activities exacerbate patients symptoms: Physical exertion, Diet Changes, Big Meal, Dehydration, Weather changes (hot and humid), Tight clothing, Stress or anxiety, Pre Menstrual period, Menstrual period, Alcohol consumption", "description": "Patient baseline and quarterly surveys, Yes/No", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Does patient feel fully recovered from COVID-19", "description": "Patient quarterly surveys, Yes/No", "time_frame": "During 9 months of follow-up" }, { "type": "secondary", "measure": "Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing)", "description": "Patient quarterly surveys, free text", "time_frame": "During 9 months of follow-up" }, { "type": "secondary", "measure": "Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling)", "description": "Patient quarterly surveys, free text", "time_frame": "During 9 months of follow-up" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ)-2", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ)-9 (if applicable)", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "PROMIS Dyspnea Functional Limitations and Severity Short Forms", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "PROMIS Applied Cognition Abilities and General Concerns Short Forms", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder (GAD)-7", "description": "Patient baseline and quarterly surveys", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "2-minute step test", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "30 sec sit to stand test", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Grip strength", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Functional Gait Assessment", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Balance tasks", "description": "Physical Therapy assessment with patient", "time_frame": "During 12 months of follow-up" }, { "type": "secondary", "measure": "Post-exertional malaise follow-up", "description": "Follow-up Physical Therapy appointment with patient, Not at all, A little bit, Somewhat, Quite a bit, Very much", "time_frame": "Per Physical Therapy encounter after PT assessment" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05167227", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06156176", "title": "Pursuing Reduction in Fatigue After COVID-19 Via Exercise and Rehabilitation (PREFACER): A Randomized Feasibility Trial", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-08-01", "start_date": "2025-04-01", "completion_date": "2026-04-01", "primary_completion_date": "2026-04-01", "conditions_raw": [ "Long-COVID", "Long COVID-19", "Post-COVID-19 Syndrome", "Post-COVID Syndrome", "Fatigue", "Post COVID-19 Condition", "Post-COVID Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Covidex" ], "sponsor": "Lawson Research Institute of St. Joseph's", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID is a complex condition that affects approximately 1.4 million Canadians following SARS-CoV-2 infection. Fatigue is the most common symptom of Long COVID. This feasibility trial will evaluate a new rehabilitation program called COVIDEx for treating fatigue after COVID-19, and compare its effectiveness to the standard treatment currently used. The experimental treatment group will receive an 8-week multi-modal rehabilitation program with two 50-minute sessions per week. 60 participants will be recruited, randomly assigned to the COVIDEx program or standard of care (SoC) and followed for 24 weeks.", "primary_outcomes": [ { "type": "primary", "measure": "Recruitment", "description": "The number of screened patients who are eligible, the proportion of eligible patients who consent, number of patients enrolled per month, reasons for non-enrolment.", "time_frame": "Baseline" }, { "type": "primary", "measure": "Intervention Fidelity", "description": "The proportion of participants who meet the acceptable level of intervention fidelity (\\>80%). A fidelity checklist will be used to assess feasibility that includes adherence (i.e., delivery of each key component of the intervention-absent/present), dosage (amount of intervention delivered, number of sessions completed, overall duration of sessions), quality of intervention delivery (i.e., mode of delivery of COVIDEx), and participant acceptability (extent to which participants in the intervention group found the intervention useful).", "time_frame": "Week 24" }, { "type": "primary", "measure": "Retention", "description": "The proportion of missed assessments and incomplete outcome measures data, and proportion of participants who withdraw from the trial.", "time_frame": "Week 24" }, { "type": "primary", "measure": "Zelen Design Acceptability", "description": "The proportion of patients in the standard of care group who provide consent to include their data in the RCT following the disclosure interview.", "time_frame": "Week 24" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in 30-Second Sit-to-Stand Test", "description": "The 30-Second Sit-to-Stand Test involves repeatedly standing up from and sitting down on a chair within a 30-second time frame, assessing lower body strength and functional fitness in individuals. Participants are timed for 30 seconds and the number of times they stand up and sit down in a chair in the 30-second period is recorded. More repetitions indicate higher functional ability (i.e., endurance, leg strength).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Borg Scale of Perceived Physical Exertion", "description": "The Borg Rating of Perceived Exertion (RPE) is a subjective scale used to assess an individual's perceived intensity of physical activity, providing a measure of their effort level during exercise. We are using the 6-20 scale (6 being easy exercise to 20 being extremely vigorous). Participants rate how difficult exercise/activity feels from 6 (no exertion at all) to 20 (maximal exertion).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in The DePaul Symptom Questionnaire", "description": "The DePaul Symptom Questionnaire (DSQ) is a self-report instrument used to assess the severity and frequency of symptoms related to chronic fatigue syndrome in individuals, covering various domains including fatigue, sleep, and cognitive issues. Participants' physical symptoms are rated on a five-point scale for frequency (0=none of the time, to 4=all of the time) and severity (0=no symptoms, 4=very severe).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (short-form)", "description": "Post-Exertional Malaise (PEM) will be assessed using the DSQ-PEM-SF. This questionnaire is used to assess the severity and frequency of symptoms related to PEM in individuals, covering various domains including fatigue, sleep, and cognitive issues.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in EQ-5D-5L", "description": "The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a standardized, self-reported, health-related quality of life questionnaire that assesses individuals across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with three levels of severity (\"no problems\" to \"extreme problems\"), providing a simple and widely used measure for health outcome assessments.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Global Rating of Change Scale", "description": "The GRoC (Global Rating of Change Scale) Scale is a tool designed to assess individuals' subjective perceptions of change over time, typically used to measure the effectiveness of interventions or treatments by comparing current status to a previous baseline. Participants will rate the change in their symptoms from -5 (much worse) to +5 (much better) and we'll be assessing change in post-COVID fatigue.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Hospital Anxiety and Depression Scale", "description": "The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire designed to assess and measure the levels of anxiety and depression in individuals. Statements are rated on a scale of 0 to 3 for how true they are for the participant. A higher score indicates a worse outcome (anxiety or depression).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Post-COVID-19 Functional Status", "description": "This form will collect information on a person's abilities to perform daily activities (and any limitations such as symptoms, pain, or depression). Effect of COVID-19 on functional status is graded on a 5-point scale from 0 (no functional limitations) to 4 (severe functional limitations).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Fatigue", "description": "The PROMIS (Patient-Reported Outcomes Measurement Information System) fatigue scale (short-form) is a self-report measure designed to assess the impact and severity of fatigue experienced by individuals. This scale will be used to measure participants' fatigue levels on a 5-point Likert scale at baseline and at weeks 4, 8, 12, and 24.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Pain", "description": "The Visual Analogue Pain Scale (VAS-Pain) is a subjective pain assessment tool where individuals mark their perceived pain intensity on a continuous line, that will range from \"no pain\" to \"worst pain imaginable,\" providing a quick and visual measure of pain severity. Participants' pain levels will be measured at baseline, and at weeks 4, 8, 12, and 24.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Blinding Success Rate", "description": "Success rate of blinding of the outcome assessors will be evaluated with the James Blinding Index (JBI) scale. The JBI is a continuous value such that 0 \\<= James BI \\<= 1. If the index is 1, all responses are incorrect, and complete blinding is inferred, albeit this may indicate unblinding in the opposite direction (e.g. opposite guessing). If the index is 0, all responses are correct, and complete unblinding is inferred. If the index is 0.5, then half of the guesses are correct and half of the guesses are incorrect, inferring random guessing. Unblinding may be claimed if the upper limit of the two-sided confidence interval is \\< 0.5. The JBI will be evaluated at the end of the trial (24-weeks). A very short questionnaire will ask participants which group they thought they were in (COVIDEx or control, to assess the success of the blinding).", "time_frame": "Week 24" }, { "type": "secondary", "measure": "Change in Brain Function", "description": "Brain function will be assessed using a Magstim Rapid II TMS system to measure Motor Evoked Potential amplitudes and cortical silent period durations of the first dorsal interosseous muscle and the tibialis anterior muscle in the dominant hemisphere's primary motor cortex using a 70 mm figure eight coil and 120mm V coil, respectively.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Burden of Outcome Measures Completeness", "description": "Proportion of missing visits, missing outcomes/data, and reasons for missingness.", "time_frame": "Week 24" }, { "type": "secondary", "measure": "Patient Perceptions", "description": "We will conduct one-on-one interviews with COVIDEx participants and treating physiotherapists at the end of the study protocol, to understand the acceptability of the intervention, perceived benefits, barriers/facilitators to adherence, implementation challenges, and experiences with the modified Zelen design. This will inform the extent to which it is feasible in a real-world setting. Participants will be asked to share their perspectives around study participation and completion to optimize our recruitment and retention strategies for the definitive trial.", "time_frame": "Week 24" } ], "outcome_measures": [ { "type": "primary", "measure": "Recruitment", "description": "The number of screened patients who are eligible, the proportion of eligible patients who consent, number of patients enrolled per month, reasons for non-enrolment.", "time_frame": "Baseline" }, { "type": "primary", "measure": "Intervention Fidelity", "description": "The proportion of participants who meet the acceptable level of intervention fidelity (\\>80%). A fidelity checklist will be used to assess feasibility that includes adherence (i.e., delivery of each key component of the intervention-absent/present), dosage (amount of intervention delivered, number of sessions completed, overall duration of sessions), quality of intervention delivery (i.e., mode of delivery of COVIDEx), and participant acceptability (extent to which participants in the intervention group found the intervention useful).", "time_frame": "Week 24" }, { "type": "primary", "measure": "Retention", "description": "The proportion of missed assessments and incomplete outcome measures data, and proportion of participants who withdraw from the trial.", "time_frame": "Week 24" }, { "type": "primary", "measure": "Zelen Design Acceptability", "description": "The proportion of patients in the standard of care group who provide consent to include their data in the RCT following the disclosure interview.", "time_frame": "Week 24" }, { "type": "secondary", "measure": "Change in 30-Second Sit-to-Stand Test", "description": "The 30-Second Sit-to-Stand Test involves repeatedly standing up from and sitting down on a chair within a 30-second time frame, assessing lower body strength and functional fitness in individuals. Participants are timed for 30 seconds and the number of times they stand up and sit down in a chair in the 30-second period is recorded. More repetitions indicate higher functional ability (i.e., endurance, leg strength).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Borg Scale of Perceived Physical Exertion", "description": "The Borg Rating of Perceived Exertion (RPE) is a subjective scale used to assess an individual's perceived intensity of physical activity, providing a measure of their effort level during exercise. We are using the 6-20 scale (6 being easy exercise to 20 being extremely vigorous). Participants rate how difficult exercise/activity feels from 6 (no exertion at all) to 20 (maximal exertion).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in The DePaul Symptom Questionnaire", "description": "The DePaul Symptom Questionnaire (DSQ) is a self-report instrument used to assess the severity and frequency of symptoms related to chronic fatigue syndrome in individuals, covering various domains including fatigue, sleep, and cognitive issues. Participants' physical symptoms are rated on a five-point scale for frequency (0=none of the time, to 4=all of the time) and severity (0=no symptoms, 4=very severe).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (short-form)", "description": "Post-Exertional Malaise (PEM) will be assessed using the DSQ-PEM-SF. This questionnaire is used to assess the severity and frequency of symptoms related to PEM in individuals, covering various domains including fatigue, sleep, and cognitive issues.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in EQ-5D-5L", "description": "The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a standardized, self-reported, health-related quality of life questionnaire that assesses individuals across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with three levels of severity (\"no problems\" to \"extreme problems\"), providing a simple and widely used measure for health outcome assessments.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Global Rating of Change Scale", "description": "The GRoC (Global Rating of Change Scale) Scale is a tool designed to assess individuals' subjective perceptions of change over time, typically used to measure the effectiveness of interventions or treatments by comparing current status to a previous baseline. Participants will rate the change in their symptoms from -5 (much worse) to +5 (much better) and we'll be assessing change in post-COVID fatigue.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Hospital Anxiety and Depression Scale", "description": "The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire designed to assess and measure the levels of anxiety and depression in individuals. Statements are rated on a scale of 0 to 3 for how true they are for the participant. A higher score indicates a worse outcome (anxiety or depression).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Post-COVID-19 Functional Status", "description": "This form will collect information on a person's abilities to perform daily activities (and any limitations such as symptoms, pain, or depression). Effect of COVID-19 on functional status is graded on a 5-point scale from 0 (no functional limitations) to 4 (severe functional limitations).", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Fatigue", "description": "The PROMIS (Patient-Reported Outcomes Measurement Information System) fatigue scale (short-form) is a self-report measure designed to assess the impact and severity of fatigue experienced by individuals. This scale will be used to measure participants' fatigue levels on a 5-point Likert scale at baseline and at weeks 4, 8, 12, and 24.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Change in Pain", "description": "The Visual Analogue Pain Scale (VAS-Pain) is a subjective pain assessment tool where individuals mark their perceived pain intensity on a continuous line, that will range from \"no pain\" to \"worst pain imaginable,\" providing a quick and visual measure of pain severity. Participants' pain levels will be measured at baseline, and at weeks 4, 8, 12, and 24.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Blinding Success Rate", "description": "Success rate of blinding of the outcome assessors will be evaluated with the James Blinding Index (JBI) scale. The JBI is a continuous value such that 0 \\<= James BI \\<= 1. If the index is 1, all responses are incorrect, and complete blinding is inferred, albeit this may indicate unblinding in the opposite direction (e.g. opposite guessing). If the index is 0, all responses are correct, and complete unblinding is inferred. If the index is 0.5, then half of the guesses are correct and half of the guesses are incorrect, inferring random guessing. Unblinding may be claimed if the upper limit of the two-sided confidence interval is \\< 0.5. The JBI will be evaluated at the end of the trial (24-weeks). A very short questionnaire will ask participants which group they thought they were in (COVIDEx or control, to assess the success of the blinding).", "time_frame": "Week 24" }, { "type": "secondary", "measure": "Change in Brain Function", "description": "Brain function will be assessed using a Magstim Rapid II TMS system to measure Motor Evoked Potential amplitudes and cortical silent period durations of the first dorsal interosseous muscle and the tibialis anterior muscle in the dominant hemisphere's primary motor cortex using a 70 mm figure eight coil and 120mm V coil, respectively.", "time_frame": "Baseline to Week 24" }, { "type": "secondary", "measure": "Burden of Outcome Measures Completeness", "description": "Proportion of missing visits, missing outcomes/data, and reasons for missingness.", "time_frame": "Week 24" }, { "type": "secondary", "measure": "Patient Perceptions", "description": "We will conduct one-on-one interviews with COVIDEx participants and treating physiotherapists at the end of the study protocol, to understand the acceptability of the intervention, perceived benefits, barriers/facilitators to adherence, implementation challenges, and experiences with the modified Zelen design. This will inform the extent to which it is feasible in a real-world setting. Participants will be asked to share their perspectives around study participation and completion to optimize our recruitment and retention strategies for the definitive trial.", "time_frame": "Week 24" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06156176", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07089719", "title": "Bevacizumab in Post-acute Sequelae of COVID-19 : Efficacy and Safety (Pilot Study)", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2025-07-28", "start_date": "2025-10-01", "completion_date": "2028-05-01", "primary_completion_date": "2028-01-01", "conditions_raw": [ "Dyspnea Caused by 2019-nCoV" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Bevacizumab Injection" ], "sponsor": "Assistance Publique - Hôpitaux de Paris", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of this research is to evaluate an innovative treatment, Bevacizumab, in patients suffering from respiratory complications related to COVID-19. These complications, particularly difficulty breathing (dyspnea) and impaired lung function, are common in some individuals after infection. The study seeks to determine whether Bevacizumab can improve breathing capacity by acting on vascular mechanisms that may be responsible for these issues. A total of 21 patients with these persistent symptoms will be included in the study, with close medical monitoring to assess both the effectiveness of the treatment and its safety.\n\nThis research aims to assess the effectiveness and safety of Bevacizumab, a medication known for its anti-angiogenic properties (which prevent the formation of new blood vessels), in patients experiencing persistent respiratory problems after COVID-19 infection. In other words, this research is based on the idea that inhibiting blood vessel formation with Bevacizumab may improve clinical outcomes in patients with severe forms of COVID-19 by reducing vascular complications associated with the infection.\n\nTo answer this research question, 21 individuals with persistent respiratory symptoms (significant dyspnea) and reduced lung diffusing capacity (DLCO less than 75% of the predicted value) at least three months after their initial COVID-19 infection will be included. The study is being conducted at Hôpital Européen Georges Pompidou, in Paris.\n\nThe total expected duration of the research is 31 months, and each patient's participation will last 7 months, which includes 2 months of treatment (five Bevacizumab injections) followed by five additional months of medical follow-up.\n\nIn this research project, we will be evaluating Bevacizumab, an experimental drug in the context of Long COVID. Bevacizumab is a monoclonal antibody used to inhibit angiogenesis (the abnormal formation of new blood vessels). While commonly used in oncology, in this study, its use aims to improve lung function in patients suffering from persistent respiratory complications after COVID-19 infection.\n\nBevacizumab will be administered as an intravenous infusion. The infusion lasts between 30 and 90 minutes. The dosage is 10 mg/kg every two weeks, for a total of five infusions over a two-month period. Additional follow-up visits will be conducted one month and five months after the end of treatment. Monitoring will include clinical examinations, laboratory tests, and lung function assessments.", "primary_outcomes": [ { "type": "primary", "measure": "Rate of patients with 10% increase of impaired DLCO", "description": "Assess efficacy of bevacizumab injection in long COVID patients with impaired DLCO (\\<75% of predicted value). The positive criteria will be a 10% increase in DLCO at three months after the introduction of bevacizumab.", "time_frame": "3 months after the introduction of bevacizumab." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Proportion of patients with recovery of clinical symptoms", "description": "Modification of clinical evaluation and in particular the clinical symptom of dyspnea and fatigue or other related clinical parameters of long-COVID patients (mMRC Scale, Borg Scale, STOP-BANG Questionnaire, WHODAS 2.0, Epworth Sleepiness Scale, which assess fatigue severity in long-COVID patients).", "time_frame": "1, 2, 3 and 7 months after the initiation of Bevacizumab." }, { "type": "secondary", "measure": "Proportion of patients with recovery of psychological, cognitive, and autonomic functions", "description": "Evaluation of psychological, cognitive, and autonomic functions. In particular, additional assessments will be conducted to evaluate psychological, cognitive, and autonomic functions with the Nijmegen Questionnaire, the Hospital Anxiety and Depression Scale, the Montreal Cognitive Assessment, the self-reported Ricci-Gagnon Physical Activity Questionnaire, the Somatic Symptom Disorder Scale-12 (SSD-12) and the Survey of Autonomic Symptoms.", "time_frame": "3 and 7 months after the initiation of Bevacizumab treatment." }, { "type": "secondary", "measure": "Proportion of patients with improvement of other parameter than DLCO explored by Pulmonary Function Test", "description": "Modification of other respiratory function markers: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, total lung capacity (TLC), residual volume (RV), and 6-minutes walking distance test between baseline and follow-up.", "time_frame": "1, 2, 3 and 7-months after the initiation of Bevacizumab treatment." }, { "type": "secondary", "measure": "Modification of DLCO", "description": "Difference of DLCO between baseline and follow-up.", "time_frame": "1 and 2 months after the initiation of Bevacizumab treatment." }, { "type": "secondary", "measure": "Circulating angiogenic biomarkers levels", "description": "Difference of circulating angiogenic biomarkers levels between baseline and follow-up.", "time_frame": "1, 2, 3 and 7 months after the initiation of Bevacizumab treatment." }, { "type": "secondary", "measure": "Number of side effects related to bevacizumab", "description": "Safety of bevacizumab in long-COVID patients regarding treatment side effects.", "time_frame": "From bevacizumab treatment initiation to the end of the follow-up at 7 months." }, { "type": "secondary", "measure": "Number of patients with hospitalization or medical consultation", "description": "Safety of bevacizumab in long-COVID patients regarding hospitalization or medical consultation.", "time_frame": "From bevacizumab treatment initiation to the end of the follow-up at 7 months." } ], "outcome_measures": [ { "type": "primary", "measure": "Rate of patients with 10% increase of impaired DLCO", "description": "Assess efficacy of bevacizumab injection in long COVID patients with impaired DLCO (\\<75% of predicted value). The positive criteria will be a 10% increase in DLCO at three months after the introduction of bevacizumab.", "time_frame": "3 months after the introduction of bevacizumab." }, { "type": "secondary", "measure": "Proportion of patients with recovery of clinical symptoms", "description": "Modification of clinical evaluation and in particular the clinical symptom of dyspnea and fatigue or other related clinical parameters of long-COVID patients (mMRC Scale, Borg Scale, STOP-BANG Questionnaire, WHODAS 2.0, Epworth Sleepiness Scale, which assess fatigue severity in long-COVID patients).", "time_frame": "1, 2, 3 and 7 months after the initiation of Bevacizumab." }, { "type": "secondary", "measure": "Proportion of patients with recovery of psychological, cognitive, and autonomic functions", "description": "Evaluation of psychological, cognitive, and autonomic functions. In particular, additional assessments will be conducted to evaluate psychological, cognitive, and autonomic functions with the Nijmegen Questionnaire, the Hospital Anxiety and Depression Scale, the Montreal Cognitive Assessment, the self-reported Ricci-Gagnon Physical Activity Questionnaire, the Somatic Symptom Disorder Scale-12 (SSD-12) and the Survey of Autonomic Symptoms.", "time_frame": "3 and 7 months after the initiation of Bevacizumab treatment." }, { "type": "secondary", "measure": "Proportion of patients with improvement of other parameter than DLCO explored by Pulmonary Function Test", "description": "Modification of other respiratory function markers: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, total lung capacity (TLC), residual volume (RV), and 6-minutes walking distance test between baseline and follow-up.", "time_frame": "1, 2, 3 and 7-months after the initiation of Bevacizumab treatment." }, { "type": "secondary", "measure": "Modification of DLCO", "description": "Difference of DLCO between baseline and follow-up.", "time_frame": "1 and 2 months after the initiation of Bevacizumab treatment." }, { "type": "secondary", "measure": "Circulating angiogenic biomarkers levels", "description": "Difference of circulating angiogenic biomarkers levels between baseline and follow-up.", "time_frame": "1, 2, 3 and 7 months after the initiation of Bevacizumab treatment." }, { "type": "secondary", "measure": "Number of side effects related to bevacizumab", "description": "Safety of bevacizumab in long-COVID patients regarding treatment side effects.", "time_frame": "From bevacizumab treatment initiation to the end of the follow-up at 7 months." }, { "type": "secondary", "measure": "Number of patients with hospitalization or medical consultation", "description": "Safety of bevacizumab in long-COVID patients regarding hospitalization or medical consultation.", "time_frame": "From bevacizumab treatment initiation to the end of the follow-up at 7 months." } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 21, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07089719", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07079787", "title": "Telerehabilitation Decision Support System: Pilot Testing Protocol", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-07-23", "start_date": "2025-07-25", "completion_date": "2025-08-29", "primary_completion_date": "2025-08-18", "conditions_raw": [ "Stroke", "Mild Cognitive Impairment (MCI)", "Vestibular Disease", "Long Covid-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Telerehab Dss Pilot Test" ], "sponsor": "University College, London", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study follows the successfully completed HOLOBalance project which was funded by the EU Horizon 2020 scheme. TheHOLOBalance platform delivers exercises demonstrated via a hologram of the physiotherapist and corrected in real time by the hologram prompts based on performance monitoring via sensors. Further information is available at: https://holobalance.eu/. HOLOBalance was developed as a comprehensive rehabilitation protocol for individualised remote (tele)rehabilitation balance physiotherapy programme. It includes different multisensory balance and gait exercises, physical activity and memory training and exergames (video games which are also exercises) to improve balance function in older adults. The system can thus assess and remotely monitor how users are performing the exercises.\n\nThis pilot testing of a multisite randomised control trial (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to investigating the usability and feasibility among a smaller sample population at each clinical site, identifying any technical bugs, and/or clinical procedural flaws to be remedied before delivery of the full-scale RCT.", "primary_outcomes": [ { "type": "primary", "measure": "Incidence of Treatment-Emergent Adverse Events (safety)", "description": "Participants will be monitored for adverse events during telephone or face-to-face contacts as part of the intervention phase and during follow-up assessments. Any adverse events related to the treatment will be reported via an adverse events form on the system database. Falls diaries will be collected weekly from participants during the intervention and monthly for up to 6 months after completion of the intervention.", "time_frame": "Baseline assessment (week 1) through to the last session of Week 3" }, { "type": "primary", "measure": "Recruitment Rate (acceptability)", "description": "percentage of recruited participants that were eligible", "time_frame": "Baseline assessment (week 1) through to the last session of Week 3" }, { "type": "primary", "measure": "Feasibility (protocol deviations/problems)", "description": "Incidence of protocol deviation and/or implementation problems reported during the intervention.", "time_frame": "Baseline assessment (week 1) through to the last session of week 3" }, { "type": "primary", "measure": "Participants experience using the system (usability)", "description": "Participants experience using the system gathered via qualitative feedback throughout the testing period and post-intervention via exit interviews", "time_frame": "Baseline assessment (week 1) through to the last session of week 3" }, { "type": "primary", "measure": "Adherence to Intervention", "description": "percentage of prescribed sessions completed throughout the intervention", "time_frame": "Week 1 through to completion at week 3" }, { "type": "primary", "measure": "Drop-out rate (acceptability)", "description": "Percentage of enrolled participants that were loss to follow-up or drop-outs", "time_frame": "Baseline (week 1) through to last session in week 3" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Functional Gait Assessment (FGA)", "description": "test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes).", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Mini Balance Evaluation Systems Test (Mini-BESTest)", "description": "a 14-item test that assesses dynamic balance, on a scale of 0 (indicating severe balance impairment) to 28 (representing normal balance with a total score of 28 points).", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA)", "description": "includes sections on visuospatial/executive function, naming, attention, language, abstraction, memory and orientation to time and place (6 questions) with a scor range from 0-30, with a higher score indicating better cognitive function.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "EuroQol five dimensional descriptive system (EQ-5D-5L)", "description": "Measure of quality-adjusted life years (QALYs). EQ-5D-5L is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS (Visual Analogue Scale) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate \"how your health is TODAY\" with a higher score indicating better health-related quality of life", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Rapid Assessment of Physical Activity (RAPA)", "description": "The 9-item self-administered Rapid Assessment of Physical Activity (RAPA) is a questionnaire that assesses levels of a wide range of physical activity level in adults older than 50 years, with a score range 1-7 and a higher score indicating ihgher levels of physical activity.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Dizziness Handicap Inventory (DHI)", "description": "The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes).", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "The Activities-specific balance confidence scale (ABC)", "description": "The Activities-specific Balance Confidence Scale (ABC) that assesses patient's perceived confidence for 16-activities of daily living without losing balance .Score range from 0-100 with higher schore indicating greater balance confidence and scores ≤67/100% indicate increased falls risk.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "The Hospital Anxiety and Depression Scale (HADS-d) depression subscale", "description": "14-item scale which assesses non-somatic anxiety (HAD-A) and depression (HAD-D) symptoms. Scores range from 0-21 for each subscale, with higher scores indicating worse outcomes (greater anxiety or depression).", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FFS)", "description": "a 9-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them. Sca;e 9-63 with higher score indicating greater fatigue.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS)", "description": "developed to enable the measuring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental wellbeing. The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible. The scale has been widely used nationally and internationally for monitoring, evaluating projects and programmes and investigating the determinants of mental wellbeing. Scale 14-70 with higher score indicating better mental wellbeing.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Situational Vertigo Questionnaire (SVQ)", "description": "The SVQ is 20-item questionnaire designed to assess discomfort in situations of intense visual salience of visual-vestibular conflict. It was originally developed as a measure of space and motion discomfort. The questions are graded on a scale from 0 (not at all) to 4 (very much), with a higher score indicating greater vertigo severity.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "The system Usability Scale (SUS)", "description": "The System Usability Scale (SUS) scale 1-5 rated on 10 aspects, with a total possible score of 0-100, with a higher score indicated better usability.", "time_frame": "Post-intervention (end of Week 3)" }, { "type": "secondary", "measure": "User experience questionnaire (UEQ)", "description": "he User Experience Questionnaire (UEQ; scale 1-7 on 26 dimensions of attractiveness, perspicuity, efficiency, dependability, stimulation and novelty with a score range of -3 (worst) to +3 (best) with a higher score indicating a more positive user experience.", "time_frame": "Post-intervention (end of Week 3)" } ], "outcome_measures": [ { "type": "primary", "measure": "Incidence of Treatment-Emergent Adverse Events (safety)", "description": "Participants will be monitored for adverse events during telephone or face-to-face contacts as part of the intervention phase and during follow-up assessments. Any adverse events related to the treatment will be reported via an adverse events form on the system database. Falls diaries will be collected weekly from participants during the intervention and monthly for up to 6 months after completion of the intervention.", "time_frame": "Baseline assessment (week 1) through to the last session of Week 3" }, { "type": "primary", "measure": "Recruitment Rate (acceptability)", "description": "percentage of recruited participants that were eligible", "time_frame": "Baseline assessment (week 1) through to the last session of Week 3" }, { "type": "primary", "measure": "Feasibility (protocol deviations/problems)", "description": "Incidence of protocol deviation and/or implementation problems reported during the intervention.", "time_frame": "Baseline assessment (week 1) through to the last session of week 3" }, { "type": "primary", "measure": "Participants experience using the system (usability)", "description": "Participants experience using the system gathered via qualitative feedback throughout the testing period and post-intervention via exit interviews", "time_frame": "Baseline assessment (week 1) through to the last session of week 3" }, { "type": "primary", "measure": "Adherence to Intervention", "description": "percentage of prescribed sessions completed throughout the intervention", "time_frame": "Week 1 through to completion at week 3" }, { "type": "primary", "measure": "Drop-out rate (acceptability)", "description": "Percentage of enrolled participants that were loss to follow-up or drop-outs", "time_frame": "Baseline (week 1) through to last session in week 3" }, { "type": "secondary", "measure": "Functional Gait Assessment (FGA)", "description": "test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes).", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Mini Balance Evaluation Systems Test (Mini-BESTest)", "description": "a 14-item test that assesses dynamic balance, on a scale of 0 (indicating severe balance impairment) to 28 (representing normal balance with a total score of 28 points).", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA)", "description": "includes sections on visuospatial/executive function, naming, attention, language, abstraction, memory and orientation to time and place (6 questions) with a scor range from 0-30, with a higher score indicating better cognitive function.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "EuroQol five dimensional descriptive system (EQ-5D-5L)", "description": "Measure of quality-adjusted life years (QALYs). EQ-5D-5L is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS (Visual Analogue Scale) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate \"how your health is TODAY\" with a higher score indicating better health-related quality of life", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Rapid Assessment of Physical Activity (RAPA)", "description": "The 9-item self-administered Rapid Assessment of Physical Activity (RAPA) is a questionnaire that assesses levels of a wide range of physical activity level in adults older than 50 years, with a score range 1-7 and a higher score indicating ihgher levels of physical activity.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Dizziness Handicap Inventory (DHI)", "description": "The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes).", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "The Activities-specific balance confidence scale (ABC)", "description": "The Activities-specific Balance Confidence Scale (ABC) that assesses patient's perceived confidence for 16-activities of daily living without losing balance .Score range from 0-100 with higher schore indicating greater balance confidence and scores ≤67/100% indicate increased falls risk.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "The Hospital Anxiety and Depression Scale (HADS-d) depression subscale", "description": "14-item scale which assesses non-somatic anxiety (HAD-A) and depression (HAD-D) symptoms. Scores range from 0-21 for each subscale, with higher scores indicating worse outcomes (greater anxiety or depression).", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FFS)", "description": "a 9-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them. Sca;e 9-63 with higher score indicating greater fatigue.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS)", "description": "developed to enable the measuring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental wellbeing. The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible. The scale has been widely used nationally and internationally for monitoring, evaluating projects and programmes and investigating the determinants of mental wellbeing. Scale 14-70 with higher score indicating better mental wellbeing.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "Situational Vertigo Questionnaire (SVQ)", "description": "The SVQ is 20-item questionnaire designed to assess discomfort in situations of intense visual salience of visual-vestibular conflict. It was originally developed as a measure of space and motion discomfort. The questions are graded on a scale from 0 (not at all) to 4 (very much), with a higher score indicating greater vertigo severity.", "time_frame": "Baseline assessment through to the last session of Week 3" }, { "type": "secondary", "measure": "The system Usability Scale (SUS)", "description": "The System Usability Scale (SUS) scale 1-5 rated on 10 aspects, with a total possible score of 0-100, with a higher score indicated better usability.", "time_frame": "Post-intervention (end of Week 3)" }, { "type": "secondary", "measure": "User experience questionnaire (UEQ)", "description": "he User Experience Questionnaire (UEQ; scale 1-7 on 26 dimensions of attractiveness, perspicuity, efficiency, dependability, stimulation and novelty with a score range of -3 (worst) to +3 (best) with a higher score indicating a more positive user experience.", "time_frame": "Post-intervention (end of Week 3)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07079787", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05965752", "title": "RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-07-18", "start_date": "2023-09-01", "completion_date": "2024-06-10", "primary_completion_date": "2024-06-10", "conditions_raw": [ "Long COVID", "Long COVID-19", "Long COVID19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Brainhq/Active Comparator Activity", "Brainhq", "Pasc Core", "Tdcs-Active" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.\n\nThis protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains.", "primary_outcomes": [ { "type": "primary", "measure": "Total Number of Participants Enrolled in Each Appendix", "description": "Appendix-specific outcome measure data will be reported under the associated NCT ID.", "time_frame": "160 Days" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Total Number of Participants Enrolled in Each Appendix", "description": "Appendix-specific outcome measure data will be reported under the associated NCT ID.", "time_frame": "160 Days" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 328, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05965752", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05467904", "title": "Double-Blind Randomized Placebo-Controlled Trial of a Proprietary Full Hemp Flower Formulation for Long COVID", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2025-07-17", "start_date": "2024-08", "completion_date": "2025-12", "primary_completion_date": "2025-05", "conditions_raw": [ "Post-acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Xltranplus, Xltran" ], "sponsor": "LUCINDA BATEMAN, MD", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a double-blind, randomized, placebo-controlled single-center clinical trial to explore the safety and efficacy of a full cannabis flower formulation, rich in cannabinoids and terpenes formulation, Xltran Plus™ and Xltran™, both compared to placebo for the treatment of Long COVID patients with prolonged symptoms caused by COVID-19.", "primary_outcomes": [ { "type": "primary", "measure": "Patient Global Impression of Change (PGIC)", "description": "PGIC is a 7 point scale rating individuals perception of overall improvement. Patients rate their change as \"very much improved,\" \"much improved,\" \"minimally improved,\" \"no change,\" \"minimally worse,\" \"much worse,\" or \"very much worse.\"", "time_frame": "Change in PGIC from beginning to end of treatment at 30 days" }, { "type": "primary", "measure": "Total Symptom Score (TSS)", "description": "TSS is the sum of patient-reported scores (0-5 scale, 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe) for each of 10 symptoms, specifically: (i) fatigue/weakness; (ii) pain, e.g., musculoskeletal, allodynia; (iii) brain fog; (iv) dysautonomia, e.g., tachycardia, hypotension, orthostatic intolerance, dizziness, vertigo, light-headedness, syncope, gastrointestinal/urinary issues; (v) headaches, including head/neck discomfort; (vi) sensory problems, e.g., sensitivity to light, sound, odor, taste, touch, or problems such as blurry vision, tinnitus, etc; (vii) sleep difficulties; (viii) shortness of breath; (ix) flu-like symptoms, e.g., sore throat, tender lymph nodes, feverishness, sinus or nasal congestion; and (x) mood disorders, e.g., anxiety, depression.", "time_frame": "Change in TSS from beginning to end of treatment at 30 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Insomnia Severity Index", "description": "A brief 7 item instrument to assess the severity of both nighttime and daytime components of insomnia", "time_frame": "Univariate time series analysis of change/trend of weekly responses over 30 days" }, { "type": "secondary", "measure": "Harvard Flourishing Index (HFI)", "description": "Consists of two questions or items from each of the five main subscales: happiness and life satisfaction, mental and physical health, meaning and purpose, character and virtue, and close social relationships.", "time_frame": "Univariate time series analysis of change/trend of weekly responses over 30 days" }, { "type": "secondary", "measure": "DANA Brain Vital", "description": "Assessment of reaction time cognitive efficiency", "time_frame": "Univariate time series analysis of change/trend of weekly cognitive efficiency over 30 days" }, { "type": "secondary", "measure": "Hours of Upright Activity", "description": "Self-reported time with feet on the floor over a 24 hours period", "time_frame": "Univariate time series analysis of change/trend of daily responses over 30 days" }, { "type": "secondary", "measure": "Daily Steps", "description": "Daily steps over a 24 hour period", "time_frame": "Univariate time series analysis of change/trend of daily steps over 30 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Patient Global Impression of Change (PGIC)", "description": "PGIC is a 7 point scale rating individuals perception of overall improvement. Patients rate their change as \"very much improved,\" \"much improved,\" \"minimally improved,\" \"no change,\" \"minimally worse,\" \"much worse,\" or \"very much worse.\"", "time_frame": "Change in PGIC from beginning to end of treatment at 30 days" }, { "type": "primary", "measure": "Total Symptom Score (TSS)", "description": "TSS is the sum of patient-reported scores (0-5 scale, 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe) for each of 10 symptoms, specifically: (i) fatigue/weakness; (ii) pain, e.g., musculoskeletal, allodynia; (iii) brain fog; (iv) dysautonomia, e.g., tachycardia, hypotension, orthostatic intolerance, dizziness, vertigo, light-headedness, syncope, gastrointestinal/urinary issues; (v) headaches, including head/neck discomfort; (vi) sensory problems, e.g., sensitivity to light, sound, odor, taste, touch, or problems such as blurry vision, tinnitus, etc; (vii) sleep difficulties; (viii) shortness of breath; (ix) flu-like symptoms, e.g., sore throat, tender lymph nodes, feverishness, sinus or nasal congestion; and (x) mood disorders, e.g., anxiety, depression.", "time_frame": "Change in TSS from beginning to end of treatment at 30 days" }, { "type": "secondary", "measure": "Insomnia Severity Index", "description": "A brief 7 item instrument to assess the severity of both nighttime and daytime components of insomnia", "time_frame": "Univariate time series analysis of change/trend of weekly responses over 30 days" }, { "type": "secondary", "measure": "Harvard Flourishing Index (HFI)", "description": "Consists of two questions or items from each of the five main subscales: happiness and life satisfaction, mental and physical health, meaning and purpose, character and virtue, and close social relationships.", "time_frame": "Univariate time series analysis of change/trend of weekly responses over 30 days" }, { "type": "secondary", "measure": "DANA Brain Vital", "description": "Assessment of reaction time cognitive efficiency", "time_frame": "Univariate time series analysis of change/trend of weekly cognitive efficiency over 30 days" }, { "type": "secondary", "measure": "Hours of Upright Activity", "description": "Self-reported time with feet on the floor over a 24 hours period", "time_frame": "Univariate time series analysis of change/trend of daily responses over 30 days" }, { "type": "secondary", "measure": "Daily Steps", "description": "Daily steps over a 24 hour period", "time_frame": "Univariate time series analysis of change/trend of daily steps over 30 days" } ], "relevance_tags": [ "General", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT05467904", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06534164", "title": "Telerehabilitation of Balance Clinical and Economic Decision Support System", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-07-10", "start_date": "2025-09-01", "completion_date": "2026-08-31", "primary_completion_date": "2026-06-30", "conditions_raw": [ "Stroke", "Mild Cognitive Impairment", "Vestibular Diseases", "Long Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Full/High Tech Telerehabilitation Decision Support System", "Basic/Low Tech Telerehabilitation Decision Support System", "Otago Home Exercise Program", "Vestibular Rehabilitation Program" ], "sponsor": "University College, London", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study follows the successfully completed HOLOBalance project which was funded by the EU Horizon 2020 scheme. TheHOLOBalance platform delivers exercises demonstrated via a hologram of the physiotherapist and corrected in real time by the hologram prompts based on performance monitoring via sensors. Further information is available at: https://holobalance.eu/. HOLOBalance was developed as a comprehensive rehabilitation protocol for individualised remote (tele)rehabilitation balance physiotherapy programme. It includes different multisensory balance and gait exercises, physical activity and memory training and exergames (video games which are also exercises) to improve balance function in older adults. The system can thus assess and remotely monitor how users are performing the exercises.\n\nThis multisite randomised control trial (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to (i) determine the system's safety, acceptability, and feasibility explore effectiveness of running such programme in comparison with the current standard care for middle-age/older adults with balance disorders/falls due to MCI, vestibular disorders, stroke or long Covid. This study also aims to (ii) assess if balance function, gait, cognitive function, balance confidence, and wellbeing can improve more compared to standard intervention and (iii) provide preliminary data for a definitive randomised controlled trial.\n\nThis study involves human participants, and each clinical site has applied for appropriate ethical approval.", "primary_outcomes": [ { "type": "primary", "measure": "Recruitment Rate (acceptability)", "description": "percentage of recruited participants that were eligible", "time_frame": "Baseline (week 0) through to post-intervention at week 10" }, { "type": "primary", "measure": "Incidence of Treatment-Emergent Adverse Events (safety)", "description": "Participants will be monitored for adverse events during telephone or face-to-face contacts as part of the intervention phase and during follow-up assessments. Any adverse events related to the treatment will be reported via an adverse events form on the system database. Falls diaries will be collected weekly from participants during the intervention and monthly for up to 6 months after completion of the intervention.", "time_frame": "Baseline (week 0) through to post-intervention at week 10" }, { "type": "primary", "measure": "Feasibility (protocol deviations/problems)", "description": "Incidence of protocol deviation and/or implementation problems reported during the intervention.", "time_frame": "Baseline (Week 0) through to post-intervention at week 10" }, { "type": "primary", "measure": "Participants experience using the system (usability)", "description": "Participants experience using the system (perceived benefits) via via weekly check in on frustration levels, technical troubleshooting and any other usability considerations, as well as during exit interviews for all TeleRehab DSS group completers.", "time_frame": "weekly and post-intervention at week 10" }, { "type": "primary", "measure": "Adherence to Intervention", "description": "percentage of prescribed sessions completed throughout the intervention", "time_frame": "Week 1 through to completion at week 9" }, { "type": "primary", "measure": "Drop-out rate (acceptability)", "description": "Percentage of enrolled participants that were loss to follow-up or drop-outs", "time_frame": "Baseline (week 0) through to post-intervention at week 10" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Mini Balance Evaluation Systems Test (Mini-BESTest)", "description": "a 14-item test that assesses dynamic balance, on a scale of 0 (indicating severe balance impairment) to 28 (representing normal balance with a total score of 28 points.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Functional Gait Assessment (FGA)", "description": "test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes).", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Incremental cost-effectiveness ratio (ICER)", "description": "Cost-effectiveness, by dividing the difference in mean QALYs; The Incremental Cost-Effectiveness Ratio (ICER) is calculated as the difference in cost (ΔC) divided by the difference in effectiveness (ΔE) between two interventions. Lower ICER values indicate better cost-effectiveness, while higher values suggest greater cost per unit of effectiveness gained. An intervention is considered cost-effective if its ICER falls below a predefined willingness-to-pay (WTP) threshold", "time_frame": "1 year before study to 1 year after the end of the intervention" }, { "type": "secondary", "measure": "EuroQol five dimensional descriptive system (EQ-5D-5L)", "description": "Measure of quality-adjusted life years (QALYs). EQ-5D-5L is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS (Visual Analogue Scale) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate \"how your health is TODAY\" with a higher score indicating better health-related quality of life .", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA)", "description": "includes sections on visuospatial/executive function, naming, attention, language, abstraction, memory and orientation to time and place (6 questions) with a scor range from 0-30, with a higher score indicating better cognitive function.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Rapid Assessment of Physical Activity (RAPA)", "description": "The 9-item self-administered Rapid Assessment of Physical Activity (RAPA) is a questionnaire that assesses levels of a wide range of physical activity level in adults older than 50 years, with a score range 1-7 and a higher score indicating ihgher levels of physical activity.", "time_frame": "Baseline (week 0) & post-intervention (Week 10)" }, { "type": "secondary", "measure": "Dizziness Handicap Inventory (DHI)", "description": "The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes).", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "The Activities-specific balance confidence scale (ABC)", "description": "The Activities-specific Balance Confidence Scale (ABC) that assesses patient's perceived confidence for 16-activities of daily living without losing balance .Score range from 0-100 with higher schore indicating greater balance confidence and scores ≤67/100% indicate increased falls risk.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "The Hospital Anxiety and Depression Scale (HADS-d) depression subscale", "description": "a 14-item scale which assesses non-somatic anxiety (HAD-A) and depression (HAD-D) symptoms. Scores range from 0-21 for each subscale, with higher scores indicating worse outcomes (greater anxiety or depression).", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FFS)", "description": "a 9-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them. Sca;e 9-63 with higher score indicating greater fatigue.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS)", "description": "developed to enable the measuring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental wellbeing. The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible. The scale has been widely used nationally and internationally for monitoring, evaluating projects and programmes and investigating the determinants of mental wellbeing. Scale 14-70 with higher score indicating better mental wellbeing.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Situational Vertigo Questionnaire(SVQ):", "description": "The SVQ is 20-item questionnaire designed to assess discomfort in situations of intense visual salience of visual-vestibular conflict. It was originally developed as a measure of space and motion discomfort. The questions are graded on a scale from 0 (not at all) to 4 (very much), with a higher score indicating greater vertigo severity.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "The system Usability Scale (SUS)", "description": "The System Usability Scale (SUS) scale 1-5 rated on 10 aspects, with a total possible score of 0-100, with a higher score indicated better usability.", "time_frame": "post-intervention (week 10)" }, { "type": "secondary", "measure": "User experience questionnaire (UEQ)", "description": "The User Experience Questionnaire (UEQ; scale 1-7 on 26 dimensions of attractiveness, perspicuity, efficiency, dependability, stimulation and novelty with a score range of -3 (worst) to +3 (best) with a higher score indicating a more positive user experience.", "time_frame": "Baseline (week 0), Week 8 & post intervention (Week 10)" }, { "type": "secondary", "measure": "Falls", "description": "Falls diary collected (self-reported)", "time_frame": "collected weekly for the duration of the 9-week intervention and up to 6 months after completing the intervention" }, { "type": "secondary", "measure": "System performance", "description": "We will also compare the TeleRehaB DSS predicted versus observed patient outcomes on the EQ-5D-5L, and secondary outcome measures, to assess the system performance", "time_frame": "post-intervention (week 10)" }, { "type": "secondary", "measure": "eHealth Literacy Assessment (eHEALS)", "description": "a 10-item likert scale questionnaire that evaluate's patients' skills in finding, evaluating and applying electronic health information. Responses range from 1 (strongly disagree, to 65 (strong agree), with total scores indicating levels of eHealth literacy. This will be used to help validate the AI-model in terms of participant allocation into the high-tech versus low-tech solution.", "time_frame": "Baseline (week 0)" }, { "type": "secondary", "measure": "The Senior technology acceptance & adoption model (STAM)", "description": "is a 38-item questionnaire, with items rated on a 1-10 Likert scale to measure factors influencing technology acceptance among older adults, with a higher scores indicating greater perceived digital literacy.", "time_frame": "Baseline (week 0)" }, { "type": "secondary", "measure": "Mobile Device Proficiency Questionnaire - short (MDPQ-s)", "description": "is a 16-question version of the full MDPQ-16. The MDPQ, its subscales, and the MDPQ-16 were found to be highly reliable and valid measures of mobile device proficiency in a large sample. We conclude that the MDPQ and MDPQ-16 may serve as useful tools for facilitating mobile device training of older adults and measuring mobile device proficiency for research purposes.", "time_frame": "Baseline (week 0)" } ], "outcome_measures": [ { "type": "primary", "measure": "Recruitment Rate (acceptability)", "description": "percentage of recruited participants that were eligible", "time_frame": "Baseline (week 0) through to post-intervention at week 10" }, { "type": "primary", "measure": "Incidence of Treatment-Emergent Adverse Events (safety)", "description": "Participants will be monitored for adverse events during telephone or face-to-face contacts as part of the intervention phase and during follow-up assessments. Any adverse events related to the treatment will be reported via an adverse events form on the system database. Falls diaries will be collected weekly from participants during the intervention and monthly for up to 6 months after completion of the intervention.", "time_frame": "Baseline (week 0) through to post-intervention at week 10" }, { "type": "primary", "measure": "Feasibility (protocol deviations/problems)", "description": "Incidence of protocol deviation and/or implementation problems reported during the intervention.", "time_frame": "Baseline (Week 0) through to post-intervention at week 10" }, { "type": "primary", "measure": "Participants experience using the system (usability)", "description": "Participants experience using the system (perceived benefits) via via weekly check in on frustration levels, technical troubleshooting and any other usability considerations, as well as during exit interviews for all TeleRehab DSS group completers.", "time_frame": "weekly and post-intervention at week 10" }, { "type": "primary", "measure": "Adherence to Intervention", "description": "percentage of prescribed sessions completed throughout the intervention", "time_frame": "Week 1 through to completion at week 9" }, { "type": "primary", "measure": "Drop-out rate (acceptability)", "description": "Percentage of enrolled participants that were loss to follow-up or drop-outs", "time_frame": "Baseline (week 0) through to post-intervention at week 10" }, { "type": "secondary", "measure": "Mini Balance Evaluation Systems Test (Mini-BESTest)", "description": "a 14-item test that assesses dynamic balance, on a scale of 0 (indicating severe balance impairment) to 28 (representing normal balance with a total score of 28 points.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Functional Gait Assessment (FGA)", "description": "test that assesses complex gait tasks (e.g. walking with head turns or stopping and turning, 5 minutes).", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Incremental cost-effectiveness ratio (ICER)", "description": "Cost-effectiveness, by dividing the difference in mean QALYs; The Incremental Cost-Effectiveness Ratio (ICER) is calculated as the difference in cost (ΔC) divided by the difference in effectiveness (ΔE) between two interventions. Lower ICER values indicate better cost-effectiveness, while higher values suggest greater cost per unit of effectiveness gained. An intervention is considered cost-effective if its ICER falls below a predefined willingness-to-pay (WTP) threshold", "time_frame": "1 year before study to 1 year after the end of the intervention" }, { "type": "secondary", "measure": "EuroQol five dimensional descriptive system (EQ-5D-5L)", "description": "Measure of quality-adjusted life years (QALYs). EQ-5D-5L is a standardized, valid and reliable simple, generic measure of health status for clinical and economic appraisal. The respondent is asked to rate their health status on these five dimensions from 1 to 5 respectively as no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS (Visual Analogue Scale) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The respondent is asked to mark an X on the scale to indicate \"how your health is TODAY\" with a higher score indicating better health-related quality of life .", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA)", "description": "includes sections on visuospatial/executive function, naming, attention, language, abstraction, memory and orientation to time and place (6 questions) with a scor range from 0-30, with a higher score indicating better cognitive function.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Rapid Assessment of Physical Activity (RAPA)", "description": "The 9-item self-administered Rapid Assessment of Physical Activity (RAPA) is a questionnaire that assesses levels of a wide range of physical activity level in adults older than 50 years, with a score range 1-7 and a higher score indicating ihgher levels of physical activity.", "time_frame": "Baseline (week 0) & post-intervention (Week 10)" }, { "type": "secondary", "measure": "Dizziness Handicap Inventory (DHI)", "description": "The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes).", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "The Activities-specific balance confidence scale (ABC)", "description": "The Activities-specific Balance Confidence Scale (ABC) that assesses patient's perceived confidence for 16-activities of daily living without losing balance .Score range from 0-100 with higher schore indicating greater balance confidence and scores ≤67/100% indicate increased falls risk.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "The Hospital Anxiety and Depression Scale (HADS-d) depression subscale", "description": "a 14-item scale which assesses non-somatic anxiety (HAD-A) and depression (HAD-D) symptoms. Scores range from 0-21 for each subscale, with higher scores indicating worse outcomes (greater anxiety or depression).", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FFS)", "description": "a 9-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them. Sca;e 9-63 with higher score indicating greater fatigue.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Warwick-Edingburgh Mental Wellbeing Scale (WEMWBS)", "description": "developed to enable the measuring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental wellbeing. The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible. The scale has been widely used nationally and internationally for monitoring, evaluating projects and programmes and investigating the determinants of mental wellbeing. Scale 14-70 with higher score indicating better mental wellbeing.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "Situational Vertigo Questionnaire(SVQ):", "description": "The SVQ is 20-item questionnaire designed to assess discomfort in situations of intense visual salience of visual-vestibular conflict. It was originally developed as a measure of space and motion discomfort. The questions are graded on a scale from 0 (not at all) to 4 (very much), with a higher score indicating greater vertigo severity.", "time_frame": "Baseline (week 0) & post intervention (Week 10)" }, { "type": "secondary", "measure": "The system Usability Scale (SUS)", "description": "The System Usability Scale (SUS) scale 1-5 rated on 10 aspects, with a total possible score of 0-100, with a higher score indicated better usability.", "time_frame": "post-intervention (week 10)" }, { "type": "secondary", "measure": "User experience questionnaire (UEQ)", "description": "The User Experience Questionnaire (UEQ; scale 1-7 on 26 dimensions of attractiveness, perspicuity, efficiency, dependability, stimulation and novelty with a score range of -3 (worst) to +3 (best) with a higher score indicating a more positive user experience.", "time_frame": "Baseline (week 0), Week 8 & post intervention (Week 10)" }, { "type": "secondary", "measure": "Falls", "description": "Falls diary collected (self-reported)", "time_frame": "collected weekly for the duration of the 9-week intervention and up to 6 months after completing the intervention" }, { "type": "secondary", "measure": "System performance", "description": "We will also compare the TeleRehaB DSS predicted versus observed patient outcomes on the EQ-5D-5L, and secondary outcome measures, to assess the system performance", "time_frame": "post-intervention (week 10)" }, { "type": "secondary", "measure": "eHealth Literacy Assessment (eHEALS)", "description": "a 10-item likert scale questionnaire that evaluate's patients' skills in finding, evaluating and applying electronic health information. Responses range from 1 (strongly disagree, to 65 (strong agree), with total scores indicating levels of eHealth literacy. This will be used to help validate the AI-model in terms of participant allocation into the high-tech versus low-tech solution.", "time_frame": "Baseline (week 0)" }, { "type": "secondary", "measure": "The Senior technology acceptance & adoption model (STAM)", "description": "is a 38-item questionnaire, with items rated on a 1-10 Likert scale to measure factors influencing technology acceptance among older adults, with a higher scores indicating greater perceived digital literacy.", "time_frame": "Baseline (week 0)" }, { "type": "secondary", "measure": "Mobile Device Proficiency Questionnaire - short (MDPQ-s)", "description": "is a 16-question version of the full MDPQ-16. The MDPQ, its subscales, and the MDPQ-16 were found to be highly reliable and valid measures of mobile device proficiency in a large sample. We conclude that the MDPQ and MDPQ-16 may serve as useful tools for facilitating mobile device training of older adults and measuring mobile device proficiency for research purposes.", "time_frame": "Baseline (week 0)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 460, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06534164", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06933017", "title": "Feasibility of an Augmented Two-Day Step Test and Causal Modeling for Post-Exertional Symptom Exacerbation in Post Covid-19 Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-07-08", "start_date": "2025-03-20", "completion_date": "2025-07-03", "primary_completion_date": "2025-07-03", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Portable Mask For Respiratory Gas Analysis", "Cardio-Pulmonary Exercise Test" ], "sponsor": "Universitair Ziekenhuis Brussel", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to evaluate exercise capacity and identify causes of Post-Exertional Symptom Exacerbation (PESE) in individuals with Long COVID. The investigators will compare the effectiveness of the Two-Day 6-Minute Incremental Step Test (6MIST) and the Cardiopulmonary Exercise Test (CPET) in detecting PESE. Additionally, the investigators will assess metabolism, mitochondrial function, autonomic symptoms, psychological factors, and physical activity. Participants will complete both the Two-Day 6MIST and the Two-Day CPET, with a one-month gap between them. Each test is performed on two consecutive days to assess the delayed symptom response. The subjective symptoms of PESE will also be measured through questionnaires. To explore potential causes of PESE, the investigators will measure metabolism using indirect calorimetry, bioelectrical impedance analysis and food diaries, mitochondrial dysfunction with NIRS technology, autonomic symptoms using the COMPASS-31 questionnaire, psychological factors with questionnaires and physical activity levels using an activity tracker. This study will determine if the Two-Day Step Test (6MIST) is a feasible alternative to the two-day CPET for measuring PESE and will help uncover underlying mechanisms contributing to symptom exacerbation.", "primary_outcomes": [ { "type": "primary", "measure": "Difference in oxygen uptake at peak (VO2 peak) between day 1 and day 2 measured with the CPET compared to measured with the Calibre device", "description": "The goal is to show that the Calibre device is a feasible alternative to the CPET.", "time_frame": "From day 1 and day 2 of experimental session 1 to day 1 and day 2 of experimental session 2, one month apart (±10 days)" }, { "type": "primary", "measure": "Difference in Rate of Perceived Exertion (RPE) measured with the CPET compared to measured with the Calibre device", "description": "Rate of Perceived Exertion is measured with the Borg RPE Scale which is a subjective measurement instrument. The scores range from 6 to 20, in which 6 is equal to no exertion at all and 20 is maximal exertion.", "time_frame": "RPE will be measured during two experimental sessions, each with two days, one month apart. On day 1, RPE is recorded 15 minutes (±15 min) before and after the test. On day 2, RPE is measured 24 hours (±120 min) after test 1 and before test 2.]" }, { "type": "primary", "measure": "Resting Energy Expenditure (kcal/kg/day), measured through Indirect Calorimetry (IC)", "description": "Measuring Resting Energy Expenditure as part of the Directed Acyclic Graph (DAG).", "time_frame": "Baseline (measured once, during the first study visit)" }, { "type": "primary", "measure": "Total Energy Expenditure (TEE) in kcal/kg/day, measured through Indirect Calorimetry (IC)", "description": "Measuring Total Energy Expenditure as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Phase angle (degrees), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring Phase Angle as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Muscle mass (kg/m2), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring muscle mass as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Fat mass index (kg/m2), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring fat mass index as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Fat-free mass index (kg/m²), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring fat free mass index as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Fat to fat-free mass ratio, measured through bioelectrical impedance analysis (BIA)", "description": "Measuring fat-free mass ratio as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Hydration (%), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring hydration as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Ratio of calorie and protein intake to individual need, measured through food diaries", "description": "Adequacy of feeding: the ratio between intake of calories and proteins and the individual need.\n\nRecord of all food and drinks consumed over a 3-day period as part of the DAG.", "time_frame": "Between day 1 of study visit and day 1 of experimental session" }, { "type": "primary", "measure": "Mean daily intake of calories, fats, proteins, and carbohydrates, measured through food diaries", "description": "Mean daily intake: calories, fats, proteins, carbohydrates Record of all food and drinks consumed over a 3-day period.", "time_frame": "Between day 1 of study visit and day 1 of experimental session" }, { "type": "primary", "measure": "Oxygen availability as the partial pressure of oxygen (mitoPO2) (mmHg), measured through Near-infrared spectroscopy (NIRS)", "description": "Measuring oxygen availability as the partial pressure of oxygen as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Kinesiophobia with the Tampa Scale for Kinesiophobia (TSK)", "description": "The Tampa Scale for Kinesiophobia (TSK) consists of 17 statements, each scored from 1 to 4, with 1 being 'strongly disagree' and 4 being 'strongly agree.' Higher scores indicate greater kinesiophobia. Measuring kinesiophobia as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Ability to bounce back after stressful events with the Brief Resilience Scale (BRS) Questionnaire", "description": "The Brief Resilience Scale (BRS) consists of 6 statements, each scored from 1 to 4, with 1 being 'strongly disagree' and 4 being 'strongly agree.' Higher scores indicate greater resilience. Measuring resilience as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Coping style with the Ways of Coping (WAYS) Questionnaire", "description": "Sixty-six statements about a stressful situation that participants experienced in the past week, for which they need to give a score ranging from 0 to 3, with 0 being \"does not apply\" or \"not used,\" and 3 being \"used a great deal\". Measuring coping style as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Autonomic symptoms, measured with the COMPASS-31 questionnaire", "description": "Measuring autonomic symptoms as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Level of Physical Activity (PA) and sedentary behavior assessed by accelerometry (activity tracker)", "description": "Using an actigraph, with a frequenncy of 60 Hertz, that participants wear at their hip on their dominant side. Measuring physical activity as part of the DAG.", "time_frame": "During 7 days before the first experimental session" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Oxygen Uptake at First Ventilatory Threshold (VO₂ in ml/min/kg) during experimental session 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Oxygen uptake at peak (VO2 in ml/min/kg) during experimental session 1 and 2 (CPET & 6MIST))", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Workload (Watts) at first ventilatory threshold during experimental session 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Workload (Watts) at peak during experimental session 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Heart Rate (bpm) peak during experimental sessions 1 and 2 (CPET & 6MIST))", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Ventilation (VE) (Tidal Volume (TV) and Respiration Rate (RR)) during experimental sessions 1 and 2 (CPET 1 6MIST)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in VE/VO2 slope during experimental sessions 1 and 2 (CPET and 6 MIST)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in VO2/HR slope (= O2 pulse) during experimental sessions 1 and 2 (CPET and 6 MIST)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Respiratory Exchange Ratio (RER) = VCO2/VO2 during experimental sessions 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Cardiorespiratory Optimal Point (COP) = VO2/VE during experimental session 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" } ], "outcome_measures": [ { "type": "primary", "measure": "Difference in oxygen uptake at peak (VO2 peak) between day 1 and day 2 measured with the CPET compared to measured with the Calibre device", "description": "The goal is to show that the Calibre device is a feasible alternative to the CPET.", "time_frame": "From day 1 and day 2 of experimental session 1 to day 1 and day 2 of experimental session 2, one month apart (±10 days)" }, { "type": "primary", "measure": "Difference in Rate of Perceived Exertion (RPE) measured with the CPET compared to measured with the Calibre device", "description": "Rate of Perceived Exertion is measured with the Borg RPE Scale which is a subjective measurement instrument. The scores range from 6 to 20, in which 6 is equal to no exertion at all and 20 is maximal exertion.", "time_frame": "RPE will be measured during two experimental sessions, each with two days, one month apart. On day 1, RPE is recorded 15 minutes (±15 min) before and after the test. On day 2, RPE is measured 24 hours (±120 min) after test 1 and before test 2.]" }, { "type": "primary", "measure": "Resting Energy Expenditure (kcal/kg/day), measured through Indirect Calorimetry (IC)", "description": "Measuring Resting Energy Expenditure as part of the Directed Acyclic Graph (DAG).", "time_frame": "Baseline (measured once, during the first study visit)" }, { "type": "primary", "measure": "Total Energy Expenditure (TEE) in kcal/kg/day, measured through Indirect Calorimetry (IC)", "description": "Measuring Total Energy Expenditure as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Phase angle (degrees), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring Phase Angle as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Muscle mass (kg/m2), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring muscle mass as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Fat mass index (kg/m2), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring fat mass index as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Fat-free mass index (kg/m²), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring fat free mass index as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Fat to fat-free mass ratio, measured through bioelectrical impedance analysis (BIA)", "description": "Measuring fat-free mass ratio as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Hydration (%), measured through Bioelectrical Impedance Analysis (BIA)", "description": "Measuring hydration as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Ratio of calorie and protein intake to individual need, measured through food diaries", "description": "Adequacy of feeding: the ratio between intake of calories and proteins and the individual need.\n\nRecord of all food and drinks consumed over a 3-day period as part of the DAG.", "time_frame": "Between day 1 of study visit and day 1 of experimental session" }, { "type": "primary", "measure": "Mean daily intake of calories, fats, proteins, and carbohydrates, measured through food diaries", "description": "Mean daily intake: calories, fats, proteins, carbohydrates Record of all food and drinks consumed over a 3-day period.", "time_frame": "Between day 1 of study visit and day 1 of experimental session" }, { "type": "primary", "measure": "Oxygen availability as the partial pressure of oxygen (mitoPO2) (mmHg), measured through Near-infrared spectroscopy (NIRS)", "description": "Measuring oxygen availability as the partial pressure of oxygen as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Kinesiophobia with the Tampa Scale for Kinesiophobia (TSK)", "description": "The Tampa Scale for Kinesiophobia (TSK) consists of 17 statements, each scored from 1 to 4, with 1 being 'strongly disagree' and 4 being 'strongly agree.' Higher scores indicate greater kinesiophobia. Measuring kinesiophobia as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Ability to bounce back after stressful events with the Brief Resilience Scale (BRS) Questionnaire", "description": "The Brief Resilience Scale (BRS) consists of 6 statements, each scored from 1 to 4, with 1 being 'strongly disagree' and 4 being 'strongly agree.' Higher scores indicate greater resilience. Measuring resilience as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Coping style with the Ways of Coping (WAYS) Questionnaire", "description": "Sixty-six statements about a stressful situation that participants experienced in the past week, for which they need to give a score ranging from 0 to 3, with 0 being \"does not apply\" or \"not used,\" and 3 being \"used a great deal\". Measuring coping style as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Autonomic symptoms, measured with the COMPASS-31 questionnaire", "description": "Measuring autonomic symptoms as part of the DAG.", "time_frame": "Baseline (measured once during the first study visit)" }, { "type": "primary", "measure": "Level of Physical Activity (PA) and sedentary behavior assessed by accelerometry (activity tracker)", "description": "Using an actigraph, with a frequenncy of 60 Hertz, that participants wear at their hip on their dominant side. Measuring physical activity as part of the DAG.", "time_frame": "During 7 days before the first experimental session" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Oxygen Uptake at First Ventilatory Threshold (VO₂ in ml/min/kg) during experimental session 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Oxygen uptake at peak (VO2 in ml/min/kg) during experimental session 1 and 2 (CPET & 6MIST))", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Workload (Watts) at first ventilatory threshold during experimental session 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Workload (Watts) at peak during experimental session 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Heart Rate (bpm) peak during experimental sessions 1 and 2 (CPET & 6MIST))", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Ventilation (VE) (Tidal Volume (TV) and Respiration Rate (RR)) during experimental sessions 1 and 2 (CPET 1 6MIST)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in VE/VO2 slope during experimental sessions 1 and 2 (CPET and 6 MIST)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in VO2/HR slope (= O2 pulse) during experimental sessions 1 and 2 (CPET and 6 MIST)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Respiratory Exchange Ratio (RER) = VCO2/VO2 during experimental sessions 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" }, { "type": "secondary", "measure": "Change from Day 1 to Day 2 in Cardiorespiratory Optimal Point (COP) = VO2/VE during experimental session 1 or 2 (CPET)", "description": "", "time_frame": "From Day 1 to Day 2 during experimental session 1 or 2 (CPET)" } ], "relevance_tags": [ "Metabolic", "Mitochondrial", "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 25, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06933017", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07046208", "title": "Effects os Physiotherapeutic Rehabilitation on Function Autonomic and Inflammatory in Patients With Long Covid", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-07-01", "start_date": "2025-08-11", "completion_date": "2026-09-30", "primary_completion_date": "2026-08-10", "conditions_raw": [ "Long COVID", "Heart Rate Variability (HRV)", "Cardiac Biomarkers", "Inflammatory Biomarkers" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Physiothreapy Protocol" ], "sponsor": "Universidade do Estado do Pará", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Introduction: Long COVID is characterized by persistent symptoms that persist for weeks or months after the acute phase of infection, with a significant impact on the cardiovascular and autonomic systems. Objectives: This study aims to evaluate the effects of a physiotherapeutic rehabilitation protocol on cardiovascular autonomic modulation and on inflammatory and cardiac biomarkers in patients with Long COVID. Methodology: This is a controlled clinical trial, carried out in a cardiorespiratory rehabilitation outpatient clinic, involving individuals with a clinical diagnosis of Long COVID undergoing a protocol of 20 aerobic, anaerobic and respiratory rehabilitation sessions. Heart rate variability (HRV) variables will be analyzed using linear and non-linear methods, in addition to serum levels of CKMB, LDH, ferritin and C-reactive protein. Expected results: Rehabilitation is expected to provide an improvement in autonomic function and a reduction in inflammatory and cardiac markers, contributing to the understanding of the pathophysiological mechanisms of Long COVID and helping to propose evidence-based therapeutic strategies.", "primary_outcomes": [ { "type": "primary", "measure": "Autonomic Modulation", "description": "cardiofrequency meter", "time_frame": "Before and afther the intervention 3 months." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Inflammation", "description": "the cardiac and inflammatory biomarkers, creatine phosphokinase isoenzyme MB (CKMB) associated with lactate dehydrogenase (LDH) and ferritin can be analysed.", "time_frame": "Before and the afther 3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Autonomic Modulation", "description": "cardiofrequency meter", "time_frame": "Before and afther the intervention 3 months." }, { "type": "secondary", "measure": "Inflammation", "description": "the cardiac and inflammatory biomarkers, creatine phosphokinase isoenzyme MB (CKMB) associated with lactate dehydrogenase (LDH) and ferritin can be analysed.", "time_frame": "Before and the afther 3 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 58, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07046208", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06251518", "title": "Investigating the Effectiveness of Vimida", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-06-18", "start_date": "2025-02-13", "completion_date": "2025-12", "primary_completion_date": "2025-09", "conditions_raw": [ "Long COVID", "Post COVID-19 Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Vimida" ], "sponsor": "Gaia AG", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This randomized controlled trial (RCT) with 160 patients suffering from fatigue after COVID-19 infection aims to investigate the effectiveness of the unguided digital therapeutic vimida for reducing post-COVID-19 fatigue. Inclusion criteria are: male, female or non-binary, age ≥18 years, diagnosis of post-COVID-19 fatigue, ≥3 months since the last infection with COVID-19, fatigue severity score (cut-off) of ≥ 16 on the Chalder Fatigue Scale (CFQ-11), consent to participation, and sufficient German language skills. Exclusion criteria are a known psychiatric or somatic condition that can explain the fatigue and current participation in a multidisciplinary rehabilitation program aimed to ameliorate the consequences of COVID-19.\n\nPatients will be randomized and allocated to either an intervention group, in which they will receive access to vimida in addition to treatment as usual (TAU; n=80), or to a control group, in which they will receive access to TAU only (n=80).\n\nThe primary endpoint will be fatigue symptoms with three months post-allocation (T1) being the primary time point for assessment of effectiveness. Six months post-allocation (T2) will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, mental health-related quality of life, work/social functioning, somatic symptoms, and anxiety symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue symptom severity", "description": "Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).", "time_frame": "3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Depressive symptoms", "description": "Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Health-related quality of life", "description": "Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Functioning", "description": "Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Somatic symptoms", "description": "Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Anxiety", "description": "Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome).", "time_frame": "3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue symptom severity", "description": "Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Depressive symptoms", "description": "Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Health-related quality of life", "description": "Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Functioning", "description": "Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Somatic symptoms", "description": "Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Anxiety", "description": "Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome).", "time_frame": "3 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 160, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06251518", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05857124", "title": "A Study Evaluating the Efficacy of the Vielight Neuro RX Gamma in the Treatment of Post COVID-19 Cognitive Impairment", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2025-06-15", "start_date": "2023-04-01", "completion_date": "2025-01-16", "primary_completion_date": "2024-09-01", "conditions_raw": [ "Post COVID-19 Cognitive Impairment" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Vielight Neuro Rx Gamma Active Device" ], "sponsor": "Vielight Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Some people who have been infected with the virus that causes COVID-19 can experience long-term effects from their infection, known as post COVID-19 conditions (PCC) or long COVID1. The medical circles often describe it as post-acute sequelae of Covid-19 (PASC). People with post-COVID conditions can have a wide range of symptoms that can last more than four weeks or even months after infection. Sometimes the symptoms can even go away or come back again. The Centers for Disease and Prevention (CDC) listed a constellation of 19 symptoms related to post COVID-19.\n\nIn research, brain fog is prominent among the most reported neurological symptoms which also include, numbness, tingling, headache, dizziness, blurred vision, tinnitus, and fatigue that last more than a year post-infection.\n\nVielight Inc. has developed a compact and portable device named the \"Vielight RX Gamma\", which is suitable for home use. The intervention is based on the science of photobiomodulation (PBM) which utilizes certain light energy to modify cellular functions. The fundamental mechanisms of PBM are based on the absorption of photons by the mitochondria to modulate cellular functions. The Vielight Neuro RX Gamma delivers light of specific wavelengths (810 nm), power and duration to the brain/nasal cavity to achieve this. The biological process involves numerous interacting mechanisms that modulate bodily functions. One result of PBM is the benefits it could offer the post COVID-19 (long COVID) population. The Vielight Neuro RX Gamma emitting NIR might reduce inflammatory markers relevant to COVID-19 and since it pulses at 40 Hz can activate the non-inflammatory M2-genotype microglia to remove markers of Alzheimer disease, such as beta-amyloid and possibly tau deposits. Using Vielight Neuro RX Gamma, the same activation of non-inflammatory markers might occur with post COVID-19 (long-COVID) patient population as well as the reduction in the brain fog.\n\nThis trial utilizes a completely remote and virtual design. It is a double blind randomized controlled trial that is expected to involve 36 participants who are confirmed to have Post- COVID cognitive impairment. Eighteen of the participants will be randomized to the active Vielight RX Gamma protocol, and the other eighteen participants will be randomized to the sham Vielight RX Gamma regimen. The trial will study patients over 120 days and ask them to track their symptoms in a daily survey.", "primary_outcomes": [ { "type": "primary", "measure": "The change in the combined results of 7 Creyos items: Spatial Planning, Monkey Ladder, Rotations, Feature Match, Paired Associates, Token Search, Polygons.", "description": "", "time_frame": "from baseline to Day 56" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Creyos scores of the 5 remaining tests (i.e. Grammatical Reasoning, Spatial Span, Digit Span, Odd One Out, Double Trouble)", "description": "", "time_frame": "0, 14, 28, 56 and 84 days" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life", "description": "", "time_frame": "0, 14, 28, 56 and 84 Days" }, { "type": "secondary", "measure": "Fatigue Assessment Scale (FAS)", "description": "", "time_frame": "0, 56 and 84 Days" }, { "type": "secondary", "measure": "The perceived deficits questionnaire - 20 item version (PDQ-20)", "description": "", "time_frame": "0, 56 and 84 days" }, { "type": "secondary", "measure": "Compliance and Technical Complications", "description": "", "time_frame": "0 to Day 56" }, { "type": "secondary", "measure": "Modified Symptom Burden Questionnaire", "description": "(Breathing Pain Fatigue Memory, Thinking and Communication Sleep Ears, Nose and Throat Stomach and Digestion Other Symptoms)", "time_frame": "0 and 56 Days" } ], "outcome_measures": [ { "type": "primary", "measure": "The change in the combined results of 7 Creyos items: Spatial Planning, Monkey Ladder, Rotations, Feature Match, Paired Associates, Token Search, Polygons.", "description": "", "time_frame": "from baseline to Day 56" }, { "type": "secondary", "measure": "Creyos scores of the 5 remaining tests (i.e. Grammatical Reasoning, Spatial Span, Digit Span, Odd One Out, Double Trouble)", "description": "", "time_frame": "0, 14, 28, 56 and 84 days" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life", "description": "", "time_frame": "0, 14, 28, 56 and 84 Days" }, { "type": "secondary", "measure": "Fatigue Assessment Scale (FAS)", "description": "", "time_frame": "0, 56 and 84 Days" }, { "type": "secondary", "measure": "The perceived deficits questionnaire - 20 item version (PDQ-20)", "description": "", "time_frame": "0, 56 and 84 days" }, { "type": "secondary", "measure": "Compliance and Technical Complications", "description": "", "time_frame": "0 to Day 56" }, { "type": "secondary", "measure": "Modified Symptom Burden Questionnaire", "description": "(Breathing Pain Fatigue Memory, Thinking and Communication Sleep Ears, Nose and Throat Stomach and Digestion Other Symptoms)", "time_frame": "0 and 56 Days" } ], "relevance_tags": [ "Metabolic", "Mitochondrial", "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 36, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05857124", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05894629", "title": "Effects of an Active Coping Program in Patients With Persistent Post-Covid Pain.", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-06-04", "start_date": "2023-02-20", "completion_date": "2023-09-30", "primary_completion_date": "2023-06-01", "conditions_raw": [ "Long COVID", "Pain" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Active Comparator: Usual Treatment" ], "sponsor": "University of Valladolid", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Justification: among the sequelae of Covid-19 in clinical practice we frequently find persistent neuromusculoskeletal pain. Previous studies carried out by this research group and in the scientific literature have shown that \"Pain Neuroscience Education\" (PNE) and Therapeutic Exercise (TE) constitute an effective care strategy in the treatment of persistent pain. Therefore, with this research we will try to respond with a treatment proposal from Primary Care (PC).\n\nObjective: to determine whether an PNE and TE program is effective in patients presenting Long Covid Pain (LCP).\n\nMethod: Randomized clinical trial. A sample of 80 subjects will be recruited. The intervention group will receive a program of TE and PNE, of 12 weeks duration: 5 weeks of PNE, of 1 weekly session of 90 minutes, and 7 weeks of TE, with a total of 19 sessions of 60 minutes duration. The control group will receive the usual treatment. An assessment will be made at the beginning and after the end of the intervention, where the following variables will be measured: quality of life, intensity, distribution and expansion of pain, healthy physical condition and blood test values. These will be evaluated by means of physical examination, questionnaires and laboratory tests.\n\nApplicability of the expected results: The proposed intervention is simple and reproducible. It requires few resources, and can produce changes in pain perception, functionality and quality of life in patients with LCP.", "primary_outcomes": [ { "type": "primary", "measure": "Quality of life (QoL)", "description": "EQ-5D questionnaire (Quality of life 5 dimension questionnaire): The EQ-5D is a brief multi-attribute health status measure composed of five questions with Likert response options (descriptive system) and a visual analogue scale (EQ-VAS). The descriptive system covers five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with three levels of severity in each dimension (no problems, some problems, and extreme problems).", "time_frame": "3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Pain Intensity", "description": "Visual Analog Scale, VAS (0-100mm).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Body Chart", "description": "Nordic Questionnaire", "time_frame": "3 months" }, { "type": "secondary", "measure": "Quantitative sensory tests", "description": "pain detection to pressure", "time_frame": "3 months" }, { "type": "secondary", "measure": "Handgrip Strength assessment", "description": "With a manual dynamometer.", "time_frame": "3 months" }, { "type": "secondary", "measure": "30 sit to stand test", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "6 Minute Walking Test (6MWT)", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "Maximal Inspiratory and Expiration Pressure (MIP/MEP)", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "Catastrophism", "description": "Pain Catastrophism Scale (ECD).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Anxiety", "description": "Beck Anxiety Questionnaire (BAI)", "time_frame": "3 months" }, { "type": "secondary", "measure": "Depression", "description": "Beck Depression Questionnaire-II (BDI-II)", "time_frame": "3 months" }, { "type": "secondary", "measure": "Drug consumption.", "description": "Record by dose of the consumption of drugs for the patient's pain pre-post intervention.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Fatigue", "description": "Modified Fatigue Impact Scale (MFIS)", "time_frame": "3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Quality of life (QoL)", "description": "EQ-5D questionnaire (Quality of life 5 dimension questionnaire): The EQ-5D is a brief multi-attribute health status measure composed of five questions with Likert response options (descriptive system) and a visual analogue scale (EQ-VAS). The descriptive system covers five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with three levels of severity in each dimension (no problems, some problems, and extreme problems).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Pain Intensity", "description": "Visual Analog Scale, VAS (0-100mm).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Body Chart", "description": "Nordic Questionnaire", "time_frame": "3 months" }, { "type": "secondary", "measure": "Quantitative sensory tests", "description": "pain detection to pressure", "time_frame": "3 months" }, { "type": "secondary", "measure": "Handgrip Strength assessment", "description": "With a manual dynamometer.", "time_frame": "3 months" }, { "type": "secondary", "measure": "30 sit to stand test", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "6 Minute Walking Test (6MWT)", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "Maximal Inspiratory and Expiration Pressure (MIP/MEP)", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "Catastrophism", "description": "Pain Catastrophism Scale (ECD).", "time_frame": "3 months" }, { "type": "secondary", "measure": "Anxiety", "description": "Beck Anxiety Questionnaire (BAI)", "time_frame": "3 months" }, { "type": "secondary", "measure": "Depression", "description": "Beck Depression Questionnaire-II (BDI-II)", "time_frame": "3 months" }, { "type": "secondary", "measure": "Drug consumption.", "description": "Record by dose of the consumption of drugs for the patient's pain pre-post intervention.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Fatigue", "description": "Modified Fatigue Impact Scale (MFIS)", "time_frame": "3 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 89, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05894629", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06996314", "title": "Effects of Auricular Vagus Nerve Stimulation Combined With Slow-paced Breathing on Individuals With Postural Orthostatic Tachycardia Syndrome.", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-06-04", "start_date": "2025-09-01", "completion_date": "2028-08-31", "primary_completion_date": "2028-03-01", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)", "Post-acute COVID-19 Syndromes" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Tvns + Slow-Paced Breathing", "Tvns Without Breathing Training" ], "sponsor": "Ali Kapan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study investigates a non-pharmacological treatment approach for Postural Orthostatic Tachycardia Syndrome (POTS), a disorder of the autonomic nervous system characterized by an excessive increase in heart rate upon standing. POTS is commonly associated with symptoms such as dizziness, fatigue, cognitive difficulties, sleep disturbances, as well as anxiety and depression, which significantly impair quality of life.\n\nThis randomized, controlled clinical trial aims to evaluate whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with slow-paced diaphragmatic breathing (at 0.1 Hz) provides greater therapeutic benefit compared to taVNS alone or sham stimulation.\n\nA total of 100 participants will be recruited and randomly assigned to one of four groups (25 per group):\n\ntaVNS with slow-paced breathing,\n\ntaVNS with spontaneous (normal) breathing,\n\nsham taVNS with slow-paced breathing, or\n\nsham taVNS with spontaneous breathing.\n\nParticipants will perform the intervention daily at home for a duration of 12 weeks. Medical and psychological assessments will be conducted before and after the intervention, including measurements of heart rate, inflammatory cytokines, and patient-reported outcomes on sleep, mood, and quality of life.\n\nThe study is conducted at the Center for Public Health, Medical University of Vienna, and is open to individuals diagnosed with POTS, including those with coexisting Post-COVID-19 syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Heart Rate From Supine to Standing (Delta HR) After 12 Weeks of Daily taVNS With or Without Slow-Paced Breathing in Individuals With POTS", "description": "Heart rate (HR) is continuously recorded via 12-lead ECG during a standardized Tilt test. Participants lie supine for 25 minutes and then stand upright for 10 minutes. The average HR from the last 10 minutes supine and the 10-minute standing phase is calculated. The primary outcome, Delta HR, is defined as the difference between upright and supine HR. This measure reflects autonomic cardiovascular response and is assessed before and after the 12-week intervention phase.", "time_frame": "Change in Heart Rate (Delta HR) from Supine to Standing at Baseline and Week 12" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Change in Heart Rate From Supine to Standing (Delta HR) After 12 Weeks of Daily taVNS With or Without Slow-Paced Breathing in Individuals With POTS", "description": "Heart rate (HR) is continuously recorded via 12-lead ECG during a standardized Tilt test. Participants lie supine for 25 minutes and then stand upright for 10 minutes. The average HR from the last 10 minutes supine and the 10-minute standing phase is calculated. The primary outcome, Delta HR, is defined as the difference between upright and supine HR. This measure reflects autonomic cardiovascular response and is assessed before and after the 12-week intervention phase.", "time_frame": "Change in Heart Rate (Delta HR) from Supine to Standing at Baseline and Week 12" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06996314", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06992414", "title": "Exploring the Therapeutic Effects of Creatine Supplementation for Long COVID-19", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-05-31", "start_date": "2025-07-02", "completion_date": "2026-10-31", "primary_completion_date": "2026-06-30", "conditions_raw": [ "Long COVID Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Creatine Monohydrate" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Individuals living with Long COVID often experiencing a degree of undue fatigue after physical or cognitive exertion secondary to the condition, timed post-exertional malaise 9PEM). This trial aims to explore the efficacy of creatine monohydrate in managing PEM", "primary_outcomes": [ { "type": "primary", "measure": "Oxygen consumption at ventilatory threshold", "description": "point of respiratory compensation point (i.e., ventilatory threshold 2) as a percent of maximal oxygen consumption", "time_frame": "From enrollment to the end of intervention at 8 weeks" }, { "type": "primary", "measure": "Heart rate at ventilatory threshold", "description": "heart rate (in bpm) at point of ventilatory threshold", "time_frame": "From enrollment to the end of intervention at 8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue", "description": "severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable", "time_frame": "From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks)" }, { "type": "secondary", "measure": "Brain fog", "description": "severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable", "time_frame": "From baseline to mid intervention (4 weeks) to post intervention (8 weeks)" } ], "outcome_measures": [ { "type": "primary", "measure": "Oxygen consumption at ventilatory threshold", "description": "point of respiratory compensation point (i.e., ventilatory threshold 2) as a percent of maximal oxygen consumption", "time_frame": "From enrollment to the end of intervention at 8 weeks" }, { "type": "primary", "measure": "Heart rate at ventilatory threshold", "description": "heart rate (in bpm) at point of ventilatory threshold", "time_frame": "From enrollment to the end of intervention at 8 weeks" }, { "type": "secondary", "measure": "Fatigue", "description": "severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable", "time_frame": "From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks)" }, { "type": "secondary", "measure": "Brain fog", "description": "severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable", "time_frame": "From baseline to mid intervention (4 weeks) to post intervention (8 weeks)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 24, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06992414", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05633407", "title": "Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2025-05-23", "start_date": "2022-09-23", "completion_date": "2024-04-18", "primary_completion_date": "2024-04-18", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Efgartigimod" ], "sponsor": "argenx", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic tachycardia syndrome (POTS) (post-COVID-19 POTS).", "primary_outcomes": [ { "type": "primary", "measure": "Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version)", "description": "Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "primary", "measure": "Change From Baseline to Week 24 in the MaPS", "description": "The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a visual analog scale ranging from 0 (no symptoms) to 10 (worst possible). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "primary", "measure": "Number of Participants With TEAEs and TESAEs", "description": "An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration.", "time_frame": "From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 236 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Percentage of Participants With Improved PGI-S at Week 24", "description": "The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An \"improved PGI-S\" was defined by a change from baseline of -3, -2 and -1.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Percentage of Participants With Improved in PGI-C at Week 24", "description": "The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of a change in their overall symptom severity. Overall change in symptoms was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An \"improved PGI-C\" was defined by a change from baseline of 1, 2 and 3.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Change From Baseline to Week 24 in the PROMIS Fatigue Short Form 8a", "description": "The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Change From Baseline to Week 24 in the PROMIS Cognitive Function Short Form 6a", "description": "PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Percent Change From Baseline in Total IgG Levels at Week 24", "description": "Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Serum Concentration of Efgartigimod", "description": "Serum samples were collected at specified timepoints to determine the concentration of efgartigimod.", "time_frame": "Pre-dose and post-dose at Baseline (Day 1), Weeks 1, 4, 12 and at Week 24" }, { "type": "secondary", "measure": "Number of Participants With ADAs Against Efgartigimod", "description": "Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline.", "time_frame": "Up to Week 24" } ], "outcome_measures": [ { "type": "primary", "measure": "Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version)", "description": "Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "primary", "measure": "Change From Baseline to Week 24 in the MaPS", "description": "The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a visual analog scale ranging from 0 (no symptoms) to 10 (worst possible). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "primary", "measure": "Number of Participants With TEAEs and TESAEs", "description": "An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration.", "time_frame": "From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 236 days" }, { "type": "secondary", "measure": "Percentage of Participants With Improved PGI-S at Week 24", "description": "The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An \"improved PGI-S\" was defined by a change from baseline of -3, -2 and -1.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Percentage of Participants With Improved in PGI-C at Week 24", "description": "The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of a change in their overall symptom severity. Overall change in symptoms was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An \"improved PGI-C\" was defined by a change from baseline of 1, 2 and 3.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Change From Baseline to Week 24 in the PROMIS Fatigue Short Form 8a", "description": "The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Change From Baseline to Week 24 in the PROMIS Cognitive Function Short Form 6a", "description": "PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Percent Change From Baseline in Total IgG Levels at Week 24", "description": "Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory.", "time_frame": "Baseline (Day 1) and Week 24" }, { "type": "secondary", "measure": "Serum Concentration of Efgartigimod", "description": "Serum samples were collected at specified timepoints to determine the concentration of efgartigimod.", "time_frame": "Pre-dose and post-dose at Baseline (Day 1), Weeks 1, 4, 12 and at Week 24" }, { "type": "secondary", "measure": "Number of Participants With ADAs Against Efgartigimod", "description": "Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline.", "time_frame": "Up to Week 24" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 53, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05633407", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06928480", "title": "Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-05-22", "start_date": "2025-05-01", "completion_date": "2026-12-31", "primary_completion_date": "2026-12-31", "conditions_raw": [ "Long Covid-19", "Emotional Disorder", "Anxiety", "Depression Disorders", "Emotion Regulation" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Unified Protocol For The Transdiagnostic Treatment Of Emotional Disorders", "Treatment As Usual" ], "sponsor": "Instituto de Investigación Sanitaria Aragón", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This Randomized Controlled Trial (RCT) aims to assess the effectiveness and acceptability of the Unified Protocol (UP) in an online group format for the treatment of emotional disorders in adults. Participants will be 90 adults (45 in the control group and 45 in the experimental group) with diagnosis of long COVID and comorbid emotional disorders. Participants will be recruited at Hospital Royo Villanova from Zaragoza, Spain.\n\nIn this study it will be explored whether the changes obtained after the intervention in emotional disorders and cognitive complaints are maintained over 12 months. Additionally, levels of chronic stress will be longitudinally evaluated in the experimental group through accumulated cortisol levels in hair, before and after the application of the UP.", "primary_outcomes": [ { "type": "primary", "measure": "General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)", "description": "It assesses the frequency, intensity, severity and interference of depressive symptomatology through 5 items. total scores range from 0 to 20 points, higher scores indicating more severe depressive symptoms.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "primary", "measure": "General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)", "description": "It consiste of 5 items that assess the frequency, intensity, severity and interference of anxious symptomatology. Total scores range from 0 to 20 points, higher scores represent more severe anxiety symptoms.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Memory Failures of Everyday, MFE (Sunderland et al., 1983; Montejo et al., 2014)", "description": "It assesses the frequency of forgetfulness and memory lapses in daily life. Errors include forgetting names, misplacing objects, difficulties in planning, or lapses in attention.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023)", "description": "It is composed by 49 items that evaluates the transdiagnostic profile of Emotional Disorders, which is composed of nine dimensions: neurotic temperament, positive temperament, depressed mood, somatic anxiety, arousal activation, social anxiety, intrusive cognitions, traumatic re-experiencing, and avoidance.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)", "description": "Evaluation through 36 items of difficulties in emotional regulation by means of 5 subscales: lack of control, rejection, interference, inattention and emotional confusion. Higher scores indicate greater difficulties in emotion regulation.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)", "description": "It is composd by 5 items assessing self-perceived health status. Higher scores indicate better quality of life.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Distress Tolerance Scale (DTS; Sandín et al., 2017)", "description": "This scale evaluates, through 15 items, distress tolerance in the following dimensions: 1) Tolerance: perceived ability to tolerate emotional distress; 2) Appraisal: subjective assessment of distress; 3) Absortion: attention absorbed by negative emotions; 4) Regulation: strategies to alleviate distress.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Perceived Stress Scale (PSS; Remor y Carrobles, 2001)", "description": "This scale consists of 14 items designed to measure the level of perceived stress in daily life over the past month. The items are rated from 0 to 4, where 0 is \"never\" and 4 is \"very often.\" Higher total scores indicate greater perceived stress.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979)", "description": "the adaptation made for this study includes 6 of the 8 items of the CSQ-8 (perceived quality, adequacy to previous expectations, recommendation of the treatment to friends or family, usefulness of the techniques learned, general satisfaction with the intervention and probability that they will choose an intervention of this type again) and one additional item related to the discomfort generated by the intervention. Likewise, a change has been made in the Likert response scale from 4 points in the original (0 = \"Bad / Not at all\" to 4 = \"Excellent/Very Much\") to 11 in the current one (0 = \"Bad / Not at all to 10 = \"Excellent/Very Much\"). Higher scores represent greater satisfaction with the treatment.", "time_frame": "After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)" }, { "type": "secondary", "measure": "Evaluation questionnaire of the UP modules (Ad hoc)", "description": "This questionnaire has been elaborated ad hoc. It is composed of 7 questions; one general question that evaluates the usefulness of the program to improve emotional regulation and six specific questions that separately evaluate the usefulness of each of the techniques that are worked on in the different modules of the UP to better regulate emotions . The response scale ranges from 0 (not at all) to 10 (very much). Higher scores represent higher satisfaction with the treatment.", "time_frame": "After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005)", "description": "Brief neuropsychological test designed to assess mild cognitive impairment. It evaluates multiple cognitive domains, including visuospatial skills, memory, working memory, attention, concentration, language, executive functions, and orientation. It has a maximum score of 30 points, with a common cutoff score of 25 to identify potential cognitive deficits. A score of 25 or lower is considered indicative of cognitive impairment.", "time_frame": "Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Digit Symbol subtest-Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997)", "description": "This cognitive test presents a coding matrix in which the digits from 1 to 9 are paired with a symbol. On the same sheet, a series of digits is displayed with a blank space where participants must draw the corresponding symbol. The task must be completed as quickly as possible, with a 120-second limit to match the symbols with their respective numbers. If participants fail to complete the first four lines within the allotted time, they are given additional time to ensure they gain enough experience with the digit-symbol association. The tota score is based on the number of symbols correctly paired within 120 seconds (maximum score: 133). Immediately after completing the task, the researcher provides the participant with a new sheet containing the digits from 1 to 9 arranged in two lines. In this second part, participants must complete the blank spaces by drawing from memory the symbols corresponding to each number, with no time limit.", "time_frame": "Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Digit subtest from Wechsler Adult Intelligence Scale-IV (WAIS-IV; Wechsler, 2008)", "description": "The direct order digit task of this subtest evaluates verbal short-term memory and consists of a numeric recall task that measures the mechanical repetition of a sequence of numbers. The reverse order digit task assesses verbal working memory and requires participants to recall a sequence of numbers in reverse order (maximum score: 9). The memory capacity evaluated with these two tasks is defined as the longest sequence that participants can repeat without errors, allowing two attempts for each sequence length (maximum score: 8).", "time_frame": "Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Cortisol and cortisona levels", "description": "Hair sample will be collected from the posterior vertex or nape area, where growth is continuous and less exposed to contaminants. For this, a small portion of hair will be tied with thread near the cut area, which will allow identification of the portion closest to the scalp at the time of analysis and prevent hair loss. Using clean scissors, the hair will be cut as close as possible to the scalp, obtaining a segment of approximately 3 cm in length. This will allow for the evaluation of cortisol levels accumulated over the last three months, as hair grows on average 1 cm per month.", "time_frame": "Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)" } ], "outcome_measures": [ { "type": "primary", "measure": "General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)", "description": "It assesses the frequency, intensity, severity and interference of depressive symptomatology through 5 items. total scores range from 0 to 20 points, higher scores indicating more severe depressive symptoms.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "primary", "measure": "General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)", "description": "It consiste of 5 items that assess the frequency, intensity, severity and interference of anxious symptomatology. Total scores range from 0 to 20 points, higher scores represent more severe anxiety symptoms.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Memory Failures of Everyday, MFE (Sunderland et al., 1983; Montejo et al., 2014)", "description": "It assesses the frequency of forgetfulness and memory lapses in daily life. Errors include forgetting names, misplacing objects, difficulties in planning, or lapses in attention.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023)", "description": "It is composed by 49 items that evaluates the transdiagnostic profile of Emotional Disorders, which is composed of nine dimensions: neurotic temperament, positive temperament, depressed mood, somatic anxiety, arousal activation, social anxiety, intrusive cognitions, traumatic re-experiencing, and avoidance.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)", "description": "Evaluation through 36 items of difficulties in emotional regulation by means of 5 subscales: lack of control, rejection, interference, inattention and emotional confusion. Higher scores indicate greater difficulties in emotion regulation.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)", "description": "It is composd by 5 items assessing self-perceived health status. Higher scores indicate better quality of life.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Distress Tolerance Scale (DTS; Sandín et al., 2017)", "description": "This scale evaluates, through 15 items, distress tolerance in the following dimensions: 1) Tolerance: perceived ability to tolerate emotional distress; 2) Appraisal: subjective assessment of distress; 3) Absortion: attention absorbed by negative emotions; 4) Regulation: strategies to alleviate distress.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Perceived Stress Scale (PSS; Remor y Carrobles, 2001)", "description": "This scale consists of 14 items designed to measure the level of perceived stress in daily life over the past month. The items are rated from 0 to 4, where 0 is \"never\" and 4 is \"very often.\" Higher total scores indicate greater perceived stress.", "time_frame": "Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979)", "description": "the adaptation made for this study includes 6 of the 8 items of the CSQ-8 (perceived quality, adequacy to previous expectations, recommendation of the treatment to friends or family, usefulness of the techniques learned, general satisfaction with the intervention and probability that they will choose an intervention of this type again) and one additional item related to the discomfort generated by the intervention. Likewise, a change has been made in the Likert response scale from 4 points in the original (0 = \"Bad / Not at all\" to 4 = \"Excellent/Very Much\") to 11 in the current one (0 = \"Bad / Not at all to 10 = \"Excellent/Very Much\"). Higher scores represent greater satisfaction with the treatment.", "time_frame": "After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)" }, { "type": "secondary", "measure": "Evaluation questionnaire of the UP modules (Ad hoc)", "description": "This questionnaire has been elaborated ad hoc. It is composed of 7 questions; one general question that evaluates the usefulness of the program to improve emotional regulation and six specific questions that separately evaluate the usefulness of each of the techniques that are worked on in the different modules of the UP to better regulate emotions . The response scale ranges from 0 (not at all) to 10 (very much). Higher scores represent higher satisfaction with the treatment.", "time_frame": "After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005)", "description": "Brief neuropsychological test designed to assess mild cognitive impairment. It evaluates multiple cognitive domains, including visuospatial skills, memory, working memory, attention, concentration, language, executive functions, and orientation. It has a maximum score of 30 points, with a common cutoff score of 25 to identify potential cognitive deficits. A score of 25 or lower is considered indicative of cognitive impairment.", "time_frame": "Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Digit Symbol subtest-Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997)", "description": "This cognitive test presents a coding matrix in which the digits from 1 to 9 are paired with a symbol. On the same sheet, a series of digits is displayed with a blank space where participants must draw the corresponding symbol. The task must be completed as quickly as possible, with a 120-second limit to match the symbols with their respective numbers. If participants fail to complete the first four lines within the allotted time, they are given additional time to ensure they gain enough experience with the digit-symbol association. The tota score is based on the number of symbols correctly paired within 120 seconds (maximum score: 133). Immediately after completing the task, the researcher provides the participant with a new sheet containing the digits from 1 to 9 arranged in two lines. In this second part, participants must complete the blank spaces by drawing from memory the symbols corresponding to each number, with no time limit.", "time_frame": "Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Digit subtest from Wechsler Adult Intelligence Scale-IV (WAIS-IV; Wechsler, 2008)", "description": "The direct order digit task of this subtest evaluates verbal short-term memory and consists of a numeric recall task that measures the mechanical repetition of a sequence of numbers. The reverse order digit task assesses verbal working memory and requires participants to recall a sequence of numbers in reverse order (maximum score: 9). The memory capacity evaluated with these two tasks is defined as the longest sequence that participants can repeat without errors, allowing two attempts for each sequence length (maximum score: 8).", "time_frame": "Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)" }, { "type": "secondary", "measure": "Cortisol and cortisona levels", "description": "Hair sample will be collected from the posterior vertex or nape area, where growth is continuous and less exposed to contaminants. For this, a small portion of hair will be tied with thread near the cut area, which will allow identification of the portion closest to the scalp at the time of analysis and prevent hair loss. Using clean scissors, the hair will be cut as close as possible to the scalp, obtaining a segment of approximately 3 cm in length. This will allow for the evaluation of cortisol levels accumulated over the last three months, as hair grows on average 1 cm per month.", "time_frame": "Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 90, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06928480", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06967428", "title": "Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2025-05-13", "start_date": "2025-09-01", "completion_date": "2026-01", "primary_completion_date": "2026-01", "conditions_raw": [ "Vaccine Adverse Reaction", "Post Acute Covid-19 Vaccination Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Combined Metabolic Modulator", "Rice Protein Powder With Vitamin C" ], "sponsor": "Independent Medical Alliance", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a condition characterized by persistent fatigue and exercise intolerance attributed to Covid-19 vaccination and confirmed by laboratory testing.\n\nThe main questions it aims to answer are:\n\nDoes the combined nutraceutical intervention improve quality of life (measured by the PAC-19QoL questionnaire) in PACVS patients?\n\nDoes the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., HbA1c, blood lactate, CRP, spike protein levels, heart rate variability, 6-minute walk distance)?\n\nResearchers will compare the intervention group (receiving the ViTAL SCAN nutraceutical) to a placebo group (receiving rice protein powder with vitamin C) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles.\n\nParticipants will:\n\nTake the assigned supplement daily for 3 months (ViTAL SCAN or placebo)\n\nAttend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring\n\nComplete quality of life and health behavior questionnaires\n\nUndergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spike protein)\n\nRecord supplement intake\n\nThis study is currently pending IRB approval and aims to enroll 100 adults with PACVS for a randomized, placebo-controlled trial.", "primary_outcomes": [ { "type": "primary", "measure": "PAC-19QoL Questionnaire", "description": "Combined score of an established survey instrument for Quality of Life in the context of Post-Acute Covid-19 Syndrome (PACS).", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "primary", "measure": "Six-minute walk test", "description": "A treadmill-administered version of the six minute walk test (6MWT) where patients walk for as long a distance as they can, without jogging or running, in 6 minutes.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Hemoglobin A1c", "description": "Hemoglobin A1c (HbA1c) reflects longer term blood sugar levels. Given that metabolism is altered in PACS patients, it may be valuable to assess their metabolic health. Elevated HbA1c was associated with an increased mortality during the acute phase of the Covid-19.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Sedentary blood lactate", "description": "Blood lactate when the patient is at rest is taken using the Arkray Lactate Pro 2 Sports Blood Lactate Meter, which uses disposable test strips.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Post-exertion blood lactate", "description": "Blood lactate taken after the six-minute walk test.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "C-Reactive Protein", "description": "C-reactive protein (CRP) , a marker of inflammation, has been found to be significantly different between long covid groups vs healthy individuals, as well as between long covid and recovered individuals.\n\nCRP is quantitatively measured at a laboratory attached to the study clinic using the Roche Cobas b 101 Blood Analyser using Roche cobas b 101 CRP Test Discs, supplied in packs of 10. Each test required a 12 μL sample of capillary whole blood, obtained via finger prick.\n\nUpon completion of the assay, CRP concentrations are recorded in mg/L with that patient's identification number. The analytical range is 3.0-400 mg/L; if a test returns an error, the value will be reported as missing.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Spike protein levels", "description": "Spike protein tests will be performed using the MSD S-PLEX SARS-CoV-2 Spike Kit using a SECTOR Imager 2400 plate reader.", "time_frame": "From an initial test at enrollment to another at the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Resting Heart Rate Variability", "description": "Heart Rate Variability is taken at rest using a Garmin vívosmart® 5.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Heart rate variability during 6MWT", "description": "HRV is taken using a Garmin vívosmart® 5 at the halfway point of the 6 minute walk test.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Resting Heart Rate", "description": "Resting Heart Rate is taken using a Garmin vívosmart® 5.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Heart Rate during 6MWT", "description": "Average heart rate is taken during the last three minutes of the 6MWT", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Post-exercise Borg category-ratio 10 scale", "description": "This test is used to assess the level of perceived exertion after the 6MWT by asking participants to rate their exertion on a scale of 1 to 10. This is useful as a measure of exercise intolerance.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Total Cholesterol", "description": "", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "HDL-Cholesterol", "description": "", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "LDL-Cholesterol", "description": "", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Triglycerides", "description": "", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" } ], "outcome_measures": [ { "type": "primary", "measure": "PAC-19QoL Questionnaire", "description": "Combined score of an established survey instrument for Quality of Life in the context of Post-Acute Covid-19 Syndrome (PACS).", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "primary", "measure": "Six-minute walk test", "description": "A treadmill-administered version of the six minute walk test (6MWT) where patients walk for as long a distance as they can, without jogging or running, in 6 minutes.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Hemoglobin A1c", "description": "Hemoglobin A1c (HbA1c) reflects longer term blood sugar levels. Given that metabolism is altered in PACS patients, it may be valuable to assess their metabolic health. Elevated HbA1c was associated with an increased mortality during the acute phase of the Covid-19.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Sedentary blood lactate", "description": "Blood lactate when the patient is at rest is taken using the Arkray Lactate Pro 2 Sports Blood Lactate Meter, which uses disposable test strips.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Post-exertion blood lactate", "description": "Blood lactate taken after the six-minute walk test.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "C-Reactive Protein", "description": "C-reactive protein (CRP) , a marker of inflammation, has been found to be significantly different between long covid groups vs healthy individuals, as well as between long covid and recovered individuals.\n\nCRP is quantitatively measured at a laboratory attached to the study clinic using the Roche Cobas b 101 Blood Analyser using Roche cobas b 101 CRP Test Discs, supplied in packs of 10. Each test required a 12 μL sample of capillary whole blood, obtained via finger prick.\n\nUpon completion of the assay, CRP concentrations are recorded in mg/L with that patient's identification number. The analytical range is 3.0-400 mg/L; if a test returns an error, the value will be reported as missing.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Spike protein levels", "description": "Spike protein tests will be performed using the MSD S-PLEX SARS-CoV-2 Spike Kit using a SECTOR Imager 2400 plate reader.", "time_frame": "From an initial test at enrollment to another at the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Resting Heart Rate Variability", "description": "Heart Rate Variability is taken at rest using a Garmin vívosmart® 5.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Heart rate variability during 6MWT", "description": "HRV is taken using a Garmin vívosmart® 5 at the halfway point of the 6 minute walk test.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Resting Heart Rate", "description": "Resting Heart Rate is taken using a Garmin vívosmart® 5.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Heart Rate during 6MWT", "description": "Average heart rate is taken during the last three minutes of the 6MWT", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Post-exercise Borg category-ratio 10 scale", "description": "This test is used to assess the level of perceived exertion after the 6MWT by asking participants to rate their exertion on a scale of 1 to 10. This is useful as a measure of exercise intolerance.", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Total Cholesterol", "description": "", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "HDL-Cholesterol", "description": "", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "LDL-Cholesterol", "description": "", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" }, { "type": "secondary", "measure": "Triglycerides", "description": "", "time_frame": "From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months\"" } ], "relevance_tags": [ "Metabolic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06967428", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05741112", "title": "The Long COVID-19 Wearable Device Study", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-05-11", "start_date": "2023-11-16", "completion_date": "2025-12-01", "primary_completion_date": "2025-12-01", "conditions_raw": [ "Long COVID", "Postural Orthostatic Tachycardia Syndrome", "Dysautonomia", "Myalgic Encephalomyelitis", "Chronic Fatigue Syndrome", "Long Covid19" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Wearable Device" ], "sponsor": "Scripps Translational Science Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "To further characterize Long COVID-19 by collecting data from individuals who already own wearable devices or are provided with a wearable device along with basic and enhanced educational materials to determine if both can improve Long COVID-19 symptom management and post-exertional malaise.", "primary_outcomes": [ { "type": "primary", "measure": "Primary Objective 1:Assess the effect of study-provided devices and enhanced educational materials to manage Long COVID-19 symptom severity, compared to general educational materials alone using data from participants survey responses.", "description": "Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change in the weekly survey responses.", "time_frame": "3 months" }, { "type": "primary", "measure": "Primary Objective 2: Collate a unique longitudinal dataset combining patients' demographics, symptoms, symptom severity, quality of life, and sensor data including sleep, activity, heart rate, heart rate variability, and Body Battery.", "description": "Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change from the baseline survey to the quarterly survey.", "time_frame": "12 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity.", "description": "Conduct within-subject comparisons on the primary and secondary endpoints listed above but such that the investigators are assessing the change between the baseline measurement at month zero and that of the quarterly survey nine months after the distribution of the device and/or enhanced education materials.", "time_frame": "12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Primary Objective 1:Assess the effect of study-provided devices and enhanced educational materials to manage Long COVID-19 symptom severity, compared to general educational materials alone using data from participants survey responses.", "description": "Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change in the weekly survey responses.", "time_frame": "3 months" }, { "type": "primary", "measure": "Primary Objective 2: Collate a unique longitudinal dataset combining patients' demographics, symptoms, symptom severity, quality of life, and sensor data including sleep, activity, heart rate, heart rate variability, and Body Battery.", "description": "Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change from the baseline survey to the quarterly survey.", "time_frame": "12 months" }, { "type": "secondary", "measure": "Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity.", "description": "Conduct within-subject comparisons on the primary and secondary endpoints listed above but such that the investigators are assessing the change between the baseline measurement at month zero and that of the quarterly survey nine months after the distribution of the device and/or enhanced education materials.", "time_frame": "12 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Very Large (1000+ participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100500, "enrollment_type": "ESTIMATED", "size_category": "Very Large (1000+ participants)", "link": "https://clinicaltrials.gov/study/NCT05741112", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06952127", "title": "Feasibility and Preliminary Efficacy of a Group-based Telerehabilitation Program in People With Post-COVID-19 Sequelae (TEPCO).", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-04-30", "start_date": "2023-04-07", "completion_date": "2024-03-29", "primary_completion_date": "2024-03-29", "conditions_raw": [ "Long COVID-19 Syndrome", "Long COVID", "Long COVID Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rehabilitation Program" ], "sponsor": "Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this study pilot randomized controlled study is to evaluate the feasibility of the study procedures and to compare the preliminary efficacy of a rehabilitation program given in a \"remote\" (telerehabilitation) or \"face-to-face\" model for adult patients who had confirmed SARS-CoV-2 infection and still have symptoms after eight weeks of infection. The main question it aims to answer is:\n\n* Are the study procedures feasible?\n* Will the two groups have similar results for the preliminary efficacy outcomes?\n\nResearchers will compare group telerehabilitation to a face-to-face group to see if it's comparable.\n\nParticipants will:\n\n* Take part in a 60-minute training session, 3 times a week in person or remotely\n* Visit the clinic before starting the training program and after 8 weeks of training\n* Keep a diary of their symptoms, if any", "primary_outcomes": [ { "type": "primary", "measure": "The feasibility of study procedures", "description": "This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % of participants who drop out or withdraw from a study (attrition rate), % completed session (adherence rate); number of adverse events and % of participants satisfaction.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Exercise capacity", "description": "Pedaling time on a cycle ergometer at constant load (i.e., 60% of maximum load).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Walking capacity", "description": "6-minute walk test Total distance walked in meters", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Lower-limb endurance", "description": "1-minute sit-to-stand test The number of completed sit-to-stand repetitions is record.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Physical performance", "description": "Short Physical Performance Battery test Is made up of a set of three tests: standing static balance in three positions (score 0-4); lower limb strength and power through getting up and sitting on a chair(score 0-4); and walking speed at normal pace (score 0-4). And an overall score on 12.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Independence in activities of daily living", "description": "The Barthel Index Ten items are scored with a number of points (the scoring is as follows: 0 = unable, 1 = needs assistance/help, 2 = independent), and then a final score is calculated by summing the points awarded to each functional skill. The higher the score, the more independent the patient is.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Clinical Frailty", "description": "Clinical Frailty Scale (CFS) Frailty score ranging from 1 (very fit) to 9 (terminally ill)", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Quality of life", "description": "Saint George's Hospital Respiratory Questionnaire (SGHRQ). Scores ranging from 0 to 100 are calculated for each component, as well as a total score that summarizes the responses to all items. A zero score indicates no impairment of quality of life, and higher scores indicate more limitations.", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "The feasibility of study procedures", "description": "This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % of participants who drop out or withdraw from a study (attrition rate), % completed session (adherence rate); number of adverse events and % of participants satisfaction.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Exercise capacity", "description": "Pedaling time on a cycle ergometer at constant load (i.e., 60% of maximum load).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Walking capacity", "description": "6-minute walk test Total distance walked in meters", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Lower-limb endurance", "description": "1-minute sit-to-stand test The number of completed sit-to-stand repetitions is record.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Physical performance", "description": "Short Physical Performance Battery test Is made up of a set of three tests: standing static balance in three positions (score 0-4); lower limb strength and power through getting up and sitting on a chair(score 0-4); and walking speed at normal pace (score 0-4). And an overall score on 12.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Independence in activities of daily living", "description": "The Barthel Index Ten items are scored with a number of points (the scoring is as follows: 0 = unable, 1 = needs assistance/help, 2 = independent), and then a final score is calculated by summing the points awarded to each functional skill. The higher the score, the more independent the patient is.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Clinical Frailty", "description": "Clinical Frailty Scale (CFS) Frailty score ranging from 1 (very fit) to 9 (terminally ill)", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Change in Quality of life", "description": "Saint George's Hospital Respiratory Questionnaire (SGHRQ). Scores ranging from 0 to 100 are calculated for each component, as well as a total score that summarizes the responses to all items. A zero score indicates no impairment of quality of life, and higher scores indicate more limitations.", "time_frame": "8 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 22, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06952127", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05922865", "title": "The Effect of Smart Sensor Combined With APP for Individualized Precise Exercise Training in Long Covid-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-04-27", "start_date": "2023-07-11", "completion_date": "2024-03-15", "primary_completion_date": "2024-02-27", "conditions_raw": [ "Coronavirus Disease", "COVID-19", "Long Covid-19", "Telerehabilitation" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Kneesup Smart Knee Assistive Device + Kneesup Care App", "Healthy Consulation" ], "sponsor": "Shang-Lin Chiang", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The coronavirus (COVID -19) has rapidly turned into a global pandemic. For patients diagnosed with COVID-19, it caused severe damage in the upper respiratory system and systemic complications, including the cardiovascular, mental, nervous, and musculoskeletal system. Previous research has indicated that these subsequent sequelae can reduce quality of life. (A. W. Wong et al., 2020) Studies have indicated that exercise training is beneficial to improve blood pressure, reduce cardiovascular factors, reduce complications, and relieve depression (J. Galloza et al., 2017) However, the current international research on the benefits of exercise rehabilitation and the improvement of quality of life in patients who have been infected with COVID-19 is still lacking. Under the international epidemic, it is pointed out that the importance of telerehabilitation has also been advocated worldwide. Previous systematic review indicated that no matter it is nervous, muscular or cardiac system disease, the efficacy of telerehabilitation is superior to face-to-face rehabilitation. The purpose of this study is to compare the effect between the intervention of KNEESUP smart knee assistive device, and the health education in routine outpatient after diagnosis of Long Covid-19.", "primary_outcomes": [ { "type": "primary", "measure": "Aerobic capacity (VO2 max in ml/kg/min )", "description": "Maximal VO2 during testing, also means aerobic capacity", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Anaerobic Threshold (mL/kg/min)", "description": "Anaerobic Threshold (AT) refers to the exercise intensity at which lactate begins to accumulate in the blood at a faster rate than it can be removed. It represents a transition point between predominantly aerobic metabolism (using oxygen) and increased anaerobic metabolism (without sufficient oxygen).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Working load in watt", "description": "Maximal Working load during testing", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Breathing reserve (ml/kg/min)", "description": "A measure used during cardiopulmonary exercise testing (CPET) to assess how much of a person's maximum ventilatory capacity is unused at peak exercise. It reflects the difference between the maximum voluntary ventilation (MVV) and the minute ventilation (VE) reached during exercise.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Rest Heart rate in beat/min", "description": "Resting heart rate during exercise testing", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "O2 pulse in ml/beat", "description": "It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Systolic blood pressure in mm Hg", "description": "The resting blood pressure during exercise testing", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Diastolic blood pressure in mm Hg", "description": "The resting blood pressure during exercise testing", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "VE/VCO2 slope", "description": "The ventilation/ perfusion abnormalities (VE/VCO2) is measured by graded exercise testing.The change in VE/VCO2 was calculated as the value at 12 weeks minus the value at baseline. A lower VE/VCO2 ratio indicates better ventilatory efficiency and reduced ventilation/perfusion abnormalities.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Heart rate recovery", "description": "The heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery.\n\nThe change in heart rate recovery was calculated as the difference between heart rate recovery at 12 weeks and heart rate recovery at baseline. A decrease of \\< 12 or 22 beats per minute in 1- or 2- min heart rate recovery, respectively, indicates an elevated risk of mortality. A faster heart rate recovery indicates better cardiovascular fitness and autonomic regulation.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "FVC (L/min)", "description": "The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry. The change in FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FVC indicates better lung function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "FEV1 (L/min)", "description": "The amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry. The change in FEV1 was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1 indicates better lung function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "FEV1/FVC (%)", "description": "The measured FEV1 is divided by the measured FVC. he change in FEV1/FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1/FVC ratio generally indicates better lung function, while a lower ratio suggests airflow limitation.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Step length (m) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Speed (m/s) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Cadence (steps per minute) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Left gait cycle (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Right gait cycle (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Turn around time (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Stand up time (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Total walking time (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Long COVID symptoms", "description": "A simple checklist to record Long COVID symptoms. Symptoms that persisted or were newly developed after acute infection were documented as sequelae. Symptoms included fatigue, shortness of breath, cognitive dysfunction (referred to as \"brain fog\"), chest pain, cough, dizziness, headache, sleep disturbances, palpitations, depression/anxiety, and olfactory dysfunction.", "time_frame": "baseline, 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Quality of life (scores)", "description": "The Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) with good validity and reliability includes the globally standardized WHOQOL-BREF with 26 items and an additional two locally developed items, making a total of 28 items. It consists of two single-facet items measuring overall quality of life and general health and four domains, including physical (7 items), psychological (6 items), social (4 items), and environmental (9 items) domains. The two additional items are being respected/accepted facet in the social domain and eating/food facet in the environment domain, respectively. The participants rated all items on a scale of 1-5, with higher scores reflecting a greater quality of life. Domain scores were derived by multiplying the mean of the facet scores within each domain by a scaling factor of 4, resulting in potential domain scores ranging from 4 to 20.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Sleeping Quality (scores)", "description": "Symptoms of sleeping quality will be assessed using Pittsburgh Sleeping Index. The content is aimed at the sleep conditions of the subjects, including seven items including personal self-evaluation of sleep quality, sleep latency, sleep hours, sleep efficiency, sleep disturbance, drug use and daytime dysfunction. Each item is calculated by the Likert four-point method, 0-3 points, the total score ranges from 0-21 points, and the higher the score, the worse the sleep quality. (MORGAN, DALLOSSO, EBRAHIM, ARIE, \\& Fentem, 1988; Tang Zhenqing et al., 2014).", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Body composition: Body weight (kg)", "description": "The InBody device is a bioelectrical impedance analysis (BIA) system designed to assess body composition in a non-invasive, rapid, and reliable manner. It quantifies key components such as skeletal muscle mass, body fat mass, total body water, and visceral fat area.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Body composition: Body fat (%)", "description": "The InBody device is a bioelectrical impedance analysis (BIA) system designed to assess body composition in a non-invasive, rapid, and reliable manner. It quantifies key components such as skeletal muscle mass, body fat mass, total body water, and visceral fat area.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Body composition: Lean mass weight (kg)", "description": "The InBody device is a bioelectrical impedance analysis (BIA) system designed to assess body composition in a non-invasive, rapid, and reliable manner. It quantifies key components such as skeletal muscle mass, body fat mass, total body water, and visceral fat area.", "time_frame": "baseline, 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Aerobic capacity (VO2 max in ml/kg/min )", "description": "Maximal VO2 during testing, also means aerobic capacity", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Anaerobic Threshold (mL/kg/min)", "description": "Anaerobic Threshold (AT) refers to the exercise intensity at which lactate begins to accumulate in the blood at a faster rate than it can be removed. It represents a transition point between predominantly aerobic metabolism (using oxygen) and increased anaerobic metabolism (without sufficient oxygen).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Working load in watt", "description": "Maximal Working load during testing", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Breathing reserve (ml/kg/min)", "description": "A measure used during cardiopulmonary exercise testing (CPET) to assess how much of a person's maximum ventilatory capacity is unused at peak exercise. It reflects the difference between the maximum voluntary ventilation (MVV) and the minute ventilation (VE) reached during exercise.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Rest Heart rate in beat/min", "description": "Resting heart rate during exercise testing", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "O2 pulse in ml/beat", "description": "It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Systolic blood pressure in mm Hg", "description": "The resting blood pressure during exercise testing", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Diastolic blood pressure in mm Hg", "description": "The resting blood pressure during exercise testing", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "VE/VCO2 slope", "description": "The ventilation/ perfusion abnormalities (VE/VCO2) is measured by graded exercise testing.The change in VE/VCO2 was calculated as the value at 12 weeks minus the value at baseline. A lower VE/VCO2 ratio indicates better ventilatory efficiency and reduced ventilation/perfusion abnormalities.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Heart rate recovery", "description": "The heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery.\n\nThe change in heart rate recovery was calculated as the difference between heart rate recovery at 12 weeks and heart rate recovery at baseline. A decrease of \\< 12 or 22 beats per minute in 1- or 2- min heart rate recovery, respectively, indicates an elevated risk of mortality. A faster heart rate recovery indicates better cardiovascular fitness and autonomic regulation.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "FVC (L/min)", "description": "The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry. The change in FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FVC indicates better lung function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "FEV1 (L/min)", "description": "The amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry. The change in FEV1 was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1 indicates better lung function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "FEV1/FVC (%)", "description": "The measured FEV1 is divided by the measured FVC. he change in FEV1/FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1/FVC ratio generally indicates better lung function, while a lower ratio suggests airflow limitation.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Step length (m) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Speed (m/s) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Cadence (steps per minute) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Left gait cycle (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Right gait cycle (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Turn around time (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Stand up time (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Gait: Total walking time (sec) through Time Up and Go Test", "description": "Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Long COVID symptoms", "description": "A simple checklist to record Long COVID symptoms. Symptoms that persisted or were newly developed after acute infection were documented as sequelae. Symptoms included fatigue, shortness of breath, cognitive dysfunction (referred to as \"brain fog\"), chest pain, cough, dizziness, headache, sleep disturbances, palpitations, depression/anxiety, and olfactory dysfunction.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Quality of life (scores)", "description": "The Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) with good validity and reliability includes the globally standardized WHOQOL-BREF with 26 items and an additional two locally developed items, making a total of 28 items. It consists of two single-facet items measuring overall quality of life and general health and four domains, including physical (7 items), psychological (6 items), social (4 items), and environmental (9 items) domains. The two additional items are being respected/accepted facet in the social domain and eating/food facet in the environment domain, respectively. The participants rated all items on a scale of 1-5, with higher scores reflecting a greater quality of life. Domain scores were derived by multiplying the mean of the facet scores within each domain by a scaling factor of 4, resulting in potential domain scores ranging from 4 to 20.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Sleeping Quality (scores)", "description": "Symptoms of sleeping quality will be assessed using Pittsburgh Sleeping Index. The content is aimed at the sleep conditions of the subjects, including seven items including personal self-evaluation of sleep quality, sleep latency, sleep hours, sleep efficiency, sleep disturbance, drug use and daytime dysfunction. Each item is calculated by the Likert four-point method, 0-3 points, the total score ranges from 0-21 points, and the higher the score, the worse the sleep quality. (MORGAN, DALLOSSO, EBRAHIM, ARIE, \\& Fentem, 1988; Tang Zhenqing et al., 2014).", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Body composition: Body weight (kg)", "description": "The InBody device is a bioelectrical impedance analysis (BIA) system designed to assess body composition in a non-invasive, rapid, and reliable manner. It quantifies key components such as skeletal muscle mass, body fat mass, total body water, and visceral fat area.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Body composition: Body fat (%)", "description": "The InBody device is a bioelectrical impedance analysis (BIA) system designed to assess body composition in a non-invasive, rapid, and reliable manner. It quantifies key components such as skeletal muscle mass, body fat mass, total body water, and visceral fat area.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Body composition: Lean mass weight (kg)", "description": "The InBody device is a bioelectrical impedance analysis (BIA) system designed to assess body composition in a non-invasive, rapid, and reliable manner. It quantifies key components such as skeletal muscle mass, body fat mass, total body water, and visceral fat area.", "time_frame": "baseline, 12 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05922865", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05633472", "title": "The Roles of Vitamin D and Microbiome in Children With Post-acute COVID-19 Syndromes (PACS) and Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-04-17", "start_date": "2022-10-18", "completion_date": "2024-08-23", "primary_completion_date": "2024-08-23", "conditions_raw": [ "Post-acute COVID-19 Syndromes" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Vitamin D" ], "sponsor": "China Medical University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "A double-blind study to evaluate the role of human microbiome and vitamin D in the development of long COVID and PACS in children.", "primary_outcomes": [ { "type": "primary", "measure": "Levels of vitamin D", "description": "Vitamin D will be measured in a blood sample by ELISA to determine baseline status.", "time_frame": "Month 0" }, { "type": "primary", "measure": "Levels of vitamin D", "description": "Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.", "time_frame": "Month 6" }, { "type": "primary", "measure": "Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein", "description": "Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.", "time_frame": "Month 0" }, { "type": "primary", "measure": "Microbiome", "description": "Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.", "time_frame": "Month 0" }, { "type": "primary", "measure": "Microbiome", "description": "Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing,and to follow the change from baseline in microbiome at month 6.", "time_frame": "Month 6" }, { "type": "primary", "measure": "Total immunoglobulin E (IgE)", "description": "Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.", "time_frame": "Month 0" }, { "type": "primary", "measure": "Total immunoglobulin E (IgE)", "description": "Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to follow the change from baseline in total IgE at month 6.", "time_frame": "Month 6" }, { "type": "primary", "measure": "Allergen-specific immunoglobulin E (IgE)", "description": "Plasma allergen-specific IgE will be measured by BioIC ®.", "time_frame": "Month 0" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Children's Somatic Symptoms Inventory (CSSI)", "description": "CSSI. Range (0-4); lower scores indicate better health", "time_frame": "Month 0 to Month 6" }, { "type": "secondary", "measure": "KINDL questionnaire", "description": "For assessing Health-Related Quality of Life in children and adolescents aged 3 years and older.", "time_frame": "Month 0 to Month 6" } ], "outcome_measures": [ { "type": "primary", "measure": "Levels of vitamin D", "description": "Vitamin D will be measured in a blood sample by ELISA to determine baseline status.", "time_frame": "Month 0" }, { "type": "primary", "measure": "Levels of vitamin D", "description": "Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.", "time_frame": "Month 6" }, { "type": "primary", "measure": "Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein", "description": "Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.", "time_frame": "Month 0" }, { "type": "primary", "measure": "Microbiome", "description": "Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.", "time_frame": "Month 0" }, { "type": "primary", "measure": "Microbiome", "description": "Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing,and to follow the change from baseline in microbiome at month 6.", "time_frame": "Month 6" }, { "type": "primary", "measure": "Total immunoglobulin E (IgE)", "description": "Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.", "time_frame": "Month 0" }, { "type": "primary", "measure": "Total immunoglobulin E (IgE)", "description": "Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to follow the change from baseline in total IgE at month 6.", "time_frame": "Month 6" }, { "type": "primary", "measure": "Allergen-specific immunoglobulin E (IgE)", "description": "Plasma allergen-specific IgE will be measured by BioIC ®.", "time_frame": "Month 0" }, { "type": "secondary", "measure": "Children's Somatic Symptoms Inventory (CSSI)", "description": "CSSI. Range (0-4); lower scores indicate better health", "time_frame": "Month 0 to Month 6" }, { "type": "secondary", "measure": "KINDL questionnaire", "description": "For assessing Health-Related Quality of Life in children and adolescents aged 3 years and older.", "time_frame": "Month 0 to Month 6" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 33, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05633472", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04904536", "title": "Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE3", "last_updated": "2025-04-10", "start_date": "2022-03-10", "completion_date": "2025-07-30", "primary_completion_date": "2025-06-30", "conditions_raw": [ "Neurocognitive Impairment, Mild" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Atorvastatin" ], "sponsor": "The George Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "STRONGER is an international, investigator initiated and conducted, pragmatic clinical trial to determine whether 40mg atorvastatin daily can improve neurocognitive function in adults with long COVID neurological symptoms. The objective is to determine effectiveness of treatment with 40mg atorvastatin over 12 months on attenuating cognitive decline and neuroinflammatory biomarkers in adults with long COVID neurological symptoms. The study design is a prospective, randomised, open-label, blinded endpoint (PROBE) study of atorvastatin 40mg on top of standard care, in patients with long COVID neurological symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Neurological Recovery", "description": "Processing speed, assessed on the oral Symbol Digit Modalities Test (SDMT)", "time_frame": "12 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Brain Imaging", "description": "White matter free water measured on diffusion MRI brain imaging", "time_frame": "12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Neurological Recovery", "description": "Processing speed, assessed on the oral Symbol Digit Modalities Test (SDMT)", "time_frame": "12 months" }, { "type": "secondary", "measure": "Brain Imaging", "description": "White matter free water measured on diffusion MRI brain imaging", "time_frame": "12 months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 3", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 190, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04904536", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05094622", "title": "Physical Training in Patients With POTS After Covid-19", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-04-06", "start_date": "2022-01-10", "completion_date": "2025-12", "primary_completion_date": "2023-12-31", "conditions_raw": [ "Covid19", "Post-acute Covid-19 Syndrome", "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Physical Exercise Program" ], "sponsor": "Karolinska Institutet", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Covid-19 has the potential to affect physical, cognitive and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describe the wide range of prolonged symptoms following the infection. Patients may need specialized rehabilitation to be able to meet the complex symptoms and problems that may arise. A more specific syndrome that seems to occur more frequently than expected in the group of non-hospitalized patients who have had Covid-19 is the postural orthostatic tachycardia syndrome (POTS).\n\nTo evaluate the effects of physical training in patients with POTS after Covid-19 a single subject design will be used (the patient is their own control). Inidividual semistructured interviews will be performed to explore and describe the patients´ experiences of the rehabilitation intervention.\n\nParticipants: Patients diagnosed with POTS after Covid-19 (N=30) will be included.\n\nProcedure and outcomes: The primary outcomes are physical activity and health-related quality of life. Secondary outcomes are: physical capacity, active standing test, Malmö-POTS-questionnaire, Anxiety and depression, fatigue, self-reported outcome measure of physical function and work ability.\n\nInitially measurements will be performed several times during a period of 2-4 weeks to obtain a baseline before the intervention starts. Then the included participants will undergo a specially designed physical training program that will be performed 3 times /week during a period of 12 weeks. The intervention of physical training will consist of different exercises to enhance muscle strength and endurance. The intervention will be individually adjusted with a progression in dose, intensity, and position. The exercise is based on a program used in a previous study. Measurements will then be repeated after completion of the intervention period.\n\nA qualitative approach, with semistructured interviews, will be used to explore the patients´ experiences of the intervention, after commence of the interventional trial.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Health-Related Quality of Life (HRQoL)", "description": "Measured with EuroQualityOf Life 5 dimensions questionnaire (EQ-5D-5L), which is an instrument that evaluates the generic quality of life. EQ-5D includes a descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A descriptive index-score between 0-1, higher score indicates higher HRQoL. EQ-5D also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "primary", "measure": "Change in time in upright position and steps per day", "description": "Measured with two accelerometers attached to upper and lower limbs to measure time (hours, minutes) in upright position during 7 consecutive days", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in walking distance during 6 minute walk test", "description": "Change in walking distance measured in meters during 6 minutes walk test (6MWT)", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in oxygen saturation during 6 minute walk test", "description": "Change in the lowest oxygen saturation level measured in percentage (%) with pulse oximetry during 6 minute walk test.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in oxygen desaturation during 6 minute walk test", "description": "Change in drop in percentage points in oxygen saturation during 6 minute walk test. The drop in percentage points is calculated by subtracting the oxygen level at rest before the test with the lowest level during the test.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in dyspnea during 6 minute walk test", "description": "Change in perceived dyspnea measured with Borg Category-Ratio scale (Borg CR-10) at the end of 6 minute walk test. Borg CR-10 ranging between 0-10. The higher the score, the higher the dyspnea.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in leg fatigue during 6 minute walk test", "description": "Change in perceived leg fatigue measured with Borg CR-10 at the end of 6 minute walk test. Borg CR-10 ranging between 0-10. The higher the score, the higher the leg fatigue.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in exertion during 6 minute walk test", "description": "Change in perceived exertion measured with Borg Rating of Perceived Exertion (Borg RPE) at the end of 6 minutes walk test. Borg RPE ranging between 6-20. The higher the score, the higher the exertion.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in heart rate during 6 minute walk test", "description": "Change in the highest heart rate measured in beats per minute with pulse oximeter during 6 minute walk test", "time_frame": "Measured before and after the intervention period of 12-16weeks to detect a change" }, { "type": "secondary", "measure": "Change in Self-reported POTS-symptoms", "description": "Measured with Malmö-POTS-questionnaire (MaPS), which is a self assessment tool examining common symptoms in POTS. MaPS consists of 12 items. Patients are asked to rate symptoms on a scale from 0-10 on each item. 0 i= no symptom and 10 = worst imaginable. Total score ranging from 0-120. Higher score indicates more POTS-symptoms.", "time_frame": "Measured before and after the intervention period of 20 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Anxiety - Generalised Anxiety Disorder 7-item scale", "description": "Measured with Generalised Anxiety Disorder 7-item scale (GAD-7) which is a self assessment tool. Total score ranging from 0-21. Higher score indicates higher anxiety.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Depression - Patient Health Questionnaire-9", "description": "Measured with Patient Health Questionnaire-9 (PHQ-9). PHQ-9 which contains 9 items. Total score ranges from 0 to 27. Higher score indicate more severe depression symptoms.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Fatigue", "description": "Measured with Fatigue Severity Scale (FSS), which is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Total score ranging from 9-63. The higher the score, the more severe the fatigue is.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Work ability", "description": "Measured with percentage of full-time work ability and Work Ability Index (WAI). WAI is a self assessment tool consisting of 7 items. Scores ranging from 7-49. Higher score indicates higher work ability.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Self-reported outcome measure of physical function", "description": "Measured with Patient Specific Functional Scale (PSFS), a questionnaire that can be used to quantify activity limitation and measure functional outcome for patients. Patients are asked to identify three to five important activities they are unable to perform or are having difficulty with because of their problem. In addition to identifying the activities, patients are asked to rate, on a scale ranging from 0-10, the current level of difficulty associated with each activity. The higher the score, the less difficulty to perform the activity.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in blood pressure during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in systolic and diastolic blood pressure after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in heart rate response during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in heart rate after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in oxygen saturation during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in oxygen saturation, measured with pulse oximetry, after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in dyspnea during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in perceived dyspnea measured with Borg CR-10 scale after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in exertion during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in perceived exertion with Borg RPE scale after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Physical activity", "description": "Measured with Frändin/Grimby activity scale, which is a self-assessment scale about current levels of physical activity, ranging from 1 to 6. The higher the score, the higher the level of physical activity.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in orthostatic symptoms", "description": "Assessed with the Vanderbilt Orthostatic Symptom Scale (VOSS). After the Active standing test (AST) the participant uses a self-assessment questionnaire about orthostatic symptoms prominent during the Active standing test (performed according to a specific protocol with measurements of responses in systolic and diastolic blood pressure after getting up to standing from the supine position). The scale range from 0=no symptoms, to 10=worst imaginable symptoms. The scale includes 9 items regarding orthostatic symptoms and the higher the score, the higher level of symptoms during the orthostatic test.", "time_frame": "Measured before and after the intervention period of 12-16 weekt to detect a change" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Health-Related Quality of Life (HRQoL)", "description": "Measured with EuroQualityOf Life 5 dimensions questionnaire (EQ-5D-5L), which is an instrument that evaluates the generic quality of life. EQ-5D includes a descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A descriptive index-score between 0-1, higher score indicates higher HRQoL. EQ-5D also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "primary", "measure": "Change in time in upright position and steps per day", "description": "Measured with two accelerometers attached to upper and lower limbs to measure time (hours, minutes) in upright position during 7 consecutive days", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in walking distance during 6 minute walk test", "description": "Change in walking distance measured in meters during 6 minutes walk test (6MWT)", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in oxygen saturation during 6 minute walk test", "description": "Change in the lowest oxygen saturation level measured in percentage (%) with pulse oximetry during 6 minute walk test.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in oxygen desaturation during 6 minute walk test", "description": "Change in drop in percentage points in oxygen saturation during 6 minute walk test. The drop in percentage points is calculated by subtracting the oxygen level at rest before the test with the lowest level during the test.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in dyspnea during 6 minute walk test", "description": "Change in perceived dyspnea measured with Borg Category-Ratio scale (Borg CR-10) at the end of 6 minute walk test. Borg CR-10 ranging between 0-10. The higher the score, the higher the dyspnea.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in leg fatigue during 6 minute walk test", "description": "Change in perceived leg fatigue measured with Borg CR-10 at the end of 6 minute walk test. Borg CR-10 ranging between 0-10. The higher the score, the higher the leg fatigue.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in exertion during 6 minute walk test", "description": "Change in perceived exertion measured with Borg Rating of Perceived Exertion (Borg RPE) at the end of 6 minutes walk test. Borg RPE ranging between 6-20. The higher the score, the higher the exertion.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in heart rate during 6 minute walk test", "description": "Change in the highest heart rate measured in beats per minute with pulse oximeter during 6 minute walk test", "time_frame": "Measured before and after the intervention period of 12-16weeks to detect a change" }, { "type": "secondary", "measure": "Change in Self-reported POTS-symptoms", "description": "Measured with Malmö-POTS-questionnaire (MaPS), which is a self assessment tool examining common symptoms in POTS. MaPS consists of 12 items. Patients are asked to rate symptoms on a scale from 0-10 on each item. 0 i= no symptom and 10 = worst imaginable. Total score ranging from 0-120. Higher score indicates more POTS-symptoms.", "time_frame": "Measured before and after the intervention period of 20 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Anxiety - Generalised Anxiety Disorder 7-item scale", "description": "Measured with Generalised Anxiety Disorder 7-item scale (GAD-7) which is a self assessment tool. Total score ranging from 0-21. Higher score indicates higher anxiety.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Depression - Patient Health Questionnaire-9", "description": "Measured with Patient Health Questionnaire-9 (PHQ-9). PHQ-9 which contains 9 items. Total score ranges from 0 to 27. Higher score indicate more severe depression symptoms.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Fatigue", "description": "Measured with Fatigue Severity Scale (FSS), which is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Total score ranging from 9-63. The higher the score, the more severe the fatigue is.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Work ability", "description": "Measured with percentage of full-time work ability and Work Ability Index (WAI). WAI is a self assessment tool consisting of 7 items. Scores ranging from 7-49. Higher score indicates higher work ability.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Self-reported outcome measure of physical function", "description": "Measured with Patient Specific Functional Scale (PSFS), a questionnaire that can be used to quantify activity limitation and measure functional outcome for patients. Patients are asked to identify three to five important activities they are unable to perform or are having difficulty with because of their problem. In addition to identifying the activities, patients are asked to rate, on a scale ranging from 0-10, the current level of difficulty associated with each activity. The higher the score, the less difficulty to perform the activity.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in blood pressure during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in systolic and diastolic blood pressure after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in heart rate response during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in heart rate after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in oxygen saturation during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in oxygen saturation, measured with pulse oximetry, after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in dyspnea during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in perceived dyspnea measured with Borg CR-10 scale after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in exertion during Active standing test", "description": "Measured with Active standing test according to a specific protocol with measurements of responses in perceived exertion with Borg RPE scale after getting up to standing from the supine position.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in Physical activity", "description": "Measured with Frändin/Grimby activity scale, which is a self-assessment scale about current levels of physical activity, ranging from 1 to 6. The higher the score, the higher the level of physical activity.", "time_frame": "Measured before and after the intervention period of 12-16 weeks to detect a change" }, { "type": "secondary", "measure": "Change in orthostatic symptoms", "description": "Assessed with the Vanderbilt Orthostatic Symptom Scale (VOSS). After the Active standing test (AST) the participant uses a self-assessment questionnaire about orthostatic symptoms prominent during the Active standing test (performed according to a specific protocol with measurements of responses in systolic and diastolic blood pressure after getting up to standing from the supine position). The scale range from 0=no symptoms, to 10=worst imaginable symptoms. The scale includes 9 items regarding orthostatic symptoms and the higher the score, the higher level of symptoms during the orthostatic test.", "time_frame": "Measured before and after the intervention period of 12-16 weekt to detect a change" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05094622", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05453201", "title": "Developing an Integrative, Recovery-Based, Post-Acute COVID-19 Syndrome (PACS) Psychotherapeutic Intervention", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-04-02", "start_date": "2022-10-01", "completion_date": "2024-09-30", "primary_completion_date": "2024-02-01", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Long Covid Coping And Recovery (Lccr) Intervention" ], "sponsor": "VA Office of Research and Development", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "Post-Acute COVID-19 Syndrome (PACS), colloquially known as Long COVID, is a prevalent phenomenon that affects thousands of Veterans in VA care. VA patients suffering from Long COVID not only experience lingering physical symptoms following COVID-19 infection, but have increased mental health problems including sleep disorders, anxiety disorders, trauma and stress-related disorders as well as increased use of opioid and non-opioid pain medications, antidepressants, and sedatives to treat these conditions. Developing recovery-oriented care, \"a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential\" is a VA priority, however available Long COVID treatments primarily target symptom relief and are not designed to promote the recovery and rehabilitation of Veterans in a mental health context. Long COVID Coping and Recovery (LCCR) is a promising manualized, recovery-focused psychotherapeutic group intervention which aims to improve psychological adjustment to Long COVID symptoms, promote resilience, and facilitate coping, based on established psychotherapeutic techniques such as skills training, acceptance-based and identity-based principles.\n\nThe investigators will assess rates of recruitment, intervention engagement, and session attendance (feasibility), Veteran satisfaction (acceptability), treatment adherence (fidelity) and preliminarily explore response to Long COVID Coping and Recovery (LCCR). Findings will be used to make a final adaptation of the treatment materials and to develop a research protocol for a large scale RCT of LCCR for Veterans with Long COVID. This study will pilot test a well-specified, group-based intervention tailored to the unique needs of Veterans with Long COVID. The results of the proposed study will provide data to 1) identify adaptations needed to optimize LCCR for Veterans with Long COVID; 2) identify possible benefits of LCCR; 3) inform development of a large scale RCT of LCCR for Veterans with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Functional Improvement Post-COVID-19 Over Time", "description": "Our primary outcome will be changes in symptom severity and subsequent functional improvement (post-COVID-19), as measured by the Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm; Sivan et al., 2022). The C19-YRSm is a 17-item self-report scale adapted from the original 22-item COVID-19 Yorkshire Rehabilitation Scale (O'Connor et al., 2022). Items are rated on a scale from 0 (none of this symptom) to 3 (extremely severe level or impact). The C19-YRSm is divided into four subscales: symptom severity, functional disability, other symptoms (item 16), and overall health (item 17). The worst scores for each item within Questions 1-10 form the symptom severity subscale (score 0-30), Questions 11-15 the functional disability subscale (0-15), Question 16 is the other symptoms subscale (score 0-25), and Question 17 is the overall health score (score 0-10). Higher scores indicate more severity. We used the symptom severity, functional disability, and overall health subscales.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Health-Related Functional Status Over Time", "description": "Changes in functional status as relates to health will be measured by the World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0; Ustun et al., 2010). The WHODAS. 2.0 has 36 items ranging from 1 (None) to 5 (Extreme or cannot do). Items are summed for subscale scores. There are six domains: 1) understanding and communicating (scores 6-30), 2) getting around (scores 5-25), 3) self-care (scores 4-20), 4) getting along with people (scores 5-25), 5a) life activities-household (scores 4-20), 5b) life activities-school/work (scores 4-20), and 6) participation in society (scores 8-40). Higher scores indicate more difficulties due to health/mental health conditions in each domain. The WHODAS 2.0 has been validated in the general population and amongst those with non-acute health conditions and has a Cronbach's alpha of .96 (Saltychev et al., 2021). We used domains 1, 2, 3, 4, 5a, and 6.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Suicide Risk Over Time", "description": "Changes in Suicide Risk will be measured by the Suicide Behaviors Questionnaire-Revised (SBQ-R; (Osman et al., 2001). The SBQ-R is a four-item measure of suicide risk. Item 1 measures lifetime suicidal thoughts, plan, and attempt; item 2 measures the frequency of suicidal ideation over the past 12 months; item 3 measures the threat of suicide attempt; and item 4 measures the perceived likelihood of future suicidal behaviors. Items are recoded (item 1: 1-4; item 2: 1-5; item 3: 1-3; item 4: 0-6) and summed for total scores (3-18). Higher scores indicate more risk.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Self-perceived Status on Several Skills Over Time", "description": "The Measure of Current Status (MOCS) has two parts (A and B). We used Part A, which consists of 13 items that measure participants' self-perceived proficiency in skills necessary for responding to challenges of everyday life. Item responses range from 0 (I cannot do this at all) to 4 (I can do this extremely well). We summed items for total scores (possible range: 0-52). Higher scores indicate greater self-perceived proficiency of the skills listed. Reliability alphas range from 0.71 to 0.89 (Antoni et al., 2006).", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Identity Concerns Over Time", "description": "Changes in identity concerns will be assessed with the Future Self-Continuity Questionnaire (FSCQ). The FSCQ measures how individuals perceive themselves in the future in three areas: vividness of the future self, similarity with the future self, and positivity toward the future self. Items range from 1-6. The total FSCQ score is averaged from all items and the total subscales scores (vividness, similarity, and positivity) are averaged from associated items (all total mean scores range from 1-6). Higher subscale scores indicate increased levels of the domain, and higher total scores indicate increased future-self continuity. The FSCQ has demonstrated high levels of reliability ( =.85) and validity. We used the total score and all three subscale scores.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Depression Over Time", "description": "Changes in depressive symptoms will be measured with the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). The PHQ-9 is a 9-item depression module from the full PHQ with each item representing a depressive symptom. Items are scored on a scale ranging from 0 (not at all) to 3 (nearly every day) to assess the frequency of each symptom over a two-week period. Items are summed for a total score (range from 0-27), with higher scores indicating increased depression severity.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Anxiety Over Time", "description": "Changes in anxiety symptoms will be measured with the GAD-7 Anxiety (Spitzer et al., 2006). The GAD-7 is a brief self-report measure to assess symptomatology and severity related to Generalized Anxiety Disorder over the course of the last two weeks. The scale has 7 items with a 4-point Likert scale responses (0 = Never to 3 = almost every day). Items are summed for a total score (ranging from 0 to 21), with higher scores indicating increased anxiety severity. The GAD-7 has excellent reliability and validity (Spitzer et al., 2006).", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Quality of Life Over Time", "description": "Changes in quality of life will be measured with the The Quality of Life Scale (QOLS; Burckhardt \\& Anderson, 2003). The QOLS measures quality of life relevant to diverse patient groups with chronic illness across 6 domains: material and physical well-being, relationships with other people, social, community, and civic activities, personal development and recreation, and independence. There are 16 items with a response scale ranging from 1 (terrible) to 7 (delighted) to indicate levels of satisfaction among the domains. Items are summed for a total score (range: 16-112), with higher scores indicating greater quality of life.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time.", "description": "Changes in Intervention Acceptability, Feasibility, and Appropriateness will be measured by Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) (Weiner et al., 2017) at each assessment point. These measures are considered \"leading indicators\" of implementation success (acceptability and feasibility of intervention and intervention appropriateness) (Proctor et al., 2011). Each measure has four items rated from 1 (completely disagree) to 5 (completely agree). Items are averaged for total scores, and higher scores indicate higher acceptability (AIM), appropriateness (IAM), and feasibility (FIM).", "time_frame": "This outcome will be measured at 2 time points: Consent & baseline and immediately post intervention (after the second 8 sessions)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Functional Improvement Post-COVID-19 Over Time", "description": "Our primary outcome will be changes in symptom severity and subsequent functional improvement (post-COVID-19), as measured by the Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm; Sivan et al., 2022). The C19-YRSm is a 17-item self-report scale adapted from the original 22-item COVID-19 Yorkshire Rehabilitation Scale (O'Connor et al., 2022). Items are rated on a scale from 0 (none of this symptom) to 3 (extremely severe level or impact). The C19-YRSm is divided into four subscales: symptom severity, functional disability, other symptoms (item 16), and overall health (item 17). The worst scores for each item within Questions 1-10 form the symptom severity subscale (score 0-30), Questions 11-15 the functional disability subscale (0-15), Question 16 is the other symptoms subscale (score 0-25), and Question 17 is the overall health score (score 0-10). Higher scores indicate more severity. We used the symptom severity, functional disability, and overall health subscales.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Health-Related Functional Status Over Time", "description": "Changes in functional status as relates to health will be measured by the World Health Organization Disability Assessment Schedule, 2nd Version (WHODAS 2.0; Ustun et al., 2010). The WHODAS. 2.0 has 36 items ranging from 1 (None) to 5 (Extreme or cannot do). Items are summed for subscale scores. There are six domains: 1) understanding and communicating (scores 6-30), 2) getting around (scores 5-25), 3) self-care (scores 4-20), 4) getting along with people (scores 5-25), 5a) life activities-household (scores 4-20), 5b) life activities-school/work (scores 4-20), and 6) participation in society (scores 8-40). Higher scores indicate more difficulties due to health/mental health conditions in each domain. The WHODAS 2.0 has been validated in the general population and amongst those with non-acute health conditions and has a Cronbach's alpha of .96 (Saltychev et al., 2021). We used domains 1, 2, 3, 4, 5a, and 6.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Suicide Risk Over Time", "description": "Changes in Suicide Risk will be measured by the Suicide Behaviors Questionnaire-Revised (SBQ-R; (Osman et al., 2001). The SBQ-R is a four-item measure of suicide risk. Item 1 measures lifetime suicidal thoughts, plan, and attempt; item 2 measures the frequency of suicidal ideation over the past 12 months; item 3 measures the threat of suicide attempt; and item 4 measures the perceived likelihood of future suicidal behaviors. Items are recoded (item 1: 1-4; item 2: 1-5; item 3: 1-3; item 4: 0-6) and summed for total scores (3-18). Higher scores indicate more risk.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Self-perceived Status on Several Skills Over Time", "description": "The Measure of Current Status (MOCS) has two parts (A and B). We used Part A, which consists of 13 items that measure participants' self-perceived proficiency in skills necessary for responding to challenges of everyday life. Item responses range from 0 (I cannot do this at all) to 4 (I can do this extremely well). We summed items for total scores (possible range: 0-52). Higher scores indicate greater self-perceived proficiency of the skills listed. Reliability alphas range from 0.71 to 0.89 (Antoni et al., 2006).", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Identity Concerns Over Time", "description": "Changes in identity concerns will be assessed with the Future Self-Continuity Questionnaire (FSCQ). The FSCQ measures how individuals perceive themselves in the future in three areas: vividness of the future self, similarity with the future self, and positivity toward the future self. Items range from 1-6. The total FSCQ score is averaged from all items and the total subscales scores (vividness, similarity, and positivity) are averaged from associated items (all total mean scores range from 1-6). Higher subscale scores indicate increased levels of the domain, and higher total scores indicate increased future-self continuity. The FSCQ has demonstrated high levels of reliability ( =.85) and validity. We used the total score and all three subscale scores.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Depression Over Time", "description": "Changes in depressive symptoms will be measured with the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). The PHQ-9 is a 9-item depression module from the full PHQ with each item representing a depressive symptom. Items are scored on a scale ranging from 0 (not at all) to 3 (nearly every day) to assess the frequency of each symptom over a two-week period. Items are summed for a total score (range from 0-27), with higher scores indicating increased depression severity.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Anxiety Over Time", "description": "Changes in anxiety symptoms will be measured with the GAD-7 Anxiety (Spitzer et al., 2006). The GAD-7 is a brief self-report measure to assess symptomatology and severity related to Generalized Anxiety Disorder over the course of the last two weeks. The scale has 7 items with a 4-point Likert scale responses (0 = Never to 3 = almost every day). Items are summed for a total score (ranging from 0 to 21), with higher scores indicating increased anxiety severity. The GAD-7 has excellent reliability and validity (Spitzer et al., 2006).", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Change in Quality of Life Over Time", "description": "Changes in quality of life will be measured with the The Quality of Life Scale (QOLS; Burckhardt \\& Anderson, 2003). The QOLS measures quality of life relevant to diverse patient groups with chronic illness across 6 domains: material and physical well-being, relationships with other people, social, community, and civic activities, personal development and recreation, and independence. There are 16 items with a response scale ranging from 1 (terrible) to 7 (delighted) to indicate levels of satisfaction among the domains. Items are summed for a total score (range: 16-112), with higher scores indicating greater quality of life.", "time_frame": "This outcome will be measured at 3 time points: Consent & baseline, immediately mid intervention (after the first 8 sessions), and immediately post intervention (after the second 8 sessions)" }, { "type": "secondary", "measure": "Changes in Intervention Acceptability, Feasibility, and Appropriateness Over Time.", "description": "Changes in Intervention Acceptability, Feasibility, and Appropriateness will be measured by Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) (Weiner et al., 2017) at each assessment point. These measures are considered \"leading indicators\" of implementation success (acceptability and feasibility of intervention and intervention appropriateness) (Proctor et al., 2011). Each measure has four items rated from 1 (completely disagree) to 5 (completely agree). Items are averaged for total scores, and higher scores indicate higher acceptability (AIM), appropriateness (IAM), and feasibility (FIM).", "time_frame": "This outcome will be measured at 2 time points: Consent & baseline and immediately post intervention (after the second 8 sessions)" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Fed" ], "enrollment": 22, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05453201", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06522750", "title": "Periodic Fasting for Treatment of Long Covid in Adults: a Pilot Study", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-03-30", "start_date": "2025-02-19", "completion_date": "2025-09-30", "primary_completion_date": "2025-06-30", "conditions_raw": [ "Long Covid", "Chronic Inflammation" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "7-Day Ambulatory Caloric Restriction Intervention Using The Buchinger-Wilhelmi Method" ], "sponsor": "University of Luxembourg", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Background:\n\nLong COVID, characterized by persistent symptoms following acute COVID-19 infection, has emerged as a significant public health concern. Symptoms range from fatigue, cognitive impairments, to respiratory difficulties, affecting patients\\' quality of life. Dietary interventions, particularly fasting, have historically been used to modulate immune responses and improve health outcomes in various conditions. The Buchinger-Wilhelmi method represents a structured and medically supervised fasting approach. Given the inflammatory nature of long COVID, fasting may offer therapeutic benefits by modulating the immune response, enhancing cellular repair mechanisms, and resetting metabolic processes.\n\nObjectives:\n\nThis clinical trial aims to assess the feasibility of a 7-day ambulatory fasting intervention using the Buchinger-Wilhelmi method on long COVID patients as primary objective. As secondary objectives, the study will investigate the potential beneficial impact of fasting on clinical, biological, and psychological parameters over a period of 4 weeks, offering insights into potential therapeutic avenues for long COVID management.\n\nStudy timeline:\n\nThe research will span a period of 4 weeks\n\nStudy population:\n\nThis study aims to recruit around 20 participants, who will all receive a fasting intervention using the Buchinger-Wilhelmi method.\n\nBiological sample and data collection:\n\nParticipants will undergo various data and sample collection procedures, including blood draws of up to 90 42 ml per visit, collection of peripheral mononuclear cells, stool samples, and completion of questionnaires in a smartphone-based Application (MyCap).\n\nSample analysis:\n\nThe collected samples will be subjected to a range of analyses, including the assessment of serological markers for routine blood chemistry, evaluation of inflammation markers, and examination of stool samples.", "primary_outcomes": [ { "type": "primary", "measure": "Nutritional protocol", "description": "Patient's level of health and wellbeing from a nutritional point of view", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Fatigue assessment Scale (FAS)", "description": "Level of fatigue through three factors (General Fatigue, Physical Fatigue and Concentration/Motivation).", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Quality of Life (WHOQOL)", "description": "Quality of Life as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Functionality (WHODAS 2.0)", "description": "Impact of Long Covid in terms of functioning.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Anxiety (GAD-7)", "description": "Generalized anxiety disorder in the last 2 weeks", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Depression (PHQ-9)", "description": "Presence and severity of depressive symptoms", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Mood States", "description": "Transient fluctuating moods or affective states", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Blood preasure", "description": "Force or pressure of blood on the arteries when the heart is pumping", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Urine Metabolomics", "description": "Metabolites in urine", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Gut Microbiome", "description": "Microbiota in stool", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Stool Metabolomics", "description": "Metabolites in stool", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Blood cytokines", "description": "Cytokines using Quanterix technology", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Blood Mitochondrial dysfunction", "description": "Mitochondrial cell-free DNA", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Blood Epigenetics", "description": "Methylation profiling microarray", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Blood test", "description": "Metabolites in blood", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Nutritional protocol", "description": "Patient's level of health and wellbeing from a nutritional point of view", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Fatigue assessment Scale (FAS)", "description": "Level of fatigue through three factors (General Fatigue, Physical Fatigue and Concentration/Motivation).", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Quality of Life (WHOQOL)", "description": "Quality of Life as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Functionality (WHODAS 2.0)", "description": "Impact of Long Covid in terms of functioning.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Anxiety (GAD-7)", "description": "Generalized anxiety disorder in the last 2 weeks", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Depression (PHQ-9)", "description": "Presence and severity of depressive symptoms", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Mood States", "description": "Transient fluctuating moods or affective states", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Blood preasure", "description": "Force or pressure of blood on the arteries when the heart is pumping", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Urine Metabolomics", "description": "Metabolites in urine", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Gut Microbiome", "description": "Microbiota in stool", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Stool Metabolomics", "description": "Metabolites in stool", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Blood cytokines", "description": "Cytokines using Quanterix technology", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Blood Mitochondrial dysfunction", "description": "Mitochondrial cell-free DNA", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Blood Epigenetics", "description": "Methylation profiling microarray", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Blood test", "description": "Metabolites in blood", "time_frame": "4 weeks" } ], "relevance_tags": [ "Metabolic", "Immunomodulatory", "Neurological / Autonomic", "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06522750", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05172206", "title": "Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-03-28", "start_date": "2022-05-20", "completion_date": "2024-01-25", "primary_completion_date": "2024-01-25", "conditions_raw": [ "COVID-19", "Long-COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Symptom-Focused Rehabilitation" ], "sponsor": "Schön Klinik Berchtesgadener Land", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Inpatient, multimodal rehabilitation represents one of the most important interventions in the disease management of post/long COVID. Different professional societies, including the German Society of Pneumology and the European Respiratory Society, recommend rehabilitation intervention to reduce the sequelae of COVID-19. However, from the perspective of science and practice, there are relevant areas that have been insufficiently investigated and are essential for the treatment success of post/long COVID patients:\n\n* Differentiation of rehabilitation effects from natural recovery after COVID-19.\n* Lack of personalized and symptom-based treatment approaches that can address the heterogeneity of symptoms in post/long COVID\n* Lack of uniform, high-quality rehabilitation standards in post-/long-COVID.\n\nTherefore, post-COVID patients will be recruited at several post-COVID practices around Germany and randomized to receive (A) a rehabilitation program or (B) usual care. The primary objective of this randomized controlled trial (RCT) is to investigate whether a 3-week symptom-oriented, inpatient, multidisciplinary rehabilitation intervention, whose content focus is standardized according to cluster assignment (fatigue, cognition, soma), has a positive effect on the quality of life (primary outcome) in post-COVID syndrome patients compared to a usual care group (standard outpatient care). All study participants will be provided with a continuous telemonitoring system (SaniQ app) throughout the study period. After the interventional phase, there will be a 3 months follow-up assessment to evaluate the maintenance effects of COVID rehabilitation.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12", "description": "the scale of the physical and mental Health component summary score ranges from minimum 0 to maximum 100 points with higher scores indicating better quality of life", "time_frame": "baseline, week 4, week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from baseline COVID-related symptoms at week 4 and week 12", "description": "the number of COVID-symptoms will recorded as well as their intensity will be rated on a scale from 0 \\[not relevant\\] until 10 \\[very severe symptom\\].", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline lung function at week 4 and week 12", "description": "following Parameters will be collected: forced expiratory volume in 1 sec, peak flow, forced vital capacity, total lung capacity, diffusion lung capacity for carbonmonoxide", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline blood gas analysis at week 4 and week 12", "description": "following parameters will be collected at rest and at the end of an incremental cycle test: partial pressure for oxygen and carbon dioxide", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline Cardiac Doppler echocardiography at week 4 and week 12", "description": "Left and right heart echocardiography will be performed", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline laboratory parameters at week 4 and week 12", "description": "blood samples will be taken from venous blood", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline exercise performance at week 4 and week 12", "description": "incremental cardiopulmonary exercise testing will be performed with spirometry", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline health care service needs at week 4 and week 12", "description": "Number of visits at the general practitioner, pulmonologist, psychologist, physiotherapist, COVID-ambulance, hospital admission until the last visit will be recorded", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline working capability at week 4 and week 12", "description": "number of days of incapacity to work until the last visit will be recorded", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline sleep quality at week 4 and week 12", "description": "Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index (total score ranges from 0 to 21 with higher scores indicating higher impairment)", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline sleep quality at week 4 and week 12", "description": "daytime sleepiness will be assessed by using the Epworth Sleepiness Scale (total score ranges from 0 to 24 with higher scores indicating higher impairment)", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline Depression status assessed by Patient Health Questionnaire 9", "description": "the total score ranges from 0 to 27 points with higher scores indicating worse Depression symptoms", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline Anxiety status assessed by Generalized Anxiety Disorder Scale 7", "description": "the total score ranges from 0 to 21 points with higher scores indicating more anxiety symptoms", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline resilience assessed by resilience scale 13", "description": "the total score ranges from 13 to 91 points with higher scores indicating higher resilience", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test", "description": "the total score ranges from 0 to 30 points with higher scores indicating a better cognitive status", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12", "description": "the total score ranges from 0 to 4 points with higher scores indicating more dyspnea", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12", "description": "the total score ranges from 0 to 64 points with higher scores indicating hyperventilation", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12", "description": "the total score ranges from 10 to 50 points with higher scores indicating more fatigue", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12", "description": "the canadian consensus criteria indicate if patients developed a chronic fatigue syndrome/myalgic encephalomyelitis", "time_frame": "baseline, week 12" }, { "type": "secondary", "measure": "Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12", "description": "the total score ranges from 0 to 4 points with higher scores indicating more impairment", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline physical activity assessed by Garmin watch at week 4 and week 12", "description": "daily total steps per day will be recorded by a Garmin watch linked to the SaniQ App", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline blood pressure assessed at week 4 and week 12", "description": "blood pressure will be measured at the upper arm using the Aponorm device", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12", "description": "Beurer pulse oximeter", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline peak flow assessed by peak flow meter at week 4 and week 12", "description": "peak flow will be assessed by smart one spirometer", "time_frame": "baseline, week 4, week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12", "description": "the scale of the physical and mental Health component summary score ranges from minimum 0 to maximum 100 points with higher scores indicating better quality of life", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline COVID-related symptoms at week 4 and week 12", "description": "the number of COVID-symptoms will recorded as well as their intensity will be rated on a scale from 0 \\[not relevant\\] until 10 \\[very severe symptom\\].", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline lung function at week 4 and week 12", "description": "following Parameters will be collected: forced expiratory volume in 1 sec, peak flow, forced vital capacity, total lung capacity, diffusion lung capacity for carbonmonoxide", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline blood gas analysis at week 4 and week 12", "description": "following parameters will be collected at rest and at the end of an incremental cycle test: partial pressure for oxygen and carbon dioxide", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline Cardiac Doppler echocardiography at week 4 and week 12", "description": "Left and right heart echocardiography will be performed", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline laboratory parameters at week 4 and week 12", "description": "blood samples will be taken from venous blood", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline exercise performance at week 4 and week 12", "description": "incremental cardiopulmonary exercise testing will be performed with spirometry", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline health care service needs at week 4 and week 12", "description": "Number of visits at the general practitioner, pulmonologist, psychologist, physiotherapist, COVID-ambulance, hospital admission until the last visit will be recorded", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline working capability at week 4 and week 12", "description": "number of days of incapacity to work until the last visit will be recorded", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline sleep quality at week 4 and week 12", "description": "Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index (total score ranges from 0 to 21 with higher scores indicating higher impairment)", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline sleep quality at week 4 and week 12", "description": "daytime sleepiness will be assessed by using the Epworth Sleepiness Scale (total score ranges from 0 to 24 with higher scores indicating higher impairment)", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline Depression status assessed by Patient Health Questionnaire 9", "description": "the total score ranges from 0 to 27 points with higher scores indicating worse Depression symptoms", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline Anxiety status assessed by Generalized Anxiety Disorder Scale 7", "description": "the total score ranges from 0 to 21 points with higher scores indicating more anxiety symptoms", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline resilience assessed by resilience scale 13", "description": "the total score ranges from 13 to 91 points with higher scores indicating higher resilience", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test", "description": "the total score ranges from 0 to 30 points with higher scores indicating a better cognitive status", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12", "description": "the total score ranges from 0 to 4 points with higher scores indicating more dyspnea", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12", "description": "the total score ranges from 0 to 64 points with higher scores indicating hyperventilation", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12", "description": "the total score ranges from 10 to 50 points with higher scores indicating more fatigue", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12", "description": "the canadian consensus criteria indicate if patients developed a chronic fatigue syndrome/myalgic encephalomyelitis", "time_frame": "baseline, week 12" }, { "type": "secondary", "measure": "Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12", "description": "the total score ranges from 0 to 4 points with higher scores indicating more impairment", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline physical activity assessed by Garmin watch at week 4 and week 12", "description": "daily total steps per day will be recorded by a Garmin watch linked to the SaniQ App", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline blood pressure assessed at week 4 and week 12", "description": "blood pressure will be measured at the upper arm using the Aponorm device", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12", "description": "Beurer pulse oximeter", "time_frame": "baseline, week 4, week 12" }, { "type": "secondary", "measure": "Change from baseline peak flow assessed by peak flow meter at week 4 and week 12", "description": "peak flow will be assessed by smart one spirometer", "time_frame": "baseline, week 4, week 12" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 132, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05172206", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05539950", "title": "Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2025-03-26", "start_date": "2022-10-01", "completion_date": "2024-12-31", "primary_completion_date": "2024-10-31", "conditions_raw": [ "Post Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cardiopulmonary Rehabilitation" ], "sponsor": "Taipei Medical University Shuang Ho Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In 2022, though the optimized acute medical treatment of COVID-19 was determined, patients often experience the sequelae (also known as post-acute COVID-19 syndrome, the patients might develop cough, breathlessness, fatigue, weakness, impaired activities of daily livings etc.). Until now, there is no consensus for post-acute COVID-19 syndrome management. Previously, the cardiopulmonary rehabilitation revealed significant benefits in heart failure or chronic obstructive pulmonary disease. The aims of the study are demonstrating the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.", "primary_outcomes": [ { "type": "primary", "measure": "Changes in Cardiopulmonary exercise testing (CPET)", "description": "CPET is a non-invasive examination, which provides assessment of the integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems. It permits the evaluation of both submaximal and peak exercise responses. CPET is currently act as a clinical applications for the evaluation of undiagnosed exercise intolerance and for the objective determination of functional capacity and impairment.", "time_frame": "Baseline, Week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes in 6 minutes walking test (6MWT)", "description": "6MWT is a commonly used test for the objective assessment of functional exercise capacity for the management of patients with moderate-to-severe pulmonary disease. This test does not require complex equipment or technical expertise. The participant is asked to walk as far as possible along a 30-m minimally trafficked corridor for a period of 6 min with the primary outcome measure being the 6-min walk distance (6MWD) measured in meters.", "time_frame": "Baseline, Week 12" }, { "type": "secondary", "measure": "Changes in Pulmonary function test (PFT)", "description": "PFT is used in investigating and monitoring of patients with respiratory pathology. PFT allows physicians to quantify the severity of the pulmonary disease, follow it up over time, and assess its response to treatment.", "time_frame": "Baseline, Week 12" }, { "type": "secondary", "measure": "Changes in 36-Item Short Form Survey (SF-36)", "description": "SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. This questionnaire includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.", "time_frame": "Baseline, Week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Changes in Cardiopulmonary exercise testing (CPET)", "description": "CPET is a non-invasive examination, which provides assessment of the integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems. It permits the evaluation of both submaximal and peak exercise responses. CPET is currently act as a clinical applications for the evaluation of undiagnosed exercise intolerance and for the objective determination of functional capacity and impairment.", "time_frame": "Baseline, Week 12" }, { "type": "secondary", "measure": "Changes in 6 minutes walking test (6MWT)", "description": "6MWT is a commonly used test for the objective assessment of functional exercise capacity for the management of patients with moderate-to-severe pulmonary disease. This test does not require complex equipment or technical expertise. The participant is asked to walk as far as possible along a 30-m minimally trafficked corridor for a period of 6 min with the primary outcome measure being the 6-min walk distance (6MWD) measured in meters.", "time_frame": "Baseline, Week 12" }, { "type": "secondary", "measure": "Changes in Pulmonary function test (PFT)", "description": "PFT is used in investigating and monitoring of patients with respiratory pathology. PFT allows physicians to quantify the severity of the pulmonary disease, follow it up over time, and assess its response to treatment.", "time_frame": "Baseline, Week 12" }, { "type": "secondary", "measure": "Changes in 36-Item Short Form Survey (SF-36)", "description": "SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. This questionnaire includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.", "time_frame": "Baseline, Week 12" } ], "relevance_tags": [ "General", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT05539950", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05682560", "title": "Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2025-03-24", "start_date": "2023-05-04", "completion_date": "2025-02-27", "primary_completion_date": "2024-07-26", "conditions_raw": [ "Long COVID", "Post-COVID Syndrome", "Post COVID-19 Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Regenecyte" ], "sponsor": "StemCyte, Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Treatment-emergent adverse events (TEAEs)", "description": "Incidence of treatment-emergent adverse events (TEAEs)", "time_frame": "Baseline to Week 26" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change of fatigue score as measured by CFQ-11", "description": "", "time_frame": "Baseline, Week 6, 12, 18 and 26" } ], "outcome_measures": [ { "type": "primary", "measure": "Treatment-emergent adverse events (TEAEs)", "description": "Incidence of treatment-emergent adverse events (TEAEs)", "time_frame": "Baseline to Week 26" }, { "type": "secondary", "measure": "Change of fatigue score as measured by CFQ-11", "description": "", "time_frame": "Baseline, Week 6, 12, 18 and 26" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05682560", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06296914", "title": "A MHealth System for Patients with POTS", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-03-21", "start_date": "2024-02-20", "completion_date": "2025-02-24", "primary_completion_date": "2025-02-24", "conditions_raw": [ "POTS - Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Potsapp" ], "sponsor": "Jami Warren", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural Orthostatic Tachycardia Syndrome (POTS) affects approximately 500,000 - 3 million Americans. This number will only increase due to the large number of patients experiencing POTS due to \"long COVID.\" POTS patients experience several symptoms, including tachycardia, palpitations, dizziness, and pre-syncope or syncope, among others. POTS can be very debilitating and not only affect patients physically but also emotionally and financially. It takes an average of four years and seven doctors for POTS patients to achieve a diagnosis and it is often a frustrating and negative experience fraught with misdiagnoses, stigma, and depression and anxiety. Recent research demonstrates that mHealth technology may be one way that POTS patients can improve their experience in the healthcare system by providing objective data to their healthcare providers. Patients may also better take care of themselves through symptom monitoring and instant patient education via mHealth technology. The two study aims are: 1) Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients; and 2) Evaluate the usability and feasibility of the mHealth app and study design. To achieve these aims, researchers in this study will work with a programmer and leaders from the mHealth Application Modernization and Mobilization Alliance (MAMMA) and stakeholders (patients, caregivers, and providers) to co-design a mHealth app for POTS patients, including key educational components guided by the IDEA model, an instructional risk communication approach. A group of diagnosis-seeking POTS (n=20) patients will pilot test the app and provide feedback for improvement as well as evaluate its usability. Results from this study will allow researchers to acquire necessary data to apply for external funding to conduct a larger clinical trial to evaluate its influence on health outcomes, such as patient experience during visits with physicians, perceived stigma, and time to diagnosis.", "primary_outcomes": [ { "type": "primary", "measure": "Change in POTSapp Usability as measured by uMARS", "description": "The usability of the POTSapp will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.", "time_frame": "Month 4 and Month 8" }, { "type": "primary", "measure": "Change in POTSapp Usage - number of page views", "description": "Usage will be measured by the number of page views as \"clicks\" on particular pages", "time_frame": "Month 4 and Month 8" }, { "type": "primary", "measure": "Change in POTSapp Usage - time spent in app", "description": "Usage will be measured by the time spent on particular pages in the app.", "time_frame": "Month 4 and Month 8" }, { "type": "primary", "measure": "Change in POTSapp Usability as measured by Health-ITUES", "description": "The Health Information Technology Usability Evaluation Scale (Health-ITUES) consists of 20 items rated on a five-point Likert scale from strongly disagree (1) to strongly agree (5). Scores range from 5-20. A higher scale value indicates higher perceived usability of the technology.", "time_frame": "Month 4 and Month 8" }, { "type": "primary", "measure": "Change in POTSapp Effectiveness as measured by Message Effectiveness scale", "description": "Message Effectiveness scale consists of 9 items that examine message believability, memorability, likelihood that the message encourages participant to speak with healthcare provider, etc. This is a 5-point Likert type scale ranging from 1 = strongly disagree to 5 = strongly agree, where lower scores equal more disagreement and higher scores equal greater agreement.", "time_frame": "Month 4 and Month 8" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Participant Quality of Life", "description": "The Centers for Disease Control (CDC) Health Related Quality Of Life (HRQOL) scale will be used for this measure. Scores on the scale range from 0 to 30 with a higher score indicating poorer quality of life and lower scores indicating greater quality of life.", "time_frame": "Baseline and at 4 and 8 months" }, { "type": "secondary", "measure": "Change in Doctor Patient Communication (DPC)", "description": "questionnaire to assess DPC. 15 questions with graded responses (Likert from 1 to 4). A higher score indicates stronger communication and a lower score indicates weaker communication.", "time_frame": "Baseline and at 4 and 8 months" }, { "type": "secondary", "measure": "Adapted IBS Perceived Stigma Scale", "description": "10-item scale that measures perceived stigma or judgment from healthcare provider. This is a 5-point Likert type scale, where lower scores indicate less perceived stigma and higher scores indicate greater perceived stigma.", "time_frame": "4 and 8 months" }, { "type": "secondary", "measure": "Cognitive Learning", "description": "10-item scale that measures cognitive learning of educational material included in the mobile app. Scores range from 0-4. Higher scores indicate greater learning and lower scores indicate less learning.", "time_frame": "4 and 8 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in POTSapp Usability as measured by uMARS", "description": "The usability of the POTSapp will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.", "time_frame": "Month 4 and Month 8" }, { "type": "primary", "measure": "Change in POTSapp Usage - number of page views", "description": "Usage will be measured by the number of page views as \"clicks\" on particular pages", "time_frame": "Month 4 and Month 8" }, { "type": "primary", "measure": "Change in POTSapp Usage - time spent in app", "description": "Usage will be measured by the time spent on particular pages in the app.", "time_frame": "Month 4 and Month 8" }, { "type": "primary", "measure": "Change in POTSapp Usability as measured by Health-ITUES", "description": "The Health Information Technology Usability Evaluation Scale (Health-ITUES) consists of 20 items rated on a five-point Likert scale from strongly disagree (1) to strongly agree (5). Scores range from 5-20. A higher scale value indicates higher perceived usability of the technology.", "time_frame": "Month 4 and Month 8" }, { "type": "primary", "measure": "Change in POTSapp Effectiveness as measured by Message Effectiveness scale", "description": "Message Effectiveness scale consists of 9 items that examine message believability, memorability, likelihood that the message encourages participant to speak with healthcare provider, etc. This is a 5-point Likert type scale ranging from 1 = strongly disagree to 5 = strongly agree, where lower scores equal more disagreement and higher scores equal greater agreement.", "time_frame": "Month 4 and Month 8" }, { "type": "secondary", "measure": "Change in Participant Quality of Life", "description": "The Centers for Disease Control (CDC) Health Related Quality Of Life (HRQOL) scale will be used for this measure. Scores on the scale range from 0 to 30 with a higher score indicating poorer quality of life and lower scores indicating greater quality of life.", "time_frame": "Baseline and at 4 and 8 months" }, { "type": "secondary", "measure": "Change in Doctor Patient Communication (DPC)", "description": "questionnaire to assess DPC. 15 questions with graded responses (Likert from 1 to 4). A higher score indicates stronger communication and a lower score indicates weaker communication.", "time_frame": "Baseline and at 4 and 8 months" }, { "type": "secondary", "measure": "Adapted IBS Perceived Stigma Scale", "description": "10-item scale that measures perceived stigma or judgment from healthcare provider. This is a 5-point Likert type scale, where lower scores indicate less perceived stigma and higher scores indicate greater perceived stigma.", "time_frame": "4 and 8 months" }, { "type": "secondary", "measure": "Cognitive Learning", "description": "10-item scale that measures cognitive learning of educational material included in the mobile app. Scores range from 0-4. Higher scores indicate greater learning and lower scores indicate less learning.", "time_frame": "4 and 8 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06296914", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06883513", "title": "Osteopathic Manipulative Therapy Effects on Post-Acute Sequelae of COVID-19 (PASC) or Long COVID", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-03-19", "start_date": "2025-05-01", "completion_date": "2025-07-03", "primary_completion_date": "2025-07-03", "conditions_raw": [ "Long-COVID", "PASC", "Long COVID Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Osteopathic Manipulative Therapy Long-Covid Protocol", "Osteopathic Manipulative Therapy Not Long-Covid Treatment Protocol" ], "sponsor": "University of Louisville", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is investigating the effects of using an Osteopathic Manipulative Therapy (OMT) treatment protocol that was shown to statistically improve smell in individuals suffering from Long-COVID olfactory (smell) dysfunction in a small single-blinded pilot trial conducted during 2021.\n\nThe questions this study is trying to answer are:\n\n1. Does this OMT protocol improve other non-smell related Long-COVID symptoms\n2. Do 2 OMT treatments improve Long-COVID symptoms more than 1 OMT treatment\n\nParticipants will:\n\n1. Week 1: Take an digital survey regarding their Long-COVID symptoms undergo Long-COVID OMT treatment or a placebo treatment\n2. Week 2: Take an digital survey regarding their Long-COVID symptoms then all will undergo Long-COVID OMT treatment\n3. Week 3: Take an digital survey regarding their Long-COVID symptoms\n4. Week 8: Take an digital survey regarding their Long-COVID symptoms", "primary_outcomes": [ { "type": "primary", "measure": "The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)", "description": "The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) is a validated tool generated to assess for Long-COVID symptom burden generated by the University of Birmingham in the UK. The SBQ™-LC assesses 123 different symptoms of Long COVID.\n\nAll items use the recall period \"In the last 7 days...\" and are scored according to one of the following:\n\n1. symptom presence (Yes/No);\n2. symptom frequency (0 = Never to 3 = Always);\n3. symptom severity (0 = None to 3 = Severe);\n4. or Interference in daily life (0 = Not at all to 3 = Severely). The SBQ™-LC has a Flesch-Kincaid Reading Grade level score of 5.33 suggesting it would be understood by a person with a 6th grade reading level according to the American education system. The SBQ™-LC's SMOG Index score of 8.27 means it should be understood by 93% of UK adults.(8-10)\n\nHigher scores suggest worsening symptom severity.\n\nMaximum raw score depends on which independent scale within the tool is measured. Ranges from 5-38 depending", "time_frame": "On arrival for baseline before any treatment (week 1). On arrival for 2nd treatment (week 2). 7 days after 2nd treatment (week 3). Final Survey on week 8 of post-enrollment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Blood Pressure(BP)", "description": "BP's will be taken before treatment regardless of arm participants are assigned at baseline. It will be repeated 10 minutes after the each treatment", "time_frame": "Each in-person treatment event, total of 1 BP at arrival after being enrolled for baseline and then a repeat 10 minutes after treatment (regardless of which treatment arm); repeat sequence at the 2nd in-person visit for a total of 4 BP readings" }, { "type": "secondary", "measure": "Heart Rate (HR)", "description": "HR's will be taken before treatment regardless of arm participants are assigned at baseline. It will be repeated 10 minutes after the each treatment", "time_frame": "Each in-person treatment event, total of 1 HR at arrival after being enrolled for baseline and then a repeat 10 minutes after treatment (regardless of which treatment arm); repeat sequence at the 2nd in-person visit for a total of 4 HR readings" } ], "outcome_measures": [ { "type": "primary", "measure": "The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)", "description": "The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) is a validated tool generated to assess for Long-COVID symptom burden generated by the University of Birmingham in the UK. The SBQ™-LC assesses 123 different symptoms of Long COVID.\n\nAll items use the recall period \"In the last 7 days...\" and are scored according to one of the following:\n\n1. symptom presence (Yes/No);\n2. symptom frequency (0 = Never to 3 = Always);\n3. symptom severity (0 = None to 3 = Severe);\n4. or Interference in daily life (0 = Not at all to 3 = Severely). The SBQ™-LC has a Flesch-Kincaid Reading Grade level score of 5.33 suggesting it would be understood by a person with a 6th grade reading level according to the American education system. The SBQ™-LC's SMOG Index score of 8.27 means it should be understood by 93% of UK adults.(8-10)\n\nHigher scores suggest worsening symptom severity.\n\nMaximum raw score depends on which independent scale within the tool is measured. Ranges from 5-38 depending", "time_frame": "On arrival for baseline before any treatment (week 1). On arrival for 2nd treatment (week 2). 7 days after 2nd treatment (week 3). Final Survey on week 8 of post-enrollment" }, { "type": "secondary", "measure": "Blood Pressure(BP)", "description": "BP's will be taken before treatment regardless of arm participants are assigned at baseline. It will be repeated 10 minutes after the each treatment", "time_frame": "Each in-person treatment event, total of 1 BP at arrival after being enrolled for baseline and then a repeat 10 minutes after treatment (regardless of which treatment arm); repeat sequence at the 2nd in-person visit for a total of 4 BP readings" }, { "type": "secondary", "measure": "Heart Rate (HR)", "description": "HR's will be taken before treatment regardless of arm participants are assigned at baseline. It will be repeated 10 minutes after the each treatment", "time_frame": "Each in-person treatment event, total of 1 HR at arrival after being enrolled for baseline and then a repeat 10 minutes after treatment (regardless of which treatment arm); repeat sequence at the 2nd in-person visit for a total of 4 HR readings" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06883513", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06876948", "title": "NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-03-14", "start_date": "2023-03-29", "completion_date": "2026-04-28", "primary_completion_date": "2025-03-29", "conditions_raw": [ "Long Covid-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Psychological Tests, Eeg, Magnetic Resonance" ], "sponsor": "Azienda Ospedaliero, Universitaria Pisana", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The study seeks to investigate the neurological effects caused by Covid-19 in children and adolescents in the 6-16 age group. To do this, neuropsychological scales, an EEG and an MRI were used.", "primary_outcomes": [ { "type": "primary", "measure": "Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.", "description": "Assessment of cognitive, neuropsychological and adaptive skills in children and adolescents with Long COVID by means of standardised tests (WISC-IV, CPT3, NEPSY II, BRIEF-2, Vineland Adaptive Behavior Scales). The tests measure attention, memory, executive functions, intellectual-adaptive functioning and quality of life.", "time_frame": "Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1)." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.", "description": "Assessment of cognitive, neuropsychological and adaptive skills in children and adolescents with Long COVID by means of standardised tests (WISC-IV, CPT3, NEPSY II, BRIEF-2, Vineland Adaptive Behavior Scales). The tests measure attention, memory, executive functions, intellectual-adaptive functioning and quality of life.", "time_frame": "Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1)." } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06876948", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05638620", "title": "Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Long COVID", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2025-03-13", "start_date": "2023-01-03", "completion_date": "2023-12-30", "primary_completion_date": "2023-06-15", "conditions_raw": [ "Post Acute COVID-19 Syndrome", "Long COVID", "Long Covid19", "COVID-19 Recurrent", "Post-Acute COVID-19", "Post-Acute COVID-19 Infection", "SARS-CoV2 Infection", "Post Acute Sequelae of COVID-19", "Dysautonomia", "Dysautonomia Like Disorder", "Dysautonomia Orthostatic Hypotension Syndrome", "Post COVID-19 Condition", "Post-COVID Syndrome", "Post COVID-19 Condition, Unspecified", "Post-COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Stellate Ganglion Block With 0.5% Bupivacaine" ], "sponsor": "Jonathann Kuo, MD", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Patient-Reported Outcomes: PROMIS-29 Score", "description": "The primary objective of the clinical effectiveness trial is to evaluate whether Dual Sympathetic Blocks performed at 0 and 1 weeks will improve patient-reported outcomes of depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities status. These domains are measured as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS-29) total scores between baseline and 4 weeks", "time_frame": "1 month" }, { "type": "primary", "measure": "Depression", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Anxiety", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Physical function", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Pain interference", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Fatigue", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Sleep disturbance", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Ability to participate in social roles and activities status", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Autonomic Symptoms: COMPASS-31 Score", "description": "The secondary objective of the clinical effectiveness trial is to evaluate whether Dual Sympathetic Blocks performed at 0 and 1 weeks will improve Dysautonomia symptoms as reflected by corresponding Composite Autonomic Symptom Scale 31 (COMPASS-31) scores between baseline and 4 weeks", "time_frame": "1 month" } ], "outcome_measures": [ { "type": "primary", "measure": "Patient-Reported Outcomes: PROMIS-29 Score", "description": "The primary objective of the clinical effectiveness trial is to evaluate whether Dual Sympathetic Blocks performed at 0 and 1 weeks will improve patient-reported outcomes of depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities status. These domains are measured as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS-29) total scores between baseline and 4 weeks", "time_frame": "1 month" }, { "type": "primary", "measure": "Depression", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Anxiety", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Physical function", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Pain interference", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Fatigue", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Sleep disturbance", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "primary", "measure": "Ability to participate in social roles and activities status", "description": "PROMIS-29 survey will measure changes in each domain scores between baseline and 4 weeks.", "time_frame": "1 month" }, { "type": "secondary", "measure": "Autonomic Symptoms: COMPASS-31 Score", "description": "The secondary objective of the clinical effectiveness trial is to evaluate whether Dual Sympathetic Blocks performed at 0 and 1 weeks will improve Dysautonomia symptoms as reflected by corresponding Composite Autonomic Symptom Scale 31 (COMPASS-31) scores between baseline and 4 weeks", "time_frame": "1 month" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05638620", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05205460", "title": "Telerehabilitation in People With Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-03-11", "start_date": "2021-10-12", "completion_date": "2023-05-20", "primary_completion_date": "2023-04-30", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Home-Based Telerehabilitation" ], "sponsor": "Tri-Service General Hospital (TSGH)", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of our study is to investigate the effectiveness of telerehabilitation in Post-COVID patients.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Exercise Capacity: Peak Oxygen Uptake (VO2peak) From Baseline to 12 Weeks", "description": "The peak oxygen uptake (VO2peak) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in VO2 peak was calculated as the value at 12 weeks minus the value at baseline. A higher VO2 peak indicates better exercise capacity.", "time_frame": "Baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Exercise Capacity: Workload (Watt) From Baseline to 12 Weeks", "description": "The workload (Watt) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in workload was calculated as the value at 12 weeks minus the value at baseline. A higher workload indicates better exercise capacity.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Exercise Capacity: Anaerobic Threshold (AT) From Baseline to 12 Weeks", "description": "The anaerobic threshold (AT) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in AT was calculated as the value at 12 weeks minus the value at baseline. A higher AT indicates better exercise capacity and endurance.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Lung Function: Forced Expiratory Volume 1 (FEV1) From Baseline to 12 Weeks", "description": "The amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry. The change in FEV₁ was calculated as the value at 12 weeks minus the value at baseline. A higher FEV₁ indicates better lung function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Lung Function: Forced Vital Capacity (FVC) From Baseline to 12 Weeks", "description": "The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry. The change in FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FVC indicates better lung function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Lung Function: FEV1/FVC % From Baseline to 12 Weeks", "description": "The measured FEV1 is divided by the measured FVC. he change in FEV₁/FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FEV₁/FVC ratio generally indicates better lung function, while a lower ratio suggests airflow limitation.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Ventilation/ Perfusion Abnormalities (VE/VCO2) From Baseline to 12 Weeks", "description": "The ventilation/ perfusion abnormalities (VE/VCO2)is measured by graded exercise testing.\n\nA cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2).\n\nThe change in VE/VCO2 was calculated as the value at 12 weeks minus the value at baseline. A lower VE/VCO2 ratio indicates better ventilatory efficiency and reduced ventilation/perfusion abnormalities.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Left Ventricular Function: O2 Pulse From Baseline to 12 Weeks", "description": "O2 Pulse is simply oxygen consumption (in ml) divided by heart rate. It is used as an index of stroke volume.The O2 pulse is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in O₂ pulse was calculated as the value at 12 weeks minus the value at baseline. A higher O₂ pulse indicates improved left ventricular function and greater cardiovascular efficiency.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Heart Rate Recovery From Baseline to 12 Weeks", "description": "The heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery.\n\nA cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in heart rate recovery was calculated as the difference between heart rate recovery at 12 weeks and heart rate recovery at baseline. A decrease of \\< 12 or 22 beats per minute in 1- or 2-min heart rate recovery, respectively, indicates an elevated risk of mortality. A faster heart rate recovery indicates better cardiovascular fitness and autonomic regulation.", "time_frame": "baseline, 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks", "description": "Taiwan version of the International Physical Activity Questionnaire. The overall physical activity (MET-min/week), vigorous intensity physical activity (MET-min/week), moderate intensity physical activity (MET-min/week), walking (MET-min/week) are measured.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Change in Confidence Level of Exercise: Questionnaire of Self-Efficacy Items From Baseline to 12 Weeks", "description": "Questionnaire of Self-Efficacy Items. A five-item self-efficacy measure designed to measure confidence in one's ability to persist with exercising in various situations was developed. A five-point scale is used to rate each item : 1 indicates \"not at all confident\", 2 indicates \"little confident\" , 3 indicates \"confident\", 4 indicates \"very confident\", 5 indicates \"strongly confident\".", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)", "description": "The Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) with good validity and reliability includes the globally standardized WHOQOL-BREF with 26 items and an additional two locally developed items, making a total of 28 items. It consists of two single-facet items measuring overall quality of life and general health and four domains, including physical (7 items), psychological (6 items), social (4 items), and environmental (9 items) domains. The two additional items are being respected/accepted facet in the social domain and eating/food facet in the environment domain, respectively. The participants rated all items on a scale of 1-5, with higher scores reflecting a greater quality of life. Domain scores were derived by multiplying the mean of the facet scores within each domain by a scaling factor of 4, resulting in potential domain scores ranging from 4 to 20.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) From Baseline to 12 Weeks", "description": "Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven \"component\" scores and the sum of scores for these seven components yields one global score. (Scores ranged from 0 to 21, with higher scores indicating poor sleep quality.)", "time_frame": "baseline, 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Exercise Capacity: Peak Oxygen Uptake (VO2peak) From Baseline to 12 Weeks", "description": "The peak oxygen uptake (VO2peak) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in VO2 peak was calculated as the value at 12 weeks minus the value at baseline. A higher VO2 peak indicates better exercise capacity.", "time_frame": "Baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Exercise Capacity: Workload (Watt) From Baseline to 12 Weeks", "description": "The workload (Watt) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in workload was calculated as the value at 12 weeks minus the value at baseline. A higher workload indicates better exercise capacity.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Exercise Capacity: Anaerobic Threshold (AT) From Baseline to 12 Weeks", "description": "The anaerobic threshold (AT) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in AT was calculated as the value at 12 weeks minus the value at baseline. A higher AT indicates better exercise capacity and endurance.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Lung Function: Forced Expiratory Volume 1 (FEV1) From Baseline to 12 Weeks", "description": "The amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry. The change in FEV₁ was calculated as the value at 12 weeks minus the value at baseline. A higher FEV₁ indicates better lung function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Lung Function: Forced Vital Capacity (FVC) From Baseline to 12 Weeks", "description": "The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry. The change in FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FVC indicates better lung function.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Lung Function: FEV1/FVC % From Baseline to 12 Weeks", "description": "The measured FEV1 is divided by the measured FVC. he change in FEV₁/FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FEV₁/FVC ratio generally indicates better lung function, while a lower ratio suggests airflow limitation.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Ventilation/ Perfusion Abnormalities (VE/VCO2) From Baseline to 12 Weeks", "description": "The ventilation/ perfusion abnormalities (VE/VCO2)is measured by graded exercise testing.\n\nA cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2).\n\nThe change in VE/VCO2 was calculated as the value at 12 weeks minus the value at baseline. A lower VE/VCO2 ratio indicates better ventilatory efficiency and reduced ventilation/perfusion abnormalities.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Left Ventricular Function: O2 Pulse From Baseline to 12 Weeks", "description": "O2 Pulse is simply oxygen consumption (in ml) divided by heart rate. It is used as an index of stroke volume.The O2 pulse is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in O₂ pulse was calculated as the value at 12 weeks minus the value at baseline. A higher O₂ pulse indicates improved left ventricular function and greater cardiovascular efficiency.", "time_frame": "baseline, 12 weeks" }, { "type": "primary", "measure": "Change in Heart Rate Recovery From Baseline to 12 Weeks", "description": "The heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery.\n\nA cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in heart rate recovery was calculated as the difference between heart rate recovery at 12 weeks and heart rate recovery at baseline. A decrease of \\< 12 or 22 beats per minute in 1- or 2-min heart rate recovery, respectively, indicates an elevated risk of mortality. A faster heart rate recovery indicates better cardiovascular fitness and autonomic regulation.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks", "description": "Taiwan version of the International Physical Activity Questionnaire. The overall physical activity (MET-min/week), vigorous intensity physical activity (MET-min/week), moderate intensity physical activity (MET-min/week), walking (MET-min/week) are measured.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Change in Confidence Level of Exercise: Questionnaire of Self-Efficacy Items From Baseline to 12 Weeks", "description": "Questionnaire of Self-Efficacy Items. A five-item self-efficacy measure designed to measure confidence in one's ability to persist with exercising in various situations was developed. A five-point scale is used to rate each item : 1 indicates \"not at all confident\", 2 indicates \"little confident\" , 3 indicates \"confident\", 4 indicates \"very confident\", 5 indicates \"strongly confident\".", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)", "description": "The Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) with good validity and reliability includes the globally standardized WHOQOL-BREF with 26 items and an additional two locally developed items, making a total of 28 items. It consists of two single-facet items measuring overall quality of life and general health and four domains, including physical (7 items), psychological (6 items), social (4 items), and environmental (9 items) domains. The two additional items are being respected/accepted facet in the social domain and eating/food facet in the environment domain, respectively. The participants rated all items on a scale of 1-5, with higher scores reflecting a greater quality of life. Domain scores were derived by multiplying the mean of the facet scores within each domain by a scaling factor of 4, resulting in potential domain scores ranging from 4 to 20.", "time_frame": "baseline, 12 weeks" }, { "type": "secondary", "measure": "Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) From Baseline to 12 Weeks", "description": "Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven \"component\" scores and the sum of scores for these seven components yields one global score. (Scores ranged from 0 to 21, with higher scores indicating poor sleep quality.)", "time_frame": "baseline, 12 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 182, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05205460", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05642923", "title": "Post-COVID-19 Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2025-03-10", "start_date": "2023-01-08", "completion_date": "2025-03-05", "primary_completion_date": "2024-06-01", "conditions_raw": [ "Post-COVID-19 Syndrome", "Post-COVID Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Synthetic Vitamin B1" ], "sponsor": "ClinAmygate", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Fatigue is recognized as one of the most commonly presented long-term complaints in individuals previously infected with SARS-CoV-2.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue scale", "description": "chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.", "time_frame": "one month" }, { "type": "primary", "measure": "Fatigue scale", "description": "chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.", "time_frame": "two month" }, { "type": "primary", "measure": "Fatigue scale", "description": "chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.", "time_frame": "three month" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Incidence of adverse events", "description": "Incidence of adverse events", "time_frame": "6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue scale", "description": "chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.", "time_frame": "one month" }, { "type": "primary", "measure": "Fatigue scale", "description": "chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.", "time_frame": "two month" }, { "type": "primary", "measure": "Fatigue scale", "description": "chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.", "time_frame": "three month" }, { "type": "secondary", "measure": "Incidence of adverse events", "description": "Incidence of adverse events", "time_frame": "6 months" } ], "relevance_tags": [ "General", "Phase 4", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 528, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05642923", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05795816", "title": "Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2025-03-10", "start_date": "2023-10-25", "completion_date": "2025-01-31", "primary_completion_date": "2025-01-30", "conditions_raw": [ "Long Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Testofen", "Microcrystalline Cellulose" ], "sponsor": "RDC Clinical Pty Ltd", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Testofen (a specialised extract of Trigonella foenum-graecum (Fenugreek) seed) compared to placebo on post COVID-19 symptoms in otherwise healthy participants 18 years and over.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Energy and Fatigue", "description": "Change in energy and fatigue as measured via Fatigue Severity Scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "primary", "measure": "Change in Energy and Fatigue", "description": "Change in energy and fatigue as measured via Global Fatigue Index. The items are scored on a 10 point scale with 1 = not at all and 10 = great deal. Higher he score = greater fatigue", "time_frame": "Baseline, week 4, week 8 and week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Memory", "description": "Change in Memory as measured by Short Term Memory testing", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Mental Acuity", "description": "Change in Mental acuity as measured by Reaction Time Test", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Muscle Strength (Hand grip)", "description": "Change in Muscle Strength (Hand grip) as measured by Dynamometer", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Hair loss/growth", "description": "Change in Hair loss/growth as measured by Hair loss questionnaire", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Libido", "description": "Change in Libido as measured by - If male, DISF-SR (Derogatis Sexual Function Index), If female, FSFI (Female Sexual Function Index)", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Stress and Mood", "description": "Change in Stress and Mood via Depression Anxiety and Stress Scale (DASS-21)", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Quality of Life Indicators", "description": "Change in Quality of Life Indicators via Symptom Burden Questionnaire - Long Covid", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Pathology results via Blood test", "description": "Change in Pathology results (Full blood count, CRP, iron, Soluble P-selectin, Testosterone, DHT, SHBG, Estrogen, IGF1, Cortisol, Prostaglandins, Inflammatory markers IL-10, IL-6, IL-17, TNF-a) as measured by Blood test", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Weight", "description": "Change in Weight as measured by scales in kg", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Height", "description": "Height as measured by tape measure in centimetres", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Safety as assessed by Adverse Events Recording", "description": "Change in Safety as assessed by Adverse Events Recording", "time_frame": "During enrolment period" }, { "type": "secondary", "measure": "Change in safety markers as assessed by pathology", "description": "Change in safety markers E/LFT as assessed by pathology", "time_frame": "Baseline, week 4, week 8 and week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Energy and Fatigue", "description": "Change in energy and fatigue as measured via Fatigue Severity Scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "primary", "measure": "Change in Energy and Fatigue", "description": "Change in energy and fatigue as measured via Global Fatigue Index. The items are scored on a 10 point scale with 1 = not at all and 10 = great deal. Higher he score = greater fatigue", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Memory", "description": "Change in Memory as measured by Short Term Memory testing", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Mental Acuity", "description": "Change in Mental acuity as measured by Reaction Time Test", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Muscle Strength (Hand grip)", "description": "Change in Muscle Strength (Hand grip) as measured by Dynamometer", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Hair loss/growth", "description": "Change in Hair loss/growth as measured by Hair loss questionnaire", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Libido", "description": "Change in Libido as measured by - If male, DISF-SR (Derogatis Sexual Function Index), If female, FSFI (Female Sexual Function Index)", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Stress and Mood", "description": "Change in Stress and Mood via Depression Anxiety and Stress Scale (DASS-21)", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Quality of Life Indicators", "description": "Change in Quality of Life Indicators via Symptom Burden Questionnaire - Long Covid", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Pathology results via Blood test", "description": "Change in Pathology results (Full blood count, CRP, iron, Soluble P-selectin, Testosterone, DHT, SHBG, Estrogen, IGF1, Cortisol, Prostaglandins, Inflammatory markers IL-10, IL-6, IL-17, TNF-a) as measured by Blood test", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Weight", "description": "Change in Weight as measured by scales in kg", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Height", "description": "Height as measured by tape measure in centimetres", "time_frame": "Baseline, week 4, week 8 and week 12" }, { "type": "secondary", "measure": "Change in Safety as assessed by Adverse Events Recording", "description": "Change in Safety as assessed by Adverse Events Recording", "time_frame": "During enrolment period" }, { "type": "secondary", "measure": "Change in safety markers as assessed by pathology", "description": "Change in safety markers E/LFT as assessed by pathology", "time_frame": "Baseline, week 4, week 8 and week 12" } ], "relevance_tags": [ "General", "Phase 3", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 150, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05795816", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06865261", "title": "Effects of L-ARGinine and Liposomal Vitamin C Supplementation On Physical Performance", "status": "UNKNOWN", "phase": "NA", "last_updated": "2025-03-07", "start_date": "2024-05-20", "completion_date": "2025-12-31", "primary_completion_date": "2025-10-31", "conditions_raw": [ "Sarcopenia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Bioarginina C" ], "sponsor": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In older age, reduced mobility is associated with an increased risk of reduced quality of life, disability, institutionalisation, and death, as well as increased healthcare expenditures. Sarcopenia is a condition characterised by a reduction in muscle mass and strength and/or function. It is associated with several adverse outcomes, such as falls, increased risk of infection, disability, institutionalisation, and death. Currently, no pharmacological treatments are available to combat sarcopenia. The management of sarcopenia relies on the adoption of an active lifestyle, comprising resistance exercise, which may be supported by an adequate intake of protein with the diet. Recently, treatment with L-arginine and liposomal vitamin C has been shown to significantly reduce fatigue, and improve physical performance and endothelial reactivity in adult patients with Long COVID. Long COVID may be considered a model of accelerated ageing, as it recapitulates several age-associated biological processes, including chronic inflammation, oxidative stress, endothelial dysfunction and malnutrition.", "primary_outcomes": [ { "type": "primary", "measure": "6MWT", "description": "Change from baseline to day 56 in the distance walked on the 6 min walk test", "time_frame": "2 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "HG", "description": "Change from baseline to day 56 in handgrip strength", "time_frame": "2 months" }, { "type": "secondary", "measure": "CST", "description": "Change from baseline to day 56 in time to complete 5-repetition chair stand test", "time_frame": "2 months" }, { "type": "secondary", "measure": "FMD", "description": "Change from baseline to day 56 in flow mediated dilation valuesbetween treatment and control group", "time_frame": "2 months" } ], "outcome_measures": [ { "type": "primary", "measure": "6MWT", "description": "Change from baseline to day 56 in the distance walked on the 6 min walk test", "time_frame": "2 months" }, { "type": "secondary", "measure": "HG", "description": "Change from baseline to day 56 in handgrip strength", "time_frame": "2 months" }, { "type": "secondary", "measure": "CST", "description": "Change from baseline to day 56 in time to complete 5-repetition chair stand test", "time_frame": "2 months" }, { "type": "secondary", "measure": "FMD", "description": "Change from baseline to day 56 in flow mediated dilation valuesbetween treatment and control group", "time_frame": "2 months" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06865261", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05422924", "title": "A Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-03-06", "start_date": "2023-08-25", "completion_date": "2025-01-31", "primary_completion_date": "2023-10-31", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Web-Based Platform." ], "sponsor": "University of Alberta", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Patients with COVID-19 may experience prolonged physical and psychological symptoms after weeks or months of the infection. This may be caused by a combination of factors including poor nutrition, low physical activity, and lack of emotional support. Leading to poor overall health and low quality of life. This evidence indicated that people with long COVID-19 need a personalized intervention. Our objective is to determine if the use of an online application that is based on preventive self-care and that includes nutrition and mindfulness will be feasible to use for patients with long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Feasibility (defined by recruitment, adherence, and retention).", "description": "The proportion of participants that agreed to participate, the engagement in the platform (login), participants who complete both visits", "time_frame": "Baseline, week 8" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes in quality of life parameters", "description": "Changes in scores of quality of life assessed by EuroQol 5-level EQ-5D.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in fat mass", "description": "Changes in fat mass (kg) using bioelectrical impedance analysis", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in lean mass", "description": "Changes in lean mass (kg) using bioelectrical impedance analysis", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in muscle cross sectional area", "description": "Changes in muscle cross sectional area (cm2) using an ultrasound", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in dietary intake", "description": "Changes in diet quality assessed by dietary intake assessed by Automated Self-Administered 24-hour dietary assessment tool and analysed with Canadian version of the Healthy Eating Index", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in mindfulness with Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID", "description": "Changes in mindfulness assessed by Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID (SBQ-LC). 9-item measure. Scores are to 0-100 linear. Higher scores indicate greater symptom burden.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in self-efficacy assessed with Patient-Reported Outcomes Measurement Information System", "description": "Changes in self-efficacy for managing chronic conditions with of 8-item questionnaire that is based on a Patient-Reported Outcomes Measurement Information System (PROMIS).The total raw score (ranging from 8 to 40) will be transferred to a T-score. A mean of 50 and a standard deviation (SD) of 10 will be the average. A higher PROMIS T-score indicates that the respondent has greater self-efficacy for managing their emotions than the general chronic condition population.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in physical function", "description": "Changes in physical function assessed by handgrip strength", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in physical performance", "description": "Changes in physical performance assessed by 6-minute walk test", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in physical activity (daily activities subscale) by the Symptom Burden Questionnaire for Long COVID.", "description": "Changes in physical activity assessed by Daily Activities Symptom Burden Questionnaire for Long COVID (SBQ-LC). Raw scores (ranging from 0 to 24) will be converted to 0-100 linear scores with conversion tables. Higher scores indicate greater symptom burden.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in physical activity using the International Physical Activity Questionnaire", "description": "Changes in physical activity assessed by International Physical Activity Questionnaire (IPAQ). This questionnaire collects information about three specific types of physical activity: walking, moderate-intensity activities and vigorous intensity activities. To compute the total score, measures of frequency (measured in days per week) and duration (time per day) are needed. We will use this information to compare over time.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in resting energy expenditure", "description": "Changes in resting energy expenditure assessed by a metabolic cart (indirect calorimetry)", "time_frame": "Baseline, week 8" } ], "outcome_measures": [ { "type": "primary", "measure": "Feasibility (defined by recruitment, adherence, and retention).", "description": "The proportion of participants that agreed to participate, the engagement in the platform (login), participants who complete both visits", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in quality of life parameters", "description": "Changes in scores of quality of life assessed by EuroQol 5-level EQ-5D.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in fat mass", "description": "Changes in fat mass (kg) using bioelectrical impedance analysis", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in lean mass", "description": "Changes in lean mass (kg) using bioelectrical impedance analysis", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in muscle cross sectional area", "description": "Changes in muscle cross sectional area (cm2) using an ultrasound", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in dietary intake", "description": "Changes in diet quality assessed by dietary intake assessed by Automated Self-Administered 24-hour dietary assessment tool and analysed with Canadian version of the Healthy Eating Index", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in mindfulness with Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID", "description": "Changes in mindfulness assessed by Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID (SBQ-LC). 9-item measure. Scores are to 0-100 linear. Higher scores indicate greater symptom burden.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in self-efficacy assessed with Patient-Reported Outcomes Measurement Information System", "description": "Changes in self-efficacy for managing chronic conditions with of 8-item questionnaire that is based on a Patient-Reported Outcomes Measurement Information System (PROMIS).The total raw score (ranging from 8 to 40) will be transferred to a T-score. A mean of 50 and a standard deviation (SD) of 10 will be the average. A higher PROMIS T-score indicates that the respondent has greater self-efficacy for managing their emotions than the general chronic condition population.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in physical function", "description": "Changes in physical function assessed by handgrip strength", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in physical performance", "description": "Changes in physical performance assessed by 6-minute walk test", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in physical activity (daily activities subscale) by the Symptom Burden Questionnaire for Long COVID.", "description": "Changes in physical activity assessed by Daily Activities Symptom Burden Questionnaire for Long COVID (SBQ-LC). Raw scores (ranging from 0 to 24) will be converted to 0-100 linear scores with conversion tables. Higher scores indicate greater symptom burden.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in physical activity using the International Physical Activity Questionnaire", "description": "Changes in physical activity assessed by International Physical Activity Questionnaire (IPAQ). This questionnaire collects information about three specific types of physical activity: walking, moderate-intensity activities and vigorous intensity activities. To compute the total score, measures of frequency (measured in days per week) and duration (time per day) are needed. We will use this information to compare over time.", "time_frame": "Baseline, week 8" }, { "type": "secondary", "measure": "Changes in resting energy expenditure", "description": "Changes in resting energy expenditure assessed by a metabolic cart (indirect calorimetry)", "time_frame": "Baseline, week 8" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 45, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05422924", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06597682", "title": "Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-03-06", "start_date": "2025-03", "completion_date": "2027-07", "primary_completion_date": "2027-07", "conditions_raw": [ "Post-acute Sequelae of SARS-COV-2 Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Prednisone", "Budesonide/Formoterol", "Vitamin C Combined With Coenzyme Q10 Oral Treatment", "Montelukast Tablets Oral Treatment" ], "sponsor": "Huashan Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is a prospective, randomized controlled, basket trial. Patients diagnosed with Post-Acute Sequelae of SARS-CoV-2 Infection who meet the inclusion and exclusion criteria are recruited and divided into three symptom clusters: Inflammatory Cardiac involvement symptoms cluster, cough symptoms cluster and fatigue symptoms cluster. Each symptom cluster is randomly divided into an experimental group and a control group, Patients who do not accept treatment can be included in the observational cohort. Subjects in the experimental group receive immunomodulatory interventions plus conventional treatment, while subjects in the control group receive conventional treatment only. Subjects in each symptom cluster undergo clinical medical record data collection, laboratory tests, and imaging examinations at specified time points, as well as records of adverse events.", "primary_outcomes": [ { "type": "primary", "measure": "Inflammatory Cardiac Involvement symptom cluster: cardiac magnetic resonance (CMR) indicators", "description": "Assessing the difference in changes in cardiac magnetic resonance (CMR) indicators \\[left ventricular ejection fraction, late gadolinium enhancement (LGE), and T1 and T2 mapping values (in milliseconds)\\] from baseline between the experimental and control groups.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Cough symptom cluster: Leicester Cough Questionnaire (LCQ) scale scores", "description": "Assessing the difference in changes in the Leicester Cough Questionnaire (LCQ) scale scores from baseline.\n\nThe total score range of the LCQ is from 3 to 21 points, with higher scores indicating a lesser impact of cough on the patient's life.", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Fatigue symptom cluster: Fatigue Severity Scale (FSS) scale scores", "description": "Assessing the difference in changes in the Fatigue Severity Scale (FSS) scale scores from baseline.\n\nThe total score range of the FSS is from 9 to 63 points, with higher scores indicating a greater severity of fatigue.", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: other relevant cardiac magnetic resonance (CMR) indicators", "description": "Assessing the changes in in other relevant cardiac magnetic resonance (CMR) indicators from baseline.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: VO2max", "description": "Assessing the changes in VO2max in cardiopulmonary exercise testing.", "time_frame": "At baseline, 4 weeks" }, { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: Kansas City Cardiomyopathy Questionnaire (KCCQ) scores", "description": "Assessing the changes in the KCCQ scores between the experimental and control groups.\n\nThe total score range of the KCCQ is from 0 to 100, with lower scores indicating poorer quality of life for heart failure patients.", "time_frame": "At baseline, 4, 8, 12, and 24 weeks" }, { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: Change in cTNT Levels", "description": "Measures the change in cardiac troponin T (cTNT) levels", "time_frame": "At baseline, 4, 8, 12 and 24 weeks" }, { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: the proportion of patients experiencing heart failure and major adverse cardiac events (MACE)", "description": "From baseline to week 52, assessing the proportion of patients experiencing heart failure and MACE between the experimental and control groups.", "time_frame": "From baseline to 52 weeks" }, { "type": "secondary", "measure": "EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores", "description": "Assessing the changes in the EQ-5D-5L questionnaire scores between the experimental and control groups.\n\nThe EQ-5D-5L is a widely used generic measure of health status consisting of two parts.\n\nThe first part (the descriptive system) provides a descriptive profile that can be used to generate a health state profile. Each health state can be assigned a summary index score. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.\n\nThe second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).", "time_frame": "At baseline, 4, 8, 12 and 24 weeks" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI) scores", "description": "Assessing the changes in the PSQI scores between the experimental and control groups.\n\nThe total score range of the PSQI is from 0 to 21, with higher scores indicating poorer sleep quality.", "time_frame": "At baseline 4, 8, 12, and 24 weeks" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-7 (GAD-7)", "description": "Assessing the changes in the GAD-7 scores between the experimental and control groups.\n\nThe total score range of the GAD-7 is from 0 to 21, with higher scores indicating more severe anxiety.", "time_frame": "At baseline, 4, 8, 12 and 24 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9) depression symptom cluster scores", "description": "Assessing the changes in the PHQ-9 cores between the experimental and control groups.\n\nThe total score range of the PHQ-9 is from 0 to 27, with higher scores indicating more severe depression.", "time_frame": "At baseline, 4, 8, 12 and 24 weeks" }, { "type": "secondary", "measure": "Cough symptom cluster: Visual Analogue Scale (VAS)", "description": "Assessing the change in the severity of cough as measured by the VAS between the experimental and control groups .\n\nThe total score range of the VAS is from 0 to 100, with higher scores indicating more severe coughing in the patient.", "time_frame": "At baseline 4, 8 and 12 weeks" }, { "type": "secondary", "measure": "Cough symptom cluster: pulmonary function and fractional exhaled nitric oxide (FeNO) levels", "description": "Assessing the changes in pulmonary function and FeNO levels between the experimental and control groups.", "time_frame": "At baseline and 8 weeks" }, { "type": "secondary", "measure": "Fatigue symptom cluster: Visual Analogue Scale (VAS)", "description": "The total score range of the VAS is from 0 to 100, with higher scores indicating more severe fatigue in the patient.", "time_frame": "At baseline, 4, 8, and 12 weeks" }, { "type": "secondary", "measure": "Change in proBNP Levels", "description": "Measures the change in N-terminal pro-brain natriuretic peptide (proBNP) levels, which are associated with heart failure.", "time_frame": "Baseline, 4, 8, 12, 24 weeks" }, { "type": "secondary", "measure": "Change in Angiotensin II Levels", "description": "Measures the change in angiotensin II levels", "time_frame": "Baseline, 4, 8, 12, 24 weeks" }, { "type": "secondary", "measure": "Change in Ferritin Levels", "description": "Measures the change in ferritin levels", "time_frame": "Baseline, 4, 8, 12, 24 weeks" }, { "type": "secondary", "measure": "Change in IL-6 Levels", "description": "Measures the change in interleukin-6 (IL-6) levels", "time_frame": "Baseline, 4, 8, 12, 24 weeks" }, { "type": "secondary", "measure": "Change in hsCRP Levels", "description": "Measures the change in high-sensitivity C-reactive protein (hsCRP) levels", "time_frame": "Baseline, 4, 8, 12, 24 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Inflammatory Cardiac Involvement symptom cluster: cardiac magnetic resonance (CMR) indicators", "description": "Assessing the difference in changes in cardiac magnetic resonance (CMR) indicators \\[left ventricular ejection fraction, late gadolinium enhancement (LGE), and T1 and T2 mapping values (in milliseconds)\\] from baseline between the experimental and control groups.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Cough symptom cluster: Leicester Cough Questionnaire (LCQ) scale scores", "description": "Assessing the difference in changes in the Leicester Cough Questionnaire (LCQ) scale scores from baseline.\n\nThe total score range of the LCQ is from 3 to 21 points, with higher scores indicating a lesser impact of cough on the patient's life.", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Fatigue symptom cluster: Fatigue Severity Scale (FSS) scale scores", "description": "Assessing the difference in changes in the Fatigue Severity Scale (FSS) scale scores from baseline.\n\nThe total score range of the FSS is from 9 to 63 points, with higher scores indicating a greater severity of fatigue.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: other relevant cardiac magnetic resonance (CMR) indicators", "description": "Assessing the changes in in other relevant cardiac magnetic resonance (CMR) indicators from baseline.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: VO2max", "description": "Assessing the changes in VO2max in cardiopulmonary exercise testing.", "time_frame": "At baseline, 4 weeks" }, { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: Kansas City Cardiomyopathy Questionnaire (KCCQ) scores", "description": "Assessing the changes in the KCCQ scores between the experimental and control groups.\n\nThe total score range of the KCCQ is from 0 to 100, with lower scores indicating poorer quality of life for heart failure patients.", "time_frame": "At baseline, 4, 8, 12, and 24 weeks" }, { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: Change in cTNT Levels", "description": "Measures the change in cardiac troponin T (cTNT) levels", "time_frame": "At baseline, 4, 8, 12 and 24 weeks" }, { "type": "secondary", "measure": "Inflammatory Cardiac Involvement symptom cluster: the proportion of patients experiencing heart failure and major adverse cardiac events (MACE)", "description": "From baseline to week 52, assessing the proportion of patients experiencing heart failure and MACE between the experimental and control groups.", "time_frame": "From baseline to 52 weeks" }, { "type": "secondary", "measure": "EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores", "description": "Assessing the changes in the EQ-5D-5L questionnaire scores between the experimental and control groups.\n\nThe EQ-5D-5L is a widely used generic measure of health status consisting of two parts.\n\nThe first part (the descriptive system) provides a descriptive profile that can be used to generate a health state profile. Each health state can be assigned a summary index score. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.\n\nThe second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).", "time_frame": "At baseline, 4, 8, 12 and 24 weeks" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI) scores", "description": "Assessing the changes in the PSQI scores between the experimental and control groups.\n\nThe total score range of the PSQI is from 0 to 21, with higher scores indicating poorer sleep quality.", "time_frame": "At baseline 4, 8, 12, and 24 weeks" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-7 (GAD-7)", "description": "Assessing the changes in the GAD-7 scores between the experimental and control groups.\n\nThe total score range of the GAD-7 is from 0 to 21, with higher scores indicating more severe anxiety.", "time_frame": "At baseline, 4, 8, 12 and 24 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9) depression symptom cluster scores", "description": "Assessing the changes in the PHQ-9 cores between the experimental and control groups.\n\nThe total score range of the PHQ-9 is from 0 to 27, with higher scores indicating more severe depression.", "time_frame": "At baseline, 4, 8, 12 and 24 weeks" }, { "type": "secondary", "measure": "Cough symptom cluster: Visual Analogue Scale (VAS)", "description": "Assessing the change in the severity of cough as measured by the VAS between the experimental and control groups .\n\nThe total score range of the VAS is from 0 to 100, with higher scores indicating more severe coughing in the patient.", "time_frame": "At baseline 4, 8 and 12 weeks" }, { "type": "secondary", "measure": "Cough symptom cluster: pulmonary function and fractional exhaled nitric oxide (FeNO) levels", "description": "Assessing the changes in pulmonary function and FeNO levels between the experimental and control groups.", "time_frame": "At baseline and 8 weeks" }, { "type": "secondary", "measure": "Fatigue symptom cluster: Visual Analogue Scale (VAS)", "description": "The total score range of the VAS is from 0 to 100, with higher scores indicating more severe fatigue in the patient.", "time_frame": "At baseline, 4, 8, and 12 weeks" }, { "type": "secondary", "measure": "Change in proBNP Levels", "description": "Measures the change in N-terminal pro-brain natriuretic peptide (proBNP) levels, which are associated with heart failure.", "time_frame": "Baseline, 4, 8, 12, 24 weeks" }, { "type": "secondary", "measure": "Change in Angiotensin II Levels", "description": "Measures the change in angiotensin II levels", "time_frame": "Baseline, 4, 8, 12, 24 weeks" }, { "type": "secondary", "measure": "Change in Ferritin Levels", "description": "Measures the change in ferritin levels", "time_frame": "Baseline, 4, 8, 12, 24 weeks" }, { "type": "secondary", "measure": "Change in IL-6 Levels", "description": "Measures the change in interleukin-6 (IL-6) levels", "time_frame": "Baseline, 4, 8, 12, 24 weeks" }, { "type": "secondary", "measure": "Change in hsCRP Levels", "description": "Measures the change in high-sensitivity C-reactive protein (hsCRP) levels", "time_frame": "Baseline, 4, 8, 12, 24 weeks" } ], "relevance_tags": [ "Immunomodulatory", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 632, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06597682", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05618587", "title": "Effect of Lithium Therapy on Long COVID Symptoms", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2025-03-05", "start_date": "2022-11-28", "completion_date": "2023-07-21", "primary_completion_date": "2023-07-21", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Lithium" ], "sponsor": "State University of New York at Buffalo", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Change from baseline to day 21" }, { "type": "primary", "measure": "Brain Fog Severity Scale", "description": "7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Change from baseline to day 21" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC)", "description": "Change in symptoms on 7-point scale. Single-item scale. Score range 1-7 with higher values signifying better outcome", "time_frame": "Day 21" }, { "type": "secondary", "measure": "Well-Being Scale", "description": "Sense of well-being over past week on 10-point scale. Score range 0-10 with higher values signifying better outcome.", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Short Form-12 Health Survey (1-week Modification)", "description": "Quality of life assessment over past week, PCS-subscale. 12-item quality of life scale. Score range 0-100 for both the Physical Component Score and the Mental Component Score with higher values signifying better outcomes.", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Desire to Continue Therapy", "description": "Single Yes/No question. Single-item scale. Score range 1-2 with higher value signifying better outcome. Reported as % of respondents recording \"yes\".", "time_frame": "Day 21" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-2 Scale", "description": "2-item questionnaire assessing anxiety frequency over the past week. 2-item scale. Score range 0-6 with higher values signifying worse outcome", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Headache and Body Pain Bother Scale", "description": "2-item questionnaire assessing frequency of headaches and body pain over the past week, Headache score. 2-item scale. Score range 2-10 with higher values signifying worse outcome", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Insomnia Severity Index", "description": "7-item questionnaire assessing insomnia severity over the past week. 7-item scale. Score range 0-28 with higher values signifying worse outcome.", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Sense of Smell and Taste Change Scale", "description": "Subjective change from baseline on a 7-point scale (score range: 1-7) with higher scores indicating better outcomes. Scores of 1 and 7 indicate sense of smell and taste were \"very much worse\" or \"very much improved\", respectively, since the start of study treatment.", "time_frame": "Day 21" }, { "type": "secondary", "measure": "Digit Symbol Substitution Test", "description": "Validated cognitive test. Score range 0-100 with higher scores indicating a better outcome.", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Delayed Recall Test", "description": "Validated cognitive test. Score range 0-5 with higher scores indicating better outcomes.", "time_frame": "Change from baseline to day 21" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Change from baseline to day 21" }, { "type": "primary", "measure": "Brain Fog Severity Scale", "description": "7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Patient Global Impression of Change (PGIC)", "description": "Change in symptoms on 7-point scale. Single-item scale. Score range 1-7 with higher values signifying better outcome", "time_frame": "Day 21" }, { "type": "secondary", "measure": "Well-Being Scale", "description": "Sense of well-being over past week on 10-point scale. Score range 0-10 with higher values signifying better outcome.", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Short Form-12 Health Survey (1-week Modification)", "description": "Quality of life assessment over past week, PCS-subscale. 12-item quality of life scale. Score range 0-100 for both the Physical Component Score and the Mental Component Score with higher values signifying better outcomes.", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Desire to Continue Therapy", "description": "Single Yes/No question. Single-item scale. Score range 1-2 with higher value signifying better outcome. Reported as % of respondents recording \"yes\".", "time_frame": "Day 21" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-2 Scale", "description": "2-item questionnaire assessing anxiety frequency over the past week. 2-item scale. Score range 0-6 with higher values signifying worse outcome", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Headache and Body Pain Bother Scale", "description": "2-item questionnaire assessing frequency of headaches and body pain over the past week, Headache score. 2-item scale. Score range 2-10 with higher values signifying worse outcome", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Insomnia Severity Index", "description": "7-item questionnaire assessing insomnia severity over the past week. 7-item scale. Score range 0-28 with higher values signifying worse outcome.", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Sense of Smell and Taste Change Scale", "description": "Subjective change from baseline on a 7-point scale (score range: 1-7) with higher scores indicating better outcomes. Scores of 1 and 7 indicate sense of smell and taste were \"very much worse\" or \"very much improved\", respectively, since the start of study treatment.", "time_frame": "Day 21" }, { "type": "secondary", "measure": "Digit Symbol Substitution Test", "description": "Validated cognitive test. Score range 0-100 with higher scores indicating a better outcome.", "time_frame": "Change from baseline to day 21" }, { "type": "secondary", "measure": "Delayed Recall Test", "description": "Validated cognitive test. Score range 0-5 with higher scores indicating better outcomes.", "time_frame": "Change from baseline to day 21" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 52, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05618587", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03554265", "title": "Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2025-03-05", "start_date": "2018-08-06", "completion_date": "2023-10-04", "primary_completion_date": "2023-10-04", "conditions_raw": [ "Traumatic Brain Injury", "Fatigue", "Cognitive Impairment", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Somatropin" ], "sponsor": "The University of Texas Medical Branch, Galveston", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Control subjects will be enrolled and will provide fecal samples monthly for 6 months. GI microbiomes will be compared between mTBI patients, PASC patients and controls at baseline as well as over the treatment period.", "primary_outcomes": [ { "type": "primary", "measure": "Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline", "description": "Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.", "time_frame": "baseline" }, { "type": "primary", "measure": "Lean Body Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months", "description": "Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.", "time_frame": "6 months" }, { "type": "primary", "measure": "Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at Baseline", "description": "Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.", "time_frame": "baseline" }, { "type": "primary", "measure": "Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months", "description": "Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.", "time_frame": "6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Basal Metabolic Rate as Measured by Resting Energy Expenditure at Baseline", "description": "Resting Energy Expenditure will be measured by capturing the expired breath of mTBI and PASC subjects while at rest with a metabolic cart over a 30 minute time period. Data will be reported as kilocalories/day.", "time_frame": "baseline" }, { "type": "secondary", "measure": "Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months", "description": "Resting Energy Expenditure will be measured by capturing the expired breath of mTBI and PASC subjects while at rest with a metabolic cart over a 30 minute time period. Data will be reported as kilocalories/day. This will be measured after 6 months of growth hormone treatment in mTBI and PASC subjects only.", "time_frame": "6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline", "description": "Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.", "time_frame": "baseline" }, { "type": "primary", "measure": "Lean Body Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months", "description": "Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.", "time_frame": "6 months" }, { "type": "primary", "measure": "Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at Baseline", "description": "Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.", "time_frame": "baseline" }, { "type": "primary", "measure": "Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months", "description": "Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Basal Metabolic Rate as Measured by Resting Energy Expenditure at Baseline", "description": "Resting Energy Expenditure will be measured by capturing the expired breath of mTBI and PASC subjects while at rest with a metabolic cart over a 30 minute time period. Data will be reported as kilocalories/day.", "time_frame": "baseline" }, { "type": "secondary", "measure": "Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months", "description": "Resting Energy Expenditure will be measured by capturing the expired breath of mTBI and PASC subjects while at rest with a metabolic cart over a 30 minute time period. Data will be reported as kilocalories/day. This will be measured after 6 months of growth hormone treatment in mTBI and PASC subjects only.", "time_frame": "6 months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 3", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 72, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03554265", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04900961", "title": "CISCO-21 Prevent and Treat Long COVID-19.", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-02-25", "start_date": "2021-06-01", "completion_date": "2025-02-21", "primary_completion_date": "2024-08-30", "conditions_raw": [ "Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Resistance Exercise" ], "sponsor": "NHS Greater Glasgow and Clyde", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Many people have long-lasting symptoms after COVID-19, such as breathlessness, fatigue and chest pain. So far, research studies of treatments for COVID-19 have focused on the life-threatening acute illness; few studies look at treatments to improve long-term health after COVID-19. COVID-19, particularly when this requires a hospital admission, can lead to weight loss and muscle wasting, contributing to worse outcomes. Muscle strengthening (resistance-based) exercise could improve outcomes in the long-term.", "primary_outcomes": [ { "type": "primary", "measure": "Incremental Shuttle Walk Test", "description": "This is a validated measure of functional capacity, with test-retest reliability and evidence of being responsive to rehabilitation interventions.", "time_frame": "at 3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Spirometry", "description": "The basic spirometry measurement will be forced vital capacity (FVC).", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Handgrip Strength", "description": "Handgrip strength will be recorded using a handheld dynamometer. For handgrip strength, measurements are performed until 3 measurements are within 5% of each other. Typically, 3 - 6 manoeuvres in each hand are performed. Responses in the dominant hand will be recorded.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Short Physical Performance Battery", "description": "The Short Physical Performance Battery (SPPB) is a series of brief, simple physical tests including of the ability to stand for 10 seconds with the feet in 3 different positions (together side-by-side (score 0 - 1), semi-tandem (score 0 - 1), and tandem (score 0 - 2)), two timed trials of a 3m or 4m walk (fastest recorded) and the time to rise from a chair 5 times. The score ranges from 0 to 12 (higher scores reflect better extremity function). The gait and chair subtests score from 0 to 4.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "EuroQol-5 dimension (EQ)-5D", "description": "EuroQol-5 dimension (EQ)-5D, a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Patient Health Questionnaire-4 (PHQ4)", "description": "Patient Health Questionnaire-4 (PHQ4), a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Brief Illness Perception Questionnaire (IPQ)", "description": "Brief Illness Perception Questionnaire (IPQ), a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Duke Activity Status Index (DASI)", "description": "Duke Activity Status Index (DASI), a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "International Physical Activity Questionnaires Short Form (IPAQ-SF)", "description": "International Physical Activity Questionnaires Short Form (IPAQ-SF), a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Fatigue questionnaire", "description": "Fatigue questionnaire, a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Fried Frailty phenotype", "description": "Weight loss; exhaustion; grip strength; low physical activity; and slow walking pace", "time_frame": "3 months" }, { "type": "secondary", "measure": "Episodes of care", "description": "Episodes of healthcare care (primary, secondary, physiotherapy, rehabilitation)", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Hospitalisation", "description": "Hospitalisation for any reason, representing a serious adverse event", "time_frame": "at 3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Incremental Shuttle Walk Test", "description": "This is a validated measure of functional capacity, with test-retest reliability and evidence of being responsive to rehabilitation interventions.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Spirometry", "description": "The basic spirometry measurement will be forced vital capacity (FVC).", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Handgrip Strength", "description": "Handgrip strength will be recorded using a handheld dynamometer. For handgrip strength, measurements are performed until 3 measurements are within 5% of each other. Typically, 3 - 6 manoeuvres in each hand are performed. Responses in the dominant hand will be recorded.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Short Physical Performance Battery", "description": "The Short Physical Performance Battery (SPPB) is a series of brief, simple physical tests including of the ability to stand for 10 seconds with the feet in 3 different positions (together side-by-side (score 0 - 1), semi-tandem (score 0 - 1), and tandem (score 0 - 2)), two timed trials of a 3m or 4m walk (fastest recorded) and the time to rise from a chair 5 times. The score ranges from 0 to 12 (higher scores reflect better extremity function). The gait and chair subtests score from 0 to 4.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "EuroQol-5 dimension (EQ)-5D", "description": "EuroQol-5 dimension (EQ)-5D, a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Patient Health Questionnaire-4 (PHQ4)", "description": "Patient Health Questionnaire-4 (PHQ4), a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Brief Illness Perception Questionnaire (IPQ)", "description": "Brief Illness Perception Questionnaire (IPQ), a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Duke Activity Status Index (DASI)", "description": "Duke Activity Status Index (DASI), a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "International Physical Activity Questionnaires Short Form (IPAQ-SF)", "description": "International Physical Activity Questionnaires Short Form (IPAQ-SF), a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Fatigue questionnaire", "description": "Fatigue questionnaire, a patient reported outcome measure.", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Fried Frailty phenotype", "description": "Weight loss; exhaustion; grip strength; low physical activity; and slow walking pace", "time_frame": "3 months" }, { "type": "secondary", "measure": "Episodes of care", "description": "Episodes of healthcare care (primary, secondary, physiotherapy, rehabilitation)", "time_frame": "at 3 months" }, { "type": "secondary", "measure": "Hospitalisation", "description": "Hospitalisation for any reason, representing a serious adverse event", "time_frame": "at 3 months" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 233, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT04900961", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06726772", "title": "Group Psychotherapy in Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-02-18", "start_date": "2021-11-01", "completion_date": "2024-01-31", "primary_completion_date": "2024-01-31", "conditions_raw": [ "Long COVID", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Group Psychotherapy" ], "sponsor": "Cantonal Hospital of St. Gallen", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of the present study was to establish a single-arm group psychotherapy and to evaluate its clinical effectiveness in long COVID patients.", "primary_outcomes": [ { "type": "primary", "measure": "Change of Fatigue Score measured with the Questionnaire \"FSS\" (Fatigue Severity Scale) from baseline to 8 weeks", "description": "9 is equivalent to no fatigue and 63 indicates the worst possible fatigue.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Insomnia Score measured with the Questionnaire \"ISI\" (Insomnia Severity Index) from baseline to 8 weeks", "description": "0 is equivalent to no insomnia and 28 indicates the worst possible insomnia.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Quality of Life and Current Health Status measured with the Questionnaire \"EQ-5D-5L\" (European Quality of Life 5 Dimensions 5 Level Version) from baseline to 8 weeks", "description": "0 (and -0.59) is equivalent to the lowest quality of life (and current health) and 100 (and 1) indicates the best possible quality of life (and current health)", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Depression and Anxiety Score measured with the Questionnaire \"HADS\" (Hospital Anxiety and Depression Scale) from baseline to 8 weeks", "description": "0 is equivalent to no depression/anxiety and 21 indicates the worst possible depression/anxiety.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Depression, Anxiety, and Somatic Symptom Scores measured with the Questionnaire \"PHQ-SADS\" (Patient Health Questionnaire) from baseline to 8 weeks", "description": "0 is equivalent to no depression/anxiety/somatic symptoms and 30 indicates the worst possible depression/anxiety/somatic symptoms.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Psychotraumatology Score measured with the Questionnaire \"IES-R\" (Impact of Event Scale-revised) from baseline to 8 weeks", "description": "-4.36 is equivalent to no psychotraumatology (no suspected PTSD) and 2.99 indicates the worst possible psychotraumatology (suspected PTSD). A score equally or greater than zero (cut-off point) indicates suspected PTSD.", "time_frame": "From enrollment to the end of treatment at 8 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Change of Fatigue Score measured with the Questionnaire \"FSS\" (Fatigue Severity Scale) from baseline to 8 weeks", "description": "9 is equivalent to no fatigue and 63 indicates the worst possible fatigue.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Insomnia Score measured with the Questionnaire \"ISI\" (Insomnia Severity Index) from baseline to 8 weeks", "description": "0 is equivalent to no insomnia and 28 indicates the worst possible insomnia.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Quality of Life and Current Health Status measured with the Questionnaire \"EQ-5D-5L\" (European Quality of Life 5 Dimensions 5 Level Version) from baseline to 8 weeks", "description": "0 (and -0.59) is equivalent to the lowest quality of life (and current health) and 100 (and 1) indicates the best possible quality of life (and current health)", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Depression and Anxiety Score measured with the Questionnaire \"HADS\" (Hospital Anxiety and Depression Scale) from baseline to 8 weeks", "description": "0 is equivalent to no depression/anxiety and 21 indicates the worst possible depression/anxiety.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Depression, Anxiety, and Somatic Symptom Scores measured with the Questionnaire \"PHQ-SADS\" (Patient Health Questionnaire) from baseline to 8 weeks", "description": "0 is equivalent to no depression/anxiety/somatic symptoms and 30 indicates the worst possible depression/anxiety/somatic symptoms.", "time_frame": "From enrollment to the end of treatment at 8 weeks" }, { "type": "primary", "measure": "Change of Psychotraumatology Score measured with the Questionnaire \"IES-R\" (Impact of Event Scale-revised) from baseline to 8 weeks", "description": "-4.36 is equivalent to no psychotraumatology (no suspected PTSD) and 2.99 indicates the worst possible psychotraumatology (suspected PTSD). A score equally or greater than zero (cut-off point) indicates suspected PTSD.", "time_frame": "From enrollment to the end of treatment at 8 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06726772", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05139979", "title": "Yogic Breathing and Guided Meditation for Long Covid Symptoms", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-02-06", "start_date": "2021-09-15", "completion_date": "2024-02-07", "primary_completion_date": "2024-02-07", "conditions_raw": [ "COVID-19", "Stress", "Shortness of Breath" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Breathing And Wellness Webinar", "Routine Daily Activity" ], "sponsor": "Beth Israel Deaconess Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients.", "primary_outcomes": [ { "type": "primary", "measure": "Compliance", "description": "The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in \"Number of days an intervention was practiced in a week\". Compliance is defined as completing 60% (4 days/week or more) of the activity that is prescribed in the protocol. This means that at least one of the three practices (Isha Kriya, Nadi Shuddhi, or Simha Kriya) must be completed once a day for a minimum of four days.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Perceived Stress Scale (PSS)", "description": "PSS is a 10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Profile of Mood States (POMS)", "description": "This is a short validated survey used to measure six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A five-point scale ranging from \"not at all\" to \"extremely\" is administered and scores for each dimension contributes to calculation of positive and negative subscales in conjunction to total mood disturbance.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Quality of Life Survey (SF12)", "description": "SF12 is a validated self-reported measure of the impact of health on everyday quality of life. It evaluates domains of physical activities, social activities, usual role activities, bodily pain, general mental health, vitality and general health perception.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Multidimensional Dyspnea Profile (MDP)", "description": "MDP is a validated scale to assess the overall breathing discomfort, sensory qualities and emotional responses using 8 questions. It is not intended for a particular activity and can be used during rest, activity or during clinical care. For assessing Long Covid patients, the first three parts (breathing discomfort and sensory qualities) are commonly used.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Somatic Symptom Scale 8 Items (SS8)", "description": "SS8 is a validated brief questionnaire to assess common somatic symptoms including pain, shortness of breath, dizziness, fatigue and trouble sleeping. Participants are asked to rate on a scale of 0 (not at all) to 4 (very much) how often they agree with various statements. Items from each of the 8 questions are then summed to create a total perceived stress score.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Qualitative Assessments", "description": "The semi-structured individual interviews will allow us to gain rich, descriptive information about the participant's experience with the long COVID symptoms, treating physicians, and the effect of the provided practices on their symptoms. The focus group interviews will be semi-structured to ensure a systematic and flexible approach to data collection, allowing us to gain rich information about the participant's general experience with the current study and what matters to them as a Long COVID patients.\n\nThe interviews will cover the following main topics: (1) Perceptions of the participants on their long COVID symptoms, (2) Perceptions of the participants on their treating physicians (3) the effect of the provided meditation practices on their long COVID symptoms (4) and what matters to the Long COVID patients as well as their general experience as participants in the current study.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." } ], "outcome_measures": [ { "type": "primary", "measure": "Compliance", "description": "The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in \"Number of days an intervention was practiced in a week\". Compliance is defined as completing 60% (4 days/week or more) of the activity that is prescribed in the protocol. This means that at least one of the three practices (Isha Kriya, Nadi Shuddhi, or Simha Kriya) must be completed once a day for a minimum of four days.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Perceived Stress Scale (PSS)", "description": "PSS is a 10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Profile of Mood States (POMS)", "description": "This is a short validated survey used to measure six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A five-point scale ranging from \"not at all\" to \"extremely\" is administered and scores for each dimension contributes to calculation of positive and negative subscales in conjunction to total mood disturbance.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Quality of Life Survey (SF12)", "description": "SF12 is a validated self-reported measure of the impact of health on everyday quality of life. It evaluates domains of physical activities, social activities, usual role activities, bodily pain, general mental health, vitality and general health perception.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Multidimensional Dyspnea Profile (MDP)", "description": "MDP is a validated scale to assess the overall breathing discomfort, sensory qualities and emotional responses using 8 questions. It is not intended for a particular activity and can be used during rest, activity or during clinical care. For assessing Long Covid patients, the first three parts (breathing discomfort and sensory qualities) are commonly used.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Somatic Symptom Scale 8 Items (SS8)", "description": "SS8 is a validated brief questionnaire to assess common somatic symptoms including pain, shortness of breath, dizziness, fatigue and trouble sleeping. Participants are asked to rate on a scale of 0 (not at all) to 4 (very much) how often they agree with various statements. Items from each of the 8 questions are then summed to create a total perceived stress score.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." }, { "type": "secondary", "measure": "Qualitative Assessments", "description": "The semi-structured individual interviews will allow us to gain rich, descriptive information about the participant's experience with the long COVID symptoms, treating physicians, and the effect of the provided practices on their symptoms. The focus group interviews will be semi-structured to ensure a systematic and flexible approach to data collection, allowing us to gain rich information about the participant's general experience with the current study and what matters to them as a Long COVID patients.\n\nThe interviews will cover the following main topics: (1) Perceptions of the participants on their long COVID symptoms, (2) Perceptions of the participants on their treating physicians (3) the effect of the provided meditation practices on their long COVID symptoms (4) and what matters to the Long COVID patients as well as their general experience as participants in the current study.", "time_frame": "For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks." } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 189, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05139979", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05840237", "title": "REGAIN: RCT of Oxaloacetate for Fatigue in Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-02-04", "start_date": "2023-06-01", "completion_date": "2025-01-30", "primary_completion_date": "2025-01-30", "conditions_raw": [ "Post-COVID-19 Syndrome", "Fatigue Syndrome, Chronic" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Anhydrous Enol-Oxaloacetate, A \"Medical Food\"", "White Rice Flour" ], "sponsor": "Terra Biological LLC", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Following acute COVID-19, some patients develop a group of debilitating symptoms that include fatigue, orthostatic intolerance, difficulty with attention and concentration (often called \"brain fog\"), myalgias and disrupted sleep. The term Long COVID is used to describe these symptoms after the initial viral infection has passed. These symptoms are the same as those that define myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).\n\nA \"Proof of Concept\" trial showed significant fatigue benefit in Long COVID patients. This randomized, placebo controlled follow-on trial will determine whether oxaloacetate can reduce fatigue and improve other symptoms in patients with Long COVID who meet diagnostic criteria for ME/CFS.", "primary_outcomes": [ { "type": "primary", "measure": "Chalder Fatigue Score", "description": "A Validated patient derived survey of fatigue", "time_frame": "42 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Global Impression of Change", "description": "A Validated patient derived survey for overall improvment", "time_frame": "42 days" }, { "type": "secondary", "measure": "Up-Time", "description": "Measurement of physical activity with a device attached to the ankle", "time_frame": "42 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Chalder Fatigue Score", "description": "A Validated patient derived survey of fatigue", "time_frame": "42 days" }, { "type": "secondary", "measure": "Global Impression of Change", "description": "A Validated patient derived survey for overall improvment", "time_frame": "42 days" }, { "type": "secondary", "measure": "Up-Time", "description": "Measurement of physical activity with a device attached to the ankle", "time_frame": "42 days" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 70, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05840237", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06792214", "title": "Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD/Remdesivir Effectiveness For the prEvention of loNg coviD Clinical Trial", "status": "RECRUITING", "phase": "PHASE4", "last_updated": "2025-01-24", "start_date": "2025-01-03", "completion_date": "2027-01", "primary_completion_date": "2026-01", "conditions_raw": [ "SARS CoV-2 Post-Acute Sequelae" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Paxlovid (Nirmatrelvir/Ritonavir)", "Remdesivir" ], "sponsor": "Mount Sinai Hospital, Canada", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The DEFEND trial will be the world's first clinical trial to study the effectiveness of Paxlovid or Veklury in the prevention of cardiovascular post-acute sequelae of SARS-CoV-2 among hospitalized adults. Additionally, this pilot study will inform the design and conduct of a future full-scale multi-centre trial by testing the feasibility and accuracy of this study design.", "primary_outcomes": [ { "type": "primary", "measure": "Recruitment rate", "description": "Recruitment rate, defined as the proportion of eligible people who consent and are randomized into the pilot trial, which will inform the feasibility of a full scale trial.", "time_frame": "From participant screening to enrolment" }, { "type": "primary", "measure": "Post-acute sequelae of COVID-19 (PASC)", "description": "Event rate of PASC at 1 year (specifically newly developed or worsening: stroke, heart failure, venous thromboembolism, diabetes or death)", "time_frame": "From enrolment to end of follow up at 1 year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Administrative data validation", "description": "Validate the accuracy of using administrative data to collect participant hospital-based outcome measures including:\n\n1. Adherence to treatment, measured by whether the participant received the study drug or not as documented in the medication administration record.\n2. Use of co-interventions (dexamethasone, tocilizumab/sarilumab, baricitinib) owing to progression of disease severity as measured by spO2 \\<92%\n3. Time to treatment initiation, as measured by the time between randomization and first treatment dose.\n\nThe validation of administrative data will be assessed by comparing concordance between manually collected data by research coordinators entered into REDCap and the GEMINI administrative database for the measures described above.", "time_frame": "From enrolment to end of follow up at 1 year" }, { "type": "secondary", "measure": "Reinfection, ICU admission, and drug safety", "description": "Any of the following treatment related adverse events as assessed with the CTCAE v6.0:\n\n1. Number and percentage of participants hospitalized with SARS-CoV-2 reinfection within 90 days following initial PCR positive test for COVID-19;\n2. Number and percentage of participants admitted to ICU during initial hospitalization;\n3. Number and percentage of participants experiencing any one of the following adverse study drug effects including dysgeusia, vomiting, or diarrhea as identified by their most responsible physician", "time_frame": "From enrolment to 90 days after initial PCR positive test for COVID-19" } ], "outcome_measures": [ { "type": "primary", "measure": "Recruitment rate", "description": "Recruitment rate, defined as the proportion of eligible people who consent and are randomized into the pilot trial, which will inform the feasibility of a full scale trial.", "time_frame": "From participant screening to enrolment" }, { "type": "primary", "measure": "Post-acute sequelae of COVID-19 (PASC)", "description": "Event rate of PASC at 1 year (specifically newly developed or worsening: stroke, heart failure, venous thromboembolism, diabetes or death)", "time_frame": "From enrolment to end of follow up at 1 year" }, { "type": "secondary", "measure": "Administrative data validation", "description": "Validate the accuracy of using administrative data to collect participant hospital-based outcome measures including:\n\n1. Adherence to treatment, measured by whether the participant received the study drug or not as documented in the medication administration record.\n2. Use of co-interventions (dexamethasone, tocilizumab/sarilumab, baricitinib) owing to progression of disease severity as measured by spO2 \\<92%\n3. Time to treatment initiation, as measured by the time between randomization and first treatment dose.\n\nThe validation of administrative data will be assessed by comparing concordance between manually collected data by research coordinators entered into REDCap and the GEMINI administrative database for the measures described above.", "time_frame": "From enrolment to end of follow up at 1 year" }, { "type": "secondary", "measure": "Reinfection, ICU admission, and drug safety", "description": "Any of the following treatment related adverse events as assessed with the CTCAE v6.0:\n\n1. Number and percentage of participants hospitalized with SARS-CoV-2 reinfection within 90 days following initial PCR positive test for COVID-19;\n2. Number and percentage of participants admitted to ICU during initial hospitalization;\n3. Number and percentage of participants experiencing any one of the following adverse study drug effects including dysgeusia, vomiting, or diarrhea as identified by their most responsible physician", "time_frame": "From enrolment to 90 days after initial PCR positive test for COVID-19" } ], "relevance_tags": [ "Persistence / Antiviral", "Phase 4", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 118, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06792214", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05676047", "title": "Cognitive Rehabilitation for Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-01-23", "start_date": "2023-05-01", "completion_date": "2025-01-21", "primary_completion_date": "2025-01-21", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cognitive Rehabilitation" ], "sponsor": "McMaster University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators are comparing two different methods for helping adults with Long Coronavirus (COVID) also known as Post-Coronavirus Syndrome or Post-Coronavirus Condition manage everyday cognitive challenges. Cognitive rehabilitation is a type of therapy that helps people who have challenges with everyday thinking because of a brain injury. One of the investigators on this project along with colleagues in the United States (US) have developed a streamlined version of cognitive rehabilitation therapy for mild traumatic brain injury (mTBI) that can be completed in person or virtually and takes place over a 3-week period. The therapy was originally designed for adults with mTBI. The investigators want to know if it can also be used to treat people with cognitive complaints from Long COVID. The investigators will provide education materials only to one group and individual cognitive rehabilitation delivered by a trained Speech Language Pathologist (SLP) or Occupational Therapist (OT) to the other group. The investigators want to find out whether the individual therapy is as feasible and accessible than the usual educational material. What the investigators learn in this study may help treat day-to-day thinking challenges in Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Recruitment Rate", "description": "The primary outcome is the rate of recruitment, average 5 per month. The primary outcome is the rate of recruitment and retention rate reported as the total number of participants recruited and retained.", "time_frame": "9 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Acceptability of the Intervention", "description": "The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Acceptability of Intervention Measure (AIM).", "time_frame": "Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment." }, { "type": "secondary", "measure": "Acceptability of the Appropriateness", "description": "The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Intervention Appropriateness Measure (IAM).", "time_frame": "Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment." }, { "type": "secondary", "measure": "Acceptability of the Feasibility", "description": "The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Feasibility of Intervention Measure (FIM).", "time_frame": "Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment" } ], "outcome_measures": [ { "type": "primary", "measure": "Recruitment Rate", "description": "The primary outcome is the rate of recruitment, average 5 per month. The primary outcome is the rate of recruitment and retention rate reported as the total number of participants recruited and retained.", "time_frame": "9 months" }, { "type": "secondary", "measure": "Acceptability of the Intervention", "description": "The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Acceptability of Intervention Measure (AIM).", "time_frame": "Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment." }, { "type": "secondary", "measure": "Acceptability of the Appropriateness", "description": "The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Intervention Appropriateness Measure (IAM).", "time_frame": "Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment." }, { "type": "secondary", "measure": "Acceptability of the Feasibility", "description": "The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Feasibility of Intervention Measure (FIM).", "time_frame": "Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05676047", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05817006", "title": "Research of the Long-COVID-19 Syndrome in the Children", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-01-23", "start_date": "2023-04-16", "completion_date": "2024-12-31", "primary_completion_date": "2024-04-30", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Device" ], "sponsor": "Samara State Medical University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "During the pandemic of the new coronavirus infection COVID-19 in the world community, in the Russian Federation, in particular in the Samara region throughout the pandemic period from the end of 2019, when the first outbreak of a new coronavirus infection occurred in Wuhan (Hubei Province) in the People's Republic of China, the main focus on prevention (development of modern vaccines), diagnosis, treatment and further rehabilitation was done on the adult population. Children acted mainly as carriers of this infection and the manifestation of the disease usually occurred in most cases (not counting children with comorbid conditions) in a mild or latent form. At the moment, after 2 years, we can say that postcovid syndrome also occurs in children, regardless of the severity of the disease.", "primary_outcomes": [ { "type": "primary", "measure": "postcovid syndrome in children", "description": "Number of Participants with research of the bridge syndrome", "time_frame": "1 year" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "postcovid syndrome in children", "description": "Number of Participants with research of the bridge syndrome", "time_frame": "1 year" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 88, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05817006", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05592418", "title": "Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2025-01-22", "start_date": "2023-06-30", "completion_date": "2023-11-30", "primary_completion_date": "2023-11-17", "conditions_raw": [ "Post COVID-19 Condition", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rintatolimod" ], "sponsor": "AIM ImmunoTech Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to assess the efficacy and safety of Ampligen® administered twice weekly by intravenous (IV) infusions in subjects experiencing the Post-COVID Condition of fatigue.", "primary_outcomes": [ { "type": "primary", "measure": "Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score)", "description": "Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores \\<55 are within normal limits, 55-60 mild, 61-70 moderate, and \\>70 severe fatigue.", "time_frame": "Baseline and Week 13" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change From Baseline to Week 6 in PROMIS Fatigue Score (T-Score)", "description": "Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores \\<55 are within normal limits, 55-60 mild, 61-70 moderate, and \\>70 severe fatigue.", "time_frame": "Baseline to Week 6" }, { "type": "secondary", "measure": "Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven", "description": "Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. For this endpoint, the last question of \"How often did you have enough energy to exercise strenuously\" was excluded. Therefore, the lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 33.4; the highest possible T-score is 76.8. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual.", "time_frame": "Baseline to Week 6 and 13" }, { "type": "secondary", "measure": "Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT)", "description": "The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance.", "time_frame": "Baseline to week 6 and week 13" }, { "type": "secondary", "measure": "Percentage of Subjects With Minimal Clinically Important Difference (MCID)", "description": "Percentage of subjects with increase of at least 54 m from baseline in the Six-Minute Walk Test (6MWT) at the end of 12-week treatment phase presented and summarized descriptively by treatment group.", "time_frame": "End of 12 week treatment phase" }, { "type": "secondary", "measure": "Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score).", "description": "Change in mean cognitive function T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Cognitive Function - Abilities short form 8a that assesses self-perceived cognitive deficits. The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 23.27; the highest possible T-score is 67.09. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the better the cognitive function of the individual. Scores \\>45 are within normal limits, 40-45 mild, 30-40 moderate, and \\<30 severe cognitive dysfunction.", "time_frame": "Baseline to Week 6 and 13" }, { "type": "secondary", "measure": "Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score)", "description": "Change in mean sleep disturbance T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance - short form 4a that assesses self-perceived sleep quality. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 32; the highest possible T-score is 73.3. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the sleep disturbance of the individual. Scores \\<55 are within normal limits, 55-60 mild, 61-70 moderate, and \\>70 severe fatigue.", "time_frame": "Baseline to Week 6 and 13" } ], "outcome_measures": [ { "type": "primary", "measure": "Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score)", "description": "Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores \\<55 are within normal limits, 55-60 mild, 61-70 moderate, and \\>70 severe fatigue.", "time_frame": "Baseline and Week 13" }, { "type": "secondary", "measure": "Change From Baseline to Week 6 in PROMIS Fatigue Score (T-Score)", "description": "Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores \\<55 are within normal limits, 55-60 mild, 61-70 moderate, and \\>70 severe fatigue.", "time_frame": "Baseline to Week 6" }, { "type": "secondary", "measure": "Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven", "description": "Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. For this endpoint, the last question of \"How often did you have enough energy to exercise strenuously\" was excluded. Therefore, the lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 33.4; the highest possible T-score is 76.8. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual.", "time_frame": "Baseline to Week 6 and 13" }, { "type": "secondary", "measure": "Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT)", "description": "The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance.", "time_frame": "Baseline to week 6 and week 13" }, { "type": "secondary", "measure": "Percentage of Subjects With Minimal Clinically Important Difference (MCID)", "description": "Percentage of subjects with increase of at least 54 m from baseline in the Six-Minute Walk Test (6MWT) at the end of 12-week treatment phase presented and summarized descriptively by treatment group.", "time_frame": "End of 12 week treatment phase" }, { "type": "secondary", "measure": "Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score).", "description": "Change in mean cognitive function T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Cognitive Function - Abilities short form 8a that assesses self-perceived cognitive deficits. The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 23.27; the highest possible T-score is 67.09. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the better the cognitive function of the individual. Scores \\>45 are within normal limits, 40-45 mild, 30-40 moderate, and \\<30 severe cognitive dysfunction.", "time_frame": "Baseline to Week 6 and 13" }, { "type": "secondary", "measure": "Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score)", "description": "Change in mean sleep disturbance T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance - short form 4a that assesses self-perceived sleep quality. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 32; the highest possible T-score is 73.3. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the sleep disturbance of the individual. Scores \\<55 are within normal limits, 55-60 mild, 61-70 moderate, and \\>70 severe fatigue.", "time_frame": "Baseline to Week 6 and 13" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 80, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05592418", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06316843", "title": "Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2025-01-22", "start_date": "2023-10-15", "completion_date": "2024-10-31", "primary_completion_date": "2024-10-31", "conditions_raw": [ "Long COVID", "PASC Post Acute Sequelae of COVID 19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Valacyclovir Celecoxib Dose 1", "Valacyclovir Celecoxib Dose 2" ], "sponsor": "Bateman Horne Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "To explore the safety and efficacy of daily doses of celecoxib + valacyclovir in the treatment of patients with prolonged symptoms caused by COVID-19.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Instrument", "description": "The PROMIS Fatigue 7a will be automatically calculated to a T-score with a standard error of 4. Higher fatigue T-scores represent worse than average fatigue. The primary efficacy analysis will be the mean change from baseline (MCFB) to Week 12 in fatigue based on the weekly survey PROMIS Fatigue 7a T-scores. A mixed models for repeated measures (MMRM) procedure will be used to compare the MCFB between the treatment and placebo arm.", "time_frame": "12 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Fatigue assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Instrument", "description": "The PROMIS Fatigue 7a will be automatically calculated to a T-score with a standard error of 4. Higher fatigue T-scores represent worse than average fatigue. The primary efficacy analysis will be the mean change from baseline (MCFB) to Week 12 in fatigue based on the weekly survey PROMIS Fatigue 7a T-scores. A mixed models for repeated measures (MMRM) procedure will be used to compare the MCFB between the treatment and placebo arm.", "time_frame": "12 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 59, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06316843", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06765421", "title": "Optimising General Practice Long COVID Care - an Educational Intervention.", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-01-09", "start_date": "2025-03", "completion_date": "2025-04", "primary_completion_date": "2025-04", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Intervention Group" ], "sponsor": "University College Dublin", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This trial will evaluate the feasibility of a pilot educational intervention for GPs that aims to enhance care and care outcomes among patients with long COVID at six general practices in the Ireland East region.\n\nOur first objective is to conduct focus groups with key stakeholders (GPs, other health professionals, patients, families/carers) that will inform the contents of an education intervention. The second objective will be to implement this educational intervention, and the third objective will be to determine whether the intervention is feasible.\n\nStudy outcomes will include:\n\n* Qualitative findings from co-design focus groups and post-intervention semi-structured interviews with GPs.\n* Practice and patient study recruitment and retention data.\n* GP / Practice characteristics: age \\& gender, practice location, general and COVID-19 patient population figures.\n* Patient characteristics: Patient age, gender, COVID-19 vaccination status, and medical history details.\n* Patient scores on a self-report measure assessing the symptoms, symptom severity, functional impact, and overall health (COVID-19 Yorkshire Rehabilitation Scale (C-19-YRS)).", "primary_outcomes": [ { "type": "primary", "measure": "Qualitative data from focus groups and post-intervention interviews", "description": "Qualitative analyses will be used to capture focus group and intervention participants' study related views and experiences, with emphasis on accounts illustrating the intervention's feasibility.", "time_frame": "Focus groups (4 weeks), post intervention interviews (4 weeks)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Study engagement data", "description": "Descriptive statistics will assess trends relating to study invitation, commencement, and completion. Qualitative analysis will examine reasons for study exclusion, non-commencement, and non-completion.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "GP and patient demographics / medical details", "description": "Descriptive statistics and qualitative analysis of open-ended responses outlining practice, GP, and patient demographics, as well as patient medical details, will be conducted.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Patients'scores on the COVID-19-YRS", "description": "Descriptive and inferential statistics outlining aggregated baseline and six-week follow-up scores on the The Covid-19 Yorkshire Rehabilitation Scale (C-19-YRS) will be calculated. The C19-YRS has four subscales concerned with the severity of patients' key symptoms, functional limitations, overall health, and additional symptoms. Each item is rated on a 0-10 numerical rating scale, where 0 represents the symptom not being present, and 10 represents the symptom being extremely severe or life disturbing.", "time_frame": "6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Qualitative data from focus groups and post-intervention interviews", "description": "Qualitative analyses will be used to capture focus group and intervention participants' study related views and experiences, with emphasis on accounts illustrating the intervention's feasibility.", "time_frame": "Focus groups (4 weeks), post intervention interviews (4 weeks)." }, { "type": "secondary", "measure": "Study engagement data", "description": "Descriptive statistics will assess trends relating to study invitation, commencement, and completion. Qualitative analysis will examine reasons for study exclusion, non-commencement, and non-completion.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "GP and patient demographics / medical details", "description": "Descriptive statistics and qualitative analysis of open-ended responses outlining practice, GP, and patient demographics, as well as patient medical details, will be conducted.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Patients'scores on the COVID-19-YRS", "description": "Descriptive and inferential statistics outlining aggregated baseline and six-week follow-up scores on the The Covid-19 Yorkshire Rehabilitation Scale (C-19-YRS) will be calculated. The C19-YRS has four subscales concerned with the severity of patients' key symptoms, functional limitations, overall health, and additional symptoms. Each item is rated on a 0-10 numerical rating scale, where 0 represents the symptom not being present, and 10 represents the symptom being extremely severe or life disturbing.", "time_frame": "6 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 72, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06765421", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06073002", "title": "Effects of a Home-Based Exercise Intervention in Subjects with Long COVID", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2024-12-11", "start_date": "2023-09-04", "completion_date": "2025-02-28", "primary_completion_date": "2025-02-28", "conditions_raw": [ "Long COVID-19", "Post-COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Home-Based Concurrent Exercise" ], "sponsor": "University of Vienna", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The current Coronavirus Disease 2019 (COVID-19) pandemic is the most severe health crisis of the 21st century. This is not only due to the deaths caused by the disease. People that were affected by COVID-19 and supposedly recovered may suffer from long lasting sequelae. The presence of symptoms longer than 3 months after the infection with the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is referred to as Post-COVID-19 Syndrome or Long COVID-19. It is estimated that 10-20 percent of all infected people are affected. The most common symptoms include persistent fatigue, reduced physical capacity, dyspnoea, ageusia, anosmia, musculoskeletal pain and neuropsychological complaints such as depression, anxiety, insomnia and a loss of concentration.\n\nConsidering the novelty of the pathology, evidence on the successful treatment of Post-COVID/Long-COVID is scarce. Physical activity has been established as a treatment option for chronic diseases that have similar symptomatic manifestations to those of Post-COVID/Long-COVID. For example, exercise therapy has shown positive effects on the health status of patients with lung disease, depression, anxiety, insomnia and cognitive impairment. However, there has been controversy whether so-called Graded Exercise Therapy (GET) is a safe treatment strategy for patients with Chronic Fatigue Syndrome (CFS). This population may experience Post Exertional Malaise (PEM), a worsening of symptoms after physical, cognitive or emotional exertion. Since COVID-19 might be an infectious trigger for CFS, particular caution has to be taken when recruiting participants and when screening them for adverse events and worsening of symptoms during an exercise intervention.\n\nIt can be hypothesized that patients suffering from Post-COVID/Long-COVID can benefit from exercise in various ways, guaranteed that there is sufficient screening for PEM before and during the intervention and training volume and intensity are increased slowly and progressively.\n\nThe current study investigates the effects of a home-based concurrent training program on various parameters in people affected by Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Change of peak oxygen consumption (VO2peak measured in ml/min/kg)", "description": "VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.", "time_frame": "at baseline and at 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change of maximum lower body isometric muscle strength (measured in N)", "description": "Maximum lower body isometric muscle strength will be assessed via a leg press with integrated isometric force measurement (Compass 530, Suessmed GmbH).", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of maximum hand grip strength (measured in kg)", "description": "Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of Standard Deviation of RR-Intervals (SDNN measured in ms)", "description": "SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of Root Mean Square of Successive Differences (RMSSD measured in ms)", "description": "RMSSD will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of health-related quality of life (HQoL) assessed via the SF-36 1.0", "description": "The SF-36 1.0 is self-administered questionnaire and will be scored according to RAND (numeric value of 0-100). A high score represents a more favorable health status.", "time_frame": "at baseline an at 12 weeks" }, { "type": "secondary", "measure": "Change of the number of present Long-COVID specific symptoms", "description": "The number of Long-COVID specific symptoms will be assessed using a list of symptoms provided by the National Institute for Health Care and Excellence (NICE). Each item will be referenced to as existent (yes) or non-existent (no) during the last 7 days.", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of fatigue assessed via the Fatigue Severity Scale (FSS)", "description": "The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale", "description": "The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of interleukin-6 (IL-6 measured in pg/ml)", "description": "IL-6 will be assessed via blood sample.", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)", "description": "TNF-α will be assessed via blood sample.", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of mean time \"correct rejection\" (CR, speed during concentrated working measured in s)", "description": "CR will be assessed via Cognitrone (Schuhfried GmbH), which is a carefully administered computer test. Participants will be given the task of comparing a series of geometric figures.", "time_frame": "at baseline and at 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of peak oxygen consumption (VO2peak measured in ml/min/kg)", "description": "VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of maximum lower body isometric muscle strength (measured in N)", "description": "Maximum lower body isometric muscle strength will be assessed via a leg press with integrated isometric force measurement (Compass 530, Suessmed GmbH).", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of maximum hand grip strength (measured in kg)", "description": "Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of Standard Deviation of RR-Intervals (SDNN measured in ms)", "description": "SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of Root Mean Square of Successive Differences (RMSSD measured in ms)", "description": "RMSSD will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of health-related quality of life (HQoL) assessed via the SF-36 1.0", "description": "The SF-36 1.0 is self-administered questionnaire and will be scored according to RAND (numeric value of 0-100). A high score represents a more favorable health status.", "time_frame": "at baseline an at 12 weeks" }, { "type": "secondary", "measure": "Change of the number of present Long-COVID specific symptoms", "description": "The number of Long-COVID specific symptoms will be assessed using a list of symptoms provided by the National Institute for Health Care and Excellence (NICE). Each item will be referenced to as existent (yes) or non-existent (no) during the last 7 days.", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of fatigue assessed via the Fatigue Severity Scale (FSS)", "description": "The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale", "description": "The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of interleukin-6 (IL-6 measured in pg/ml)", "description": "IL-6 will be assessed via blood sample.", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)", "description": "TNF-α will be assessed via blood sample.", "time_frame": "at baseline and at 12 weeks" }, { "type": "secondary", "measure": "Change of mean time \"correct rejection\" (CR, speed during concentrated working measured in s)", "description": "CR will be assessed via Cognitrone (Schuhfried GmbH), which is a carefully administered computer test. Participants will be given the task of comparing a series of geometric figures.", "time_frame": "at baseline and at 12 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06073002", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06091293", "title": "Narrative Intervention for Long COVID-19 (NICO)", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-12-10", "start_date": "2022-10-01", "completion_date": "2022-12-01", "primary_completion_date": "2022-12-01", "conditions_raw": [ "Long COVID", "Long Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Narrative Intervention For Long Covid-19" ], "sponsor": "University of Colorado, Denver", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This T1 proof of concept trial is designed to test the Narrative Intervention for Long COVID-19 intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Personal Health Questionnarrie- 8 item (PHQ8)", "description": "Measurement of depression widely used in clinical and research settings", "time_frame": "Baseline and 3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Generalized Anxiety Disorder- 7 item (GAD7)", "description": "Measurement of anxiety widely used in clinical and research settings", "time_frame": "Baseline and 3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Personal Health Questionnarrie- 8 item (PHQ8)", "description": "Measurement of depression widely used in clinical and research settings", "time_frame": "Baseline and 3 months" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder- 7 item (GAD7)", "description": "Measurement of anxiety widely used in clinical and research settings", "time_frame": "Baseline and 3 months" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 12, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06091293", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05833217", "title": "Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2", "status": "RECRUITING", "phase": "NA", "last_updated": "2024-12-04", "start_date": "2023-06-06", "completion_date": "2025-12-31", "primary_completion_date": "2025-05-02", "conditions_raw": [ "Long COVID", "Insulin Resistance", "Insulin Sensitivity" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Adipose Tissue Biopsy", "Steady State Plasma Glucose (Sspg) Test" ], "sponsor": "Stanford University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators are studying the pathophysiologic links between obesity, insulin resistance (IR), adipose tissue infection, and post-acute sequelae of COVID-19 (PASC). This study looks at whether adipose (fat) tissue contributes to PASC by driving chronic inflammation or by serving as a reservoir for SARS-CoV-2 persistence. The results will not only determine whether obesity and IR are risk factors for PASC, but will also define fundamental biology that sets the stage for the investigation of novel or existing therapies that target the causal pathways identified.", "primary_outcomes": [ { "type": "primary", "measure": "Triglyceride/HDL-cholesterol ratio", "description": "Investigate the relationship between insulin resistance, as described by triglyceride/HDL-cholesterol ratio, and incident PASC (long COVID).", "time_frame": "2 years" }, { "type": "primary", "measure": "Concentration of Viral RNA in Adipose Tissue", "description": "Investigate the expression of viral RNA in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as known MODY transcription factors measured by PCR between COVID-19 infected participants and healthy controls.", "time_frame": "2 years" }, { "type": "primary", "measure": "Rate of Inflammatory Response", "description": "Investigate inflammatory response to PPARgamma agonist (drug) and other compounds tested in vitro in human fat cells. Compare plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay between participants identified as Insulin Sensitive (IS) and Insulin Resistant (IR) using the 2-stage Steady State Plasma Glucose test.", "time_frame": "2 years" }, { "type": "primary", "measure": "Rate of Inflammatory Gene Expression in Adipose Tissue", "description": "Investigate the expression of inflammatory genes in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as defensin chemokine receptors and platelet activation factors measured by PCR between COVID-19 infected participants and healthy controls.", "time_frame": "2 years" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Triglyceride/HDL-cholesterol ratio", "description": "Investigate the relationship between insulin resistance, as described by triglyceride/HDL-cholesterol ratio, and incident PASC (long COVID).", "time_frame": "2 years" }, { "type": "primary", "measure": "Concentration of Viral RNA in Adipose Tissue", "description": "Investigate the expression of viral RNA in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as known MODY transcription factors measured by PCR between COVID-19 infected participants and healthy controls.", "time_frame": "2 years" }, { "type": "primary", "measure": "Rate of Inflammatory Response", "description": "Investigate inflammatory response to PPARgamma agonist (drug) and other compounds tested in vitro in human fat cells. Compare plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay between participants identified as Insulin Sensitive (IS) and Insulin Resistant (IR) using the 2-stage Steady State Plasma Glucose test.", "time_frame": "2 years" }, { "type": "primary", "measure": "Rate of Inflammatory Gene Expression in Adipose Tissue", "description": "Investigate the expression of inflammatory genes in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as defensin chemokine receptors and platelet activation factors measured by PCR between COVID-19 infected participants and healthy controls.", "time_frame": "2 years" } ], "relevance_tags": [ "Persistence / Antiviral", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 55, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05833217", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05823896", "title": "ImPROving Quality of LIFe in the Long COVID Patient", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2024-12-04", "start_date": "2023-05-01", "completion_date": "2024-11-28", "primary_completion_date": "2024-11-28", "conditions_raw": [ "Post-COVID-19 Syndrome", "Long COVID", "Long Covid19", "COVID-19", "POTS - Postural Orthostatic Tachycardia Syndrome", "Post COVID-19 Condition", "Post-COVID Syndrome", "Post COVID-19 Condition, Unspecified", "Postinfectious Inflammation", "Postinfectious Disorder" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Paxlovid (Nirmatrelvir/Ritonavir)" ], "sponsor": "Karolinska Institutet", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to investigate the efficacy of orally administered nirmatrelvir/ritonavir compared with placebo/ritonavir to improve quality of life in non-hospitalized adult participants suffering from post-acute COVID-19 syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in quality of life over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale.", "time_frame": "Baseline and day 16" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from baseline in quality of life over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in hemodynamic response over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on hemodynamic response (only patients diagnosed with postural orthostatic tachycardia syndrome, POTS). Change from baseline in delta maximum heart rate during active standing test.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in dysautonomia over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on dysautonomia symptoms. Change from baseline as measured using the Composite Autonomic Symptom Score (Compass31) questionnaire.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in fever in patients with POTS over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on fever (only patients diagnosed with POTS). Change from baseline in POTS-specific symptoms as measured by using the Malmo POTS score, MAPS.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in endothelial function over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on reactive hyperemia index. Change from baseline in endothelial function measured using the EndoPat® device.", "time_frame": "Baseline and day 45" }, { "type": "secondary", "measure": "Change from baseline in heart rate over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on 24-h average heart rate. Change from baseline in heart rate using ECG monitoring device.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in fever over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on fever. Change from baseline in body temperature.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in physical capacity over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on physical capacity. Change from baseline as measured by 6-minute walk test.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in handgrip strength over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on handgrip strength. Change from baseline as measured by JAMAR hand dynamometer.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in physical activity over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on physical activity. Change from baseline as measured by accelerometer.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in post-exertional malaise over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on post-exertional malaise. Change from baseline in total score as measured by the Post-Exertional Malaise (PEM) short form.", "time_frame": "Baseline and day 90" }, { "type": "secondary", "measure": "Change from baseline in fatigue over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on fatigue. Change from baseline as measured by the fatigue severity scale (FSS) and mental fatigue scale (MFS).", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in cognitive dysfunction over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on cognitive dysfunction. Change from baseline over time as measured by the Montreal Cognitive Assessment (MoCA) test.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in dyspnea over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on dyspnea measured as change from baseline in respiratory symptoms using the Chronic obstructive disease assessment (CAT) and Modified Medical Research Council (mMRC) tests.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in plasma biomarkers over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on plasma biomarkers. Change from baseline in the following plasma biomarkers: D-dimer, CRP, ESR, ferritin, NTproBNP and LD.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in dysfunctional breathing patterns over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on dysfunctional breathing patterns. Change from baseline in Njimegen questionnaire.", "time_frame": "Baseline and days 16, 45 and 90" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in quality of life over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale.", "time_frame": "Baseline and day 16" }, { "type": "secondary", "measure": "Change from baseline in quality of life over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on quality of life measured as change from baseline using the EQ-5D-5L VAS scale.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in hemodynamic response over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on hemodynamic response (only patients diagnosed with postural orthostatic tachycardia syndrome, POTS). Change from baseline in delta maximum heart rate during active standing test.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in dysautonomia over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on dysautonomia symptoms. Change from baseline as measured using the Composite Autonomic Symptom Score (Compass31) questionnaire.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in fever in patients with POTS over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on fever (only patients diagnosed with POTS). Change from baseline in POTS-specific symptoms as measured by using the Malmo POTS score, MAPS.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in endothelial function over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on reactive hyperemia index. Change from baseline in endothelial function measured using the EndoPat® device.", "time_frame": "Baseline and day 45" }, { "type": "secondary", "measure": "Change from baseline in heart rate over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on 24-h average heart rate. Change from baseline in heart rate using ECG monitoring device.", "time_frame": "Baseline and days 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in fever over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on fever. Change from baseline in body temperature.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in physical capacity over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on physical capacity. Change from baseline as measured by 6-minute walk test.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in handgrip strength over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on handgrip strength. Change from baseline as measured by JAMAR hand dynamometer.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in physical activity over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on physical activity. Change from baseline as measured by accelerometer.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in post-exertional malaise over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on post-exertional malaise. Change from baseline in total score as measured by the Post-Exertional Malaise (PEM) short form.", "time_frame": "Baseline and day 90" }, { "type": "secondary", "measure": "Change from baseline in fatigue over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on fatigue. Change from baseline as measured by the fatigue severity scale (FSS) and mental fatigue scale (MFS).", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in cognitive dysfunction over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on cognitive dysfunction. Change from baseline over time as measured by the Montreal Cognitive Assessment (MoCA) test.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in dyspnea over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on dyspnea measured as change from baseline in respiratory symptoms using the Chronic obstructive disease assessment (CAT) and Modified Medical Research Council (mMRC) tests.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in plasma biomarkers over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on plasma biomarkers. Change from baseline in the following plasma biomarkers: D-dimer, CRP, ESR, ferritin, NTproBNP and LD.", "time_frame": "Baseline and days 16, 45 and 90" }, { "type": "secondary", "measure": "Change from baseline in dysfunctional breathing patterns over time", "description": "The effect of oral administration of nirmatrelvir/ritonavir on dysfunctional breathing patterns. Change from baseline in Njimegen questionnaire.", "time_frame": "Baseline and days 16, 45 and 90" } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 219, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05823896", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06492577", "title": "Combined Pulmonary Rehabilitation and PMR for Long-Term COVID-19 Symptoms: A RCT", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-12-03", "start_date": "2024-07-15", "completion_date": "2024-12-01", "primary_completion_date": "2024-10-06", "conditions_raw": [ "Long Covid19", "Pulmonary Rehabilitation", "Progressive Muscle Relaxation" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Pulmonary Rehabilitation Protocol", "Progressive Muscle Relaxation Protocol" ], "sponsor": "Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "Our study aimed to evaluate the effectiveness of a 21-day program combining pulmonary rehabilitation (PR) with progressive muscle relaxation (PMR) in patients experiencing long-term symptoms of COVID-19. Participants with persistent symptoms will be randomly assigned to either a PR group or a PR combined with PMR group. The PR program includes aerobic exercises, strength training, and breathing exercises, while the PMR sessions involve systematic muscle tensing and relaxation techniques. We will measure outcomes such as lung function, exercise capacity, anxiety, depression, and sleep quality using validated questionnaires and clinical tests.", "primary_outcomes": [ { "type": "primary", "measure": "Lung function", "description": "Spirometry is a pulmonary function test used to assess lung function by measuring the volume and speed of air that can be inhaled and exhaled. During the procedure, the patient sits upright, uses a nose clip, and takes a deep breath in. They then exhale as forcefully and quickly as possible into a spirometer through a disposable mouthpiece. This process measures the maximum volume of air expelled (Forced Vital Capacity, FVC) and the volume expelled in the first second (Forced Expiratory Volume in One Second, FEV1). The test is repeated at least three times to ensure accuracy, and the best effort is recorded.", "time_frame": "20 minutes" }, { "type": "primary", "measure": "Exercise capacity", "description": "The exercise capacity evaluation will be conducted using the 6-minute walk test (6MWT). During the test, the patient is instructed to walk back and forth along a flat, straight 30-meter course for six minutes, aiming to cover as much distance as possible. The total distance walked in six minutes is measured in meters. Rest periods are allowed if necessary, but the clock continues to run.", "time_frame": "20 minutes" }, { "type": "primary", "measure": "Anxiety", "description": "Anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7). This self-administered questionnaire consists of seven items, each scored from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 21. Higher scores indicate greater levels of anxiety.", "time_frame": "At inclusion and at the end of the study" }, { "type": "primary", "measure": "Depression", "description": "Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). This self-administered questionnaire includes nine items, each scored from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. Higher scores indicate more severe depression.", "time_frame": "20 minutes" }, { "type": "primary", "measure": "Sleep Quality", "description": "Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). This self-rated questionnaire assesses sleep quality and disturbances over a one-month period. It consists of 19 items, generating seven component scores that are summed to produce a global score ranging from 0 to 21, with higher scores indicating worse sleep quality.", "time_frame": "20 minutes" }, { "type": "primary", "measure": "Psychological Well-being", "description": "Psychological well-being will be assessed using the General Health Questionnaire-12 (GHQ-12). This self-administered questionnaire includes 12 items, each scored on a 4-point scale (less than usual, no more than usual, rather more than usual, or much more than usual), with a total score ranging from 0 to 36. Higher scores indicate greater levels of psychological distress.", "time_frame": "20 minutes" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Lung function", "description": "Spirometry is a pulmonary function test used to assess lung function by measuring the volume and speed of air that can be inhaled and exhaled. During the procedure, the patient sits upright, uses a nose clip, and takes a deep breath in. They then exhale as forcefully and quickly as possible into a spirometer through a disposable mouthpiece. This process measures the maximum volume of air expelled (Forced Vital Capacity, FVC) and the volume expelled in the first second (Forced Expiratory Volume in One Second, FEV1). The test is repeated at least three times to ensure accuracy, and the best effort is recorded.", "time_frame": "20 minutes" }, { "type": "primary", "measure": "Exercise capacity", "description": "The exercise capacity evaluation will be conducted using the 6-minute walk test (6MWT). During the test, the patient is instructed to walk back and forth along a flat, straight 30-meter course for six minutes, aiming to cover as much distance as possible. The total distance walked in six minutes is measured in meters. Rest periods are allowed if necessary, but the clock continues to run.", "time_frame": "20 minutes" }, { "type": "primary", "measure": "Anxiety", "description": "Anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7). This self-administered questionnaire consists of seven items, each scored from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 21. Higher scores indicate greater levels of anxiety.", "time_frame": "At inclusion and at the end of the study" }, { "type": "primary", "measure": "Depression", "description": "Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). This self-administered questionnaire includes nine items, each scored from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. Higher scores indicate more severe depression.", "time_frame": "20 minutes" }, { "type": "primary", "measure": "Sleep Quality", "description": "Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). This self-rated questionnaire assesses sleep quality and disturbances over a one-month period. It consists of 19 items, generating seven component scores that are summed to produce a global score ranging from 0 to 21, with higher scores indicating worse sleep quality.", "time_frame": "20 minutes" }, { "type": "primary", "measure": "Psychological Well-being", "description": "Psychological well-being will be assessed using the General Health Questionnaire-12 (GHQ-12). This self-administered questionnaire includes 12 items, each scored on a 4-point scale (less than usual, no more than usual, rather more than usual, or much more than usual), with a total score ranging from 0 to 36. Higher scores indicate greater levels of psychological distress.", "time_frame": "20 minutes" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other Gov" ], "enrollment": 61, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06492577", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05096884", "title": "Post-Acute Sequelae of Coronavirus-19 (COVID-19) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study", "status": "TERMINATED", "phase": "EARLY_PHASE1", "last_updated": "2024-12-03", "start_date": "2022-03-23", "completion_date": "2023-09-12", "primary_completion_date": "2023-09-12", "conditions_raw": [ "Tachycardia", "Dyspnea", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Metoprolol Succinate" ], "sponsor": "Hackensack Meridian Health", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Most patients with acute COVID-19 (Coronavirus 19) recover within weeks, however a significant number of individuals will develop the post-acute COVID 19 syndrome (PASC). As of July 2021, the post COVID syndrome qualifies as a disability under the Americans with Disabilities Act. The symptoms which comprise this condition are highly variable and often extraordinarily debilitating. They may be distinct from the initial presentation or may mimic those which defined the initial infection. The post COVID syndrome can be diagnosed when symptoms persist longer than 3 months and may extend to beyond one year. There are risks for permanent levels of disability. Patients who seemingly did not have active COVID-19 symptoms in the days following infectious exposure may also develop post Covid syndromes. These syndromes are considered to constitute a distinct clinical entity which has of yet no clearly defined pathogenic mechanism or validated treatment algorithms.\n\nInternational investigative efforts are now underway to determine who might develop the post COVID syndrome, it's long term consequences and how best to treat its many problematic symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Change in 6 Minute Walk Test at the End of Treatment Period", "description": "To assess the reduction of symptoms in patients with PASC Dyspnea on Exertion (DOE) and associated tachycardia when treated with beta blockers as captured in patients walk test. Walk test will be performed at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline).", "time_frame": "12 weeks from baseline walk test" }, { "type": "primary", "measure": "Change in Zva Measurement at the End of Treatment Period", "description": "To assess the reduction of symptoms in patients with PASC Dyspnea on Exertion (DOE) and associated tachycardia when treated with beta blockers as captured in Zva measurement calculated from patient's TTE (transthoracic echocardiogram).\n\nTTE (and Zva) will be performed at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline).", "time_frame": "12 weeks from baseline transthoracic echocardiogram (TTE)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Minnesota Living With Heart Failure Score at the End of Treatment Period", "description": "Subjective improvement in Dyspnea on Exertion (DOE), tachycardia and well being score as measured by the Minnesota Living with Heart Failure.\n\nThe Minnesota Living with Heart Failure questionnaire will be administered at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline). Minnesota Living with Heart Failure questionnaire is a 21-item questionnaire with each item having a 6 point Likert scale (0-5), Zero represents \"No symptom\" and 5 represents high intensity of symptom. The questionnaire has 3 dimension and they measure Physical, socio-economic and emotional/psychological aspects respectively. The total score is the sum of all item responses for total and dimension scores.", "time_frame": "12 weeks from baseline" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in 6 Minute Walk Test at the End of Treatment Period", "description": "To assess the reduction of symptoms in patients with PASC Dyspnea on Exertion (DOE) and associated tachycardia when treated with beta blockers as captured in patients walk test. Walk test will be performed at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline).", "time_frame": "12 weeks from baseline walk test" }, { "type": "primary", "measure": "Change in Zva Measurement at the End of Treatment Period", "description": "To assess the reduction of symptoms in patients with PASC Dyspnea on Exertion (DOE) and associated tachycardia when treated with beta blockers as captured in Zva measurement calculated from patient's TTE (transthoracic echocardiogram).\n\nTTE (and Zva) will be performed at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline).", "time_frame": "12 weeks from baseline transthoracic echocardiogram (TTE)." }, { "type": "secondary", "measure": "Change in Minnesota Living With Heart Failure Score at the End of Treatment Period", "description": "Subjective improvement in Dyspnea on Exertion (DOE), tachycardia and well being score as measured by the Minnesota Living with Heart Failure.\n\nThe Minnesota Living with Heart Failure questionnaire will be administered at day 1 (baseline) and at 2-4 weeks post treatment completion which consists of 8 weeks metoprolol succinate (approximately 12 weeks from baseline). Minnesota Living with Heart Failure questionnaire is a 21-item questionnaire with each item having a 6 point Likert scale (0-5), Zero represents \"No symptom\" and 5 represents high intensity of symptom. The questionnaire has 3 dimension and they measure Physical, socio-economic and emotional/psychological aspects respectively. The total score is the sum of all item responses for total and dimension scores.", "time_frame": "12 weeks from baseline" } ], "relevance_tags": [ "General", "EARLY_Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 14, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05096884", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05668091", "title": "A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults with Long COVID.", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2024-12-02", "start_date": "2023-04-14", "completion_date": "2024-08-21", "primary_completion_date": "2024-04-09", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Paxlovid (Nirmatrelvir/Ritonavir)", "Ritonavir" ], "sponsor": "Harlan M Krumholz", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This decentralized trial is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled study in an anticipated 100 non-hospitalized highly symptomatic adult participants with long COVID. It seeks to determine the efficacy, safety, and tolerability of 15 days of Paxlovid (nirmatrelvir/ritonavir), an anti-viral agent, compared with placebo plus ritonavir. The hypothesis is that viral persistence contributes to long COVID in some patients and nirmatrelvir/ritonavir compared with placebo/ritonavir can improve general health status in participants with long COVID. The study will also seek immune signatures associated with treatment response (overseen by Professor Akiko Iwasaki).\n\nThe decentralized study does not require site visits, and participants in all 48 states including the District of Columbia, who meet entry criteria can enroll. It is designed to make it convenient to participate. The study drugs will be delivered to the participant's designated address.\n\nLong COVID is also known as post-acute sequelae of SARS-CoV-2 (PASC).", "primary_outcomes": [ { "type": "primary", "measure": "National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS)-29 version 2.1 Physical Health Summary Score", "description": "The difference in NIH PROMIS-29 version 2.1 Physical Health Summary Score at Day 28 between nirmatrelvir/ritonavir and placebo/ritonavir treatment estimated with a longitudinal analysis of covariance (ANCOVA) that controls for age, sex, and baseline PROMIS-29 Physical Health Summary Score. PROMIS-29 was selected as a well-validated, non-proprietary general health assessment. PROMIS-29 is a self-report 29-item questionnaire from 7 primary PROMIS domains (depression, physical function, pain interference, fatigue, sleep disturbance, and satisfaction with participation in social roles). PROMIS-29 assessments are transformed into a T-score metric, so that scores have a normal distribution with a population mean T-score of 50 and standard deviation of 10. Higher scores mean better outcomes.", "time_frame": "Day 28" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Modified General Symptom Questionnaire-30 (Modified GSQ-30)", "description": "Difference in GSQ-30 between nirmatrelvir/ritonavir and placebo/ritonavir groups. The GSQ-30 is a 30-item questionnaire developed to assess symptom burden over a 2-week time period. The GSQ-30 asks: \"how much have you been bothered by any of the following?\" with 5 options: \"not at all,\" \"a little bit,\" \"somewhat,\" \"quite a bit,\" and \"very much\" (scored 0-4); total score ranges from 0 to 120. The GSQ-30 reflects physical and neuropsychiatric symptoms. An additional question (not included in the scoring) asks whether any of the 30 GSQ symptoms have impaired work, social, or family functioning, and asks the rank order of severity (up to 7 items) to identify the symptoms of most concern to the individual. Total score ranges from 0 to 120; a higher score means worse outcome. To align with the other trial questionnaires, we will modified the recall period to 1-week.", "time_frame": "Day 28 and at Day 15, and Weeks 6, 10, 14, 18, and 24" }, { "type": "secondary", "measure": "PROMIS® Cognitive Function v.2.0 - Short Form 6a", "description": "Difference in PROMIS® Cognitive Function v.2.0 - Short Form 6a between nirmatrelvir/ritonavir and placebo/ritonavir groups. The PROMIS® Cognitive Function v.2.0 - Short Form 6a is a 6-item sub-set scale of the PROMIS® Cognitive Function item bank that assesses patient-perceived cognitive deficits.", "time_frame": "Day 28 and at Day 15, and Weeks 6, 10, 14, 18 and 24" }, { "type": "secondary", "measure": "COVID Core Outcome Measure for Recovery", "description": "Difference in COVID Core Outcome Measure for Recovery Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The COVID Core Outcome Measure for Recovery is a single item intended to measure a return to the pre-illness state. Its purpose in this trial is to have a question that directly assesses the participant's perception of their recovery from their SARS-CoV-2 infection. It is scored on a 5-point Likert scale from 0 (completely recovered) to 4 (not recovered at all). Complete recovery means the participant no longer has symptoms related to illness and can do usual daily activities and has returned to their previous state of health and mind (before illness).", "time_frame": "Day 28 and at Day 15, and Weeks 14 and 24" }, { "type": "secondary", "measure": "EuroQol EQ-5D-5L Utility Score-VAS (USA Version)", "description": "Difference in EuroQol EQ-5D-5L Utility Score and VAS Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The EQ-5D-5L is a descriptive system in which respondents are asked to report their current state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which has 5 levels of response (no problems, slight problems, moderate problems, severe problems, and extreme problems). There is also a visual analogue scale (VAS). In total there are 6 items. The higher the EQ-VAS score, the better the quality of life.", "time_frame": "Day 28 and at Day 15, and Weeks 14 and 24" }, { "type": "secondary", "measure": "Functional Assessment of Chronic Illness Therapy (FACIT)-Item GP5", "description": "Difference in FACIT-Item GP5 Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The single-item FACIT-Item GP5, \"I am bothered by side effects of treatment,\" was included to have a question on the experience with the trial drug and will be prefaced to focus on the trial drug. It is a summary measure of the overall tolerability of treatment, with 5 levels of response: not at all, a little bit, somewhat, quite a bit, and very much. It has a 7-day recall period.", "time_frame": "Day 28 and Day 15" }, { "type": "secondary", "measure": "PROMIS-29 Overall and Mental Health Summary Score", "description": "Difference in PROMIS-29 Overall and Mental Health Summary Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and 7 health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using 4 items per domain. There is no total score, but each axis forms its own score. Higher scores mean better outcomes.", "time_frame": "Day 28 and at Day 15, and Weeks 6, 10, 14, 18 and 24" }, { "type": "secondary", "measure": "Difference in number of hospitalizations and deaths", "description": "Difference in occurrence of hospitalizations and deaths between nirmatrelvir/ritonavir and placebo/ritonavir groups.", "time_frame": "Day 1 through Week 24 (End of Study)" }, { "type": "secondary", "measure": "Proportion of participants who experience individual Serious Adverse Events (SAE)", "description": "Proportion of participants who experience individual SAEs", "time_frame": "up to 6 weeks post starting study drug" }, { "type": "secondary", "measure": "Incidence of SAEs leading to discontinuation", "description": "The number of SAEs leading to discontinuation in the study", "time_frame": "Day 15" }, { "type": "secondary", "measure": "Patient Global Impression of Severity", "description": "Based on FDA's recommendations, we will include the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales. These anchor scales can help interpret a clinically meaningful within-patient score change for the key primary and secondary endpoints. We will include two PGIS and two PGIC scales. The PGIS 1 is a single-item questionnaire that asks respondents: \"Overall, how would you rate the severity of your long COVID symptoms over the past week?\". Responses are: \"none,\" \"mild,\" \"moderate,\" \"severe,\" and \"very severe.\" The PGIS 2 asks \"Overall, how would you rate the impact of your symptoms on your overall health over the past week?\". Responses are: \"none,\" \"mild,\" \"moderate,\" \"severe,\" and \"very severe.\" The PGISs will be administered at the same intervals as the primary endpoint (PROMIS-29).", "time_frame": "Baseline, Day 15, Day 28, Week 6, Week 10, Week 14, Week 24" }, { "type": "secondary", "measure": "Patient Global Impression of Change", "description": "The PGIC 1 asks: \"Overall, how would you rate the change in your long COVID symptoms since you started the study?\". There 7-point scale options: 1) \"very much better\", 2) \"much better\", 3) \"minimally better\", 4) \"no change\", 5) \"minimally worse\", 6) \"much worse\", or 7) \"very much worse\". Higher scores indicate a change for the worse. The PGIC 2 asks \"Overall, how would you rate your overall health since you started the study?\". There 7-point scale options: 1) \"very much better\", 2) \"much better\", 3) \"minimally better\", 4) \"no change\", 5) \"minimally worse\", 6) \"much worse\", or 7) \"very much worse\". Higher scores indicate a change for the worse. The PGICs will be administered at the same intervals as the primary endpoint (PROMIS-29) with the exception of baseline. These instruments have been used extensively in patient-centered research.", "time_frame": "Day 15, Day 28, Week 6, Week 10, Week 14, Week 24" } ], "outcome_measures": [ { "type": "primary", "measure": "National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS)-29 version 2.1 Physical Health Summary Score", "description": "The difference in NIH PROMIS-29 version 2.1 Physical Health Summary Score at Day 28 between nirmatrelvir/ritonavir and placebo/ritonavir treatment estimated with a longitudinal analysis of covariance (ANCOVA) that controls for age, sex, and baseline PROMIS-29 Physical Health Summary Score. PROMIS-29 was selected as a well-validated, non-proprietary general health assessment. PROMIS-29 is a self-report 29-item questionnaire from 7 primary PROMIS domains (depression, physical function, pain interference, fatigue, sleep disturbance, and satisfaction with participation in social roles). PROMIS-29 assessments are transformed into a T-score metric, so that scores have a normal distribution with a population mean T-score of 50 and standard deviation of 10. Higher scores mean better outcomes.", "time_frame": "Day 28" }, { "type": "secondary", "measure": "Modified General Symptom Questionnaire-30 (Modified GSQ-30)", "description": "Difference in GSQ-30 between nirmatrelvir/ritonavir and placebo/ritonavir groups. The GSQ-30 is a 30-item questionnaire developed to assess symptom burden over a 2-week time period. The GSQ-30 asks: \"how much have you been bothered by any of the following?\" with 5 options: \"not at all,\" \"a little bit,\" \"somewhat,\" \"quite a bit,\" and \"very much\" (scored 0-4); total score ranges from 0 to 120. The GSQ-30 reflects physical and neuropsychiatric symptoms. An additional question (not included in the scoring) asks whether any of the 30 GSQ symptoms have impaired work, social, or family functioning, and asks the rank order of severity (up to 7 items) to identify the symptoms of most concern to the individual. Total score ranges from 0 to 120; a higher score means worse outcome. To align with the other trial questionnaires, we will modified the recall period to 1-week.", "time_frame": "Day 28 and at Day 15, and Weeks 6, 10, 14, 18, and 24" }, { "type": "secondary", "measure": "PROMIS® Cognitive Function v.2.0 - Short Form 6a", "description": "Difference in PROMIS® Cognitive Function v.2.0 - Short Form 6a between nirmatrelvir/ritonavir and placebo/ritonavir groups. The PROMIS® Cognitive Function v.2.0 - Short Form 6a is a 6-item sub-set scale of the PROMIS® Cognitive Function item bank that assesses patient-perceived cognitive deficits.", "time_frame": "Day 28 and at Day 15, and Weeks 6, 10, 14, 18 and 24" }, { "type": "secondary", "measure": "COVID Core Outcome Measure for Recovery", "description": "Difference in COVID Core Outcome Measure for Recovery Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The COVID Core Outcome Measure for Recovery is a single item intended to measure a return to the pre-illness state. Its purpose in this trial is to have a question that directly assesses the participant's perception of their recovery from their SARS-CoV-2 infection. It is scored on a 5-point Likert scale from 0 (completely recovered) to 4 (not recovered at all). Complete recovery means the participant no longer has symptoms related to illness and can do usual daily activities and has returned to their previous state of health and mind (before illness).", "time_frame": "Day 28 and at Day 15, and Weeks 14 and 24" }, { "type": "secondary", "measure": "EuroQol EQ-5D-5L Utility Score-VAS (USA Version)", "description": "Difference in EuroQol EQ-5D-5L Utility Score and VAS Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The EQ-5D-5L is a descriptive system in which respondents are asked to report their current state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which has 5 levels of response (no problems, slight problems, moderate problems, severe problems, and extreme problems). There is also a visual analogue scale (VAS). In total there are 6 items. The higher the EQ-VAS score, the better the quality of life.", "time_frame": "Day 28 and at Day 15, and Weeks 14 and 24" }, { "type": "secondary", "measure": "Functional Assessment of Chronic Illness Therapy (FACIT)-Item GP5", "description": "Difference in FACIT-Item GP5 Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The single-item FACIT-Item GP5, \"I am bothered by side effects of treatment,\" was included to have a question on the experience with the trial drug and will be prefaced to focus on the trial drug. It is a summary measure of the overall tolerability of treatment, with 5 levels of response: not at all, a little bit, somewhat, quite a bit, and very much. It has a 7-day recall period.", "time_frame": "Day 28 and Day 15" }, { "type": "secondary", "measure": "PROMIS-29 Overall and Mental Health Summary Score", "description": "Difference in PROMIS-29 Overall and Mental Health Summary Score between nirmatrelvir/ritonavir and placebo/ritonavir groups. The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and 7 health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using 4 items per domain. There is no total score, but each axis forms its own score. Higher scores mean better outcomes.", "time_frame": "Day 28 and at Day 15, and Weeks 6, 10, 14, 18 and 24" }, { "type": "secondary", "measure": "Difference in number of hospitalizations and deaths", "description": "Difference in occurrence of hospitalizations and deaths between nirmatrelvir/ritonavir and placebo/ritonavir groups.", "time_frame": "Day 1 through Week 24 (End of Study)" }, { "type": "secondary", "measure": "Proportion of participants who experience individual Serious Adverse Events (SAE)", "description": "Proportion of participants who experience individual SAEs", "time_frame": "up to 6 weeks post starting study drug" }, { "type": "secondary", "measure": "Incidence of SAEs leading to discontinuation", "description": "The number of SAEs leading to discontinuation in the study", "time_frame": "Day 15" }, { "type": "secondary", "measure": "Patient Global Impression of Severity", "description": "Based on FDA's recommendations, we will include the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales. These anchor scales can help interpret a clinically meaningful within-patient score change for the key primary and secondary endpoints. We will include two PGIS and two PGIC scales. The PGIS 1 is a single-item questionnaire that asks respondents: \"Overall, how would you rate the severity of your long COVID symptoms over the past week?\". Responses are: \"none,\" \"mild,\" \"moderate,\" \"severe,\" and \"very severe.\" The PGIS 2 asks \"Overall, how would you rate the impact of your symptoms on your overall health over the past week?\". Responses are: \"none,\" \"mild,\" \"moderate,\" \"severe,\" and \"very severe.\" The PGISs will be administered at the same intervals as the primary endpoint (PROMIS-29).", "time_frame": "Baseline, Day 15, Day 28, Week 6, Week 10, Week 14, Week 24" }, { "type": "secondary", "measure": "Patient Global Impression of Change", "description": "The PGIC 1 asks: \"Overall, how would you rate the change in your long COVID symptoms since you started the study?\". There 7-point scale options: 1) \"very much better\", 2) \"much better\", 3) \"minimally better\", 4) \"no change\", 5) \"minimally worse\", 6) \"much worse\", or 7) \"very much worse\". Higher scores indicate a change for the worse. The PGIC 2 asks \"Overall, how would you rate your overall health since you started the study?\". There 7-point scale options: 1) \"very much better\", 2) \"much better\", 3) \"minimally better\", 4) \"no change\", 5) \"minimally worse\", 6) \"much worse\", or 7) \"very much worse\". Higher scores indicate a change for the worse. The PGICs will be administered at the same intervals as the primary endpoint (PROMIS-29) with the exception of baseline. These instruments have been used extensively in patient-centered research.", "time_frame": "Day 15, Day 28, Week 6, Week 10, Week 14, Week 24" } ], "relevance_tags": [ "Immunomodulatory", "Persistence / Antiviral", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05668091", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06441955", "title": "Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program.", "status": "RECRUITING", "phase": "PHASE4", "last_updated": "2024-11-27", "start_date": "2024-03-01", "completion_date": "2030-09-30", "primary_completion_date": "2030-09-30", "conditions_raw": [ "COVID-19, Long Haul" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Paxlovid (Nirmatrelvir/Ritonavir)", "Physiological Evaluation", "Moderna Covid-19 Vaccine", "Biopsychological", "Behavioral", "Genetic", "Multidisciplinary Approach" ], "sponsor": "Well- Konnect Healthcare Services and Research Firm", "sponsor_type": "NETWORK", "primary_purpose": "N/A", "brief_summary": "Investigators are conducting a study on alternative treatments for patients who have received an current or previous positive COVID-19 diagnosis with mild-serve symptoms or undiagnosable condition after testing positive for severe acute COVID-19 infection and are experiencing long-haul symptoms. The symptoms of long COVID can include extreme tiredness (fatigue), shortness of breath, memory and concentration issues (brain fog), heart palpitations, dizziness, joint pain, muscle aches, cough, headaches, anxiety, and depression.\n\nIt's important to note that there are various other symptoms that individuals can experience after a COVID-19 infection, such as loss of smell, chest pain or tightness, difficulty sleeping (insomnia), pins and needles, depression, anxiety, tinnitus, earaches, nausea, diarrhea, stomach aches, loss of appetite, cough, headaches, sore throat, and changes to the sense of smell or taste.\n\nTo be included in the study, participants must have had symptoms for more than 4 weeks. The goal of the study is to measure biomarkers, identify new ones through clinical trials, and individualize and optimize treatment plans, which may or may not include COVID-19 post-market antivirals, vaccines, and medical care.\n\nIt's essential to conduct thorough clinical trials to understand the long-term effects of COVID-19 and to develop personalized treatment plans for individuals experiencing long-haul symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Adherence", "description": "Well-Konnect Biopsychosoical Framework and assessment tool (WKBF tool) compared to the APA biopsychological assessment.\n\nHealth literacy surveillance care program evaluation tool aims to lay the groundwork for a more inclusive and equitable approach to leveraging genomic data and interventions to improve health outcomes for all individuals.", "time_frame": "- Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Pharmaco surveillance", "description": "Evaluate methodological advantages and limitations of an international pharmacosurveillance system based on electronic health records (EHRs). Adverse outcome; Electronic health record; Health informatics; Medication adherence; Pharmacoepidemiology; Pharmacosurveillance; Risk assessment.", "time_frame": "- Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Adherence", "description": "Well-Konnect Biopsychosoical Framework and assessment tool (WKBF tool) compared to the APA biopsychological assessment.\n\nHealth literacy surveillance care program evaluation tool aims to lay the groundwork for a more inclusive and equitable approach to leveraging genomic data and interventions to improve health outcomes for all individuals.", "time_frame": "- Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months" }, { "type": "secondary", "measure": "Pharmaco surveillance", "description": "Evaluate methodological advantages and limitations of an international pharmacosurveillance system based on electronic health records (EHRs). Adverse outcome; Electronic health record; Health informatics; Medication adherence; Pharmacoepidemiology; Pharmacosurveillance; Risk assessment.", "time_frame": "- Participant Selection and Baseline Data Collection: 36 months - Longitudinal Observation and Intervention Implementation: 24 months - Data Analysis and Findings Dissemination: 36 months" } ], "relevance_tags": [ "Persistence / Antiviral", "Neurological / Autonomic", "Phase 4", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Network" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06441955", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05298878", "title": "Virtual Physical Rehabilitation for Patients Living with Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-11-27", "start_date": "2022-08-01", "completion_date": "2024-03-28", "primary_completion_date": "2023-09-22", "conditions_raw": [ "COVID-19", "Post COVID-19", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Intervention Group: Virtual Home-Based Rehabilitation Plus Usual Outpatient Care" ], "sponsor": "McGill University Health Centre/Research Institute of the McGill University Health Centre", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to investigate whether a timely, virtual home-based physical rehabilitation program for patients living with long COVID can improve functional mobility compared to usual care.", "primary_outcomes": [ { "type": "primary", "measure": "Change in the basic mobility domain of the Activity Measure for Post-Acute Care (AM-PAC)", "description": "The AM-PAC is a validated, self-reported instrument assessing activity limitations based on the International Classification of Functioning, Disability, and Health (ICF). Each item is scored from 1 (unable to perform) to 4 (none or no difficulty) with lower scores indicating lower levels of function.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in lower-body strength", "description": "The 1-minute sit-to-stand test (1-min STS) is feasible to use in hospital survivors of COVID-19. It is used to assess lower body-strength, exercise tolerance, and exertional desaturation. The score is the total number of stands within one minute.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in functional mobility", "description": "The fast-Timed-Up-and-Go test (TUG) assesses physical function and functional mobility. The score consists of the time taken to complete the test activity, in seconds.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in fatigue", "description": "Measured by the Fatigue Visual Analog Scale.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in dyspnea", "description": "Measured by the Transition Dyspnea Index.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in health-related quality of life", "description": "Measured by the Short Form 12-item Health Survey (SF-12).", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in health state utilities", "description": "Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L).", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in anxiety and depression", "description": "Measured by the Hospital Anxiety and Depression Scale.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in cognitive function", "description": "Measured by the AM-PAC Cognition Subscale.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in the degree of distress in response to trauma", "description": "Measured by the Impact of Event Scale - Revised.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Self-reported health service use", "description": "Doctors visits, emergency department visits and hospital readmission etc.", "time_frame": "30 days after the 8-week period." } ], "outcome_measures": [ { "type": "primary", "measure": "Change in the basic mobility domain of the Activity Measure for Post-Acute Care (AM-PAC)", "description": "The AM-PAC is a validated, self-reported instrument assessing activity limitations based on the International Classification of Functioning, Disability, and Health (ICF). Each item is scored from 1 (unable to perform) to 4 (none or no difficulty) with lower scores indicating lower levels of function.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in lower-body strength", "description": "The 1-minute sit-to-stand test (1-min STS) is feasible to use in hospital survivors of COVID-19. It is used to assess lower body-strength, exercise tolerance, and exertional desaturation. The score is the total number of stands within one minute.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in functional mobility", "description": "The fast-Timed-Up-and-Go test (TUG) assesses physical function and functional mobility. The score consists of the time taken to complete the test activity, in seconds.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in fatigue", "description": "Measured by the Fatigue Visual Analog Scale.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in dyspnea", "description": "Measured by the Transition Dyspnea Index.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in health-related quality of life", "description": "Measured by the Short Form 12-item Health Survey (SF-12).", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in health state utilities", "description": "Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L).", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in anxiety and depression", "description": "Measured by the Hospital Anxiety and Depression Scale.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in cognitive function", "description": "Measured by the AM-PAC Cognition Subscale.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Change in the degree of distress in response to trauma", "description": "Measured by the Impact of Event Scale - Revised.", "time_frame": "Baseline, Week 8 (up to 1 week), and at 6 months." }, { "type": "secondary", "measure": "Self-reported health service use", "description": "Doctors visits, emergency department visits and hospital readmission etc.", "time_frame": "30 days after the 8-week period." } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 132, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05298878", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05472090", "title": "A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2024-11-26", "start_date": "2022-08-18", "completion_date": "2023-07-27", "primary_completion_date": "2023-07-12", "conditions_raw": [ "Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection", "COVID-19", "Long COVID", "Long Haul COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Tnx-102 Sl" ], "sponsor": "Tonix Pharmaceuticals, Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken once daily at bedtime for the management of multi-site pain associated with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Daily Diary Pain NRS", "description": "Change from Baseline in the diary Numeric Rating Scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity scores at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.", "time_frame": "Week 14" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Daily Diary Sleep Quality NRS", "description": "Mean change from baseline in the weekly average of the daily diary numeric rating scale (NRS) assessment of sleep quality at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.", "time_frame": "Week 14" }, { "type": "secondary", "measure": "PROMIS Fatigue -Short Form 8a", "description": "Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue at the Week 14 endpoint. Subjects are asked to reflect on their fatigue symptoms in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.", "time_frame": "Week 14" }, { "type": "secondary", "measure": "PROMIS Cognitive Function - Abilities-Short Form 8a", "description": "Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for cognitive function at the Week 14 endpoint. Subjects are asked to reflect on their cognitive function and abilities in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.", "time_frame": "Week 14" } ], "outcome_measures": [ { "type": "primary", "measure": "Daily Diary Pain NRS", "description": "Change from Baseline in the diary Numeric Rating Scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity scores at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.", "time_frame": "Week 14" }, { "type": "secondary", "measure": "Daily Diary Sleep Quality NRS", "description": "Mean change from baseline in the weekly average of the daily diary numeric rating scale (NRS) assessment of sleep quality at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.", "time_frame": "Week 14" }, { "type": "secondary", "measure": "PROMIS Fatigue -Short Form 8a", "description": "Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue at the Week 14 endpoint. Subjects are asked to reflect on their fatigue symptoms in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.", "time_frame": "Week 14" }, { "type": "secondary", "measure": "PROMIS Cognitive Function - Abilities-Short Form 8a", "description": "Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for cognitive function at the Week 14 endpoint. Subjects are asked to reflect on their cognitive function and abilities in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.", "time_frame": "Week 14" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 63, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05472090", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05268523", "title": "Self-Management Interventions for Long COVID-19", "status": "RECRUITING", "phase": "NA", "last_updated": "2024-11-25", "start_date": "2021-11-23", "completion_date": "2025-12-01", "primary_completion_date": "2025-06-01", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Mindfulness Skills Intervention" ], "sponsor": "Toronto Rehabilitation Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to investigate and compare the feasibility and efficacy of two group-based interventions (education vs. mindfulness) to help self-manage Long-COVID symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Brief-COPE", "description": "The Brief-COPE (Coping Orientation to Problems Experienced Inventory) is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Total scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style (scores ranging from 1-4, where the higher the score, the better the coping ability). Increase in score is the better outcome, indicating improved coping ability.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in LOT", "description": "The Life Orientation Test (LOT) is a 10-item scale that assesses one's dispositional level of optimism, coping and resilience. Respondents use a 5-point rating scale (0 = strongly disagree; 4 = strongly agree) to show how much they agree with 10 statements about positive and negative expectations. All scores are summed to obtain a total score from 0-24 with higher ratings meaning more optimism. Increase in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Kessler Psychological Distress Scale (K10)", "description": "This is a 10-item questionnaire measuring level of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Participant answer experiencing each feeling from 'none of the time' (score=1) to 'all of the time' (score=5). Scores of the 10 items summed to produce a total score between 10 and 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress. Decrease in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in SSS-8", "description": "The Somatic Symptom Scale - 8 (SSS-8) is a brief, 8-item self-report questionnaire used to assess somatic symptom burden. Participants rate how often they experience somatic symptoms (e.g. back pain, dizziness, headaches) on a scale from 0 (Not at all to) to 4 (Very much). Scores are summed to obtain total score between 0 and 32, the higher the score, the higher the somatic symptom burden. Decrease in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Perceived Medical Condition Self-Management Scale", "description": "The Perceived Medical Condition Self-Management Scale (PMCSMS) evaluates self-measured ability to manage a chronic health condition (Long COVID). Participants answer the 8 questions using a scale from 1-5, with 1 signifying \"strongly disagree\" and 5 signifying \"strongly agree\". All scores are summed to obtain a total score from 8-401 with higher ratings meaning better management. Increase in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in the Depression, Anxiety and Stress Scale", "description": "The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) measures the emotional states of depression, anxiety and stress. Participants rate 21 emotional states on a scale of 0-3 to indicate how much the statement applied to them over the past week, with 0=never, to 3=almost always. Scores are summed to obtain total scores for each Depression, Anxiety and Stress category ranging between 0 and 21, the higher the score, the more severe the symptoms. Decrease in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Quality of Life Enjoyment and Satisfaction Questionnaire", "description": "TheQuality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score. The higher the score, the better the life enjoyment and satisfaction. Increase in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Adapted Illness Intrusiveness Rating", "description": "The Adapted Illness Intrusiveness Rating (AIIR) measures intrusiveness of symptoms in daily life. 13 items ask about how much Long-COVID and/or its treatment interferes with daily life on a scale of 1=not at all, to 7=very much. Scores are summed for domains of Physical Well-Being and Diet, Work and Finances, Marital, Sexual, and Family Relations, Recreation and Social Relations Items, Other Aspects of Life. The higher the total scores, the more intrusive the illness. Decrease in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in self-reported physician visits", "description": "Participants will report how many times they have visited a physician during the past month. Answers will range from 0 to 10 or more. Reduction in the number of physician visits is the desired outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Self-efficacy", "description": "The Self-Efficacy (Ages 18+) - Item Bank/Fixed Form is part of the measures in NIH Toolbox that measures self-efficacy, or the capacity to manage functioning and have control over meaningful events. Participants rate how often they experience events on a scale of 1=never to 4=very often. Items are summed to obtain total score. The higher the number, the higher their self-efficacy. Increase in score is the better outcome", "time_frame": "Baseline and 1-week post-intervention." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Feasibility: session feedback questionnaire", "description": "Designed by our team, this session feedback questionnaires includes 3 questions asking the participant how useful and applicable they found the content taught during intervention sessions. Participants answer on a likert scale ranging from 1=\"Not at all useful\" to 5=\"Very useful\". Higher score is desired.", "time_frame": "At the end of each weekly session for a duration of 8 weeks." }, { "type": "secondary", "measure": "Feasibility: Recruitment rate", "description": "Determined by dividing the number of patients consented by the number of eligible patients approached. Rate closer to 1 is desired.", "time_frame": "Collected during recruitment" }, { "type": "secondary", "measure": "Feasibility: Retention rate", "description": "Determined by dividing the number of consented patients at baseline by the number of consented patients retained at follow-up. Factors influencing retention (e.g., medical status) will be reported as percentages. Rate closer to 1 is desired", "time_frame": "Collected during recruitment and 1 week post-follow-up" }, { "type": "secondary", "measure": "Feasibility: Adherence rate", "description": "Determined by calculating the percentage of patients adhering to at least 80% of the training protocol. Compliance rates to be computed for individual participants weekly, and for full cohort at end of study. Rate closer to 100% is desired. Factors influencing recruitment, retention and completion will be documented and reported as percentages", "time_frame": "Collected during each of the 8 session (1 sessions/week, 8 weeks)" }, { "type": "secondary", "measure": "Feasibility: qualitative interview", "description": "Following an interview guide, participants will be asked two broad open questions, then probed for additional details. Participants will be asked about pros and cons of intervention design, then probed for further details based on the Workgroup for Intervention Development and Evaluation Research (WIDER) recommendations regarding content, format, delivery, timing issues and personnel. They will also discuss the impact of the intervention on health and health-related actions, then be probed for how the intervention affected self-management of Long-COVID symptoms and health care visits. A qualitative thematic analysis will be applied and key themes will be reported on.", "time_frame": "1 week post-intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Brief-COPE", "description": "The Brief-COPE (Coping Orientation to Problems Experienced Inventory) is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Total scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style (scores ranging from 1-4, where the higher the score, the better the coping ability). Increase in score is the better outcome, indicating improved coping ability.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in LOT", "description": "The Life Orientation Test (LOT) is a 10-item scale that assesses one's dispositional level of optimism, coping and resilience. Respondents use a 5-point rating scale (0 = strongly disagree; 4 = strongly agree) to show how much they agree with 10 statements about positive and negative expectations. All scores are summed to obtain a total score from 0-24 with higher ratings meaning more optimism. Increase in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Kessler Psychological Distress Scale (K10)", "description": "This is a 10-item questionnaire measuring level of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Participant answer experiencing each feeling from 'none of the time' (score=1) to 'all of the time' (score=5). Scores of the 10 items summed to produce a total score between 10 and 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress. Decrease in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in SSS-8", "description": "The Somatic Symptom Scale - 8 (SSS-8) is a brief, 8-item self-report questionnaire used to assess somatic symptom burden. Participants rate how often they experience somatic symptoms (e.g. back pain, dizziness, headaches) on a scale from 0 (Not at all to) to 4 (Very much). Scores are summed to obtain total score between 0 and 32, the higher the score, the higher the somatic symptom burden. Decrease in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Perceived Medical Condition Self-Management Scale", "description": "The Perceived Medical Condition Self-Management Scale (PMCSMS) evaluates self-measured ability to manage a chronic health condition (Long COVID). Participants answer the 8 questions using a scale from 1-5, with 1 signifying \"strongly disagree\" and 5 signifying \"strongly agree\". All scores are summed to obtain a total score from 8-401 with higher ratings meaning better management. Increase in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in the Depression, Anxiety and Stress Scale", "description": "The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) measures the emotional states of depression, anxiety and stress. Participants rate 21 emotional states on a scale of 0-3 to indicate how much the statement applied to them over the past week, with 0=never, to 3=almost always. Scores are summed to obtain total scores for each Depression, Anxiety and Stress category ranging between 0 and 21, the higher the score, the more severe the symptoms. Decrease in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Quality of Life Enjoyment and Satisfaction Questionnaire", "description": "TheQuality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score. The higher the score, the better the life enjoyment and satisfaction. Increase in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Adapted Illness Intrusiveness Rating", "description": "The Adapted Illness Intrusiveness Rating (AIIR) measures intrusiveness of symptoms in daily life. 13 items ask about how much Long-COVID and/or its treatment interferes with daily life on a scale of 1=not at all, to 7=very much. Scores are summed for domains of Physical Well-Being and Diet, Work and Finances, Marital, Sexual, and Family Relations, Recreation and Social Relations Items, Other Aspects of Life. The higher the total scores, the more intrusive the illness. Decrease in score is the better outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in self-reported physician visits", "description": "Participants will report how many times they have visited a physician during the past month. Answers will range from 0 to 10 or more. Reduction in the number of physician visits is the desired outcome.", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "primary", "measure": "Change in Self-efficacy", "description": "The Self-Efficacy (Ages 18+) - Item Bank/Fixed Form is part of the measures in NIH Toolbox that measures self-efficacy, or the capacity to manage functioning and have control over meaningful events. Participants rate how often they experience events on a scale of 1=never to 4=very often. Items are summed to obtain total score. The higher the number, the higher their self-efficacy. Increase in score is the better outcome", "time_frame": "Baseline and 1-week post-intervention." }, { "type": "secondary", "measure": "Feasibility: session feedback questionnaire", "description": "Designed by our team, this session feedback questionnaires includes 3 questions asking the participant how useful and applicable they found the content taught during intervention sessions. Participants answer on a likert scale ranging from 1=\"Not at all useful\" to 5=\"Very useful\". Higher score is desired.", "time_frame": "At the end of each weekly session for a duration of 8 weeks." }, { "type": "secondary", "measure": "Feasibility: Recruitment rate", "description": "Determined by dividing the number of patients consented by the number of eligible patients approached. Rate closer to 1 is desired.", "time_frame": "Collected during recruitment" }, { "type": "secondary", "measure": "Feasibility: Retention rate", "description": "Determined by dividing the number of consented patients at baseline by the number of consented patients retained at follow-up. Factors influencing retention (e.g., medical status) will be reported as percentages. Rate closer to 1 is desired", "time_frame": "Collected during recruitment and 1 week post-follow-up" }, { "type": "secondary", "measure": "Feasibility: Adherence rate", "description": "Determined by calculating the percentage of patients adhering to at least 80% of the training protocol. Compliance rates to be computed for individual participants weekly, and for full cohort at end of study. Rate closer to 100% is desired. Factors influencing recruitment, retention and completion will be documented and reported as percentages", "time_frame": "Collected during each of the 8 session (1 sessions/week, 8 weeks)" }, { "type": "secondary", "measure": "Feasibility: qualitative interview", "description": "Following an interview guide, participants will be asked two broad open questions, then probed for additional details. Participants will be asked about pros and cons of intervention design, then probed for further details based on the Workgroup for Intervention Development and Evaluation Research (WIDER) recommendations regarding content, format, delivery, timing issues and personnel. They will also discuss the impact of the intervention on health and health-related actions, then be probed for how the intervention affected self-management of Long-COVID symptoms and health care visits. A qualitative thematic analysis will be applied and key themes will be reported on.", "time_frame": "1 week post-intervention" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 270, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05268523", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06348186", "title": "Fascial Tissue Response to Manual Therapy: Implications in Long COVID-19", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-11-20", "start_date": "2024-02-01", "completion_date": "2025-08-31", "primary_completion_date": "2024-04-01", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Guidebook", "Guidebook And Myofascial Reorganization® (Rmf)." ], "sponsor": "University of the State of Santa Catarina", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "According to the World Health Organization (WHO), as of mid-September 2022, more than 21 million Brazilians have recovered from COVID-19. However, post-infection symptoms continue to appear months after the end of the acute infection, a syndrome called long COVID. Therefore, the aim of this study is to investigate the responses of fascia-focused manual therapy in participants with long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Functioning and disability", "description": "Will be assessed using the \"World Health Organization Disability Assessment\" questionnaire (WHO-DAS 2.0), translated and validated for the Brazilian population by Silveira et al. (2013).", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Biomechanical and tissue viscoelastic properties", "description": "Will be evaluated by MyotonPro (MytonPro, Myoton Ltd.s., Tartu, Estonia)", "time_frame": "6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Work capacity", "description": "Will be assessed by the \"Work Limitations Questionnaire, WLQ-25\" translated and validated for the Brazilian population by Soárez et al (2007).", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Level of Quality of life", "description": "Will be assessed by the \"World Health Organization Questionnaire\" in its short version, validated in the Brazilian population and by the \"Medical Outcomes Study 36-Item Short Form Health\" questionnaire Survey\" validated for Brazilian-Portuguese.", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Upper limb dysfunctions", "description": "Will be assessed using the Arm, Shoulder and Hand Dysfunctions questionnaire (DASH), translated and validated for the Brazilian population by Orfale et al (2005).", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Balance", "description": "Will be assessed using the Neurocom Balance Platform (VRS Sport) and its NeuroCom®Balance Manager program (Neurocom International, Inc, Clackamas, OR).", "time_frame": "6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Functioning and disability", "description": "Will be assessed using the \"World Health Organization Disability Assessment\" questionnaire (WHO-DAS 2.0), translated and validated for the Brazilian population by Silveira et al. (2013).", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Biomechanical and tissue viscoelastic properties", "description": "Will be evaluated by MyotonPro (MytonPro, Myoton Ltd.s., Tartu, Estonia)", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Work capacity", "description": "Will be assessed by the \"Work Limitations Questionnaire, WLQ-25\" translated and validated for the Brazilian population by Soárez et al (2007).", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Level of Quality of life", "description": "Will be assessed by the \"World Health Organization Questionnaire\" in its short version, validated in the Brazilian population and by the \"Medical Outcomes Study 36-Item Short Form Health\" questionnaire Survey\" validated for Brazilian-Portuguese.", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Upper limb dysfunctions", "description": "Will be assessed using the Arm, Shoulder and Hand Dysfunctions questionnaire (DASH), translated and validated for the Brazilian population by Orfale et al (2005).", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Balance", "description": "Will be assessed using the Neurocom Balance Platform (VRS Sport) and its NeuroCom®Balance Manager program (Neurocom International, Inc, Clackamas, OR).", "time_frame": "6 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06348186", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06633666", "title": "Acupuncture for Post COVID-19 Condition (Long COVID) Neuropsychiatric Symptoms", "status": "RECRUITING", "phase": "NA", "last_updated": "2024-11-13", "start_date": "2023-07-30", "completion_date": "2026-04-30", "primary_completion_date": "2026-01-31", "conditions_raw": [ "Long Covid19", "Neuropsychiatric Symptom", "Acupuncture" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Acupuncture" ], "sponsor": "Hong Kong Baptist University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In this study, a 12-week pragmatic, randomized, double-blinded clinical trial will be conducted to evaluate the efficacy of acupuncture for the treatment of long Covid neuropsychiatric symptoms and provide reference for clinical non-drug treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale", "description": "The MMSE can evaluate of five different domains of cognitive functions: (1) Orientation, with a maximum of 10 points, (2) Memory, with a maximum of 6 points, (3) Attention and calculation, with a maximum of 5 points, (4) Language, with a maximum of 8 points, and (5) Design copying, with a maximum of 1 point. It has a maximum score of 30, with MMSE score denotes severity of cognitive impairment as follows; mild: MMSE 21 to 24, moderate: MMSE 10 to 20, severe: MMSE less than 10.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Depression on the Chinese Beck Depression Inventory (CBDI)", "description": "The scale has a total of 21 questions, with an overall score of 63, 14-19 being mild depression, 20-28 being moderate depression, and above 29 being severe depression.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Score of Insomnia Severity Index (ISI)", "description": "The Insomnia Severity Index in Chinese includes 5 questions to assess the severity and impact of insomnia, on an 0 to 4 scale, with the higher score reflecting worse insomnia symptoms.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form", "description": "BFI-T form is to assess the severity of fatigue and the impact of fatigue on daily functioning. Scoring Respondents rate each item on a 0-10 numeric scale, with 0 meaning \"no fatigue\" and 10 meaning \"fatigue as bad as you can imagine.\" Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Hamilton Depression Scale (HAMD)", "description": "A validated 24-item scale used to assess depressive severity across emotional, cognitive, and somatic domains. Scores range as follows: 0-7 (normal), 8-17 (mild depression), 18-24 (moderate depression), and ≥25 (severe depression), with higher scores indicating more severe depressive symptoms.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Hamilton Anxiety Rating Scale (HAMA)", "description": "A 14-item scale for assessing anxiety symptoms across somatic and psychological domains. Scoring ranges are: 0-7 (normal), 8-14 (mild anxiety), 15-28 (moderate anxiety), and ≥29 (severe anxiety), with higher scores indicating greater anxiety severity.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Traditional Chinese Medicine Symptom Scale", "description": "A TCM-specific symptom scale following \"Guidelines for Clinical Research on New Chinese Medicine,\" assessing syndrome severity based on TCM diagnostics. Scores quantify symptom burden with defined thresholds for mild, moderate, and severe syndrome levels, enabling standardized assessment of TCM syndrome differentiation.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" } ], "outcome_measures": [ { "type": "primary", "measure": "Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale", "description": "The MMSE can evaluate of five different domains of cognitive functions: (1) Orientation, with a maximum of 10 points, (2) Memory, with a maximum of 6 points, (3) Attention and calculation, with a maximum of 5 points, (4) Language, with a maximum of 8 points, and (5) Design copying, with a maximum of 1 point. It has a maximum score of 30, with MMSE score denotes severity of cognitive impairment as follows; mild: MMSE 21 to 24, moderate: MMSE 10 to 20, severe: MMSE less than 10.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Depression on the Chinese Beck Depression Inventory (CBDI)", "description": "The scale has a total of 21 questions, with an overall score of 63, 14-19 being mild depression, 20-28 being moderate depression, and above 29 being severe depression.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Score of Insomnia Severity Index (ISI)", "description": "The Insomnia Severity Index in Chinese includes 5 questions to assess the severity and impact of insomnia, on an 0 to 4 scale, with the higher score reflecting worse insomnia symptoms.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form", "description": "BFI-T form is to assess the severity of fatigue and the impact of fatigue on daily functioning. Scoring Respondents rate each item on a 0-10 numeric scale, with 0 meaning \"no fatigue\" and 10 meaning \"fatigue as bad as you can imagine.\" Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Hamilton Depression Scale (HAMD)", "description": "A validated 24-item scale used to assess depressive severity across emotional, cognitive, and somatic domains. Scores range as follows: 0-7 (normal), 8-17 (mild depression), 18-24 (moderate depression), and ≥25 (severe depression), with higher scores indicating more severe depressive symptoms.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Hamilton Anxiety Rating Scale (HAMA)", "description": "A 14-item scale for assessing anxiety symptoms across somatic and psychological domains. Scoring ranges are: 0-7 (normal), 8-14 (mild anxiety), 15-28 (moderate anxiety), and ≥29 (severe anxiety), with higher scores indicating greater anxiety severity.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" }, { "type": "secondary", "measure": "Traditional Chinese Medicine Symptom Scale", "description": "A TCM-specific symptom scale following \"Guidelines for Clinical Research on New Chinese Medicine,\" assessing syndrome severity based on TCM diagnostics. Scores quantify symptom burden with defined thresholds for mild, moderate, and severe syndrome levels, enabling standardized assessment of TCM syndrome differentiation.", "time_frame": "At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 160, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06633666", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05630040", "title": "VNS for Long-COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-11-08", "start_date": "2022-11-11", "completion_date": "2024-10-03", "primary_completion_date": "2024-10-03", "conditions_raw": [ "Post-COVID-19 Syndrome", "Postural Tachycardia Syndrome", "Dysautonomia" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Non-Invasive Vagus Nerve Stimulation" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function.\n\nThis will be a placebo controlled, randomized controlled trial with a crossover design built in. This study will aim to recruit 40 people with Long COVID to be a part of this research.", "primary_outcomes": [ { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Baseline (Week 0)" }, { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Week 2" }, { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Week 5" }, { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Week 8" }, { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Higher scores indicate worse health outcomes. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Higher scores indicate worse health outcomes. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Higher scores indicate worse health outcomes. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body in different ways.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Baseline (Week 0)" }, { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Week 2" }, { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Week 5" }, { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Week 8" }, { "type": "primary", "measure": "Composite Dysautonomia Symptom Score (COMPASS 31)", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.\n\nThe total score will be between 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale measures fatigue severity. The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Neuro Quality of Life Score", "description": "The NeuroQOL is a self-report of health-related quality of life in 17 domains and sub-domains for adults. Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format. All items are rated on a five-option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency (\"never\" to \"always\"). Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Medical Research Council (MRC) Dyspnoea Scale", "description": "The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). Full scale from 1-5, with higher score indicating more severe symptoms.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Higher scores indicate worse health outcomes. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Higher scores indicate worse health outcomes. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Higher scores indicate worse health outcomes. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Post-Exertional Malaise (PEM) Screener", "description": "Post-exertional malaise (PEM) is the worsening of symptoms following even minor physical or mental exertion, with symptoms typically worsening 12 to 48 hours after activity and lasting for days or even weeks. The PEM assesses symptom frequency and severity over a 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. Total score ranges 0-40, with higher scores indicate worse health outcomes.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "EQ-5D-5L Quality of Life Score", "description": "The EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state, thus, higher scores indicate better health outcomes.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body in different ways.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Plasma IL-6 levels", "description": "Plasma IL-6 levels as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Plasma IL-1 levels", "description": "Plasma IL-1 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Plasma IL-10 levels", "description": "Plasma IL-10 levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Plasma HS-CRP levels", "description": "Plasma HS-CRP levels: as a metric of sympathetic nervous system activation. Plasma testing evaluates for evidence of inflammation in the body.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Morning salivary cortisol levels", "description": "Morning salivary cortisol levels: As a metric of sympathetic nervous system activation. Morning salivary cortisol levels evaluate changes in the body's waking hormone responses, which indicate changes in nervous system activation in response to the intervention.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Baseline (Week 0)" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Week 5" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "End-tidal CO2 levels", "description": "End-tidal CO2 levels: As a metric of sympathetic nervous system activation measured using a capnograph. Patients with post-COVID dysautonomia will be hypocapnic (low end-tidal CO2). High or low levels of end-tidal CO2 can drive symptoms in patients.", "time_frame": "Week 12" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05630040", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05371288", "title": "The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19", "status": "WITHDRAWN", "phase": "EARLY_PHASE1", "last_updated": "2024-11-05", "start_date": "2025-06", "completion_date": "2025-11", "primary_completion_date": "2025-09", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "N-Acetylcysteine (NAC)" ], "sponsor": "University of California, Irvine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this research study is to assess if glutathione, along with NAC (N-acetyl cysteine) and Alpha lipoic acid (ALA), can help reverse some of the COVID long-haul symptoms.Subjects will be randomized in to one of two groups. Depending on the group they are randomized in to, subjects will be taking either a combination of NAC, Alamax CR, and liposomal GSH or the same three nutritional supplements with a multivitamin and magnesium. Regardless of the group, subjects will be asked questions to assess their COVID symptoms, physical and mental health status. They will also be asked to take blood samples.", "primary_outcomes": [ { "type": "primary", "measure": "Assess Changes in Symptoms of Post-Acute Sequelae of COVID (PASC)", "description": "With the goal of reversing symptoms of Post-Acute Sequelae of COVID, this outcome measure aims to evaluate changes in symptoms before and after therapy, and determining which, if any symptoms are improved in each arm of the trial.", "time_frame": "Symptoms will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy" }, { "type": "primary", "measure": "Change in Quality of Life Using SF-36 Survey", "description": "The SF-36 survey is a multipurpose, short-form health survey with 36 questions to evaluate health-related Quality of Life . It yields an eight-scale profile of scores as well as physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group.", "time_frame": "Will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy" }, { "type": "primary", "measure": "COVID Severity of Symptoms Questionnaire", "description": "This will evaluate the changes in the severity of symptoms over time with treatment.", "time_frame": "Day 15, 28, end of months 2, 3, 4" }, { "type": "primary", "measure": "Change in Time to Clinical Recovery (TTCR)", "description": "Starting on day one of subjects' treatment, subjects will be asked if symptoms have improved or worsened, and the time it took for symptoms to change since their last treatment: (0 \\[no change\\], +1 \\[improved within 7 days\\], + 2 \\[improved within 14 days\\], +3 \\[improved within 28 days\\] + 4 \\[symptom resolved\\]; - 1 \\[worsened within 7 days\\], -2 \\[worsened within 14 days\\], - 3 \\[worsened within 28 days\\], - 4 \\[debilitating last 28 days\\]", "time_frame": "Day 15 and 28 (month 1), and at the end of months 2, 3 and 4" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Assess Changes in Symptoms of Post-Acute Sequelae of COVID (PASC)", "description": "With the goal of reversing symptoms of Post-Acute Sequelae of COVID, this outcome measure aims to evaluate changes in symptoms before and after therapy, and determining which, if any symptoms are improved in each arm of the trial.", "time_frame": "Symptoms will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy" }, { "type": "primary", "measure": "Change in Quality of Life Using SF-36 Survey", "description": "The SF-36 survey is a multipurpose, short-form health survey with 36 questions to evaluate health-related Quality of Life . It yields an eight-scale profile of scores as well as physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group.", "time_frame": "Will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy" }, { "type": "primary", "measure": "COVID Severity of Symptoms Questionnaire", "description": "This will evaluate the changes in the severity of symptoms over time with treatment.", "time_frame": "Day 15, 28, end of months 2, 3, 4" }, { "type": "primary", "measure": "Change in Time to Clinical Recovery (TTCR)", "description": "Starting on day one of subjects' treatment, subjects will be asked if symptoms have improved or worsened, and the time it took for symptoms to change since their last treatment: (0 \\[no change\\], +1 \\[improved within 7 days\\], + 2 \\[improved within 14 days\\], +3 \\[improved within 28 days\\] + 4 \\[symptom resolved\\]; - 1 \\[worsened within 7 days\\], -2 \\[worsened within 14 days\\], - 3 \\[worsened within 28 days\\], - 4 \\[debilitating last 28 days\\]", "time_frame": "Day 15 and 28 (month 1), and at the end of months 2, 3 and 4" } ], "relevance_tags": [ "General", "EARLY_Phase 1", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT05371288", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05035628", "title": "Cardiopulmonary Rehabilitation in Long COVID-19 Patients With Persistent Breathlessness and Fatigue", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-11-05", "start_date": "2021-09-15", "completion_date": "2023-05-31", "primary_completion_date": "2023-05-31", "conditions_raw": [ "COVID-19 Respiratory Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cardiopulmonary Exercise Training" ], "sponsor": "Louis Bherer", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The objective of this project is to assess the effects of a 2-month cardiopulmonary rehabilitation program on cardiorespiratory fitness in long COVID19 patients. Quality of life, functional capacity, functional respiratory capacity, inflammatory profile, coagulation markers, cognitive functions and brain O2 saturation will also be assessed before and after the exercise rehabilitation program.", "primary_outcomes": [ { "type": "primary", "measure": "Change in cardiorespiratory fitness", "description": "Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)", "time_frame": "Baseline and post-intervention at 2 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in 6-min walking test performance", "description": "maximum distance performed in 6 minutes (distance, m)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Functional mobility", "description": "Timed up and Go test (s).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Lower limb muscles strength", "description": "Timed Sit-to-Stand test (s).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Quality-of-life", "description": "36-Item Short Form Health Survey (Scale ranges from 0-100, with a higher score indicating a better health status).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Anxiety", "description": "State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Anxiety", "description": "Perceived Stress Scale questionnaire (Score ranges from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Sleep quality", "description": "Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). severe).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in functional respiratory capacity", "description": "forced expiratory volume in 1 second (L.)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in general cognitive functioning", "description": "Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in processing speed", "description": "Validated remote version of neuropsychological tests (Z-score)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in executive functions", "description": "Validated remote version of neuropsychological tests (Z-score)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in episodic memory", "description": "Validated remote version of neuropsychological tests (Z-score)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in inflammatory profile", "description": "C-reactive protein (mg/L/L)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in oxidative stress", "description": "serum levels of uric acid (mg/dL), albumin (g/L)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in markers of coagulation", "description": "fibrinogen (g/L)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in neurovascular coupling", "description": "Changes in brain activity evoked by a N-back task and walking relative to baseline will be assessed by t-statistics maps, computed from variations of \\[HbO\\] and \\[HbR\\] measured by NIRS at the prefrontal cortex.", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in cerebral pulsatility - cortical frontal region", "description": "Pulsatility will be measured as the normalized difference of relative near-infrared light intensity changes between systole and diastole, using NIRS in the prefrontal cortical region.", "time_frame": "Baseline and post-intervention at 2 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in cardiorespiratory fitness", "description": "Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in 6-min walking test performance", "description": "maximum distance performed in 6 minutes (distance, m)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Functional mobility", "description": "Timed up and Go test (s).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Lower limb muscles strength", "description": "Timed Sit-to-Stand test (s).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Quality-of-life", "description": "36-Item Short Form Health Survey (Scale ranges from 0-100, with a higher score indicating a better health status).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Anxiety", "description": "State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Anxiety", "description": "Perceived Stress Scale questionnaire (Score ranges from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in Sleep quality", "description": "Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). severe).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in functional respiratory capacity", "description": "forced expiratory volume in 1 second (L.)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in general cognitive functioning", "description": "Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in processing speed", "description": "Validated remote version of neuropsychological tests (Z-score)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in executive functions", "description": "Validated remote version of neuropsychological tests (Z-score)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in episodic memory", "description": "Validated remote version of neuropsychological tests (Z-score)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in inflammatory profile", "description": "C-reactive protein (mg/L/L)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in oxidative stress", "description": "serum levels of uric acid (mg/dL), albumin (g/L)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in markers of coagulation", "description": "fibrinogen (g/L)", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in neurovascular coupling", "description": "Changes in brain activity evoked by a N-back task and walking relative to baseline will be assessed by t-statistics maps, computed from variations of \\[HbO\\] and \\[HbR\\] measured by NIRS at the prefrontal cortex.", "time_frame": "Baseline and post-intervention at 2 months" }, { "type": "secondary", "measure": "Change in cerebral pulsatility - cortical frontal region", "description": "Pulsatility will be measured as the normalized difference of relative near-infrared light intensity changes between systole and diastole, using NIRS in the prefrontal cortical region.", "time_frame": "Baseline and post-intervention at 2 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05035628", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06055270", "title": "Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia", "status": "UNKNOWN", "phase": "PHASE3", "last_updated": "2024-10-23", "start_date": "2024-02-15", "completion_date": "2026-05-15", "primary_completion_date": "2025-12-24", "conditions_raw": [ "Parosmia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Stellate Ganglion Block" ], "sponsor": "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic olfactory dysfunction, both hyposmia and parosmia, from the COVID-19 pandemic is a growing public health crisis, affecting up to 1.2 million people in the United States. Olfactory dysfunction significantly impacts one's quality of life by decreasing the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to perform specific jobs. Olfactory loss is also an independent predictor of anxiety, depression, and mortality.\n\nRecent research suggests that parosmia, more so than hyposmia, can increase anxiety, depression, and even suicidal ideation. While the pandemic has advanced the scientific community's interest in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Persistent symptoms after an acute COVID-19 infection, or \"Long COVID\" symptoms, have been hypothesized to result from sympathetic nervous system dysfunction. Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous system. Studies before the COVID-19 pandemic have supported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, and recent news reports and a published case series have described a dramatic benefit in both olfactory function and other long COVID symptoms in patients receiving stellate ganglion blocks. A previous pilot study using stellate ganglion blocks of 20 participants with persistent COVID-19 olfactory dysfunction resulted in modest improvements in subjective olfactory function, smell identification, and olfactory-specific quality of life, but it lacked a control group.\n\nTherefore, we propose a double-blinded, placebo-controlled, randomized clinical trial assessing the efficacy of a stellate ganglion block with Lidocaine versus saline injection in up to 50 participants with persistent COVID-19-associated olfactory dysfunction.", "primary_outcomes": [ { "type": "primary", "measure": "Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR)", "description": "The DisODOR is a disease-specific questionnaire that assesses for physical problems, functional limitations, and emotional consequences of parosmia secondary to any etiology. The instrument contains 29 total items with each scored on a 5-point Likert scale from 0 to 4. The minimal clinically important difference (MCID) for the instrument is 15.", "time_frame": "Baseline, 1, 3, and 12 months after SGB" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Clinical Global Impression - Severity Scale (CGI-S)", "description": "The baseline severity of parosmia will be measured with the CGI-S scale. The CGI-S scale measures disease severity in clinical condition based on a 5-point Likert scale.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Clinical Global Impression - Improvement Scale (CGI-I)", "description": "The overall response to treatment will be measured with the CGI-I scale. The CGI-I Scale measures response to treatment for a number of disorders and has good internal consistency and validity.32 The CGI-I scale measures change in clinical condition based on a 7-point Likert scale. The CGI-I for parosmia asks, \"Compared to before your stellate ganglion block, how would you describe your parosmia (things do not smell the same as you remember)?\" Response options for each are: (1) Much better now than before, (2) Moderately better now than before, (3) Slightly better now than before, (4) About the same, (5) Slightly worse now than before, (6) Moderately worse now than before, and (7) Much worse now than before. Responders are defined as those who report \"slightly better now than before\" or greater.", "time_frame": "1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "University of Pennsylvania Smell Identification Test (UPSIT, Sensonics, New Jersey).", "description": "The UPSIT is a test of olfactory identification and consists of four 10-page booklets, with a total of 40 items. On each page, there is a different \"scratch and sniff\" strip and four choice options. Subjects are asked to scratch each strip with a pencil to release the scents, detect the smell, and identify the smell from the four choice options. The UPSIT comes from a scoring rubric that identifies the normalcy benchmark based on age and gender, which is \\>34 in women and \\>33 in men.33,34 The UPSIT is commercially available, takes 10-15 minutes to complete, and is the gold standard test to assess smell identification. The minimal clinically important difference of the UPSIT is 4.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Long-COVID Questionnaire (LCQ)", "description": "Symptoms assessed via the LCQ are derived from the Symptom Burden Questionnaire for Long Covid35, which included tiredness/fatigue, shortness of breath, brain fogginess, headache, cough, depression, low-grade fevers, palpitations, dizziness, muscle pain, and joint pains. At baseline, participants are asked to rank the current severity of each problem on a 5-point Likert scale. At each follow-up visit, participants are asked to rank their overall improvement in each of the 11 symptoms compared to their symptoms prior to their first SGB. The improvement options are based on the CGI-I 7-point Likert scale.", "time_frame": "Baseline, 1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "Olfaction Catastrophizing Scale (OCS)", "description": "The pain catastrophizing scale (PCS) was developed to measure the negative mental response to actual or anticipated pain. The OCS was derived from the validated PCS to similarly measure the negative mental response to smell dysfunction loss. Multiple thoughts/feelings will be assessed on a 5-point Likert scale with a maximum score of 52. At each visit, subjects will be asked to complete the OCS.", "time_frame": "Baseline, 1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "The HADS was developed for screen for anxiety and depression in the general population. It consists of 7 questions for anxiety and 7 questions for depression each ranked on a 4-point Likert Scale. A score of 0-7 is considered normal, 8-10 is borderline abnormal anxiety or depression, and a score of 11-21 corresponds with screening positive for anxiety or depression. Subjects will be screened for anxiety and depression on their initial visit.", "time_frame": "Baseline, 1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "Pre-Intervention Expectations", "description": "A significant number of social media and news stories have discussed anecdotal success of stellate ganglion blocks for COVID-19-induced olfactory dysfunction. As a result, we propose that participants may have a distorted pre-operative expectation that may affect their subjective rating of improvement in olfaction. Therefore, participants will be asked at baseline, \"How confident are you that the stellate ganglion block will improve your smell loss or smell distortion?\" Possible answer choices: Not at all, Slightly confident, Somewhat confident, Very confident, Extremely confident.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Patient Satisfaction with Treatment", "description": "Participants will be asked at the 1-month virtual visit, \"Overall, how satisfied were you with the stellate ganglion block treatment for your parosmia?\" Possible answer choices: 1) Completely dissatisfied, 2) Mostly dissatisfied, 3) Somewhat dissatisfied, 4) Neither satisfied or dissatisfied, 5) Somewhat satisfied, 6) Mostly satisfied, 7) Completely satisfied. Patients will also be asked at the final visit, \"Would you recommend this treatment to a family member or close friend who also suffers from chronic smell loss due to COVID-19?\" Possible answer choices: 1) Yes, 2) No.", "time_frame": "1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "Assessment of the Blind", "description": "Immediately after the initial injection, participants will be asked, \"Which intervention do you think you received?\" Answer choices: 1)Lidocaine (active medication) 2) Saline (placebo).", "time_frame": "1 Month after SGB" } ], "outcome_measures": [ { "type": "primary", "measure": "Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR)", "description": "The DisODOR is a disease-specific questionnaire that assesses for physical problems, functional limitations, and emotional consequences of parosmia secondary to any etiology. The instrument contains 29 total items with each scored on a 5-point Likert scale from 0 to 4. The minimal clinically important difference (MCID) for the instrument is 15.", "time_frame": "Baseline, 1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "Clinical Global Impression - Severity Scale (CGI-S)", "description": "The baseline severity of parosmia will be measured with the CGI-S scale. The CGI-S scale measures disease severity in clinical condition based on a 5-point Likert scale.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Clinical Global Impression - Improvement Scale (CGI-I)", "description": "The overall response to treatment will be measured with the CGI-I scale. The CGI-I Scale measures response to treatment for a number of disorders and has good internal consistency and validity.32 The CGI-I scale measures change in clinical condition based on a 7-point Likert scale. The CGI-I for parosmia asks, \"Compared to before your stellate ganglion block, how would you describe your parosmia (things do not smell the same as you remember)?\" Response options for each are: (1) Much better now than before, (2) Moderately better now than before, (3) Slightly better now than before, (4) About the same, (5) Slightly worse now than before, (6) Moderately worse now than before, and (7) Much worse now than before. Responders are defined as those who report \"slightly better now than before\" or greater.", "time_frame": "1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "University of Pennsylvania Smell Identification Test (UPSIT, Sensonics, New Jersey).", "description": "The UPSIT is a test of olfactory identification and consists of four 10-page booklets, with a total of 40 items. On each page, there is a different \"scratch and sniff\" strip and four choice options. Subjects are asked to scratch each strip with a pencil to release the scents, detect the smell, and identify the smell from the four choice options. The UPSIT comes from a scoring rubric that identifies the normalcy benchmark based on age and gender, which is \\>34 in women and \\>33 in men.33,34 The UPSIT is commercially available, takes 10-15 minutes to complete, and is the gold standard test to assess smell identification. The minimal clinically important difference of the UPSIT is 4.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Long-COVID Questionnaire (LCQ)", "description": "Symptoms assessed via the LCQ are derived from the Symptom Burden Questionnaire for Long Covid35, which included tiredness/fatigue, shortness of breath, brain fogginess, headache, cough, depression, low-grade fevers, palpitations, dizziness, muscle pain, and joint pains. At baseline, participants are asked to rank the current severity of each problem on a 5-point Likert scale. At each follow-up visit, participants are asked to rank their overall improvement in each of the 11 symptoms compared to their symptoms prior to their first SGB. The improvement options are based on the CGI-I 7-point Likert scale.", "time_frame": "Baseline, 1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "Olfaction Catastrophizing Scale (OCS)", "description": "The pain catastrophizing scale (PCS) was developed to measure the negative mental response to actual or anticipated pain. The OCS was derived from the validated PCS to similarly measure the negative mental response to smell dysfunction loss. Multiple thoughts/feelings will be assessed on a 5-point Likert scale with a maximum score of 52. At each visit, subjects will be asked to complete the OCS.", "time_frame": "Baseline, 1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "The HADS was developed for screen for anxiety and depression in the general population. It consists of 7 questions for anxiety and 7 questions for depression each ranked on a 4-point Likert Scale. A score of 0-7 is considered normal, 8-10 is borderline abnormal anxiety or depression, and a score of 11-21 corresponds with screening positive for anxiety or depression. Subjects will be screened for anxiety and depression on their initial visit.", "time_frame": "Baseline, 1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "Pre-Intervention Expectations", "description": "A significant number of social media and news stories have discussed anecdotal success of stellate ganglion blocks for COVID-19-induced olfactory dysfunction. As a result, we propose that participants may have a distorted pre-operative expectation that may affect their subjective rating of improvement in olfaction. Therefore, participants will be asked at baseline, \"How confident are you that the stellate ganglion block will improve your smell loss or smell distortion?\" Possible answer choices: Not at all, Slightly confident, Somewhat confident, Very confident, Extremely confident.", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Patient Satisfaction with Treatment", "description": "Participants will be asked at the 1-month virtual visit, \"Overall, how satisfied were you with the stellate ganglion block treatment for your parosmia?\" Possible answer choices: 1) Completely dissatisfied, 2) Mostly dissatisfied, 3) Somewhat dissatisfied, 4) Neither satisfied or dissatisfied, 5) Somewhat satisfied, 6) Mostly satisfied, 7) Completely satisfied. Patients will also be asked at the final visit, \"Would you recommend this treatment to a family member or close friend who also suffers from chronic smell loss due to COVID-19?\" Possible answer choices: 1) Yes, 2) No.", "time_frame": "1, 3, and 12 months after SGB" }, { "type": "secondary", "measure": "Assessment of the Blind", "description": "Immediately after the initial injection, participants will be asked, \"Which intervention do you think you received?\" Answer choices: 1)Lidocaine (active medication) 2) Saline (placebo).", "time_frame": "1 Month after SGB" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 3", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 44, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06055270", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06108297", "title": "Lithium Long COVID Dose-finding Study", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2024-10-22", "start_date": "2023-10-12", "completion_date": "2024-05-02", "primary_completion_date": "2024-03-26", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Lithium" ], "sponsor": "State University of New York at Buffalo", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This open-label study will assess if lithium dosages of 30-45mg/day are associated with greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50 patients with long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale (FSS)", "description": "7-item scale. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "primary", "measure": "Brain Fog Severity Scale (BFSS)", "description": "7-item scale. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Well Being Scale", "description": "Single-item question. Score range 0-10 with higher values signifying better outcome.", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Short Form-12 Health Survey", "description": "12-item quality of life scale. Score range 0-100 for both the Physical Component Score and the Mental Component Score with higher values signifying better outcomes.", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "FSS scores in those with FSS score ≥28 at baseline", "description": "7-item scale. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "BFSS scores in those with FSS score ≥28 at baseline", "description": "7-item scale. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale", "description": "21-item scale. Score range 0-84 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Perceived Deficits Questionnaire, 5-Item Version", "description": "5-item scale. Score range 1-20 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Beck Depression Inventory-II", "description": "21-item scale. Score range 0-63 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder Scale-2", "description": "2-item scale. Score range 0-6 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Headache and Body Pain Bother Scale", "description": "2-item scale. Score range 2-10 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Insomnia Severity Index", "description": "7-item scale. Score range 0-28 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Patient Global Impression of Change", "description": "Single-item scale. Score range 1-7 with higher values signifying better outcome", "time_frame": "End-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Desire to Continue Therapy Scale", "description": "Single-item scale. Score range 1-2 with higher value signifying better outcome", "time_frame": "End-of-titration (up to 11 weeks)" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale (FSS)", "description": "7-item scale. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "primary", "measure": "Brain Fog Severity Scale (BFSS)", "description": "7-item scale. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Well Being Scale", "description": "Single-item question. Score range 0-10 with higher values signifying better outcome.", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Short Form-12 Health Survey", "description": "12-item quality of life scale. Score range 0-100 for both the Physical Component Score and the Mental Component Score with higher values signifying better outcomes.", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "FSS scores in those with FSS score ≥28 at baseline", "description": "7-item scale. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "BFSS scores in those with FSS score ≥28 at baseline", "description": "7-item scale. Score range 1-49 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale", "description": "21-item scale. Score range 0-84 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Perceived Deficits Questionnaire, 5-Item Version", "description": "5-item scale. Score range 1-20 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Beck Depression Inventory-II", "description": "21-item scale. Score range 0-63 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder Scale-2", "description": "2-item scale. Score range 0-6 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Headache and Body Pain Bother Scale", "description": "2-item scale. Score range 2-10 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Insomnia Severity Index", "description": "7-item scale. Score range 0-28 with higher values signifying worse outcome", "time_frame": "Baseline to end-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Patient Global Impression of Change", "description": "Single-item scale. Score range 1-7 with higher values signifying better outcome", "time_frame": "End-of-titration (up to 11 weeks)" }, { "type": "secondary", "measure": "Desire to Continue Therapy Scale", "description": "Single-item scale. Score range 1-2 with higher value signifying better outcome", "time_frame": "End-of-titration (up to 11 weeks)" } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 5, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06108297", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05212688", "title": "Randomised Study to Investigate the Effectiveness of Acupuncture for the Relief of Long COVID-19 Related Fatigue", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2024-10-18", "start_date": "2022-07-19", "completion_date": "2024-09-25", "primary_completion_date": "2024-09-25", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Acupuncture" ], "sponsor": "Royal Marsden NHS Foundation Trust", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The Covid pandemic has left us with a significant number of people suffering from Long COVID, which is a clinical diagnosis of significant and varying ongoing symptoms at least 12 weeks following COVID-19 infection and characterised frequently by fatigue and breathlessness. Acupuncture has been shown to help breathlessness and fatigue in other conditions including in patients with cancer. Cancer related fatigue in the largest study, was assessed by the multiple functional inventory (MFI) score, assessing 5 domains of health, to give a single score.\n\nWe aim to randomise 160 patients, 80 in each arm. Randomisation and recruitment should take 24 months.\n\nEach patient will be offered 6 weeks of weekly acupuncture treatment with a structured questionnaire on wellbeing or no acupuncture with a structure questionnaire on well-being. Both groups of patients will be given continued general advice on management of their symptoms. The next point of involvement will be at 12 weeks which will also be the final visit unless patients in Arm B (Active Control) chose crossover to receive acupuncture. Data at this point will correspond to the end of the participants participation. Over the next 3 months data will be cleaned and analysed.\n\nThe primary endpoint is General Fatigue scores, as self-reported by patients using the MFI, at 6 weeks. A 2-unit difference between groups (Acupuncture vs Active Control) in General Fatigue score is considered clinically important.\n\nThe secondary endpoints will include differences in scores of various questionnaires and tests.", "primary_outcomes": [ { "type": "primary", "measure": "General Fatigue Score", "description": "The primary outcome will be the difference in General Fatigue scores, as self-reported by patients using the MFI ( Multidimensional Fatigue Inventory)\n\n, at 6 weeks. The MFI is a brief 20 item validated scale measuring general fatigue and other dimensions of physical and mental fatigue, activity and motivation.", "time_frame": "6 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "General Fatigue Score", "description": "The primary outcome will be the difference in General Fatigue scores, as self-reported by patients using the MFI ( Multidimensional Fatigue Inventory)\n\n, at 6 weeks. The MFI is a brief 20 item validated scale measuring general fatigue and other dimensions of physical and mental fatigue, activity and motivation.", "time_frame": "6 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 119, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05212688", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06311435", "title": "Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19", "status": "RECRUITING", "phase": "NA", "last_updated": "2024-10-18", "start_date": "2024-03-15", "completion_date": "2026-03-15", "primary_completion_date": "2026-03-15", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rna Biomarker Blood Test" ], "sponsor": "MaxWell Clinic, PLC", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The Primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood RNA from patients with long COVID together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Develop algorithm to classify RNA sequences to identify long COVID", "description": "The Primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood RNA from patients with long COVID together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long COVID", "time_frame": "30 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID", "description": "The secondary objective of this study is to determine if it is possible to develop an algorithm that can subclassify specific blood RNA biomarkers in long COVID patients into various symptom-related subcategories to provide clinically relevant treatment options.", "time_frame": "30 Days" } ], "outcome_measures": [ { "type": "primary", "measure": "Develop algorithm to classify RNA sequences to identify long COVID", "description": "The Primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood RNA from patients with long COVID together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long COVID", "time_frame": "30 days" }, { "type": "secondary", "measure": "Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID", "description": "The secondary objective of this study is to determine if it is possible to develop an algorithm that can subclassify specific blood RNA biomarkers in long COVID patients into various symptom-related subcategories to provide clinically relevant treatment options.", "time_frame": "30 Days" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 224, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06311435", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05453175", "title": "Uninterrupted and Interrupted Sitting in Long COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-10-03", "start_date": "2022-10-07", "completion_date": "2024-07-30", "primary_completion_date": "2024-07-30", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Interrupting Sitting With Physical Activity" ], "sponsor": "University of Winchester", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "People who sit uninterrupted for prolonged periods time have been shown to have poorer cardiovascular health compared to those that regularly interrupt it (e.g. standing up and moving). Cognition and brain function has also been shown to be impaired following uninterrupted sitting. Research has shown that interrupting sitting with exercise improves cardiovascular health in healthy men and women cognition, feeling of fatigue and cerebral oxygenation. Low intensity physical activity can help people with Long coronavirus disease (COVID) by reducing feelings of fatigue.\n\nIndividuals with long COVID have symptoms such as fatigue and brain fog. As such, people with long COVID may spend more time sitting during the day and demonstrate worsened cardiovascular and cognitive health. As such, there may be greater levels of cognitive decline and worsened cardiovascular health outcomes. In this study the investigators are interested in assessing the cardiovascular health and brain function of people with (and without) long COVID before and after uninterrupted and interrupted sitting.\n\nInterruptions will be every 30 minutes during a 120 minute sitting period. Interruptions are self-paced and include up to three minutes of walking, five heel raises and five sit-to-stands at each interruption. To ensure external validity of the project, all interruptions are functional activities which can be reproducible in a home environment. Vascular health and cognitive function will be assessed before and after the interrupted and uninterrupted trials. Eligible participants will be aged over 18 years, have displayed symptoms of long COVID for more than 4 weeks, and have been diagnosed with long COVID via their GP or through a long COVID clinic. Involvement in the study will include three visits to a physiology laboratory at the University of Winchester or University of Gloucestershire. Involvement can be expected to last up to 40 days to account for the necessary time required between laboratory visits.", "primary_outcomes": [ { "type": "primary", "measure": "Pulse Wave Velocity", "description": "Carotid femoral pulse wave velocity (PWV) using SphygmoCor XCEL. Lower numbers represent healthier PWV, and in turn better vascular health", "time_frame": "Change from baseline to 120 minutes post baseline" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Central and peripheral pulse wave analysis", "description": "A non-invasive method of measuring blood pressure, arterial stiffness, how much time the heart spends pumping, and the ability of the arterial system to meet the heart's energy requirements", "time_frame": "Change from baseline to 120 minutes post baseline" }, { "type": "secondary", "measure": "Cognitive function", "description": "A two part cognitive assessment completed on an IPad using visual screening and working memory. Scores that are lower in time (seconds) and errors indicate better performance at the task", "time_frame": "Change from baseline to 120 minutes post baseline" }, { "type": "secondary", "measure": "Quality of Life - EuroQuol 5 Dimensions 5 levels (EQ-5D-5L)", "description": "5-item questionnaire that assesses quality of life. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension", "time_frame": "Baseline" } ], "outcome_measures": [ { "type": "primary", "measure": "Pulse Wave Velocity", "description": "Carotid femoral pulse wave velocity (PWV) using SphygmoCor XCEL. Lower numbers represent healthier PWV, and in turn better vascular health", "time_frame": "Change from baseline to 120 minutes post baseline" }, { "type": "secondary", "measure": "Central and peripheral pulse wave analysis", "description": "A non-invasive method of measuring blood pressure, arterial stiffness, how much time the heart spends pumping, and the ability of the arterial system to meet the heart's energy requirements", "time_frame": "Change from baseline to 120 minutes post baseline" }, { "type": "secondary", "measure": "Cognitive function", "description": "A two part cognitive assessment completed on an IPad using visual screening and working memory. Scores that are lower in time (seconds) and errors indicate better performance at the task", "time_frame": "Change from baseline to 120 minutes post baseline" }, { "type": "secondary", "measure": "Quality of Life - EuroQuol 5 Dimensions 5 levels (EQ-5D-5L)", "description": "5-item questionnaire that assesses quality of life. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension", "time_frame": "Baseline" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 45, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05453175", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06064838", "title": "Effects of Cacao Flavonoids in Long COVID-19 Patients (FLALOC)", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-10-01", "start_date": "2023-08-01", "completion_date": "2024-09-30", "primary_completion_date": "2024-08-01", "conditions_raw": [ "Long Covid19", "Fatigue Syndrome, Chronic" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Flavonoids" ], "sponsor": "Guillermo Ceballos Reyes", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The study use a triple blind, placebo-controlled design enrolling male and female subjects between 30-70 yo to evaluate the effect of daily consumption of a cacao supplement on inflammation, endothelial damage, handgrip strength, fatigue scale and quality of life.", "primary_outcomes": [ { "type": "primary", "measure": "Interleukin-1b", "description": "Plasmatic concentration", "time_frame": "At 0 and 90 day" }, { "type": "primary", "measure": "Interleukin-6", "description": "Plasmatic concentration", "time_frame": "At 0 and 90 day" }, { "type": "primary", "measure": "TNF-alpha", "description": "Plasmatic concentration", "time_frame": "At 0 and 90 day" }, { "type": "primary", "measure": "Syndecan-1", "description": "Plasmatic concentration", "time_frame": "At 0 and 90 day" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "EQ-5D questionnaire", "description": "Self-administered health index that explores five domains", "time_frame": "At 0 and 90 day" }, { "type": "secondary", "measure": "Analog Visual Scale", "description": "Use of a Analog Visual Scale to measure the quality of life, graded 0 (worst) to 100 (best) for the perception of wellbeing.", "time_frame": "At 0 and 90 day" }, { "type": "secondary", "measure": "Numerical fatigue rating scale", "description": "fatigue rating scale graded 0 (best) to 100 (worst)", "time_frame": "At 0 and 90 day" }, { "type": "secondary", "measure": "Handgrip strength", "description": "Measures static force in kilograms that the hand can squeeze around a dynamometer", "time_frame": "At 0 and 90 day" } ], "outcome_measures": [ { "type": "primary", "measure": "Interleukin-1b", "description": "Plasmatic concentration", "time_frame": "At 0 and 90 day" }, { "type": "primary", "measure": "Interleukin-6", "description": "Plasmatic concentration", "time_frame": "At 0 and 90 day" }, { "type": "primary", "measure": "TNF-alpha", "description": "Plasmatic concentration", "time_frame": "At 0 and 90 day" }, { "type": "primary", "measure": "Syndecan-1", "description": "Plasmatic concentration", "time_frame": "At 0 and 90 day" }, { "type": "secondary", "measure": "EQ-5D questionnaire", "description": "Self-administered health index that explores five domains", "time_frame": "At 0 and 90 day" }, { "type": "secondary", "measure": "Analog Visual Scale", "description": "Use of a Analog Visual Scale to measure the quality of life, graded 0 (worst) to 100 (best) for the perception of wellbeing.", "time_frame": "At 0 and 90 day" }, { "type": "secondary", "measure": "Numerical fatigue rating scale", "description": "fatigue rating scale graded 0 (best) to 100 (worst)", "time_frame": "At 0 and 90 day" }, { "type": "secondary", "measure": "Handgrip strength", "description": "Measures static force in kilograms that the hand can squeeze around a dynamometer", "time_frame": "At 0 and 90 day" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 46, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06064838", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04482595", "title": "BIO 300 Oral Suspension in Previously Hospitalized Long COVID Patients", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2024-10-01", "start_date": "2020-11-11", "completion_date": "2025-04-30", "primary_completion_date": "2024-07-31", "conditions_raw": [ "COVID-19", "Long COVID", "Pulmonary Fibrosis", "Post-acute Respiratory Complications of COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Bio 300 Oral Suspension" ], "sponsor": "Humanetics Corporation", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate the safety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lung function in patients that were hospitalized for severe COVID-19-related illness and continue to experience post-acute respiratory complications associated with Long-COVID after discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.", "primary_outcomes": [ { "type": "primary", "measure": "Change in DLCO", "description": "Diffusing capacity of the lungs for carbon monoxide (DLCO)", "time_frame": "12 Weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in 6 Minute Walk Test", "description": "6 minute walk test (6MWT)", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Change in FVC", "description": "Forced vital capacity (FVC)", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in St. George's Respiratory Questionnaire (SGRQ) Scores", "description": "Patient reported outcome to measure impact on overall health, daily life, and perceived well-being in patients with impaired pulmonary function. Scores range from 0-100 with higher scores indicating more limitations.", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Pulmonary Fibrosis on HRCT Scan", "description": "Evidence of pulmonary fibrosis on high resolution computerized tomography (HRCT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Incidence of Re-Hospitalization", "description": "Incidence of hospitalization after initial discharge and initiating treatment", "time_frame": "12 Months" }, { "type": "secondary", "measure": "All-Cause Mortality", "description": "Mortality at 12 months after initiating treatment", "time_frame": "12 Months" }, { "type": "secondary", "measure": "Change in FEV1", "description": "Forced expiratory volume in one second (FEV1)", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in FEV1/FVC Ratio", "description": "Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in 6 Minute Walk Test", "description": "6 minute walk test (6MWT)", "time_frame": "6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Pulse Oximetry at Rest and During the 6MWT", "description": "Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT)", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in DLCO", "description": "Diffusing capacity of the lungs for carbon monoxide (DLCO)", "time_frame": "6 Months and 12 Months" }, { "type": "secondary", "measure": "Adverse Events Related to BIO 300 Oral Suspension", "description": "Evaluate the safety of BIO 300 Oral Suspension treatment", "time_frame": "12 Months" }, { "type": "secondary", "measure": "Change in Clinical Laboratory Values", "description": "Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL)", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Clinical Laboratory Values", "description": "Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL)", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Clinical Laboratory Values for Albumin", "description": "Monitoring of blood serum levels for albumin (g/dL)", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Clinical Laboratory Values for Serum Enzymes", "description": "Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L)", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Complete Blood Counts with Differential", "description": "Monitoring of white blood cell, red blood cell and platelet counts", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in DLCO", "description": "Diffusing capacity of the lungs for carbon monoxide (DLCO)", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Change in 6 Minute Walk Test", "description": "6 minute walk test (6MWT)", "time_frame": "12 Weeks" }, { "type": "secondary", "measure": "Change in FVC", "description": "Forced vital capacity (FVC)", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in St. George's Respiratory Questionnaire (SGRQ) Scores", "description": "Patient reported outcome to measure impact on overall health, daily life, and perceived well-being in patients with impaired pulmonary function. Scores range from 0-100 with higher scores indicating more limitations.", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Pulmonary Fibrosis on HRCT Scan", "description": "Evidence of pulmonary fibrosis on high resolution computerized tomography (HRCT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Incidence of Re-Hospitalization", "description": "Incidence of hospitalization after initial discharge and initiating treatment", "time_frame": "12 Months" }, { "type": "secondary", "measure": "All-Cause Mortality", "description": "Mortality at 12 months after initiating treatment", "time_frame": "12 Months" }, { "type": "secondary", "measure": "Change in FEV1", "description": "Forced expiratory volume in one second (FEV1)", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in FEV1/FVC Ratio", "description": "Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in 6 Minute Walk Test", "description": "6 minute walk test (6MWT)", "time_frame": "6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Pulse Oximetry at Rest and During the 6MWT", "description": "Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT)", "time_frame": "12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in DLCO", "description": "Diffusing capacity of the lungs for carbon monoxide (DLCO)", "time_frame": "6 Months and 12 Months" }, { "type": "secondary", "measure": "Adverse Events Related to BIO 300 Oral Suspension", "description": "Evaluate the safety of BIO 300 Oral Suspension treatment", "time_frame": "12 Months" }, { "type": "secondary", "measure": "Change in Clinical Laboratory Values", "description": "Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL)", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Clinical Laboratory Values", "description": "Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL)", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Clinical Laboratory Values for Albumin", "description": "Monitoring of blood serum levels for albumin (g/dL)", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Clinical Laboratory Values for Serum Enzymes", "description": "Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L)", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" }, { "type": "secondary", "measure": "Change in Complete Blood Counts with Differential", "description": "Monitoring of white blood cell, red blood cell and platelet counts", "time_frame": "4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04482595", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05244044", "title": "Pulmonary Rehabilitation for Long COVID (Post COVID-19 Condition)", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-10-01", "start_date": "2022-04-19", "completion_date": "2024-02-29", "primary_completion_date": "2023-12-18", "conditions_raw": [ "COVID-19", "Long COVID", "Post COVID-19 Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Pulmonary Rehabilitation In Primary Care" ], "sponsor": "University Hospital, Antwerp", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In the PuRe COVID study (a randomized, controlled, multicenter, pragmatic trial) the investigators aim to assess the effect of a pulmonary rehabilitation program in primary care on exercise capacity (6MWT) and daily life physical activity in patients with long COVID.\n\n134 patients with long COVID, defined by self-reported persistent COVID related symptoms ≥6 weeks after COVID-19 infection and a positive symptom score (CAT score ≥10 or mMRC score ≥2 or CIS-fatigue ≥36 or PCFS score of ≥2), will be recruited and divided into an intervention group or a control group. The intervention group will get twelve weeks of primary care pulmonary rehabilitation (PR) including coaching by primary care physiotherapists. The control group consists of usual care, which does not include a pulmonary rehabilitation program.\n\nThis study will help determine whether the type of symptoms or affected body system can impact recovery form long covid during rehabilitation and after follow-up. The investigators will analyze determinants and risk factors that characterize non-responders and non-adherers to better understand which patients with long COVID benefit from rehabilitation.", "primary_outcomes": [ { "type": "primary", "measure": "Exercise capacity", "description": "Change in functional exercise capacity measured by 6-minute walk test (6MWT).", "time_frame": "Baseline - 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in physical activity", "description": "Change in physical activity as objectively measured by an activity tracker (number of steps).", "time_frame": "Baseline - 12 weeks" }, { "type": "secondary", "measure": "Change in COVID-19 related symptoms", "description": "The COVID-19 related symptoms will be measured with the COPD assessment test (CAT). The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms.", "time_frame": "Baseline - 12 weeks - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in quality of life", "description": "The quality of life will be measured with the EQ-5D-5L.", "time_frame": "Baseline - 12 weeks - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in fatigue", "description": "The changes of the level of fatigue will be measured with the Checklist Individual Strength -fatigue (CIS-fatigue) score. The total CIS-fatigue score ranges from 20 to 140 where 20 represents no symptoms and 140 very bad symptoms.", "time_frame": "Baseline - 12 weeks - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in dyspnoea", "description": "Changes in dyspnoea, measured with the modified medical research council (mMRC). The total mMRC scale ranges from 0 to 4 score where 0 represents no dyspnoea and 4 a lot of dyspnoea.", "time_frame": "Baseline - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in functional status", "description": "The functional status will be measured by the post COVID-19 functional status scale (PCFS). It is an ordinal score ranging from 0 to 4 where 4 means the patient has a lot of limitations in daily life.", "time_frame": "Baseline - 12 weeks - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in work productivity and activity impairment.", "description": "This will be measured with the \"work productivity and activity impairment\" questionnaire (WPAI), consisting of 6 questions.", "time_frame": "Baseline - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in anxiety and depression symptoms.", "description": "This will be measured by the Hospital Anxiety and depression scale (HADS). The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.", "time_frame": "Baseline - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in dysfunctional breathing", "description": "This will be measured with the Nijmegen questionnaire. 16 questions will be asked, ranging from 0 to 4. The higher the score, the more likely it is that they have dysfunctional breathing.", "time_frame": "Baseline - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in exercise capacity", "description": "The functional exercise capacity will be measured by 6-minute walk test (6MWT).", "time_frame": "Baseline - 24 weeks" }, { "type": "secondary", "measure": "Predictors of response in 6- minute walk distance (6MWD)", "description": "The predictors will be based on baseline symptom scores (CAT, mMRC, CIS), baseline 6MWD and hospitalisation status.", "time_frame": "Post pulmonary rehabilitation" } ], "outcome_measures": [ { "type": "primary", "measure": "Exercise capacity", "description": "Change in functional exercise capacity measured by 6-minute walk test (6MWT).", "time_frame": "Baseline - 12 weeks" }, { "type": "secondary", "measure": "Change in physical activity", "description": "Change in physical activity as objectively measured by an activity tracker (number of steps).", "time_frame": "Baseline - 12 weeks" }, { "type": "secondary", "measure": "Change in COVID-19 related symptoms", "description": "The COVID-19 related symptoms will be measured with the COPD assessment test (CAT). The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms.", "time_frame": "Baseline - 12 weeks - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in quality of life", "description": "The quality of life will be measured with the EQ-5D-5L.", "time_frame": "Baseline - 12 weeks - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in fatigue", "description": "The changes of the level of fatigue will be measured with the Checklist Individual Strength -fatigue (CIS-fatigue) score. The total CIS-fatigue score ranges from 20 to 140 where 20 represents no symptoms and 140 very bad symptoms.", "time_frame": "Baseline - 12 weeks - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in dyspnoea", "description": "Changes in dyspnoea, measured with the modified medical research council (mMRC). The total mMRC scale ranges from 0 to 4 score where 0 represents no dyspnoea and 4 a lot of dyspnoea.", "time_frame": "Baseline - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in functional status", "description": "The functional status will be measured by the post COVID-19 functional status scale (PCFS). It is an ordinal score ranging from 0 to 4 where 4 means the patient has a lot of limitations in daily life.", "time_frame": "Baseline - 12 weeks - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in work productivity and activity impairment.", "description": "This will be measured with the \"work productivity and activity impairment\" questionnaire (WPAI), consisting of 6 questions.", "time_frame": "Baseline - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in anxiety and depression symptoms.", "description": "This will be measured by the Hospital Anxiety and depression scale (HADS). The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.", "time_frame": "Baseline - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in dysfunctional breathing", "description": "This will be measured with the Nijmegen questionnaire. 16 questions will be asked, ranging from 0 to 4. The higher the score, the more likely it is that they have dysfunctional breathing.", "time_frame": "Baseline - 24 weeks - 36 weeks" }, { "type": "secondary", "measure": "Change in exercise capacity", "description": "The functional exercise capacity will be measured by 6-minute walk test (6MWT).", "time_frame": "Baseline - 24 weeks" }, { "type": "secondary", "measure": "Predictors of response in 6- minute walk distance (6MWD)", "description": "The predictors will be based on baseline symptom scores (CAT, mMRC, CIS), baseline 6MWD and hospitalisation status.", "time_frame": "Post pulmonary rehabilitation" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 76, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05244044", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05356936", "title": "Pilot Study of Vitamin K2 (MK-7) and Vitamin D3 Supplementation and the Effects on PASC Symptomatology and Inflammatory Biomarkers", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-09-27", "start_date": "2022-06-01", "completion_date": "2024-08-01", "primary_completion_date": "2024-04-01", "conditions_raw": [ "Post-acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Vitamin K2", "Vitamin D3" ], "sponsor": "University Hospitals Cleveland Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Participants are being asked to take part in this research study because they have had a previous diagnosis (at least 3 months ago) of COVID-19 and are experiencing persistent, recurrent or even new symptoms, i.e. post-acute sequelae of SARS-CoV-2 (PASC). The Investigators are interested in studying the effects of Vitamin K2 (MK-7) and Vitamin D3 supplementation on PASC symptoms and the underlying inflammatory process.", "primary_outcomes": [ { "type": "primary", "measure": "Change in high-sensitivity C-reactive protein (hs-CRP) as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in interleukin 6 (IL-6) as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in intestinal fatty acid binding protein (Ifab) as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in soluble Tumor Necrosis Factor Receptor II ( sTNF-RII) as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in Vitamin K2 (MK-7) levels as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in Vitamin D3 levels as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Percent of subjects with >Grade 2 adverse events as measured by patient report", "description": "", "time_frame": "Up to 24 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in high-sensitivity C-reactive protein (hs-CRP) as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in interleukin 6 (IL-6) as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in intestinal fatty acid binding protein (Ifab) as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in soluble Tumor Necrosis Factor Receptor II ( sTNF-RII) as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in Vitamin K2 (MK-7) levels as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "primary", "measure": "Change in Vitamin D3 levels as measured by blood test", "description": "", "time_frame": "Baseline, week 12, week 24" }, { "type": "secondary", "measure": "Percent of subjects with >Grade 2 adverse events as measured by patient report", "description": "", "time_frame": "Up to 24 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 151, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05356936", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05121766", "title": "Feasibility Pilot Clinical Trial of Omega-3 Supplement vs. Placebo for Post Covid-19 Recovery Among Health Care Workers", "status": "TERMINATED", "phase": "PHASE1", "last_updated": "2024-09-19", "start_date": "2022-01-10", "completion_date": "2023-04-21", "primary_completion_date": "2023-04-21", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Omega-3" ], "sponsor": "Hackensack Meridian Health", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a two-arm, double blind randomized 12-week study to supplement omega-3 (Eicosapentaenoic acid - EPA + docosahexaenoic acid - DHA) among 100 adults (age 18+) who had coronavirus-19 (covid-19) and are experiencing possible after-effects from post-acute sequelae of covid-19 (also called post-covid syndrome or long covid syndrome).", "primary_outcomes": [ { "type": "primary", "measure": "Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Compliance as Captured by the Number of Participants Who Remain Compliant for the Whole Duration of the Study by Taking All Pills Daily", "description": "Number of participants who remain compliant for 12 weeks", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Recruitment as Illustrated by the Number of Screen Failures (Potential Participants Approached But Not Interested in Participating).", "description": "Number of participants who expressed interest in learning about the study", "time_frame": "6 months recruitment efforts (starting on actual study start date)" }, { "type": "primary", "measure": "Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Retention as Illustrated by the Number of Participants That Initiate But do Not Complete the Study.", "description": "Number of participants who initiate but do not complete study", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Shortness of Breath", "description": "Self-reported shortness of breath as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" }, { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Cough", "description": "Self-reported cough as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" }, { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Fatigue", "description": "Self-reported fatigue as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" }, { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Smell", "description": "Self-reported loss of smell as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" }, { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Taste", "description": "Self-reported loss of taste as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" } ], "outcome_measures": [ { "type": "primary", "measure": "Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Compliance as Captured by the Number of Participants Who Remain Compliant for the Whole Duration of the Study by Taking All Pills Daily", "description": "Number of participants who remain compliant for 12 weeks", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Recruitment as Illustrated by the Number of Screen Failures (Potential Participants Approached But Not Interested in Participating).", "description": "Number of participants who expressed interest in learning about the study", "time_frame": "6 months recruitment efforts (starting on actual study start date)" }, { "type": "primary", "measure": "Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Retention as Illustrated by the Number of Participants That Initiate But do Not Complete the Study.", "description": "Number of participants who initiate but do not complete study", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Shortness of Breath", "description": "Self-reported shortness of breath as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" }, { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Cough", "description": "Self-reported cough as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" }, { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Fatigue", "description": "Self-reported fatigue as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" }, { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Smell", "description": "Self-reported loss of smell as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" }, { "type": "secondary", "measure": "Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Taste", "description": "Self-reported loss of taste as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).", "time_frame": "12 weeks from baseline" } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 32, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05121766", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05693064", "title": "The Impact of Chiropractic on Long COVID-19", "status": "SUSPENDED", "phase": "NA", "last_updated": "2024-08-28", "start_date": "2025-01-15", "completion_date": "2025-08-01", "primary_completion_date": "2025-06-15", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Chiropractic Adjustments" ], "sponsor": "Life University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this waitlist-controlled, single-blind, one-way crossover, pilot trial is to evaluate the potential effects of \\~8 weeks of chiropractic care on patient-reported fatigue and the autonomic nervous system in adults with long COVID. This study will allow us to estimate the standard deviation of the primary endpoint in our population with which a formal power calculation for a future randomized, controlled trial can be performed.", "primary_outcomes": [ { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "Preliminary" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "Baseline (Day 1)" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "2-3 weeks on wait-list" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "8 weeks on wait-list" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "2 - 3 weeks following start of intervention" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "Post intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "2 - 3 weeks following start of intervention" }, { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm", "time_frame": "Preliminary" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC", "time_frame": "Post intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "Preliminary" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "Baseline (Day 1)" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "2-3 weeks on wait-list" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "8 weeks on wait-list" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "2 - 3 weeks following start of intervention" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "2 - 3 weeks following start of intervention" }, { "type": "secondary", "measure": "EEG resting state broadband power", "description": "256-channel hydronet cap", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "EEG resting state functional connectivity", "description": "256-channel hydronet cap", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "ECG mean interbeat interval", "description": "3 sensors on torso", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "ECG respiratory sinus arrhythmia (RSA)", "description": "3 sensors on torso", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) pre-ejection period (PEP)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "Impedance cardiogram (ICG) initial systolic time interval (ISTI)", "description": "2 sensors on chest and 2 sensors on back", "time_frame": "Post intervention" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm", "time_frame": "Preliminary" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm", "time_frame": "Baseline (Day 1)" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm", "time_frame": "2-3 weeks on wait-list" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC", "time_frame": "8 weeks on wait-list" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm", "time_frame": "2-3 weeks following start of intervention" }, { "type": "secondary", "measure": "Patient-reported outcomes", "description": "5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC", "time_frame": "Post intervention" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05693064", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05389592", "title": "Treatment of COVID-19 Post-acute Cognitive Impairment Sequelae With tDCS", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-08-27", "start_date": "2022-06-30", "completion_date": "2023-03-30", "primary_completion_date": "2022-11-30", "conditions_raw": [ "Cognitive Impairment", "Post-Acute Sequelae of SARS-CoV-2 Infection", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Active Tdcs And Cognitive Training" ], "sponsor": "University of Sao Paulo", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "After almost 2 years of pandemic, the consequences of the post-COVID syndrome, or PASC (Post Acute-Sequelae of Sars-CoV-2), have become a major challenge in the management of affected patients, generating costs for health services. and insecurity regarding treatments for the sequelae, given the complex and still poorly understood pathophysiology of COVID-19.\n\nThis troubling scenario raises important questions about the impact of COVID-19 on central nervous system sequelae, including the risk of cognitive decline in old age and progression to dementia. Therefore, studies that propose the possibility of treatment for this new clinical condition and that are free from systemic side effects, such as transcranial direct current stimulation (tDCS) and cognitive treatment, are extremely important in the face of this scenario. In addition, the evaluation of the neural mechanisms underlying the cognitive alterations of the PASC syndrome and after the treatment using multimodal magnetic resonance imaging (MRI) becomes relevant in view of the lack of studies related to the topic.\n\nTherefore, the objective of this double-blind randomized clinical trial is to assess whether tDCS associated with cognitive training can improve symptoms in patients with persistent cognitive deficits that started between 1 and 6 months after the resolution of acute COVID-19 infection (PASC) compared to the sham (placebo) group, in addition to exploring the structural, microstructural, functional and modeled electric field changes associated with cognitive alterations due to PASC syndrome and tDCS combined with cognitive treatment. 60 patients aged between 18 and 70 years and with a positive diagnosis of mild to moderate COVID-19 in the last 6 months in relation to the time of entry into the study will be recruited. All of them will be pre-screened online and in person to confirm the cognitive dysfunction associated with PASC.", "primary_outcomes": [ { "type": "primary", "measure": "Change in neuropsychological assessment between experimental groups", "description": "A battery of neuropsychological tests to assess memory, attention, executive functions and mood.", "time_frame": "Week 0 (baseline) and Week 4 (endpoint)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in pupillary reflex", "description": "Roland system, composed of a Ganzfeld (Roland Consult), with light-emitting diodes responsible for the stimulus and an infrared camera, capable of recording images in the dark with high spatial and temporal resolution, in continuous recording in recording mode at 30 Hz", "time_frame": "Week 0 (baseline) and Week 4 (endpoint)" }, { "type": "secondary", "measure": "Brain changes using multimodal magnetic resonance imaging (MRI)", "description": "Functional and structural MRI scans", "time_frame": "Week 0 (baseline)" }, { "type": "secondary", "measure": "Change in heart rate variability (HRV) between experimental groups", "description": "Heart rate measure with Polar device", "time_frame": "Week 0 (baseline) and Week 4 (endpoint)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in neuropsychological assessment between experimental groups", "description": "A battery of neuropsychological tests to assess memory, attention, executive functions and mood.", "time_frame": "Week 0 (baseline) and Week 4 (endpoint)" }, { "type": "secondary", "measure": "Change in pupillary reflex", "description": "Roland system, composed of a Ganzfeld (Roland Consult), with light-emitting diodes responsible for the stimulus and an infrared camera, capable of recording images in the dark with high spatial and temporal resolution, in continuous recording in recording mode at 30 Hz", "time_frame": "Week 0 (baseline) and Week 4 (endpoint)" }, { "type": "secondary", "measure": "Brain changes using multimodal magnetic resonance imaging (MRI)", "description": "Functional and structural MRI scans", "time_frame": "Week 0 (baseline)" }, { "type": "secondary", "measure": "Change in heart rate variability (HRV) between experimental groups", "description": "Heart rate measure with Polar device", "time_frame": "Week 0 (baseline) and Week 4 (endpoint)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05389592", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04842448", "title": "Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2024-08-22", "start_date": "2021-09-15", "completion_date": "2024-06-17", "primary_completion_date": "2023-09-27", "conditions_raw": [ "COVID-19", "Post COVID-19 Condition", "Post COVID-19 Condition, Unspecified", "Post COVID Condition", "Post-COVID Syndrome", "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Hyperbaric Oxygen Therapy (HBOT)" ], "sponsor": "Karolinska University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID Syndrome (Long COVID), Post Acute COVID-19 Syndrome (PACS) or Post COVID-19 Syndrome (PCS) is defined as 'signs and symptoms that develop during or following an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis'. 1 in 10 infected individuals may suffer persistent symptoms, and we are facing an emerging problem that will severely affect individuals, health care systems and society for years to come.\n\nWe explore hyperbaric oxygen administered in a randomized placebo-controlled clinical trial as a potential treatment for patients suffering from Long COVID.\n\nThe overall hypothesis to be evaluated is that hyperbaric oxygen (HBO2) alleviates symptoms associated with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "RAND 36 change", "description": "Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical health (RP) and physical functioning (PF).\n\nRAND 36 is a self-reporting questionnaire that contains 36 items that measure eight concepts of health in general terms, at present and past four weeks. Numeric values from the survey are coded so that all items are scored from 0 (lowest score) to 100 (highest possible score). Scores then represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the eight scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.", "time_frame": "Baseline and 13 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Endothelial dysfunction", "description": "Mean change from baseline to 13 weeks in Reactive Hyperemia Index (RHI)", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "6-min walk test", "description": "Mean change from baseline to 13 weeks in the 6-min walk test", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "30/60 min chair stand", "description": "Mean change from baseline to 13 weeks in the 30/60 sec chair stand", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "EQ-5D", "description": "Mean change from baseline to 13 weeks in EQ-5D.\n\nEuroQol-5 Dimensions questionnaire is a widely used self-reporting questionnaire that measure 5 dimensions of health TODAY at three or five levels (EQ-5D-3L or EQ-5D-5L) of severity; no problems, some/moderate problems and extreme problems/unable.The health dimensions are mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS) 0-100 which it used as a quantitative measure of overall health status. EQ-5D is the most widely used questionnaire for health-economic evaluation.", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "RAND 36 normalization", "description": "Proportion of subjects with a normalisation of levels in RAND-36 domains role limitations due to physical health and physical functioning respectively, at 13 weeks.", "time_frame": "Baseline and 13 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "RAND 36 change", "description": "Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical health (RP) and physical functioning (PF).\n\nRAND 36 is a self-reporting questionnaire that contains 36 items that measure eight concepts of health in general terms, at present and past four weeks. Numeric values from the survey are coded so that all items are scored from 0 (lowest score) to 100 (highest possible score). Scores then represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the eight scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "Endothelial dysfunction", "description": "Mean change from baseline to 13 weeks in Reactive Hyperemia Index (RHI)", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "6-min walk test", "description": "Mean change from baseline to 13 weeks in the 6-min walk test", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "30/60 min chair stand", "description": "Mean change from baseline to 13 weeks in the 30/60 sec chair stand", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "EQ-5D", "description": "Mean change from baseline to 13 weeks in EQ-5D.\n\nEuroQol-5 Dimensions questionnaire is a widely used self-reporting questionnaire that measure 5 dimensions of health TODAY at three or five levels (EQ-5D-3L or EQ-5D-5L) of severity; no problems, some/moderate problems and extreme problems/unable.The health dimensions are mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS) 0-100 which it used as a quantitative measure of overall health status. EQ-5D is the most widely used questionnaire for health-economic evaluation.", "time_frame": "Baseline and 13 weeks" }, { "type": "secondary", "measure": "RAND 36 normalization", "description": "Proportion of subjects with a normalisation of levels in RAND-36 domains role limitations due to physical health and physical functioning respectively, at 13 weeks.", "time_frame": "Baseline and 13 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04842448", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05813899", "title": "Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome", "status": "TERMINATED", "phase": "NA", "last_updated": "2024-08-15", "start_date": "2023-01-16", "completion_date": "2024-04-30", "primary_completion_date": "2023-12-31", "conditions_raw": [ "Post-COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ps23 Heat-Treated" ], "sponsor": "Mackay Memorial Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "To evaluate whether probiotics PS23 can improve the symptoms of patients with long COVID-19 ; also to evaluate the effects on blood cortisol and inflammation-related indicators in patients.", "primary_outcomes": [ { "type": "primary", "measure": "Clinical Global Impression scales of Severity rated by clinician（CGI）", "description": "The CGIC is a single-item questionnaire that asks the investigator to assess a patient's TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as \"much improved\" or \"very much improved\" at the week 6 visit.", "time_frame": "From Baseline to 6 Weeks Assessed" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Wechsler Adult Intelligence Scale 4th version", "description": "The WAIS-IV is a measure of cognitive function in older adolescents and adults. Participants complete the Digit Span subtest, which measures auditory working memory for numerical information.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Color Trails Test（CTT）", "description": "There are two subtests: CTT1 \\& CTT2. The time spend to complete the two subtest is used representing executive function of the participants.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Insomnia Severity Index（ISI）", "description": "The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16", "description": "The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "State and Trait Anxiety Index (STAI)", "description": "The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from \"Almost Never\" to \"Almost Always\"). Higher scores indicate greater anxiety.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Patient Heath Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool.Depression Severity: 0- none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Visual Analogue Scale-GI (VAS-GI)", "description": "Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics or placebo.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Patient Global Impression scales of Improvement rated by patient（PGI-C）", "description": "The PGIC consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome.", "time_frame": "From Baseline to 6 Weeks Assessed" } ], "outcome_measures": [ { "type": "primary", "measure": "Clinical Global Impression scales of Severity rated by clinician（CGI）", "description": "The CGIC is a single-item questionnaire that asks the investigator to assess a patient's TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as \"much improved\" or \"very much improved\" at the week 6 visit.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Wechsler Adult Intelligence Scale 4th version", "description": "The WAIS-IV is a measure of cognitive function in older adolescents and adults. Participants complete the Digit Span subtest, which measures auditory working memory for numerical information.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Color Trails Test（CTT）", "description": "There are two subtests: CTT1 \\& CTT2. The time spend to complete the two subtest is used representing executive function of the participants.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Insomnia Severity Index（ISI）", "description": "The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16", "description": "The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "State and Trait Anxiety Index (STAI)", "description": "The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from \"Almost Never\" to \"Almost Always\"). Higher scores indicate greater anxiety.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Patient Heath Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool.Depression Severity: 0- none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Visual Analogue Scale-GI (VAS-GI)", "description": "Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics or placebo.", "time_frame": "From Baseline to 6 Weeks Assessed" }, { "type": "secondary", "measure": "Patient Global Impression scales of Improvement rated by patient（PGI-C）", "description": "The PGIC consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome.", "time_frame": "From Baseline to 6 Weeks Assessed" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 39, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05813899", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06535165", "title": "Effect of Red Beetroot Juice Intake in Adults With Long COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-08-05", "start_date": "2021-03-01", "completion_date": "2021-07-31", "primary_completion_date": "2021-07-31", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Red Beetroot Juice" ], "sponsor": "Catholic University of the Sacred Heart", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Red beetroot juice may have positive effects on multiple pathways involved in long COVID. The aim of this pilot study was to explore the impact of beetroot juice supplementation on physical function, gut microbiota, and systemic inflammation in adults with long-COVID", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue resistance", "description": "The time (in seconds) when the pressure dropped to 50% of the maximum grip strength", "time_frame": "14 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Six-minute walk test", "description": "The distance walked (in meters) on the 6-min walk test", "time_frame": "14 days" }, { "type": "secondary", "measure": "Flow-mediated dilation", "description": "the dilation of the brachial artery after a transitory bout of forearm ischemia", "time_frame": "14 days" }, { "type": "secondary", "measure": "Changes in the concentration of gut microbial species", "description": "Changes in the concentration of gut microbial species as assessed through 16S rRNA analysis", "time_frame": "14 days" }, { "type": "secondary", "measure": "Fecal water metabolomics", "description": "Changes in fecal water metabolomics by nuclear magnetic resonance (NMR) spectroscopy", "time_frame": "14 days" }, { "type": "secondary", "measure": "Changes in the concentration of circulating inflammatory mediators", "description": "Changes in the concentration of circulating cytokines, chemokines, growth factors, extracellular vesicles", "time_frame": "14 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue resistance", "description": "The time (in seconds) when the pressure dropped to 50% of the maximum grip strength", "time_frame": "14 days" }, { "type": "secondary", "measure": "Six-minute walk test", "description": "The distance walked (in meters) on the 6-min walk test", "time_frame": "14 days" }, { "type": "secondary", "measure": "Flow-mediated dilation", "description": "the dilation of the brachial artery after a transitory bout of forearm ischemia", "time_frame": "14 days" }, { "type": "secondary", "measure": "Changes in the concentration of gut microbial species", "description": "Changes in the concentration of gut microbial species as assessed through 16S rRNA analysis", "time_frame": "14 days" }, { "type": "secondary", "measure": "Fecal water metabolomics", "description": "Changes in fecal water metabolomics by nuclear magnetic resonance (NMR) spectroscopy", "time_frame": "14 days" }, { "type": "secondary", "measure": "Changes in the concentration of circulating inflammatory mediators", "description": "Changes in the concentration of circulating cytokines, chemokines, growth factors, extracellular vesicles", "time_frame": "14 days" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 31, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06535165", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06379672", "title": "Resonance Breathing Training for Long Covid-related Myocardial Injury", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-07-30", "start_date": "2024-08-25", "completion_date": "2024-10-05", "primary_completion_date": "2024-09-25", "conditions_raw": [ "Long COVID", "Myocardial Injury" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Resonance Breathing" ], "sponsor": "Chengdu Sport University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury", "primary_outcomes": [ { "type": "primary", "measure": "New YorkHeart Association (NYHA)", "description": "The scale is divided into four levels\n\nGrade 1 is unrestricted activity. Daily physical activity does not cause significant shortness of breath, fatigue or palpitations Grade 2 is a mild limitation of activity. Asymptomatic at rest, daily activities may cause significant shortness of breath, fatigue or palpitations Grade 3 is marked limitation of activity. May be asymptomatic at rest, but may cause significant shortness of breath, fatigue, or palpitations with less than daily activity.\n\nGrade 4 is symptomatic at rest, with discomfort associated with any physical activity. Class IVa for those who can move around indoors or at the bedside without intravenous drug administration; Class IVb for those who cannot get out of bed and require intravenous drug administration.", "time_frame": "12weeks" }, { "type": "primary", "measure": "left ventricle global longitudinal strain, LVGLS", "description": "The magnitude of overall longitudinal myocardial strain in the left ventricle on two-dimensional speckle tracking echocardiograms as an average of the peak longitudinal strain in all myocardial segments. The normal range is (-25% to -17%) in men and (-25% to -18%) in women.", "time_frame": "12weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "hypertension", "description": "Blood pressure included both systolic and diastolic blood pressure and was observed before and after the intervention for any reduction in blood pressure.", "time_frame": "12weeks" }, { "type": "secondary", "measure": "Average heart rate", "description": "One-minute average heart rate (at rest).", "time_frame": "12weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "New YorkHeart Association (NYHA)", "description": "The scale is divided into four levels\n\nGrade 1 is unrestricted activity. Daily physical activity does not cause significant shortness of breath, fatigue or palpitations Grade 2 is a mild limitation of activity. Asymptomatic at rest, daily activities may cause significant shortness of breath, fatigue or palpitations Grade 3 is marked limitation of activity. May be asymptomatic at rest, but may cause significant shortness of breath, fatigue, or palpitations with less than daily activity.\n\nGrade 4 is symptomatic at rest, with discomfort associated with any physical activity. Class IVa for those who can move around indoors or at the bedside without intravenous drug administration; Class IVb for those who cannot get out of bed and require intravenous drug administration.", "time_frame": "12weeks" }, { "type": "primary", "measure": "left ventricle global longitudinal strain, LVGLS", "description": "The magnitude of overall longitudinal myocardial strain in the left ventricle on two-dimensional speckle tracking echocardiograms as an average of the peak longitudinal strain in all myocardial segments. The normal range is (-25% to -17%) in men and (-25% to -18%) in women.", "time_frame": "12weeks" }, { "type": "secondary", "measure": "hypertension", "description": "Blood pressure included both systolic and diastolic blood pressure and was observed before and after the intervention for any reduction in blood pressure.", "time_frame": "12weeks" }, { "type": "secondary", "measure": "Average heart rate", "description": "One-minute average heart rate (at rest).", "time_frame": "12weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 70, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06379672", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05597722", "title": "Addressing Cognitive Fog in Long-COVID-19 Patients", "status": "TERMINATED", "phase": "PHASE4", "last_updated": "2024-07-22", "start_date": "2023-04-04", "completion_date": "2023-05-18", "primary_completion_date": "2023-05-18", "conditions_raw": [ "Cognitive Impairment", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Digital Cognitive Behavioral Intervention-Rxwell", "Amphetamine-Dextroamphetamine" ], "sponsor": "Eva Szigethy", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will assess two options to help patients better manage the cognitive fog and emotional distress that may be associated with having Long-COVID. Long-COVID is post-COVID conditions or symptoms lasting more than four weeks after infection. Clinicians from the UPMC Long-COVID Clinic leading this study are evaluating the utility of computer-based evaluation of COVID-related cognitive fog and the helpfulness of two intervention strategies to treat moderate cognitive impairment using a randomized trial. The two intervention strategies include 1) a standardized dosing of amphetamine/dextroamphetamine medication that has been used to improve cognitive fog; and 2) a digital behavioral tool with an embedded health coach that is used on a mobile phone.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Cognitive Impairment - MOCA", "description": "The MOCA is a validated screening tool that provides a total score to assess for mild cognitive impairment.", "time_frame": "Compare baseline to 12 weeks" }, { "type": "primary", "measure": "Change in Cognitive Impairment - BrainCheck", "description": "BrainCheck is an FDA approved validated, automated, remote neurocognitive assessments in multiple domains.", "time_frame": "Compare baseline to 12 weeks" }, { "type": "primary", "measure": "Change in Cognitive Impairment - ImPACT", "description": "ImPACT is an FDA approved computerized neurocognitive concussion assessment tool that provides composite sores to evaluate cognitive abilities.", "time_frame": "Compare baseline to 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Depression - PHQ8", "description": "Patient Health Questionnaire (PHQ8) will be utilized to measure change in depression severity from baseline up to 12 weeks after baseline.\n\nThe PHQ-8 is an 8 item questionnaire. Scores can range from 0-24. A score of 0-4 indicates no depressive symptoms; 5-9 indicates mild depressive symptoms; 10-19 indicates moderate depressive symptoms; 20-24 indicates severe depressive symptoms.", "time_frame": "Compare baseline up to 12 weeks" }, { "type": "secondary", "measure": "Change in Quality of Life - SWLS", "description": "Satisfaction with Life Scale (SWLS) will be utilized to measure change in quality of life from baseline up to 12 weeks after baseline.\n\nSWLS is a five item measure with a maximum score of 35. Higher score correlate with higher satisfaction of life. Scores 31-35 extremely satisfied. Scores less than 9 indicate extremely dissatisfied.", "time_frame": "Compare baseline up to 12 weeks" }, { "type": "secondary", "measure": "Change in Disability", "description": "Sheehan Disability Scale assess functional impairment in three inter-related domains; work/school, social and family life. The three items are summed into a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).", "time_frame": "Compare baseline up to 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Cognitive Impairment - MOCA", "description": "The MOCA is a validated screening tool that provides a total score to assess for mild cognitive impairment.", "time_frame": "Compare baseline to 12 weeks" }, { "type": "primary", "measure": "Change in Cognitive Impairment - BrainCheck", "description": "BrainCheck is an FDA approved validated, automated, remote neurocognitive assessments in multiple domains.", "time_frame": "Compare baseline to 12 weeks" }, { "type": "primary", "measure": "Change in Cognitive Impairment - ImPACT", "description": "ImPACT is an FDA approved computerized neurocognitive concussion assessment tool that provides composite sores to evaluate cognitive abilities.", "time_frame": "Compare baseline to 12 weeks" }, { "type": "secondary", "measure": "Change in Depression - PHQ8", "description": "Patient Health Questionnaire (PHQ8) will be utilized to measure change in depression severity from baseline up to 12 weeks after baseline.\n\nThe PHQ-8 is an 8 item questionnaire. Scores can range from 0-24. A score of 0-4 indicates no depressive symptoms; 5-9 indicates mild depressive symptoms; 10-19 indicates moderate depressive symptoms; 20-24 indicates severe depressive symptoms.", "time_frame": "Compare baseline up to 12 weeks" }, { "type": "secondary", "measure": "Change in Quality of Life - SWLS", "description": "Satisfaction with Life Scale (SWLS) will be utilized to measure change in quality of life from baseline up to 12 weeks after baseline.\n\nSWLS is a five item measure with a maximum score of 35. Higher score correlate with higher satisfaction of life. Scores 31-35 extremely satisfied. Scores less than 9 indicate extremely dissatisfied.", "time_frame": "Compare baseline up to 12 weeks" }, { "type": "secondary", "measure": "Change in Disability", "description": "Sheehan Disability Scale assess functional impairment in three inter-related domains; work/school, social and family life. The three items are summed into a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).", "time_frame": "Compare baseline up to 12 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 4", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 7, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05597722", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05200858", "title": "Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-07-16", "start_date": "2022-03-01", "completion_date": "2023-12-01", "primary_completion_date": "2023-10-01", "conditions_raw": [ "Postacute Sequelae of Sars-CoV-2", "Post-Acute COVID-19 Syndrome", "Widespread Chronic Pain", "Fatigue Syndrome, Chronic", "Gait, Unsteady" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Tens - High-Dose", "Tens - Low-Dose" ], "sponsor": "Baylor College of Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of the pilot study is to examine acceptability and proof of concept effectiveness of a wireless TENS technology to address PASC associated FM. Sample size (n=30) is convenient and designed to explore acceptability and feasibility. Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize TENS low-dose devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 4 weeks. Then, the patients will come back after four weeks (4W). At this 4th week visit, both groups will be unblinded and the IG will keep their high-dose TENS device and the PG group will switch from a low-dose TENS to a high-dose TENS device. Both groups will continue to deliver 3-5 hour of stimulation daily, until their final 8th week follow up visit (8W). The primary outcome will be pain. Secondary outcomes include fatigue, limb strength and perfusion, gait assessment (cadence, stride time, double support), balance, pulse oximetry, and quality of life. The coordinator will utilize a weekly spreadsheet showing utilization (therapy sessions/day, logged in the Quell health Cloud) so compliance can be monitored and those that are not using the device can be encouraged.", "primary_outcomes": [ { "type": "primary", "measure": "Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase)", "description": "Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere.", "time_frame": "baseline to 4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Mean Change in Pain Severity From Baseline to 4 Weeks (Blinded Phase)", "description": "Pain severity will be assessed using the Brief Pain Inventory questionnaire composite score for severity. The maximum score is 10, meaning pain as bad as one can imagine, while the minimum score is zero, meaning no pain.", "time_frame": "Baseline to 4 weeks" }, { "type": "secondary", "measure": "Mean Change in Functional Interference From Fatigue From Baseline to 4 Weeks (Blinded Phase)", "description": "Functional interference from fatigue will be assessed calculating the Global Fatigue Index (GFI) obtained from a validated questionnaire called Multidimensional Assessment Fatigue, which has a minimum score of 0 (no fatigue) and a maximum sore of 100 (severe fatigue).", "time_frame": "Baseline to 4 weeks" }, { "type": "secondary", "measure": "Stride Time at 4 Weeks During a Simple Walking Task (Blinded Phase)", "description": "Stride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.", "time_frame": "at 4 weeks" }, { "type": "secondary", "measure": "Cadence at 4 Weeks During a Simple Walking Task (Blinded Phase)", "description": "Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.", "time_frame": "at 4 weeks" }, { "type": "secondary", "measure": "Double Support Phase at 4 Weeks During a Simple Walking Task (Blinded Phase)", "description": "Double Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.", "time_frame": "at 4 weeks" }, { "type": "secondary", "measure": "Cadence at 4 Weeks During a Dual Walking Task (Blinded Phase)", "description": "Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.", "time_frame": "at 4 weeks" }, { "type": "secondary", "measure": "Cadence at 4 Weeks During a Fast Walking Task (Blinded Phase)", "description": "Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Cadence is defined as rate of number of steps per minute.", "time_frame": "at 4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase)", "description": "Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere.", "time_frame": "baseline to 4 weeks" }, { "type": "secondary", "measure": "Mean Change in Pain Severity From Baseline to 4 Weeks (Blinded Phase)", "description": "Pain severity will be assessed using the Brief Pain Inventory questionnaire composite score for severity. The maximum score is 10, meaning pain as bad as one can imagine, while the minimum score is zero, meaning no pain.", "time_frame": "Baseline to 4 weeks" }, { "type": "secondary", "measure": "Mean Change in Functional Interference From Fatigue From Baseline to 4 Weeks (Blinded Phase)", "description": "Functional interference from fatigue will be assessed calculating the Global Fatigue Index (GFI) obtained from a validated questionnaire called Multidimensional Assessment Fatigue, which has a minimum score of 0 (no fatigue) and a maximum sore of 100 (severe fatigue).", "time_frame": "Baseline to 4 weeks" }, { "type": "secondary", "measure": "Stride Time at 4 Weeks During a Simple Walking Task (Blinded Phase)", "description": "Stride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.", "time_frame": "at 4 weeks" }, { "type": "secondary", "measure": "Cadence at 4 Weeks During a Simple Walking Task (Blinded Phase)", "description": "Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.", "time_frame": "at 4 weeks" }, { "type": "secondary", "measure": "Double Support Phase at 4 Weeks During a Simple Walking Task (Blinded Phase)", "description": "Double Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.", "time_frame": "at 4 weeks" }, { "type": "secondary", "measure": "Cadence at 4 Weeks During a Dual Walking Task (Blinded Phase)", "description": "Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.", "time_frame": "at 4 weeks" }, { "type": "secondary", "measure": "Cadence at 4 Weeks During a Fast Walking Task (Blinded Phase)", "description": "Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Cadence is defined as rate of number of steps per minute.", "time_frame": "at 4 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05200858", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05690503", "title": "Glutamatergic Modulation as a Treatment for Depressive Symptoms Among Patients With Post-acute Sequelae of COVID (PASC): A Pilot Trial", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2024-07-16", "start_date": "2023-03-20", "completion_date": "2025-12-31", "primary_completion_date": "2025-06-30", "conditions_raw": [ "Post-acute Sequelae of COVID-19", "Depressive Symptoms", "Cognitive Dysfunction" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ci-581A", "Ci-581B" ], "sponsor": "New York State Psychiatric Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Post-acute sequelae of SARS-CoV2 (PASC), colloquially known as \"long-COVID,\" is thought to affect between 10-30% of all COVID-19 survivors. Patients with PASC also report worsening behavioral health symptoms over time that include new-onset depression, anxiety, and even suicidal behavior. The purpose of this randomized, double-blind, controlled trial is to test the efficacy of a glutamate modulator among PASC patients suffering from new-onset or worsening of depressive symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Reduction in depressive symptoms", "description": "", "time_frame": "from baseline to week 5." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Improvement in neurocognitive symptoms of PASC", "description": "", "time_frame": "from baseline to week 5." } ], "outcome_measures": [ { "type": "primary", "measure": "Reduction in depressive symptoms", "description": "", "time_frame": "from baseline to week 5." }, { "type": "secondary", "measure": "Improvement in neurocognitive symptoms of PASC", "description": "", "time_frame": "from baseline to week 5." } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 12, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05690503", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06054438", "title": "Examining the Function of Cs4 on Post-COVID-19 Disorders", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-07-09", "start_date": "2023-04-17", "completion_date": "2024-03-31", "primary_completion_date": "2024-03-31", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Chinese Medicine Nutritional Supplement Cs4" ], "sponsor": "The University of Hong Kong", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Cordyceps is a medicinal Chinese medicine. The benefits of cordyceps-related therapeutic action have been studied due to its anti-inflammation and immunomodulation features. Thus, Cordyceps may have efficacy against health problems in the post-COVID era. the Cs4 is a Chinese medicine nutritional supplement fermented by Cordyceps. This Project conducts a two-stage waitlist-controlled trial to examine the therapeutic effect of the Cs4 on long-COVID patients. 110 Patients will be recruited and divided into two groups. Each group contains 55 patients. In the first-stage clinical trial for 12 weeks, group A will have treatment while group B will have no Cs4 treatment. In the second-stage clinical trial for 12 weeks, group A will have no Cs4 treatment while group B will have Cs4 treatment. A 12-week follow-up will be conducted after the intervention of Cs4 for group A. The primary outcome will be the change from 0 to 12 weeks in symptom severity measured by self-declared modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm). In our study, we intend to analyse the efficacy of Cs4 on the improvement of long Covid symptoms by using a comprehensive measurement to cover most symptoms, and be condition-specific. The secondary outcomes will include the change from 0 to 12 weeks of Insomnia Severity Index (ISI), Brief Fatigue Inventory Form, St. George's Respiratory Questionnaire (SGRQ), Hospital Anxiety and Depression Scale (HADS), and the Short Form 12 (SF12). Blood tests will be assessed for safety study. primary outcomes and secondary outcomes will be assessed at baseline (week 0) and week 12. The anticipated outcome of the study is to provide evidence of Cs4 in the improvement of long COVID symptoms. This project can serve to the development of a nutritional supplement for the management of post-COVID-related health problems.", "primary_outcomes": [ { "type": "primary", "measure": "the change in symptom severity from 0 to 12 weeks measured by the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)", "description": "Symptom severity is one of the sub-scale of C19-YRSm. Range 0-78, with higher scores indicating greater impact of symptoms. C19-YRSm is the first validated scale describing post-COVID-19 symptoms and grading the severity of symptoms and functional disability.", "time_frame": "will be assessed at baseline and 12 weeks." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "the change in Insomnia Severity Index (ISI) from 0 to 12 weeks", "description": "To evaluate insomnia. Maximum values: 28, minimum values:0. Higher scores mean a worse outcome.", "time_frame": "will be assessed at baseline and 12 weeks." }, { "type": "secondary", "measure": "the change in Brief Fatigue Inventory Form (BFI) from 0 to 12 weeks", "description": "To evaluate fatigue. Maximum values: 10, minimum values:0. Higher scores mean a worse outcome.", "time_frame": "will be assessed at baseline and 12 weeks." }, { "type": "secondary", "measure": "the change in St. George's Respiratory Questionnaire (SGRQ) from 0 to 12 weeks", "description": "To evaluate respiratory symptoms. Maximum values: 100, minimum values:0. Higher scores mean a worse outcome.", "time_frame": "will be assessed at baseline and 12 weeks." }, { "type": "secondary", "measure": "the change in Hospital Anxiety and Depression Scale (HADS) from 0 to 12 weeks", "description": "To evaluate anxiety and depression. Maximum values: 21, minimum values:0. Higher scores mean a worse outcome.", "time_frame": "will be assessed at baseline and 12 weeks." }, { "type": "secondary", "measure": "the change in Short Form 12 (SF12) from 0 to 12 weeks", "description": "To evaluate overall quality of life. Maximum values: 100, minimum values:0. Higher scores mean better physical and mental health functioning.", "time_frame": "will be assessed at baseline and 12 weeks." } ], "outcome_measures": [ { "type": "primary", "measure": "the change in symptom severity from 0 to 12 weeks measured by the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)", "description": "Symptom severity is one of the sub-scale of C19-YRSm. Range 0-78, with higher scores indicating greater impact of symptoms. C19-YRSm is the first validated scale describing post-COVID-19 symptoms and grading the severity of symptoms and functional disability.", "time_frame": "will be assessed at baseline and 12 weeks." }, { "type": "secondary", "measure": "the change in Insomnia Severity Index (ISI) from 0 to 12 weeks", "description": "To evaluate insomnia. Maximum values: 28, minimum values:0. Higher scores mean a worse outcome.", "time_frame": "will be assessed at baseline and 12 weeks." }, { "type": "secondary", "measure": "the change in Brief Fatigue Inventory Form (BFI) from 0 to 12 weeks", "description": "To evaluate fatigue. Maximum values: 10, minimum values:0. Higher scores mean a worse outcome.", "time_frame": "will be assessed at baseline and 12 weeks." }, { "type": "secondary", "measure": "the change in St. George's Respiratory Questionnaire (SGRQ) from 0 to 12 weeks", "description": "To evaluate respiratory symptoms. Maximum values: 100, minimum values:0. Higher scores mean a worse outcome.", "time_frame": "will be assessed at baseline and 12 weeks." }, { "type": "secondary", "measure": "the change in Hospital Anxiety and Depression Scale (HADS) from 0 to 12 weeks", "description": "To evaluate anxiety and depression. Maximum values: 21, minimum values:0. Higher scores mean a worse outcome.", "time_frame": "will be assessed at baseline and 12 weeks." }, { "type": "secondary", "measure": "the change in Short Form 12 (SF12) from 0 to 12 weeks", "description": "To evaluate overall quality of life. Maximum values: 100, minimum values:0. Higher scores mean better physical and mental health functioning.", "time_frame": "will be assessed at baseline and 12 weeks." } ], "relevance_tags": [ "Immunomodulatory", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 110, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06054438", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06492798", "title": "Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients", "status": "UNKNOWN", "phase": "PHASE1", "last_updated": "2024-07-09", "start_date": "2023-09-01", "completion_date": "2026-08-31", "primary_completion_date": "2025-07-01", "conditions_raw": [ "Long COVID", "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Umbilical Cord Mesenchymal Stem Cell" ], "sponsor": "Changhai Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to evaluate the effectiveness and safety of mesenchymal stem cell therapy in long-COVID patients. The main questions it aims to answer include:\n\n* whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients\n* whether umbilical cord mesenchymal stem cell therapy is safe for long-COVID patients.\n\nParticipants' demographics, chief complaints, and vital signs will be collected and recorded. Basic physical examinations, bloodwork routine, biochemical indexes, oxygen saturation (SpO2) levels, 6-minute walk tests, high-resolution computed tomography (HRCT) scan (if necessary) results will be conducted.\n\nParticipants will receive either an intravenous infusion of mesenchymal stem cells, or a placebo for one time. Participants' symptoms will be assessed on Day 28 of the trial. If there is no significant effect, an additional infusion will be given on Days 35-42, and the symptoms will be reassessed 28 days after that.\n\nContinuous nebulized inhalation of UCMSC-derived exosomes will be administered for 5 days twice daily to treatment group, with no treatment given to the control group. Researchers will compare data and information collected from the treatment and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.", "primary_outcomes": [ { "type": "primary", "measure": "Common Terminology Criteria for Adverse Events (CTCAE5.0)", "description": "CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.", "time_frame": "28th day" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Common Terminology Criteria for Adverse Events (CTCAE5.0)", "description": "CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.", "time_frame": "12th week, 24th week" } ], "outcome_measures": [ { "type": "primary", "measure": "Common Terminology Criteria for Adverse Events (CTCAE5.0)", "description": "CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.", "time_frame": "28th day" }, { "type": "secondary", "measure": "Common Terminology Criteria for Adverse Events (CTCAE5.0)", "description": "CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.", "time_frame": "12th week, 24th week" } ], "relevance_tags": [ "General", "Phase 1", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 76, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06492798", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06113679", "title": "Pilot Randomized Study of RD-X19 Tx Device in Subjects With PCC (Long Covid) in the Outpatient Setting", "status": "TERMINATED", "phase": "NA", "last_updated": "2024-07-05", "start_date": "2023-10-30", "completion_date": "2024-06-21", "primary_completion_date": "2024-05-24", "conditions_raw": [ "Post COVID-19 Condition (PCC)" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rdx-19" ], "sponsor": "EmitBio Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Duration of Treatment: 7 days, 2 times per day.\n\nFollowing Randomization on Week 1 Day 1, Subjects will continue to have televisits and rate symptoms and upright activity weekly during a 5 week follow up. Subjects will be followed via in clinic visits at week 2/day 8 (+3/-0 days) and Week 6 / day 36, (+3/-3days). Subjects will receive a weekly televisit during Week 3 / day 15 (+3/-3), Week 4 / day 22 (+3/-3), and Week 5 / day 29 (+3/-3).", "primary_outcomes": [ { "type": "primary", "measure": "Primary Symptom Improvement", "description": "Improvement of one or more primary PCC signs/symptom(s) - cough, fatigue, shortness of breath, cognitive dysfunction/brain fog as compared to sham, with or without fluctuation.", "time_frame": "5 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Secondary Symptom Improvement", "description": "Improvement of one or more secondary PCC signs/symptoms as compared to sham, with or without fluctuation:\n\n* chest pain\n* altered smell/taste\n* headache\n* joint pain\n* muscle pain/spasms\n* post exertional malaise\n* sleep disorders\n* tachycardia/palpitations,and\n* GI/abdominal symptoms (include but not limited to abdominal pain, nausea, diarrhea, vomiting).", "time_frame": "5 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Primary Symptom Improvement", "description": "Improvement of one or more primary PCC signs/symptom(s) - cough, fatigue, shortness of breath, cognitive dysfunction/brain fog as compared to sham, with or without fluctuation.", "time_frame": "5 weeks" }, { "type": "secondary", "measure": "Secondary Symptom Improvement", "description": "Improvement of one or more secondary PCC signs/symptoms as compared to sham, with or without fluctuation:\n\n* chest pain\n* altered smell/taste\n* headache\n* joint pain\n* muscle pain/spasms\n* post exertional malaise\n* sleep disorders\n* tachycardia/palpitations,and\n* GI/abdominal symptoms (include but not limited to abdominal pain, nausea, diarrhea, vomiting).", "time_frame": "5 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 41, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06113679", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04695704", "title": "Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19:", "status": "TERMINATED", "phase": "PHASE3", "last_updated": "2024-07-03", "start_date": "2021-08-11", "completion_date": "2023-08-28", "primary_completion_date": "2023-07-24", "conditions_raw": [ "Covid19", "SARS (Disease)" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Montelukast" ], "sponsor": "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Recently, a new clinical presentation called \"long covid\" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations This project aims to evaluate the efficacy of Montelukast in improving the quality of life associated with respiratory symptoms in patients with persistent COVID-19 symptoms. The main objective is to compare the efficacy of low-dose Montelukast versus placebo to improve respiratory symptoms in patients with persistent COVID-19 symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "COP Assessment Test Scale (CAT)", "description": "Quality of life of respiratory symptoms according to COPD Assessment Test (CAT The COPD Assessment Test (CAT) is a questionnaire for people with COPD, designed to measure the impact of COPD on a person's life, and how this changes over time.Quality of life of respiratory symptoms according to COPD Assessment Test (CAT). This is a validated self-administered scale to quantify and monitor the impact of COPD on well-being and daily life. It consists of 8 items (from 0 to 5 points), and a total score of 0-40 (0-9 mild, 10-20 moderate, 21-30 severe and 31-40 very severe), being higher scores worse outcome. A difference of 2 or more points in health status is considered clinically significant.", "time_frame": "7, 14, 21 and 28 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "1min sit-to-stand test", "description": "Exercise capacity: number of repetitions performed in the 1min sit-to-stand test", "time_frame": "14 and 28 days" }, { "type": "secondary", "measure": "O2 desaturation", "description": "O2 desaturation ≥ 4% with effort (1min sit-to-stand test)", "time_frame": "14 and 28 days" }, { "type": "secondary", "measure": "Visual Analogical Scale (VAS)", "description": "Symptoms evaluated using numeric Visual Analogical Scale (VAS): asthenia, headache, ageusia, anosmia, and rhinitis . It is numbered from 0-10, where 0 is the absence and 10 the greatest intensity, meaning higher scores worse outcome. The patient selects the number that best evaluates the intensity of the symptom.", "time_frame": "7, 14, 21 and 28 days" }, { "type": "secondary", "measure": "All-cause mortality", "description": "Mortality from any cause during the study", "time_frame": "7, 14, 21 and 28 days" }, { "type": "secondary", "measure": "Number of visits to primary care", "description": "Number of visits of any kind to primary health care settings (phone visit or face to face visit) during the study period.", "time_frame": "28 days" }, { "type": "secondary", "measure": "Number of visits to the emergency room", "description": "Number of visits to emergency room form primary health o hospital settings during the study period.", "time_frame": "28 days" }, { "type": "secondary", "measure": "Number of hospital admissions.", "description": "Number of hospital admissions during the study period.", "time_frame": "28 days" }, { "type": "secondary", "measure": "Medication side effects", "description": "Number and type of adverse reactions during the study period related to medication.", "time_frame": "7, 14, 21 and 28 days" }, { "type": "secondary", "measure": "Days of sick leave", "description": "Number of days of incapacity for work (sick leave) during the study period.", "time_frame": "28 days" }, { "type": "secondary", "measure": "Factors of inflamatory and prothrombotic processes: D-Dimer, N-terminal prohormone of brain natriuretic peptide (NT Pro-BNP), C-reactive protenin and Antinuclear antibodies (ANA)", "description": "To analyze wether the factors of inflamatory and prothrombotic processes (D-Dimer, Pro-BNP, C-reactive protein, and ANA) at the begining of the study are response predictors to the treatment.", "time_frame": "0 and 28 days" } ], "outcome_measures": [ { "type": "primary", "measure": "COP Assessment Test Scale (CAT)", "description": "Quality of life of respiratory symptoms according to COPD Assessment Test (CAT The COPD Assessment Test (CAT) is a questionnaire for people with COPD, designed to measure the impact of COPD on a person's life, and how this changes over time.Quality of life of respiratory symptoms according to COPD Assessment Test (CAT). This is a validated self-administered scale to quantify and monitor the impact of COPD on well-being and daily life. It consists of 8 items (from 0 to 5 points), and a total score of 0-40 (0-9 mild, 10-20 moderate, 21-30 severe and 31-40 very severe), being higher scores worse outcome. A difference of 2 or more points in health status is considered clinically significant.", "time_frame": "7, 14, 21 and 28 days" }, { "type": "secondary", "measure": "1min sit-to-stand test", "description": "Exercise capacity: number of repetitions performed in the 1min sit-to-stand test", "time_frame": "14 and 28 days" }, { "type": "secondary", "measure": "O2 desaturation", "description": "O2 desaturation ≥ 4% with effort (1min sit-to-stand test)", "time_frame": "14 and 28 days" }, { "type": "secondary", "measure": "Visual Analogical Scale (VAS)", "description": "Symptoms evaluated using numeric Visual Analogical Scale (VAS): asthenia, headache, ageusia, anosmia, and rhinitis . It is numbered from 0-10, where 0 is the absence and 10 the greatest intensity, meaning higher scores worse outcome. The patient selects the number that best evaluates the intensity of the symptom.", "time_frame": "7, 14, 21 and 28 days" }, { "type": "secondary", "measure": "All-cause mortality", "description": "Mortality from any cause during the study", "time_frame": "7, 14, 21 and 28 days" }, { "type": "secondary", "measure": "Number of visits to primary care", "description": "Number of visits of any kind to primary health care settings (phone visit or face to face visit) during the study period.", "time_frame": "28 days" }, { "type": "secondary", "measure": "Number of visits to the emergency room", "description": "Number of visits to emergency room form primary health o hospital settings during the study period.", "time_frame": "28 days" }, { "type": "secondary", "measure": "Number of hospital admissions.", "description": "Number of hospital admissions during the study period.", "time_frame": "28 days" }, { "type": "secondary", "measure": "Medication side effects", "description": "Number and type of adverse reactions during the study period related to medication.", "time_frame": "7, 14, 21 and 28 days" }, { "type": "secondary", "measure": "Days of sick leave", "description": "Number of days of incapacity for work (sick leave) during the study period.", "time_frame": "28 days" }, { "type": "secondary", "measure": "Factors of inflamatory and prothrombotic processes: D-Dimer, N-terminal prohormone of brain natriuretic peptide (NT Pro-BNP), C-reactive protenin and Antinuclear antibodies (ANA)", "description": "To analyze wether the factors of inflamatory and prothrombotic processes (D-Dimer, Pro-BNP, C-reactive protein, and ANA) at the begining of the study are response predictors to the treatment.", "time_frame": "0 and 28 days" } ], "relevance_tags": [ "General", "Phase 3", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 86, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04695704", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05019963", "title": "Enhancing COVID Rehabilitation With Technology", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-07-03", "start_date": "2022-05-02", "completion_date": "2024-09", "primary_completion_date": "2024-08", "conditions_raw": [ "Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Nexj Connected Wellness" ], "sponsor": "University of Ottawa", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) a global pandemic. Ontario has confirmed more than 547,000 cases of COVID-19 since testing began. For many of these patients, symptoms resolve within 4 weeks of onset. However, it is becoming apparent that a significant number of individuals are experiencing symptoms that persist long after the acute infection, known as Long COVID. These individuals have a wide constellation of presenting symptoms, often varying from initial presentation. For this study, we will be enrolling individuals receiving care at The Ottawa Hospital for Long COVID. This study aims to determine the following four things: 1) will adding electronic case management improve quality of life three months after coming to hospital with Long COVID; 2) is the electronic case management platform cost effective; 3) is there any factors that predict outcomes at 3 months; 4) to determine how a personalized rehabilitation program supported by a digital platform could be implemented for individuals with Long COVID. We will enroll individuals from The Ottawa Hospital who will then be randomly assigned to receive either usual care or usual care plus electronic case management, through a platform called NexJ Connected Wellness. Participants will also complete questionnaires every 4 weeks for 3 months. We will be looking at quality of life, mental and physical health, cognitive symptoms, fatigue and pain.", "primary_outcomes": [ { "type": "primary", "measure": "Change in WHODAS 2.0 score", "description": "The WHODAS is the 36-item self report questionnaire measuring health and disability from the previous 30 days across six domains of functioning: cognition, mobility, self-care, getting along, life activities and participation. Responses are scored on a 5 point Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme/Cannot Do (4). Change from baseline to week 12 will be measured as primary outcome.", "time_frame": "Baseline and Week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "WHO Post-COVID CRF", "description": "The WHO Post-COVID CRF will measure characteristics of COVID-19 infection and post-COVID symptoms including demographics, pregnancy, pre-COVID health status, and details about the acute COVID infection, vaccination status, occupational status, functioning, post-COVID symptoms, clinical tests and scales (including neurological, radiographic, blood tests, heart and lung function, mental health, function, and musculoskeletal tests) new diagnoses or complications related to COVID infection, and health service use, symptoms.", "time_frame": "Module 1 will be administered at baseline only. Modules 2 and 3 will be administered at baseline and 12 weeks." }, { "type": "secondary", "measure": "PHQ-9", "description": "A 9-item questionnaire that assesses the severity of depression symptoms experienced within the last two weeks. Participants are asked to rate each symptom of depression on a Likert scale from 0 (not at all) to 3 (nearly every day).", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "GAD-7", "description": "A 7-item questionnaire that assesses the severity of anxiety symptoms experienced within the last two weeks.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "PSQI", "description": "The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality in the previous month and takes 5-10 minutes to complete. It has been translated into over 50 languages.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "PCL-5", "description": "A 20-item self-report measure that assesses the presence and severity of PTSD symptoms, corresponding with DSM-5 criteria for PTSD", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "EQ-5D-5L", "description": "This is a 5-item questionnaire that assesses health-related quality of life, including mobility, self-care, ability to participate in one's usual activities, pain or discomfort, and anxiety or depression and a Visual Analogue Scale (VAS) which asks participants to evaluate their overall health on a scale from 0-100.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "The Fatigue Severity Scale is a 9-item self-report that measures the severity and functional impact of fatigue.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "Fatigue Numeric Rating Scale", "description": "A single item patient reported outcome, scored on a scale of 0-10.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "Pain Numeric Rating Scale", "description": "The Pain Numeric Rating Scale will be used to assess pain intensity using a 0-10 ranking scale, where 0 represents \"no pain\" and 10 \"unbearable pain\".", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "MRC Dyspnoea Scale", "description": "A 5-item self report scale that evaluates statements of perceived breathlessness.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "WEMWBS", "description": "The Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) (short version) is a 7-item scale which measures multiple aspects of mental wellbeing.", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "Oral Trail Making Test A and B", "description": "Used to evaluate executive function, visual attention and task switching in participants. During TMT A, participants will be asked to count down out louad as quickly as they can sequentially, starting at \"1\" until the end. During TMT B, participants will be asked to speak outloud, alternating between numbers and letters (e.g. 1-A-2-B etc).", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "Hopkins Verbal Learning Test-Revised (HVLT-R)", "description": "The Hopkins Verbal Learning Test-Revised (HVLT-R) will be used to evaluate verbal learning and memory capabilities in participants33. The HVLT consists of a 12-item word list, composed of four words from each of three semantic categories.", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "Digit Span subset", "description": "The Digit Span subset, a component of the Working Memory Index of the Weschler's Adult Intelligence Scale - 4th Edition (WAIS-IV), will be used to assess attention and working memory34. Participants will be read a series of numbers and then asked to recall the numbers to the examiner in order (forward span), in reverse order (backward span) and in sequence (sequence span).", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "Phonemic and Semantic Verbal Fluency (or Controlled Oral Word Association Test)", "description": "The Phonemic and Semantic Verbal Fluency (or Controlled Oral Word Association Test) test will be used to assess verbal fluency. Participants will be given one minute to produce as many unique words as possible: 1) within a semantic category (category fluency for Animals); and 2) starting with a given letter (letter fluency for letters F, A and S).", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "AUDIT", "description": "Alcohol use: The AUDIT questionnaire is designed to assess alcohol consumption, drinking behavior, adverse reactions, alcohol-related problems. Among those who were known to misuse alcohol, the AUDIT successfully detected an alcohol use disorder 99% of the time 53. The AUDIT-C is the first 3-items of the AUDIT and will be used as a screening questionnaire. Participants who score above 4 on the AUDIT-C will also be asked to complete the Full AUDIT (the additional seven questions).", "time_frame": "Baseline" }, { "type": "secondary", "measure": "ASSIST", "description": "Alcohol and Substance Use: The ASSIST is a clinical interview collecting information regarding use of tobacco, alcohol, cannabis, cocaine, amphetamine type stimulants, sedatives, hallucinogens, inhalants, opioids, and other drugs. Internal Consistency (Chronbach's alpha) was over 0.80 for the majority of domains and good concurrent validity", "time_frame": "Baseline" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in WHODAS 2.0 score", "description": "The WHODAS is the 36-item self report questionnaire measuring health and disability from the previous 30 days across six domains of functioning: cognition, mobility, self-care, getting along, life activities and participation. Responses are scored on a 5 point Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme/Cannot Do (4). Change from baseline to week 12 will be measured as primary outcome.", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "WHO Post-COVID CRF", "description": "The WHO Post-COVID CRF will measure characteristics of COVID-19 infection and post-COVID symptoms including demographics, pregnancy, pre-COVID health status, and details about the acute COVID infection, vaccination status, occupational status, functioning, post-COVID symptoms, clinical tests and scales (including neurological, radiographic, blood tests, heart and lung function, mental health, function, and musculoskeletal tests) new diagnoses or complications related to COVID infection, and health service use, symptoms.", "time_frame": "Module 1 will be administered at baseline only. Modules 2 and 3 will be administered at baseline and 12 weeks." }, { "type": "secondary", "measure": "PHQ-9", "description": "A 9-item questionnaire that assesses the severity of depression symptoms experienced within the last two weeks. Participants are asked to rate each symptom of depression on a Likert scale from 0 (not at all) to 3 (nearly every day).", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "GAD-7", "description": "A 7-item questionnaire that assesses the severity of anxiety symptoms experienced within the last two weeks.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "PSQI", "description": "The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality in the previous month and takes 5-10 minutes to complete. It has been translated into over 50 languages.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "PCL-5", "description": "A 20-item self-report measure that assesses the presence and severity of PTSD symptoms, corresponding with DSM-5 criteria for PTSD", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "EQ-5D-5L", "description": "This is a 5-item questionnaire that assesses health-related quality of life, including mobility, self-care, ability to participate in one's usual activities, pain or discomfort, and anxiety or depression and a Visual Analogue Scale (VAS) which asks participants to evaluate their overall health on a scale from 0-100.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "The Fatigue Severity Scale is a 9-item self-report that measures the severity and functional impact of fatigue.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "Fatigue Numeric Rating Scale", "description": "A single item patient reported outcome, scored on a scale of 0-10.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "Pain Numeric Rating Scale", "description": "The Pain Numeric Rating Scale will be used to assess pain intensity using a 0-10 ranking scale, where 0 represents \"no pain\" and 10 \"unbearable pain\".", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "MRC Dyspnoea Scale", "description": "A 5-item self report scale that evaluates statements of perceived breathlessness.", "time_frame": "Baseline, Week 4, Week8 and Week 12" }, { "type": "secondary", "measure": "WEMWBS", "description": "The Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) (short version) is a 7-item scale which measures multiple aspects of mental wellbeing.", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "Oral Trail Making Test A and B", "description": "Used to evaluate executive function, visual attention and task switching in participants. During TMT A, participants will be asked to count down out louad as quickly as they can sequentially, starting at \"1\" until the end. During TMT B, participants will be asked to speak outloud, alternating between numbers and letters (e.g. 1-A-2-B etc).", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "Hopkins Verbal Learning Test-Revised (HVLT-R)", "description": "The Hopkins Verbal Learning Test-Revised (HVLT-R) will be used to evaluate verbal learning and memory capabilities in participants33. The HVLT consists of a 12-item word list, composed of four words from each of three semantic categories.", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "Digit Span subset", "description": "The Digit Span subset, a component of the Working Memory Index of the Weschler's Adult Intelligence Scale - 4th Edition (WAIS-IV), will be used to assess attention and working memory34. Participants will be read a series of numbers and then asked to recall the numbers to the examiner in order (forward span), in reverse order (backward span) and in sequence (sequence span).", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "Phonemic and Semantic Verbal Fluency (or Controlled Oral Word Association Test)", "description": "The Phonemic and Semantic Verbal Fluency (or Controlled Oral Word Association Test) test will be used to assess verbal fluency. Participants will be given one minute to produce as many unique words as possible: 1) within a semantic category (category fluency for Animals); and 2) starting with a given letter (letter fluency for letters F, A and S).", "time_frame": "Baseline and Week 12" }, { "type": "secondary", "measure": "AUDIT", "description": "Alcohol use: The AUDIT questionnaire is designed to assess alcohol consumption, drinking behavior, adverse reactions, alcohol-related problems. Among those who were known to misuse alcohol, the AUDIT successfully detected an alcohol use disorder 99% of the time 53. The AUDIT-C is the first 3-items of the AUDIT and will be used as a screening questionnaire. Participants who score above 4 on the AUDIT-C will also be asked to complete the Full AUDIT (the additional seven questions).", "time_frame": "Baseline" }, { "type": "secondary", "measure": "ASSIST", "description": "Alcohol and Substance Use: The ASSIST is a clinical interview collecting information regarding use of tobacco, alcohol, cannabis, cocaine, amphetamine type stimulants, sedatives, hallucinogens, inhalants, opioids, and other drugs. Internal Consistency (Chronbach's alpha) was over 0.80 for the majority of domains and good concurrent validity", "time_frame": "Baseline" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 106, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05019963", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05731570", "title": "Cognitive Rehabilitation for People With Cognitive Covid19", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-06-21", "start_date": "2023-02-14", "completion_date": "2024-09", "primary_completion_date": "2024-07", "conditions_raw": [ "Long Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cognitive Rehabilitation" ], "sponsor": "University College, London", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Cognitive impairment is increasingly recognised as a major component of long Covid, and is estimated to be present in 25-75% of affected individuals. This impairment impacts quality of life and the loss of functional ability has major consequences for affected people, their families and the wider economy given people's difficulty in returning to work.\n\nThis study will focus on helping people recover from cognitive Covid. This will involve use of rehabilitation strategies aimed at improving function in those cognitive functions identified in Stage 1 as being most affected, and assessing the benefit of rehabilitation on quality of life and people's ability to return to everyday function. These strategies will be co-produced in collaboration with a group of people living with cognitive Covid. At the end of Stage 2 we will produce a freely available \"Covid-19 Cognitive Recovery Guide\" for affected people, their close contacts and clinicians.\n\nIn conclusion, cognitive impairment is frequently observed in long Covid but at present little is understood about its nature, or how it can be treated. The sheer scale of the CV19 pandemic makes this a top priority unmet need for healthcare worldwide. The aim of this study is to meet this need and to deliver a treatment plan for affected people which will help them return to normal life and working ability.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Goal-attainment", "description": "performance on goals selected by participants", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in cognitive function", "description": "set of tests to measure objective improvements in cognitive function", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in quality of life (EQ-5D-5L)", "description": "Measure of quality of life", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Life Space Questionnaire", "description": "Measures the extent of mobility", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Social Functioning (SF-DEM)", "description": "patient reported outcome measure to assess social functioning", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Instrumental Activities of Daily Living (IADL) Scale", "description": "assessment of independent living skills", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Generalised Anxiety Disorder Assessment (GAD-7)", "description": "measures levels of anxiety", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire (PHQ-8)", "description": "measures depressive disorders", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Chalder Fatigue Scale", "description": "measures the severity of tiredness in fatiguing illnesses", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Pittsburgh Sleep Quality (PSQI)", "description": "slef reported questionnaire that assesses sleep quality", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM).", "description": "measures presence and severity of post-exertional malaise", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Client Service Receipt Inventory (CSRI)", "description": "tool used to collect information on the whole range of services and supports study participants may use", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Goal-attainment", "description": "performance on goals selected by participants", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in cognitive function", "description": "set of tests to measure objective improvements in cognitive function", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in quality of life (EQ-5D-5L)", "description": "Measure of quality of life", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Life Space Questionnaire", "description": "Measures the extent of mobility", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Social Functioning (SF-DEM)", "description": "patient reported outcome measure to assess social functioning", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Instrumental Activities of Daily Living (IADL) Scale", "description": "assessment of independent living skills", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Generalised Anxiety Disorder Assessment (GAD-7)", "description": "measures levels of anxiety", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire (PHQ-8)", "description": "measures depressive disorders", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Chalder Fatigue Scale", "description": "measures the severity of tiredness in fatiguing illnesses", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Pittsburgh Sleep Quality (PSQI)", "description": "slef reported questionnaire that assesses sleep quality", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM).", "description": "measures presence and severity of post-exertional malaise", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" }, { "type": "secondary", "measure": "Change in Client Service Receipt Inventory (CSRI)", "description": "tool used to collect information on the whole range of services and supports study participants may use", "time_frame": "measured at baseline, 3 and 6 months post-randomisation" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 78, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05731570", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05566379", "title": "Mindfulness in Post Acute Sequelae of SARS-CoV-2 Infection (PASC) Dysautonomia", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-06-14", "start_date": "2023-02-28", "completion_date": "2023-07-29", "primary_completion_date": "2023-07-29", "conditions_raw": [ "Long COVID", "Dysautonomia" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Mindfulness - Mindful Awareness Practices" ], "sponsor": "University of California, Los Angeles", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The current pilot study will recruit participants experiencing new, returning, or ongoing symptoms related to COVID-19 illness for at least four weeks after being first infected with SARS-CoV-2. All participants will attend a virtual 6-week course entitled Mindful Awareness Practices (MAPs) created, hosted and led by expert facilitators from the Mindful Awareness Research Center (MARC) at University of California Los Angeles (UCLA). This intervention will consist of a mix of lecture, practice, group feedback, and discussion regarding mindfulness. Mindfulness is the mental state achieved by focusing one's awareness on the present while acknowledging and accepting any feelings, thoughts, or bodily sensations. The research team will collect self-reported measures of mental health symptoms, physical health symptoms, and demographic information before and after participants attend MAPs. Objective health measures will also be collected by the research team including an active stand test, a 6-minute walk, and a blood sample.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The six domain scores sum to a total score of 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)" }, { "type": "primary", "measure": "Change from baseline in Active Stand Test of hemodynamic symptom parameters, exercise tolerance.", "description": "Active Stand Test. Clinically, an active stand test can be used to assess short-term neural and cardiovascular function and identify the hemodynamic correlates of patient symptoms and attributable causes of (pre-)syncope, and to detect autonomic dysfunction, variants of orthostatic hypotension, postural orthostatic tachycardia syndrome and orthostatic hypertension. During a standardized active stand test procedure, heart rate and blood pressure are measured after resting lying down, then immediately upon standing and after 2, 5 and 10 minutes.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)" }, { "type": "primary", "measure": "Change from baseline of Six Minute Walk in hemodynamic parameters, exercise tolerance", "description": "Six Minute Walk. The six-minute walk (6MWT) was developed in 1963 by Balke to evaluate functional capacity and endurance during physical activity. The standardized six-minute walk test (6MWT) measures the maximum distance an individual is able to walk over a total of six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a flat marked walkway. Baseline heart rate and oxygen saturation are measured then continuously monitored to identify the lowest oxygen saturation, which may occur before the end of the test. The patient's baseline and post-test perceived dyspnea and fatigue are rated using the Borg scale 0-10 (0 none- 10 maximum).", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)" }, { "type": "primary", "measure": "Change from baseline in mean score in Health-Related Quality of Life (QOL) SF-20", "description": "Self-reported QOL SF-20. A 20-item questionnaire. The survey measures health across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question).\n\nScores across each of these domains are reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score. Raw scores are transformed to fit the 0% to 100% interval as described in the original publication (note that for question #1 on general health, an initial transformation is performed as follows: 1 = 5, 2 = 4.36, 3 = 3.43, 4 = 1.99, 5 = 1). Reversal of scoring is completed as necessary such that the highest score always represents the best possible score. The exception to this scoring pattern is the pain score, for which 0% represents the best possible score and 100% the worst possible score.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from baseline in mean scores of PSS- Perceived Stress Scale.", "description": "Perceived Stress Scale (PSS) appraises thoughts and feelings in perception of stress. It is a 10-item scale (score 0-40) with upper scores signifying increased perceived stress. While the aim is to capture stress level, the PSS is used to obtain a patients' perceptions of their own stress.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of GAD7- Generalized Anxiety Disorder", "description": "Generalized Anxiety Disorder (GAD7) It is a 7-item scale (score 0-21), with acuity distinguished as mild (5-9), moderate (10-14) or severe (15-21) distress (Spitzer et al. 2006). The higher score indicates greater anxiety.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of PHQ-8 - Depressive Symptoms", "description": "Depression (PHQ8) adapted from the PHQ-9, is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. A PHQ-8 score of 0 to 4 indicates no depression, of 5 to 9 indicates mild depression, of 10 to 14 indicates moderate depression, of 15 to 19 indicates moderately severe depression, and of 20 or higher indicates severe depression.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of IES-R - event-related distress scale", "description": "Impact of Event Scale -Revised (IES-R). is a 22-item self-report measure that assesses subjective distress caused by traumatic events. The IES-R contains seven additional items related to the hyperarousal symptoms of PTSD, which were not included in the original IES. Items correspond directly to 14 of the 17 The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of PTSD. Respondents are asked to identify a specific stressful life event and then indicate how much they were distressed or bothered during the past seven days by each \"difficulty\" listed. Items are rated on a 5-point scale ranging from 0 (\"not at all\") to 4 (\"extremely\"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of FSI - The Fatigue Symptom Inventory.", "description": "The Fatigue Symptom Inventory (FSI) is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life in the past week. Severity is measured on point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue in the past week as well as current fatigue. Frequency is measured by the number of days (0-7) that respondents felt fatigued and the extent of each day they felt fatigued (0=none of the day; 10=the entire day). Perceived interference is measured on point scales (0=no interference; 10=extreme interference) that assess the degree to which fatigue was felt to interfere with with general level of activity, enjoyment, and mood.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of the ISI - The Insomnia Severity Index", "description": "The Insomnia Severity Index (ISI) is a seven-item self-report questionnaire, which asks respondents to rate the nature and symptoms of their sleep problems. Dimensions evaluated are severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of well-being from MHC-SF-The Mental Health Continuum Short Form", "description": "The Mental Health Continuum Short Form (MHC-SF) is a 14- item scale containing 3 items for emotional (hedonic) well-being, 5 items for social well-being, and 6 items for psychological well-being (eudaimonic). Each of the items can be scored between 0 and 5, with the total score on the scale can range from 0 to 70 points. Higher scores indicate a higher level of emotional wellbeing. This scale also provides a flourishing and languishing mental health indicator based on these three subscales.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of CD-RISC 10 - Connor Davidson Resilience Scale.", "description": "Connor Davidson Resilience Scale (CD-RISC 10) is a 10-item scale (score 0-40) that measures components of adaptation, coping and recovery in response to stressful events, trauma, or tragedy. The higher scores reflect greater resilience.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in the composite autonomic symptom score COMPASS-31 for autonomic symptoms", "description": "COMPASS-31 (the composite autonomic symptom) score is a self-rating questionnaire evaluating six domains of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains. The six domain scores sum to a total score of 0 to 100, and a higher score indicates more severe autonomic symptoms. It is based on the original Autonomic Symptom Profile (ASP) and COMPASS, is internally consistent and applies a much-simplified scoring algorithm suitable for widespread use in autonomic research and practice.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)" }, { "type": "primary", "measure": "Change from baseline in Active Stand Test of hemodynamic symptom parameters, exercise tolerance.", "description": "Active Stand Test. Clinically, an active stand test can be used to assess short-term neural and cardiovascular function and identify the hemodynamic correlates of patient symptoms and attributable causes of (pre-)syncope, and to detect autonomic dysfunction, variants of orthostatic hypotension, postural orthostatic tachycardia syndrome and orthostatic hypertension. During a standardized active stand test procedure, heart rate and blood pressure are measured after resting lying down, then immediately upon standing and after 2, 5 and 10 minutes.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)" }, { "type": "primary", "measure": "Change from baseline of Six Minute Walk in hemodynamic parameters, exercise tolerance", "description": "Six Minute Walk. The six-minute walk (6MWT) was developed in 1963 by Balke to evaluate functional capacity and endurance during physical activity. The standardized six-minute walk test (6MWT) measures the maximum distance an individual is able to walk over a total of six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a flat marked walkway. Baseline heart rate and oxygen saturation are measured then continuously monitored to identify the lowest oxygen saturation, which may occur before the end of the test. The patient's baseline and post-test perceived dyspnea and fatigue are rated using the Borg scale 0-10 (0 none- 10 maximum).", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention ( 1-2 weeks post intervention completion)" }, { "type": "primary", "measure": "Change from baseline in mean score in Health-Related Quality of Life (QOL) SF-20", "description": "Self-reported QOL SF-20. A 20-item questionnaire. The survey measures health across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question).\n\nScores across each of these domains are reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score. Raw scores are transformed to fit the 0% to 100% interval as described in the original publication (note that for question #1 on general health, an initial transformation is performed as follows: 1 = 5, 2 = 4.36, 3 = 3.43, 4 = 1.99, 5 = 1). Reversal of scoring is completed as necessary such that the highest score always represents the best possible score. The exception to this scoring pattern is the pain score, for which 0% represents the best possible score and 100% the worst possible score.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of PSS- Perceived Stress Scale.", "description": "Perceived Stress Scale (PSS) appraises thoughts and feelings in perception of stress. It is a 10-item scale (score 0-40) with upper scores signifying increased perceived stress. While the aim is to capture stress level, the PSS is used to obtain a patients' perceptions of their own stress.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of GAD7- Generalized Anxiety Disorder", "description": "Generalized Anxiety Disorder (GAD7) It is a 7-item scale (score 0-21), with acuity distinguished as mild (5-9), moderate (10-14) or severe (15-21) distress (Spitzer et al. 2006). The higher score indicates greater anxiety.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of PHQ-8 - Depressive Symptoms", "description": "Depression (PHQ8) adapted from the PHQ-9, is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. A PHQ-8 score of 0 to 4 indicates no depression, of 5 to 9 indicates mild depression, of 10 to 14 indicates moderate depression, of 15 to 19 indicates moderately severe depression, and of 20 or higher indicates severe depression.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of IES-R - event-related distress scale", "description": "Impact of Event Scale -Revised (IES-R). is a 22-item self-report measure that assesses subjective distress caused by traumatic events. The IES-R contains seven additional items related to the hyperarousal symptoms of PTSD, which were not included in the original IES. Items correspond directly to 14 of the 17 The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of PTSD. Respondents are asked to identify a specific stressful life event and then indicate how much they were distressed or bothered during the past seven days by each \"difficulty\" listed. Items are rated on a 5-point scale ranging from 0 (\"not at all\") to 4 (\"extremely\"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of FSI - The Fatigue Symptom Inventory.", "description": "The Fatigue Symptom Inventory (FSI) is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life in the past week. Severity is measured on point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue in the past week as well as current fatigue. Frequency is measured by the number of days (0-7) that respondents felt fatigued and the extent of each day they felt fatigued (0=none of the day; 10=the entire day). Perceived interference is measured on point scales (0=no interference; 10=extreme interference) that assess the degree to which fatigue was felt to interfere with with general level of activity, enjoyment, and mood.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of the ISI - The Insomnia Severity Index", "description": "The Insomnia Severity Index (ISI) is a seven-item self-report questionnaire, which asks respondents to rate the nature and symptoms of their sleep problems. Dimensions evaluated are severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of well-being from MHC-SF-The Mental Health Continuum Short Form", "description": "The Mental Health Continuum Short Form (MHC-SF) is a 14- item scale containing 3 items for emotional (hedonic) well-being, 5 items for social well-being, and 6 items for psychological well-being (eudaimonic). Each of the items can be scored between 0 and 5, with the total score on the scale can range from 0 to 70 points. Higher scores indicate a higher level of emotional wellbeing. This scale also provides a flourishing and languishing mental health indicator based on these three subscales.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" }, { "type": "secondary", "measure": "Change from baseline in mean scores of CD-RISC 10 - Connor Davidson Resilience Scale.", "description": "Connor Davidson Resilience Scale (CD-RISC 10) is a 10-item scale (score 0-40) that measures components of adaptation, coping and recovery in response to stressful events, trauma, or tragedy. The higher scores reflect greater resilience.", "time_frame": "Baseline / Pre Intervention(1-2 weeks prior to intervention), Post Intervention (1-2 weeks post intervention completion); 4 weeks post intervention" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05566379", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06456502", "title": "Effectiveness of Non-invasive Neuromodulation in Patients With Long-COVID", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-06-13", "start_date": "2024-06", "completion_date": "2026-06-30", "primary_completion_date": "2026-06-30", "conditions_raw": [ "Long-COVID", "Post-acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Non-Invasive Neuromodulation" ], "sponsor": "Universidad Rey Juan Carlos", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Sleep quality and duration are critical to cognitive, emotional and physical well-being, and poor sleep quality has been associated with an increased risk of cognitive, psychological and cardiometabolic disorders. Several important physiological activities occur during sleep including a reduction in heart rate and blood pressure. In addition, sleep exerts important modulatory effects on hormone release. Previous studies have shown that lack of sleep can generate exaggerated cortisol responses or psychological and physiological stressors. Cortisol has widespread effects throughout the body and brain, affecting mood, arousal, energy, metabolic processes, and immune and inflammatory system functioning. Therefore, disruptions in cortisol secretion during the night can influence a wide variety of processes in our body that may contribute to the perception of poorer sleep quality. In addition, the salivary enzyme α-amylase is considered a biomarker of cognitive, psychosocial, emotional or physical stress. It is important to note that the autonomic nervous system (ANS) regulates several physiological processes, including heart rate, blood pressure, respiration, and digestion. The ANS consists primarily of the sympathetic system and the parasympathetic system. Increased parasympathetic activity is considered to promote health, whereas a dominant or overactive sympathetic branch is considered to be detrimental to health.\n\nA recent study found that both sleep quality and quantity of sleep were associated with resting ANS functioning. They found that poorer sleep quality was associated with greater sympathetic dominance. Research on the sympathetic and parasympathetic branches of the ANS has shown that autonomic imbalances are precursors to disease formation and other health-related risks. Coronavirus disease 2019 (COVID-19), has in many cases involved the presence of long-lasting symptoms several weeks or months after surviving acute infection with the virus, leading to a new disease called long COVID-19 or post-COVID-19 syndrome (PCS). A recent study showed that sleep quality influences the relationship between symptoms associated with sensitization and mood disorders with health-related quality of life in people suffering from long COVID.\n\nNon-invasive neuromodulation directed to ANS may be an option to treat the sleep disorders observed in patients with long COVID.\n\nOBJETIVES:\n\nTherefore, the primary objective of this study is to evaluate the efficacy of a treatment protocol on the ANS by means of non-invasive neuromodulation in aspects related to sleep in long COVID patients compared to placebo. As secondary objectives, we propose to evaluate the efficacy of a treatment protocol on the ANS by non-invasive neuromodulation in aspects related to ANS functioning, psychological variables, fatigue, pain perception and quality of life in patients with long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Sleep quality", "description": "The aspects of sleep to be assessed by means of the Pittsburgh sleep quality index (PSQI) scale and the sleep diary to be completed each morning and handed in on the last day of treatment.", "time_frame": "Baseline, at the of 15th session, at 6 month an at one year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Heart variability", "description": "Through the We Cardio device, which provides variables such as resting heart rate (HRV) and the root mean square difference of successive interval between two successive R-waves (RMSSD), which reflects beat-to-beat variation in heart rate and is the main time-domain measure used to estimate vagal (parasympathetic) changes reflected in HRV.", "time_frame": "Baseline and at 8 weeks" }, { "type": "secondary", "measure": "Cortisol and alpha amylase levels", "description": "Cortisol and alpha amylase levels will be assessed with salivary tests that will be analyzed using a Soma cube reader device.", "time_frame": "Baseline and at 8 weeks" }, { "type": "secondary", "measure": "Psychological variables", "description": "Depression and anxiety will be evaluated by means of the hospital anxiety and depression scale (HADS) validated in spanish and with a high level of reliability and sensitivity for these variables", "time_frame": "Baseline, at 8 weeks, at 6 month an at one year" }, { "type": "secondary", "measure": "The quality of life", "description": "This variable will be evaluated by means of the EuroQol 5D (EQ-5D). It is a standardized instrument developed to describe and assess health-related quality of life (HRQoL)", "time_frame": "Baseline, at 8 weeks, at 6 month an at one year" }, { "type": "secondary", "measure": "Disability", "description": "The impact of the disease on patients will be assessed using the severe acute respiratory syndrome (SARS) functional impairment checklist (FIC), which is a questionnaire that assesses physical and psychological symptoms, as well as disability-related domains. The FIC has been shown to be valid, to show good reliability and to exhibit good psychometric properties for use as a tool to assess physical symptoms and disability-related domains in patients with SARS and patients with persistent COVID.", "time_frame": "Baseline, at 8 weeks, at 6 month an at one year" }, { "type": "secondary", "measure": "Pain intensity", "description": "Pain will be assessed by means of a numeric pain rating scale (NPRS), which allows measuring the intensity of pain described by the patient with maximum reproducibility between observers.", "time_frame": "Baseline, at 8 weeks, at 6 month an at one year" } ], "outcome_measures": [ { "type": "primary", "measure": "Sleep quality", "description": "The aspects of sleep to be assessed by means of the Pittsburgh sleep quality index (PSQI) scale and the sleep diary to be completed each morning and handed in on the last day of treatment.", "time_frame": "Baseline, at the of 15th session, at 6 month an at one year" }, { "type": "secondary", "measure": "Heart variability", "description": "Through the We Cardio device, which provides variables such as resting heart rate (HRV) and the root mean square difference of successive interval between two successive R-waves (RMSSD), which reflects beat-to-beat variation in heart rate and is the main time-domain measure used to estimate vagal (parasympathetic) changes reflected in HRV.", "time_frame": "Baseline and at 8 weeks" }, { "type": "secondary", "measure": "Cortisol and alpha amylase levels", "description": "Cortisol and alpha amylase levels will be assessed with salivary tests that will be analyzed using a Soma cube reader device.", "time_frame": "Baseline and at 8 weeks" }, { "type": "secondary", "measure": "Psychological variables", "description": "Depression and anxiety will be evaluated by means of the hospital anxiety and depression scale (HADS) validated in spanish and with a high level of reliability and sensitivity for these variables", "time_frame": "Baseline, at 8 weeks, at 6 month an at one year" }, { "type": "secondary", "measure": "The quality of life", "description": "This variable will be evaluated by means of the EuroQol 5D (EQ-5D). It is a standardized instrument developed to describe and assess health-related quality of life (HRQoL)", "time_frame": "Baseline, at 8 weeks, at 6 month an at one year" }, { "type": "secondary", "measure": "Disability", "description": "The impact of the disease on patients will be assessed using the severe acute respiratory syndrome (SARS) functional impairment checklist (FIC), which is a questionnaire that assesses physical and psychological symptoms, as well as disability-related domains. The FIC has been shown to be valid, to show good reliability and to exhibit good psychometric properties for use as a tool to assess physical symptoms and disability-related domains in patients with SARS and patients with persistent COVID.", "time_frame": "Baseline, at 8 weeks, at 6 month an at one year" }, { "type": "secondary", "measure": "Pain intensity", "description": "Pain will be assessed by means of a numeric pain rating scale (NPRS), which allows measuring the intensity of pain described by the patient with maximum reproducibility between observers.", "time_frame": "Baseline, at 8 weeks, at 6 month an at one year" } ], "relevance_tags": [ "Metabolic", "Immunomodulatory", "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 44, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06456502", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06085911", "title": "RCT Long COVID-19 Rehabilitation", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-06-11", "start_date": "2023-11-03", "completion_date": "2025-11", "primary_completion_date": "2025-02", "conditions_raw": [ "Rehabilitation", "Post-Acute COVID-19 Syndrome", "Post-Infectious Disorders" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "One Day Course", "Individual Follow-Ups" ], "sponsor": "University Hospital of North Norway", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The Coronavirus 2019 (COVID-19) pandemic has resulted in at least four million infections in Norway. The vast majority of cases are diagnosed and followed up in the community, but some with extensive symptoms and large degree of reduced function are referred to regional Covid-clinics. In total this patient group is placing an enormous burden on the already over stretched health care services. As the pandemic subsides the emerging threat of long-term disability from COVID remains to be quantified. Brain fog and cognitive symptoms are common in long COVID in 30% of mild infections resulting in sick leave and loss of daily function, with women overrepresented among long COVID sufferers. The true prevalence and underlying mechanisms of long COVID remains to be quantified. Although vaccination prevents severe infection and death, we have little knowledge on how best to rehabilitate those who suffers from long COVID.\n\nHere we propose to develop knowledge on treatment interventions to counteract disability from long COVID and lessening the burden on health care services. We will conduct a study of where we compare a short group intervention with systematic personalised neurocognitive rehabilitation to document symptom alleviation. Our overarching goal is to develop effective programmes for this evolving disease to reduce the suffering for the patients, and thereby reducing costs for health services and society at large.", "primary_outcomes": [ { "type": "primary", "measure": "Symptom reduction", "description": "A reduction in number present symptoms is evaluated in each patient group. A significant greater alleviation in the of number symptoms at three months is considered as a better prognosis.", "time_frame": "3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptoms grouped by systems reduction", "description": "All individual symptoms separately, and grouped by systems (systemic symptoms, chest-symptoms, cognitive, other neurocognitive symptoms) and as full recovery (absence of all symptoms) at 3-, 6- and 12 months.", "time_frame": "12 month follow-up" }, { "type": "secondary", "measure": "Graded symptom reduction", "description": "Graded responses for separate symptoms and symptom constellations, including an ordinal variable graded 0-3 for the presence of neurocognitive relevant symptoms and dyspnea.", "time_frame": "3-12 months" }, { "type": "secondary", "measure": "Work improvement", "description": "Improvement in work participation", "time_frame": "3-12 months" }, { "type": "secondary", "measure": "Quality of life improvement", "description": "Improvement in quality of life measured by EQ-5D-5L and measurement of Quality-adjusted life year (QALY)", "time_frame": "3-12 months" }, { "type": "secondary", "measure": "Neuropsychological functions improvement", "description": "Improvement of neuropsychological functions", "time_frame": "6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Symptom reduction", "description": "A reduction in number present symptoms is evaluated in each patient group. A significant greater alleviation in the of number symptoms at three months is considered as a better prognosis.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Symptoms grouped by systems reduction", "description": "All individual symptoms separately, and grouped by systems (systemic symptoms, chest-symptoms, cognitive, other neurocognitive symptoms) and as full recovery (absence of all symptoms) at 3-, 6- and 12 months.", "time_frame": "12 month follow-up" }, { "type": "secondary", "measure": "Graded symptom reduction", "description": "Graded responses for separate symptoms and symptom constellations, including an ordinal variable graded 0-3 for the presence of neurocognitive relevant symptoms and dyspnea.", "time_frame": "3-12 months" }, { "type": "secondary", "measure": "Work improvement", "description": "Improvement in work participation", "time_frame": "3-12 months" }, { "type": "secondary", "measure": "Quality of life improvement", "description": "Improvement in quality of life measured by EQ-5D-5L and measurement of Quality-adjusted life year (QALY)", "time_frame": "3-12 months" }, { "type": "secondary", "measure": "Neuropsychological functions improvement", "description": "Improvement of neuropsychological functions", "time_frame": "6 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06085911", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06172803", "title": "Restoring Energy With Sub-symptom Threshold Optimized Rehabilitation Exercise for Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-06-06", "start_date": "2023-10-01", "completion_date": "2024-01-15", "primary_completion_date": "2024-01-15", "conditions_raw": [ "Long Covid19", "Exercise Intolerance", "Riboflavin-Responsive" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Restoring Energy With Sub-Symptom Threshold Aerobic Rehabilitation Exercise", "Light Stretching/Breathing Exercises" ], "sponsor": "Columbia University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The overall goal of this study is to find out if rehabilitation exercise can help people who have long COVID. Participants will be randomized by chance to receive either aerobic exercise or breathing exercise (combined with stretches). Participants will be guided and supported in completing a tailored, 6-week home exercise program to be performed 5 - 6 days a week, prescribed and supervised by rehabilitation therapists. Participants will perform breathing exercises, which will be supervised by an occupational therapist. The focus of Aim 1 is to determine feasibility of implementing RESToRE in long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Number of participants who enrolled", "description": "Feasibility of the RESToRE program will be determined by measuring the number of participants who enroll.", "time_frame": "10 weeks" }, { "type": "primary", "measure": "Number of participants who completed", "description": "Feasibility of the RESToRE program will be determined by measuring the number of participants who complete (participated through the end of the study).", "time_frame": "10 weeks" }, { "type": "primary", "measure": "Number of participants who adhered to session attendance", "description": "Feasibility of the RESToRE program will be determined by measuring the number of participants who achieve ≥80% exercise adherence and session attendance.", "time_frame": "10 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "PROMIS-29 scale score", "description": "This toll/questionnaire is designed to measure participants quality of life. Score range is 1-5, with higher score correlating to worse outcomes.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "Rand 36-Item Health Survey (SF-36) score", "description": "This survey evaluates participants mental and physical health with 8 scales aggregated. Score range is 1-6, with the higher score correlating to worse overall health outcomes.", "time_frame": "Baseline and Post Intervention at 8 weeks" }, { "type": "secondary", "measure": "VO2 % predicted from Cardiopulmonary Exercise Testing (CPET)", "description": "VO2 % predicted (oxygen consumption) based on normative data. Participants' scores will be compared to norms for assessing exercise ability. Group means will be compared.", "time_frame": "Baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "Number of participants with orthostatic hypocapnia.", "description": "The Nasa Lean Test: Participants will stand and lean against a wall with shoulder blades touching and heels 6 - 8 inches from the wall for 10 minutes. HR, BP, SpO2, ETCO2, and symptoms will be recorded in standing leaning posture every minute for 10 mins. Capnography will be used to identify orthostatic hypocapnia.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "EuroQol: Education Quotient-5D Visual Analogue Scale score", "description": "This is to measure quality of life. Score range is 0-100, with 100 being the best health you can imagine and 0 being the worst health.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "General Symptom Questionnaire (SGQ-30) score", "description": "This is to assess participants symptoms regarding pain/fatigue, psychiatric, neurological, and viral-like. Score range is 0 which is not at all to 4 which is very much. Higher score represents worst symptoms.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "PROMIS Cognitive Function score", "description": "This is an 8-item Short Form, measuring perceived difficulties in cognition (e.g., attention, concentration, executive functioning). Score range is 1-5. 1 is very often to 5 which is never. The higher score is better.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "Global Change Assessment (GCA) score", "description": "This is to measure patients change of symptoms in terms of physical function and fatigue throughout the study. Score range is -7 to 7. -7 is a very great deal worse and 7 is a great deal better. The higher the score the better.", "time_frame": "baseline and post intervention at 8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of participants who enrolled", "description": "Feasibility of the RESToRE program will be determined by measuring the number of participants who enroll.", "time_frame": "10 weeks" }, { "type": "primary", "measure": "Number of participants who completed", "description": "Feasibility of the RESToRE program will be determined by measuring the number of participants who complete (participated through the end of the study).", "time_frame": "10 weeks" }, { "type": "primary", "measure": "Number of participants who adhered to session attendance", "description": "Feasibility of the RESToRE program will be determined by measuring the number of participants who achieve ≥80% exercise adherence and session attendance.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "PROMIS-29 scale score", "description": "This toll/questionnaire is designed to measure participants quality of life. Score range is 1-5, with higher score correlating to worse outcomes.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "Rand 36-Item Health Survey (SF-36) score", "description": "This survey evaluates participants mental and physical health with 8 scales aggregated. Score range is 1-6, with the higher score correlating to worse overall health outcomes.", "time_frame": "Baseline and Post Intervention at 8 weeks" }, { "type": "secondary", "measure": "VO2 % predicted from Cardiopulmonary Exercise Testing (CPET)", "description": "VO2 % predicted (oxygen consumption) based on normative data. Participants' scores will be compared to norms for assessing exercise ability. Group means will be compared.", "time_frame": "Baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "Number of participants with orthostatic hypocapnia.", "description": "The Nasa Lean Test: Participants will stand and lean against a wall with shoulder blades touching and heels 6 - 8 inches from the wall for 10 minutes. HR, BP, SpO2, ETCO2, and symptoms will be recorded in standing leaning posture every minute for 10 mins. Capnography will be used to identify orthostatic hypocapnia.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "EuroQol: Education Quotient-5D Visual Analogue Scale score", "description": "This is to measure quality of life. Score range is 0-100, with 100 being the best health you can imagine and 0 being the worst health.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "General Symptom Questionnaire (SGQ-30) score", "description": "This is to assess participants symptoms regarding pain/fatigue, psychiatric, neurological, and viral-like. Score range is 0 which is not at all to 4 which is very much. Higher score represents worst symptoms.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "PROMIS Cognitive Function score", "description": "This is an 8-item Short Form, measuring perceived difficulties in cognition (e.g., attention, concentration, executive functioning). Score range is 1-5. 1 is very often to 5 which is never. The higher score is better.", "time_frame": "baseline and post intervention at 8 weeks" }, { "type": "secondary", "measure": "Global Change Assessment (GCA) score", "description": "This is to measure patients change of symptoms in terms of physical function and fatigue throughout the study. Score range is -7 to 7. -7 is a very great deal worse and 7 is a great deal better. The higher the score the better.", "time_frame": "baseline and post intervention at 8 weeks" } ], "relevance_tags": [ "Metabolic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 4, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06172803", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06251011", "title": "Effects of Physiotherapy Via Telerehabilitation in Patients With COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-06-05", "start_date": "2024-02-09", "completion_date": "2024-06-04", "primary_completion_date": "2024-06-01", "conditions_raw": [ "COVID-19", "Long COVID-19", "Cardiopulmonary Function", "Physical Function" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Exercise Training" ], "sponsor": "Chulabhorn Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to evaluate the effects of Physiotherapy Via Video Calls on Cardiopulmonary Functions, Physical Function, Cognitive Function, Activity Daily Livings, and Quality of Life in Patients With COVID-19.", "primary_outcomes": [ { "type": "primary", "measure": "Cardiopulmonary function", "description": "using Cardiopulmonary exercise testing (CPET)", "time_frame": "at day 28 and 90 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Patient's quality of life", "description": "using the The World Health Organization Quality of Life (WHOQOL-BREF-THAI) 26 items; the final score ranges from 24-120; higher score means participants satisfied with the quality of life.", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Functional capacity", "description": "using Duke Activity status index The final score ranges between zero and 58.2 points; The higher the score, the better the functional capacity.", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Anxiety and depression", "description": "using Hospital Anxiety and Depression Scale (HADS) The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A total subscale score of \\>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Insomnia", "description": "using Insomnia Severity Index (ISI) The final score ranges between zero and 28 points. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Cognitive function", "description": "using Thai Mental State Examination The final score ranges between zero and 30 points. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Muscle strength", "description": "using 1-minute sit to stand", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Cardiopulmonary function", "description": "using Cardiopulmonary exercise testing (CPET)", "time_frame": "at day 28 and 90 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Patient's quality of life", "description": "using the The World Health Organization Quality of Life (WHOQOL-BREF-THAI) 26 items; the final score ranges from 24-120; higher score means participants satisfied with the quality of life.", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Functional capacity", "description": "using Duke Activity status index The final score ranges between zero and 58.2 points; The higher the score, the better the functional capacity.", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Anxiety and depression", "description": "using Hospital Anxiety and Depression Scale (HADS) The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A total subscale score of \\>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Insomnia", "description": "using Insomnia Severity Index (ISI) The final score ranges between zero and 28 points. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Cognitive function", "description": "using Thai Mental State Examination The final score ranges between zero and 30 points. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" }, { "type": "primary", "measure": "Muscle strength", "description": "using 1-minute sit to stand", "time_frame": "at day 3 and 21 after positive in COVID-19 testing" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 32, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06251011", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04944121", "title": "Phase 2 Study of RSLV-132 in Subjects With Long COVID", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2024-05-29", "start_date": "2021-06-25", "completion_date": "2023-11-30", "primary_completion_date": "2023-10-31", "conditions_raw": [ "Post-acute Corona Virus 19 (COVID-19) (Long COVID)" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rslv-132" ], "sponsor": "Resolve Therapeutics", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to assess the efficacy (decrease in profound fatigue), safety and pharmacokinetics of RSLV-132 in subjects with long Corona Virus (COVID) syndome", "primary_outcomes": [ { "type": "primary", "measure": "PROMIS Fatigue SF 7a T-score", "description": "Mean change in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue 7a) T-score at the end of treatment compared to baseline. The PROMIS Fatigue 7a consists of seven questions measuring symptoms severity at five-point intervals, with higher scores representing a worse outcome.", "time_frame": "From Baseline to Day 71" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "FACIT Fatigue questionnaire", "description": "Comparison of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire at the end of treatment compared to baseline. The FACIT-F is a 13 item measure of fatigue with a 7 day recall memory. Items are scored on a five point scale (0-not at all to 4-very much). The total score therefore ranges from 0 to 52, with higher scores reflecting greater fatigue.", "time_frame": "From Baseline to Day 71" }, { "type": "secondary", "measure": "Long COVID-19-related Symptom Assessment patient questionnaire", "description": "Comparison of the Long COVID-19-related Symptom Assessment patient questionnaire at the end of treatment compared to baseline. Subjects will be asked to describe the severity of eight COVID-19 related symptoms (muscle pain, joint pain, chest pain, brain fog, chills, sweats, abdominal pain and chest tightness) over the last 7 days on a four point scale (0-none to 3-severe) with a higher score representing a worse outcome.", "time_frame": "From Baseline to Day 71" }, { "type": "secondary", "measure": "Patient-reported Global Impression of Severity questionnaire", "description": "Comparison of the Patient-reported Global Impression of Severity (PGIS) questionnaire at the end of treatment compared to baseline. Subjects will be asked to describe the severity of fatigue on the assessment day compared to the past 7 days on a four point scale (1-no improvement to 4-significant improvement) with a higher score representing a better outcome.", "time_frame": "From Baseline to Day 71" }, { "type": "secondary", "measure": "Digit Symbol Substitution Test", "description": "Comparison of the Digit Symbol Substitution Test (DSST) at the end of treatment compared to baseline. The DSST is a highly validated measure of the patient's ability to focus and concentrate of a simple task. Subjects with profound fatigue take more time to complete the test.", "time_frame": "From Baseline to Day 71" }, { "type": "secondary", "measure": "Physician Global Assessment", "description": "Comparison of the Physician Global Assessment at the end of treatment compared to baseline. The assessment is measured on a 0 to 100 mm scale with score 0 to be no disease activity and score 100 to be the most severe disease activity.", "time_frame": "From Baseline to Day 71" } ], "outcome_measures": [ { "type": "primary", "measure": "PROMIS Fatigue SF 7a T-score", "description": "Mean change in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue 7a) T-score at the end of treatment compared to baseline. The PROMIS Fatigue 7a consists of seven questions measuring symptoms severity at five-point intervals, with higher scores representing a worse outcome.", "time_frame": "From Baseline to Day 71" }, { "type": "secondary", "measure": "FACIT Fatigue questionnaire", "description": "Comparison of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire at the end of treatment compared to baseline. The FACIT-F is a 13 item measure of fatigue with a 7 day recall memory. Items are scored on a five point scale (0-not at all to 4-very much). The total score therefore ranges from 0 to 52, with higher scores reflecting greater fatigue.", "time_frame": "From Baseline to Day 71" }, { "type": "secondary", "measure": "Long COVID-19-related Symptom Assessment patient questionnaire", "description": "Comparison of the Long COVID-19-related Symptom Assessment patient questionnaire at the end of treatment compared to baseline. Subjects will be asked to describe the severity of eight COVID-19 related symptoms (muscle pain, joint pain, chest pain, brain fog, chills, sweats, abdominal pain and chest tightness) over the last 7 days on a four point scale (0-none to 3-severe) with a higher score representing a worse outcome.", "time_frame": "From Baseline to Day 71" }, { "type": "secondary", "measure": "Patient-reported Global Impression of Severity questionnaire", "description": "Comparison of the Patient-reported Global Impression of Severity (PGIS) questionnaire at the end of treatment compared to baseline. Subjects will be asked to describe the severity of fatigue on the assessment day compared to the past 7 days on a four point scale (1-no improvement to 4-significant improvement) with a higher score representing a better outcome.", "time_frame": "From Baseline to Day 71" }, { "type": "secondary", "measure": "Digit Symbol Substitution Test", "description": "Comparison of the Digit Symbol Substitution Test (DSST) at the end of treatment compared to baseline. The DSST is a highly validated measure of the patient's ability to focus and concentrate of a simple task. Subjects with profound fatigue take more time to complete the test.", "time_frame": "From Baseline to Day 71" }, { "type": "secondary", "measure": "Physician Global Assessment", "description": "Comparison of the Physician Global Assessment at the end of treatment compared to baseline. The assessment is measured on a 0 to 100 mm scale with score 0 to be no disease activity and score 100 to be the most severe disease activity.", "time_frame": "From Baseline to Day 71" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 112, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04944121", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06423495", "title": "Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-05-21", "start_date": "2022-06-05", "completion_date": "2024-12-22", "primary_completion_date": "2023-12-22", "conditions_raw": [ "Anosmia", "Ageusia", "COVID-19", "Rehabilitation", "Laser Therapy" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Low-Intensity Laser Treatment" ], "sponsor": "Gaffree & Guinle Universitary Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "On January 30, 2020, the WHO (World Health Organization) declared the new coronavirus pandemic as the sixth public health emergency of international concern. In February 2020, the virus was designated by the Coronavirus Study Group of the International Committee on Virus Taxonomy as severe acute respiratory syndrome coronavirus 2. Many reports have described the appearance of olfactory or gustatory dysfunction simultaneously with other pre-established symptoms of COVID-19. Symptoms such as loss of taste or smell may appear 2 to 14 days after being infected with COVID-19. Worldwide, evidence regarding anosmia (loss of smell) and dysgeusia (change in taste) has been associated with COVID-19 infection. OBJECTIVES: To evaluate the effectiveness of low-intensity laser in treating changes in smell and taste after COVID-19 infection and map which changes obtained the best results. MATERIAL AND METHODS: This is an intervention study whose sample will consist of 30 individuals with loss of smell and taste for more than 6 months after COVID-19 infection, aged 18 years or older.", "primary_outcomes": [ { "type": "primary", "measure": "effectiveness of low-intensity laser in the treatment of olfactory dysfunction in long term covid-19", "description": "evaluate the effectiveness of low-intensity laser", "time_frame": "20 minutes session with photobiomodulation therapy twice a week, for a total of 16 sessions" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "effectiveness of low-intensity laser in the treatment of olfactory dysfunction in long term covid-19", "description": "evaluate the effectiveness of low-intensity laser", "time_frame": "20 minutes session with photobiomodulation therapy twice a week, for a total of 16 sessions" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06423495", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05497089", "title": "Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2024-05-17", "start_date": "2022-08-29", "completion_date": "2024-05-10", "primary_completion_date": "2024-05-10", "conditions_raw": [ "Post-COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Temelimab 54Mg/Kg" ], "sponsor": "GeNeuro SA", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This study is a Phase 2, 24-week, randomized, prospective, double-blind, multicenter study in patients experiencing neuropsychiatric symptoms and functional impairment in the course of PASC. The purpose of the study is to evaluate the efficacy and safety of Temelimab as a treatment for PASC neuropsychiatric symptoms in patients who had severe acute respiratory syndrome coronavirus - type 2 (SARS-CoV-2) infection but did not undergo intensive care treatment during the acute period. Patients meeting eligibility criteria will be randomized to Temelimab or placebo in a 1:1 ratio via interactive voice/web response system to obtain 182 protocol completers. The randomization will be stratified by age (≤65 years versus \\>65 years).", "primary_outcomes": [ { "type": "primary", "measure": "Improvement in fatigue in PASC patients", "description": "Occurrence of an improvement in fatigue, measured by a decrease of ≥3 points in the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a) score, at Week 24 as compared to baseline.", "time_frame": "24 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue", "description": "Change from baseline to Week 24 in the Severity of fatigue as measured by the PROMIS Fatigue SF 7a score", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Change from baseline to Week 24 in 5 domain scores (verbal memory test, digit sequencing test, Token Motor Test, verbal semantic and letter fluency, and Tower of London) as measured by BAC tests", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Change from baseline to Week 24 in Symbol Digit Modalities Test (SDMT) score", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Change from baseline to Week 24 in Cognitive function as measured by the composite score of the BAC excluding symbol coding test", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Change from baseline to Week 24 in Cognitive function as measured by the Perceived Deficits Questionnaire, 20 items (PDQ-20)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Anxiety", "description": "Change from baseline to Week 24 in Severity of anxiety as measured by the Generalized Anxiety Disorder, 7 Items (GAD 7)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Depression", "description": "Change from baseline to Week 24 in Severity of depression as measured by the Patient Health Questionnaire, 9 Items (PHQ-9)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Overall quality of Life", "description": "Change from baseline to Week 24 in Overall quality of life as measured by the European Quality of Life 5 Dimensions, 5 Levels (EQ5D-5L)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Functional impairment", "description": "Change from baseline to Week 24 in Level of functional impairment as measured by the Sheehan Disability Scale (SDS)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Status", "description": "Change from baseline to Week 24 in Post-COVID-19 Functional Status Scale (PCFS)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Safety and tolerability of Temelimab in PASC patients", "description": "Incidence of serious AEs \\[SAEs\\], AEs and analysis of physical examination findings, clinical laboratory values results", "time_frame": "24 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Improvement in fatigue in PASC patients", "description": "Occurrence of an improvement in fatigue, measured by a decrease of ≥3 points in the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a) score, at Week 24 as compared to baseline.", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Fatigue", "description": "Change from baseline to Week 24 in the Severity of fatigue as measured by the PROMIS Fatigue SF 7a score", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Change from baseline to Week 24 in 5 domain scores (verbal memory test, digit sequencing test, Token Motor Test, verbal semantic and letter fluency, and Tower of London) as measured by BAC tests", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Change from baseline to Week 24 in Symbol Digit Modalities Test (SDMT) score", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Change from baseline to Week 24 in Cognitive function as measured by the composite score of the BAC excluding symbol coding test", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Cognitive function", "description": "Change from baseline to Week 24 in Cognitive function as measured by the Perceived Deficits Questionnaire, 20 items (PDQ-20)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Anxiety", "description": "Change from baseline to Week 24 in Severity of anxiety as measured by the Generalized Anxiety Disorder, 7 Items (GAD 7)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Depression", "description": "Change from baseline to Week 24 in Severity of depression as measured by the Patient Health Questionnaire, 9 Items (PHQ-9)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Overall quality of Life", "description": "Change from baseline to Week 24 in Overall quality of life as measured by the European Quality of Life 5 Dimensions, 5 Levels (EQ5D-5L)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Functional impairment", "description": "Change from baseline to Week 24 in Level of functional impairment as measured by the Sheehan Disability Scale (SDS)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Status", "description": "Change from baseline to Week 24 in Post-COVID-19 Functional Status Scale (PCFS)", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Safety and tolerability of Temelimab in PASC patients", "description": "Incidence of serious AEs \\[SAEs\\], AEs and analysis of physical examination findings, clinical laboratory values results", "time_frame": "24 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 203, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05497089", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05793736", "title": "Prevention of Long Covid Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-05-13", "start_date": "2023-02-02", "completion_date": "2023-10-30", "primary_completion_date": "2023-10-30", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Biofeedback, Psychology", "Quality of Life", "Depressive Symptoms", "Fatigue", "Anxiety", "Pain", "Cognitive Symptom" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Biofeedback Training", "Treatment As Usual" ], "sponsor": "University of Cagliari", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management in post-Covid-19 syndrome.\n\nThe main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with long covid, and also to verify improvement induced by the technique in relation to: cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms", "primary_outcomes": [ { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score", "description": "short self-administered tool used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to DSM-IV. The score has a range between 0 and 27. Scores between 0 and 9 indicate the presence of a sub-threshold depression. The score of 10 is indicated as the point at which the sensitivity and specificity of the instrument are recognized as optimal for highlighting depressions of clinical relevance", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score", "description": "The Brief Fatigue Inventory (BFI) is a brief screening tool designed to assess the severity and impact of fatigue on daily functioning.", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Short Form Health Survey (SF-12) score", "description": "The Short Form Health Survey (SF-12), brief version of SF-36 questionnaire, made up of twelve questions, includes the following dimensions: physical activity, disturbance in physical health, physical condition, self-assessment of health status, vitality, social activity and mental health. Higher SF-12 scores recorded a greeting and QoL performance.", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Matrix test (Spinnler H, Tognoni G., 1987) score", "description": "Evaluates the indicators of selective attention", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Trail Making Test (Giovagnoli et al.,1996) score", "description": "Evaluates cognitive functions such as cognitive flexibility and inhibitory control and attention", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Digit Span (Orsini et al., 1987; Mondini et al., 2003) score", "description": "Evaluate verbal short-term memory and working memory", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Stroop Test (Caffarra et al.; 2002) score", "description": "Evaluates selective attention, the processes of inhibition of irrelevant information and cognitive flexibility", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Frontal Assessment Battery - FAB (Dubois et al.; 2000) score", "description": "It is a functionality screening battery global executive performance by means of a series of cognitive and behavioral tests", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Rey's Word Test (Caltagirone et al. 1995) score", "description": "Evaluates long-term memory, semantic memory, specifies in which phase of the mnemonic process the deficit is", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change in Checklist on tolerability, possible side effects after the biofeedback session", "description": "Checklist on tolerability, possible side effects after the biofeedback session", "time_frame": "At the end of each biofeedback session" }, { "type": "primary", "measure": "Intervention satisfaction questionnaire", "description": "Intervention satisfaction questionnaire", "time_frame": "T1 (5weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Visual Analog Scale VAS (Scott Huskisson, 1976) score", "description": "Allows you to have a visual representation of the amplitude of the pain perceived by the person ache", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Self-Rating Anxiety Scale (SAS) score", "description": "SAS is a 20-item self-report assessment device built to measure anxiety levels, based on scoring in 4 groups of manifestations: cognitive, autonomic, motor and central nervous system symptoms.", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score", "description": "short self-administered tool used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to DSM-IV. The score has a range between 0 and 27. Scores between 0 and 9 indicate the presence of a sub-threshold depression. The score of 10 is indicated as the point at which the sensitivity and specificity of the instrument are recognized as optimal for highlighting depressions of clinical relevance", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score", "description": "The Brief Fatigue Inventory (BFI) is a brief screening tool designed to assess the severity and impact of fatigue on daily functioning.", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Short Form Health Survey (SF-12) score", "description": "The Short Form Health Survey (SF-12), brief version of SF-36 questionnaire, made up of twelve questions, includes the following dimensions: physical activity, disturbance in physical health, physical condition, self-assessment of health status, vitality, social activity and mental health. Higher SF-12 scores recorded a greeting and QoL performance.", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Matrix test (Spinnler H, Tognoni G., 1987) score", "description": "Evaluates the indicators of selective attention", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Trail Making Test (Giovagnoli et al.,1996) score", "description": "Evaluates cognitive functions such as cognitive flexibility and inhibitory control and attention", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Digit Span (Orsini et al., 1987; Mondini et al., 2003) score", "description": "Evaluate verbal short-term memory and working memory", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Stroop Test (Caffarra et al.; 2002) score", "description": "Evaluates selective attention, the processes of inhibition of irrelevant information and cognitive flexibility", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Frontal Assessment Battery - FAB (Dubois et al.; 2000) score", "description": "It is a functionality screening battery global executive performance by means of a series of cognitive and behavioral tests", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Rey's Word Test (Caltagirone et al. 1995) score", "description": "Evaluates long-term memory, semantic memory, specifies in which phase of the mnemonic process the deficit is", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change in Checklist on tolerability, possible side effects after the biofeedback session", "description": "Checklist on tolerability, possible side effects after the biofeedback session", "time_frame": "At the end of each biofeedback session" }, { "type": "primary", "measure": "Intervention satisfaction questionnaire", "description": "Intervention satisfaction questionnaire", "time_frame": "T1 (5weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Visual Analog Scale VAS (Scott Huskisson, 1976) score", "description": "Allows you to have a visual representation of the amplitude of the pain perceived by the person ache", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" }, { "type": "primary", "measure": "Change from Baseline to 5 weeks and to 9 weeks in Self-Rating Anxiety Scale (SAS) score", "description": "SAS is a 20-item self-report assessment device built to measure anxiety levels, based on scoring in 4 groups of manifestations: cognitive, autonomic, motor and central nervous system symptoms.", "time_frame": "T0 (0 weeks); T1 (5weeks); T2 (9 weeks)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 17, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05793736", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06404411", "title": "The Efficacy of Aerobic Exercise in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-05-13", "start_date": "2024-06-30", "completion_date": "2025-12-30", "primary_completion_date": "2025-06-30", "conditions_raw": [ "Long COVID", "Myocardial Injury" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Assigned Interventions", "Conventional Rehabilitation" ], "sponsor": "Chengdu Sport University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "A study of the efficacy of aerobic exercise based on cardiopulmonary exercise test in the rehabilitation of patients with COVID-19-related myocardial injury", "primary_outcomes": [ { "type": "primary", "measure": "VO2peak", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "METpeak", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "AT", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "VEpeak", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "BR", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "VO2/HRpeak", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Six-minute walk test distance, 6MWD", "description": "Select a 30-meter-long section of the corridor and post the location of the starting and ending points. Subjects were instructed to walk back and forth through the 30-meter passageway for 6 minutes, covering the longest distance as fast as they could.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SDNN", "description": "Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SDANN", "description": "Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "RMSSD", "description": "Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "physical composite scale，PCS", "description": "The SF-12v2 is a shortened version of the scale developed based on the SF-36, which is comprehensive, simple, and less time-consuming, and is used to evaluate subjects' quality of life with 12 entries and 8 dimensions: general health, somatic functioning, somatic functioning, bodily pain, vitality, social functioning, affective functioning, and mental health. The higher the score, the better the quality of life and functional status of the patient.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "mental health composite scale，MCS", "description": "The SF-12v2 is a shortened version of the scale developed based on the SF-36, which is comprehensive, simple, and less time-consuming, and is used to evaluate subjects' quality of life with 12 entries and 8 dimensions: general health, somatic functioning, somatic functioning, bodily pain, vitality, social functioning, affective functioning, and mental health. The higher the score, the better the quality of life and functional status of the patient.", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "VO2peak", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "METpeak", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "AT", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "VEpeak", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "BR", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "VO2/HRpeak", "description": "All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Six-minute walk test distance, 6MWD", "description": "Select a 30-meter-long section of the corridor and post the location of the starting and ending points. Subjects were instructed to walk back and forth through the 30-meter passageway for 6 minutes, covering the longest distance as fast as they could.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SDNN", "description": "Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "SDANN", "description": "Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "RMSSD", "description": "Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "physical composite scale，PCS", "description": "The SF-12v2 is a shortened version of the scale developed based on the SF-36, which is comprehensive, simple, and less time-consuming, and is used to evaluate subjects' quality of life with 12 entries and 8 dimensions: general health, somatic functioning, somatic functioning, bodily pain, vitality, social functioning, affective functioning, and mental health. The higher the score, the better the quality of life and functional status of the patient.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "mental health composite scale，MCS", "description": "The SF-12v2 is a shortened version of the scale developed based on the SF-36, which is comprehensive, simple, and less time-consuming, and is used to evaluate subjects' quality of life with 12 entries and 8 dimensions: general health, somatic functioning, somatic functioning, bodily pain, vitality, social functioning, affective functioning, and mental health. The higher the score, the better the quality of life and functional status of the patient.", "time_frame": "12 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06404411", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05697042", "title": "Merging Yoga and Self-Management Skills for Symptoms of Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-05-13", "start_date": "2023-02-01", "completion_date": "2023-12-30", "primary_completion_date": "2023-12-30", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "My-Skills For Long Covid" ], "sponsor": "University of Colorado, Denver", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID patients experience high symptom burden for many months after initial infection of the COVID-19 virus. This study will investigate a mobile intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) as a complementary therapy for fatigue, pain, mood and quality of life in long COVID patients at the UCHealth Center for Integrative Medicine. The study aim is to assess the feasibility and acceptability of MY-Skills Mobile and research procedures including planned assessments.", "primary_outcomes": [ { "type": "primary", "measure": "Feasibility- Recruitment", "description": "90% of screened patients will be eligible; 50% of eligible patients will consent", "time_frame": "Week 1" }, { "type": "primary", "measure": "Feasibility- Use", "description": "\\>50% yoga session attendance and modules will be completed", "time_frame": "Week 8" }, { "type": "primary", "measure": "Feasibility- Attrition", "description": "\\<20% attrition", "time_frame": "Week 8" }, { "type": "primary", "measure": "Feasibility-Usability", "description": "User Mobile Application Rating Scale; \\<90% of participants to rate intervention between 3-5 (5-point scale)", "time_frame": "Week 8" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptom Burden Scale for Long COVID", "description": "Newly developed 14 scale for breathing, circulation, memory, thinking/communication, movement, sleep, ear/nose/throat, stomach, other symptoms and impact on daily life.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "PROMIS Fatigue", "description": "13-item assessing fatigue experience and impact on function", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Brief Pain Inventory", "description": "9-item for severity of pain and impact of pain on daily function", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Short Form 36", "description": "36-item function, pain, mental health, emotional well-being, fatigue, and general health perception", "time_frame": "Week 8" } ], "outcome_measures": [ { "type": "primary", "measure": "Feasibility- Recruitment", "description": "90% of screened patients will be eligible; 50% of eligible patients will consent", "time_frame": "Week 1" }, { "type": "primary", "measure": "Feasibility- Use", "description": "\\>50% yoga session attendance and modules will be completed", "time_frame": "Week 8" }, { "type": "primary", "measure": "Feasibility- Attrition", "description": "\\<20% attrition", "time_frame": "Week 8" }, { "type": "primary", "measure": "Feasibility-Usability", "description": "User Mobile Application Rating Scale; \\<90% of participants to rate intervention between 3-5 (5-point scale)", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Symptom Burden Scale for Long COVID", "description": "Newly developed 14 scale for breathing, circulation, memory, thinking/communication, movement, sleep, ear/nose/throat, stomach, other symptoms and impact on daily life.", "time_frame": "Week 8" }, { "type": "secondary", "measure": "PROMIS Fatigue", "description": "13-item assessing fatigue experience and impact on function", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Brief Pain Inventory", "description": "9-item for severity of pain and impact of pain on daily function", "time_frame": "Week 8" }, { "type": "secondary", "measure": "Short Form 36", "description": "36-item function, pain, mental health, emotional well-being, fatigue, and general health perception", "time_frame": "Week 8" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 16, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05697042", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06065033", "title": "Exercise Interventions in Post-acute Sequelae of Covid-19", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2024-05-08", "start_date": "2023-09-09", "completion_date": "2024-03-29", "primary_completion_date": "2024-03-29", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Exercise" ], "sponsor": "University of Virginia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC.\n\nThe investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers.", "primary_outcomes": [ { "type": "primary", "measure": "VO2peak", "description": "Change in VO2peak (L/min) measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Left ventricular strain", "description": "Global longitudinal strain and global circumferential strain measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Left ventricular diastolic function", "description": "Diastolic dysfunction grade measured pre- and post-intervention", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Forced expiratory volume in one second (FEV1)", "description": "FEV1 measured via spirometry pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Forced vital capacity (FVC)", "description": "FVC measured via spirometry pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Post COVID-19 Functional Status scale", "description": "Measures subjects functional limitations due to COVID-19 and will be measured via pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Symptom Burden Questionnaire for Long Covid (SBQ-LC)", "description": "Burden of symptoms will be via the SBQ-LC measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "International Physical Activity Questionnaire (IPAQ)", "description": "Physical activity levels will be assessed via IPAQ measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "NTproBNP", "description": "Assess changes in NTproBNP (pg/ml) as a biomarker of myocardial strain at pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "C-reactive protein (CRP)", "description": "C-reactive protein (mg/dl) will be used as a biomarker for inflammation to be measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Lipids", "description": "A lipid panel will be performed to measure total cholesterol, triglycerides, high-density lipoproteins, and low-density lipoprotein (mg/dl) to assess changes in cardiometabolic health pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Fasting glucose", "description": "Fasting blood glucose levels (mg/dl) will be tested to assess changes in cardiometabolic health pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Insulin", "description": "Fasting insulin levels (U/ml) will be tested to assess changes in cardiometabolic health pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Erythrocyte sedimentation rate (ESR)", "description": "ESR will be measured to assess inflammation pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "IL-1", "description": "Inflammation will be measured via IL-1 pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "IL-6", "description": "Inflammation will be measured via IL-6 pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "TNF-a", "description": "Inflammation will be measured via TNF-a pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Fibrinogen", "description": "Fibrinogen will be measured pre- and post-intervention to measure clotting", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "D-dimer", "description": "D-dimer will be measured pre- and post-intervention to measure clotting", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "VO2peak", "description": "Change in VO2peak (L/min) measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Left ventricular strain", "description": "Global longitudinal strain and global circumferential strain measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Left ventricular diastolic function", "description": "Diastolic dysfunction grade measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Forced expiratory volume in one second (FEV1)", "description": "FEV1 measured via spirometry pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Forced vital capacity (FVC)", "description": "FVC measured via spirometry pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Post COVID-19 Functional Status scale", "description": "Measures subjects functional limitations due to COVID-19 and will be measured via pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Symptom Burden Questionnaire for Long Covid (SBQ-LC)", "description": "Burden of symptoms will be via the SBQ-LC measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "International Physical Activity Questionnaire (IPAQ)", "description": "Physical activity levels will be assessed via IPAQ measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "NTproBNP", "description": "Assess changes in NTproBNP (pg/ml) as a biomarker of myocardial strain at pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "C-reactive protein (CRP)", "description": "C-reactive protein (mg/dl) will be used as a biomarker for inflammation to be measured pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Lipids", "description": "A lipid panel will be performed to measure total cholesterol, triglycerides, high-density lipoproteins, and low-density lipoprotein (mg/dl) to assess changes in cardiometabolic health pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Fasting glucose", "description": "Fasting blood glucose levels (mg/dl) will be tested to assess changes in cardiometabolic health pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Insulin", "description": "Fasting insulin levels (U/ml) will be tested to assess changes in cardiometabolic health pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Erythrocyte sedimentation rate (ESR)", "description": "ESR will be measured to assess inflammation pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "IL-1", "description": "Inflammation will be measured via IL-1 pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "IL-6", "description": "Inflammation will be measured via IL-6 pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "TNF-a", "description": "Inflammation will be measured via TNF-a pre- and post-intervention", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Fibrinogen", "description": "Fibrinogen will be measured pre- and post-intervention to measure clotting", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "D-dimer", "description": "D-dimer will be measured pre- and post-intervention to measure clotting", "time_frame": "4 weeks" } ], "relevance_tags": [ "Immunomodulatory", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT06065033", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05254301", "title": "Nutrition and LOComotoric Rehabilitation in Long COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-05-08", "start_date": "2022-04-24", "completion_date": "2024-01-30", "primary_completion_date": "2024-01-30", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Intervention Group" ], "sponsor": "Universitair Ziekenhuis Brussel", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID is a new phenomenon, in which individuals who experienced a SARS-CoV-2 infection still experience one or more symptoms, such as exercise intolerance, fatigue and/or muscle pains in addition to other COVID-related symptoms, weeks to months after initial infection.\n\nThe aim of this pilot-study is to learn about which complaints patients continue to experience after their infection and how this affects their lives to a greater or lesser extent and whether a patient-tailored physical rehabilitation programme combined with individualised nutritional therapy leads to a faster recovery compared to a classic exercise program with the physiotherapist.", "primary_outcomes": [ { "type": "primary", "measure": "1-minute sit-to-stand (1-MSTS)", "description": "Testing of endurance and muscle strength of the lower extremities (standing up from a sitting position for as many repetitions as possible during 1 minute)", "time_frame": "Change from Baseline Repetitions Sit-To-Stand's in one minute at 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Multi-dimensional Fatigue Inventor (MFI-20)", "description": "The MFI is a self-report instrument designed to measure fatigue and was initially developed in Dutch17 for patients with cancer. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. It consists of 20 items divided over 5 dimensions (each 4 items) and is scored on a 5-point Likert scale. The higher the score the more severe the fatigue and by consequence the more impact fatigue has on daily functioning.", "time_frame": "Change from Baseline MFI-20 at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." }, { "type": "secondary", "measure": "EuroQol five-dimensional (five-level version) (EQ-5D-5L)", "description": "Health-related Quality of Life will be measured by the EQ-5D-5L. This questionnaire comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels from no problems tot extreme problems. Next it contains a self-rated health status on a vertical visual analogue scale where the endpoints are labelled the best health you can imagine' and 'the worst health you can imagine'. This test has proven valuable for assessing physical health-related QoL (25).", "time_frame": "Change from Baseline EQ-5D-5L at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." }, { "type": "secondary", "measure": "Post-COVID-19 Functional Status (PCFS)", "description": "Functional status will be evaluated for changes using the PCFS, specifically developed for COVID patients by Klok and colleagues.", "time_frame": "Change from Baseline PCFS at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "Mental status will be evaluated for differences using HADS.This test is a simple tool to assess both anxiety and depression, each with 7 questions.", "time_frame": "Change from Baseline HADS at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." }, { "type": "secondary", "measure": "Work Productivity and Activity Impairment (WPAI)", "description": "Work capability will also be assessed using the Work Productivity and Activity Impairment. With 6 questions it asks about the decline in productivity and activity in the past 7 days. There are 3 versions available but all evaluate on absence, presence, loss of productivity and decline of activities during work. The WPAI is considered the best validated questionnaire for determining health-related work productivity and has been validated in various chronic inflammatory diseases.", "time_frame": "Change from Baseline WPAI at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." } ], "outcome_measures": [ { "type": "primary", "measure": "1-minute sit-to-stand (1-MSTS)", "description": "Testing of endurance and muscle strength of the lower extremities (standing up from a sitting position for as many repetitions as possible during 1 minute)", "time_frame": "Change from Baseline Repetitions Sit-To-Stand's in one minute at 12 weeks" }, { "type": "secondary", "measure": "Multi-dimensional Fatigue Inventor (MFI-20)", "description": "The MFI is a self-report instrument designed to measure fatigue and was initially developed in Dutch17 for patients with cancer. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. It consists of 20 items divided over 5 dimensions (each 4 items) and is scored on a 5-point Likert scale. The higher the score the more severe the fatigue and by consequence the more impact fatigue has on daily functioning.", "time_frame": "Change from Baseline MFI-20 at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." }, { "type": "secondary", "measure": "EuroQol five-dimensional (five-level version) (EQ-5D-5L)", "description": "Health-related Quality of Life will be measured by the EQ-5D-5L. This questionnaire comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels from no problems tot extreme problems. Next it contains a self-rated health status on a vertical visual analogue scale where the endpoints are labelled the best health you can imagine' and 'the worst health you can imagine'. This test has proven valuable for assessing physical health-related QoL (25).", "time_frame": "Change from Baseline EQ-5D-5L at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." }, { "type": "secondary", "measure": "Post-COVID-19 Functional Status (PCFS)", "description": "Functional status will be evaluated for changes using the PCFS, specifically developed for COVID patients by Klok and colleagues.", "time_frame": "Change from Baseline PCFS at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "Mental status will be evaluated for differences using HADS.This test is a simple tool to assess both anxiety and depression, each with 7 questions.", "time_frame": "Change from Baseline HADS at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." }, { "type": "secondary", "measure": "Work Productivity and Activity Impairment (WPAI)", "description": "Work capability will also be assessed using the Work Productivity and Activity Impairment. With 6 questions it asks about the decline in productivity and activity in the past 7 days. There are 3 versions available but all evaluate on absence, presence, loss of productivity and decline of activities during work. The WPAI is considered the best validated questionnaire for determining health-related work productivity and has been validated in various chronic inflammatory diseases.", "time_frame": "Change from Baseline WPAI at 12 weeks, at 6 weeks intervention, at 12 weeks, and at 6 weeks post-intervention." } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 65, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05254301", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05890508", "title": "Electro-acupuncture for Long Covid Neuropsychiatric Symptoms", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-05-07", "start_date": "2024-03-01", "completion_date": "2026-04-30", "primary_completion_date": "2026-01-31", "conditions_raw": [ "Long Covid19", "Neuropsychiatric Symptoms", "Electro-acupuncture" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Acupuncture" ], "sponsor": "Hong Kong Baptist University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In this study, a 16-week randomized, sham-controlled, double-blinded clinical trial will be conducted to to investigate the efficacy and safety of electro-acupuncture compared to sham acupuncture for treatment of long covid neuropsychiatric symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale", "description": "The MMSE can evaluate of five different domains of cognitive functions: (1) Orientation, with a maximum of 10 points, (2) Memory, with a maximum of 6 points, (3) Attention and calculation, with a maximum of 5 points, (4) Language, with a maximum of 8 points, and (5) Design copying, with a maximum of 1 point. It has a maximum score of 30, with MMSE score denotes severity of cognitive impairment as follows; mild: MMSE 21 to 24, moderate: MMSE 10 to 20, severe: MMSE less than 10.", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." }, { "type": "primary", "measure": "Depression on the Chinese Beck Depression Inventory (CBDI)", "description": "The scale has a total of 21 questions, with an overall score of 63, 14-19 being mild depression, 20-28 being moderate depression, and above 29 being severe depression.", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Score of Insomnia Severity Index (ISI)", "description": "The Insomnia Severity Index in Chinese includes 5 questions to assess the severity and impact of insomnia, on an 0 to 4 scale, with the higher score reflecting worse insomnia symptoms.", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." }, { "type": "secondary", "measure": "Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form", "description": "BFI-T form is to assess the severity of fatigue and the impact of fatigue on daily functioning. Scoring Respondents rate each item on a 0-10 numeric scale, with 0 meaning \"no fatigue\" and 10 meaning \"fatigue as bad as you can imagine.\" Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." }, { "type": "secondary", "measure": "Score of the Short Form 12 (SF12)", "description": "The SF-12V2 is a widely used generic HRQoL instrument, and its Chinese version has been validated and normed in the general Chinese population in Hong Kong. It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The scores are generated using an algorithm to generate a combined physical and mental health score for comparison with normative data. In the normative data: 1) the mean score was set to 50; 2) a score \\> 50 indicated better physical or mental health than the mean; 3) a score \\< 50 indicated worse physical or mental health than the mean.", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." } ], "outcome_measures": [ { "type": "primary", "measure": "Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale", "description": "The MMSE can evaluate of five different domains of cognitive functions: (1) Orientation, with a maximum of 10 points, (2) Memory, with a maximum of 6 points, (3) Attention and calculation, with a maximum of 5 points, (4) Language, with a maximum of 8 points, and (5) Design copying, with a maximum of 1 point. It has a maximum score of 30, with MMSE score denotes severity of cognitive impairment as follows; mild: MMSE 21 to 24, moderate: MMSE 10 to 20, severe: MMSE less than 10.", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." }, { "type": "primary", "measure": "Depression on the Chinese Beck Depression Inventory (CBDI)", "description": "The scale has a total of 21 questions, with an overall score of 63, 14-19 being mild depression, 20-28 being moderate depression, and above 29 being severe depression.", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." }, { "type": "secondary", "measure": "Score of Insomnia Severity Index (ISI)", "description": "The Insomnia Severity Index in Chinese includes 5 questions to assess the severity and impact of insomnia, on an 0 to 4 scale, with the higher score reflecting worse insomnia symptoms.", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." }, { "type": "secondary", "measure": "Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form", "description": "BFI-T form is to assess the severity of fatigue and the impact of fatigue on daily functioning. Scoring Respondents rate each item on a 0-10 numeric scale, with 0 meaning \"no fatigue\" and 10 meaning \"fatigue as bad as you can imagine.\" Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." }, { "type": "secondary", "measure": "Score of the Short Form 12 (SF12)", "description": "The SF-12V2 is a widely used generic HRQoL instrument, and its Chinese version has been validated and normed in the general Chinese population in Hong Kong. It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The scores are generated using an algorithm to generate a combined physical and mental health score for comparison with normative data. In the normative data: 1) the mean score was set to 50; 2) a score \\> 50 indicated better physical or mental health than the mean; 3) a score \\< 50 indicated worse physical or mental health than the mean.", "time_frame": "At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up)." } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 150, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05890508", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06391970", "title": "Digital Cognition Study During Long-COVID", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-04-30", "start_date": "2023-04-15", "completion_date": "2025-09-30", "primary_completion_date": "2024-08-01", "conditions_raw": [ "COVID-19, Long Haul" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cognitive Screening" ], "sponsor": "Luxembourg Institute of Health", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "The persistence of the COVID-19 disease symptoms, such as extreme fatigue, shortness of breath, cardiovascular complications, depression and anxiety, pain, brain fog, loss of taste/smell, headaches as well as loss of memory has been evoked in many studies. This project aims at approaching the persistent symptomatology on cognition, more than 1 year after the infection.\n\nWhen we refer to cognition, we refer to everything associated with knowledge, that is, the accumulation of information we have acquired through learning or from our experience. We can define cognitive processes as the processes we use to incorporate new knowledge and make decisions based on it. Through these processes several cognitive functions intervene: perception, attention, memory, reasoning, language, learning, decision-making. All of these cognitive functions work together to integrate knowledge as a whole and create an interpretation of the world around us. Usually neuropsychological tests are used to evaluate cognitive problems, they consist in different exercises sometimes with words, figures to draw, images to remember, movement to repeat, numbers to link together etc.\n\nThe DigiCog project here propose\n\n1. to test and validate a very novel device, which uses the eyes movement during tasks to evaluate very quickly the cognitive functioning;\n2. to study potential cognitive problems long-term after COVID-19; and\n3. to explore how cognition could be preserved.\n\nFinally, this project will also help to bring the innovative device tested to the market, for accurately monitoring people with long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Cognitive status assessed with the digital device, of individuals with/without symptoms persisting long-term after COVID-19 disease.", "description": "", "time_frame": "Each assessment and evaluation session lasts approximately 20 minutes and occurs once." }, { "type": "primary", "measure": "Cognitive status assessed with the gold standard procedure, of individuals with/without symptoms persisting long-term after COVID-19 disease.", "description": "", "time_frame": "Each assessment and evaluation session lasts approximately 1 h and occurs once." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Cognitive status assessed with the digital device, of individuals with/without symptoms persisting long-term after COVID-19 disease.", "description": "", "time_frame": "Each assessment and evaluation session lasts approximately 20 minutes and occurs once." }, { "type": "primary", "measure": "Cognitive status assessed with the gold standard procedure, of individuals with/without symptoms persisting long-term after COVID-19 disease.", "description": "", "time_frame": "Each assessment and evaluation session lasts approximately 1 h and occurs once." } ], "relevance_tags": [ "Persistence / Antiviral", "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other Gov" ], "enrollment": 300, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06391970", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06074848", "title": "tDCS in the Management of Post-COVID Disorders", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2024-04-24", "start_date": "2023-08-25", "completion_date": "2024-09-28", "primary_completion_date": "2024-07-01", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Transcranial Direct Current Stimulation", "Motor Training", "Cognitive Training" ], "sponsor": "Universidade Federal de Pernambuco", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Different physical and mental morbidities such as pain, fatigue, depressed mood and cognitive impairment can be triggered by coronavirus infection. Transcranial direct current stimulation (tDCS), an easy-to-apply, non-pharmacological and safe technique, has been used to attenuate these symptoms caused by other diseases, and, therefore, it is expected that it can also attenuate them when generated by COVID-19. It is known that the persistent inflammatory state observed after COVID-19 would be related to the progression of these negative symptoms. As non-invasive brain stimulation can also attenuate acute and persistent inflammation, it can be estimated that tDCS can be a useful tool to recover immune function and reduce post-COVID-19 morbidity.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue - Modified Fatigue Impact Scale (MFIS)", "description": "The MFIS is a scale that contains 21 items that analyze cognitive, physical and psychosocial issues. The physical domain allows scores from 0 to 36, the cognitive domain from 0 to 40 and the psychosocial domain from 0 to 8. The total MFIS score is given by the sum of the three domains and varies from 0 to 84 points. Values below 38 correspond to the absence of fatigue, and above this value, the higher the score, the greater the individual's degree of fatigue.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Pain measure - Brief Pain Inventory (BPI)", "description": "assesses severity of pain, impact of pain on daily functions, location of pain, analgesics, and amount of pain relief in the past 24 hours and past week on an 11-point scale ranging from 0 (no pain/no interference) to 10 (the worst possible). Including a body diagram to assess the location of pain (item 2), scores range from 0 to 10 and are calculated as the average of the total items. A high score represents a high pain intensity or pain interference", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Pain measure - Visual Analog Scale (VAS)", "description": "consiste em uma régua numerada de 0 a 10 e dividida em três partes, leve, moderada e intensa, com auxílio visual para facilitar a mensuração da intensidade da dor do paciente.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - Montreal Cognitive Assessment Instrument (MoCA)", "description": "quickly identifies cognitive declines in patients with a maximum score of 30 (points), evaluates eight cognitive domains: 1. Executive function: with the Trail Making Test B (adapted - 1 point), phonemic verbal fluency (1 point) and abstraction verbal (2 points). 2. Visual-spatial ability: drawing the clock (3 points) and copying the cube (1 point). 3. memory: delayed recall of words 5 minutes (5 points). 4. Attention/5. Concentration/6. Working memory: digit memory (forward sense - 1 point), digit memory (backward sense - 1 point), sustained attention task (target detection - 1 point) and serial subtraction of 7 (3 points). 7. Language: naming 3 unfamiliar animals (3 points), repetition of 2 syntactically complex sentences - phonemic verbal fluency (above - 2 points). 8. Orientation: temporal (4 points) and spatial (2 points). It has a total score of 30 points. The cutoff score is 26 points, indicating the presence of cognitive deficit. Score above said is considered normal.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - FAS Test", "description": "is a Verbal Fluency Test/Phonological Fluency Test that assesses verbal learning and the ability to produce words verbally. The total score is given by adding up all correct words starting with the three letters.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - CFL Test", "description": "is a Verbal Fluency Test/Phonological Fluency Test that assesses verbal learning and the ability to produce words verbally. The total score is given by adding up all correct words starting with the three letters.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - Random Number Generator", "description": "Assesses language and executive function. Numbers are produced randomly when a previously recorded sound signal is heard. You must speak numbers from 1 to 10 without speaking sequences.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - Digit span", "description": "Used to assess the ability to focus, maintain attention, mental manipulation and memory. It consists of repeating the numbers said by the evaluator, where in the first phase they will be said in direct order (16 points) and in the second phase in reverse order (14 points). Together they add up to a maximum score of 30 points.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Depressed mood - Hospital Anxiety and Depression Scale (HADS)", "description": "measures symptoms of anxiety and depression divided into an anxiety subscale (HADS-Anxiety) and a depression subscale (HADS-Depression). Each question has a variable score from zero to four points, with 14 questions in total. From 0 - 7 points indicates anxiety and depression unlikely; 8 - 11 points indicate possible anxiety and depression and 12 - 21 points indicate probable anxiety and depression.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Depressed mood - Brunel Mood Scale (BRUMS)", "description": "Used to quickly measure a patient's mood using six subscales: tension, depression, anger, vigor, fatigue and confusion. It contains 24 questions that must be evaluated according to a scale of 0 to 4 points, each subscale has a score that can vary from 0 - 16.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "COVID clinical situation", "description": "It will be carried out using the Case Report Form - CRF (Post COVID-19) from the Pan American Health Organization (PAHO). Using the first two modules, module 1 comprises demographic data and clinical information related to the acute episode of COVID-19 and module 2 includes questions related to vaccination, occupational and functional status of the volunteer. Based on these questionnaires, it is possible to identify the patient's status in their episodes of contagion with COVID-19 and the degree of support that was needed in each case, as well as the main symptoms and characteristics of the case.", "time_frame": "pre-intervention" }, { "type": "secondary", "measure": "Level of physical activity", "description": "The short version of IPAQ will be performed to identify if the volunteer has a life with active physical activities. It makes it possible to estimate the weekly time used for physical activities.", "time_frame": "pre-intervention" }, { "type": "secondary", "measure": "State of strength and effort", "description": "the handgrip strength test and perceived exertion performed with the dynamometer will be used to quantitatively indicate the muscle strength of the hand and forearm and to assess the level of effort exerted through the BORG scale.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "secondary", "measure": "Exercise capacity - 6-minute walk test", "description": "the participant's functional capacity and aerobic resistance will be evaluated through the 6-minute walk test. The test measures the distance that the volunteer covers in a period of 6 minutes walking at a steady speed.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "secondary", "measure": "Immunometabolic evaluation", "description": "will begin with the participant's blood collection. Stimulation of whole blood with LPS, culture of peripheral blood mononuclear cells (PBMC), evaluation of oxidative stress, evaluation of adenine and purine LPS levels in plasma, analysis of immunophenotyping and apoptosis by flow cytometry, evaluation of expression of purinoreceptors, mitochondrial assays in monocytes and T lymphocytes, evaluation of the generation of reactive oxygen species and quantification of several mediators by ELISA.", "time_frame": "pre-intervention and 72 hours after the last intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue - Modified Fatigue Impact Scale (MFIS)", "description": "The MFIS is a scale that contains 21 items that analyze cognitive, physical and psychosocial issues. The physical domain allows scores from 0 to 36, the cognitive domain from 0 to 40 and the psychosocial domain from 0 to 8. The total MFIS score is given by the sum of the three domains and varies from 0 to 84 points. Values below 38 correspond to the absence of fatigue, and above this value, the higher the score, the greater the individual's degree of fatigue.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Pain measure - Brief Pain Inventory (BPI)", "description": "assesses severity of pain, impact of pain on daily functions, location of pain, analgesics, and amount of pain relief in the past 24 hours and past week on an 11-point scale ranging from 0 (no pain/no interference) to 10 (the worst possible). Including a body diagram to assess the location of pain (item 2), scores range from 0 to 10 and are calculated as the average of the total items. A high score represents a high pain intensity or pain interference", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Pain measure - Visual Analog Scale (VAS)", "description": "consiste em uma régua numerada de 0 a 10 e dividida em três partes, leve, moderada e intensa, com auxílio visual para facilitar a mensuração da intensidade da dor do paciente.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - Montreal Cognitive Assessment Instrument (MoCA)", "description": "quickly identifies cognitive declines in patients with a maximum score of 30 (points), evaluates eight cognitive domains: 1. Executive function: with the Trail Making Test B (adapted - 1 point), phonemic verbal fluency (1 point) and abstraction verbal (2 points). 2. Visual-spatial ability: drawing the clock (3 points) and copying the cube (1 point). 3. memory: delayed recall of words 5 minutes (5 points). 4. Attention/5. Concentration/6. Working memory: digit memory (forward sense - 1 point), digit memory (backward sense - 1 point), sustained attention task (target detection - 1 point) and serial subtraction of 7 (3 points). 7. Language: naming 3 unfamiliar animals (3 points), repetition of 2 syntactically complex sentences - phonemic verbal fluency (above - 2 points). 8. Orientation: temporal (4 points) and spatial (2 points). It has a total score of 30 points. The cutoff score is 26 points, indicating the presence of cognitive deficit. Score above said is considered normal.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - FAS Test", "description": "is a Verbal Fluency Test/Phonological Fluency Test that assesses verbal learning and the ability to produce words verbally. The total score is given by adding up all correct words starting with the three letters.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - CFL Test", "description": "is a Verbal Fluency Test/Phonological Fluency Test that assesses verbal learning and the ability to produce words verbally. The total score is given by adding up all correct words starting with the three letters.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - Random Number Generator", "description": "Assesses language and executive function. Numbers are produced randomly when a previously recorded sound signal is heard. You must speak numbers from 1 to 10 without speaking sequences.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Cognitive deficit - Digit span", "description": "Used to assess the ability to focus, maintain attention, mental manipulation and memory. It consists of repeating the numbers said by the evaluator, where in the first phase they will be said in direct order (16 points) and in the second phase in reverse order (14 points). Together they add up to a maximum score of 30 points.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Depressed mood - Hospital Anxiety and Depression Scale (HADS)", "description": "measures symptoms of anxiety and depression divided into an anxiety subscale (HADS-Anxiety) and a depression subscale (HADS-Depression). Each question has a variable score from zero to four points, with 14 questions in total. From 0 - 7 points indicates anxiety and depression unlikely; 8 - 11 points indicate possible anxiety and depression and 12 - 21 points indicate probable anxiety and depression.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "primary", "measure": "Depressed mood - Brunel Mood Scale (BRUMS)", "description": "Used to quickly measure a patient's mood using six subscales: tension, depression, anger, vigor, fatigue and confusion. It contains 24 questions that must be evaluated according to a scale of 0 to 4 points, each subscale has a score that can vary from 0 - 16.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "secondary", "measure": "COVID clinical situation", "description": "It will be carried out using the Case Report Form - CRF (Post COVID-19) from the Pan American Health Organization (PAHO). Using the first two modules, module 1 comprises demographic data and clinical information related to the acute episode of COVID-19 and module 2 includes questions related to vaccination, occupational and functional status of the volunteer. Based on these questionnaires, it is possible to identify the patient's status in their episodes of contagion with COVID-19 and the degree of support that was needed in each case, as well as the main symptoms and characteristics of the case.", "time_frame": "pre-intervention" }, { "type": "secondary", "measure": "Level of physical activity", "description": "The short version of IPAQ will be performed to identify if the volunteer has a life with active physical activities. It makes it possible to estimate the weekly time used for physical activities.", "time_frame": "pre-intervention" }, { "type": "secondary", "measure": "State of strength and effort", "description": "the handgrip strength test and perceived exertion performed with the dynamometer will be used to quantitatively indicate the muscle strength of the hand and forearm and to assess the level of effort exerted through the BORG scale.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "secondary", "measure": "Exercise capacity - 6-minute walk test", "description": "the participant's functional capacity and aerobic resistance will be evaluated through the 6-minute walk test. The test measures the distance that the volunteer covers in a period of 6 minutes walking at a steady speed.", "time_frame": "pre-intervention, 72 hours after the last intervention and 15 days after completion." }, { "type": "secondary", "measure": "Immunometabolic evaluation", "description": "will begin with the participant's blood collection. Stimulation of whole blood with LPS, culture of peripheral blood mononuclear cells (PBMC), evaluation of oxidative stress, evaluation of adenine and purine LPS levels in plasma, analysis of immunophenotyping and apoptosis by flow cytometry, evaluation of expression of purinoreceptors, mitochondrial assays in monocytes and T lymphocytes, evaluation of the generation of reactive oxygen species and quantification of several mediators by ELISA.", "time_frame": "pre-intervention and 72 hours after the last intervention" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Anti-inflammatory", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 48, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06074848", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06379737", "title": "Multi-systemic Rehabilitative Interventions in Long COVID-19 Patients in Two Different Settings: a Randomized Controlled Trial", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-04-23", "start_date": "2023-01-01", "completion_date": "2023-12-20", "primary_completion_date": "2023-12-20", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Multi-Systemic Rehabilitation" ], "sponsor": "Padua University General Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Objective: This study aimed to evaluate the effectiveness of a multisystem rehabilitation program for Long Covid patients in two different settings.\n\nDesign: Randomized controlled trial. Settings: Health resort and home-based. Participants: 72 Long Covid patients. Interventions: Patients were randomly assigned into two groups: Group A (n=36) received health resort intervention, and Group B (n=36) received home-based care. Both groups underwent a 5-week rehabilitation program, involving motor, respiratory, and cognitive exercises, two sessions per week.\n\nOutcomes: Assessments were conducted before (T0) and after treatment (T1), at 3 (T2) and 6 months (T3), including respiratory and physical function, handgrip strength, fatigue, pain, quality of life, psychological function, and satisfaction.", "primary_outcomes": [ { "type": "primary", "measure": "Numerical Rating Scale (NRS)", "description": "a commonly used pain assessment tool that involves asking patients to rate their pain verbally or visually on a scale from 0 to 10, with 0 indicating no pain and 10 representing the worst possible pain", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Hand grip strength", "description": "the strength of the dominant hand was assessed using a digital handheld dynamometer", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Barthel Dyspnea Scale", "description": "The Barthel Dyspnea Scale is a validated tool used to measure the severity of dyspnea. It evaluates various activities and tasks that may provoke dyspnea, allowing to assess and monitor the impact of dyspnea on a patient's daily life", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Fatigue Assessment Scale", "description": "a self-report questionnaire designed to assess the severity and impact of fatigue. It consists of 10 items, describing different aspects of fatigue.", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Beck's Depression Inventory (BDI", "description": "the BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Beck Anxiety Inventory (BAI)", "description": "the BAI is a self-report questionnaire designed to assess the severity of anxiety symptoms and consists of 21 items that measure various aspects of anxiety", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "12-Item Short Form Health Survey (SF-12)", "description": "The SF-12 is employed for assessing health-related quality of life (HRQoL). It is a shortened version of the SF-36, consisting of 12 items that measure eight health domains, including physical functioning, limitations due to physical health problems, bodily pain, general health perception, vitality, social functioning, limitations due to emotional problems, and mental health", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patients satisfaction", "description": "Specifically designed questionnaire (Likert scale)", "time_frame": "immediately after intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Numerical Rating Scale (NRS)", "description": "a commonly used pain assessment tool that involves asking patients to rate their pain verbally or visually on a scale from 0 to 10, with 0 indicating no pain and 10 representing the worst possible pain", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Hand grip strength", "description": "the strength of the dominant hand was assessed using a digital handheld dynamometer", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Barthel Dyspnea Scale", "description": "The Barthel Dyspnea Scale is a validated tool used to measure the severity of dyspnea. It evaluates various activities and tasks that may provoke dyspnea, allowing to assess and monitor the impact of dyspnea on a patient's daily life", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Fatigue Assessment Scale", "description": "a self-report questionnaire designed to assess the severity and impact of fatigue. It consists of 10 items, describing different aspects of fatigue.", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Beck's Depression Inventory (BDI", "description": "the BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "Beck Anxiety Inventory (BAI)", "description": "the BAI is a self-report questionnaire designed to assess the severity of anxiety symptoms and consists of 21 items that measure various aspects of anxiety", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "primary", "measure": "12-Item Short Form Health Survey (SF-12)", "description": "The SF-12 is employed for assessing health-related quality of life (HRQoL). It is a shortened version of the SF-36, consisting of 12 items that measure eight health domains, including physical functioning, limitations due to physical health problems, bodily pain, general health perception, vitality, social functioning, limitations due to emotional problems, and mental health", "time_frame": "immediately before and after intervention and 3 and 6 months follow-ups" }, { "type": "secondary", "measure": "Patients satisfaction", "description": "Specifically designed questionnaire (Likert scale)", "time_frame": "immediately after intervention" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 72, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06379737", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06374446", "title": "Effect of Virtual Reality in Patients With Long Covid-19", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-04-18", "start_date": "2024-04-20", "completion_date": "2024-06-30", "primary_completion_date": "2024-06-15", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Classical Treatment", "Virtual Reality Combined With Classical Treatment", "Virtual Reality" ], "sponsor": "Istinye University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "SARS-CoV-2 was first detected in Wuhan, Hubei Province, China, in late 2019. It is a highly contagious virus that has been reported to occur in humans and is said to cause pneumonia.\n\nCovid-19 infection is transmitted through droplets during coughing and sneezing and through contact with the mouth, nose or eyes after contaminated hands. The most obvious symptoms of Covid-19 symptoms include cough, dyspnea and fever. Covid-19, which can also be seen asymptomatic, is in intensive care it may be severe enough to require hospitalization, cause multiple organ failure and even death it could be. Musculoskeletal symptoms such as fatigue, myalgia, and arthralgia are common with Covid-19 are the symptoms. The first case in Turkey was reported on March 11, 2020.\n\nLong-term Covid or Chronic Post Covid Syndrome are multi-system syndromes that last more than 12 weeks and physical, cognitive, psychological, social and occupational domains. The most commonly reported long covid symptoms are; fatigue, shortness of breath, cough, joint pain, chest pain.\n\nVirtual reality application provides its users with content created using computer technology. In a virtual environment with a high perception of reality, the aim is to enable mirror neuron activation, enabling the individual to interact with virtual objects and events with three-dimensional movements and to create the perception of doing all these in the real world.\n\nVirtual reality for training, treatment, rehabilitation, analysis and testing purposes in healthcare can be used. It is possible to use virtual reality for different purposes, for treatment and rehabilitation. With virtual reality applications in treatment and rehabilitation processes It was stated that patient motivation will increase and patient fear and anxiety will decrease.\n\nNo study was found in the literature investigating the effect of virtual reality application on fatigue, functional capacity and respiratory function in long-term Covid-19 patients. The purpose of this study; To investigate the effect of virtual reality application on fatigue, functional level and respiratory function in long-term Covid-19 patients.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue", "description": "It will be evaluated with the Visual Analog Scale. It will be used to objectively determine the degree of pain at rest and during activity. Visual Analogue Scale is a 10 cm line drawn in the horizontal plane on a white sheet of paper. The words \"no pain\" are on the left end and \"the most severe pain you have ever encountered in your life\" are on the right. It was explained to the patient that the severity of pain increased from left to right, and he was asked to mark the severity of his own pain separately on this line at rest and during movement. There will be 2 different evaluations as Visual Analogue Scale-Rest and Visual Analogue ScaleActivity. Evaluations will be measured at the start of treatment and at the end of the study.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Kinesiophobia", "description": "Kinesiophobia means fear of movement. Tampa Kinesiophobia Scale consists of 17 items. It determines the impact of injury and fear on the inability to perform movements in daily life and activities. In questions, the patient ticks the box for the answer he finds appropriate. The score for each question is determined by the answer. There is a score range of 1-4. The overall score is in the range of 17-68. The total score is calculated after reversing items 4, 8, 12 and 16. The higher the total score, the higher the level of kinesiophobia.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Evaluation of Respiratory Function", "description": "It is performed with a respiratory function test. It is performed with a spirometer device according to the American Thoracic Society and European Respiratory Society criteria; forced vital capacity (FVC), forced expiratory volume (FEV1), forced expiratory volume/ forced vital capacity (FEV1/FVC), 20 peak expiratory flow (PEF) and forced expiratory flow 25-75% (FEF25-75%) values are recorded.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Shuttle Walking Test", "description": "This test is an exercise test in which you walk for 12 minutes at increasing speed between two cones 10 m apart, with each 10-meter journey between the two cones counting as one shuttle. Testing is continued until the patient is unable to continue testing due to shortness of breath, the heart rate reaches 85% of the maximum expected heart rate, or the test is completed for 12 minutes. What is actually measured in this test is the distance walked. It is calculated based on the number of sit-ups completed. In healthy people, a walking distance of 824 m can be reached between the ages of 40-49, 788 m between the ages of 50-59, 699 m between the ages of 60-69, and 633 m for people aged 70 and over. .", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Endurance Shuttle Walking Test", "description": "Endurance Shuttle Walking Test In this test, you walk at a constant speed between cones 10 m apart. The selected speed is 85% of the person's maximum capacity measured in the shuttle walking test at increasing speed. Therefore, before this test, the patient must undergo a shuttle walking test at an increased speed. The test is terminated in 20 minutes. It is a test developed to determine submaximal exercise capacity in daily living activities. It is aimed to eliminate individual differences by directing the walking speed externally with audible signals. In this test, walking time, heart rate, oxygen saturation and dyspnea level are measured.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Sit and Reach Test", "description": "It was used to measure hamstrings flexibility. The test was performed by measuring the distance from the hands to the tip of the toes while the patient was in a long sitting position in bed, without bending his knees. His last destination was recorded. If the hands did not touch the feet, the values were recorded as negative, if they passed the feet, the values were recorded as positive.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Peripheral Muscle Strength", "description": "It will be evaluated with a hand dynamometer and myometer. Hand grip strength is a simple measurement method used to measure upper extremity function. Measurement of hand grip strength is used in many studies in the field of pulmonary rehabilitation because it is an easy and useful method. There are different types of dynamometers. However, the Jamar hand dynamometer, which has high validity and reliability, is recommended by the American Association of Hand Therapists, and is considered the gold standard, is used in the studies. Elbow and shoulder flexors, shoulder abduction and knee extension will be measured with a myometer. Tests will begin to be administered after detailed information about how the test is performed and a trial has been carried out once. The measurements will be repeated 3 times and the arithmetic average will be accepted as the value taken by the device and will be recorded on the patient follow-up forms.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "The Nottingham Health Profile", "description": "The Nottingham Health Profile will be used in our quality of life assessment. In the questionnaire consisting of 38 items, 6 different parameters related to health status are evaluated. These parameters are physical activity (8 items), emotional reactions (9 items), energy (3 items), social isolation (5 items), pain (8 items), and sleep (5 items). Each subparameter is scored between 0-100. A high score indicates worsening health. The total score is obtained by summing all sub-parameter scores.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Dyspnea", "description": "Individuals is dyspnea level will be measured using the Modified Medical Research Council (MMRC) Dyspnea Scale. The scale, which was created considering different physical activities that cause the feeling of dyspnea, has five items and the scoring is between 0-4 points. 0: no shortness of breath except during strenuous exercise, 1: shortness of breath when rushing on level ground or going up a slight incline, 2: walking slower than people of the same age due to shortness of breath or having to stop for breath when walking at their own pace on the level; 3: Pauses for breath after walking ∼100 m or after a few minutes at the level, 4: Too out of breath to leave the house or out of breath when dressing or undressing", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Energy Consumption", "description": "ActiGraph wGT3X-BT device is used for objective measurement of physical activity. It is a device worn on various parts of the body, mostly on the thigh, ankle, waist and wrist, that records physical movement associated with daily living activities and sleep. Data regarding the number of steps and time spent in different physical activity intensities are obtained with the device. It is requested that the attached devices should not be removed for 7 days, except for swimming, bathing and water-requiring situations. The epoch length of the device should be set to 1, 5, 15, 30 or 60 seconds. It must be worn at least 4 days a week, including one on the weekend, and at least 10 hours a day. ActiGraph energy expenditure is estimated by calculating the vector size. Predictive equations have been developed to convert these numbers into units of energy expenditure. Energy consumption is calculated in METs or kilocalories. It is considered the gold standard in terms of energy consumption.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Posture Analysis", "description": "Corbin et al.'s form will be used when performing posture evaluation on individuals. This form is based on scoring postural disorders observed from the lateral and posterior according to their severity (0: none, 1: mild, 2: moderate, 3: severe). It also allows classifying the individual's postural status according to the total scores obtained. Observations are analyzed from posterior and lateral regions", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Covid-19 Yorkshire Performance", "description": "C19-YRS consists of 22 items, with each item rated on an 11-point numerical rating performance from 0 to 10. The C19-YRS is divided into four subscales (total score range for each subscale): symbol gender score (0-100), functional disability score (0-50), supplementary score (0-60), and general health (0-10). )", "time_frame": "6 weeks" }, { "type": "primary", "measure": "FACIT Fatigue Scale", "description": "There are 13 questions in this dimension, detailed by Tennant et al., for the objective assessment of fatigue. This test, which has 5 options such as not at all, very little, a little, a lot and a lot, should be taken into consideration for the last week when filling out. The feeling of fatigue and burnout that the person encounters in his daily life and activities will be questioned", "time_frame": "6 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Fatigue", "description": "It will be evaluated with the Visual Analog Scale. It will be used to objectively determine the degree of pain at rest and during activity. Visual Analogue Scale is a 10 cm line drawn in the horizontal plane on a white sheet of paper. The words \"no pain\" are on the left end and \"the most severe pain you have ever encountered in your life\" are on the right. It was explained to the patient that the severity of pain increased from left to right, and he was asked to mark the severity of his own pain separately on this line at rest and during movement. There will be 2 different evaluations as Visual Analogue Scale-Rest and Visual Analogue ScaleActivity. Evaluations will be measured at the start of treatment and at the end of the study.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Kinesiophobia", "description": "Kinesiophobia means fear of movement. Tampa Kinesiophobia Scale consists of 17 items. It determines the impact of injury and fear on the inability to perform movements in daily life and activities. In questions, the patient ticks the box for the answer he finds appropriate. The score for each question is determined by the answer. There is a score range of 1-4. The overall score is in the range of 17-68. The total score is calculated after reversing items 4, 8, 12 and 16. The higher the total score, the higher the level of kinesiophobia.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Evaluation of Respiratory Function", "description": "It is performed with a respiratory function test. It is performed with a spirometer device according to the American Thoracic Society and European Respiratory Society criteria; forced vital capacity (FVC), forced expiratory volume (FEV1), forced expiratory volume/ forced vital capacity (FEV1/FVC), 20 peak expiratory flow (PEF) and forced expiratory flow 25-75% (FEF25-75%) values are recorded.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Shuttle Walking Test", "description": "This test is an exercise test in which you walk for 12 minutes at increasing speed between two cones 10 m apart, with each 10-meter journey between the two cones counting as one shuttle. Testing is continued until the patient is unable to continue testing due to shortness of breath, the heart rate reaches 85% of the maximum expected heart rate, or the test is completed for 12 minutes. What is actually measured in this test is the distance walked. It is calculated based on the number of sit-ups completed. In healthy people, a walking distance of 824 m can be reached between the ages of 40-49, 788 m between the ages of 50-59, 699 m between the ages of 60-69, and 633 m for people aged 70 and over. .", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Endurance Shuttle Walking Test", "description": "Endurance Shuttle Walking Test In this test, you walk at a constant speed between cones 10 m apart. The selected speed is 85% of the person's maximum capacity measured in the shuttle walking test at increasing speed. Therefore, before this test, the patient must undergo a shuttle walking test at an increased speed. The test is terminated in 20 minutes. It is a test developed to determine submaximal exercise capacity in daily living activities. It is aimed to eliminate individual differences by directing the walking speed externally with audible signals. In this test, walking time, heart rate, oxygen saturation and dyspnea level are measured.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Sit and Reach Test", "description": "It was used to measure hamstrings flexibility. The test was performed by measuring the distance from the hands to the tip of the toes while the patient was in a long sitting position in bed, without bending his knees. His last destination was recorded. If the hands did not touch the feet, the values were recorded as negative, if they passed the feet, the values were recorded as positive.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Peripheral Muscle Strength", "description": "It will be evaluated with a hand dynamometer and myometer. Hand grip strength is a simple measurement method used to measure upper extremity function. Measurement of hand grip strength is used in many studies in the field of pulmonary rehabilitation because it is an easy and useful method. There are different types of dynamometers. However, the Jamar hand dynamometer, which has high validity and reliability, is recommended by the American Association of Hand Therapists, and is considered the gold standard, is used in the studies. Elbow and shoulder flexors, shoulder abduction and knee extension will be measured with a myometer. Tests will begin to be administered after detailed information about how the test is performed and a trial has been carried out once. The measurements will be repeated 3 times and the arithmetic average will be accepted as the value taken by the device and will be recorded on the patient follow-up forms.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "The Nottingham Health Profile", "description": "The Nottingham Health Profile will be used in our quality of life assessment. In the questionnaire consisting of 38 items, 6 different parameters related to health status are evaluated. These parameters are physical activity (8 items), emotional reactions (9 items), energy (3 items), social isolation (5 items), pain (8 items), and sleep (5 items). Each subparameter is scored between 0-100. A high score indicates worsening health. The total score is obtained by summing all sub-parameter scores.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Dyspnea", "description": "Individuals is dyspnea level will be measured using the Modified Medical Research Council (MMRC) Dyspnea Scale. The scale, which was created considering different physical activities that cause the feeling of dyspnea, has five items and the scoring is between 0-4 points. 0: no shortness of breath except during strenuous exercise, 1: shortness of breath when rushing on level ground or going up a slight incline, 2: walking slower than people of the same age due to shortness of breath or having to stop for breath when walking at their own pace on the level; 3: Pauses for breath after walking ∼100 m or after a few minutes at the level, 4: Too out of breath to leave the house or out of breath when dressing or undressing", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Energy Consumption", "description": "ActiGraph wGT3X-BT device is used for objective measurement of physical activity. It is a device worn on various parts of the body, mostly on the thigh, ankle, waist and wrist, that records physical movement associated with daily living activities and sleep. Data regarding the number of steps and time spent in different physical activity intensities are obtained with the device. It is requested that the attached devices should not be removed for 7 days, except for swimming, bathing and water-requiring situations. The epoch length of the device should be set to 1, 5, 15, 30 or 60 seconds. It must be worn at least 4 days a week, including one on the weekend, and at least 10 hours a day. ActiGraph energy expenditure is estimated by calculating the vector size. Predictive equations have been developed to convert these numbers into units of energy expenditure. Energy consumption is calculated in METs or kilocalories. It is considered the gold standard in terms of energy consumption.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Posture Analysis", "description": "Corbin et al.'s form will be used when performing posture evaluation on individuals. This form is based on scoring postural disorders observed from the lateral and posterior according to their severity (0: none, 1: mild, 2: moderate, 3: severe). It also allows classifying the individual's postural status according to the total scores obtained. Observations are analyzed from posterior and lateral regions", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Covid-19 Yorkshire Performance", "description": "C19-YRS consists of 22 items, with each item rated on an 11-point numerical rating performance from 0 to 10. The C19-YRS is divided into four subscales (total score range for each subscale): symbol gender score (0-100), functional disability score (0-50), supplementary score (0-60), and general health (0-10). )", "time_frame": "6 weeks" }, { "type": "primary", "measure": "FACIT Fatigue Scale", "description": "There are 13 questions in this dimension, detailed by Tennant et al., for the objective assessment of fatigue. This test, which has 5 options such as not at all, very little, a little, a lot and a lot, should be taken into consideration for the last week when filling out. The feeling of fatigue and burnout that the person encounters in his daily life and activities will be questioned", "time_frame": "6 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 56, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06374446", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06348212", "title": "Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-04-04", "start_date": "2024-04", "completion_date": "2025-12", "primary_completion_date": "2025-08", "conditions_raw": [ "Long COVID", "Brain Fog", "Cognitive Change" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Lactobacillus Paracasei Ps23", "Microcrystalline Cellulose" ], "sponsor": "Taipei Veterans General Hospital, Taiwan", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to test whether the intervention of probiotics supplement can improve symptoms of long covid syndrome.\n\nParticipants will be given probiotics or placebo capsules for two month. Symptom questionnaires, cognitive function, eeg and fecal sample are recorded/collected before and after the supplement.\n\nResearchers will compare the probiotic group and the placebo to see if probiotic supplement really make differences.", "primary_outcomes": [ { "type": "primary", "measure": "Long covid related symptoms", "description": "A list of symptoms related to long covid including cough, fatigue. brain fog etc.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Hospital Anxiety and Depression Scale", "description": "A measurement of the degree of depression and anxiety, with 7 questions each and 0-3 points for each question. Two scores ranging from 0-21 will be calculated, with higher points meaning more severe depression or anxiety.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "The Pittsburgh sleep quality index", "description": "A measurement of the degree of sleep disturbance/disorder. The score ranges from 0-21, with higher points meaning more severe sleep problem.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Fatigue Severity Scale", "description": "A measurement of the degree of fatigue, with score ranging from 7-49 and higher points meaning more severe fatigue.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "GI symptoms", "description": "Rome Criteria Questionnaire in functional UGI disease and Rome Criteria Questionnaire in IBS are included in the questionnaire are measured to see if probiotic/placebo supplement results in adverse gi events or a change of bowel habits.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Cognitive function-Digit symbol substitution test", "description": "a list of paired numbers and symbols are given to participants, and they are ask to match symbols to numbers accordingly. The number of question they answer within 90 second will be recorded.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Cognitive function-The Montreal Cognitive Assessment(MoCA)", "description": "Score ranging from 0-30, with higher meaning better cognitive function", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Cognitive function-Color Trails making Test", "description": "The test is composed of two parts, easy and hard. The time taken to finish the two parts are recorded", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Cognitive function-Cogstate Brief Battery (CBB)", "description": "A cognitive test on ipad.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "EEG", "description": "2 minutes of resting-state eye-open eeg were recored. After a brief rest, a working memory task will be repeated for 12 times.\n\nIn the task, subjects will be shown balls in a 5\\*5 chart, the location of which They are asked to remember. 6 second later, they are shown another ball, and they will be asked if the location of the newly shown ball are identical with any of the originally shown balls.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Gut microbiota", "description": "Subjects will be asked to collect their fecal sample and the bacterial DNA/RNA will be extracted and analyzed.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Fecal metabolite", "description": "Subjects will be asked to collect their fecal sample and the SCFAs in the sample will be measured.", "time_frame": "baseline and two months after probiotic/placebo supplement" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Long covid related symptoms", "description": "A list of symptoms related to long covid including cough, fatigue. brain fog etc.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Hospital Anxiety and Depression Scale", "description": "A measurement of the degree of depression and anxiety, with 7 questions each and 0-3 points for each question. Two scores ranging from 0-21 will be calculated, with higher points meaning more severe depression or anxiety.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "The Pittsburgh sleep quality index", "description": "A measurement of the degree of sleep disturbance/disorder. The score ranges from 0-21, with higher points meaning more severe sleep problem.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Fatigue Severity Scale", "description": "A measurement of the degree of fatigue, with score ranging from 7-49 and higher points meaning more severe fatigue.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "GI symptoms", "description": "Rome Criteria Questionnaire in functional UGI disease and Rome Criteria Questionnaire in IBS are included in the questionnaire are measured to see if probiotic/placebo supplement results in adverse gi events or a change of bowel habits.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Cognitive function-Digit symbol substitution test", "description": "a list of paired numbers and symbols are given to participants, and they are ask to match symbols to numbers accordingly. The number of question they answer within 90 second will be recorded.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Cognitive function-The Montreal Cognitive Assessment(MoCA)", "description": "Score ranging from 0-30, with higher meaning better cognitive function", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Cognitive function-Color Trails making Test", "description": "The test is composed of two parts, easy and hard. The time taken to finish the two parts are recorded", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Cognitive function-Cogstate Brief Battery (CBB)", "description": "A cognitive test on ipad.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "EEG", "description": "2 minutes of resting-state eye-open eeg were recored. After a brief rest, a working memory task will be repeated for 12 times.\n\nIn the task, subjects will be shown balls in a 5\\*5 chart, the location of which They are asked to remember. 6 second later, they are shown another ball, and they will be asked if the location of the newly shown ball are identical with any of the originally shown balls.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Gut microbiota", "description": "Subjects will be asked to collect their fecal sample and the bacterial DNA/RNA will be extracted and analyzed.", "time_frame": "baseline and two months after probiotic/placebo supplement" }, { "type": "primary", "measure": "Fecal metabolite", "description": "Subjects will be asked to collect their fecal sample and the SCFAs in the sample will be measured.", "time_frame": "baseline and two months after probiotic/placebo supplement" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other Gov" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06348212", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04751669", "title": "Efficacy of a Dietary Supplementation in Reducing Hospital Admissions for COVID-19. Randomized Clinical Trial", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-03-25", "start_date": "2021-08-09", "completion_date": "2023-10-26", "primary_completion_date": "2023-10-26", "conditions_raw": [ "Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Vitamin And Trace Elements" ], "sponsor": "Fundació Institut Germans Trias i Pujol", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "A double-blind, placebo-controlled, randomized clinical trial to assess efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and incidence of Long Covid.\n\nWe want to assess the need for hospital admission for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) infection in outpatients diagnosed of COVID-19 disease, taking a micronutrient supplementation for 14 days. The outcome Will be measured within 1 month after beginning the study treatment. The patients will be followed-up for a period of 180 days for the incidence of Long Covid", "primary_outcomes": [ { "type": "primary", "measure": "Need for hospital admission", "description": "The need for hospitalization of documented SARS-CoV-2 infection (positive polymerase chain reaction or transcription-mediated amplification test or antigen test or positive serology or diagnostic test available) over the course of the disease", "time_frame": "From baseline to 1 month after beginning the study treatment" }, { "type": "primary", "measure": "Incidence of Long Covid.", "description": "Incidence of long Covid or symptoms persistence following World Health Organization definition", "time_frame": "6 months after beginning the study treatment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration (in ng/mL)", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Vitamin B12)", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in pg/mL", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Iron, Zinc and Copper )", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/dL", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Vitamin A and Vitamin E)", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in mg/L", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Selenium )", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/L", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Vitamin C)", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in mg/dL", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in ng/mL", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission ( Vitamin B12)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in pg/mL", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Iron, Zinc and Copper)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in mcg/dL", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Vitamin A and Vitamin E)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in mg/L", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Selenium)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in mcg/L", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Vitamin C)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in mg/dL", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)", "description": "Evaluation of micronutrient status after the study treatment in ng/mL", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Vitamin B12)", "description": "Evaluation of micronutrient status after the study treatment in pg/mL", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Iron, Zinc, and Copper)", "description": "Evaluation of micronutrient status after the study treatment in mcg/dL", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Vitamin A and Vitamin E)", "description": "Evaluation of micronutrient status after the study treatment in mg/L", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Selenium)", "description": "Evaluation of micronutrient status after the study treatment in mcg/L", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Vitamin C)", "description": "Evaluation of micronutrient status after the study treatment in mg/dL", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Inflammatory parameters", "description": "Evaluation of C-Reactive Protein, InterLeukin-6 and D-dimer progression during the clinical course of SARS-CoV-2 infection in outpatients", "time_frame": "From baseline to 30 days of the study treatment ending" }, { "type": "secondary", "measure": "Thromboembolic disease", "description": "Evaluation of thromboembolic disease developed during the clinical course of SARS-CoV-2 infection", "time_frame": "From baseline to 30 days of the study treatment ending" }, { "type": "secondary", "measure": "Oxygen supplementation", "description": "Assess the need for oxygen therapy during the clinical course of the infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "High-Flow oxygen supplementation", "description": "The need for high-flow oxygen therapy during the clinical course of infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Invasive mechanical ventilation", "description": "The cumulative incidence of mechanical ventilation requirement for SARS-CoV-2 infection documented", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Tracheostomy", "description": "The need for tracheostomy during the clinical course of SARS-CoV-2 infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Renal replacement", "description": "The need for renal replacement therapies during the clinical course of SARS-CoV-2 infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Death", "description": "The cumulative incidence of death from SARS-CoV-2 infection is documented", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Intensive Care Unit Admission", "description": "The cumulative incidence of admission to intensive care for SARS-CoV-2 infection documented", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Cumulative hospital admission", "description": "The cumulative incidence of hospital admission for a documented SARS-CoV-2 infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Hospitalization needs (days)", "description": "Number of days hospitalized for a SARS-CoV-2 documented infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Survival", "description": "Survival", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Adverse events", "description": "Adverse events", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Serious Adverse Events", "description": "Serious adverse events (hospital admissions and mortality)", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Persistence (or not) of Covid-19 Clinical Symptoms (directly asking patient for peristence of Neurologic, Psicologic, Digestive, Cardiovascular, Respiratory and Osteomuscular Symptoms).", "description": "Assess the Post-Covid19 Persistent Symptoms, directly asking patient for Symptoms at the moment of an On site visit at Day 90 and at thelephonic contact on Day 180.\n\nQuestionnaire to the patient to asess persistent symptoms on the following areas:\n\nNeurologic: Montreal Cognitive Assessment (Mo-CA-BLIND) and Persistent cefalea Psicologic: Anxiety, depression, sleep and mood transtorns Digestive: dispepsia, diarrea, constipation Cardiovascular: tachicardia, arrhythmia, acute mycardial infarction and Ictus Respiratory: dispnea, chest pain Osteomuscular: astenia, artralgia and myalgia and other symptoms expressed by the patient.", "time_frame": "From baseline to the study follow-up period: Maximum 6 months." }, { "type": "secondary", "measure": "Cognitive status", "description": "Assess the Post-Covid19 cognitive status with MoCA-Blind test.", "time_frame": "At baseline and at Day 180." }, { "type": "secondary", "measure": "EQ-5D", "description": "Assess the evolution of quality of life during the study.\n\nEQ-5D-5L quality of life questionnaire will be administered", "time_frame": "At baseline and at Day 180." } ], "outcome_measures": [ { "type": "primary", "measure": "Need for hospital admission", "description": "The need for hospitalization of documented SARS-CoV-2 infection (positive polymerase chain reaction or transcription-mediated amplification test or antigen test or positive serology or diagnostic test available) over the course of the disease", "time_frame": "From baseline to 1 month after beginning the study treatment" }, { "type": "primary", "measure": "Incidence of Long Covid.", "description": "Incidence of long Covid or symptoms persistence following World Health Organization definition", "time_frame": "6 months after beginning the study treatment" }, { "type": "secondary", "measure": "Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration (in ng/mL)", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Vitamin B12)", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in pg/mL", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Iron, Zinc and Copper )", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/dL", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Vitamin A and Vitamin E)", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in mg/L", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Selenium )", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/L", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient basal status (Vitamin C)", "description": "Evaluation of micronutrient status prior to the nutritional supplement administration in mg/dL", "time_frame": "Within day 1 at study inclusion" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in ng/mL", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission ( Vitamin B12)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in pg/mL", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Iron, Zinc and Copper)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in mcg/dL", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Vitamin A and Vitamin E)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in mg/L", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Selenium)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in mcg/L", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at hospital admission (Vitamin C)", "description": "Evaluation of micronutrient status in patients requiring hospitalization in mg/dL", "time_frame": "Within the first day of hospital admission" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)", "description": "Evaluation of micronutrient status after the study treatment in ng/mL", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Vitamin B12)", "description": "Evaluation of micronutrient status after the study treatment in pg/mL", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Iron, Zinc, and Copper)", "description": "Evaluation of micronutrient status after the study treatment in mcg/dL", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Vitamin A and Vitamin E)", "description": "Evaluation of micronutrient status after the study treatment in mg/L", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Selenium)", "description": "Evaluation of micronutrient status after the study treatment in mcg/L", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Micronutrient status at end of study (Vitamin C)", "description": "Evaluation of micronutrient status after the study treatment in mg/dL", "time_frame": "Within 90 days of the study treatment ending" }, { "type": "secondary", "measure": "Inflammatory parameters", "description": "Evaluation of C-Reactive Protein, InterLeukin-6 and D-dimer progression during the clinical course of SARS-CoV-2 infection in outpatients", "time_frame": "From baseline to 30 days of the study treatment ending" }, { "type": "secondary", "measure": "Thromboembolic disease", "description": "Evaluation of thromboembolic disease developed during the clinical course of SARS-CoV-2 infection", "time_frame": "From baseline to 30 days of the study treatment ending" }, { "type": "secondary", "measure": "Oxygen supplementation", "description": "Assess the need for oxygen therapy during the clinical course of the infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "High-Flow oxygen supplementation", "description": "The need for high-flow oxygen therapy during the clinical course of infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Invasive mechanical ventilation", "description": "The cumulative incidence of mechanical ventilation requirement for SARS-CoV-2 infection documented", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Tracheostomy", "description": "The need for tracheostomy during the clinical course of SARS-CoV-2 infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Renal replacement", "description": "The need for renal replacement therapies during the clinical course of SARS-CoV-2 infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Death", "description": "The cumulative incidence of death from SARS-CoV-2 infection is documented", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Intensive Care Unit Admission", "description": "The cumulative incidence of admission to intensive care for SARS-CoV-2 infection documented", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Cumulative hospital admission", "description": "The cumulative incidence of hospital admission for a documented SARS-CoV-2 infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Hospitalization needs (days)", "description": "Number of days hospitalized for a SARS-CoV-2 documented infection", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Survival", "description": "Survival", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Adverse events", "description": "Adverse events", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Serious Adverse Events", "description": "Serious adverse events (hospital admissions and mortality)", "time_frame": "From baseline to the study follow-up period: Maximum 3 months" }, { "type": "secondary", "measure": "Persistence (or not) of Covid-19 Clinical Symptoms (directly asking patient for peristence of Neurologic, Psicologic, Digestive, Cardiovascular, Respiratory and Osteomuscular Symptoms).", "description": "Assess the Post-Covid19 Persistent Symptoms, directly asking patient for Symptoms at the moment of an On site visit at Day 90 and at thelephonic contact on Day 180.\n\nQuestionnaire to the patient to asess persistent symptoms on the following areas:\n\nNeurologic: Montreal Cognitive Assessment (Mo-CA-BLIND) and Persistent cefalea Psicologic: Anxiety, depression, sleep and mood transtorns Digestive: dispepsia, diarrea, constipation Cardiovascular: tachicardia, arrhythmia, acute mycardial infarction and Ictus Respiratory: dispnea, chest pain Osteomuscular: astenia, artralgia and myalgia and other symptoms expressed by the patient.", "time_frame": "From baseline to the study follow-up period: Maximum 6 months." }, { "type": "secondary", "measure": "Cognitive status", "description": "Assess the Post-Covid19 cognitive status with MoCA-Blind test.", "time_frame": "At baseline and at Day 180." }, { "type": "secondary", "measure": "EQ-5D", "description": "Assess the evolution of quality of life during the study.\n\nEQ-5D-5L quality of life questionnaire will be administered", "time_frame": "At baseline and at Day 180." } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 252, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT04751669", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05848518", "title": "Exercise for Health in Patients With Post-acute Sequelae of COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-03-19", "start_date": "2023-05-15", "completion_date": "2024-01-31", "primary_completion_date": "2023-09-30", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rehabilitation Program" ], "sponsor": "Campus docent Sant Joan de Déu-Universitat de Barcelona", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Background: Many patients with COVID-19 present the so-called post-acute sequelae of COVID-19 such as fatigue, post-stress discomfort, dyspnea, headache, pain mental impairment, incapacity to perform daily physical tasks ant exercise intolerance. This study aims to investigate the effects of different exercise programs on physical and mental fitness, physical condition and biomarkers of the immune system and oxidative stress in older COVID-19 survivors. Methods: The sample will be made up of 120 eligible participants, over the age of 60 years who have had COVID-19 disease and are survivors and present persistent COVID-19 symptomatology diagnosed by the corresponding physician. The participants will be randomly assigned to the experimental groups: supervised endurance group (SEG, n = 30), supervised strength group (SSG, n = 30), supervised concurrent group (SCG, n = 30), which will perform the corresponding exercise program 3 days a week compared to the control group (CG, n = 30), which will not carry out a supervised exercise program. The design of this project will include assessment of cardiorespiratory fitness, muscle fitness, pain and mental health, and biomarkers of inflammation and oxidative stress.", "primary_outcomes": [ { "type": "primary", "measure": "Cardiorespiratory fitness: absolute oxygen uptake", "description": "absolute oxygen uptake (peak VO2) in L/min", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: relative oxygen uptake", "description": "relative oxygen uptake (peak VO2) in mL/kg/min", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: ventilation", "description": "minute ventilation (VE) in L/min.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: ventilatory equivalent for oxygen", "description": "Ventilatory equivalent for oxygen (VE/VO2)", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: ventilatory equivalent for carbon dioxide", "description": "Ventilatory equivalent for carbon dioxide (VE/VCO2)", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: respiratory exchange ratio", "description": "Respiratory exchange ratio (RER)", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: End-tidal partial pressure", "description": "End-tidal partial pressure of oxygen and carbon dioxide (PetO2 and PetCO2, respectively) in mmHg.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Sit and stand test", "description": "Sit and stand test for 30 seconds. The number of times in 30 seconds the participant can completely stand up from a seated position with the back straight and the feet on the floor without pushing with the arms will be counted.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: countermovement jump", "description": "Countermovement jumps: Flight Height in cm", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: countermovement test", "description": "Countermovement jumps: power output of the lower extremities in watts", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Upper limb strength", "description": "This will be evaluated with the bicep curl test made with a 2 kg weight for women and a 4 Kg weight for men. The number of elbow curls made in 30 seconds with each upper limb will be counted.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: hand grip strength", "description": "Hand grip strength: Force in Newtons Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Motor Agility/Dynamic balance", "description": "Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered in seconds", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Isokinetic strength test", "description": "The isokinetic knee flexor and extensor test: peak torque in N m", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Isokinetic strength testing", "description": "The isokinetic knee flexor and extensor test: power output in Watts", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Body composition: fat mass", "description": "Fat mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Body composition: fat free mass", "description": "Fat free mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Body composition: muscle mass", "description": "Muscle mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of oxidative stress biomarkers: thiobarbituric acid reactive substances", "description": "Determination of oxidized lipids by the thiobarbituric acid reactive substances (TBARS) in mmols (fluorimetry technique).", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of oxidative stress biomarkers: Advanced Oxidation Protein Products", "description": "Determination of oxidized proteins by the Advanced Oxidation Protein Products (AOPP) in nmol Cl-T/mg protein, (colorimetry technique)", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of oxidative stress biomarkers: nitrites and nitrates", "description": "Determination of nitrites and nitrates (colorimetry) in nmol/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of biomarkers of antioxidant enzymes: superoxide dismutase", "description": "superoxide dismutase (SOD) in units/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of biomarkers of antioxidant enzymes: catalase", "description": "catalase (CAT) in units/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of biomarkers of antioxidant enzymes: glutathion peroxidase", "description": "Glutathion peroxidase (GPx) in units/mL.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of inflammation biomarkers: Interleukines", "description": "Interleukin 6 and 10 (IL-6 and IL-10) in ng/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of inflammation biomarkers: adiponectin", "description": "adiponectin in mg/L", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of biomarkers of inflammation: Tumor necrosis factor", "description": "Tumor Necrosis Factor-alpha in pg/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain using the pupillometer: pupil diameter", "description": "basal and maximum diameter of the pupil in mm", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain using the pupillometer:variation of pupil", "description": "percentage of variation of pupil diameter in %", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain using the pupillometer: pupil variation", "description": "variation of the pupil in mm", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain using the pupillometer: Intensity of reflex of dilatation", "description": "Intensity of reflex of dilatation, latency.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain with a pressure algometer: algometers", "description": "Pain will be quantified with a pressure algometer + pupillometer in older COVID-19 survivors.\n\nA pressure algometer allows the application of a controlled and quantifiable nociceptive stimulus on a body surface.\n\nAlgometers apply a pressure stimulus that can be useful for applying a standardized painful stimulus, having a different nature from that applied with the pupillometer which is a stimulus of electric origin.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Mental health", "description": "Psychosocial variables will be evaluated using the Hospital Anxiety and Depression Scale (HADS), which is made up of 7 items for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) will be scored on a scale of 4 points from 0 (none) to 3 (much more). The highest scores indicate the highest levels of anxiety or depression", "time_frame": "1 week per group" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Cardiorespiratory fitness: absolute oxygen uptake", "description": "absolute oxygen uptake (peak VO2) in L/min", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: relative oxygen uptake", "description": "relative oxygen uptake (peak VO2) in mL/kg/min", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: ventilation", "description": "minute ventilation (VE) in L/min.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: ventilatory equivalent for oxygen", "description": "Ventilatory equivalent for oxygen (VE/VO2)", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: ventilatory equivalent for carbon dioxide", "description": "Ventilatory equivalent for carbon dioxide (VE/VCO2)", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: respiratory exchange ratio", "description": "Respiratory exchange ratio (RER)", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Cardiorespiratory fitness: End-tidal partial pressure", "description": "End-tidal partial pressure of oxygen and carbon dioxide (PetO2 and PetCO2, respectively) in mmHg.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Sit and stand test", "description": "Sit and stand test for 30 seconds. The number of times in 30 seconds the participant can completely stand up from a seated position with the back straight and the feet on the floor without pushing with the arms will be counted.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: countermovement jump", "description": "Countermovement jumps: Flight Height in cm", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: countermovement test", "description": "Countermovement jumps: power output of the lower extremities in watts", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Upper limb strength", "description": "This will be evaluated with the bicep curl test made with a 2 kg weight for women and a 4 Kg weight for men. The number of elbow curls made in 30 seconds with each upper limb will be counted.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: hand grip strength", "description": "Hand grip strength: Force in Newtons Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Motor Agility/Dynamic balance", "description": "Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered in seconds", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Isokinetic strength test", "description": "The isokinetic knee flexor and extensor test: peak torque in N m", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Muscular fitness: Isokinetic strength testing", "description": "The isokinetic knee flexor and extensor test: power output in Watts", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Body composition: fat mass", "description": "Fat mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Body composition: fat free mass", "description": "Fat free mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Body composition: muscle mass", "description": "Muscle mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of oxidative stress biomarkers: thiobarbituric acid reactive substances", "description": "Determination of oxidized lipids by the thiobarbituric acid reactive substances (TBARS) in mmols (fluorimetry technique).", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of oxidative stress biomarkers: Advanced Oxidation Protein Products", "description": "Determination of oxidized proteins by the Advanced Oxidation Protein Products (AOPP) in nmol Cl-T/mg protein, (colorimetry technique)", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of oxidative stress biomarkers: nitrites and nitrates", "description": "Determination of nitrites and nitrates (colorimetry) in nmol/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of biomarkers of antioxidant enzymes: superoxide dismutase", "description": "superoxide dismutase (SOD) in units/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of biomarkers of antioxidant enzymes: catalase", "description": "catalase (CAT) in units/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of biomarkers of antioxidant enzymes: glutathion peroxidase", "description": "Glutathion peroxidase (GPx) in units/mL.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of inflammation biomarkers: Interleukines", "description": "Interleukin 6 and 10 (IL-6 and IL-10) in ng/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of inflammation biomarkers: adiponectin", "description": "adiponectin in mg/L", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Concentration of biomarkers of inflammation: Tumor necrosis factor", "description": "Tumor Necrosis Factor-alpha in pg/mL", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain using the pupillometer: pupil diameter", "description": "basal and maximum diameter of the pupil in mm", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain using the pupillometer:variation of pupil", "description": "percentage of variation of pupil diameter in %", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain using the pupillometer: pupil variation", "description": "variation of the pupil in mm", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain using the pupillometer: Intensity of reflex of dilatation", "description": "Intensity of reflex of dilatation, latency.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Evaluation of the degree of pain with a pressure algometer: algometers", "description": "Pain will be quantified with a pressure algometer + pupillometer in older COVID-19 survivors.\n\nA pressure algometer allows the application of a controlled and quantifiable nociceptive stimulus on a body surface.\n\nAlgometers apply a pressure stimulus that can be useful for applying a standardized painful stimulus, having a different nature from that applied with the pupillometer which is a stimulus of electric origin.", "time_frame": "1 week per group" }, { "type": "primary", "measure": "Mental health", "description": "Psychosocial variables will be evaluated using the Hospital Anxiety and Depression Scale (HADS), which is made up of 7 items for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) will be scored on a scale of 4 points from 0 (none) to 3 (much more). The highest scores indicate the highest levels of anxiety or depression", "time_frame": "1 week per group" } ], "relevance_tags": [ "Immunomodulatory", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05848518", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05601180", "title": "Evaluation of the Efficacy of Respicure® (Resveratrol / Quercetin) in the Management of Respiratory Conditions Including Asthma,COPD and Long COVID.", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-03-19", "start_date": "2022-10-27", "completion_date": "2024-01-15", "primary_completion_date": "2024-01-15", "conditions_raw": [ "Asthma", "Chronic Obstructive Pulmonary Disease", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Respicure®", "Standard Of Care" ], "sponsor": "Beker Laboratories", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Interventional, Prospective, National, Multicentre, Randomised, Open-label, Controlled Clinical Study Comparing Two Parallel Groups, One Control Arm (Standard Treatment) Versus Intervention Arm (Standard Treatment + Study Product) Evaluating the Efficacy of Respicure® 0.38% /0.38% (Resveratrol / Quercetin) Phytotherapy Product From BEKER Laboratories as an add-on Treatment in the Management of Respiratory Conditions Including Asthma (Partially Controlled),COPD (Stage A, B, C and D) and long COVID in Algerian Adult Patients .", "primary_outcomes": [ { "type": "primary", "measure": "Change of asthma symptoms in partially controlled patients .", "description": "The assessment of asthma management will be based on:\n\n1\\. Improvement in symptoms measured at baseline and during the follow-up period and results will be compared to those of the control group to determine asthma control using the following criteria:\n\n* Daytime symptoms at most twice a week,\n* No nocturnal awakenings,\n* Need for rescue medication at most twice a week,\n* No limitation of activities.", "time_frame": "Change from Baseline at 3 months" }, { "type": "primary", "measure": "Change of COPD symptoms in patients with stage A, B, C or D.", "description": "The assessment of reduction in symptoms will be be compared to those of the control group and will be based on reducing CAT scoring \"COPD assessment test\" to be less than 10.", "time_frame": "Change from Baseline at 3 months" }, { "type": "primary", "measure": "Change of COPD symptoms in patients with stage A, B, C or D.", "description": "The assessment of reduction in symptoms will be based on reducing mMRC scoring \"modified Medical Research Council\" where 0 being the best and 4 being the worst.", "time_frame": "Change from Baseline at 3 months." }, { "type": "primary", "measure": "Change of respiratory symptoms related to long COVID.", "description": "The assessment of the respiratory symptoms linked to long COVID will be based on the reduction in dyspnea and cough by measuring m mMRC scoring \"modified Medical Research Council\" where 0 being the best and 4 being the worst.", "time_frame": "Change from Baseline at 3 months" }, { "type": "primary", "measure": "Change of respiratory symptoms related to long COVID.", "description": "The assessment of the respiratory symptoms linked to long COVID will be based on:\n\n\\- Improvement of Blood oxygen saturation.", "time_frame": "Change from Baseline at 3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Tolerance", "description": "Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Morbidity for Asthma patients", "description": "Minimisation or absence of hospitalisation and Reduction of number of exacerbations", "time_frame": "3 months" }, { "type": "secondary", "measure": "Change of CAT scoring for Asthma patients", "description": "Improvement of CAT scoring (Asthma control test) more than 20.", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Change of Respiratory function for Asthma patients", "description": "Evaluation of respiratory function by spirometry to detect Variation of PEF (Peak expiratory flow) compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Change of Respiratory function for Asthma patients", "description": "Evaluation of respiratory function by spirometry to detect:\n\nImproved FEV1/FVC ratio (Forced expiratory volume in one second/ Forced vital capacity) compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Change of Respiratory function for Asthma patients", "description": "Evaluation of respiratory function by spirometry to detect a decreased FEV1 (Forced expiratory volume in one second) variability compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Morbidity & Exacerbations for COPD patients", "description": "Minimisation or absence of hospitalisation and The prevention of future exacerbations \"time to onset of the 1st exacerbation in six (06) months\",", "time_frame": "6 months" }, { "type": "secondary", "measure": "Exacerbations for COPD patients", "description": "The prevention of future exacerbations \"time to onset of the 1st exacerbation in six (06) months\",", "time_frame": "6 months." }, { "type": "secondary", "measure": "Change of Respiratory function for COPD patients", "description": "Evaluation of respiratory function by spirometry to detect variation of PEF (Peak expiratory flow) compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Change of Respiratory function for COPD patients", "description": "Evaluation of respiratory function by spirometry to detect variation of FEV (Forced expiratory volume) compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Morbidity for long COVID patients", "description": "Minimisation or absence of hospitalisation", "time_frame": "6 months." } ], "outcome_measures": [ { "type": "primary", "measure": "Change of asthma symptoms in partially controlled patients .", "description": "The assessment of asthma management will be based on:\n\n1\\. Improvement in symptoms measured at baseline and during the follow-up period and results will be compared to those of the control group to determine asthma control using the following criteria:\n\n* Daytime symptoms at most twice a week,\n* No nocturnal awakenings,\n* Need for rescue medication at most twice a week,\n* No limitation of activities.", "time_frame": "Change from Baseline at 3 months" }, { "type": "primary", "measure": "Change of COPD symptoms in patients with stage A, B, C or D.", "description": "The assessment of reduction in symptoms will be be compared to those of the control group and will be based on reducing CAT scoring \"COPD assessment test\" to be less than 10.", "time_frame": "Change from Baseline at 3 months" }, { "type": "primary", "measure": "Change of COPD symptoms in patients with stage A, B, C or D.", "description": "The assessment of reduction in symptoms will be based on reducing mMRC scoring \"modified Medical Research Council\" where 0 being the best and 4 being the worst.", "time_frame": "Change from Baseline at 3 months." }, { "type": "primary", "measure": "Change of respiratory symptoms related to long COVID.", "description": "The assessment of the respiratory symptoms linked to long COVID will be based on the reduction in dyspnea and cough by measuring m mMRC scoring \"modified Medical Research Council\" where 0 being the best and 4 being the worst.", "time_frame": "Change from Baseline at 3 months" }, { "type": "primary", "measure": "Change of respiratory symptoms related to long COVID.", "description": "The assessment of the respiratory symptoms linked to long COVID will be based on:\n\n\\- Improvement of Blood oxygen saturation.", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Tolerance", "description": "Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Morbidity for Asthma patients", "description": "Minimisation or absence of hospitalisation and Reduction of number of exacerbations", "time_frame": "3 months" }, { "type": "secondary", "measure": "Change of CAT scoring for Asthma patients", "description": "Improvement of CAT scoring (Asthma control test) more than 20.", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Change of Respiratory function for Asthma patients", "description": "Evaluation of respiratory function by spirometry to detect Variation of PEF (Peak expiratory flow) compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Change of Respiratory function for Asthma patients", "description": "Evaluation of respiratory function by spirometry to detect:\n\nImproved FEV1/FVC ratio (Forced expiratory volume in one second/ Forced vital capacity) compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Change of Respiratory function for Asthma patients", "description": "Evaluation of respiratory function by spirometry to detect a decreased FEV1 (Forced expiratory volume in one second) variability compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Morbidity & Exacerbations for COPD patients", "description": "Minimisation or absence of hospitalisation and The prevention of future exacerbations \"time to onset of the 1st exacerbation in six (06) months\",", "time_frame": "6 months" }, { "type": "secondary", "measure": "Exacerbations for COPD patients", "description": "The prevention of future exacerbations \"time to onset of the 1st exacerbation in six (06) months\",", "time_frame": "6 months." }, { "type": "secondary", "measure": "Change of Respiratory function for COPD patients", "description": "Evaluation of respiratory function by spirometry to detect variation of PEF (Peak expiratory flow) compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Change of Respiratory function for COPD patients", "description": "Evaluation of respiratory function by spirometry to detect variation of FEV (Forced expiratory volume) compared to baseline (in %)", "time_frame": "Change from Baseline at 3 months" }, { "type": "secondary", "measure": "Morbidity for long COVID patients", "description": "Minimisation or absence of hospitalisation", "time_frame": "6 months." } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 402, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05601180", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05760092", "title": "The Use of Photobiomodulation in the Treatment of Oral Complaints of Long COVID-19.A Randomized Controlled Trial.", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2024-03-12", "start_date": "2023-03-01", "completion_date": "2024-03-08", "primary_completion_date": "2024-02-01", "conditions_raw": [ "Xerostomia", "COVID-19", "Long COVID", "Persistent COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Institutional Standard Treatment For Xerostomia And Long Covid", "Photobiomodulation Therapy" ], "sponsor": "University of Nove de Julho", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Coronavirus (COVID-19) is a newly emerging zoonotic agent that emerged in December 2019 in China (2019-nCoV) as a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV -2). Long COVID-19, or Post-Covid Syndrome or Long-term COVID-19, is a post-viral syndrome that persists after the acute infection has resolved. The most frequent symptoms of Lonf-term COVID are fatigue and dyspnea. But two classes of symptoms have been received scientific attention: the musculoskeletal pain and oral complaints related to Long COVID, mainly xerostomia and burning mouth. Photobiomodulation (PBM) therapy is often used for oral diseases and presents itself as a non-invasive, low-cost, safe therapy that has benefits in relation to the quality of life of patients with xerostomia. This study aims to investigate the clinical effectiveness of the use of a Photobiomodulation protocol in the treatment xerostomia and oral complaints related to Long-Covid. This will be a single-center, randomized, controlled, blinded clinical trial that will involve patients with Long COVID in follow-up at the Medical and Multiprofessional outpatient clinic of University Nove de Julho (UNINOVE) which remained hospitalized with COVID-19 at Lydia Storópoli Universitarian Hospital during the year 2022 and who were discharged from the inpatient treatment from January to December 2022. All those patients presenting xerostomia, burning mouth or oral complaints related to Long Covid will be randomized into 2 groups: PBM Group (standard rehabilitation treatment for Long COVID and xerostomia + PBM therapy) or PBM placebo group (standard rehabilitation treatment for Long COVID and xerostomia + placebo PBM therapy). PBM consists of the application of Red LED on the 3 pairs of major salivary glands (parotid, submandibular and sublingual) extraorally, transcutaneously, 3 J/cm2, for 36 seconds, twice a week for 06 weeks. Functional and quality of life evaluations will be perform pre and post therapy period.", "primary_outcomes": [ { "type": "primary", "measure": "Brazilian version of the SF 36 Quality of Life Scale", "description": "Assessment of general quality of life, translated and validated for the Brazilian population, composed of assessments in the following domains: functional capacity, limitation due to physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health.", "time_frame": "pre-treatment and post-treatment moment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Nutritional assessment", "description": "Anthropometric measurements of body weight, height and calculation of the Body Mass Index (BMI) according to the World Health Organization (WHO) reference standard for adults and Lipschitz criterion for elderly patients.", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Salivary ph, Stimulated salivary flow and unstimulated salivary flow", "description": "Total salivary flow rates (SFRs) at rest and during stimulation will be determined according to the guidelines for unstimulated and stimulated total saliva collection provided by Navazesh and Kumar (1993). To characterize hyposalivation, investigators will use the Sreebny criterion (2000) according to which the abnormal salivary flow is lower than 0.1 ml/min without stimulation and 0.5 ml/min with stimulation. Salivary pH (unstimulated salivary flow) will also be evaluated, which will be performed using pH indicator paper tape, color scale ranging from 0.0 to 14.0 (gradation 1.0; precision 0.2) The strips will be dipped in samples of saliva for 5 min. Then the test fields of the strips will be compared with the color scales. Whereas healthy saliva must have a pH between 6.5 to 7.4.", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Oral Health Impact Profile (OHIP-14)", "description": "Assessment of Oral Health-related Quality of Life, by OHIP-14 , translated and validated for Brazilian population", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Xerostomia Inventory XI", "description": "A multi-item approach to measuring and quantify dry mouth.", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Functional Independence Measure (FIM)", "description": "A translated and validated for the Brazilian population of general assessment of functional independence", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Post-Covid-19 Functional Status Scale", "description": "A tool to measure the full spectrum of functional outcomes following COVID-19.", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "The World Health Organization Disability Assessment Schedule (WHODAS 2.0)", "description": "The World Health Organization Disability Assessment Schedule (WHODAS 2.0) was designed to assess the functioning level in six life domains (cognition, mobility, selfcare, getting along, life activities, and participation in community activities)", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Brazilian version of the SF 36 Quality of Life Scale", "description": "Assessment of general quality of life, translated and validated for the Brazilian population, composed of assessments in the following domains: functional capacity, limitation due to physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health.", "time_frame": "pre-treatment and post-treatment moment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Nutritional assessment", "description": "Anthropometric measurements of body weight, height and calculation of the Body Mass Index (BMI) according to the World Health Organization (WHO) reference standard for adults and Lipschitz criterion for elderly patients.", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Salivary ph, Stimulated salivary flow and unstimulated salivary flow", "description": "Total salivary flow rates (SFRs) at rest and during stimulation will be determined according to the guidelines for unstimulated and stimulated total saliva collection provided by Navazesh and Kumar (1993). To characterize hyposalivation, investigators will use the Sreebny criterion (2000) according to which the abnormal salivary flow is lower than 0.1 ml/min without stimulation and 0.5 ml/min with stimulation. Salivary pH (unstimulated salivary flow) will also be evaluated, which will be performed using pH indicator paper tape, color scale ranging from 0.0 to 14.0 (gradation 1.0; precision 0.2) The strips will be dipped in samples of saliva for 5 min. Then the test fields of the strips will be compared with the color scales. Whereas healthy saliva must have a pH between 6.5 to 7.4.", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Oral Health Impact Profile (OHIP-14)", "description": "Assessment of Oral Health-related Quality of Life, by OHIP-14 , translated and validated for Brazilian population", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Xerostomia Inventory XI", "description": "A multi-item approach to measuring and quantify dry mouth.", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Functional Independence Measure (FIM)", "description": "A translated and validated for the Brazilian population of general assessment of functional independence", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "Post-Covid-19 Functional Status Scale", "description": "A tool to measure the full spectrum of functional outcomes following COVID-19.", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" }, { "type": "primary", "measure": "The World Health Organization Disability Assessment Schedule (WHODAS 2.0)", "description": "The World Health Organization Disability Assessment Schedule (WHODAS 2.0) was designed to assess the functioning level in six life domains (cognition, mobility, selfcare, getting along, life activities, and participation in community activities)", "time_frame": "pre-treatment and post-treatment (after 04 weeks of treatment)" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 10, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05760092", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06294756", "title": "Sulfureous Water Therapy in Viral Respiratory Diseases", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-03-06", "start_date": "2023-05-30", "completion_date": "2023-09-30", "primary_completion_date": "2023-08-01", "conditions_raw": [ "Long-COVID", "Post COVID-19 Condition", "Chronic COVID-19 Syndrome", "Post Acute Sequelae of COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Inhalation Of Sulfurous Thermal Water", "Inhalation Of Sterile Distilled Non-Pyrogenic Water" ], "sponsor": "University of Roma La Sapienza", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this double-blind, interventional, randomized case-control, pilot trial is to evaluate the effects of active sulfurous (STW) versus placebo (SDW) inhalations on blood test parameters, serum inflammatory cytokines, spirometry data, as well as qualitative and quantitative changes in the nasal microbiome of subjects affected by long Covid.\n\nThe main questions it aims to answer are:\n\n* if STW inhalations are effective on respiratory issues due to long covid compared to the placebo inhalation (SDW)\n* if STW inhalations are effective on long covid related fatigue issues compared to the placebo inhalation (SDW)\n* if H2S inhaled with STW is effective in modulating (decreasing) cytokines which are related to long covid cytokine storm compared to placebo inhalation with no H2S (SDW)\n* if STW inhalation modify nasal microbiome both from a qualitative and quantitative point of view respect to placebo inhalation (SDW) Participants will be randomly assigned to active inhalations (STW) or placebo inhalations (SDW) arm and subjected to 12 consecutive sessions of 20 minutes.\n\nBoth arms will be tested for:\n\n* cytokines and inflammatory markers concentration (IL1b, IL6, ACE, GSS, S100B, Hs-CRP)\n* spirometry (resting, forced, DLCO)\n* exertion response (6 minutes walking test)\n* nasal microbiome sampling at visit 1 (enrolment), at visit 2(right after the inhalation treatment) and at visit 3 (3 months after treatment).\n\nResearchers will compare results reported by STW to those of SDW group to see if significative differences are detectable.", "primary_outcomes": [ { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters.", "description": "To assess the prior treatment whole pulmonary functionality by spirometry and DLCO spirometry", "time_frame": "Day1" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters.", "description": "To assess the whole pulmonary functionality at 14 days since inhalations start by spirometry and DLCO spirometry", "time_frame": "Day 14" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters", "description": "To assess the whole pulmonary functionality at 90 days since inhalations start by spirometry and DLCO spirometry.", "time_frame": "Day 90" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID", "description": "To assess the cardiopulmonary response to physical exertion prior inhalations therapy with the six minutes walking test (6MWT)", "time_frame": "Day 1" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID", "description": "To assess the cardiopulmonary response involved during physical exertion at 14 days since inhalations start with the six minutes walking test (6MWT)", "time_frame": "Day 14" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID", "description": "To assess the cardiopulmonary response to physical exertion at 90 days since inhalations start with the six minutes walking test (6MWT)", "time_frame": "Day 90" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients.", "description": "To assess serum inflammatory responses prior inhalations treatment by determining IL-6, IL-1β, S100B, GSS, ACE serum concentration", "time_frame": "Day 1" }, { "type": "secondary", "measure": "To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients.", "description": "To assess serum inflammatory responses at 14 days since inhalations treatment start by determining IL-6, IL-1β, S100B, GSS, ACE serum concentration", "time_frame": "Day 14" }, { "type": "secondary", "measure": "To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients.", "description": "To assess serum inflammatory responses at 90 days since inhalations treatment start by determining IL-6, IL-1β, S100B, GSS, ACE serum concentration", "time_frame": "Day 90" }, { "type": "secondary", "measure": "to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection", "description": "Collection with swabs and 16SrDNA analysis of the nasopharyngeal secretions prior inhalations treatment.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection", "description": "Collection with swabs and 16S rDNA analysis of the nasopharyngeal secretions at 14 days since inhalations treatment start", "time_frame": "Day 14" }, { "type": "secondary", "measure": "to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection", "description": "Collection with swabs and 16S rDNA analysis of the nasopharyngeal secretions at 90 days since inhalations treatment start", "time_frame": "Day 90" } ], "outcome_measures": [ { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters.", "description": "To assess the prior treatment whole pulmonary functionality by spirometry and DLCO spirometry", "time_frame": "Day1" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters.", "description": "To assess the whole pulmonary functionality at 14 days since inhalations start by spirometry and DLCO spirometry", "time_frame": "Day 14" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters", "description": "To assess the whole pulmonary functionality at 90 days since inhalations start by spirometry and DLCO spirometry.", "time_frame": "Day 90" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID", "description": "To assess the cardiopulmonary response to physical exertion prior inhalations therapy with the six minutes walking test (6MWT)", "time_frame": "Day 1" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID", "description": "To assess the cardiopulmonary response involved during physical exertion at 14 days since inhalations start with the six minutes walking test (6MWT)", "time_frame": "Day 14" }, { "type": "primary", "measure": "To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID", "description": "To assess the cardiopulmonary response to physical exertion at 90 days since inhalations start with the six minutes walking test (6MWT)", "time_frame": "Day 90" }, { "type": "secondary", "measure": "To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients.", "description": "To assess serum inflammatory responses prior inhalations treatment by determining IL-6, IL-1β, S100B, GSS, ACE serum concentration", "time_frame": "Day 1" }, { "type": "secondary", "measure": "To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients.", "description": "To assess serum inflammatory responses at 14 days since inhalations treatment start by determining IL-6, IL-1β, S100B, GSS, ACE serum concentration", "time_frame": "Day 14" }, { "type": "secondary", "measure": "To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients.", "description": "To assess serum inflammatory responses at 90 days since inhalations treatment start by determining IL-6, IL-1β, S100B, GSS, ACE serum concentration", "time_frame": "Day 90" }, { "type": "secondary", "measure": "to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection", "description": "Collection with swabs and 16SrDNA analysis of the nasopharyngeal secretions prior inhalations treatment.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection", "description": "Collection with swabs and 16S rDNA analysis of the nasopharyngeal secretions at 14 days since inhalations treatment start", "time_frame": "Day 14" }, { "type": "secondary", "measure": "to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection", "description": "Collection with swabs and 16S rDNA analysis of the nasopharyngeal secretions at 90 days since inhalations treatment start", "time_frame": "Day 90" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06294756", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06255600", "title": "High-definition Transcranial Direct Current Stimulation and Chlorella Pyrenoidosa to Reduce Cardiovascular Risk", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-03-05", "start_date": "2021-08-10", "completion_date": "2024-06-28", "primary_completion_date": "2024-06-28", "conditions_raw": [ "Cardiovascular Diseases", "Long Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "High Definition-Transcranial Direct Current Stimulation", "Chlorella Pyrenoidosa" ], "sponsor": "Federal University of Paraíba", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Recent investigations have shown that of the patients who were affected by SARCov2 have remained with persistent symptoms in a high proportion. In these considerations, the literature has suggested nomenclatures such as \"post-COVID-19\" and \"chronic COVID-19\", \"long -COVID\" and Post-Covid Syndrome for patients recovered from SARCov2 reporting persistent symptoms and signs for weeks to months after resolution of the acute infection. Furthermore, there may be cardiovascular complications in affected patients, the consequences of which can lead to muscle contractility disorders, vascular insufficiency, cardiac arrest, reinforcing the need for controlled, randomized studies, as well as follow-up and monitoring of these. Furthermore, cardiovascular diseases (CVD) are part of the health problems that lead to the most deaths in the world, they also lead to a high proportion of hospital admissions, due to the worsening of the pathology and a higher incidence in the elderly population. The worsening of CVD conditions leads to inadequate food consumption at the hospital level, causing changes in several nutrients, including vitamin B12. The reduction in B12 levels leads to changes in several systems, including the cardiovascular system, and due to the increase in homocysteine and the triggering of the inflammatory cascade. Studies indicate that B12 supplementation through Chlorella (microalgae - functional food) reduced cardiovascular risk and modulated the inflammatory cascade. In combination, neurostimulation has presented aspects that promote pain neuromodulation, due to the improvement of respiratory patterns and inflammatory modulation. More specifically, there is a protocol with promoting findings, this being HD-tDCS. In this sense, this research aims to evaluate the effects of HD-tDCS and the consumption of Chlorella Pyrenoidosa to improve B12 levels in patients with cardiovascular risk post-COVID-19.", "primary_outcomes": [ { "type": "primary", "measure": "Change B12 by blood analysis biochemical", "description": "Change B12 (above 148pmol/L)", "time_frame": "After five week of the group of research start" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change Methylmalonic Acid and Homocysteine", "description": "Change blood levels of Methylmalonic Acid and Homocysteine (below 270nmol/L and 12mmol/L, respectively)", "time_frame": "After five week of the group of research start" } ], "outcome_measures": [ { "type": "primary", "measure": "Change B12 by blood analysis biochemical", "description": "Change B12 (above 148pmol/L)", "time_frame": "After five week of the group of research start" }, { "type": "secondary", "measure": "Change Methylmalonic Acid and Homocysteine", "description": "Change blood levels of Methylmalonic Acid and Homocysteine (below 270nmol/L and 12mmol/L, respectively)", "time_frame": "After five week of the group of research start" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06255600", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06147050", "title": "Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents", "status": "UNKNOWN", "phase": "PHASE3", "last_updated": "2024-03-04", "start_date": "2024-04", "completion_date": "2024-12", "primary_completion_date": "2024-10", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Metformin" ], "sponsor": "Purpose Life Sciences", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long Covid is a multisystem condition comprising often severe symptoms that follow a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Long COVID often manifests as fatigue and neurocognitive impairment (also referred to as 'brain fog'). Based on two systematic reviews of Covid-19 cases in neonates, children and adolescents under 19 years of age, fatigue caused by Long Covid can persist for years and can lead to work disability and labour shortages, posing a public health emergency with lasting health, mental, and economic impacts. To date, no treatment has shown to be broadly effective for the treatment of Long Covid. An experimental study has demonstrated that metformin, a common diabetes drug, might reduce the incidence of long COVID if given during the acute phase of COVID-19. The study, however, did not look at whether metformin would be effective as a treatment for those who already have long COVID. It also did not report the results by age groups, so it is not clear if the effect of metformin differs for people younger than 35 years of age. Therefore, a pilot, adaptive randomized controlled trial, which will evaluate the feasibility of conducting a large platform trial and will also evaluate the efficacy and safety of using metformin (versus placebo, a look-alike substance with no active ingredient) in managing fatigue in long COVID adolescent patients with persistent (long term) features of fatigue (chronic fatigue syndrome) has been proposed.", "primary_outcomes": [ { "type": "primary", "measure": "Mean Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL-MFS) score at 90 days post-randomization", "description": "The PedsQL-MFS questionnaire is a validated instrument that is designed to measure fatigue in the pediatric population. The questionnaire is validated for different age groups, including adolescents. The questionnaire is comprised of three dimensions including general fatigue, sleep/rest fatigue, and cognitive fatigue. It includes 18 likert-type questions. It is scored from 0 to 100, with a higher score representing lower levels of fatigue. A score below 75 will be used to represent clinically significant pain", "time_frame": "90 days post-randomization" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Mean PedsQL-MFS score at 30 days post-randomization", "description": "The PedsQL-MFS questionnaire is a validated instrument that is designed to measure fatigue in the pediatric population. The questionnaire is validated for different age groups, including adolescents. The questionnaire is comprised of three dimensions including general fatigue, sleep/rest fatigue, and cognitive fatigue. It includes 18 likert-type questions. It is scored from 0 to 100, with a higher score representing lower levels of fatigue. A score below 75 will be used to represent clinically significant pain", "time_frame": "30 days post-randomization" }, { "type": "secondary", "measure": "Mean PedsQL-MFS score at 60 days post-randomization", "description": "The PedsQL-MFS questionnaire is a validated instrument that is designed to measure fatigue in the pediatric population. The questionnaire is validated for different age groups, including adolescents. The questionnaire is comprised of three dimensions including general fatigue, sleep/rest fatigue, and cognitive fatigue. It includes 18 likert-type questions. It is scored from 0 to 100, with a higher score representing lower levels of fatigue. A score below 75 will be used to represent clinically significant pain", "time_frame": "60 days post-randomization" }, { "type": "secondary", "measure": "Mean Chalder Fatigue Scale (CFS) score at 30 days post-randomization", "description": "The CFS includes 11 likert-type questions that ask about feeling tired or lacking in energy. the questionnaire is scored from 0 to 33, with higher scores representing a higher level of fatigue. The CFS bas been validated and is widely used to assess fatigue across multiple populations", "time_frame": "30 days post-randomization" }, { "type": "secondary", "measure": "Mean CFS score at 60 days post-randomization", "description": "The CFS includes 11 likert-type questions that ask about feeling tired or lacking in energy. the questionnaire is scored from 0 to 33, with higher scores representing a higher level of fatigue. The CFS bas been validated and is widely used to assess fatigue across multiple populations", "time_frame": "60 days post-randomization" }, { "type": "secondary", "measure": "Mean CFS score at 90 days post-randomization", "description": "The CFS includes 11 likert-type questions that ask about feeling tired or lacking in energy. the questionnaire is scored from 0 to 33, with higher scores representing a higher level of fatigue. The CFS bas been validated and is widely used to assess fatigue across multiple populations", "time_frame": "90 days post-randomization" }, { "type": "secondary", "measure": "Mean difference in change in health-related quality of life (HRQL) measured by EQ-5D-Y over 90 days from randomization", "description": "The EQ-5D questionnaires used globally as a generic measure of health status. The EQ-5D-Y descriptive system comprises the following five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems. The younger patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the younger patient's health state. The EQ VAS records the younger patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled \"The best health you can imagine\" and \"The worst health you can imagine\".", "time_frame": "90 days post-randomization" }, { "type": "secondary", "measure": "Odds ratio of the all-cause death over 90 days from randomization.", "description": "Additionally, on days 30, 60, and 90, local research personnel will ascertain participant status on the all-cause death and all-cause unplanned hospitalization endpoints", "time_frame": "30, 60 and 90 days post-randomization" }, { "type": "secondary", "measure": "Odds ratio of all-cause unexpected hospitalization over 90 days", "description": "Additionally, on days 30, 60, and 90, local research personnel will ascertain participant status on the all-cause death and all-cause unplanned hospitalization endpoints", "time_frame": "30, 60 and 90 days post-randomization" }, { "type": "secondary", "measure": "Safety of metformin in this patient population", "description": "Incidence of Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) from the day of first visit till end of study visit (90 days post randomization)", "time_frame": "90 days post-randomization" } ], "outcome_measures": [ { "type": "primary", "measure": "Mean Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL-MFS) score at 90 days post-randomization", "description": "The PedsQL-MFS questionnaire is a validated instrument that is designed to measure fatigue in the pediatric population. The questionnaire is validated for different age groups, including adolescents. The questionnaire is comprised of three dimensions including general fatigue, sleep/rest fatigue, and cognitive fatigue. It includes 18 likert-type questions. It is scored from 0 to 100, with a higher score representing lower levels of fatigue. A score below 75 will be used to represent clinically significant pain", "time_frame": "90 days post-randomization" }, { "type": "secondary", "measure": "Mean PedsQL-MFS score at 30 days post-randomization", "description": "The PedsQL-MFS questionnaire is a validated instrument that is designed to measure fatigue in the pediatric population. The questionnaire is validated for different age groups, including adolescents. The questionnaire is comprised of three dimensions including general fatigue, sleep/rest fatigue, and cognitive fatigue. It includes 18 likert-type questions. It is scored from 0 to 100, with a higher score representing lower levels of fatigue. A score below 75 will be used to represent clinically significant pain", "time_frame": "30 days post-randomization" }, { "type": "secondary", "measure": "Mean PedsQL-MFS score at 60 days post-randomization", "description": "The PedsQL-MFS questionnaire is a validated instrument that is designed to measure fatigue in the pediatric population. The questionnaire is validated for different age groups, including adolescents. The questionnaire is comprised of three dimensions including general fatigue, sleep/rest fatigue, and cognitive fatigue. It includes 18 likert-type questions. It is scored from 0 to 100, with a higher score representing lower levels of fatigue. A score below 75 will be used to represent clinically significant pain", "time_frame": "60 days post-randomization" }, { "type": "secondary", "measure": "Mean Chalder Fatigue Scale (CFS) score at 30 days post-randomization", "description": "The CFS includes 11 likert-type questions that ask about feeling tired or lacking in energy. the questionnaire is scored from 0 to 33, with higher scores representing a higher level of fatigue. The CFS bas been validated and is widely used to assess fatigue across multiple populations", "time_frame": "30 days post-randomization" }, { "type": "secondary", "measure": "Mean CFS score at 60 days post-randomization", "description": "The CFS includes 11 likert-type questions that ask about feeling tired or lacking in energy. the questionnaire is scored from 0 to 33, with higher scores representing a higher level of fatigue. The CFS bas been validated and is widely used to assess fatigue across multiple populations", "time_frame": "60 days post-randomization" }, { "type": "secondary", "measure": "Mean CFS score at 90 days post-randomization", "description": "The CFS includes 11 likert-type questions that ask about feeling tired or lacking in energy. the questionnaire is scored from 0 to 33, with higher scores representing a higher level of fatigue. The CFS bas been validated and is widely used to assess fatigue across multiple populations", "time_frame": "90 days post-randomization" }, { "type": "secondary", "measure": "Mean difference in change in health-related quality of life (HRQL) measured by EQ-5D-Y over 90 days from randomization", "description": "The EQ-5D questionnaires used globally as a generic measure of health status. The EQ-5D-Y descriptive system comprises the following five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems. The younger patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the younger patient's health state. The EQ VAS records the younger patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled \"The best health you can imagine\" and \"The worst health you can imagine\".", "time_frame": "90 days post-randomization" }, { "type": "secondary", "measure": "Odds ratio of the all-cause death over 90 days from randomization.", "description": "Additionally, on days 30, 60, and 90, local research personnel will ascertain participant status on the all-cause death and all-cause unplanned hospitalization endpoints", "time_frame": "30, 60 and 90 days post-randomization" }, { "type": "secondary", "measure": "Odds ratio of all-cause unexpected hospitalization over 90 days", "description": "Additionally, on days 30, 60, and 90, local research personnel will ascertain participant status on the all-cause death and all-cause unplanned hospitalization endpoints", "time_frame": "30, 60 and 90 days post-randomization" }, { "type": "secondary", "measure": "Safety of metformin in this patient population", "description": "Incidence of Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) from the day of first visit till end of study visit (90 days post randomization)", "time_frame": "90 days post-randomization" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 3", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 16, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06147050", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06267300", "title": "Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial", "status": "UNKNOWN", "phase": "PHASE3", "last_updated": "2024-02-28", "start_date": "2024-10-01", "completion_date": "2026-04-01", "primary_completion_date": "2025-10-01", "conditions_raw": [ "Post-COVID-19 Syndrome", "Post-COVID Syndrome", "Post COVID-19 Condition", "Post-COVID Condition", "Post COVID-19 Condition, Unspecified", "Long COVID", "Long Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Hyperbaric Oxygen Therapy (HBOT)" ], "sponsor": "Erasmus Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action.\n\nThe main questions it aims to answer are:\n\n* What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID?\n* What are the changes in absence from work after treatment with HBOT?\n* What is the cost-effectiveness of treatment with HBOT?\n* What are possible mechanisms of action of HBOT?\n\nParticipants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months.", "primary_outcomes": [ { "type": "primary", "measure": "Physical and mental component scores of the 36-item Short Form Survey (SF-36)", "description": "Range 0-100, with higher scores indicating higher quality of life", "time_frame": "Week 20 (i.e. 3-months after end of HBOT)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Euroqol-5D (EQ-5D)", "description": "Descriptive for 5 dimensions + visual analogue score (VAS, range 0-100 with higher scores indicating higher quality of life)", "time_frame": "Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment)." }, { "type": "secondary", "measure": "Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns", "description": "", "time_frame": "Worn continuously until week 34" }, { "type": "secondary", "measure": "Biochemical parameters", "description": "", "time_frame": "Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)" }, { "type": "secondary", "measure": "Absence from work", "description": "", "time_frame": "Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment)." }, { "type": "secondary", "measure": "Cost-effectiveness", "description": "", "time_frame": "Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment)." } ], "outcome_measures": [ { "type": "primary", "measure": "Physical and mental component scores of the 36-item Short Form Survey (SF-36)", "description": "Range 0-100, with higher scores indicating higher quality of life", "time_frame": "Week 20 (i.e. 3-months after end of HBOT)" }, { "type": "secondary", "measure": "Euroqol-5D (EQ-5D)", "description": "Descriptive for 5 dimensions + visual analogue score (VAS, range 0-100 with higher scores indicating higher quality of life)", "time_frame": "Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment)." }, { "type": "secondary", "measure": "Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns", "description": "", "time_frame": "Worn continuously until week 34" }, { "type": "secondary", "measure": "Biochemical parameters", "description": "", "time_frame": "Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)" }, { "type": "secondary", "measure": "Absence from work", "description": "", "time_frame": "Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment)." }, { "type": "secondary", "measure": "Cost-effectiveness", "description": "", "time_frame": "Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment)." } ], "relevance_tags": [ "General", "Phase 3", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06267300", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06013072", "title": "Pre-probiotic Supplementation for Post-covid Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-02-06", "start_date": "2022-10-01", "completion_date": "2024-01-15", "primary_completion_date": "2023-12-31", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Dietary Supplement: Experimental" ], "sponsor": "University of Novi Sad, Faculty of Sport and Physical Education", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with a pre-probiotic on patient- and clinician-reported outcomes, and brain tissue metabolism in patients with post-covid fatigue syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue", "description": "Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)", "time_frame": "Change from baseline fatigue at 3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Brain creatine", "description": "Magnetic resonance spectra for brain creatine concentrations", "time_frame": "Change from baseline brain creatine concentrations at 3 months" }, { "type": "secondary", "measure": "Patient-reported symptoms", "description": "Scale of symptoms assessed by Visal Analog Scales (VAS), minimum 0 maximum 10; higher scores mean a worse outcome", "time_frame": "Change from baseline fatigue at 3 months" }, { "type": "secondary", "measure": "Time to exhaustion", "description": "Running time to exhaustion during incrementaltestontreadmill", "time_frame": "Change from baseline time to exhaustion at 3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue", "description": "Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)", "time_frame": "Change from baseline fatigue at 3 months" }, { "type": "secondary", "measure": "Brain creatine", "description": "Magnetic resonance spectra for brain creatine concentrations", "time_frame": "Change from baseline brain creatine concentrations at 3 months" }, { "type": "secondary", "measure": "Patient-reported symptoms", "description": "Scale of symptoms assessed by Visal Analog Scales (VAS), minimum 0 maximum 10; higher scores mean a worse outcome", "time_frame": "Change from baseline fatigue at 3 months" }, { "type": "secondary", "measure": "Time to exhaustion", "description": "Running time to exhaustion during incrementaltestontreadmill", "time_frame": "Change from baseline time to exhaustion at 3 months" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 32, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06013072", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06231225", "title": "Study on the Effect of Incentive Spirometer-based Respiratory Training on the Long COVID-19", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-01-30", "start_date": "2024-07-01", "completion_date": "2026-08-01", "primary_completion_date": "2025-06-30", "conditions_raw": [ "COVID-19 Pandemic", "Diabetes", "Hypertension", "Cardiac Disease", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Incentive Spirometer Respiratory Training" ], "sponsor": "National Taipei University of Nursing and Health Sciences", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The COVID-19 pandemic has emerged as the most significant public health crisis of the 21st century. As of the end of January 2023, global confirmed cases have exceeded 670 million, with a domestic cumulative total of 10.24 million cases, including occurrences of reinfection. Beyond acute symptoms following infection, patients and society face the challenge of long-term complications associated with COVID-19. Termed 'Post COVID-19 condition' or 'Long COVID' by the World Health Organization (WHO), this encompasses symptoms appearing within three months of the initial infection. Symptoms of Long COVID reveal chronic damage inflicted by the virus on multiple organ systems, including fatigue, cognitive impairment, chest tightness, palpitations, difficulty breathing, and depression.\n\nDespite continuous efforts by healthcare professionals to find suitable treatments, no medication has been confirmed to effectively prevent or reduce post-COVID-19 sequelae. These health issues impose significant burdens and disturbances on patients' quality of life, economies, and societies.", "primary_outcomes": [ { "type": "primary", "measure": "Post-COVID-19 Functional Status scale", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Lung function indices", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Hemoglobin and oxygen levels", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Six-minute walk test (6MWT)", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Dyspnoea-12 (D-12) scale", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" } ], "outcome_measures": [ { "type": "primary", "measure": "Post-COVID-19 Functional Status scale", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Lung function indices", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Hemoglobin and oxygen levels", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Six-minute walk test (6MWT)", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Dyspnoea-12 (D-12) scale", "description": "for check the effect of respiratory training", "time_frame": "through study completion, an average of 1 year" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06231225", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04905888", "title": "Hyperbaric Oxygen for Long COVID-19 Pulmonary Sequela", "status": "WITHDRAWN", "phase": "PHASE2", "last_updated": "2024-01-23", "start_date": "2021-11-08", "completion_date": "2023-12-31", "primary_completion_date": "2022-12-31", "conditions_raw": [ "Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Hyperbaric Oxygen Therapy (HBOT)" ], "sponsor": "Peter Lindholm", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a pilot study in 24 subjects where half will be randomized to 10 treatments with hyperbaric oxygen (HBO). It will primarily study pulmonary sequelae with imaging and physiological measurements (low dose chest computer tomography (CT), Ventilation/perfusion with magnetic resonance imaging (VA/Q MRI), cardiopulmonary exercise testing with pulse oximetry (SpO2) and spirometry including diffusion capacity for carbon monoxide (DLCO). The target patient group will be previously healthy whom have had covid-19 with lingering symptoms past 12 weeks of recovery from the acute phase.", "primary_outcomes": [ { "type": "primary", "measure": "Exercise tolerance", "description": "Cardiopulmonary exercise testing with pulse oximetry and maximal oxygen uptake,VO2max (ml/kg/min)", "time_frame": "3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Excercise tolerance walk test", "description": "6 minute walk test, in meters", "time_frame": "3 months" }, { "type": "secondary", "measure": "Dyspnea perception 1", "description": "UCSD Shortness of breath (SOB) 24 questions using a 0-6-point scale per question Total score (0-120) The higher the score the greater the dyspnea", "time_frame": "3 Months" }, { "type": "secondary", "measure": "Dyspnea perception 2", "description": "PROMIS dyspnea questionnaire/scales (Patient-Reported Outcomes Measurement Information System).\n\nShortness of Breath in general (0-10) Intensity of Shortness of breath (0-10) Frequency of Shortness of breath (0-10) Duration of Shortness of breath (0-10) The higher the score the greater the dyspnea", "time_frame": "3 Months" }, { "type": "secondary", "measure": "Pulmonary function test 1", "description": "Spirometry FEV1 (L) FEV1 %predicted FVC (L) FVC %predicted PEF (l/Min) PEF %predicted", "time_frame": "3 months" }, { "type": "secondary", "measure": "Pulmonary function test 2", "description": "Lung Diffusion Capacity DLCO (ml/min/mmHg) DLCO %predicted", "time_frame": "3 months" }, { "type": "secondary", "measure": "V̇A/Q̇ matching measured with magnetic resonance imaging", "description": "pulmonary ventilation/perfusion matching with Lung heterogeneity expressed as relative dispersion in ventilation and perfusion.", "time_frame": "3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Exercise tolerance", "description": "Cardiopulmonary exercise testing with pulse oximetry and maximal oxygen uptake,VO2max (ml/kg/min)", "time_frame": "3 months" }, { "type": "secondary", "measure": "Excercise tolerance walk test", "description": "6 minute walk test, in meters", "time_frame": "3 months" }, { "type": "secondary", "measure": "Dyspnea perception 1", "description": "UCSD Shortness of breath (SOB) 24 questions using a 0-6-point scale per question Total score (0-120) The higher the score the greater the dyspnea", "time_frame": "3 Months" }, { "type": "secondary", "measure": "Dyspnea perception 2", "description": "PROMIS dyspnea questionnaire/scales (Patient-Reported Outcomes Measurement Information System).\n\nShortness of Breath in general (0-10) Intensity of Shortness of breath (0-10) Frequency of Shortness of breath (0-10) Duration of Shortness of breath (0-10) The higher the score the greater the dyspnea", "time_frame": "3 Months" }, { "type": "secondary", "measure": "Pulmonary function test 1", "description": "Spirometry FEV1 (L) FEV1 %predicted FVC (L) FVC %predicted PEF (l/Min) PEF %predicted", "time_frame": "3 months" }, { "type": "secondary", "measure": "Pulmonary function test 2", "description": "Lung Diffusion Capacity DLCO (ml/min/mmHg) DLCO %predicted", "time_frame": "3 months" }, { "type": "secondary", "measure": "V̇A/Q̇ matching measured with magnetic resonance imaging", "description": "pulmonary ventilation/perfusion matching with Lung heterogeneity expressed as relative dispersion in ventilation and perfusion.", "time_frame": "3 months" } ], "relevance_tags": [ "General", "Phase 2", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT04905888", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05608629", "title": "Vagus Nerve Stimulation as Treatment for Long Covid", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-01-08", "start_date": "2022-06-06", "completion_date": "2022-12-05", "primary_completion_date": "2022-12-05", "conditions_raw": [ "Long COVID", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Transcutaneous Non-Invasive Vagus Nerve Stimulation" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. Inclusion criteria required the patient to fulfill criteria for having chronic fatigue syndrome. To date, fourteen patients provided evaluable data. Eight of these fulfilled the study's requirements for treatment success.", "primary_outcomes": [ { "type": "primary", "measure": "Number of Participants With Treatment Success", "description": "Treatment success is defined as patient had to improve on 2 of the following:\n\na 14% improvement in SF-36 -- physical function (0-100 scale, higher score = less disability;\n\nreport of marked or moderate improvement (2-3 on a scale going from +3 to -3\\] based on the treatment \\[patient global indication of change (0-7, higher score = more improvement);\n\ngoing from fatigue case to no fatigue on Chalder fatigue scale (0-3, higher score = more fatigue;\n\nimprovement on VAS of at least 2 points \\[VAS going from none \\[0\\] to 5 \\[very severe\\] with at least a 3 \\[substantial\\] on one of the following Sx --\\> fatigue, brain fog, widespread pain", "time_frame": "Baseline to post-treatment at 6-weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Number of Participants With Change in the Profile of Mood States (POMS)", "description": "Number of participants with reductions of at least 10 points on the short version of the Profile of Mood States. The POMS ranges from 0 -120. Higher score indicates poorer health outcomes.", "time_frame": "6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of Participants With Treatment Success", "description": "Treatment success is defined as patient had to improve on 2 of the following:\n\na 14% improvement in SF-36 -- physical function (0-100 scale, higher score = less disability;\n\nreport of marked or moderate improvement (2-3 on a scale going from +3 to -3\\] based on the treatment \\[patient global indication of change (0-7, higher score = more improvement);\n\ngoing from fatigue case to no fatigue on Chalder fatigue scale (0-3, higher score = more fatigue;\n\nimprovement on VAS of at least 2 points \\[VAS going from none \\[0\\] to 5 \\[very severe\\] with at least a 3 \\[substantial\\] on one of the following Sx --\\> fatigue, brain fog, widespread pain", "time_frame": "Baseline to post-treatment at 6-weeks" }, { "type": "secondary", "measure": "Number of Participants With Change in the Profile of Mood States (POMS)", "description": "Number of participants with reductions of at least 10 points on the short version of the Profile of Mood States. The POMS ranges from 0 -120. Higher score indicates poorer health outcomes.", "time_frame": "6 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 17, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05608629", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05679505", "title": "Vagus Nerve Stimulation for Post-COVID Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-01-05", "start_date": "2022-10-27", "completion_date": "2023-01-04", "primary_completion_date": "2023-01-01", "conditions_raw": [ "Long COVID", "Vagus Nerve Stimulations", "Heart Rates", "Autonomic Nervous System Disorders" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Auricular Transcutaneous Vagus Nerve Stimulation" ], "sponsor": "Bahçeşehir University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of this study is to increase parasympathetic activity and decrease the severity of symptoms by providing vagal stimulation with the t-VNS method in order to suppress the increased sympathetic activity in patients with prolonged Covid symptoms.The main question\\[s\\] it aims to answer are:\n\nQuestion 1:Is left ear transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?\n\nQuestion 2:Is bilateral auricular transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?\n\nA 5-minute heart rate variability measurement will be performed to measure the effectiveness of vagus nerve stimulation in participants.HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time", "primary_outcomes": [ { "type": "primary", "measure": "Heart Rate Variability", "description": "HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time. It analyzes the change in the beat-beat intervals of the heart and reflects the balance between PNS and SNS. During the analysis of heart rate variability measurement, the results obtained from sub-parameters such as stress index, time-domain and frequency-domain measurements allow evaluation of PNS and SNS activity.", "time_frame": "After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "The Fatigue Severity Scale, which is applied in the form of a questionnaire to determine the severity of fatigue accompanied by chronic diseases, consists of a total of 9 questions and according to the results obtained, it gives results as No Fatigue (\\<2.8 points) and chronic fatigue syndrome (\\>6.1 points).", "time_frame": "After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later)." } ], "outcome_measures": [ { "type": "primary", "measure": "Heart Rate Variability", "description": "HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time. It analyzes the change in the beat-beat intervals of the heart and reflects the balance between PNS and SNS. During the analysis of heart rate variability measurement, the results obtained from sub-parameters such as stress index, time-domain and frequency-domain measurements allow evaluation of PNS and SNS activity.", "time_frame": "After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later)." }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "The Fatigue Severity Scale, which is applied in the form of a questionnaire to determine the severity of fatigue accompanied by chronic diseases, consists of a total of 9 questions and according to the results obtained, it gives results as No Fatigue (\\<2.8 points) and chronic fatigue syndrome (\\>6.1 points).", "time_frame": "After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later)." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05679505", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06166030", "title": "IMMUNERECOV CONTRIBUTES TO IMPROVEMENT OF RESPIRATORY AND IMMUNOLOGICAL RESPONSE IN POST-COVID-19 PATIENTS.", "status": "UNKNOWN", "phase": "PHASE3", "last_updated": "2023-12-12", "start_date": "2023-12-10", "completion_date": "2024-12-15", "primary_completion_date": "2024-12-10", "conditions_raw": [ "Long Covid19", "Dietary Supplements", "Respiratory Tract Infections", "Inflammation" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Nutritional Blend (Immunerecov)." ], "sponsor": "Federal University of São Paulo", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Background: COVID-19 left consequences in different organs from months to years requiring different types of rehabilitation. In fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-COVID-19 patients. Objectives: Thus, the present study investigated whether 30 days of supplementation with a nutritional blend (ImmuneRecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin C, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-COVID-19 patients.", "primary_outcomes": [ { "type": "primary", "measure": "Effects of ImmuneRecov on Lung Function and Immune Response", "description": "Effects of ImmuneRecov on Lung Function and Immune Response", "time_frame": "Effects of 30 days supplementation with ImmuneRecov on Lung Function and Immune Response" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Effects of ImmuneRecov on Peripheral and Respiratory Muscle Strength", "description": "Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength", "time_frame": "Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength" } ], "outcome_measures": [ { "type": "primary", "measure": "Effects of ImmuneRecov on Lung Function and Immune Response", "description": "Effects of ImmuneRecov on Lung Function and Immune Response", "time_frame": "Effects of 30 days supplementation with ImmuneRecov on Lung Function and Immune Response" }, { "type": "secondary", "measure": "Effects of ImmuneRecov on Peripheral and Respiratory Muscle Strength", "description": "Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength", "time_frame": "Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength" } ], "relevance_tags": [ "Immunomodulatory", "Anti-inflammatory", "Phase 3", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 58, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06166030", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06159296", "title": "Effect of Inhaled Hydroxy Gas on Long COVID Symptoms", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-12-06", "start_date": "2023-09-25", "completion_date": "2024-05-31", "primary_completion_date": "2024-05-31", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Hydroxy Gas" ], "sponsor": "Oxford Brookes University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to see if several weeks of self-administered, home-based, treatment involving breathing hydroxy gas (a mixture of hydrogen and oxygen) for at least 2 hours a day for 3 weeks, will relieve symptoms in patients suffering from Long COVID. The main question it aims to answer is whether inhaling hydroxy gas might be a useful treatment option to help patients with long COVID cope better and recover quicker from this condition.\n\nParticipants will wear a nasal canula (placed in their nostrils) to inhale a gas from a machine that they will be trained to use at home. In one 3-week period, the machine will deliver hydroxy gas (treatment) and in a separate 3-week period the machine will deliver normal air (placebo). The order of the treatment or placebo periods will be randomized and separated by a minimum of 3-weeks during which the participants will not use the machine ('washout' period). Neither the participant nor the investigators will know which 3-week period is the treatment and which is the placebo phase. Participants will visit the laboratory (or be tested at home) at the start and end of each 3-week period.\n\nTesting will involve measuring physical ability (handgrip strength, how far they can walk in 6 minutes, how many times they can stand up and sit down in a minute), breathing problems (how hard they can blow out, how breathless they feel), cognitive ability (how quickly they can mark out a trail based on numbers and letters), and state of mind (mood).\n\nThe investigators hypothesize that compared to inhaling placebo, inhaling the hydroxy gas will produce greater improvement in physical ability, relieve breathing problems, and enhance cognitive ability and mood, thereby showing that it can relieve key symptoms of long COVID", "primary_outcomes": [ { "type": "primary", "measure": "Breathlessness", "description": "Total dyspnoea score in the preceding 2 weeks, quantified from the D-12 questionnaire (% maximum score). Sample size estimate was based on this measure.", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Exertional dyspnea", "description": "Change in total dyspnoea score from rest to peak exercise quantified using the D12 questionnaire", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)" }, { "type": "secondary", "measure": "Physical capacity (muscle fatigue)", "description": "(i) Distance walked at their own pace during the 6-minute walk test and the number of sit to stands achieved in 1 minute.\n\n(ii) Handgrip strength measured using a hand dynamometer as the maximum squeeze (kg) sustained for 5 second (iii) Peak expiratory flow rate (PEF) achieved by blowing into a Wright's peak flow meter as hard as possible (Liters per minute)", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)" }, { "type": "secondary", "measure": "Psychological state and cognitive ability", "description": "(i) Mood cluster scores for \"sedation\", \"discontentment\", and \"tension\" derived from the Bond Lader mood questionnaire (%full scale) (ii) Time taken to complete a trail marking task based on joining sequential numbers and/or letters", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)" }, { "type": "secondary", "measure": "General long COVID symptom burden", "description": "Overall % score on the long COVID Symptom Burden Questionnaire", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)" } ], "outcome_measures": [ { "type": "primary", "measure": "Breathlessness", "description": "Total dyspnoea score in the preceding 2 weeks, quantified from the D-12 questionnaire (% maximum score). Sample size estimate was based on this measure.", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)." }, { "type": "secondary", "measure": "Exertional dyspnea", "description": "Change in total dyspnoea score from rest to peak exercise quantified using the D12 questionnaire", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)" }, { "type": "secondary", "measure": "Physical capacity (muscle fatigue)", "description": "(i) Distance walked at their own pace during the 6-minute walk test and the number of sit to stands achieved in 1 minute.\n\n(ii) Handgrip strength measured using a hand dynamometer as the maximum squeeze (kg) sustained for 5 second (iii) Peak expiratory flow rate (PEF) achieved by blowing into a Wright's peak flow meter as hard as possible (Liters per minute)", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)" }, { "type": "secondary", "measure": "Psychological state and cognitive ability", "description": "(i) Mood cluster scores for \"sedation\", \"discontentment\", and \"tension\" derived from the Bond Lader mood questionnaire (%full scale) (ii) Time taken to complete a trail marking task based on joining sequential numbers and/or letters", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)" }, { "type": "secondary", "measure": "General long COVID symptom burden", "description": "Overall % score on the long COVID Symptom Burden Questionnaire", "time_frame": "Week 0 and Week 4 (just before and after the first 3 week period of home-administration), Week 6 and week 10 (just before and after the start of the second 3 week period of home-administration)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 25, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06159296", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06156241", "title": "Stem Cell Study for Long COVID-19 Neurological Symptoms", "status": "UNKNOWN", "phase": "PHASE1", "last_updated": "2023-12-05", "start_date": "2024-01", "completion_date": "2026-02", "primary_completion_date": "2025-12", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Stem Cell" ], "sponsor": "Charles Cox", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this research study is to test the safety and benefit of a human cord blood derived stem cell infusion as a treatment for individuals with post COVID-19 neurological problems. Participants in the study will have 6 clinic visits over a 12 to 14 mo. period with each visit lasting 2 to 6 hours. Participants will receive 1 stem cell infusion at study visit #3. Participants will have a brain PET and MRI scan at the baseline and 6mo. post-infusion visits. Follow-up safety assessments will be conducted at 6mo. and 1yr. after the stem cell infusion.", "primary_outcomes": [ { "type": "primary", "measure": "Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.", "description": "Physical Exam", "time_frame": "Assessed for the first 24 hours after each stem cell infusion." }, { "type": "primary", "measure": "Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.", "description": "Clinical Lab Assessments", "time_frame": "Assessed for the first 24 hours after each stem cell infusion." }, { "type": "primary", "measure": "Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.", "description": "Vital Signs", "time_frame": "Assessed for the first 24 hours after each stem cell infusion." }, { "type": "primary", "measure": "Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.", "description": "Subject Report of Adverse Event(s)", "time_frame": "Assessed for the first 24 hours after each stem cell infusion." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Investigate if the hCTMSC infusions reduce the neuroinflammatory response following an acute COVID-19 infection as measured by the degree of microglial activation.", "description": "Comparison of Brain PET Scan at baseline visit and at 6 months post-infusion.", "time_frame": "Baseline visit to 6 months post-infusion." } ], "outcome_measures": [ { "type": "primary", "measure": "Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.", "description": "Physical Exam", "time_frame": "Assessed for the first 24 hours after each stem cell infusion." }, { "type": "primary", "measure": "Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.", "description": "Clinical Lab Assessments", "time_frame": "Assessed for the first 24 hours after each stem cell infusion." }, { "type": "primary", "measure": "Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.", "description": "Vital Signs", "time_frame": "Assessed for the first 24 hours after each stem cell infusion." }, { "type": "primary", "measure": "Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.", "description": "Subject Report of Adverse Event(s)", "time_frame": "Assessed for the first 24 hours after each stem cell infusion." }, { "type": "secondary", "measure": "Investigate if the hCTMSC infusions reduce the neuroinflammatory response following an acute COVID-19 infection as measured by the degree of microglial activation.", "description": "Comparison of Brain PET Scan at baseline visit and at 6 months post-infusion.", "time_frame": "Baseline visit to 6 months post-infusion." } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 12, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06156241", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05770193", "title": "Effect of Kinesio Tape Versus Diaphragmatic Breathing Exercise In Post COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-12-05", "start_date": "2023-03-11", "completion_date": "2023-11-30", "primary_completion_date": "2023-08-30", "conditions_raw": [ "Post COVID-19 Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Pursed Lip Breathing", "Cognitive Behavior Therapy", "Diaphragmatic Breathing Exercise", "Kinesio Tape" ], "sponsor": "Cairo University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "According to WHO, current evidence suggests some people experience a variety of long-term effects after they recover from their initial illness. These effects are collectively known as post COVID-19 condition or \"long COVID. While most people who develop COVID-19 fully recover, some people develop effects like fatigue, breathlessness, functional activities and cognitive dysfunction. At present, there is no specific medication therapy for people with post COVID-19 condition.", "primary_outcomes": [ { "type": "primary", "measure": "Modified Medical research council", "description": "It will used to assess Dyspnea, This test is very easy to perform; it is valid and correlates with clinical parameters and parameters of respiratory function.", "time_frame": "6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Pulse oximeter", "description": "It will be used to measure oxygen saturation. It is a valid tool to measure oxygen saturation. Powers et al, concluded that Pulse oximeter is useful tool in estimating percent arterial oxygen saturation of hemoglobin in healthy subjects.\n\nIt will be attached to the thump and the reading will be recorded", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Arabic version of The Fatigue Severity Scale", "description": "It will be used to measure fatigue level. The FSS showed satisfactory reliability and validity and thus can be regarded as a feasible measure of self-reported fatigue.\n\nIn addition to measuring the presence and degree of fatigue in a sample of Arabic patients, the Arabic version of the FSS also shown indications of internal consistency, relative test-retest reliability, and construct validity, supporting its application in clinical practice and research.", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "six-minute walk test", "description": "It will be used to measure physical or functional performance. The 6-min walk is a reliable and valid measure of physical endurance in older adults and it moderately reflects overall physical functional performance.\n\nA newer application of the six-minute walk test is noted for patients who have had COVID-19 pneumonia with prolonged respiratory symptoms.", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "The World Health Organization Quality-of-Life Scale (WHOQOL-BREF).", "description": "The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) provides a reliable, valid, and brief assessment of quality-of-life.\n\nThe Arabic translation of the WHOQOL-BREF has impressive reliability and validity indices. There will be a four-domain score. The four domain scores will denote an individual perception of quality of life in each particular domain. Domain scores are scaled in a positive direction higher scores denote higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100", "time_frame": "6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Modified Medical research council", "description": "It will used to assess Dyspnea, This test is very easy to perform; it is valid and correlates with clinical parameters and parameters of respiratory function.", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Pulse oximeter", "description": "It will be used to measure oxygen saturation. It is a valid tool to measure oxygen saturation. Powers et al, concluded that Pulse oximeter is useful tool in estimating percent arterial oxygen saturation of hemoglobin in healthy subjects.\n\nIt will be attached to the thump and the reading will be recorded", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Arabic version of The Fatigue Severity Scale", "description": "It will be used to measure fatigue level. The FSS showed satisfactory reliability and validity and thus can be regarded as a feasible measure of self-reported fatigue.\n\nIn addition to measuring the presence and degree of fatigue in a sample of Arabic patients, the Arabic version of the FSS also shown indications of internal consistency, relative test-retest reliability, and construct validity, supporting its application in clinical practice and research.", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "six-minute walk test", "description": "It will be used to measure physical or functional performance. The 6-min walk is a reliable and valid measure of physical endurance in older adults and it moderately reflects overall physical functional performance.\n\nA newer application of the six-minute walk test is noted for patients who have had COVID-19 pneumonia with prolonged respiratory symptoms.", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "The World Health Organization Quality-of-Life Scale (WHOQOL-BREF).", "description": "The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) provides a reliable, valid, and brief assessment of quality-of-life.\n\nThe Arabic translation of the WHOQOL-BREF has impressive reliability and validity indices. There will be a four-domain score. The four domain scores will denote an individual perception of quality of life in each particular domain. Domain scores are scaled in a positive direction higher scores denote higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100", "time_frame": "6 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05770193", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05668039", "title": "Enhanced External Counterpulsation to Treat Long COVID-19 Fatigue", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-11-30", "start_date": "2023-04-01", "completion_date": "2024-07", "primary_completion_date": "2024-04-01", "conditions_raw": [ "Post-Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Enhanced External Counterpulsation" ], "sponsor": "Sheba Medical Center", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "The goal of this double blind, outcome-assessor blind, randomized controlled trial, is to compare the effectiveness of external encounter counterpulsation (EECP) versus sham procedure in participants with long COVID-19 fatigue.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Whether EECP improves fatigue score\n* Whether EECP improves quality of life, six-minute walk test, and endothelial function Participants will attend 15 sessions (1-hour each) of EECP during 5 weeks Researchers will compare EECP versus sham procedure for the above outcomes.", "primary_outcomes": [ { "type": "primary", "measure": "Change in fatigue score", "description": "Change in PROMIS Fatigue 7a T score from baseline. Minimum score is 29, maximum 83, higher levels indicate worse outcome", "time_frame": "15 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in quality of life score", "description": "Quality of life improvement per SF-36. Minimum value - 0 and maximum - 100, higher levels indicate worse outcome", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Change in six-minute walk test", "description": "Six-minute walk distance improvement in meters", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Cahnge in endothelial function", "description": "Endothelial dysfunction improvement by EndoPat test", "time_frame": "15 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in fatigue score", "description": "Change in PROMIS Fatigue 7a T score from baseline. Minimum score is 29, maximum 83, higher levels indicate worse outcome", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Change in quality of life score", "description": "Quality of life improvement per SF-36. Minimum value - 0 and maximum - 100, higher levels indicate worse outcome", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Change in six-minute walk test", "description": "Six-minute walk distance improvement in meters", "time_frame": "15 weeks" }, { "type": "secondary", "measure": "Cahnge in endothelial function", "description": "Endothelial dysfunction improvement by EndoPat test", "time_frame": "15 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other Gov" ], "enrollment": 32, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05668039", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06091358", "title": "Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-11-30", "start_date": "2023-10-20", "completion_date": "2024-04-20", "primary_completion_date": "2024-03-29", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Pro2" ], "sponsor": "University of Bath", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This pilot investigation will recruit people with Long COVID to participate in a 4 week individualized inspiratory muscle training intervention with pre and post spirometry testing and additional functional outcomes to assess the effectiveness of the intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Maximal inspiratory muscle pressure (MIP) at week 4.", "description": "Maximal inspiratory muscle pressure (cmH20)", "time_frame": "Baseline, and week 4" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Peak expiratory flow (PEF) at week 4.", "description": "Peak expiratory flow (PEF) (l/min)", "time_frame": "Baseline, and week 4" }, { "type": "secondary", "measure": "Change in Ventilatory threshold (VT) at week 4.", "description": "Ventilatory threshold (VT)", "time_frame": "Baseline, and week 4" }, { "type": "secondary", "measure": "Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).", "description": "BDI and TDI", "time_frame": "Baseline, and week 4" }, { "type": "secondary", "measure": "Change in 6 minute walk test distance at week 4", "description": "6 minute walk test difference (m)", "time_frame": "Baseline, and week 4" }, { "type": "secondary", "measure": "Change in Forced ventilatory equivalent 1 second (FEV1) at week 4", "description": "Forced ventilatory equivalent 1 second (FEV1) (%)", "time_frame": "Baseline, and week 4" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Maximal inspiratory muscle pressure (MIP) at week 4.", "description": "Maximal inspiratory muscle pressure (cmH20)", "time_frame": "Baseline, and week 4" }, { "type": "secondary", "measure": "Change in Peak expiratory flow (PEF) at week 4.", "description": "Peak expiratory flow (PEF) (l/min)", "time_frame": "Baseline, and week 4" }, { "type": "secondary", "measure": "Change in Ventilatory threshold (VT) at week 4.", "description": "Ventilatory threshold (VT)", "time_frame": "Baseline, and week 4" }, { "type": "secondary", "measure": "Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).", "description": "BDI and TDI", "time_frame": "Baseline, and week 4" }, { "type": "secondary", "measure": "Change in 6 minute walk test distance at week 4", "description": "6 minute walk test difference (m)", "time_frame": "Baseline, and week 4" }, { "type": "secondary", "measure": "Change in Forced ventilatory equivalent 1 second (FEV1) at week 4", "description": "Forced ventilatory equivalent 1 second (FEV1) (%)", "time_frame": "Baseline, and week 4" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 16, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06091358", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05481177", "title": "Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort", "status": "UNKNOWN", "phase": "PHASE4", "last_updated": "2023-11-29", "start_date": "2023-06-14", "completion_date": "2024-09-01", "primary_completion_date": "2024-09-01", "conditions_raw": [ "Long Haul COVID", "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ivabradine" ], "sponsor": "Uniformed Services University of the Health Sciences", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "The purpose of the study is three-fold. The primary aim is to identify the proportion of Long-Haul COVID (LHC) and non-LHC volunteers with relevant symptoms actually have postural orthostatic tachycardia syndrome (POTS). The second is to determine benefit of ivabradine treatment. Ivabradine is a drug approved to treat tachycardia in persons with heart failure. The third is to characterize risk factors and outcomes among volunteers with and without LHC. This will include comparison with COVID-19-positive individuals who did not develop long-COVID symptoms.\n\nThe study will improve basic and applied knowledge of LHC and its associated cardiovascular and autonomic consequences. Cellular and molecular characterization of LHC and non-LHC participants will be performed with a nested clinical trial for Ivabradine responsiveness on reduction of tachycardia. It is hoped that a greater understanding of LHC, and related autonomic dysfunction in particular will help to identify treatment paradigms and therapeutic targets for improving recovery and enhancing health for those affected.", "primary_outcomes": [ { "type": "primary", "measure": "Change in standing heart rate following 3 months treatment.", "description": "The primary endpoint will be a reduction in standing heart rate at 3 months. Up to 200 evaluable subjects will be enrolled in the general LHC cohort with the expectation that at least 20% of those recruited will have POTS or otherwise IST causing symptoms appropriate for enrollment to the nested RCT (ivabradine vs. placebo). This will yield an RCT study population of at least 40 evaluable subjects. Study recruiting will be aimed at volunteers with features of POTS. Drop-outs in all cohorts may be replaced.", "time_frame": "3 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Change in standing heart rate following 3 months treatment.", "description": "The primary endpoint will be a reduction in standing heart rate at 3 months. Up to 200 evaluable subjects will be enrolled in the general LHC cohort with the expectation that at least 20% of those recruited will have POTS or otherwise IST causing symptoms appropriate for enrollment to the nested RCT (ivabradine vs. placebo). This will yield an RCT study population of at least 40 evaluable subjects. Study recruiting will be aimed at volunteers with features of POTS. Drop-outs in all cohorts may be replaced.", "time_frame": "3 months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 4", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Fed" ], "enrollment": 250, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05481177", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05719012", "title": "Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19", "status": "WITHDRAWN", "phase": "PHASE2", "last_updated": "2023-11-21", "start_date": "2023-04-01", "completion_date": "2024-03-30", "primary_completion_date": "2023-12-01", "conditions_raw": [ "Long COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Uc-Mscs" ], "sponsor": "Shanghai East Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19", "primary_outcomes": [ { "type": "primary", "measure": "Six min walking distances", "description": "The maximum distance a person can walk in 6 min and acts as an endurance walking measure.", "time_frame": "Changes from baseline index at Day 30, Day 60, Day 90 and Day 180" }, { "type": "primary", "measure": "Lung function", "description": "The lung function assessed using FEV1, FEV1/FVC and DLco", "time_frame": "Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes of the levels of Inflammatory cytokines", "description": "The levels of Inflammatory cytokines", "time_frame": "Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180" }, { "type": "secondary", "measure": "Changes of the scores of Multidimensional Fatigue Inventory", "description": "The degree of fatigue", "time_frame": "Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180" } ], "outcome_measures": [ { "type": "primary", "measure": "Six min walking distances", "description": "The maximum distance a person can walk in 6 min and acts as an endurance walking measure.", "time_frame": "Changes from baseline index at Day 30, Day 60, Day 90 and Day 180" }, { "type": "primary", "measure": "Lung function", "description": "The lung function assessed using FEV1, FEV1/FVC and DLco", "time_frame": "Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180" }, { "type": "secondary", "measure": "Changes of the levels of Inflammatory cytokines", "description": "The levels of Inflammatory cytokines", "time_frame": "Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180" }, { "type": "secondary", "measure": "Changes of the scores of Multidimensional Fatigue Inventory", "description": "The degree of fatigue", "time_frame": "Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180" } ], "relevance_tags": [ "General", "Phase 2", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT05719012", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06142240", "title": "Efficacy of Two Therapeutic Exercise Modalities for Patients With Persistent COVID", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-11-21", "start_date": "2023-06-01", "completion_date": "2025-09-01", "primary_completion_date": "2025-04-01", "conditions_raw": [ "Persistent COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Exercise Programe" ], "sponsor": "Facultat de ciencies de la Salut Universitat Ramon Llull", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Symptoms of long-standing sequelae and complications of COVID-19, termed Long COVID19 or persistent COVID, have been reported worldwide. However, the etiology underlying the prolonged or fluctuating symptomatology is limited and there is no uniform and widely accepted definition.Patients describe persistent COVID as a fluctuating disease with variable and persistent symptoms.Most of the effects correspond to clinical symptoms such as fatigue, headache, arthralgias, hyposmia, gustatory sensations, etc. Fatigue is the most common and prolonged symptom of persistent COVID. Knowledge of the pathophysiological mechanisms of fatigue in COVID-19 disease, as well as the therapeutic approach, remains limited due to the relatively recent onset of this pathology. In particular, muscle strength training has been shown to improve muscle function and fatigue, not only during treatment, but also at long-term follow-up.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue", "description": "this is the main variable of the study. It will be measured using the self-report scale \"Fatigue Impact Scale\" (FIS) (Fisk et al., 1994), which assesses the perception of functional limitation caused by fatigue in three areas: physical, cognitive and psychosocial. Range 0 (no problem) to 4 (extrem problem)", "time_frame": "hour" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Exercise capacity", "description": "will be assessed using the six-minute walk test (6MWT). In the 6MWT we will measure the total number of metres the patient is able to walk for 6 minutes. The test will be performed in an indoor corridor of 30m distance, repeated 2 times with a pause of at least 30min between them.", "time_frame": "hour" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue", "description": "this is the main variable of the study. It will be measured using the self-report scale \"Fatigue Impact Scale\" (FIS) (Fisk et al., 1994), which assesses the perception of functional limitation caused by fatigue in three areas: physical, cognitive and psychosocial. Range 0 (no problem) to 4 (extrem problem)", "time_frame": "hour" }, { "type": "secondary", "measure": "Exercise capacity", "description": "will be assessed using the six-minute walk test (6MWT). In the 6MWT we will measure the total number of metres the patient is able to walk for 6 minutes. The test will be performed in an indoor corridor of 30m distance, repeated 2 times with a pause of at least 30min between them.", "time_frame": "hour" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06142240", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05080244", "title": "WHO COVID-19 - Evaluation of the Efficacy of Probiotics to Reduce the Occurrence of Long COVID", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-11-07", "start_date": "2021-10-28", "completion_date": "2022-12-04", "primary_completion_date": "2022-12-04", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Probiotics" ], "sponsor": "Centre de recherche du Centre hospitalier universitaire de Sherbrooke", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Probiotics may be considered as an option of treatment for long COVID since they have anti-viral effect, trigger immunomodulation and have low side-effects. This randomized controlled trial aims to reduce the number of patients with long COVID by 25% 90 days after the COVID-19 diagnosis by taking probiotics in a symptomatic population, self-caring at home. During the acute phase of the disease, participants will take two capsules (probiotics or placebo) per day for 10 days and one capsule (probiotics or placebo) per day for the following 15 days. A follow-up will be done twice during the acute phase, 14 days and 28 days after starting to take the investigational product (compliance to treatment, side effects, etc.). At inclusion and at Day14, Day30 and Day90 after the COVID-19 diagnosis, a questionnaire will be administered (COVID-19 symptoms, anxiety, functioning difficulties, etc.) and 2 saliva and 2 stool (viral and microbiota analyzes) self-samples will be performed.", "primary_outcomes": [ { "type": "primary", "measure": "Reduce by 25% the number of patients with LONG-COV during follow-up at D90 by taking probiotics during the acute phase of COVID-19", "description": "COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS)", "time_frame": "90 days after the COVID-19 diagnosis." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Compare the proportion of patients presenting COVID-19 symptoms and severity of symptoms at D14, D30 and D90 by taking probiotics during the acute phase of COVID-19.", "description": "COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS)", "time_frame": "14,30 and 90 days after the COVID-19 diagnosis." }, { "type": "secondary", "measure": "Describe the symptoms severity and evolution by study group and baseline characteristics.", "description": "COVID-19 symptoms (FLU-PRO), baseline characteristics", "time_frame": "Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis" }, { "type": "secondary", "measure": "Determine/identify prognostic factors measured at baseline (inclusion) associated with LONG-COV (sociodemographic, clinical factors).", "description": "COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS), baseline characteristics", "time_frame": "Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis" } ], "outcome_measures": [ { "type": "primary", "measure": "Reduce by 25% the number of patients with LONG-COV during follow-up at D90 by taking probiotics during the acute phase of COVID-19", "description": "COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS)", "time_frame": "90 days after the COVID-19 diagnosis." }, { "type": "secondary", "measure": "Compare the proportion of patients presenting COVID-19 symptoms and severity of symptoms at D14, D30 and D90 by taking probiotics during the acute phase of COVID-19.", "description": "COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS)", "time_frame": "14,30 and 90 days after the COVID-19 diagnosis." }, { "type": "secondary", "measure": "Describe the symptoms severity and evolution by study group and baseline characteristics.", "description": "COVID-19 symptoms (FLU-PRO), baseline characteristics", "time_frame": "Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis" }, { "type": "secondary", "measure": "Determine/identify prognostic factors measured at baseline (inclusion) associated with LONG-COV (sociodemographic, clinical factors).", "description": "COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS), baseline characteristics", "time_frame": "Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis" } ], "relevance_tags": [ "Immunomodulatory", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 618, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05080244", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05556733", "title": "FMT for Post-acute COVID-19 Syndrome", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-10-31", "start_date": "2022-09-28", "completion_date": "2024-06-30", "primary_completion_date": "2023-09-13", "conditions_raw": [ "Post-Acute COVID19 Syndrome", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Faecal Microbiota Transplantation" ], "sponsor": "Chinese University of Hong Kong", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In recovered COVID-19 patients, emerging global data have reported the presence of long COVID, that is, at least one symptom that an alternative diagnosis cannot explain has been persistent for four or more weeks after the initial infection. We demonstrated previously that almost 80% of recovered COVID-19 patients in Hong Kong suffer from Long COVID for more than 6 months, affecting multiple body systems.\n\nIn a recent study, the five most common Long COVID symptoms were fatigue, memory problem, difficulty sleeping, anxiety and hair loss. One promising hypothesis is the involvement of the gut microbiota, a collection of the trillions of gut microorganisms that play important immunomodulatory roles against infections.\n\nFaecal microbiota transplantation (FMT), which is the infusion of processed faeces from healthy donors to the gut of affected subjects, has shown impressive therapeutic effects for recurrent Clostridioides difficile infection and other emerging indications. Gut microorganisms together with the metabolites in the donated faeces could potentially modulate the gut microbiota of the recipient and treat the dysbiosis associated with pathological health conditions. To date, no study has yet to assess the therapeutic effects of FMT in post-COVID-19 neuropsychiatric conditions.", "primary_outcomes": [ { "type": "primary", "measure": "Change in insomnia severity", "description": "Severity of insomnia will be measured by a 7-item Insomnia Severity Index (ISI). ISI is a self-report questionnaire used to evaluate the nature, severity and impact of insomnia. Total score ranges from 0 to 28. Higher score indicates more severe insomnia.", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in sleep quality", "description": "Quality of sleep will be measured by a 19-item Pittsburgh Sleep Quality Index (PSQI). PSQI is a self-report questionnaire used to evaluate sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Total score ranges from 0 to 21. Lower score indicates healthier sleep quality.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in anxiety symptoms", "description": "Anxiety symptoms will be assessed by a 7-item Generalised Anxiety Disorder-7 scale (GAD-7). GAD-7 is a widely used diagnostic self-report scale for the screening, diagnosis and severity assessment of anxiety disorder. Total score ranges from 0 to 21. Higher score indicates more severe anxiety.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in daytime sleepiness", "description": "Daytime sleepiness will be measured by a 8-item Epworth Sleepiness Scale (ESS). ESS is a widely used self-report questionnaire used to evaluate daytime sleepiness in the field of sleep medicine. Total score ranges from 0 to 24. Higher score indicates more daytime sleepiness.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in fatigue symptoms", "description": "Fatigue symptoms will be assessed by a 20-item Multidimensional Fatigue Inventory (MFI). MFI is a self-report questionnaire used to evaluate five dimensions of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Each dimension has four items. Total score of each dimension ranges from 4 to 20. Higher score indicates more severe fatigue for that dimension.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in sleep diary parameters", "description": "Consensus Sleep Diary (CSD) will be used to record sleep time, wake time and subjective sleeping quality daily. Parameters including sleep onset latency, time awake after sleep onset, total wake time, total sleep time and sleep efficiency will be calculated.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in gut microbiota composition", "description": "Relative abundance of gut bacteria at species level will be assessed by metagenomic analysis.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in gut microbiota diversity and richness", "description": "Species diversity (Shannon index) and richness (number of observed species) will be calculated based on the relative abundance of gut bacteria.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Similarity of gut microbiota composition to donor", "description": "Engraftment of donor species after intervention will be assessed by the similarity of gut microbiota composition to the donor.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in blood cytokine profile", "description": "Change in blood cytokine profile will be assessed, including levels of interferon gamma, interleukins, leptin, vascular endothelial growth factor, membrane-bound immunoglobulin, and tumour necrosis factor-α etc.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in blood cortisol", "description": "Change in blood cortisol will be assessed", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in Melatonin level", "description": "Change in blood melatonin will be assessed", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in insomnia severity", "description": "Severity of insomnia will be measured by a 7-item Insomnia Severity Index (ISI). ISI is a self-report questionnaire used to evaluate the nature, severity and impact of insomnia. Total score ranges from 0 to 28. Higher score indicates more severe insomnia.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in sleep quality", "description": "Quality of sleep will be measured by a 19-item Pittsburgh Sleep Quality Index (PSQI). PSQI is a self-report questionnaire used to evaluate sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Total score ranges from 0 to 21. Lower score indicates healthier sleep quality.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in anxiety symptoms", "description": "Anxiety symptoms will be assessed by a 7-item Generalised Anxiety Disorder-7 scale (GAD-7). GAD-7 is a widely used diagnostic self-report scale for the screening, diagnosis and severity assessment of anxiety disorder. Total score ranges from 0 to 21. Higher score indicates more severe anxiety.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in daytime sleepiness", "description": "Daytime sleepiness will be measured by a 8-item Epworth Sleepiness Scale (ESS). ESS is a widely used self-report questionnaire used to evaluate daytime sleepiness in the field of sleep medicine. Total score ranges from 0 to 24. Higher score indicates more daytime sleepiness.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in fatigue symptoms", "description": "Fatigue symptoms will be assessed by a 20-item Multidimensional Fatigue Inventory (MFI). MFI is a self-report questionnaire used to evaluate five dimensions of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Each dimension has four items. Total score of each dimension ranges from 4 to 20. Higher score indicates more severe fatigue for that dimension.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in sleep diary parameters", "description": "Consensus Sleep Diary (CSD) will be used to record sleep time, wake time and subjective sleeping quality daily. Parameters including sleep onset latency, time awake after sleep onset, total wake time, total sleep time and sleep efficiency will be calculated.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in gut microbiota composition", "description": "Relative abundance of gut bacteria at species level will be assessed by metagenomic analysis.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in gut microbiota diversity and richness", "description": "Species diversity (Shannon index) and richness (number of observed species) will be calculated based on the relative abundance of gut bacteria.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Similarity of gut microbiota composition to donor", "description": "Engraftment of donor species after intervention will be assessed by the similarity of gut microbiota composition to the donor.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in blood cytokine profile", "description": "Change in blood cytokine profile will be assessed, including levels of interferon gamma, interleukins, leptin, vascular endothelial growth factor, membrane-bound immunoglobulin, and tumour necrosis factor-α etc.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in blood cortisol", "description": "Change in blood cortisol will be assessed", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Change in Melatonin level", "description": "Change in blood melatonin will be assessed", "time_frame": "12 weeks" } ], "relevance_tags": [ "Immunomodulatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05556733", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06095258", "title": "A Practical RCT of TCM in the Treatment of LCOVID and Analysis of Syndrome Types and Medication Characteristics.", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2023-10-26", "start_date": "2023-12-01", "completion_date": "2026-02-28", "primary_completion_date": "2025-11-30", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Traditional Chinese Medicine Treatment", "Western Medicine Treatment" ], "sponsor": "Chinese University of Hong Kong", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a multi-center, outcome assessor-blinded, practical randomized controlled trial, aiming to compare the actual clinical effectiveness of individualized traditional Chinese medicine and conventional Western medicine in the treatment of long COVID.\n\nTotally 162 patients with long COVID recruited into the study will be randomly assigned to the traditional Chinese medicine treatment group or the Western medicine control group. Patients in the treatment group will receive individualized TCM syndrome differentiation treatment, and patients in the control group will receive conventional Western medicine symptomatic treatment from general Western medicine practitioners for 4 weeks. All patients were followed up once a week (±2 days) during treatment period and followed up by 4 weeks (±2 days) after the treatment. Outcome measurements will be conducted at baseline, the end of treatment (week 4 ±2 days) and the follow-up visit (week 8 ±2 days).", "primary_outcomes": [ { "type": "primary", "measure": "5-level EQ-5D version (EQ-5D-5L)", "description": "The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated \\[38\\]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).", "time_frame": "4 weeks" }, { "type": "primary", "measure": "5-level EQ-5D version (EQ-5D-5L)", "description": "The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated \\[38\\]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)", "description": "The Chinese version of the Measure Yourself Medical Outcome Profile has been validated \\[39\\]. This questionnaire asks respondents to name one or two symptoms of greatest concern and the daily activities that are limited by these symptoms. Respondents rate these symptoms and activities, as well as their general health status, on a scale from 0 to 6 (0 is best, 6 is worst).", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)", "description": "The Chinese version of the Measure Yourself Medical Outcome Profile has been validated \\[39\\]. This questionnaire asks respondents to name one or two symptoms of greatest concern and the daily activities that are limited by these symptoms. Respondents rate these symptoms and activities, as well as their general health status, on a scale from 0 to 6 (0 is best, 6 is worst).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)", "description": "This improved version of the scale allows patients to self-assess the main symptoms of the COVID, the degree of functional limitation and overall health status. There are 17 items in total, including shortness of breath, cough/throat sensitivity/voice change, fatigue, changes in smell or taste, pain or discomfort, and cognition. problems, palpitations/dizziness, tiredness/exacerbation after work, anxiety/depression, sleep problems, communication, walking or moving, self-care, other daily activities, social roles), and other symptoms (such as fever, hair loss, dry eyes, tinnitus, nausea, etc.) and general health, etc. Each item is scored from 0 to 3 (0 is asymptomatic, 1 is mild and does not affect daily life, 2 is moderate and affects daily life to a certain extent, and 3 is severe or affects daily life comprehensively).", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)", "description": "This improved version of the scale allows patients to self-assess the main symptoms of the COVID, the degree of functional limitation and overall health status. There are 17 items in total, including shortness of breath, cough/throat sensitivity/voice change, fatigue, changes in smell or taste, pain or discomfort, and cognition. problems, palpitations/dizziness, tiredness/exacerbation after work, anxiety/depression, sleep problems, communication, walking or moving, self-care, other daily activities, social roles), and other symptoms (such as fever, hair loss, dry eyes, tinnitus, nausea, etc.) and general health, etc. Each item is scored from 0 to 3 (0 is asymptomatic, 1 is mild and does not affect daily life, 2 is moderate and affects daily life to a certain extent, and 3 is severe or affects daily life comprehensively).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Serum level change of inflammatory factors", "description": "Inflammatory markers including interferon (IFN-β), interferon (IFN-λ2/3), pentraxin 3 (PTX3) and interleukin 6 will be measured.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Safety assessment", "description": "In order to evaluate the safety of the traditional Chinese medicine treatment, the patient's complete blood count (CBC) and liver and kidney function indicators will be tested before starting the study treatment and after the treatment ends.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Adverse event", "description": "Subjects will be asked about the occurrence of any adverse events during the intervention period.", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "5-level EQ-5D version (EQ-5D-5L)", "description": "The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated \\[38\\]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).", "time_frame": "4 weeks" }, { "type": "primary", "measure": "5-level EQ-5D version (EQ-5D-5L)", "description": "The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated \\[38\\]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)", "description": "The Chinese version of the Measure Yourself Medical Outcome Profile has been validated \\[39\\]. This questionnaire asks respondents to name one or two symptoms of greatest concern and the daily activities that are limited by these symptoms. Respondents rate these symptoms and activities, as well as their general health status, on a scale from 0 to 6 (0 is best, 6 is worst).", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)", "description": "The Chinese version of the Measure Yourself Medical Outcome Profile has been validated \\[39\\]. This questionnaire asks respondents to name one or two symptoms of greatest concern and the daily activities that are limited by these symptoms. Respondents rate these symptoms and activities, as well as their general health status, on a scale from 0 to 6 (0 is best, 6 is worst).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)", "description": "This improved version of the scale allows patients to self-assess the main symptoms of the COVID, the degree of functional limitation and overall health status. There are 17 items in total, including shortness of breath, cough/throat sensitivity/voice change, fatigue, changes in smell or taste, pain or discomfort, and cognition. problems, palpitations/dizziness, tiredness/exacerbation after work, anxiety/depression, sleep problems, communication, walking or moving, self-care, other daily activities, social roles), and other symptoms (such as fever, hair loss, dry eyes, tinnitus, nausea, etc.) and general health, etc. Each item is scored from 0 to 3 (0 is asymptomatic, 1 is mild and does not affect daily life, 2 is moderate and affects daily life to a certain extent, and 3 is severe or affects daily life comprehensively).", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)", "description": "This improved version of the scale allows patients to self-assess the main symptoms of the COVID, the degree of functional limitation and overall health status. There are 17 items in total, including shortness of breath, cough/throat sensitivity/voice change, fatigue, changes in smell or taste, pain or discomfort, and cognition. problems, palpitations/dizziness, tiredness/exacerbation after work, anxiety/depression, sleep problems, communication, walking or moving, self-care, other daily activities, social roles), and other symptoms (such as fever, hair loss, dry eyes, tinnitus, nausea, etc.) and general health, etc. Each item is scored from 0 to 3 (0 is asymptomatic, 1 is mild and does not affect daily life, 2 is moderate and affects daily life to a certain extent, and 3 is severe or affects daily life comprehensively).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Serum level change of inflammatory factors", "description": "Inflammatory markers including interferon (IFN-β), interferon (IFN-λ2/3), pentraxin 3 (PTX3) and interleukin 6 will be measured.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Safety assessment", "description": "In order to evaluate the safety of the traditional Chinese medicine treatment, the patient's complete blood count (CBC) and liver and kidney function indicators will be tested before starting the study treatment and after the treatment ends.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Adverse event", "description": "Subjects will be asked about the occurrence of any adverse events during the intervention period.", "time_frame": "4 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 162, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06095258", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05630339", "title": "Magnesium and Vitamin D Combination for Post-COVID Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-09-28", "start_date": "2022-01-30", "completion_date": "2023-09-01", "primary_completion_date": "2023-05-01", "conditions_raw": [ "Post-COVID-19 Syndrome", "Long COVID", "Vitamin D Deficiency", "Magnesium Deficiency" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Magnesium Chloride", "Vitamin D" ], "sponsor": "Coordinación de Investigación en Salud, Mexico", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "The goal of this double-blind randomized controlled clinical trial is to determine the efficacy of the administration of magnesium chloride + vitamin D as an adjuvant in the treatment of post-Coronavirus Disease (COVID) syndrome.\n\nThe participants will be integrated: a) Intervention group that will receive 1 g of magnesium chloride (equivalent to 300 mg of elemental magnesium) + 4000 IU of vitamin D once a day, for four months. b) Control group that will receive inert placebo for four months.\n\nThe outcome variable will be the improvement of the post-COVID syndrome. At the beginning and end of the study, blood samples will be taken to determine serum levels of vitamin D, total magnesium, ionic magnesium, calcium, fasting glucose and lipid profile.\n\nThe evaluation of the efficacy and safety of the proposed intervention will be carried out by establishing the differences between the intervention and control groups.", "primary_outcomes": [ { "type": "primary", "measure": "Change from Baseline Post-COVID syndrome symptoms at 4 months", "description": "The presence of two or more of the following signs and/or symptoms will be considered a suspicion of post-COVID syndrome: Fatigue, shortness of breath, cough, joint pain, chest pain, muscle pain, headache, tachycardia, arrhythmias, loss of smell, loss of taste, memory problems, concentration problems, depression, anxiety, insomnia, skin rashes, hair loss.", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Post-COVID Functional Status at 4 months", "description": "Post-COVID Functional Status Scale", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Serum vitamin D levels at 4 months", "description": "Recovery of serum vitamin D levels from deficiency (\\< 30 ng/mL) to normally (30 - 100 ng/mL).\n\nThe serum concentration of the 25 OH vitamin D fraction will be determined by the enzyme-linked immunosorbent assay (ELISA) method, the serum levels of magnesium and calcium by colorimetric techniques (A15 Clinical Analyzer, Biosystems, USA).", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Serum Magnesium levels at 4 months", "description": "Recovery of serum magnesium levels from deficiency (\\< 2.0 mg/dL) to normally (2.0 - 2.5 mg/dL).", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Mental State levels at 4 months", "description": "Mini Mental State Examination", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Anxiety Symptoms at 4 months", "description": "Beck Anxiety Inventory", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Depression Symptoms at 4 months", "description": "Beck Depression Inventory", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Post-traumatic Stress Symptoms at 4 months", "description": "Severity of Post-traumatic Stress Symptoms", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Dyspnea Symptoms at 4 months", "description": "modified Medical Research Council (mMRC) dyspnea scale", "time_frame": "First control date, and four months after treatment initiation." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from Baseline Fasting Blood Glucose levels at 4 months", "description": "Normal values: 70 - 100 mg/dL", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "secondary", "measure": "Change from Baseline Serum Lipid Profile at 4 months", "description": "Normal values: total cholesterol 100 - 200 mg/dL; HDL-cholesterol 40 - 60 mg/dL; triglycerides 50 - 150 mg/dL.", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "secondary", "measure": "Change from Baseline Serum Calcium levels at 4 months", "description": "Normal values: 8.4 - 10.2 mg/dL", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "secondary", "measure": "Change from Baseline Serum Creatinine levels at 4 months", "description": "Normal values: 0.5 - 1.2 mg/dL", "time_frame": "First control assessment, and four months after treatment initiation." } ], "outcome_measures": [ { "type": "primary", "measure": "Change from Baseline Post-COVID syndrome symptoms at 4 months", "description": "The presence of two or more of the following signs and/or symptoms will be considered a suspicion of post-COVID syndrome: Fatigue, shortness of breath, cough, joint pain, chest pain, muscle pain, headache, tachycardia, arrhythmias, loss of smell, loss of taste, memory problems, concentration problems, depression, anxiety, insomnia, skin rashes, hair loss.", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Post-COVID Functional Status at 4 months", "description": "Post-COVID Functional Status Scale", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Serum vitamin D levels at 4 months", "description": "Recovery of serum vitamin D levels from deficiency (\\< 30 ng/mL) to normally (30 - 100 ng/mL).\n\nThe serum concentration of the 25 OH vitamin D fraction will be determined by the enzyme-linked immunosorbent assay (ELISA) method, the serum levels of magnesium and calcium by colorimetric techniques (A15 Clinical Analyzer, Biosystems, USA).", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Serum Magnesium levels at 4 months", "description": "Recovery of serum magnesium levels from deficiency (\\< 2.0 mg/dL) to normally (2.0 - 2.5 mg/dL).", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Mental State levels at 4 months", "description": "Mini Mental State Examination", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Anxiety Symptoms at 4 months", "description": "Beck Anxiety Inventory", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Depression Symptoms at 4 months", "description": "Beck Depression Inventory", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Post-traumatic Stress Symptoms at 4 months", "description": "Severity of Post-traumatic Stress Symptoms", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "primary", "measure": "Change from Baseline Dyspnea Symptoms at 4 months", "description": "modified Medical Research Council (mMRC) dyspnea scale", "time_frame": "First control date, and four months after treatment initiation." }, { "type": "secondary", "measure": "Change from Baseline Fasting Blood Glucose levels at 4 months", "description": "Normal values: 70 - 100 mg/dL", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "secondary", "measure": "Change from Baseline Serum Lipid Profile at 4 months", "description": "Normal values: total cholesterol 100 - 200 mg/dL; HDL-cholesterol 40 - 60 mg/dL; triglycerides 50 - 150 mg/dL.", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "secondary", "measure": "Change from Baseline Serum Calcium levels at 4 months", "description": "Normal values: 8.4 - 10.2 mg/dL", "time_frame": "First control assessment, and four months after treatment initiation." }, { "type": "secondary", "measure": "Change from Baseline Serum Creatinine levels at 4 months", "description": "Normal values: 0.5 - 1.2 mg/dL", "time_frame": "First control assessment, and four months after treatment initiation." } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other Gov" ], "enrollment": 150, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05630339", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04880161", "title": "A Study to Evaluate Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2023-09-21", "start_date": "2021-07-26", "completion_date": "2022-02-21", "primary_completion_date": "2021-12-22", "conditions_raw": [ "Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ampion" ], "sponsor": "Ampio Pharmaceuticals. Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This is a phase I study to evaluate the safety and efficacy of inhaled Ampion on patients with prolonged respiratory symptoms due to COVID-19 (Long COVID).", "primary_outcomes": [ { "type": "primary", "measure": "The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo", "description": "Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of inhalation Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.", "time_frame": "Baseline to Day 28" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo", "description": "Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of inhalation Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.", "time_frame": "Baseline to Day 28" } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 32, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04880161", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06042777", "title": "Non-pharmacological and TCM-based Treatment for Long COVID Symptoms", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-09-21", "start_date": "2023-09-30", "completion_date": "2024-08-31", "primary_completion_date": "2024-05-31", "conditions_raw": [ "Long Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Acupuncture And Tcm-Based Lifestyle Management" ], "sponsor": "The Hong Kong Polytechnic University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Cognitive impairment is one of the commonly reported Long COVID symptoms, mainly in terms of memory, attention, and executive function. The cognitive symptoms of Long COVID are similar to \"brain fog\" or \"chemo brain\", manifested as low energy, disorientation, difficulties in attention and communication which are common conditions in cancer patients after chemotherapy. Given the negative impact of such cognitive impairment in daily living and working, it is important to develop effective treatment and self-management techniques to enhance cognitive functions in COVID-19 survivors. Acupuncture, acupressure, dantian breathing, and qigong are promising treatment and self-management techniques to remedy the cognitive impairment in people with Long COVID. Since acupressure, dantian breathing, and qigong are feasible for self-practice, they can be trained to promote a healthy lifestyle. The present study is a randomized controlled trial to evaluate the efficacy of acupuncture, lifestyle management (including dantian breathing, qigong, and acupressure), and acupuncture + lifestyle management to improve general cognitive function of people with Long COVID symptoms, compared with wait-list control. We will recruit 100 COVID-19 survivors who experience at least mild cognitive impairment and/or self-complaint of cognitive difficulty for at least 12 weeks after clinical recovery from COVID-19 infection. They will be randomly assigned to the following groups: (1) Acupuncture Group; (2) Lifestyle Management Group; (3) Acupuncture + Lifestyle Management Group; and (4) Waitlist Control Group. Acupuncture and lifestyle management will each take 8 weeks, with two 50-min sessions per week. Primary outcome is general cognitive function. Secondary outcomes cover fatigue, physical fitness, neurocognitive function, psychological distress, and health-related quality of life, pro-inflammatory cytokines (IL-6, TNF-α) and salivary cortisol. Assessment will be conducted at baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).", "primary_outcomes": [ { "type": "primary", "measure": "Global cognitive function", "description": "Overall status of cognitive function", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Global cognitive function", "description": "Overall status of cognitive function", "time_frame": "baseline and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Cardiopulmonary function", "description": "", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Fatigue", "description": "", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Health-related quality-of-life", "description": "", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Psychological distress", "description": "Depression, anxiety, and stress", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Neurocognitive functions", "description": "Attention, processing speed, working memory, and executive function", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Neurobiological outcomes", "description": "IL-6, TNF-α, and cortisol", "time_frame": "baseline and post-intervention (8 weeks after baseline)" } ], "outcome_measures": [ { "type": "primary", "measure": "Global cognitive function", "description": "Overall status of cognitive function", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline)" }, { "type": "secondary", "measure": "Global cognitive function", "description": "Overall status of cognitive function", "time_frame": "baseline and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Cardiopulmonary function", "description": "", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Fatigue", "description": "", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Health-related quality-of-life", "description": "", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Psychological distress", "description": "Depression, anxiety, and stress", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Neurocognitive functions", "description": "Attention, processing speed, working memory, and executive function", "time_frame": "baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline)." }, { "type": "secondary", "measure": "Neurobiological outcomes", "description": "IL-6, TNF-α, and cortisol", "time_frame": "baseline and post-intervention (8 weeks after baseline)" } ], "relevance_tags": [ "Metabolic", "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06042777", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05705154", "title": "Connecting Breath and Mind for CYP With Long COVID", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-09-08", "start_date": "2023-04-30", "completion_date": "2024-03-30", "primary_completion_date": "2024-03-30", "conditions_raw": [ "Post-COVID-19 Syndrome", "Anxiety", "Breathlessness" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Psychology Interventions" ], "sponsor": "Royal Brompton & Harefield NHS Foundation Trust", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Recruitment target: Phase I: Co-design of intervention: 5 to 15 CYP aged between 12-18 years of age referred to the pan-London long COVID MDT.\n\nPhase II: Randomised pilot: 40 patients (12-18 years) will be recruited from a potential pool of 214 patients referred to the pan-London long COVID MDT.\n\nMethods: Phase I: Co-design Design and setting The intervention will be co-designed with CYP following a process informed by practice-base evidence, which centres the voices and wisdom of CYP, focuses on creativity and playfulness, and systemic and narrative approaches. The process will involve: 1) Refining the intentions of key stakeholders (including ways of bringing psychological and physiological principles into the intervention); 2) Participation of CYP; 3) Creativity and playfulness and 4) Responding to feedback (see Salvo et al., 2022).\n\nPhase II. Pilot Population: 40 patients (12-18 years) will be recruited from a potential pool of 214 patients referred to the pan-London long COVID MDT. CYP will be randomised to receive either standard treatment or standard treatment plus intervention.\n\nStudy Treatment Standard treatment consists of virtual MDT discussion with referrer and advice signposting into local services for specific issues. They are sent leaflets and information. If a patient is severely affected enough to be seen face to face, they are offered an interdisciplinary consultation, and tailored input from therapies and psychological services.\n\nAccess to bite size videos and leaflets covering the following topics: sleep, pacing, activity management, school reintegration, managing friendships, eating well and emotional wellbeing. Young people are invited to a single virtual group Q\\&A session to bring any queries after watching the videos.\n\nThe leaflets and online sessions have been developed by professionals from the Evelina, Great Ormond Street Hospital, Imperial, University College London Hospital, and the Whittington. The bite size videos and live sessions are delivered by a clinical psychologist, a dietitian, specialist nurse, occupational therapist, and physiotherapist. More complex or severely affected patients will receive one to one treatment with members of the MDT as required.\n\nIntervention\n\nBased on clinical expertise and theory, it is anticipated the following elements may be included in the intervention.:\n\n* Progressive breathing pattern retraining, including education, self-observation, relaxation, body scanning, postural re-alignment\n* Identifying the connections between body and mind to address anxiety and breathlessness\n* Coping skills for managing anxiety using principles from narrative therapy and mindfulness\n* Online materials to improve self-efficacy with home practice\n* Social connection with other CYP for peer support, and resource sharing\n* Activities to help CYP reconnect with their usual activities, skills, abilities, interests, support systems", "primary_outcomes": [ { "type": "primary", "measure": "Impact score of Strength and Difficulties (SDQ) questionnaire", "description": "25 item questionnaire comprising of 5 scales of 5 items", "time_frame": "Through study completion, an average of 24 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Revised Childhood Anxiety and Depression Scale (RCADS) questionnaire", "description": "The revised Child Anxiety and Depression Scale is a 47 item youth self reported questionnaire with subscales", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "EQ-5D-Y", "description": "The EQ-5D-Y descriptive system comprises of the five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried/ sad/ unhappy", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "SF-36 Quality of Life", "description": "36 item health survey - self reported quality of life measure", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "11 item Chandler Fatigue Questionnaire", "description": "11 item questionnaire is divided into two components, one that measures physical fatigue and on that measures mental fatigue", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "Visual Analogue Scale (VAS) Pain scale", "description": "0-10 visual analogue scale of self reported pain", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "FitBit Activity monitoring", "description": "Daily step count, daily distance travelled, daily stairs climbed, sedentary minutes, low, moderate and vigorous activity minutes, sleep hours and wear time", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "Physiotherapy assessment of dysfunctional breathing", "description": "Multi-dimensional physiotherapy assessment of breathing pattern", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "Qualitative feedback", "description": "concurrent and retrospective feedback on the standard and new intervention", "time_frame": "Through study completion, an average of 24 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Impact score of Strength and Difficulties (SDQ) questionnaire", "description": "25 item questionnaire comprising of 5 scales of 5 items", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "Revised Childhood Anxiety and Depression Scale (RCADS) questionnaire", "description": "The revised Child Anxiety and Depression Scale is a 47 item youth self reported questionnaire with subscales", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "EQ-5D-Y", "description": "The EQ-5D-Y descriptive system comprises of the five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried/ sad/ unhappy", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "SF-36 Quality of Life", "description": "36 item health survey - self reported quality of life measure", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "11 item Chandler Fatigue Questionnaire", "description": "11 item questionnaire is divided into two components, one that measures physical fatigue and on that measures mental fatigue", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "Visual Analogue Scale (VAS) Pain scale", "description": "0-10 visual analogue scale of self reported pain", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "FitBit Activity monitoring", "description": "Daily step count, daily distance travelled, daily stairs climbed, sedentary minutes, low, moderate and vigorous activity minutes, sleep hours and wear time", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "Physiotherapy assessment of dysfunctional breathing", "description": "Multi-dimensional physiotherapy assessment of breathing pattern", "time_frame": "Through study completion, an average of 24 weeks" }, { "type": "secondary", "measure": "Qualitative feedback", "description": "concurrent and retrospective feedback on the standard and new intervention", "time_frame": "Through study completion, an average of 24 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05705154", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05961462", "title": "Effects of Exercise Training on Patients With Long COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-09-06", "start_date": "2023-01-10", "completion_date": "2023-08-30", "primary_completion_date": "2023-07-30", "conditions_raw": [ "Long COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Exercise Training" ], "sponsor": "Guangdong Provincial People's Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Effects of Exercise training on Patients With Long COVID-19, is a single-center, randomized, controlled trial designed to evaluate the effects of 4- week aerobic exercise administered to patients with long COVID-19 symptoms. The main outcome is cardiopulmonary fitness and long COVID-19 symptom improvement. Quality of life, depression, anxiety, insomnia status and perceived stress will also be assessed before and after the exercise program.", "primary_outcomes": [ { "type": "primary", "measure": "Symptom improvement", "description": "Improvement or Recovery of Long-term COVID-19 Symptoms", "time_frame": "Week 4" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Peak oxygen uptake", "description": "The cardiopulmonary fitness assessed by Cardiopulmonary Exercise Test", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Quality of life measured by 12-Item Short Form Health Survey (SF12)", "description": "Using 12-Item Short Form Health Survey to evaluate quality of life.", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Anxiety measured by Generalized Anxiety Disorder 7-item scale (GAD-7)", "description": "Using Generalized Anxiety Disorder 7-item scale to evaluate anxiety status.", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Depression measured by Patient Health Questionnaire 9-item scale (PHQ-9)", "description": "Using Patient Health Questionnaire 9-item scale to evaluate depression status.", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Insomnia measured by Insomnia Severity Index (ISI)", "description": "Using Insomnia Severity Index to evaluate insomnia status.", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Perceived stress measured by Perceived Stress Scale (PSS)", "description": "Using Perceived Stress Scale to evaluate stress level.", "time_frame": "Week 4" } ], "outcome_measures": [ { "type": "primary", "measure": "Symptom improvement", "description": "Improvement or Recovery of Long-term COVID-19 Symptoms", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Peak oxygen uptake", "description": "The cardiopulmonary fitness assessed by Cardiopulmonary Exercise Test", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Quality of life measured by 12-Item Short Form Health Survey (SF12)", "description": "Using 12-Item Short Form Health Survey to evaluate quality of life.", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Anxiety measured by Generalized Anxiety Disorder 7-item scale (GAD-7)", "description": "Using Generalized Anxiety Disorder 7-item scale to evaluate anxiety status.", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Depression measured by Patient Health Questionnaire 9-item scale (PHQ-9)", "description": "Using Patient Health Questionnaire 9-item scale to evaluate depression status.", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Insomnia measured by Insomnia Severity Index (ISI)", "description": "Using Insomnia Severity Index to evaluate insomnia status.", "time_frame": "Week 4" }, { "type": "secondary", "measure": "Perceived stress measured by Perceived Stress Scale (PSS)", "description": "Using Perceived Stress Scale to evaluate stress level.", "time_frame": "Week 4" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 24, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05961462", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05040893", "title": "A Pilot Study of a PhysiOthErapy-based Tailored Intervention for Long COVID (COVID-19)", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-08-29", "start_date": "2022-03-04", "completion_date": "2023-11-30", "primary_completion_date": "2023-08-09", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Physiotherapy" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to determine the benefits and feasibility of physiotherapy in the recovery of ongoing symptoms after COVID-19 illness. Long COVID Syndrome (Long COVID) is defined by persistent symptoms (including breathlessness, chest pain and fatigue) after COVID-19 illness that continue for more than 12 weeks and cannot be explained by another diagnosis. The goal of this project is to explore physiotherapy as treatment for patients suffering from Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Feasibility (patient recruitment and retention rate)", "description": "Feasibility will be determined by recruitment of 12 participants within 3 months, retention of \\>70% of participants and mean completion of \\>70% of all supervised physiotherapy sessions.", "time_frame": "120 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Quality of life (QOL)", "description": "The EuroQol-visual analogue scale (EQ-VAS) will be used to measure QOL. The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine and 'The worst health you can imagine. The EQ-VAS is the main patient-reported outcome of interest and has an MCID of 8. In addition, the EQ-5D-5L ( 5-level EuroQol-5D)will be used to measure QOL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents select the level which most closely matches their health state (no problems, slight problems, moderate problems, severe problems or extreme problems). The choices made within each domain relate to a 1-digit number. Combining these digits results in a 5-digit number, which will be converted into a utility weight.", "time_frame": "120 days" }, { "type": "secondary", "measure": "Self-reported functional status", "description": "The Post-COVID Functional Scale (PCFS) will be used to measure participant self-reported functional impairment. It covers the full spectrum of functional outcomes, and focuses on limitations in usual activities in five scale grades (0 - 4). Grade 0 reflects the absence of any functional limitation, and upward of grade 1, symptoms, pain or anxiety are present to an increasing degree. Grade 4 reflects severe functional limitations.", "time_frame": "120 days" }, { "type": "secondary", "measure": "Self-efficacy for symptom management", "description": "The PROMIS Self-efficacy for Managing Chronic Conditions item bank will be used to measure self-efficacy to manage symptoms and self-efficacy to manage daily activities in both cases, the 4-item short forms). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with higher scores indicating greater severity of depression.", "time_frame": "120 days" }, { "type": "secondary", "measure": "Six-minute walk test", "description": "The distance a patient can walk during six minutes.", "time_frame": "120 days" }, { "type": "secondary", "measure": "One-minute sit-to-stand test", "description": "The participant will be asked to fully stand and sit back without using their arms and to perform as many repetitions as they safely can within one minute.", "time_frame": "120 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Feasibility (patient recruitment and retention rate)", "description": "Feasibility will be determined by recruitment of 12 participants within 3 months, retention of \\>70% of participants and mean completion of \\>70% of all supervised physiotherapy sessions.", "time_frame": "120 days" }, { "type": "secondary", "measure": "Quality of life (QOL)", "description": "The EuroQol-visual analogue scale (EQ-VAS) will be used to measure QOL. The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine and 'The worst health you can imagine. The EQ-VAS is the main patient-reported outcome of interest and has an MCID of 8. In addition, the EQ-5D-5L ( 5-level EuroQol-5D)will be used to measure QOL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents select the level which most closely matches their health state (no problems, slight problems, moderate problems, severe problems or extreme problems). The choices made within each domain relate to a 1-digit number. Combining these digits results in a 5-digit number, which will be converted into a utility weight.", "time_frame": "120 days" }, { "type": "secondary", "measure": "Self-reported functional status", "description": "The Post-COVID Functional Scale (PCFS) will be used to measure participant self-reported functional impairment. It covers the full spectrum of functional outcomes, and focuses on limitations in usual activities in five scale grades (0 - 4). Grade 0 reflects the absence of any functional limitation, and upward of grade 1, symptoms, pain or anxiety are present to an increasing degree. Grade 4 reflects severe functional limitations.", "time_frame": "120 days" }, { "type": "secondary", "measure": "Self-efficacy for symptom management", "description": "The PROMIS Self-efficacy for Managing Chronic Conditions item bank will be used to measure self-efficacy to manage symptoms and self-efficacy to manage daily activities in both cases, the 4-item short forms). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with higher scores indicating greater severity of depression.", "time_frame": "120 days" }, { "type": "secondary", "measure": "Six-minute walk test", "description": "The distance a patient can walk during six minutes.", "time_frame": "120 days" }, { "type": "secondary", "measure": "One-minute sit-to-stand test", "description": "The participant will be asked to fully stand and sit back without using their arms and to perform as many repetitions as they safely can within one minute.", "time_frame": "120 days" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 15, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05040893", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05543590", "title": "Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2023-08-14", "start_date": "2023-02", "completion_date": "2025-10", "primary_completion_date": "2025-02", "conditions_raw": [ "Long-Haul COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Plasmapheresis", "Blood Collection", "Stool Samples", "Pet Scan", "Cycle Ergometer Stress Test", "Medical Consultations" ], "sponsor": "Hôpital Européen Marseille", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Many patients infected with SARS-Cov-2 present in the months following infection with non-specific symptoms such as non-resolving fatigue, cognitive disorders, dyspnea, headaches, myalgias, sleep disorders, anosmia/ ageusia and post exertion malaise. The persistence of these symptoms is called \"post covid syndrome\" or \"long Covid\".\n\nAccording to the literature, the pathophysiological mechanisms involved in post-covid syndromes would include an inadequate immune response, activation of autoimmunity, persistence of pro-inflammatory biomarkers, endothelial dysfunction and alterations in the intestinal microbiota.\n\nIn view of the involved pathophysiological mechanisms, linked to the circulation of pro-inflammatory molecules, autoimmunity or endothelial activation, the role of immuno-modulation in the treatment of long Covid need to be evaluated.\n\nPlasma exchange (PE) by decreasing blood levels of pro-inflammatory cytokines and/or autoimmune markers results in moderate to marked clinical improvement in various types of autoantibody-associated inflammatory, autoimmune and neurological diseases.\n\nThe goal of our study is to evaluate the effects of plasmapheresis in patients with moderate to severe long-term COVID compared to patients receiving no treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline", "description": "", "time_frame": "3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Observation of the evolution of the fatigue (Chalder scale) felt by the patients during the 6 months of the study in the two groups of patients", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Evaluation of the quality of life (SF-36) of patients at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Evaluation of the overall impression of change of patients at month 3 and month 6 (PGIC scale)", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Evolution at month 3 and month 6 of the following clinical signs: post-exertional malaise, dyspnea, headache, myalgia, neuropathic pain, cognitive impairment, anosmia/ageusia, anxiety/depression", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Assessment of patients' functional status at month 3 and month 6 (Post-COVID-19 functional status scale)", "description": "", "time_frame": "3 months 6 months" }, { "type": "secondary", "measure": "Evaluation of the professional or student activity at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Percentage of patients with 25% improvement in neuromuscular activity of M wave abnormalities at month 6 compared to baseline", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Percentage of patients with improved brain and/or spinal cord metabolism at month 6 compared to baseline", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Evolution of cytokine profiles and lymphocyte activation markers at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Rate and evolution of autoimmune markers at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Level and evolution of endothelial activity markers at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Evaluation of the microbiotic signature at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "Observation of the evolution of the fatigue (Chalder scale) felt by the patients during the 6 months of the study in the two groups of patients", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Evaluation of the quality of life (SF-36) of patients at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Evaluation of the overall impression of change of patients at month 3 and month 6 (PGIC scale)", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Evolution at month 3 and month 6 of the following clinical signs: post-exertional malaise, dyspnea, headache, myalgia, neuropathic pain, cognitive impairment, anosmia/ageusia, anxiety/depression", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Assessment of patients' functional status at month 3 and month 6 (Post-COVID-19 functional status scale)", "description": "", "time_frame": "3 months 6 months" }, { "type": "secondary", "measure": "Evaluation of the professional or student activity at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Percentage of patients with 25% improvement in neuromuscular activity of M wave abnormalities at month 6 compared to baseline", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Percentage of patients with improved brain and/or spinal cord metabolism at month 6 compared to baseline", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Evolution of cytokine profiles and lymphocyte activation markers at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Rate and evolution of autoimmune markers at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Level and evolution of endothelial activity markers at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" }, { "type": "secondary", "measure": "Evaluation of the microbiotic signature at month 3 and month 6", "description": "", "time_frame": "3 months and 6 months" } ], "relevance_tags": [ "Immunomodulatory", "Persistence / Antiviral", "Neurological / Autonomic", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT05543590", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05752331", "title": "Feasibility of Personalised Health Behaviour Coaching to Support Symptoms and Activities of Daily Living in Those With Long COVID-19.", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-08-04", "start_date": "2022-11-01", "completion_date": "2023-06-15", "primary_completion_date": "2023-05-31", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Physical Activity Behavioural Modification" ], "sponsor": "Bournemouth University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This pilot RCT aims to assess whether a simple PA behavioural modification intervention can be delivered safely and feasibly to individuals with Long COVID suffering long standing symptoms with concerns regarding their ability to perform activities of daily living.\n\nParticipants will be randomised to receive an 8-week physical activity behavioural modification intervention alongside usual care or usual care alone. The primary outcome for this study is to assess the safety and feasibility of the intervention, including recruitment targets, randomisation, completion rates and acceptability to the study.", "primary_outcomes": [ { "type": "primary", "measure": "Participant recruitment", "description": "At least 40% of eligible participants recruited to the study", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Participant randomisation", "description": "At least 80% of participants randomised following informed consent", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Participant completion", "description": "At least 80% of randomised participants completing the intervention period and post assessment visit", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Participant acceptability", "description": "Assessed through a project tailored questionnaire on completing of the study", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Objective physical activity", "description": "Accelerometer steps/day, Movement intensity \\& time spend in domains of activity.", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Exercise capacity", "description": "Incremental shuttle walk test", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Muscular strength and endurance", "description": "30-second sit to stand test and hand grip dynamometry", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Lung Function", "description": "Spirometry measures of FEV1 and FVC", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Health related quality of life", "description": "EQ-5D-5L", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Breathlessness", "description": "COPD Assessment Test (CAT) and MRC dyspnea scale", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Fatigue", "description": "Chalder fatigue scale", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Anxiety and Depression", "description": "Hospital anxiety and depression scale", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Cognitive impairment", "description": "MoCA", "time_frame": "8-weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Participant recruitment", "description": "At least 40% of eligible participants recruited to the study", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Participant randomisation", "description": "At least 80% of participants randomised following informed consent", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Participant completion", "description": "At least 80% of randomised participants completing the intervention period and post assessment visit", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Participant acceptability", "description": "Assessed through a project tailored questionnaire on completing of the study", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Objective physical activity", "description": "Accelerometer steps/day, Movement intensity \\& time spend in domains of activity.", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Exercise capacity", "description": "Incremental shuttle walk test", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Muscular strength and endurance", "description": "30-second sit to stand test and hand grip dynamometry", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Lung Function", "description": "Spirometry measures of FEV1 and FVC", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Health related quality of life", "description": "EQ-5D-5L", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Breathlessness", "description": "COPD Assessment Test (CAT) and MRC dyspnea scale", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Fatigue", "description": "Chalder fatigue scale", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Anxiety and Depression", "description": "Hospital anxiety and depression scale", "time_frame": "8-weeks" }, { "type": "secondary", "measure": "Cognitive impairment", "description": "MoCA", "time_frame": "8-weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 32, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05752331", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05975034", "title": "Investigation of the Use of a Probiotic Supplement in People With Long COVID", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-08-03", "start_date": "2023-06-12", "completion_date": "2023-12-11", "primary_completion_date": "2023-12-11", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Probiotic" ], "sponsor": "Sheffield Hallam University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue severity scale (FSS)", "description": "9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle", "time_frame": "12 weeks" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Measure that assesses self-reported fatigue and its impact upon daily activities and function", "time_frame": "12 weeks" }, { "type": "primary", "measure": "EQ-5D-5L", "description": "Multi-attribute generic health status measure", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a", "description": "Evaluation of ability to participate in social roles and activities", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Ecological Momentary Assessment (EMA) app", "description": "Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "IBS-SSS", "description": "Composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Gastrointestinal Symptom Rating Scale", "description": "15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "MRC Dyspnoea scale", "description": "Assesses the degree of functional disability due to dyspnoea", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "International. Physical Activity Questionnaire (short form)", "description": "Assesses moderate-to-vigorous physical activity and sedentary behaviour", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Accelerometery data", "description": "Longitudinal measurement of movement", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Cambridge Neuropsychological Test Automated Battery (CANTAB)", "description": "Computer-based cognitive assessment system", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "16S rRNA sequencing", "description": "Analysis of the composition and diversity of the gut microbiome", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Analysis of inflammatory markers", "description": "Measurement of cytokines (including IL-8, IL-6) by ELISA", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue severity scale (FSS)", "description": "9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle", "time_frame": "12 weeks" }, { "type": "primary", "measure": "FACIT fatigue scale", "description": "Measure that assesses self-reported fatigue and its impact upon daily activities and function", "time_frame": "12 weeks" }, { "type": "primary", "measure": "EQ-5D-5L", "description": "Multi-attribute generic health status measure", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a", "description": "Evaluation of ability to participate in social roles and activities", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Ecological Momentary Assessment (EMA) app", "description": "Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "IBS-SSS", "description": "Composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Gastrointestinal Symptom Rating Scale", "description": "15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "MRC Dyspnoea scale", "description": "Assesses the degree of functional disability due to dyspnoea", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "International. Physical Activity Questionnaire (short form)", "description": "Assesses moderate-to-vigorous physical activity and sedentary behaviour", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Accelerometery data", "description": "Longitudinal measurement of movement", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Cambridge Neuropsychological Test Automated Battery (CANTAB)", "description": "Computer-based cognitive assessment system", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "16S rRNA sequencing", "description": "Analysis of the composition and diversity of the gut microbiome", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Analysis of inflammatory markers", "description": "Measurement of cytokines (including IL-8, IL-6) by ELISA", "time_frame": "12 weeks" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 240, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05975034", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05973136", "title": "Telerehabilitation for Post COVID-19 Condition", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-08-02", "start_date": "2022-04-01", "completion_date": "2022-08-08", "primary_completion_date": "2022-08-08", "conditions_raw": [ "Long COVID", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Telerehabilitation Program Based On Cardiorespiratory Principles" ], "sponsor": "Université de Sherbrooke", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of patients with COVID-19 report persistent symptoms up to 8 months after the infection. There are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate the acceptability and the potential impact of the program on treating patients with functional limitations and persistent fatigue symptoms. It's a pre and post-study without a control group.", "primary_outcomes": [ { "type": "primary", "measure": "The feasibility of the program", "description": "This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % who completed the intervention (retention rate) and % completed session/anticipated session (adherence).\n\nThe security of the program will be evaluated by the number of falls or near fall.\n\nTechnical difficulty", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Acceptability", "description": "The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Fatigue and post-exercise malaise", "description": "This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Heart rate variability (resting)", "description": "Measured with the POLAR H10", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Functional capacity", "description": "Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Exercise capacity", "description": "6-minute walk test", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Lower-limb endurance (estimated)", "description": "1-minute sit-to-stand test", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "The feasibility of the program", "description": "This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % who completed the intervention (retention rate) and % completed session/anticipated session (adherence).\n\nThe security of the program will be evaluated by the number of falls or near fall.\n\nTechnical difficulty", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Acceptability", "description": "The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Fatigue and post-exercise malaise", "description": "This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Heart rate variability (resting)", "description": "Measured with the POLAR H10", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Functional capacity", "description": "Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Exercise capacity", "description": "6-minute walk test", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Lower-limb endurance (estimated)", "description": "1-minute sit-to-stand test", "time_frame": "12 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 7, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05973136", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05631171", "title": "Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-07-20", "start_date": "2022-12-13", "completion_date": "2023-06-30", "primary_completion_date": "2023-06-30", "conditions_raw": [ "Post-Acute COVID19 Syndrome", "Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Adhera® Fatigue Digital Program" ], "sponsor": "Adhera Health, Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Adhera® Fatigue Digital Program (or AFDP) is a digital health program based on behavioral and emotional change techniques that provides personalized physical and emotional self-management support for patients with long COVID-related fatigue.\n\nThe digital health solution is designed to be used for 3 months, and includes a mobile application and a smartwatch. This is a clinical study, with 30 participants in the experimental intervention group and 30 in the control group, that will be carried out at the Jordi Gol Primary Care Research Institute (IDIAPJGol) - Institut Català de la Salut and Distrito sanitario Aljarafe-Sevilla Norte (DASN) - Servicio Andaluz de Salud, in Spain. The investigators will focus on evaluating the feasibility of the program in supporting fatigue and also physical and emotional self-management and, consequently, in improving the patients' well-being and quality of life.", "primary_outcomes": [ { "type": "primary", "measure": "Health-related quality of life", "description": "measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.", "time_frame": "baseline" }, { "type": "primary", "measure": "Health-related quality of life", "description": "measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.", "time_frame": "month 1" }, { "type": "primary", "measure": "Health-related quality of life", "description": "measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.", "time_frame": "month 3" }, { "type": "primary", "measure": "Fatigue", "description": "Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.", "time_frame": "baseline" }, { "type": "primary", "measure": "Fatigue", "description": "Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.", "time_frame": "month 1" }, { "type": "primary", "measure": "Fatigue", "description": "Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.", "time_frame": "month 3" }, { "type": "primary", "measure": "Emotional wellness", "description": "measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.", "time_frame": "baseline" }, { "type": "primary", "measure": "Emotional wellness", "description": "measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.", "time_frame": "month 1" }, { "type": "primary", "measure": "Emotional wellness", "description": "measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.", "time_frame": "month 3" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Behavioral outcome: Usability", "description": "Digital health solution usability and acceptance assessed with the System Usability Scale (SUS) questionnaire from Bangor et al., 2008. SUS can range between score 0 and 100, with higher values representing higher usability.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Behavioral outcome: Usability", "description": "Digital health solution usability and acceptance assessed with the System Usability Scale (SUS) questionnaire from Bangor et al., 2008. SUS can range between score 0 and 100, with higher values representing higher usability.", "time_frame": "month 3" }, { "type": "secondary", "measure": "Fatigue-related symptomatology", "description": "questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Fatigue-related symptomatology", "description": "questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.", "time_frame": "month 3" }, { "type": "secondary", "measure": "Mood", "description": "measured using the Positive and Negative Affect Schedule (PANAS) from Watson et al., 1988. Positive Affect Score can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score can range from 10 - 50, with lower scores representing lower levels of negative affect.", "time_frame": "baseline" }, { "type": "secondary", "measure": "Mood", "description": "measured using the Positive and Negative Affect Schedule (PANAS) from Watson et al., 1988. Positive Affect Score can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score can range from 10 - 50, with lower scores representing lower levels of negative affect.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Mood", "description": "measured using the Positive and Negative Affect Schedule (PANAS) from Watson et al., 1988. Positive Affect Score can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score can range from 10 - 50, with lower scores representing lower levels of negative affect.", "time_frame": "month 3" }, { "type": "secondary", "measure": "Social, psychological and emotional wellness", "description": "Mental Health Continuum Short Form (MHC-SF) from Keyes et al., 2008. Items are summed, yielding a total score ranging from 0 to 70. Subscale scores range from 0 to 15 for the emotional (hedonic) well-being, from 0 to 25 for social well-being, and from 0 to 30 for psychological well-being. Flourishing mental health is defined by reporting ≥ 1 of 3 hedonic signs and ≥ 6 of 11 eudaimonic signs (social and psychological subscales combined) experienced \"every day\" or \"5-6 times a week.\" Higher scores indicate greater levels of positive well-being.", "time_frame": "baseline" }, { "type": "secondary", "measure": "Social, psychological and emotional wellness", "description": "Mental Health Continuum Short Form (MHC-SF) from Keyes et al., 2008. Items are summed, yielding a total score ranging from 0 to 70. Subscale scores range from 0 to 15 for the emotional (hedonic) well-being, from 0 to 25 for social well-being, and from 0 to 30 for psychological well-being. Flourishing mental health is defined by reporting ≥ 1 of 3 hedonic signs and ≥ 6 of 11 eudaimonic signs (social and psychological subscales combined) experienced \"every day\" or \"5-6 times a week.\" Higher scores indicate greater levels of positive well-being.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Social, psychological and emotional wellness", "description": "Mental Health Continuum Short Form (MHC-SF) from Keyes et al., 2008. Items are summed, yielding a total score ranging from 0 to 70. Subscale scores range from 0 to 15 for the emotional (hedonic) well-being, from 0 to 25 for social well-being, and from 0 to 30 for psychological well-being. Flourishing mental health is defined by reporting ≥ 1 of 3 hedonic signs and ≥ 6 of 11 eudaimonic signs (social and psychological subscales combined) experienced \"every day\" or \"5-6 times a week.\" Higher scores indicate greater levels of positive well-being.", "time_frame": "month 3" }, { "type": "secondary", "measure": "Self-efficacy", "description": "Self-Efficacy Scale (GSE) from Schwartzer \\& Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.", "time_frame": "baseline" }, { "type": "secondary", "measure": "Self-efficacy", "description": "Self-Efficacy Scale (GSE) from Schwartzer \\& Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Self-efficacy", "description": "Self-Efficacy Scale (GSE) from Schwartzer \\& Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.", "time_frame": "month 3" } ], "outcome_measures": [ { "type": "primary", "measure": "Health-related quality of life", "description": "measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.", "time_frame": "baseline" }, { "type": "primary", "measure": "Health-related quality of life", "description": "measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.", "time_frame": "month 1" }, { "type": "primary", "measure": "Health-related quality of life", "description": "measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.", "time_frame": "month 3" }, { "type": "primary", "measure": "Fatigue", "description": "Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.", "time_frame": "baseline" }, { "type": "primary", "measure": "Fatigue", "description": "Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.", "time_frame": "month 1" }, { "type": "primary", "measure": "Fatigue", "description": "Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.", "time_frame": "month 3" }, { "type": "primary", "measure": "Emotional wellness", "description": "measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.", "time_frame": "baseline" }, { "type": "primary", "measure": "Emotional wellness", "description": "measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.", "time_frame": "month 1" }, { "type": "primary", "measure": "Emotional wellness", "description": "measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.", "time_frame": "month 3" }, { "type": "secondary", "measure": "Behavioral outcome: Usability", "description": "Digital health solution usability and acceptance assessed with the System Usability Scale (SUS) questionnaire from Bangor et al., 2008. SUS can range between score 0 and 100, with higher values representing higher usability.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Behavioral outcome: Usability", "description": "Digital health solution usability and acceptance assessed with the System Usability Scale (SUS) questionnaire from Bangor et al., 2008. SUS can range between score 0 and 100, with higher values representing higher usability.", "time_frame": "month 3" }, { "type": "secondary", "measure": "Fatigue-related symptomatology", "description": "questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Fatigue-related symptomatology", "description": "questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.", "time_frame": "month 3" }, { "type": "secondary", "measure": "Mood", "description": "measured using the Positive and Negative Affect Schedule (PANAS) from Watson et al., 1988. Positive Affect Score can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score can range from 10 - 50, with lower scores representing lower levels of negative affect.", "time_frame": "baseline" }, { "type": "secondary", "measure": "Mood", "description": "measured using the Positive and Negative Affect Schedule (PANAS) from Watson et al., 1988. Positive Affect Score can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score can range from 10 - 50, with lower scores representing lower levels of negative affect.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Mood", "description": "measured using the Positive and Negative Affect Schedule (PANAS) from Watson et al., 1988. Positive Affect Score can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score can range from 10 - 50, with lower scores representing lower levels of negative affect.", "time_frame": "month 3" }, { "type": "secondary", "measure": "Social, psychological and emotional wellness", "description": "Mental Health Continuum Short Form (MHC-SF) from Keyes et al., 2008. Items are summed, yielding a total score ranging from 0 to 70. Subscale scores range from 0 to 15 for the emotional (hedonic) well-being, from 0 to 25 for social well-being, and from 0 to 30 for psychological well-being. Flourishing mental health is defined by reporting ≥ 1 of 3 hedonic signs and ≥ 6 of 11 eudaimonic signs (social and psychological subscales combined) experienced \"every day\" or \"5-6 times a week.\" Higher scores indicate greater levels of positive well-being.", "time_frame": "baseline" }, { "type": "secondary", "measure": "Social, psychological and emotional wellness", "description": "Mental Health Continuum Short Form (MHC-SF) from Keyes et al., 2008. Items are summed, yielding a total score ranging from 0 to 70. Subscale scores range from 0 to 15 for the emotional (hedonic) well-being, from 0 to 25 for social well-being, and from 0 to 30 for psychological well-being. Flourishing mental health is defined by reporting ≥ 1 of 3 hedonic signs and ≥ 6 of 11 eudaimonic signs (social and psychological subscales combined) experienced \"every day\" or \"5-6 times a week.\" Higher scores indicate greater levels of positive well-being.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Social, psychological and emotional wellness", "description": "Mental Health Continuum Short Form (MHC-SF) from Keyes et al., 2008. Items are summed, yielding a total score ranging from 0 to 70. Subscale scores range from 0 to 15 for the emotional (hedonic) well-being, from 0 to 25 for social well-being, and from 0 to 30 for psychological well-being. Flourishing mental health is defined by reporting ≥ 1 of 3 hedonic signs and ≥ 6 of 11 eudaimonic signs (social and psychological subscales combined) experienced \"every day\" or \"5-6 times a week.\" Higher scores indicate greater levels of positive well-being.", "time_frame": "month 3" }, { "type": "secondary", "measure": "Self-efficacy", "description": "Self-Efficacy Scale (GSE) from Schwartzer \\& Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.", "time_frame": "baseline" }, { "type": "secondary", "measure": "Self-efficacy", "description": "Self-Efficacy Scale (GSE) from Schwartzer \\& Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.", "time_frame": "month 1" }, { "type": "secondary", "measure": "Self-efficacy", "description": "Self-Efficacy Scale (GSE) from Schwartzer \\& Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.", "time_frame": "month 3" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 58, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05631171", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05951803", "title": "Effectiveness of a Psychological Intervention on Mental Health and Sleep.", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-07-19", "start_date": "2023-06-23", "completion_date": "2024-02-01", "primary_completion_date": "2023-12-20", "conditions_raw": [ "Insomnia Chronic", "Anxiety", "Depression", "Sleep Quality", "Life Quality" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Brief Behavioral Intervention In Insomnia" ], "sponsor": "Hospital General de Mexico", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "Background: The COVID-19 pandemic represented a global public health problem that brought considerable consequences to the physical and mental health of the entire population. Objective: To compare the effectiveness of the brief behavioral intervention for insomnia by teleconsultation (BBII-TC) with the brief behavioral intervention for face-to-face insomnia (BBII) on symptoms of insomnia, anxiety, depression, quality of sleep and life in a sample. of patients with long COVID. Methodology: Randomized controlled trial of equivalence with two groups in parallel (1:1) with repeated measures in pretreatment, posttreatment and follow-up at 3 months. The sample will be composed of male or female participants, in an age range of 18 to 40 years. The sample size was calculated, obtaining a total of 52 participants, the expected effect size is .40, with a significance of 0.05 and a probability error of 80%. Participants in the two groups will be assessed with the following instruments: Sleep Diary, Patient Health Questionnaire 9, Pittsburgh Sleep Quality Index , Insomnia Severity Index, SF-36 Health Survey and Generalized Anxiety Disorder 7; at the beginning and end of treatment; and in a follow-up at 3 months. TData analysis: The Kolmogrov-Smirnov test will be carried out to determine the normality of the data, in case the distribution is parametric, an ANOVA of repeated measures will be carried out for the comparison of data between the pre, post and monitoring for each of the groups; in the event that the data does not have a normal distribution, the Friedman test will be performed for the comparison of repeated measures. Finally, to avoid bias in the data analysis, an external investigator will be asked to perform the randomization and data processing.", "primary_outcomes": [ { "type": "primary", "measure": "Sleep diary", "description": "Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "Patient Health Questionnaire 9 (PHQ-9)", "description": "Self-applied questionnaire that assesses the presence and severity of depressive symptoms. It is made up of 9 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range of 0 to 27. These scores are interpreted from 0 to 5 (mild), 6 to 10 (moderate), 11 to 15 (moderately severe) and 16 to 27. (severe). Within its psychometric properties, the original version has a high internal consistency with a Cronbach's alpha of 0.86, while the Mexican version was 0.89.", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "Self-administered questionnaire that assesses sleep quality. It is made up of 24 reagents; the total score has a range of 0 to 21 points; where a total score less than 5 points indicates good sleep quality and a score greater than 5 points is interpreted as poor sleep quality. In the Mexican population, he obtained a Cronbach's Alpha of 0.78.", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "Insomnia Severity Index (ISI)", "description": "Self-administered questionnaire of 8 items on a Likert scale from 0 (none) to 4 (Very severe), which assesses nighttime symptoms, sleep quality, and daytime symptoms of insomnia; it has a reliability of 0.82 in its original version; and it has similar psychometric indicators in a version validated in Spanish. In its version for the Mexican population, it obtained a 0.84 reliability coefficient.", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "SF-36 Health Survey", "description": "It is a self-applicable instrument that evaluates the quality of life of people, it is divided into 8 dimensions associated with health such as: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. Each of these dimensions is evaluated in a different way, being a Likert scale between 4 and 5 response options and dichotomous (yes/no) in others. Within the Mexican version, the psychometric properties showed a high internal consistency with a Cronbach's alpha of 0.93.", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "Generalized Anxiety Disorder 7 (GAD-7)", "description": "Self-administered questionnaire that assesses the presence and severity of generalized anxiety symptoms. It is made up of 7 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range from 0 to 21. It is interpreted that a score greater than 10 is considered as generalized anxiety. Within its psychometric properties, the version translated into Spanish has a high internal consistency with a Cronbach's alpha of 0.8.", "time_frame": "1 week after starting treatment." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Sleep diary", "description": "Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Patient Health Questionnaire 9 (PHQ-9)", "description": "Self-applied questionnaire that assesses the presence and severity of depressive symptoms. It is made up of 9 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range of 0 to 27. These scores are interpreted from 0 to 5 (mild), 6 to 10 (moderate), 11 to 15 (moderately severe) and 16 to 27. (severe). Within its psychometric properties, the original version has a high internal consistency with a Cronbach's alpha of 0.86, while the Mexican version was 0.89.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "Self-administered questionnaire that assesses sleep quality. It is made up of 24 reagents; the total score has a range of 0 to 21 points; where a total score less than 5 points indicates good sleep quality and a score greater than 5 points is interpreted as poor sleep quality. In the Mexican population, he obtained a Cronbach's Alpha of 0.78.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Self-administered questionnaire of 8 items on a Likert scale from 0 (none) to 4 (Very severe), which assesses nighttime symptoms, sleep quality, and daytime symptoms of insomnia; it has a reliability of 0.82 in its original version; and it has similar psychometric indicators in a version validated in Spanish. In its version for the Mexican population, it obtained a 0.84 reliability coefficient.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "SF-36 Health Survey", "description": "It is a self-applicable instrument that evaluates the quality of life of people, it is divided into 8 dimensions associated with health such as: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. Each of these dimensions is evaluated in a different way, being a Likert scale between 4 and 5 response options and dichotomous (yes/no) in others. Within the Mexican version, the psychometric properties showed a high internal consistency with a Cronbach's alpha of 0.93.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder 7 (GAD-7)", "description": "Self-administered questionnaire that assesses the presence and severity of generalized anxiety symptoms. It is made up of 7 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range from 0 to 21. It is interpreted that a score greater than 10 is considered as generalized anxiety. Within its psychometric properties, the version translated into Spanish has a high internal consistency with a Cronbach's alpha of 0.8.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Sleep diary", "description": "Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "Patient Health Questionnaire 9 (PHQ-9)", "description": "Self-applied questionnaire that assesses the presence and severity of depressive symptoms. It is made up of 9 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range of 0 to 27. These scores are interpreted from 0 to 5 (mild), 6 to 10 (moderate), 11 to 15 (moderately severe) and 16 to 27. (severe). Within its psychometric properties, the original version has a high internal consistency with a Cronbach's alpha of 0.86, while the Mexican version was 0.89.", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "Self-administered questionnaire that assesses sleep quality. It is made up of 24 reagents; the total score has a range of 0 to 21 points; where a total score less than 5 points indicates good sleep quality and a score greater than 5 points is interpreted as poor sleep quality. In the Mexican population, he obtained a Cronbach's Alpha of 0.78.", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Self-administered questionnaire of 8 items on a Likert scale from 0 (none) to 4 (Very severe), which assesses nighttime symptoms, sleep quality, and daytime symptoms of insomnia; it has a reliability of 0.82 in its original version; and it has similar psychometric indicators in a version validated in Spanish. In its version for the Mexican population, it obtained a 0.84 reliability coefficient.", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "SF-36 Health Survey", "description": "It is a self-applicable instrument that evaluates the quality of life of people, it is divided into 8 dimensions associated with health such as: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. Each of these dimensions is evaluated in a different way, being a Likert scale between 4 and 5 response options and dichotomous (yes/no) in others. Within the Mexican version, the psychometric properties showed a high internal consistency with a Cronbach's alpha of 0.93.", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder 7 (GAD-7)", "description": "Self-administered questionnaire that assesses the presence and severity of generalized anxiety symptoms. It is made up of 7 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range from 0 to 21. It is interpreted that a score greater than 10 is considered as generalized anxiety. Within its psychometric properties, the version translated into Spanish has a high internal consistency with a Cronbach's alpha of 0.8.", "time_frame": "follow-up 3 months after the end of treatment" } ], "outcome_measures": [ { "type": "primary", "measure": "Sleep diary", "description": "Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "Patient Health Questionnaire 9 (PHQ-9)", "description": "Self-applied questionnaire that assesses the presence and severity of depressive symptoms. It is made up of 9 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range of 0 to 27. These scores are interpreted from 0 to 5 (mild), 6 to 10 (moderate), 11 to 15 (moderately severe) and 16 to 27. (severe). Within its psychometric properties, the original version has a high internal consistency with a Cronbach's alpha of 0.86, while the Mexican version was 0.89.", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "Self-administered questionnaire that assesses sleep quality. It is made up of 24 reagents; the total score has a range of 0 to 21 points; where a total score less than 5 points indicates good sleep quality and a score greater than 5 points is interpreted as poor sleep quality. In the Mexican population, he obtained a Cronbach's Alpha of 0.78.", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "Insomnia Severity Index (ISI)", "description": "Self-administered questionnaire of 8 items on a Likert scale from 0 (none) to 4 (Very severe), which assesses nighttime symptoms, sleep quality, and daytime symptoms of insomnia; it has a reliability of 0.82 in its original version; and it has similar psychometric indicators in a version validated in Spanish. In its version for the Mexican population, it obtained a 0.84 reliability coefficient.", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "SF-36 Health Survey", "description": "It is a self-applicable instrument that evaluates the quality of life of people, it is divided into 8 dimensions associated with health such as: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. Each of these dimensions is evaluated in a different way, being a Likert scale between 4 and 5 response options and dichotomous (yes/no) in others. Within the Mexican version, the psychometric properties showed a high internal consistency with a Cronbach's alpha of 0.93.", "time_frame": "1 week after starting treatment." }, { "type": "primary", "measure": "Generalized Anxiety Disorder 7 (GAD-7)", "description": "Self-administered questionnaire that assesses the presence and severity of generalized anxiety symptoms. It is made up of 7 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range from 0 to 21. It is interpreted that a score greater than 10 is considered as generalized anxiety. Within its psychometric properties, the version translated into Spanish has a high internal consistency with a Cronbach's alpha of 0.8.", "time_frame": "1 week after starting treatment." }, { "type": "secondary", "measure": "Sleep diary", "description": "Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Patient Health Questionnaire 9 (PHQ-9)", "description": "Self-applied questionnaire that assesses the presence and severity of depressive symptoms. It is made up of 9 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range of 0 to 27. These scores are interpreted from 0 to 5 (mild), 6 to 10 (moderate), 11 to 15 (moderately severe) and 16 to 27. (severe). Within its psychometric properties, the original version has a high internal consistency with a Cronbach's alpha of 0.86, while the Mexican version was 0.89.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "Self-administered questionnaire that assesses sleep quality. It is made up of 24 reagents; the total score has a range of 0 to 21 points; where a total score less than 5 points indicates good sleep quality and a score greater than 5 points is interpreted as poor sleep quality. In the Mexican population, he obtained a Cronbach's Alpha of 0.78.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Self-administered questionnaire of 8 items on a Likert scale from 0 (none) to 4 (Very severe), which assesses nighttime symptoms, sleep quality, and daytime symptoms of insomnia; it has a reliability of 0.82 in its original version; and it has similar psychometric indicators in a version validated in Spanish. In its version for the Mexican population, it obtained a 0.84 reliability coefficient.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "SF-36 Health Survey", "description": "It is a self-applicable instrument that evaluates the quality of life of people, it is divided into 8 dimensions associated with health such as: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. Each of these dimensions is evaluated in a different way, being a Likert scale between 4 and 5 response options and dichotomous (yes/no) in others. Within the Mexican version, the psychometric properties showed a high internal consistency with a Cronbach's alpha of 0.93.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder 7 (GAD-7)", "description": "Self-administered questionnaire that assesses the presence and severity of generalized anxiety symptoms. It is made up of 7 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range from 0 to 21. It is interpreted that a score greater than 10 is considered as generalized anxiety. Within its psychometric properties, the version translated into Spanish has a high internal consistency with a Cronbach's alpha of 0.8.", "time_frame": "4 weeks after starting treatment" }, { "type": "secondary", "measure": "Sleep diary", "description": "Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "Patient Health Questionnaire 9 (PHQ-9)", "description": "Self-applied questionnaire that assesses the presence and severity of depressive symptoms. It is made up of 9 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range of 0 to 27. These scores are interpreted from 0 to 5 (mild), 6 to 10 (moderate), 11 to 15 (moderately severe) and 16 to 27. (severe). Within its psychometric properties, the original version has a high internal consistency with a Cronbach's alpha of 0.86, while the Mexican version was 0.89.", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "Self-administered questionnaire that assesses sleep quality. It is made up of 24 reagents; the total score has a range of 0 to 21 points; where a total score less than 5 points indicates good sleep quality and a score greater than 5 points is interpreted as poor sleep quality. In the Mexican population, he obtained a Cronbach's Alpha of 0.78.", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Self-administered questionnaire of 8 items on a Likert scale from 0 (none) to 4 (Very severe), which assesses nighttime symptoms, sleep quality, and daytime symptoms of insomnia; it has a reliability of 0.82 in its original version; and it has similar psychometric indicators in a version validated in Spanish. In its version for the Mexican population, it obtained a 0.84 reliability coefficient.", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "SF-36 Health Survey", "description": "It is a self-applicable instrument that evaluates the quality of life of people, it is divided into 8 dimensions associated with health such as: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. Each of these dimensions is evaluated in a different way, being a Likert scale between 4 and 5 response options and dichotomous (yes/no) in others. Within the Mexican version, the psychometric properties showed a high internal consistency with a Cronbach's alpha of 0.93.", "time_frame": "follow-up 3 months after the end of treatment" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder 7 (GAD-7)", "description": "Self-administered questionnaire that assesses the presence and severity of generalized anxiety symptoms. It is made up of 7 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range from 0 to 21. It is interpreted that a score greater than 10 is considered as generalized anxiety. Within its psychometric properties, the version translated into Spanish has a high internal consistency with a Cronbach's alpha of 0.8.", "time_frame": "follow-up 3 months after the end of treatment" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other Gov" ], "enrollment": 36, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05951803", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05204511", "title": "Exercise and Post-COVID/ Long-COVID: Effects of Different Training Modalities on Various Parameters in People Affected by the Sequelae of COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-07-19", "start_date": "2022-02-10", "completion_date": "2023-05-31", "primary_completion_date": "2023-05-31", "conditions_raw": [ "Long COVID-19", "Post-COVID-19 Syndrome", "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Endurance Training", "Concurrent Training" ], "sponsor": "University of Vienna", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The current COVID-19 pandemic is the most severe health crisis of the 21st century. This is not only due to the deaths caused by the disease. People that were affected by COVID-19 and supposedly recovered may suffer from long lasting sequelae. The presence of symptoms longer than 3 months after the infection with SARS-CoV-2 is referred to as Post-COVID-19 Syndrome or Long COVID-19. It is estimated that 10-20 percent of all infected people are affected. The most common symptoms include persistent fatigue, reduced physical capacity, dyspnoea, ageusia, anosmia, musculoskeletal pain and neuropsychological complaints such as depression, anxiety, insomnia and a loss of concentration.\n\nConsidering the novelty of the pathology, evidence on the successful treatment of Post-COVID/Long-COVID is scarce. Physical activity has been established as a treatment option for chronic diseases that have similar symptomatic manifestations to those of Post-COVID/Long-COVID. For example, exercise therapy has shown positive effects on the health status of patients with lung disease, depression, anxiety, insomnia and cognitive impairment. However, there has been controversy whether so-called Graded Exercise Therapy (GET) is a safe treatment strategy for patients with Chronic Fatigue Syndrome (CFS). This population may experience Post Exertional Malaise (PEM), a worsening of symptoms after physical, cognitive or emotional exertion. Since COVID-19 might be an infectious trigger for CFS, particular caution has to be taken when recruiting participants and when screening them for adverse events and worsening of symptoms during an exercise intervention.\n\nIt can be hypothesized that patients suffering from Post-COVID/Long-COVID can benefit from exercise in various ways, guaranteed that there is sufficient screening for PEM before and during the intervention and training volume and intensity are increased slowly and progressively.\n\nThe current study investigates the effects of two different training modalities, endurance training and a combination of endurance training and resistance training, on various parameters in people affected by Post-COVID/Long-COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Change of peak oxygen consumption (VO2peak measured in ml/min/kg)", "description": "VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.", "time_frame": "Baseline - 6 weeks - 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change of maximum lower body isometric muscle strength (measured in N)", "description": "Maximum lower body isometric muscle strength will be assessed via a leg press with integrated isometric force measurement (Compass 530, Suessmed GmbH).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of maximum hand grip strength (measured in kg)", "description": "Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of Standard Deviation of RR-Intervals (SDNN measured in ms)", "description": "SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of Root Mean Square of Successive Differences (RMSSD measured in ms)", "description": "RMSSD will be assessed via a respiratory sinus arrythmia measurement (BioSign).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)", "description": "hs-CRP will be assessed via blood sample.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of interleukin-6 (IL-6 measured in pg/ml)", "description": "IL-6 will be assessed via blood sample.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)", "description": "TNF-α will be assessed via blood sample.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of health-related quality of life (HQoL) assessed via the SF-36 1.0", "description": "The SF-36 1.0 is self-administered questionnaire and will be scored according to RAND (numeric value of 0-100). A high score represents a more favorable health status.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of mean time \"correct rejection\" (CR, speed during concentrated working measured in s)", "description": "CR will be assessed via Cognitrone (Schuhfried GmbH), which is a carefully administered computer test. Participants will be given the task of comparing a series of geometric figures.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of the number of present Post-COVID/Long-COVID specific symptoms", "description": "The number of Post-COVID/Long-COVID specific symptoms will be assessed using a list of symptoms provided by the National Institute for Health Care and Excellence (NICE). Each item will be referenced to as existent (yes) or non-existent (no) during the last 7 days.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of fatigue assessed via the Fatigue Severity Scale (FSS)", "description": "The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale", "description": "The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of absolute body fat (BF measured in kg)", "description": "BF will be assessed via a bioelectrical impedance analysis (seca BCA01A).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of absolute lean body mass (LBM measured in kg)", "description": "LBM will be assessed via a bioelectrical impedance analysis (seca BCA01A).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of step count per day", "description": "Step count will be assessed daily during the 12-week intervention period using a wearable device (Polar Unite)", "time_frame": "daily for 12 weeks starting with the first day of the intervention period" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of peak oxygen consumption (VO2peak measured in ml/min/kg)", "description": "VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of maximum lower body isometric muscle strength (measured in N)", "description": "Maximum lower body isometric muscle strength will be assessed via a leg press with integrated isometric force measurement (Compass 530, Suessmed GmbH).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of maximum hand grip strength (measured in kg)", "description": "Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of Standard Deviation of RR-Intervals (SDNN measured in ms)", "description": "SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of Root Mean Square of Successive Differences (RMSSD measured in ms)", "description": "RMSSD will be assessed via a respiratory sinus arrythmia measurement (BioSign).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)", "description": "hs-CRP will be assessed via blood sample.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of interleukin-6 (IL-6 measured in pg/ml)", "description": "IL-6 will be assessed via blood sample.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)", "description": "TNF-α will be assessed via blood sample.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of health-related quality of life (HQoL) assessed via the SF-36 1.0", "description": "The SF-36 1.0 is self-administered questionnaire and will be scored according to RAND (numeric value of 0-100). A high score represents a more favorable health status.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of mean time \"correct rejection\" (CR, speed during concentrated working measured in s)", "description": "CR will be assessed via Cognitrone (Schuhfried GmbH), which is a carefully administered computer test. Participants will be given the task of comparing a series of geometric figures.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of the number of present Post-COVID/Long-COVID specific symptoms", "description": "The number of Post-COVID/Long-COVID specific symptoms will be assessed using a list of symptoms provided by the National Institute for Health Care and Excellence (NICE). Each item will be referenced to as existent (yes) or non-existent (no) during the last 7 days.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of fatigue assessed via the Fatigue Severity Scale (FSS)", "description": "The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale", "description": "The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of absolute body fat (BF measured in kg)", "description": "BF will be assessed via a bioelectrical impedance analysis (seca BCA01A).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of absolute lean body mass (LBM measured in kg)", "description": "LBM will be assessed via a bioelectrical impedance analysis (seca BCA01A).", "time_frame": "Baseline - 6 weeks - 12 weeks" }, { "type": "secondary", "measure": "Change of step count per day", "description": "Step count will be assessed daily during the 12-week intervention period using a wearable device (Polar Unite)", "time_frame": "daily for 12 weeks starting with the first day of the intervention period" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 66, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05204511", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05947617", "title": "Safety, Efficacy, and Dosing of VIX001 in Patients With Neurological Symptoms of Post Acute COVID-19 Syndrome (PACS).", "status": "UNKNOWN", "phase": "PHASE1", "last_updated": "2023-07-17", "start_date": "2023-10-01", "completion_date": "2025-09-01", "primary_completion_date": "2025-04-01", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Cognitive Impairment", "Neurological Complication" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Vix001" ], "sponsor": "Neobiosis, LLC", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The study, identified as VIX001-PACS-01, is a Phase 1, open-label, dose-escalation trial evaluating the safety, tolerability, preliminary efficacy, and dose effect of VIX001, an amniotic fluid product, in patients with Post-Acute COVID-19 Syndrome (PACS) and cognitive impairment. Conducted at the University of Miami Hospital and Clinics, the trial aims to enroll up to nine participants, or up to 18 using a 3+3 dose escalation design. Intravenous injections of VIX001 will be administered at three ascending doses (1 ml, 3 ml, or 10 ml), and participants will be assessed for safety, cognitive impairment, pain, activity, and quality of life at baseline and various timepoints. The primary objective is to evaluate the safety of VIX001, while secondary objectives include assessing its potential efficacy and patient-reported outcomes. The study duration is expected to last approximately 18 months, including enrollment, evaluation, and post-study observation periods. The findings will contribute to understanding VIX001's safety and efficacy in treating PACS-related cognitive impairment.", "primary_outcomes": [ { "type": "primary", "measure": "Change from Baseline Six Minute Walk Test (6MWT) with oximetry.", "description": "Physiologic assessments", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline Transthoracic Echocardiogram in 3 Dimensions (3-D TTE).", "description": "Physiologic assessments", "time_frame": "Day 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline Pulmonary Function Test (PFT) with bronchodilation if abnormal.", "description": "Physiologic assessments", "time_frame": "Day 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline Sleep time and depth parameters derived from wearable device (Biostrap).", "description": "Physiologic assessments", "time_frame": "Day 180" }, { "type": "primary", "measure": "Change from Baseline Heart Rate Variability (HRV) during sleep, derived from wearable device (Biostrap).", "description": "Physiologic assessments", "time_frame": "Day 180" }, { "type": "primary", "measure": "Change from Baseline UPSIT testers.", "description": "Physiologic assessments", "time_frame": "Day 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline Montreal Cognitive Assessment (MoCA).", "description": "Physiologic assessments", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline NASA 10-Minute Lean Test.", "description": "Physiologic assessments", "time_frame": "Day 7, 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline CNS Vital Signs test battery.", "description": "Physiologic assessments", "time_frame": "Day 7, 30, 90, 180" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "PROMIS", "description": "Patient-Reported outcomes\n\n1. Sleep Disturbance\n2. Fatigue\n3. Physical Function\n4. Pain Interference", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "secondary", "measure": "mMRC Scale.", "description": "Patient-Reported outcomes", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "secondary", "measure": "General Anxiety Disorder (GAD-7).", "description": "Patient-Reported outcomes", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "secondary", "measure": "Personal Health Questionnaire Depression Scale (PHQ-8).", "description": "Patient-Reported outcomes", "time_frame": "Day 0, 7, 30, 90, 180" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from Baseline Six Minute Walk Test (6MWT) with oximetry.", "description": "Physiologic assessments", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline Transthoracic Echocardiogram in 3 Dimensions (3-D TTE).", "description": "Physiologic assessments", "time_frame": "Day 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline Pulmonary Function Test (PFT) with bronchodilation if abnormal.", "description": "Physiologic assessments", "time_frame": "Day 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline Sleep time and depth parameters derived from wearable device (Biostrap).", "description": "Physiologic assessments", "time_frame": "Day 180" }, { "type": "primary", "measure": "Change from Baseline Heart Rate Variability (HRV) during sleep, derived from wearable device (Biostrap).", "description": "Physiologic assessments", "time_frame": "Day 180" }, { "type": "primary", "measure": "Change from Baseline UPSIT testers.", "description": "Physiologic assessments", "time_frame": "Day 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline Montreal Cognitive Assessment (MoCA).", "description": "Physiologic assessments", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline NASA 10-Minute Lean Test.", "description": "Physiologic assessments", "time_frame": "Day 7, 30, 90, 180" }, { "type": "primary", "measure": "Change from Baseline CNS Vital Signs test battery.", "description": "Physiologic assessments", "time_frame": "Day 7, 30, 90, 180" }, { "type": "secondary", "measure": "PROMIS", "description": "Patient-Reported outcomes\n\n1. Sleep Disturbance\n2. Fatigue\n3. Physical Function\n4. Pain Interference", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "secondary", "measure": "mMRC Scale.", "description": "Patient-Reported outcomes", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "secondary", "measure": "General Anxiety Disorder (GAD-7).", "description": "Patient-Reported outcomes", "time_frame": "Day 0, 7, 30, 90, 180" }, { "type": "secondary", "measure": "Personal Health Questionnaire Depression Scale (PHQ-8).", "description": "Patient-Reported outcomes", "time_frame": "Day 0, 7, 30, 90, 180" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 9, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05947617", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05225220", "title": "Multimodal Investigation of Post COVID-19 in Females", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-07-07", "start_date": "2022-03-01", "completion_date": "2023-01-06", "primary_completion_date": "2023-01-06", "conditions_raw": [ "Post COVID-19", "Cognitive Dysfunction" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Parasym Device" ], "sponsor": "Casa Colina Hospital and Centers for Healthcare", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to investigate the effects of transcutaneous vagus nerve stimulation (t-VNS) on Long Covid symptoms in females and to identify factors influencing susceptibility and recovery-particularly in the cognitive domain, as over 80% of long-haulers experience \"brain fog\".", "primary_outcomes": [ { "type": "primary", "measure": "Change in Flanker Inhibitory Control and Attention Test (Flanker) scores", "description": "Flanker is a non-verbal NIH Toolbox Cognition Battery assessment that measures both a participant's attention and inhibitory control.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "primary", "measure": "Change in Picture Sequence Memory Test (PSMT) scores", "description": "PSMT is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's episodic memory.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "primary", "measure": "Change in Dimensional Change Card Sort Test (DCCS) scores", "description": "DCCS is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's executive functioning.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "primary", "measure": "Change in Pattern Comparison Processing Speed scores", "description": "Pattern Comparison Processing Speed is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's processing speed.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "primary", "measure": "Change in List Sorting Working Memory scores", "description": "List Sorting Working Memory is an oral NIH Toolbox Cognition Battery assessment that measures a participant's working memory.", "time_frame": "At baseline, at week 3, and at week 7" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Magnetic Resonance Imaging (MRI)", "description": "MRI scans will be acquired on a Siemens Magnetom Verio 3T Scanner at Casa Colina Imaging Center to assess structural changes.", "time_frame": "At baseline and at week 3" }, { "type": "secondary", "measure": "Change in resting state Electroencephalograph (EEG) signals", "description": "Using a 64-channel EEG system, we will perform resting-state EEG recordings to assess power spectral density changes.", "time_frame": "At baseline and at week 3" }, { "type": "secondary", "measure": "Change in blood marker levels", "description": "Blood markers related to COVID-19, inflammation, brain injury, and neuroplasticity will be analyzed using the Ella automated immunoassay system.", "time_frame": "At baseline and at week 3" }, { "type": "secondary", "measure": "Change in BURNS Anxiety Inventory scores", "description": "The BURNS Anxiety Inventory is a self-reported rating scale that measures anxiety symptoms.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "secondary", "measure": "Change in Becks Depression Inventory (BDI) scores", "description": "The BDI is a self-reported rating inventory that measures characteristic attitudes and symptoms of depression.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "secondary", "measure": "Change in PROMIS Sleep Disturbance scores", "description": "The PROMIS Sleep Disturbance (8b) is a self-reported measure for perception of sleep quality, depth of sleep, satisfaction with sleep, and perception of difficulty getting and staying asleep.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "secondary", "measure": "Change in Fatigue Severity Scale scores", "description": "The Fatigue Severity Scale is a self-reported 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "secondary", "measure": "Change in Sniffin' Sticks olfactory performance", "description": "The Sniffin' Sticks test (Burghardt®, Wedel, Germany) assesses odor threshold, odor discrimination, and odor identification.", "time_frame": "At baseline, at week 3, and at week 7" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Flanker Inhibitory Control and Attention Test (Flanker) scores", "description": "Flanker is a non-verbal NIH Toolbox Cognition Battery assessment that measures both a participant's attention and inhibitory control.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "primary", "measure": "Change in Picture Sequence Memory Test (PSMT) scores", "description": "PSMT is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's episodic memory.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "primary", "measure": "Change in Dimensional Change Card Sort Test (DCCS) scores", "description": "DCCS is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's executive functioning.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "primary", "measure": "Change in Pattern Comparison Processing Speed scores", "description": "Pattern Comparison Processing Speed is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's processing speed.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "primary", "measure": "Change in List Sorting Working Memory scores", "description": "List Sorting Working Memory is an oral NIH Toolbox Cognition Battery assessment that measures a participant's working memory.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "secondary", "measure": "Change in Magnetic Resonance Imaging (MRI)", "description": "MRI scans will be acquired on a Siemens Magnetom Verio 3T Scanner at Casa Colina Imaging Center to assess structural changes.", "time_frame": "At baseline and at week 3" }, { "type": "secondary", "measure": "Change in resting state Electroencephalograph (EEG) signals", "description": "Using a 64-channel EEG system, we will perform resting-state EEG recordings to assess power spectral density changes.", "time_frame": "At baseline and at week 3" }, { "type": "secondary", "measure": "Change in blood marker levels", "description": "Blood markers related to COVID-19, inflammation, brain injury, and neuroplasticity will be analyzed using the Ella automated immunoassay system.", "time_frame": "At baseline and at week 3" }, { "type": "secondary", "measure": "Change in BURNS Anxiety Inventory scores", "description": "The BURNS Anxiety Inventory is a self-reported rating scale that measures anxiety symptoms.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "secondary", "measure": "Change in Becks Depression Inventory (BDI) scores", "description": "The BDI is a self-reported rating inventory that measures characteristic attitudes and symptoms of depression.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "secondary", "measure": "Change in PROMIS Sleep Disturbance scores", "description": "The PROMIS Sleep Disturbance (8b) is a self-reported measure for perception of sleep quality, depth of sleep, satisfaction with sleep, and perception of difficulty getting and staying asleep.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "secondary", "measure": "Change in Fatigue Severity Scale scores", "description": "The Fatigue Severity Scale is a self-reported 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.", "time_frame": "At baseline, at week 3, and at week 7" }, { "type": "secondary", "measure": "Change in Sniffin' Sticks olfactory performance", "description": "The Sniffin' Sticks test (Burghardt®, Wedel, Germany) assesses odor threshold, odor discrimination, and odor identification.", "time_frame": "At baseline, at week 3, and at week 7" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 25, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05225220", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05932797", "title": "Multimodal Long Covid19", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-07-06", "start_date": "2023-05-03", "completion_date": "2024-11-18", "primary_completion_date": "2024-11-18", "conditions_raw": [ "Long COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Multimodal Intervention In Long Covid19" ], "sponsor": "Universidad de Magallanes", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Due to the COVID-19 pandemic, the world has seen the need to identify groups of patients who experience various effects in the medium and long term after recovering from the initial illness. These medium- and long-term effects are collectively known as the post-COVID-19 condition, Long-COVID, or prolonged COVID. Current evidence indicates, with conservative estimates, that between 10% and 20% of the population could be affected. Its nature is varied and ranges from physical conditions such as chronic fatigue, dyspnea and muscle weakness, to neurocognitive (compromised memory, decreased concentration) and psychological (anxiety, depression, anguish, stress). Early recognition and treatment of this symptom burden is essential for physical recovery and mental health. Due to its multivariate nature, it has been suggested that optimal recovery of patients' quality of life would only be achieved to the extent that their main symptoms are addressed from an interdisciplinary perspective.", "primary_outcomes": [ { "type": "primary", "measure": "Number of participants with treatment-related adverse events assessed by Cardiorespiratory Capacity", "description": "The primary outcome of the study will be measured by a maximal cardiopulmonary exercise test (CPET) on a cycloergometer. The protocol will be individualised and will include a 3-minute warm-up at 20 Watts, followed by an increasing workload of 10-20 W/min (depending on the participant's fitness level) until exhaustion, maintaining a cadence greater than 60 rpm. Electrocardiogram and oxygen saturation will be continuously monitored, while rating of perceived exertion and blood pressure will be measured every two minutes during the test. Continuously measured at rest, as well as during exercise and recovery: minute ventilation, oxygen consumption and carbon dioxide production. Gas exchange shall be collected on a breath-by-breath basis and expressed as a 15-second time average for analysis.", "time_frame": "24 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Cardiorespiratory profiles", "description": "Fatigue Assessment Scale (FAS) - The FAS questionnaire consists of 10 questions and its objective is to investigate the presence of fatigue in a patient, its response is by means of a likert-type scale in which higher scores imply a greater degree of fatigue, its measurement parameters are based on two categories whose maximum score is 50 points. FAS scores 10 - 21: no fatigue (normal) FAS scores 22 - 50: substantial fatigue", "time_frame": "24 months" }, { "type": "secondary", "measure": "Cardiorespiratory profiles", "description": "Test Time Up and GO - Its objective is to evaluate the dynamic balance, as well as the functional capacity and mobility of a person to perform activities of daily living. establishing mobility parameters in such a way that the more time used, the lower the mobility capacity. Less than 10 seconds: independent mobility. Between 10 and 20 seconds: mostly independent mobility. More than 20 seconds: reduced mobility.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Cardiorespiratory profiles", "description": "Six-minute walk test - The 6-minute walk test is a submaximal exercise test used to assess aerobic capacity and endurance. The distance walked for a time of 6 minutes is used as a result to compare changes in performance capacity. The more meters the patient runs, the better his cardiorespiratory functional capacity. If a patient reaches 304 meters in the 6 minutes, he achieves cardiorespiratory functional independence category, if he achieves less than that distance, a decrease in cardiorespiratory functional capacity is established.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Psychological profiles", "description": "Beck Anxiety Scale - consists of a 21-item self-administered instrument in which the patient is asked to report the extent to which he or she has been affected by each of the 21 symptoms described in the scale. Each item has four possible response options: not at all, mildly, moderately and severely. Values from 0 to 3 are assigned to each of the items. The values for each item are summed to obtain a total score that can range from 0 to 63 points. A total between 0 and 7 points is interpreted as a minimum level of anxiety, between 8 to 15 points corresponds to a mild level of anxiety, from 16 to 25 points is moderate anxiety and from 26 to 63 points is considered severe anxiety.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Psychological profiles", "description": "Beck Depression Scale - It consists of a 21-item self-administered instrument designed to assess the severity of depressive symptomatology in adults. In each of the items, the person has to choose, from a set of four alternatives ordered from least to most severe, the statement that best describes his or her state during the last two weeks, including the day on which he or she completes the instrument. As for the correction, each item is valued from 0 to 3 points depending on the alternative chosen and, after directly adding the score of each item, a total score can be obtained that varies from 0 to 63 points; thus, its categories range from minimal depression (0-13); mild depression (14-19), moderate depression (20-28) and severe depression (29-63).", "time_frame": "24 months" }, { "type": "secondary", "measure": "Neurocognitive profiles", "description": "Montreal Cognitive Assessment - This instrument examines cognitive dysfunctions associated with attention, concentration, executive functions (including abstraction capacity), memory, language, visuoconstructive abilities, calculation and orientation. The maximum score is 30 points and its score is proportional to the level of cognitive functionality, so that the lower the score, the greater the cognitive impairment. A score equal to or higher than 26 points is considered normal; a score lower than 10 points implies incipient cognitive impairment; from 20 to 23 points: Mild cognitive impairment and if the patient achieves 26 points or more, there is no alteration of cognitive functions.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Functional profiles", "description": "Barthel Index - It is a test that provides ranges with scores between 0 and 100, regarding the level of functional behavioral independence for a patient. The closer a subject's score is to 0, the more dependent he/she is; the closer to 100, the more independent he/she is. Based on the results obtained in the evaluation with the Barthel Index or Scale, the classification will be: Total Dependent (less than 20 points), Severe Dependence (20 - 35 points), Moderate Dependence (40 - 55 points), Mild Dependence (greater than or equal to 60 points) and Independence (100 points).", "time_frame": "24 months" }, { "type": "secondary", "measure": "Quality of life indicators", "description": "Short Form 12 Health Survey - Health related quality of life questionnaire. The response options of the SF-12 form Likert-type scales that evaluate intensity or frequency of quality of life indicators associated with health. The number of response options ranges from three to six, depending on the item, and each question is given a value that is then transformed into a scale from 0 to 100. The scores have a mean of 50 with a standard deviation of 10, so that values above 50 indicate better health-related quality of life or below 50 indicate a worse state of health-related quality of life.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Nutritional profile", "description": "Body composition analyzer - This instrument establishes the level of body fat in people, establishing frames of reference with scores differentiated by sex, classifying as low range in men when their score is less than 9.9%, and women less than 17.9%; normal level: Men between 10 to 19.9%, women between 18 to 27.9%; High: Men between 20 to 58%, women between 28.0 to 58%. Therefore, the higher the percentage, the higher the degree of health risks associated with overweight.", "time_frame": "24 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of participants with treatment-related adverse events assessed by Cardiorespiratory Capacity", "description": "The primary outcome of the study will be measured by a maximal cardiopulmonary exercise test (CPET) on a cycloergometer. The protocol will be individualised and will include a 3-minute warm-up at 20 Watts, followed by an increasing workload of 10-20 W/min (depending on the participant's fitness level) until exhaustion, maintaining a cadence greater than 60 rpm. Electrocardiogram and oxygen saturation will be continuously monitored, while rating of perceived exertion and blood pressure will be measured every two minutes during the test. Continuously measured at rest, as well as during exercise and recovery: minute ventilation, oxygen consumption and carbon dioxide production. Gas exchange shall be collected on a breath-by-breath basis and expressed as a 15-second time average for analysis.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Cardiorespiratory profiles", "description": "Fatigue Assessment Scale (FAS) - The FAS questionnaire consists of 10 questions and its objective is to investigate the presence of fatigue in a patient, its response is by means of a likert-type scale in which higher scores imply a greater degree of fatigue, its measurement parameters are based on two categories whose maximum score is 50 points. FAS scores 10 - 21: no fatigue (normal) FAS scores 22 - 50: substantial fatigue", "time_frame": "24 months" }, { "type": "secondary", "measure": "Cardiorespiratory profiles", "description": "Test Time Up and GO - Its objective is to evaluate the dynamic balance, as well as the functional capacity and mobility of a person to perform activities of daily living. establishing mobility parameters in such a way that the more time used, the lower the mobility capacity. Less than 10 seconds: independent mobility. Between 10 and 20 seconds: mostly independent mobility. More than 20 seconds: reduced mobility.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Cardiorespiratory profiles", "description": "Six-minute walk test - The 6-minute walk test is a submaximal exercise test used to assess aerobic capacity and endurance. The distance walked for a time of 6 minutes is used as a result to compare changes in performance capacity. The more meters the patient runs, the better his cardiorespiratory functional capacity. If a patient reaches 304 meters in the 6 minutes, he achieves cardiorespiratory functional independence category, if he achieves less than that distance, a decrease in cardiorespiratory functional capacity is established.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Psychological profiles", "description": "Beck Anxiety Scale - consists of a 21-item self-administered instrument in which the patient is asked to report the extent to which he or she has been affected by each of the 21 symptoms described in the scale. Each item has four possible response options: not at all, mildly, moderately and severely. Values from 0 to 3 are assigned to each of the items. The values for each item are summed to obtain a total score that can range from 0 to 63 points. A total between 0 and 7 points is interpreted as a minimum level of anxiety, between 8 to 15 points corresponds to a mild level of anxiety, from 16 to 25 points is moderate anxiety and from 26 to 63 points is considered severe anxiety.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Psychological profiles", "description": "Beck Depression Scale - It consists of a 21-item self-administered instrument designed to assess the severity of depressive symptomatology in adults. In each of the items, the person has to choose, from a set of four alternatives ordered from least to most severe, the statement that best describes his or her state during the last two weeks, including the day on which he or she completes the instrument. As for the correction, each item is valued from 0 to 3 points depending on the alternative chosen and, after directly adding the score of each item, a total score can be obtained that varies from 0 to 63 points; thus, its categories range from minimal depression (0-13); mild depression (14-19), moderate depression (20-28) and severe depression (29-63).", "time_frame": "24 months" }, { "type": "secondary", "measure": "Neurocognitive profiles", "description": "Montreal Cognitive Assessment - This instrument examines cognitive dysfunctions associated with attention, concentration, executive functions (including abstraction capacity), memory, language, visuoconstructive abilities, calculation and orientation. The maximum score is 30 points and its score is proportional to the level of cognitive functionality, so that the lower the score, the greater the cognitive impairment. A score equal to or higher than 26 points is considered normal; a score lower than 10 points implies incipient cognitive impairment; from 20 to 23 points: Mild cognitive impairment and if the patient achieves 26 points or more, there is no alteration of cognitive functions.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Functional profiles", "description": "Barthel Index - It is a test that provides ranges with scores between 0 and 100, regarding the level of functional behavioral independence for a patient. The closer a subject's score is to 0, the more dependent he/she is; the closer to 100, the more independent he/she is. Based on the results obtained in the evaluation with the Barthel Index or Scale, the classification will be: Total Dependent (less than 20 points), Severe Dependence (20 - 35 points), Moderate Dependence (40 - 55 points), Mild Dependence (greater than or equal to 60 points) and Independence (100 points).", "time_frame": "24 months" }, { "type": "secondary", "measure": "Quality of life indicators", "description": "Short Form 12 Health Survey - Health related quality of life questionnaire. The response options of the SF-12 form Likert-type scales that evaluate intensity or frequency of quality of life indicators associated with health. The number of response options ranges from three to six, depending on the item, and each question is given a value that is then transformed into a scale from 0 to 100. The scores have a mean of 50 with a standard deviation of 10, so that values above 50 indicate better health-related quality of life or below 50 indicate a worse state of health-related quality of life.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Nutritional profile", "description": "Body composition analyzer - This instrument establishes the level of body fat in people, establishing frames of reference with scores differentiated by sex, classifying as low range in men when their score is less than 9.9%, and women less than 17.9%; normal level: Men between 10 to 19.9%, women between 18 to 27.9%; High: Men between 20 to 58%, women between 28.0 to 58%. Therefore, the higher the percentage, the higher the degree of health risks associated with overweight.", "time_frame": "24 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05932797", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05815693", "title": "Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-06-29", "start_date": "2023-04-13", "completion_date": "2023-11-30", "primary_completion_date": "2023-11-30", "conditions_raw": [ "Post Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Mindfulness-Based Stress Reduction" ], "sponsor": "Azienda Socio Sanitaria Territoriale di Lecco", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The consequences of the Intensive Care Unit and the Covid-19 disease are still uncertain. However, many studies are bringing out often psychological and dramatic consequences for many COVID-survivor patients.\n\nAmong the ex-covid patients discharged from our Intensive Care Unit and with at least one covid-related psychological consequence, we want to evaluate the effectiveness for long-term consequences of COVID-19 of mindfulness-based stress reduction (MBSR) or usual care.", "primary_outcomes": [ { "type": "primary", "measure": "Chronic pain", "description": "pain that persists or recurs for longer than 3 months, and it exerts an enormous personal and economic burden, affecting more than 30% of people worldwide", "time_frame": "6 months and 1 year" }, { "type": "primary", "measure": "Anxiety", "description": "an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure", "time_frame": "6 months and 1 year" }, { "type": "primary", "measure": "Depression", "description": "a depressed mood or loss of pleasure or interest in activities for long periods of time", "time_frame": "6 months and 1 year" }, { "type": "primary", "measure": "Insomnia", "description": "a common sleep disorder that can make it hard to fall asleep, hard to stay asleep, or cause you to wake up too early and not be able to get back to sleep", "time_frame": "6 months and 1 year" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Chronic pain", "description": "pain that persists or recurs for longer than 3 months, and it exerts an enormous personal and economic burden, affecting more than 30% of people worldwide", "time_frame": "6 months and 1 year" }, { "type": "primary", "measure": "Anxiety", "description": "an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure", "time_frame": "6 months and 1 year" }, { "type": "primary", "measure": "Depression", "description": "a depressed mood or loss of pleasure or interest in activities for long periods of time", "time_frame": "6 months and 1 year" }, { "type": "primary", "measure": "Insomnia", "description": "a common sleep disorder that can make it hard to fall asleep, hard to stay asleep, or cause you to wake up too early and not be able to get back to sleep", "time_frame": "6 months and 1 year" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 140, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05815693", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05684952", "title": "The Efficacy and Safety of a Chinese Herbal Medicine for Long COVID Associated Fatigue", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2023-06-28", "start_date": "2023-05-30", "completion_date": "2024-02-01", "primary_completion_date": "2024-01-15", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Shenlingcao Oral Liquid" ], "sponsor": "Hong Kong Baptist University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue: Change of scores in Chalder fatigue scale (0-33 points)", "description": "The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Insomnia: Change of scores in Insomnia Severity Index (ISI)", "description": "The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)", "description": "The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)", "description": "HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Muscle strength: Change of Hand Grip Strength (HGS)", "description": "Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Long Covid related symptoms", "description": "Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Safety: number of adverse events", "description": "Assessed by number of adverse events or side effects", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Exploratory outcome: Immunology analysis", "description": "Assessed by the change of important immune index in serumImmune index", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Exploratory outcome: Gut microbiota analysis", "description": "Assessed by the change of gut microbiota composition and its metabolimics.", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue: Change of scores in Chalder fatigue scale (0-33 points)", "description": "The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Insomnia: Change of scores in Insomnia Severity Index (ISI)", "description": "The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)", "description": "The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)", "description": "HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Muscle strength: Change of Hand Grip Strength (HGS)", "description": "Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Long Covid related symptoms", "description": "Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Safety: number of adverse events", "description": "Assessed by number of adverse events or side effects", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Exploratory outcome: Immunology analysis", "description": "Assessed by the change of important immune index in serumImmune index", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Exploratory outcome: Gut microbiota analysis", "description": "Assessed by the change of gut microbiota composition and its metabolimics.", "time_frame": "4 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 152, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05684952", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05918965", "title": "Vagus Stimulation in Female Long COVID Patients.", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-06-26", "start_date": "2023-03-22", "completion_date": "2025-03-01", "primary_completion_date": "2025-03-01", "conditions_raw": [ "Vagus Nerve Diseases", "Long COVID", "Long Covid19", "Post-COVID-19 Syndrome", "Post-COVID Syndrome", "Post COVID-19 Condition", "Post COVID Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Transcutaneous Electrical Vagal Neurostimulation" ], "sponsor": "Medical University of Vienna", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of the present pilot study is to investigate the acceptance, feasibility and implementation of the vagus nerv stimulation in Long COVID patients. Additionally, the effects on parameters of the autonomic nervous system as well as on symptoms of Long COVID will be described in a pre/post comparison.\n\nFor this purpose, a total of 45 female Long COVID patients will participate in the randomized controlled pilot study. Patients will perform auricular vagus stimulation daily for 12 weeks. The patient collective will be randomized into three groups (A: 10 hertz, B: 25 hertz, C: 2 hertz=control group).\n\nIf appropriate results are obtained, further adequately powered intervention studies are planned.", "primary_outcomes": [ { "type": "primary", "measure": "Heart rate variability", "description": "20-minute documentation of the heart rate variability with a 24-hour-elektrocardiography", "time_frame": "3 times for 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "blood pressure and pulse", "description": "via Boso Medicus plus their mutiplication for the rate-pressure-product", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Saliva cortisol", "description": "in the morning until the latest 10am", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Questionnaire Brief Fatigue Inventory (BFI)", "description": "Fatigue evaluation", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Questionnaire Short form (SF)-36", "description": "Health related quality of life evaluation", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Questionnaire Borg-Scale", "description": "Dyspnea evaluation", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Questionnaire Insomnia Severity Index (ISI)", "description": "Sleep evaluation", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Status scale (PCFS)", "description": "Grade 0-4", "time_frame": "3 times for 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Heart rate variability", "description": "20-minute documentation of the heart rate variability with a 24-hour-elektrocardiography", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "blood pressure and pulse", "description": "via Boso Medicus plus their mutiplication for the rate-pressure-product", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Saliva cortisol", "description": "in the morning until the latest 10am", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Questionnaire Brief Fatigue Inventory (BFI)", "description": "Fatigue evaluation", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Questionnaire Short form (SF)-36", "description": "Health related quality of life evaluation", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Questionnaire Borg-Scale", "description": "Dyspnea evaluation", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Questionnaire Insomnia Severity Index (ISI)", "description": "Sleep evaluation", "time_frame": "3 times for 12 weeks" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Status scale (PCFS)", "description": "Grade 0-4", "time_frame": "3 times for 12 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 45, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05918965", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05780450", "title": "Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-06-13", "start_date": "2023-04-01", "completion_date": "2023-07", "primary_completion_date": "2023-07", "conditions_raw": [ "COVID-19", "Long COVID", "Long Covid19", "SARS CoV 2 Infection", "Persistent COVID-19", "Migraine Disorders", "Headaches Chronic", "Cluster Headache", "Arthralgia", "Myalgia", "Chronic Pain", "Post-COVID-19 Syndrome", "Post COVID-19 Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Transcranial Direct Current Therapy" ], "sponsor": "Fundación Universidad Católica de Valencia San Vicente Mártir", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to verify the efficacy / effectiveness of treatment with transcranial direct therapy (TDCS) in patients with Persistent Covid who present headaches, migraines and chronic pain, such as arthralgias and myalgias.\n\nTranscranial Direct Therapy is used in the field of Physiotherapy and Rehabilitation, with results that prove to be effective for the treatment of patients suffering from symptoms such as migraines, headaches, chronic pain, fibromyalgia or chronic neuropathic pain.\n\nAs can be seen, in the case of patients with Persistent Covid we find several of these symptoms, so it is suggested that, if Transcranial Direct Current Therapy (TDCs) is giving such good results, relieving these symptoms, why can not give such good results and help so much in patients with Persistent Covid, If many of the symptoms are the same, even if the origin or cause is different.", "primary_outcomes": [ { "type": "primary", "measure": "CHANGE FROM PRE-TREATMENT DEGREE CHRONIC BODY PAIN AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS", "description": "MEASURED WITH 2 SPECIFIC PAIN SCALES (EVA-Visual Analog SCALE AND MCGILL PAIN QUESTIONNAIRE). EVA SCALE (0 no pain-10 maximun pain). MCGILL QUESTIONNAIRE (0 no pain-66 maximun pain)", "time_frame": "PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS" }, { "type": "primary", "measure": "CHANGE FROM PRE-TREATMENT INTENSE MIGRAINES OR HEADACHES AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS", "description": "MEASURED WITH 2 SPECIFIC SCALES (MIDAS-Migraine dissability Assessment SCALE AND HIT-6 QUESTIONNAIRE-headache impact test). MIDAS SCALE (0 nil disability - \\>21 severe disability). HIT-6 QUESTIONNAIRE (0 no impact - \\>60 very severe impact).", "time_frame": "PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "CHANGE FROM PRE-TREATMENT QUALITY OF LIFE (SF-12 QUESTIONNAIRE) AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS", "description": "MEASURED WITH 1 SPECIFIC SCALE (SF-12 QUESTIONNAIRE). (0 worst quality of life - 100 best quality of life)", "time_frame": "PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS" }, { "type": "secondary", "measure": "CHANGE FROM PRE-TREATMENT MOOD AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS", "description": "MEASURED WITH 1 SPECIFIC SCALE (EVEA-mood rating SCALE). (0 nothing - 10 a lot)", "time_frame": "PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS" } ], "outcome_measures": [ { "type": "primary", "measure": "CHANGE FROM PRE-TREATMENT DEGREE CHRONIC BODY PAIN AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS", "description": "MEASURED WITH 2 SPECIFIC PAIN SCALES (EVA-Visual Analog SCALE AND MCGILL PAIN QUESTIONNAIRE). EVA SCALE (0 no pain-10 maximun pain). MCGILL QUESTIONNAIRE (0 no pain-66 maximun pain)", "time_frame": "PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS" }, { "type": "primary", "measure": "CHANGE FROM PRE-TREATMENT INTENSE MIGRAINES OR HEADACHES AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS", "description": "MEASURED WITH 2 SPECIFIC SCALES (MIDAS-Migraine dissability Assessment SCALE AND HIT-6 QUESTIONNAIRE-headache impact test). MIDAS SCALE (0 nil disability - \\>21 severe disability). HIT-6 QUESTIONNAIRE (0 no impact - \\>60 very severe impact).", "time_frame": "PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS" }, { "type": "secondary", "measure": "CHANGE FROM PRE-TREATMENT QUALITY OF LIFE (SF-12 QUESTIONNAIRE) AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS", "description": "MEASURED WITH 1 SPECIFIC SCALE (SF-12 QUESTIONNAIRE). (0 worst quality of life - 100 best quality of life)", "time_frame": "PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS" }, { "type": "secondary", "measure": "CHANGE FROM PRE-TREATMENT MOOD AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS", "description": "MEASURED WITH 1 SPECIFIC SCALE (EVEA-mood rating SCALE). (0 nothing - 10 a lot)", "time_frame": "PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 27, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05780450", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05669261", "title": "Treatment of Long COVID Symptoms Utilizing Autologous Stem Cells Following COVID-19 Infection", "status": "UNKNOWN", "phase": "PHASE1", "last_updated": "2023-06-09", "start_date": "2023-08-01", "completion_date": "2024-02-01", "primary_completion_date": "2023-12-31", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Adipose Tissue Harvest", "Atcell" ], "sponsor": "American CryoStem Corporation", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The project is described as a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and secondarily to be vigilant for signals of amelioration of symptoms associated with Post-Acute Sequelae of SARS-CoV-2 infection", "primary_outcomes": [ { "type": "primary", "measure": "Assessment of the Incidence of Serious Adverse Events (SAEs)", "description": "Observed Adverse Events (AE's) in the placebo control group will be compared to observed AE in the experimental treatment, if any, in order to assess safety of the experimental treatment.", "time_frame": "Upon completion of final post treatment clinical visit of all participants" }, { "type": "primary", "measure": "Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)", "description": "Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "One week post administration" }, { "type": "primary", "measure": "Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)", "description": "Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "Two weeks post administration" }, { "type": "primary", "measure": "Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)", "description": "Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "Three weeks post administration" }, { "type": "primary", "measure": "Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)", "description": "Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "Four weeks post administration" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Assessment of Changes in Exosome/Cytokine/Chemokine Testing", "description": "Blood samples will be collected for testing to measure the selected cytokine and chemokines blood panels described below at screening (baseline), at the pre-treatment clinical visit, and the one- and four-week clinical visits following treatment", "time_frame": "Once per week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of change in completion time -Six-minute walk test (6MWT)", "description": "The 6MWT is a self-paced walking test in which the subject is instructed to walk as fast as possible for 6 minutes. The 6WMT will be completed by each participant at the screening, pre-Treatment clinical visit and at the one week and four week post treatment clinical visits.", "time_frame": "Four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Complete blood count with differential (CBC with diff) Laboratory Testing Results", "description": "Complete blood count with differential (CBC with diff)Test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Lactate dehydrogenase (LDH) Laboratory Testing Results", "description": "Lactate dehydrogenase (LDH) test results are to be assessed in this study are complete blood count with differential (CBC with diff), to identify any significant change in results positive or negative with the change reported as a percentage change from baseline", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Prothrombin time/partial thromboplastin time (PT/PTT Coagulation factors II) Laboratory Testing Results", "description": "Prothrombin time/partial thromboplastin time (PT/PTT Coagulation factors II) test results are to be assessed to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Troponin Laboratory Testing Results", "description": "Troponin test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in D-dimer Laboratory Testing Results", "description": "D-dimer test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Fibrinogen (Coagulation factors II) Laboratory Testing Results", "description": "Fibrinogen (Coagulation factors II) test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in estimated glomerular filtration rate Laboratory Testing Results", "description": "estimated glomerular filtration rate (eGFR) test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Urinalyses Laboratory Testing Results", "description": "Urinalyses test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Spot creatinine Laboratory Testing Results", "description": "Spot creatinine test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" } ], "outcome_measures": [ { "type": "primary", "measure": "Assessment of the Incidence of Serious Adverse Events (SAEs)", "description": "Observed Adverse Events (AE's) in the placebo control group will be compared to observed AE in the experimental treatment, if any, in order to assess safety of the experimental treatment.", "time_frame": "Upon completion of final post treatment clinical visit of all participants" }, { "type": "primary", "measure": "Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)", "description": "Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "One week post administration" }, { "type": "primary", "measure": "Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)", "description": "Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "Two weeks post administration" }, { "type": "primary", "measure": "Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)", "description": "Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "Three weeks post administration" }, { "type": "primary", "measure": "Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)", "description": "Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "Four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Changes in Exosome/Cytokine/Chemokine Testing", "description": "Blood samples will be collected for testing to measure the selected cytokine and chemokines blood panels described below at screening (baseline), at the pre-treatment clinical visit, and the one- and four-week clinical visits following treatment", "time_frame": "Once per week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of change in completion time -Six-minute walk test (6MWT)", "description": "The 6MWT is a self-paced walking test in which the subject is instructed to walk as fast as possible for 6 minutes. The 6WMT will be completed by each participant at the screening, pre-Treatment clinical visit and at the one week and four week post treatment clinical visits.", "time_frame": "Four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Complete blood count with differential (CBC with diff) Laboratory Testing Results", "description": "Complete blood count with differential (CBC with diff)Test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Lactate dehydrogenase (LDH) Laboratory Testing Results", "description": "Lactate dehydrogenase (LDH) test results are to be assessed in this study are complete blood count with differential (CBC with diff), to identify any significant change in results positive or negative with the change reported as a percentage change from baseline", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Prothrombin time/partial thromboplastin time (PT/PTT Coagulation factors II) Laboratory Testing Results", "description": "Prothrombin time/partial thromboplastin time (PT/PTT Coagulation factors II) test results are to be assessed to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Troponin Laboratory Testing Results", "description": "Troponin test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in D-dimer Laboratory Testing Results", "description": "D-dimer test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Fibrinogen (Coagulation factors II) Laboratory Testing Results", "description": "Fibrinogen (Coagulation factors II) test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in estimated glomerular filtration rate Laboratory Testing Results", "description": "estimated glomerular filtration rate (eGFR) test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Urinalyses Laboratory Testing Results", "description": "Urinalyses test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" }, { "type": "secondary", "measure": "Assessment of Change in Spot creatinine Laboratory Testing Results", "description": "Spot creatinine test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.", "time_frame": "Each week for four weeks post administration" } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05669261", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05445674", "title": "Plasma Exchange Therapy for Post- COVID-19 Condition: A Pilot, Randomized Double-Blind Study", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2023-06-07", "start_date": "2022-09-22", "completion_date": "2023-06-06", "primary_completion_date": "2023-06-06", "conditions_raw": [ "Post-COVID19 Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Plasma Exchange Procedure" ], "sponsor": "Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "PAX is a prospective, randomized (1:1), double-blind, placebo-controlled study, that have as a objective to evaluate the safety and tolerability of plasma exchange (PE) in patients with Post Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange. The participants will be randomized in two arms: (1) 6 sessions of PE (Plasma Exchange) with human serum albumin 5% or (2) 6 sessions with placebo (infusion of of sterile saline solution 0.9%) on days 1, 3, 8, 10, 15 and 17.", "primary_outcomes": [ { "type": "primary", "measure": "Evaluate the safety and tolerability of PE in patients with Post-Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange (placebo)", "description": "Proportion of adverse events (AEs) through day 90, considering:\n\n* All AEs\n* Grade 3 and 4 AEs\n* AEs leading to study discontinuation", "time_frame": "Within 90 days from the treatment start" }, { "type": "primary", "measure": "Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS)", "description": "Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS), being 0 the better outcome and 4 the worse outcome", "time_frame": "From baseline to day 90" }, { "type": "primary", "measure": "Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the fatigue severity scale (FSS)", "description": "Grade 0, 1 o 2 functional disability assessed by the fatigue severity scale (FSS), being 1 the better outcome and 70 the worse outcome", "time_frame": "From baseline to day 90" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Assess the ability of PE to improve PCC symptoms", "description": "Can Ruti PCC symptoms scale questionnare by days 0, 8, 15, 22, 45 and 90", "time_frame": "At days 0, 8, 15, 22, 45 and 90" }, { "type": "secondary", "measure": "Assess the impact of PE on quality of life in subjects with PCC", "description": "Quality of life questionnaires: EuroQol-5D questionnaire being 5 the better outcome and 15 the worse outcome.", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Assess the impact of PE on quality of life in subjects with PCC using MOS-HIV questionnaire", "description": "Quality of life questionnaires: MOS-HIV questionnaire being 4 the better outcome and 1 the worse outcome.", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Assess the impact of PE on neurocognitive symptoms in subjects with PCC using NeuScreen fluency Test", "description": "The neurocognitive evaluation assessed by the NeuScreen fluency test (Seconds)", "time_frame": "At days 0, 22 and 90" }, { "type": "secondary", "measure": "Assess the impact of PE on neurocognitive symptoms in subjects with PCC using MEF-30 questionnaire", "description": "The neurocognitive evaluation assessed by the MEF-30 questionnaire, with being 0 the better outcome and 120 being the worse outcome.", "time_frame": "At days 0, 22 and 90" }, { "type": "secondary", "measure": "Assess the impact of PE on neurocognitive symptoms in subjects with PCC using HADs questionnaire", "description": "The neurocognitive evaluation assessed by the HADs questionnaire, with being 0 as the better outcome and 21 being the worse outcome.", "time_frame": "At days 0, 22 and 90" }, { "type": "secondary", "measure": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the determination of SARS-CoV-2 specific igG", "description": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the determination of SARS-CoV-2 specific igG in plasma (Arbitrary Units, AU)", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the neutralization activity evaluation", "description": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the analysis of reciprocal titers of neutralizing antibodies against SARS-CoV-2", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the T-Cell response", "description": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the reduction of T-Cell response (%) from plasma samples", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Determination of residual SARS-CoV-2 particles (RNA) in plasma from subjects with PCC", "description": "Virological assessment to determine the residual SARS-CoV-2 RNA (copies/mL)", "time_frame": "At days 0, 8, 15, 22, 45, and 90" }, { "type": "secondary", "measure": "Changes in microbiota associated with PE in subjects with PCC", "description": "Stool assessment to determine the residual SARS-CoV-2 RNA (copies/mL)", "time_frame": "At day 1, 8, 15, 22, 45 and 90" } ], "outcome_measures": [ { "type": "primary", "measure": "Evaluate the safety and tolerability of PE in patients with Post-Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange (placebo)", "description": "Proportion of adverse events (AEs) through day 90, considering:\n\n* All AEs\n* Grade 3 and 4 AEs\n* AEs leading to study discontinuation", "time_frame": "Within 90 days from the treatment start" }, { "type": "primary", "measure": "Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS)", "description": "Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS), being 0 the better outcome and 4 the worse outcome", "time_frame": "From baseline to day 90" }, { "type": "primary", "measure": "Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the fatigue severity scale (FSS)", "description": "Grade 0, 1 o 2 functional disability assessed by the fatigue severity scale (FSS), being 1 the better outcome and 70 the worse outcome", "time_frame": "From baseline to day 90" }, { "type": "secondary", "measure": "Assess the ability of PE to improve PCC symptoms", "description": "Can Ruti PCC symptoms scale questionnare by days 0, 8, 15, 22, 45 and 90", "time_frame": "At days 0, 8, 15, 22, 45 and 90" }, { "type": "secondary", "measure": "Assess the impact of PE on quality of life in subjects with PCC", "description": "Quality of life questionnaires: EuroQol-5D questionnaire being 5 the better outcome and 15 the worse outcome.", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Assess the impact of PE on quality of life in subjects with PCC using MOS-HIV questionnaire", "description": "Quality of life questionnaires: MOS-HIV questionnaire being 4 the better outcome and 1 the worse outcome.", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Assess the impact of PE on neurocognitive symptoms in subjects with PCC using NeuScreen fluency Test", "description": "The neurocognitive evaluation assessed by the NeuScreen fluency test (Seconds)", "time_frame": "At days 0, 22 and 90" }, { "type": "secondary", "measure": "Assess the impact of PE on neurocognitive symptoms in subjects with PCC using MEF-30 questionnaire", "description": "The neurocognitive evaluation assessed by the MEF-30 questionnaire, with being 0 the better outcome and 120 being the worse outcome.", "time_frame": "At days 0, 22 and 90" }, { "type": "secondary", "measure": "Assess the impact of PE on neurocognitive symptoms in subjects with PCC using HADs questionnaire", "description": "The neurocognitive evaluation assessed by the HADs questionnaire, with being 0 as the better outcome and 21 being the worse outcome.", "time_frame": "At days 0, 22 and 90" }, { "type": "secondary", "measure": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the determination of SARS-CoV-2 specific igG", "description": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the determination of SARS-CoV-2 specific igG in plasma (Arbitrary Units, AU)", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the neutralization activity evaluation", "description": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the analysis of reciprocal titers of neutralizing antibodies against SARS-CoV-2", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the T-Cell response", "description": "Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the reduction of T-Cell response (%) from plasma samples", "time_frame": "At day 0, 8, 15, 22, 45 and 90." }, { "type": "secondary", "measure": "Determination of residual SARS-CoV-2 particles (RNA) in plasma from subjects with PCC", "description": "Virological assessment to determine the residual SARS-CoV-2 RNA (copies/mL)", "time_frame": "At days 0, 8, 15, 22, 45, and 90" }, { "type": "secondary", "measure": "Changes in microbiota associated with PE in subjects with PCC", "description": "Stool assessment to determine the residual SARS-CoV-2 RNA (copies/mL)", "time_frame": "At day 1, 8, 15, 22, 45 and 90" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05445674", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05681455", "title": "Physiotherapy for Persistent Function by Superficial Neuromodulation", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-06-06", "start_date": "2023-06-15", "completion_date": "2023-07-30", "primary_completion_date": "2023-06-15", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Dysautonomia", "Neuromodulation" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Neuromodulation Nesa Nxsignal® Device" ], "sponsor": "Universidad Rey Juan Carlos", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Objectives:\n\nTo evaluate pressure pain thresholds, fatigue scales, quality of life and sleep quality, in women with Persistent Covid (PC), pre- and post-treatment using electrotherapy and in a placebo group of PC patients.\n\nRelevance:\n\nThis trial can be a tool for patients affected by CP who present pain and fatigue problems, insomnia or signs of imbalance of their Autonomic Nervous System. It aims to improve their rest and recovery for a better quality of life that allows them to recover their Activities of Daily Living.\n\nWe have designed the study with a commitment to placebo group treatment after completion, if positive results are obtained.\n\nA 6-month and 1-year follow-up will be scheduled.\n\nSecondary objectives:\n\nTo analyze the effects on quality of life, fatigue and sleep. To analyze the presence of cardiac variability and pre- and post-treatment cortisol values.\n\nPatients and Methods:\n\n12 patients with CP will receive 15 sessions of electrotherapy. 12 will receive a placebo.\n\nMechanical sensitivity pre-post, by means of an algometer, cardiac variability, cortisol levels, and other variables, will be measured by means of questionnaires.\n\nMechanical sensitivity to pain will be measured using an algometer (Baseline 12-0300 MMT). Patients will be instructed to report when the sensation of pressure changes to pain.\n\nThe pre-post electrotherapy treatment described above will be measured, the differences in mechanical sensitivity, pain threshold to pressure, the Pittsburg questionnaires, SF-36, MFIS and EQooL-5.\n\nFollow-up will be done at 6 months and at one year. The study design is a triple-blind randomized controlled clinical trial. Patients who sign the consent form will be evaluated by an internist who will perform a physical examination at the clinic of the Faculty of Nursing and Physiotherapy of the Pontifical University of Salamanca (UPSA).\n\nThe sample will be randomized. 12 patients will receive treatment and 12 patients will receive a placebo. With a commitment to treat these patients in the event that positive results are obtained after the end of the study.\n\nA biphasic microcurrent will be applied with a frequency between 1.14 Hertz and 14.29 Hertz and intensities between 0.1 and 0.9 mA.\n\nFrequency: 2 times a week. A total of 15 sessions in 7.5 weeks. The session time with microcurrents will last 60 minutes.\n\n.", "primary_outcomes": [ { "type": "primary", "measure": "Pain Pressure Threshold", "description": "Central sensitization by assessment of the Pressure Pain Threshold (PPU) in kg: Baseline 12-0300 MMT algometer at cervical C5-C6, dorsal D5-D6 and anterior tibial muscle.", "time_frame": "Change from Baseline Pain Pressure Threshold at 1 year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Quality of life RELATED TO HEALTH", "description": "SF-36 questionnaire", "time_frame": "Change from baseline quality of life related to health at 1 year" }, { "type": "secondary", "measure": "Quality of life RELATED TO HEALTH", "description": "EuroQool-5-D questionnaire", "time_frame": "Change from baseline quality of life related to health at 1 year" }, { "type": "secondary", "measure": "effects on fatigue", "description": "MFIS questionnaire (Modificated Fatigue Impact Scale)", "time_frame": "Change from Baseline fatigue at 1 year" }, { "type": "secondary", "measure": "Quality of sleep", "description": "Pittsburg questionnaire", "time_frame": "Change from Baseline Quality of Sleep at 1 year" }, { "type": "secondary", "measure": "cardiac variability", "description": "HRV (cardiac variability)\" in ms 2. \"SDNN (Standard deviation of all R-R intervals)\" in ms 3. \"rMSSD (Root mean square of the union of adjacent R-R intervals)\" in ms", "time_frame": "Change from Baseline Cardiac variability at 1 year" }, { "type": "secondary", "measure": "Cortisol levels", "description": "Soma OFCII cube device in nmol/L", "time_frame": "Change from Baseline Cortisol level at 1 year" } ], "outcome_measures": [ { "type": "primary", "measure": "Pain Pressure Threshold", "description": "Central sensitization by assessment of the Pressure Pain Threshold (PPU) in kg: Baseline 12-0300 MMT algometer at cervical C5-C6, dorsal D5-D6 and anterior tibial muscle.", "time_frame": "Change from Baseline Pain Pressure Threshold at 1 year" }, { "type": "secondary", "measure": "Quality of life RELATED TO HEALTH", "description": "SF-36 questionnaire", "time_frame": "Change from baseline quality of life related to health at 1 year" }, { "type": "secondary", "measure": "Quality of life RELATED TO HEALTH", "description": "EuroQool-5-D questionnaire", "time_frame": "Change from baseline quality of life related to health at 1 year" }, { "type": "secondary", "measure": "effects on fatigue", "description": "MFIS questionnaire (Modificated Fatigue Impact Scale)", "time_frame": "Change from Baseline fatigue at 1 year" }, { "type": "secondary", "measure": "Quality of sleep", "description": "Pittsburg questionnaire", "time_frame": "Change from Baseline Quality of Sleep at 1 year" }, { "type": "secondary", "measure": "cardiac variability", "description": "HRV (cardiac variability)\" in ms 2. \"SDNN (Standard deviation of all R-R intervals)\" in ms 3. \"rMSSD (Root mean square of the union of adjacent R-R intervals)\" in ms", "time_frame": "Change from Baseline Cardiac variability at 1 year" }, { "type": "secondary", "measure": "Cortisol levels", "description": "Soma OFCII cube device in nmol/L", "time_frame": "Change from Baseline Cortisol level at 1 year" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 24, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05681455", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05874089", "title": "VSL#3® vs Placebo in the Treatment of Fatigue and Other Symptoms in Long Covid (DELong#3)", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-05-24", "start_date": "2022-11-03", "completion_date": "2023-11-03", "primary_completion_date": "2023-09-03", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Vsl#3®" ], "sponsor": "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to evaluate the effectiveness of VSL#3® in reducing Fatigue and other symptoms in Long Covid Syndrome compared to placebo.", "primary_outcomes": [ { "type": "primary", "measure": "Assessment of Fatigue variation after 4 weeks of treatment (t4)", "description": "To determine if there is a statistically significant variation in the scores on the Chalder Fatigue Scale between the treated group and the placebo group after 4 weeks of treatment (t4)", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Assessment of Fatigue variation after 4 weeks of follow-up (t8)", "description": "To determine if there is a statistically significant difference in the scores on the Chalder Fatigue Scale between the treated group and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Evaluation of Anxiety and Depression variation after 4 weeks of treatment (t4)", "description": "To determine if there is a statistically significant difference in the scores on the Hospital Anxiety and Depression Scale (HAD) between the treated group and to the placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Evaluation of Anxiety and Depression variation after 4 weeks of follow-up (t8)", "description": "To determine if there is a statistically significant difference in the scores on the Hospital Anxiety and Depression Scale (HAD) between the treated group and to the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Measurement of Quality of Life variation after 4 weeks of treatment (t4)", "description": "To determine if there is a statistically significant difference in the scores on the Short Form Health Survey (SF)-36 between the treated group and placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measurement of Quality of Life variation after 4 weeks of follow-up (t8)", "description": "To determine if there is a statistically significant difference in the scores on the Short Form Health Survey (SF)-36 between the treated group and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Assessment of Gastrointestinal Symptoms variation after 4 weeks of treatment (t4)", "description": "To determine if there is a statistically significant difference in the scores on the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) between the placebo group and the treated group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Assessment of Gastrointestinal Symptoms variation after4 weeks of follow-up (t8)", "description": "To determine if there is a statistically significant difference in the scores on the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) between the placebo group and the treated group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Analysis of Somatization variation after 4 weeks of treatment (t4)", "description": "To identify the level of somatization of symptoms by comparing the scores on the SCL-12 for the somatization of Symptom Checklist-90 (SCL-90) between the treated group and the placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Analysis of Somatization variation after 4 weeks of treatment (t4)", "description": "To identify the level of somatization of symptoms by comparing the scores on the SCL-12 for the somatization of Symptom Checklist-90 (SCL-90) between the treated groups and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Evaluation of Functional Status variation after 4 weeks of treatment (t4)", "description": "To assess the general functional status of the patients by comparing the scores on the Karnofsky Performance Status (KPS) Scale between the treated group and the placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Evaluation of Functional Status variation after 4 weeks of follow-up (t8)", "description": "To assess the general functional status of the patients by comparing the scores on the Karnofsky Performance Status (KPS) Scale between the treated group and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Physician's Assessment of General Health variation after 4 weeks of treatment (t4)", "description": "To determine the physician's evaluation of the patient's general state of health using a visual-analogue scale (VAS) and comparing it between the treated group and the placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Physician's Assessment of General Health variation after 4 weeks of follow-up (t8)", "description": "To determine the physician's evaluation of the patient's general state of health using a visual-analogue scale (VAS) and comparing it between the treated group and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Analysis of PBMC and Serum Expression of inflammatory mediators at baseline (t0) and after 4 weeks of treatment (t4)", "description": "Evaluation of multiple cytokines and chemokines in plasma samples and of immune cell phenotypes in peripheral blood mononuclear cells (PBMCs)", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Investigation of Faecal Microbiota Variation after 4 weeks of treatment (t4)", "description": "To analyze the variation of the bacterial component of the faecal microbiota in terms of alpha and beta diversity and explore its correlation with clinical response on fatigue in both the placebo group and the treated group by using. Shotgun metagenomics and 16S sequencing of faecal samples at baseline and after 4 weeks of treatment (t4) generate serial gut microbial taxonomic and bacterial functional profiles.", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Assessment of Fatigue variation after 4 weeks of treatment (t4)", "description": "To determine if there is a statistically significant variation in the scores on the Chalder Fatigue Scale between the treated group and the placebo group after 4 weeks of treatment (t4)", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Assessment of Fatigue variation after 4 weeks of follow-up (t8)", "description": "To determine if there is a statistically significant difference in the scores on the Chalder Fatigue Scale between the treated group and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Evaluation of Anxiety and Depression variation after 4 weeks of treatment (t4)", "description": "To determine if there is a statistically significant difference in the scores on the Hospital Anxiety and Depression Scale (HAD) between the treated group and to the placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Evaluation of Anxiety and Depression variation after 4 weeks of follow-up (t8)", "description": "To determine if there is a statistically significant difference in the scores on the Hospital Anxiety and Depression Scale (HAD) between the treated group and to the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Measurement of Quality of Life variation after 4 weeks of treatment (t4)", "description": "To determine if there is a statistically significant difference in the scores on the Short Form Health Survey (SF)-36 between the treated group and placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Measurement of Quality of Life variation after 4 weeks of follow-up (t8)", "description": "To determine if there is a statistically significant difference in the scores on the Short Form Health Survey (SF)-36 between the treated group and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Assessment of Gastrointestinal Symptoms variation after 4 weeks of treatment (t4)", "description": "To determine if there is a statistically significant difference in the scores on the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) between the placebo group and the treated group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Assessment of Gastrointestinal Symptoms variation after4 weeks of follow-up (t8)", "description": "To determine if there is a statistically significant difference in the scores on the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) between the placebo group and the treated group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Analysis of Somatization variation after 4 weeks of treatment (t4)", "description": "To identify the level of somatization of symptoms by comparing the scores on the SCL-12 for the somatization of Symptom Checklist-90 (SCL-90) between the treated group and the placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Analysis of Somatization variation after 4 weeks of treatment (t4)", "description": "To identify the level of somatization of symptoms by comparing the scores on the SCL-12 for the somatization of Symptom Checklist-90 (SCL-90) between the treated groups and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Evaluation of Functional Status variation after 4 weeks of treatment (t4)", "description": "To assess the general functional status of the patients by comparing the scores on the Karnofsky Performance Status (KPS) Scale between the treated group and the placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Evaluation of Functional Status variation after 4 weeks of follow-up (t8)", "description": "To assess the general functional status of the patients by comparing the scores on the Karnofsky Performance Status (KPS) Scale between the treated group and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Physician's Assessment of General Health variation after 4 weeks of treatment (t4)", "description": "To determine the physician's evaluation of the patient's general state of health using a visual-analogue scale (VAS) and comparing it between the treated group and the placebo group after 4 weeks of treatment", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Physician's Assessment of General Health variation after 4 weeks of follow-up (t8)", "description": "To determine the physician's evaluation of the patient's general state of health using a visual-analogue scale (VAS) and comparing it between the treated group and the placebo group after 4 weeks of follow-up", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Analysis of PBMC and Serum Expression of inflammatory mediators at baseline (t0) and after 4 weeks of treatment (t4)", "description": "Evaluation of multiple cytokines and chemokines in plasma samples and of immune cell phenotypes in peripheral blood mononuclear cells (PBMCs)", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Investigation of Faecal Microbiota Variation after 4 weeks of treatment (t4)", "description": "To analyze the variation of the bacterial component of the faecal microbiota in terms of alpha and beta diversity and explore its correlation with clinical response on fatigue in both the placebo group and the treated group by using. Shotgun metagenomics and 16S sequencing of faecal samples at baseline and after 4 weeks of treatment (t4) generate serial gut microbial taxonomic and bacterial functional profiles.", "time_frame": "4 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 96, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05874089", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05855356", "title": "Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-05-11", "start_date": "2023-02-01", "completion_date": "2024-03-27", "primary_completion_date": "2023-12-30", "conditions_raw": [ "Post-Acute COVID-19 Syndrome", "Dysautonomia" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Rehabilitation", "Standard Of Care" ], "sponsor": "Evangelismos Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Dysautonomia in post-covid-19 condition appears to affect a significant number of patients, with reports raising the incidence up to 61%, having an overlap with myalgic encephalomyelitis/ chronic fatigue syndrome. Quality of life and daily function is significantly impacted and conservative management interventions, despite the lack of high quality evidence up to now, are needed to ameliorate disability. 50 adults with a dysautonomia post-covid-19 diagnosis based on the Ewing battery and a NASA lean test will be enrolled in a randomized single blinded controlled trial with a crossover design. Feasibility and lack of definite dysautonomia diagnosis will be the primary out-comes, while secondary outcomes will be health-related, clinical and cardiopulmonary exercise test indicators. Safety and acceptance will also be checked, primarily excluding participants with post exertional malaise. The Long-CoViD patients Causal Diagnosis and Rehabilitation study in patients with Dysautonomia (LoCoDiRE-Dys) study intervention will consist of an educational module, breathing retraining and an individualized exercise intervention of biweekly sessions for two months with regular assessment of both groups. LoCoDiRe- Dys aims to be the first post-covid-19 randomized study in people with dysautonomia offering a multimodal intervention both in diagnosis and management", "primary_outcomes": [ { "type": "primary", "measure": "Number of patients with lack of definite Dysautonomia Diagnosis", "description": "Ewing Battery is a validated instrument to diagnose dysautonomia, with a definite diagnosis when 2 out of 4 heart rate tests are abnormal", "time_frame": "4 months" }, { "type": "primary", "measure": "Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial", "description": "Process measures that will substantiate offering of the service", "time_frame": "4 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "10 minutes NASA Lean Test", "description": "Validated measure to record orthostatic intolerance, recording of blood pressure and heart rate in 5 min supine position, and every minute when standing up till 10 min", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Six minute Walk Test", "description": "Validated measure, a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "1 minute sit to stand test", "description": "Validated measure to record the times standing up from a chair, closely related with cardiorespiratory capacity and lower limb strength", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "Validated measure to record fatigue severity as reported by the patient, 9 statements each in a scale of 1-7, min 9 max 63", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "modified Medical Research Council Dyspnea Scale", "description": "Validated measure to record functional disability because of dyspnea as reported by the patient in a scale 0-4", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Nijmegen Questionnaire", "description": "Validated measure to record dysfunctional breathing as recorded by the patient with each statement valued 0-4, with A score of over 23 out of 64 suggest a positive diagnosis of hyperventilation syndrome.", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment", "description": "Validated measure for rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation, with a normal score over 25/30", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "International Physical Activity Questionnaire", "description": "Validated measure with 27 item self reporting physical activity of the patient", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale", "description": "Validated measure, a 14-item measure designed to assess anxiety and depression symptoms in medical patients. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "EuroQoL 5 Dimensions 5 Levels", "description": "Validated measure, a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Cardiorespiratory exercise test", "description": "A specialized type of stress test or exercise test that measures exercise ability", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Lower Extremity Strength", "description": "Assessment of lower extremity strength using a dynamometer.", "time_frame": "checked at [0], [8] and [16] weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of patients with lack of definite Dysautonomia Diagnosis", "description": "Ewing Battery is a validated instrument to diagnose dysautonomia, with a definite diagnosis when 2 out of 4 heart rate tests are abnormal", "time_frame": "4 months" }, { "type": "primary", "measure": "Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial", "description": "Process measures that will substantiate offering of the service", "time_frame": "4 months" }, { "type": "secondary", "measure": "10 minutes NASA Lean Test", "description": "Validated measure to record orthostatic intolerance, recording of blood pressure and heart rate in 5 min supine position, and every minute when standing up till 10 min", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Six minute Walk Test", "description": "Validated measure, a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "1 minute sit to stand test", "description": "Validated measure to record the times standing up from a chair, closely related with cardiorespiratory capacity and lower limb strength", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "Validated measure to record fatigue severity as reported by the patient, 9 statements each in a scale of 1-7, min 9 max 63", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "modified Medical Research Council Dyspnea Scale", "description": "Validated measure to record functional disability because of dyspnea as reported by the patient in a scale 0-4", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Nijmegen Questionnaire", "description": "Validated measure to record dysfunctional breathing as recorded by the patient with each statement valued 0-4, with A score of over 23 out of 64 suggest a positive diagnosis of hyperventilation syndrome.", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment", "description": "Validated measure for rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation, with a normal score over 25/30", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "International Physical Activity Questionnaire", "description": "Validated measure with 27 item self reporting physical activity of the patient", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale", "description": "Validated measure, a 14-item measure designed to assess anxiety and depression symptoms in medical patients. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "EuroQoL 5 Dimensions 5 Levels", "description": "Validated measure, a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Cardiorespiratory exercise test", "description": "A specialized type of stress test or exercise test that measures exercise ability", "time_frame": "checked at [0], [8] and [16] weeks" }, { "type": "secondary", "measure": "Lower Extremity Strength", "description": "Assessment of lower extremity strength using a dynamometer.", "time_frame": "checked at [0], [8] and [16] weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05855356", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05851846", "title": "Amygdala Insula Retraining in the Management of Long COVID Symptoms", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-05-10", "start_date": "2023-05-15", "completion_date": "2024-06-15", "primary_completion_date": "2024-05-15", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Amygdala Insula Retraining" ], "sponsor": "Miami VA Healthcare System", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "The goal of the study is to compare a mind body intervention against usual care in patients with fatigue with long COVID.\n\nOur research questions include\n\n1. Is the mind body intervention additive to usual care in long COVID\n2. Can the mind body intervention change laboratory markers, heart rate variability and dysautonomia.", "primary_outcomes": [ { "type": "primary", "measure": "Modified Yorkshire COVID-19 scale", "description": "Long COVID symptom scale", "time_frame": "3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Heart rate variability", "description": "SSDN", "time_frame": "3 months" }, { "type": "secondary", "measure": "COMPASS-31", "description": "Dysautonomia scale", "time_frame": "3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Modified Yorkshire COVID-19 scale", "description": "Long COVID symptom scale", "time_frame": "3 months" }, { "type": "secondary", "measure": "Heart rate variability", "description": "SSDN", "time_frame": "3 months" }, { "type": "secondary", "measure": "COMPASS-31", "description": "Dysautonomia scale", "time_frame": "3 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Fed" ], "enrollment": 130, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05851846", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05012826", "title": "Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-05-10", "start_date": "2021-09-20", "completion_date": "2023-07-06", "primary_completion_date": "2023-06-06", "conditions_raw": [ "Covid19", "SARS-CoV-2 Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Osteopathic Manipulative Treatment In Addition To Physiotherapy", "Physiotherapy" ], "sponsor": "Centro Universitário Augusto Motta", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Background: Fatigue is among the most common symptoms of the long-term effects of coronavirus (long COVID). This study aims to compare the effectiveness of osteopathic manipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PT alone on fatigue and functional limitations after two months post randomization in adults with long COVID.\n\nMethods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomized controlled superiority trial. Seventy-six participants will be randomly allocated to OMT+PT or PT. The PT includes usual care interventions including motor and respiratory exercises targeting cardiorespiratory and skeletal muscle functions. The OMT entails direct, indirect, visceral, and cranial techniques. Patients will be evaluated before and after a 2-month intervention program, and at 3-month follow-up session. Primary objectives comprise fatigue and functional limitations at 2-month post randomization as assessed by the fatigue severity scale and the Post-COVID Functional State scale. Secondary objectives comprise fatigue and functional limitations at 3 months, and the perceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient).", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue Severity Scale: the scale consists of 9 items on how fatigue interferes with certain activities. Severity is classified according to a self-report scale. The scale consists of a 7-point score where 1 = strongly disagree and 7 = strongly agree. The minimum score is 9 and the maximum is 63. The higher the score is the greater the severity of fatigue (Krupp et al., 1989; Toledo et al., 2011). The Portuguese-Brazil version of FSS has high reliability (Cronbach's alpha = 0.93) and good construct validity with pain and fatigue instruments (Pearson correlation of 0.60 and 0.56, respectively)", "time_frame": "90 days" }, { "type": "primary", "measure": "Functional status", "description": "The Post-COVID Functional State Scale : The scale has a score from 0 to 4 with 0 being no functional limitation and 4 severe functional limitation. In the present study, we will use the patient's flowchart and questionnaire with translation into Portuguese language (https://osf.io/qgpdv/) regarding his condition on the day of application (Klok et al., 2020).The Portuguese-Brazil version of PCFS has weak-to-strong construct validity (Pearson correlation in range 0.233 to 0.661) with health-related quality of life", "time_frame": "90 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Global impression of recovery", "description": "The Perceived Change Scale (Patient Version): . It has 19 items, 18 of which assess the perceived changes related to: occupation and physical health, psychological dimension and sleep, relationships, and emotional stability, in addition to a last item that globally assesses the perceived change. Each item has 3-point Likert responses, where point 1 equates to worse than before, 2 to no change and 3 to better than before (Bandeira et al., 2011; Perreault et al., 2010).than before \\[43\\]. The Portuguese-Brazil version of EMP-patient has good internal consistency (Cronbach alpha = 0.85), test-retest temporal stability (Pearson correlation = 0.93) and convergent construct validity with a service satisfaction instrument (Pearson correlation = 0.37)", "time_frame": "90 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue Severity Scale: the scale consists of 9 items on how fatigue interferes with certain activities. Severity is classified according to a self-report scale. The scale consists of a 7-point score where 1 = strongly disagree and 7 = strongly agree. The minimum score is 9 and the maximum is 63. The higher the score is the greater the severity of fatigue (Krupp et al., 1989; Toledo et al., 2011). The Portuguese-Brazil version of FSS has high reliability (Cronbach's alpha = 0.93) and good construct validity with pain and fatigue instruments (Pearson correlation of 0.60 and 0.56, respectively)", "time_frame": "90 days" }, { "type": "primary", "measure": "Functional status", "description": "The Post-COVID Functional State Scale : The scale has a score from 0 to 4 with 0 being no functional limitation and 4 severe functional limitation. In the present study, we will use the patient's flowchart and questionnaire with translation into Portuguese language (https://osf.io/qgpdv/) regarding his condition on the day of application (Klok et al., 2020).The Portuguese-Brazil version of PCFS has weak-to-strong construct validity (Pearson correlation in range 0.233 to 0.661) with health-related quality of life", "time_frame": "90 days" }, { "type": "secondary", "measure": "Global impression of recovery", "description": "The Perceived Change Scale (Patient Version): . It has 19 items, 18 of which assess the perceived changes related to: occupation and physical health, psychological dimension and sleep, relationships, and emotional stability, in addition to a last item that globally assesses the perceived change. Each item has 3-point Likert responses, where point 1 equates to worse than before, 2 to no change and 3 to better than before (Bandeira et al., 2011; Perreault et al., 2010).than before \\[43\\]. The Portuguese-Brazil version of EMP-patient has good internal consistency (Cronbach alpha = 0.85), test-retest temporal stability (Pearson correlation = 0.93) and convergent construct validity with a service satisfaction instrument (Pearson correlation = 0.37)", "time_frame": "90 days" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 104, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05012826", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05848401", "title": "Biosound Therapy as a Treatment for Long COVID Patients", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-05-08", "start_date": "2021-04-29", "completion_date": "2022-01-19", "primary_completion_date": "2022-01-05", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Biosound Therapy System" ], "sponsor": "Anxiety Relief Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aimed to explore the impact of the Biosound Therapy Systerm on long COVID symptoms while determining feasibility of a future full-scale Randomized Controlled Trial. It was hypothesized that Biosound treatment would significantly improve long COVID.\n\nThe goal of this clinical trial is to learn about Biosound Therapy System's impact on long COVID symptoms. The main questions it aims to answer are:\n\n* How does Biosound Therapy impact long COVID symptoms?\n* Is the protocol for this trial feasible for a future full-scale Randomized Controlled Trial?\n\nParticipants with long COVID symptoms will be assigned to a control group and treatment group. The control group will receive no treatment. The treatment group will have 8 sessions of Biosound Therapy. Researchers will compare the treatment and control group to see if there's a difference in long COVID symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "The Patient Health Questionnaire (PHQ-9)", "description": "9-item questionnaire assessing for Major Depressive Disorder", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Generalized Anxiety Disorder 7-item scale (GAD-7)", "description": "7-item questionnaire assessing for generalized anxiety disorder", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Cambridge Brain Sciences (CBS) tasks", "description": "The CBS tasks measure reasoning, short-term memory, and verbal ability through 12 online tasks simulating puzzles or video games.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "COVID-19 Persistent Symptom Questionnaire.", "description": "The authors developed The COVID-19 Persistent Symptom Questionnaire to measure common persistent COVID-19 symptoms at their worst over the last week on a scale of 0-3.", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Recruitment Rate", "description": "Recruiting individuals with long COVID symptoms into a trial of the Biosound Therapy System", "time_frame": "Through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Retention Rate", "description": "Retaining participants for a 4 week trial for the proposed battery of assessments. Retention rate (%) of participants enrolled into the trial who completed the 4 week protocol.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Open-ended questions to participants about their experience", "description": "Participants will be asked, \"1. Can you describe your experience receiving BTS in this study? 2. How did you perceive this treatment helping or not helping your symptoms?\"", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "The Patient Health Questionnaire (PHQ-9)", "description": "9-item questionnaire assessing for Major Depressive Disorder", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Generalized Anxiety Disorder 7-item scale (GAD-7)", "description": "7-item questionnaire assessing for generalized anxiety disorder", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Cambridge Brain Sciences (CBS) tasks", "description": "The CBS tasks measure reasoning, short-term memory, and verbal ability through 12 online tasks simulating puzzles or video games.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "COVID-19 Persistent Symptom Questionnaire.", "description": "The authors developed The COVID-19 Persistent Symptom Questionnaire to measure common persistent COVID-19 symptoms at their worst over the last week on a scale of 0-3.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Recruitment Rate", "description": "Recruiting individuals with long COVID symptoms into a trial of the Biosound Therapy System", "time_frame": "Through study completion, an average of 1 year" }, { "type": "secondary", "measure": "Retention Rate", "description": "Retaining participants for a 4 week trial for the proposed battery of assessments. Retention rate (%) of participants enrolled into the trial who completed the 4 week protocol.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Open-ended questions to participants about their experience", "description": "Participants will be asked, \"1. Can you describe your experience receiving BTS in this study? 2. How did you perceive this treatment helping or not helping your symptoms?\"", "time_frame": "4 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 13, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05848401", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05817032", "title": "Effect of Telerehabilitation Practice in Long COVID-19 Patients", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-04-18", "start_date": "2023-05", "completion_date": "2023-11", "primary_completion_date": "2023-10", "conditions_raw": [ "Long COVID-19", "Long COVID", "Post COVID-19 Condition", "Post-COVID-19 Syndrome", "Post-COVID Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Telerehabilitation", "Standard Rehabilitation Care" ], "sponsor": "Universitas Indonesia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to test the efficacy of telerehabilitation practice in Long COVID-19 patients. The main question\\[s\\] it aims to answer are whether telerehabilitation practice in Long COVID-19 patients help to reduce stress oxidative, reduce inflammation, improve functional capacity and improve quality of life.\n\nParticipants will receive 12 weeks of telerehabilitation practice Researchers will compare intervention group (that received telerehabilitation) and control group (that received standard treatment) to see if there is better outcome in intervention group.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in quality of life status measured using European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire at 12 weeks", "description": "European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire is a validated instrument to measure quality of life. It is a descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.", "time_frame": "Baseline and week 12" }, { "type": "primary", "measure": "Change from baseline the distance from Six Minute Walk Test at 12 weeks", "description": "Six minute walk test is a validated instrument developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.", "time_frame": "Baseline and week 12" }, { "type": "primary", "measure": "Change from baseline the mean Glutathione (GSH)/ oxidized GSH (GSSG) ratio at 12 weeks", "description": "The ratio of reduced Glutathione (GSH) to oxidized GSH (GSSG) is an indicator of cellular health, with reduced GSH constituting up to 98% of cellular GSH under normal conditions. It will be measured using The Glutathione GSH/GSSG Assay Kit, which is designed to accurately measure total, reduced and oxidized glutathione in biological samples using an enzymatic method that utilizes Ellman's Reagent (DTNB) and glutathione reductase (GR).", "time_frame": "Baseline and week 12" }, { "type": "primary", "measure": "Change from baseline the mean endothelial microparticles at 12 weeks", "description": "Endothelial microparticles is an emerging marker of endothelial dysfunction and also considered to play a major biological role in inflammation, vascular injury, angiogenesis, and thrombosis. Techniques to measure circulating endothelial microparticles rely on differential centrifugation in platelet-free plasma and on the identification of cell-surface Cluster of Differentiations (CD) antigens.", "time_frame": "Baseline and week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from baseline the score from Brief Fatigue Inventory (BFI) questionnaire at 12 weeks", "description": "Brief Fatigue Inventory (BFI) questionnaire is a valid instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. A global fatigue score can be obtained by averaging all the items on the BFI.", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change from baseline the score from hand grip strength test using handgrip dynamometer at 12 weeks", "description": "The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. Handgrip strength is important because people with strong hands tend to be strong elsewhere, so this test is often used as a general test of strength.", "time_frame": "Baseline and 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in quality of life status measured using European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire at 12 weeks", "description": "European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire is a validated instrument to measure quality of life. It is a descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.", "time_frame": "Baseline and week 12" }, { "type": "primary", "measure": "Change from baseline the distance from Six Minute Walk Test at 12 weeks", "description": "Six minute walk test is a validated instrument developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.", "time_frame": "Baseline and week 12" }, { "type": "primary", "measure": "Change from baseline the mean Glutathione (GSH)/ oxidized GSH (GSSG) ratio at 12 weeks", "description": "The ratio of reduced Glutathione (GSH) to oxidized GSH (GSSG) is an indicator of cellular health, with reduced GSH constituting up to 98% of cellular GSH under normal conditions. It will be measured using The Glutathione GSH/GSSG Assay Kit, which is designed to accurately measure total, reduced and oxidized glutathione in biological samples using an enzymatic method that utilizes Ellman's Reagent (DTNB) and glutathione reductase (GR).", "time_frame": "Baseline and week 12" }, { "type": "primary", "measure": "Change from baseline the mean endothelial microparticles at 12 weeks", "description": "Endothelial microparticles is an emerging marker of endothelial dysfunction and also considered to play a major biological role in inflammation, vascular injury, angiogenesis, and thrombosis. Techniques to measure circulating endothelial microparticles rely on differential centrifugation in platelet-free plasma and on the identification of cell-surface Cluster of Differentiations (CD) antigens.", "time_frame": "Baseline and week 12" }, { "type": "secondary", "measure": "Change from baseline the score from Brief Fatigue Inventory (BFI) questionnaire at 12 weeks", "description": "Brief Fatigue Inventory (BFI) questionnaire is a valid instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. A global fatigue score can be obtained by averaging all the items on the BFI.", "time_frame": "Baseline and 12 weeks" }, { "type": "secondary", "measure": "Change from baseline the score from hand grip strength test using handgrip dynamometer at 12 weeks", "description": "The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. Handgrip strength is important because people with strong hands tend to be strong elsewhere, so this test is often used as a general test of strength.", "time_frame": "Baseline and 12 weeks" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 22, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05817032", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05808400", "title": "Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Exosomes in Treating Chronic Cough After COVID-19", "status": "UNKNOWN", "phase": "EARLY_PHASE1", "last_updated": "2023-04-14", "start_date": "2023-02-15", "completion_date": "2025-02-15", "primary_completion_date": "2024-02-15", "conditions_raw": [ "Long COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Msc-Derived Exosomes" ], "sponsor": "Huazhong University of Science and Technology", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This clinical trial aims to evaluate the safety and effectiveness of umbilical cord mesenchymal stem cell (UCMSC)-derived extracellular vesicle nebulization inhalation therapy for the treatment of chronic cough after COVID-19 infection. The main objective is to assess whether UCMSC-derived exosome nebulization inhalation therapy alleviates chronic cough after COVID-19.\n\nParticipants will be asked to complete a questionnaire to help researchers evaluate their cough severity and to record their scores before nebulization inhalation of UCMSC-derived exosomes. Participants will receive either continuous nebulized inhalation of UCMSC-derived exosomes for 5 days, twice daily, or no treatment. Researchers will compare the experimental and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.", "primary_outcomes": [ { "type": "primary", "measure": "Cough Evaluation Test", "description": "This score is to evaluate the relief of cough symptoms. Higher scores mean worse outcome. Minimum score is 5, maximum score is 25.", "time_frame": "6-14days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Improvement or relief time of symptoms", "description": "This indicator is to evaluate how many days it takes to alleviate cough", "time_frame": "6th, 15th, 28th day" } ], "outcome_measures": [ { "type": "primary", "measure": "Cough Evaluation Test", "description": "This score is to evaluate the relief of cough symptoms. Higher scores mean worse outcome. Minimum score is 5, maximum score is 25.", "time_frame": "6-14days" }, { "type": "secondary", "measure": "Improvement or relief time of symptoms", "description": "This indicator is to evaluate how many days it takes to alleviate cough", "time_frame": "6th, 15th, 28th day" } ], "relevance_tags": [ "General", "EARLY_Phase 1", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05808400", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05196529", "title": "Inspiratory Muscle Training in ME/CFS and COVID-19 Survivors", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-04-12", "start_date": "2022-05-09", "completion_date": "2023-01-31", "primary_completion_date": "2023-01-31", "conditions_raw": [ "Myalgic Encephalomyelitis", "Post-acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Inspiratory Muscle Training" ], "sponsor": "York University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Coronavirus-2019 (COVID-19) is a viral disease leading to respiratory dysfunction, but it may also affect the brain and result in the development of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This may be the result of the COVID-19 virus infecting regions of the brain responsible for respiratory control. The symptoms of COVID-19 long haulers and ME/CFS may be lessened via an 8-week inspiratory muscle training protocol which is a simple and easy training protocol which can be done at a patient's home.\n\nThus, this project will investigate changes in the breathing and cardiovascular responses to stimuli in three groups of participants: 1) healthy control individuals; 2) patients diagnosed with ME/CFS (mild to moderate symptoms); and 3) individuals with previous COVID-19 infection with long-haul symptoms lasting for at least 3 months. Participants will 1) breathe hypoxic gas (10% O2) for 5 minutes; 2) breath hypercapnic gas (5% CO2) for 5 minutes; 3) breathe at a rate of 6 breaths per minute for a total of 8 breaths (paced deep breathing); and 4) complete 10 minutes upright tilt (70 degrees head up on a tilt-table). Patients will also complete 2 questionnaires concerning their symptoms and a 15 minute cognitive function test on a lab laptop. This will allow for the assessment of the brain's control over blood pressure and breathing. Participants will also complete a 6-minute walking exercise test at their own speed as a measure of their aerobic fitness. We hypothesize that COVID-19 survivors will have a worse cardiovascular and autonomic response and lower fitness, similar to ME/CFS patients, compared to healthy participants.Further, this will be improved after 8-weeks of inspiratory muscle training. These results may help clinicians recognize ME/CFS symptoms in patients recovering from COVID-19.", "primary_outcomes": [ { "type": "primary", "measure": "Chemoreflex function", "description": "Ventilatory responses to the administration of 10% hypoxia or 5% hypercapnia will be measured.", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Clinical autonomic function", "description": "Cardiovascular responses to autonomic battery of tests", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Vascular function", "description": "Brachial artery dilation response to 5 minutes of circulatory occlusion (flow-mediated dilation).", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Cognitive function", "description": "Performance on proprietary cognitive function software", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Cardiorespiratory fitness", "description": "6-minute walk distance", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "ME symptoms", "description": "DePaul symptom questionnaire", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Chemoreflex function", "description": "Ventilatory responses to the administration of 10% hypoxia or 5% hypercapnia will be measured.", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Clinical autonomic function", "description": "Cardiovascular responses to autonomic battery of tests", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Vascular function", "description": "Brachial artery dilation response to 5 minutes of circulatory occlusion (flow-mediated dilation).", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Cognitive function", "description": "Performance on proprietary cognitive function software", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Cardiorespiratory fitness", "description": "6-minute walk distance", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "ME symptoms", "description": "DePaul symptom questionnaire", "time_frame": "8 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05196529", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05616806", "title": "Long COVID-19 Intervention Using Digital Health & Technology", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-04-04", "start_date": "2023-07-01", "completion_date": "2025-01-01", "primary_completion_date": "2024-07-01", "conditions_raw": [ "Long COVID", "Distress Tolerance" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Iendure" ], "sponsor": "Rhode Island Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The current study seeks to pilot test the iENDURE (Enhancing Distress tolerance to Uplift motivation in Recovery) intervention among 10 participants with Long COVID (Coronavirus Disease) symptoms. Following informed consent procedures, participants will complete a brief baseline assessment of self-report measures. Participants will then engage in the iENDURE intervention (described below) for 4 weeks. At the end of the intervention period, participants will complete another brief assessment of self-report measures and a qualitative interview about their experience with the program. Participants will be compensated for completing the baseline and post-intervention assessments", "primary_outcomes": [ { "type": "primary", "measure": "Client Satisfaction Score (CSQ-8)", "description": "Measure satisfaction scores after 4 weeks of using the intervention for this group of participants with Long COVID as measured by the client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "System Usability Score (SUS)", "description": "Measure usability after 4 weeks for this group of participants with Long COVID as measured by the 10 item system usability scale. In the SUS instrument, even and odd questions are scored differently. Odd questions are scored 0-4 based on the 1-5 selection, where a selection of 1 equals 0 points, a selection of 2 equals 1 point, and so on. Even questions are scored 4-0 on the 1-5 selection where a selection of 1 equals 4 points, a selection of 2 equals 3 points, and so on. Scores for all ten questions are added up for a total score between 0-40 points. This total is multiplied by 2.5 to generate a SUS score between 0-100 points. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.", "time_frame": "4 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Client Satisfaction Score (CSQ-8)", "description": "Measure satisfaction scores after 4 weeks of using the intervention for this group of participants with Long COVID as measured by the client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "System Usability Score (SUS)", "description": "Measure usability after 4 weeks for this group of participants with Long COVID as measured by the 10 item system usability scale. In the SUS instrument, even and odd questions are scored differently. Odd questions are scored 0-4 based on the 1-5 selection, where a selection of 1 equals 0 points, a selection of 2 equals 1 point, and so on. Even questions are scored 4-0 on the 1-5 selection where a selection of 1 equals 4 points, a selection of 2 equals 3 points, and so on. Scores for all ten questions are added up for a total score between 0-40 points. This total is multiplied by 2.5 to generate a SUS score between 0-100 points. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.", "time_frame": "4 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 10, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05616806", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05589272", "title": "TDCS-potentiated Generalization of Cognitive Training in the Rehabilitation of Long COVID Symptoms", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2023-03-13", "start_date": "2023-02-01", "completion_date": "2024-09-01", "primary_completion_date": "2023-09-01", "conditions_raw": [ "Post-acute Sequelae SARS-CoV-2 Infection (PASC)" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Active Tdcs" ], "sponsor": "University of Minnesota", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The overarching goals of this study are to employ cognitive testing to understand how transcranial direct current stimulation (tDCS), when used concurrently with cognitive training tasks, can affect cognitive impairment symptoms in individuals with long COVID, or post-acute sequelae SARS-CoV-2 infection (PASC), and to examine variability in response between active and sham tDCS treatment groups.", "primary_outcomes": [ { "type": "primary", "measure": "Cognitive improvement effects of WM training with active tDCS vs. sham", "description": "shown by WM task progression and performance on cognitive testing measures", "time_frame": "baseline and post-test assessment, 4 weeks" }, { "type": "primary", "measure": "Generalization of cognitive effects of active tDCS vs. sham", "description": "includes effect on PASC-related cognitive impairment symptoms", "time_frame": "baseline and post-test assessment, 4 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Cognitive improvement effects of WM training with active tDCS vs. sham", "description": "shown by WM task progression and performance on cognitive testing measures", "time_frame": "baseline and post-test assessment, 4 weeks" }, { "type": "primary", "measure": "Generalization of cognitive effects of active tDCS vs. sham", "description": "includes effect on PASC-related cognitive impairment symptoms", "time_frame": "baseline and post-test assessment, 4 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT05589272", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05531019", "title": "COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-02-28", "start_date": "2021-09-22", "completion_date": "2022-12-18", "primary_completion_date": "2022-12-08", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Echinochrome A" ], "sponsor": "Fernando Saldarini", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of this study is to assess the efficacy and efficiency of a nutraceutical from sea urchin eggs with Echinochrome A in the inflammation of tissues in subjects with long Corona Virus (COVID) syndome", "primary_outcomes": [ { "type": "primary", "measure": "Change of symptoms over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) during rutine medical checkup.", "description": "Measuring the symptoms as presence o absence of chest pain, cough, headache, sleep disorders, dysgeusia, myalgia, arthralgia.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change of lung capacity over four times (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during spirometry.", "description": "The main variables of forced spirometry that are measured are the forced vital capacity (FVC) and the forced expiratory volume in the first second (FEV1). The FVC represents the maximum volume of air exhaled in a maximal effort expiratory maneuver, initiated after a maximal inspiration maneuver, expressed in liters. FEV1 corresponds to the maximum volume of air exhaled in the first second of the FVC maneuver, also expressed in liters. In turn, the FEV1/FVC ratio shows the relationship between both parameters.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline, 4 weeks, 8 weeks, 12 weeks)", "description": "The 6MWT is used, among other things, to assess and control cardiovascular and pulmonary performance below the anaerobic threshold. This test is used for the clinical evaluation of the basic motor property endurance and measures the distance a patient can walk as quickly as possible on a flat, hard surface in a period of 6 minutes. It will be measured in meters.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change of depression measured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the Beck Health Questionnaire.", "description": "The Beck Anxiety Inventory is a useful tool to assess somatic symptoms of anxiety, both in anxiety disorders and depressive symptoms. The questionnaire consists of 21 questions, providing a score range between 0 and 63.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the quality of life meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via visual analog scale of EuroQol (EQ-VAS).", "description": "EQ-VAS which is a scale of 0 to 100 that allows individuals to place themselves according to how they perceive their overall health status (0 is the worst and 100 the best health status)", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Presence or absence of Myocarditis meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via electrocardiogram.", "description": "Electrocardiographic signs in patients with myocarditis include T-wave and ST-segment abnormalities, ST-segment elevation", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Trial Making test (TMT).", "description": "The TMT is timed (seconds) and performed in two parts using only a pen and a piece of paper.It can provide insights into a person's cognitive function based on how fast they can search, scan, and process visual information without losing track of what they are doing.The test also provides information about a person's mental flexibility.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Phonological verbal fluency test.", "description": "Verbal fluency tests are commonly used to investigate lexical skills and semantic knowledge. for number of words beginning with the letters F, A, and S and for to al number of words beginning with either letter generated per minute.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Frontal assessment battery (FAB).", "description": "The Frontal Assessment Battery (FAB) is a cognitive test that incorporates several clinical assessments to screen for frontotemporal dementia (FTD), including S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via clock test (CDT).", "description": "The CDT is used to quickly assess visuospatial and praxis abilities, and may determine the presence or absence of both attention and executive dysfunctions: ask the patient to draw the face of a clock and then to draw the hands to indicate a particular time.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Analogies (WAIS-III).", "description": "Wais-III is an instrument for assessing Verbal Comprehension, it refers to conceptualization, knowledge and verbal expression. The subject must answer questions that measure practical knowledge, word meanings, reasoning, and the ability to express ideas in words. The Analogies subtest assesses fluid intelligence where the subject's ability to solve new problems that do not depend on schooling or formal culture is reflected: before a series of words presented, the examinee must explain the similarity of common objects or concepts that those terms represent. Maximum direct score 33 points.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the memory over time-points ) baseline, 4 weeks, 8 weeks, 12 weeks) via Rey Auditory Verbal Learning Test.", "description": "The test is designed as a list-learning paradigm in which the patient hears a list of 15 nouns and is asked to recall as many words from the list as possible. After five repetitions of free-recall, a second \"interference\" list (List B) is presented in the same manner, and the participant is asked to recall as many words from List B as possible. After the interference trial, the participant is immediately asked to recall the words from List A, which she or he heard five times previously. After a 20 min delay, the participant is asked to again recall the words from List A. After this \"delayed recall\" task, a list of 50 words is presented containing all of the words from Lists A. The score given for each trial is the total number of words recalled. Normal scores are 6 words hit on the first trial and 12 or 13 on the fifth trial.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the memory failures of every-day (MFE)", "description": "The Memory Failures of Everyday-MFE Questionnaire was used for the subjective assessment of memory. It consists of 28 items on situations and activities of daily living. Each item was scored on a 0-2 point scale (\"never or rarely\", \"sometimes\", \"many times\").", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the overall cognitive ability over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during Addenbrooke's Cognitive Examination Revised (ACE-R) test.", "description": "The ACE-R takes between 12 and 20 min (average 16) to administer and score in a clinical setting. It contains 5 sub-scores, each one representing one cognitive domain: attention/orientation (18 points), memory (26 points), fluency (14 points), language (26 points) and visuospatial (16 points). ACE-R maximum score is 100, composed by the addition of the all domains", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the overall memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during Digit Span (WAIS-III): Forward.", "description": "The Digit Span score is the length of the longest correctly repeated sequence. The idea was to test how much a person can receive, process and remember for a variety of elements. On average a person is not capable of retaining more than 7 pieces of information. This means that when the longest repeated sequence is 7, the participant reached level 7. The test was assessed in forward orders of the digits.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the assess aspects such as selective attention and inhibitory control over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Stroop test.", "description": "Throughout the Stroop test, a total of three different tasks are carried out, through three sheets in which five columns of 20 elements appear. Each one of the tasks is carried out during a certain time (for example, forty-five seconds), scoring the successes for later evaluation. The successes that the subject has had during the test or the time it takes to react to the stimulation are valued, paying attention to what is reflected in each of the sheets or tasks.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Boston Nomination Test.", "description": "The Boston vocabulary test consists of 60 figures, ordered from the easiest to the most difficult. The figures are presented in order, allowing the subject 20 seconds to respond. The scores provided by the test are: - The number of correct answers given spontaneously.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via semantic Verbal Fluency test.", "description": "The Semantic Verbal Fluency (SVF) test entails the generation of words from a given category within a pre-set time of 60 seconds.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in sleep behaviors over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via The Pittsburgh Sleep Quality Index (PSQI)", "description": "The Pittsburgh Sleep Quality Index (PSQI) is the most widely used sleep questionnaire in adults, consisting of 24 questions. The first 19 questions are answered by the evaluated person taking into account what they have experienced during the last month.\n\nResultados de traducción Sleep quality index (PSQI)", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in concussion over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via king figure method.", "description": "Demonstration and test cards for the King-Devick test, a candidate rapid sideline screening for concussion based on speed of rapid number naming. To perform the King-Devick test, participants are asked to read the numbers on each card from left to right as quickly as possible, but without making any errors. Following completion of the demonstration card (upper left), subjects are then asked to read each of the three test cards in the same manner. The times required to complete each card are recorded in seconds using a stopwatch. The sum of the three test card time scores constitutes the summary score for the entire test, the King-Devick time score. Numbers of errors made in reading the test cards are also recorded; misspeaks on numbers are recorded as errors only if the subject does not immediately correct the mistake before going on to the next number.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in olfactory-specific quality of life over time-points (baseline, 4 weeñs, 8 weeks, 12 weeks) via questionnaire of olfactory disorders-negative statements (QOD-NS) and a short version of QOD-NS (sQOD-NS).", "description": "The QOD-NS questionnaire consists of 17 negative statements about the degree to which patients suffered from olfactory impairment. Patients can agree, partly agree, partly disagree, or disagree in each statement which ranges from 0 to 3. A total score of 0-51 is calculated with higher scores reflecting worse olfactory-specific quality of life. For the sQOD-NS questionnaire composed of 7 items, the total scores range from 0 to 21.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in dyspnea scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via modified Medical Research Council (mMRC) dyspnoea scale.", "description": "The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in scale of Asthenia over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via asthenia scale.", "description": "Analog scale from 0 to 100 mm", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Fatigue scale over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via Krupp Clader CFQ-11 Fatigue Intensity Scale.", "description": "The Chalder Fatigue Questionnaire (CFQ) also referred to as the Chalder Fatigue Scale, is an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales. Seven items represent physical fatigue (items 1-7) and 4 represent mental fatigue (items 8-11). Each item is scored 0-3; less than usual (0), no more than usual (1), more than usual (2) and much more than usual (3). The ratings of items are added together to calculate the total score (range=0-33). High scores represent high levels of fatigue.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Emotions scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Brackets RULER scale.", "description": "Brackets' RULER syllabus consists of five key skills, which anyone can learn. The acronym \"RULER\" stands for Recognize, Understand, Label, Express, and Regulate. The first three skills allow us to practice identifying our emotions. The last two allow us to develop the necessary skills to deal with them. The RULER curriculum is about gathering information by recognizing and understanding emotions. Apply emotional intelligence to various situations.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change of Von Willebrand Factor over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.", "description": "Von Willebrand factor will be measured by an automated, highly sensitive and specific immuno-turbidimetric assay (Liatest antigenic Stago, France. VWF in %. VWF an \"acute phase protein\" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes, and represent the best biomarkers as endothelial pertubation.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change of D Dimer over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.", "description": "D Dimer (\\<500 ng/ml FEU) is altered in prothrombotic or thrombotic processes.plasma levels of D-Dimer will be measured by sandwich ELISA in citrated plasma (VIDAS D-Dimer, BioMerieux SA ).", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change of HS-CRP over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.", "description": "CRP (\\< 0,5 mg/dl) is an \"acute phase protein\" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes; ultra-sensitive CRP is additionally a risk assessment marker of aterosclerosis", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change of Ferritin over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.", "description": "Ferritin (Men: 12 to 300 ng/mL Women: 12 to 150 ng/mL.) is an \"acute phase protein\" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of symptoms over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) during rutine medical checkup.", "description": "Measuring the symptoms as presence o absence of chest pain, cough, headache, sleep disorders, dysgeusia, myalgia, arthralgia.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change of lung capacity over four times (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during spirometry.", "description": "The main variables of forced spirometry that are measured are the forced vital capacity (FVC) and the forced expiratory volume in the first second (FEV1). The FVC represents the maximum volume of air exhaled in a maximal effort expiratory maneuver, initiated after a maximal inspiration maneuver, expressed in liters. FEV1 corresponds to the maximum volume of air exhaled in the first second of the FVC maneuver, also expressed in liters. In turn, the FEV1/FVC ratio shows the relationship between both parameters.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change of walking distance during a six minutes walk test (6MWT) over time-points (baseline, 4 weeks, 8 weeks, 12 weeks)", "description": "The 6MWT is used, among other things, to assess and control cardiovascular and pulmonary performance below the anaerobic threshold. This test is used for the clinical evaluation of the basic motor property endurance and measures the distance a patient can walk as quickly as possible on a flat, hard surface in a period of 6 minutes. It will be measured in meters.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change of depression measured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the Beck Health Questionnaire.", "description": "The Beck Anxiety Inventory is a useful tool to assess somatic symptoms of anxiety, both in anxiety disorders and depressive symptoms. The questionnaire consists of 21 questions, providing a score range between 0 and 63.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the quality of life meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via visual analog scale of EuroQol (EQ-VAS).", "description": "EQ-VAS which is a scale of 0 to 100 that allows individuals to place themselves according to how they perceive their overall health status (0 is the worst and 100 the best health status)", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Presence or absence of Myocarditis meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via electrocardiogram.", "description": "Electrocardiographic signs in patients with myocarditis include T-wave and ST-segment abnormalities, ST-segment elevation", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Trial Making test (TMT).", "description": "The TMT is timed (seconds) and performed in two parts using only a pen and a piece of paper.It can provide insights into a person's cognitive function based on how fast they can search, scan, and process visual information without losing track of what they are doing.The test also provides information about a person's mental flexibility.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Phonological verbal fluency test.", "description": "Verbal fluency tests are commonly used to investigate lexical skills and semantic knowledge. for number of words beginning with the letters F, A, and S and for to al number of words beginning with either letter generated per minute.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Frontal assessment battery (FAB).", "description": "The Frontal Assessment Battery (FAB) is a cognitive test that incorporates several clinical assessments to screen for frontotemporal dementia (FTD), including S-word generation, similarities, Luria's test, grasp reflex, and the Go-No-Go test.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via clock test (CDT).", "description": "The CDT is used to quickly assess visuospatial and praxis abilities, and may determine the presence or absence of both attention and executive dysfunctions: ask the patient to draw the face of a clock and then to draw the hands to indicate a particular time.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the cognitive function meassured over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Analogies (WAIS-III).", "description": "Wais-III is an instrument for assessing Verbal Comprehension, it refers to conceptualization, knowledge and verbal expression. The subject must answer questions that measure practical knowledge, word meanings, reasoning, and the ability to express ideas in words. The Analogies subtest assesses fluid intelligence where the subject's ability to solve new problems that do not depend on schooling or formal culture is reflected: before a series of words presented, the examinee must explain the similarity of common objects or concepts that those terms represent. Maximum direct score 33 points.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the memory over time-points ) baseline, 4 weeks, 8 weeks, 12 weeks) via Rey Auditory Verbal Learning Test.", "description": "The test is designed as a list-learning paradigm in which the patient hears a list of 15 nouns and is asked to recall as many words from the list as possible. After five repetitions of free-recall, a second \"interference\" list (List B) is presented in the same manner, and the participant is asked to recall as many words from List B as possible. After the interference trial, the participant is immediately asked to recall the words from List A, which she or he heard five times previously. After a 20 min delay, the participant is asked to again recall the words from List A. After this \"delayed recall\" task, a list of 50 words is presented containing all of the words from Lists A. The score given for each trial is the total number of words recalled. Normal scores are 6 words hit on the first trial and 12 or 13 on the fifth trial.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via the memory failures of every-day (MFE)", "description": "The Memory Failures of Everyday-MFE Questionnaire was used for the subjective assessment of memory. It consists of 28 items on situations and activities of daily living. Each item was scored on a 0-2 point scale (\"never or rarely\", \"sometimes\", \"many times\").", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the overall cognitive ability over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during Addenbrooke's Cognitive Examination Revised (ACE-R) test.", "description": "The ACE-R takes between 12 and 20 min (average 16) to administer and score in a clinical setting. It contains 5 sub-scores, each one representing one cognitive domain: attention/orientation (18 points), memory (26 points), fluency (14 points), language (26 points) and visuospatial (16 points). ACE-R maximum score is 100, composed by the addition of the all domains", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the overall memory over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) assessed during Digit Span (WAIS-III): Forward.", "description": "The Digit Span score is the length of the longest correctly repeated sequence. The idea was to test how much a person can receive, process and remember for a variety of elements. On average a person is not capable of retaining more than 7 pieces of information. This means that when the longest repeated sequence is 7, the participant reached level 7. The test was assessed in forward orders of the digits.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in the assess aspects such as selective attention and inhibitory control over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Stroop test.", "description": "Throughout the Stroop test, a total of three different tasks are carried out, through three sheets in which five columns of 20 elements appear. Each one of the tasks is carried out during a certain time (for example, forty-five seconds), scoring the successes for later evaluation. The successes that the subject has had during the test or the time it takes to react to the stimulation are valued, paying attention to what is reflected in each of the sheets or tasks.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Boston Nomination Test.", "description": "The Boston vocabulary test consists of 60 figures, ordered from the easiest to the most difficult. The figures are presented in order, allowing the subject 20 seconds to respond. The scores provided by the test are: - The number of correct answers given spontaneously.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in the expression of language over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via semantic Verbal Fluency test.", "description": "The Semantic Verbal Fluency (SVF) test entails the generation of words from a given category within a pre-set time of 60 seconds.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in sleep behaviors over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via The Pittsburgh Sleep Quality Index (PSQI)", "description": "The Pittsburgh Sleep Quality Index (PSQI) is the most widely used sleep questionnaire in adults, consisting of 24 questions. The first 19 questions are answered by the evaluated person taking into account what they have experienced during the last month.\n\nResultados de traducción Sleep quality index (PSQI)", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in concussion over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via king figure method.", "description": "Demonstration and test cards for the King-Devick test, a candidate rapid sideline screening for concussion based on speed of rapid number naming. To perform the King-Devick test, participants are asked to read the numbers on each card from left to right as quickly as possible, but without making any errors. Following completion of the demonstration card (upper left), subjects are then asked to read each of the three test cards in the same manner. The times required to complete each card are recorded in seconds using a stopwatch. The sum of the three test card time scores constitutes the summary score for the entire test, the King-Devick time score. Numbers of errors made in reading the test cards are also recorded; misspeaks on numbers are recorded as errors only if the subject does not immediately correct the mistake before going on to the next number.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in olfactory-specific quality of life over time-points (baseline, 4 weeñs, 8 weeks, 12 weeks) via questionnaire of olfactory disorders-negative statements (QOD-NS) and a short version of QOD-NS (sQOD-NS).", "description": "The QOD-NS questionnaire consists of 17 negative statements about the degree to which patients suffered from olfactory impairment. Patients can agree, partly agree, partly disagree, or disagree in each statement which ranges from 0 to 3. A total score of 0-51 is calculated with higher scores reflecting worse olfactory-specific quality of life. For the sQOD-NS questionnaire composed of 7 items, the total scores range from 0 to 21.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Changes in dyspnea scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via modified Medical Research Council (mMRC) dyspnoea scale.", "description": "The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in scale of Asthenia over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via asthenia scale.", "description": "Analog scale from 0 to 100 mm", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Fatigue scale over time-point (baseline, 4 weeks, 8 weeks, 12 weeks) via Krupp Clader CFQ-11 Fatigue Intensity Scale.", "description": "The Chalder Fatigue Questionnaire (CFQ) also referred to as the Chalder Fatigue Scale, is an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales. Seven items represent physical fatigue (items 1-7) and 4 represent mental fatigue (items 8-11). Each item is scored 0-3; less than usual (0), no more than usual (1), more than usual (2) and much more than usual (3). The ratings of items are added together to calculate the total score (range=0-33). High scores represent high levels of fatigue.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "primary", "measure": "Change in Emotions scale over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via Brackets RULER scale.", "description": "Brackets' RULER syllabus consists of five key skills, which anyone can learn. The acronym \"RULER\" stands for Recognize, Understand, Label, Express, and Regulate. The first three skills allow us to practice identifying our emotions. The last two allow us to develop the necessary skills to deal with them. The RULER curriculum is about gathering information by recognizing and understanding emotions. Apply emotional intelligence to various situations.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change of Von Willebrand Factor over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.", "description": "Von Willebrand factor will be measured by an automated, highly sensitive and specific immuno-turbidimetric assay (Liatest antigenic Stago, France. VWF in %. VWF an \"acute phase protein\" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes, and represent the best biomarkers as endothelial pertubation.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change of D Dimer over time-points (baseline, 4 weeks, 12 weeks, 12 weeks) via blood sample.", "description": "D Dimer (\\<500 ng/ml FEU) is altered in prothrombotic or thrombotic processes.plasma levels of D-Dimer will be measured by sandwich ELISA in citrated plasma (VIDAS D-Dimer, BioMerieux SA ).", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change of HS-CRP over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.", "description": "CRP (\\< 0,5 mg/dl) is an \"acute phase protein\" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes; ultra-sensitive CRP is additionally a risk assessment marker of aterosclerosis", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" }, { "type": "secondary", "measure": "Change of Ferritin over time-points (baseline, 4 weeks, 8 weeks, 12 weeks) via blood sample.", "description": "Ferritin (Men: 12 to 300 ng/mL Women: 12 to 150 ng/mL.) is an \"acute phase protein\" which increases in infections (bacterial, less viral and fungi), inflammation, post-OP, malignant processes.", "time_frame": "Baseline, 4 weeks, 8 weeks, 12 weeks" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 54, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05531019", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05419219", "title": "TaiChi-DTx for Treating Long Covid Symptoms", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-02-15", "start_date": "2022-06-01", "completion_date": "2023-12-31", "primary_completion_date": "2023-05-31", "conditions_raw": [ "Fatigue", "Dyspnea", "Cognitive Impairment", "Muscle Pain" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "The Multi-Domain Tai Chi Digital Therapy Software Application" ], "sponsor": "Tim Shi", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The randomized controlled trial will be conducted to evaluate the effectiveness of a Multi-domain Tai Chi Digital Therapy for treating the individuals suffering from the long term COVID-19 syndrome (Long COVID).", "primary_outcomes": [ { "type": "primary", "measure": "Change in Physical Activity ability measured by 6-minute walking distance measurement (6MWT)", "description": "The 6-min walk test (6 MWT), a recognized norm by American Thoracic Society, is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-min walk distance (6 MWD) in a 30 meter or 100 foot walkway provides a measure for the integrated response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Overall respiratory relief measured by the Post-COVID-19 Functional Status (PCFS) Scale", "description": "The PCFS scale covers the entire range of functional limitations, including changes in lifestyle, sports, and social activities, and has been widely used as a standard tool to assess recovery after COVID-19 infections (Garout, M.A, 2022). The assignment of a PCFS scale grade concerns the average situation of the past week. The symptoms included in PCFS are dyspnea, pain, fatigue, muscle weakness, memory loss, depression, and anxiety.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Cognitive impairment improvement measured by the well-validated neuropsychological measurement tests", "description": "Assessment tools including Number Span forward (attention) and backward (working memory) (Becker et al. 2021), and Trail Making Test (processing speed and executive functioning), etc (Douaud, G, et al. 2022).", "time_frame": "4-6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in number of hours/days absent from work related to Long COVID symptoms survey by web-based questionnaires (time frame 6 months after SARS-CoV-2 infection)", "description": "The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)", "time_frame": "4-6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Physical Activity ability measured by 6-minute walking distance measurement (6MWT)", "description": "The 6-min walk test (6 MWT), a recognized norm by American Thoracic Society, is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-min walk distance (6 MWD) in a 30 meter or 100 foot walkway provides a measure for the integrated response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Overall respiratory relief measured by the Post-COVID-19 Functional Status (PCFS) Scale", "description": "The PCFS scale covers the entire range of functional limitations, including changes in lifestyle, sports, and social activities, and has been widely used as a standard tool to assess recovery after COVID-19 infections (Garout, M.A, 2022). The assignment of a PCFS scale grade concerns the average situation of the past week. The symptoms included in PCFS are dyspnea, pain, fatigue, muscle weakness, memory loss, depression, and anxiety.", "time_frame": "4 weeks" }, { "type": "primary", "measure": "Cognitive impairment improvement measured by the well-validated neuropsychological measurement tests", "description": "Assessment tools including Number Span forward (attention) and backward (working memory) (Becker et al. 2021), and Trail Making Test (processing speed and executive functioning), etc (Douaud, G, et al. 2022).", "time_frame": "4-6 weeks" }, { "type": "secondary", "measure": "Change in number of hours/days absent from work related to Long COVID symptoms survey by web-based questionnaires (time frame 6 months after SARS-CoV-2 infection)", "description": "The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)", "time_frame": "4-6 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 200, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05419219", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05725538", "title": "Exercise Intervention Using mHealth in Patients With Post-Acute COVID-19 Syndrome: a Randomized Clinical Trial", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-02-13", "start_date": "2023-03-15", "completion_date": "2024-09-15", "primary_completion_date": "2024-03-15", "conditions_raw": [ "Post-Acute COVID19 Syndrome", "Long COVID", "Post COVID-19 Condition" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Covidreapp Group" ], "sponsor": "University of Cadiz", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Post-Acute Syndrome COVID-19 is a disease resulting from infection by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that between 10 and 35% of infected persons suffer symptoms afterwards, and in hospitalized patients it can reach 85%. These sequelae have individual, social and economic repercussions, so effective rehabilitation alternatives are necessary. Physical exercise is recommended as rehabilitation for these patients. Moreover, the implementation of m-Health supported interventions is a proven alternative in patients with Post-Acute COVID-19 Syndrome or other conditions, which improves therapeutic adherence and patient autonomy. Therefore, the development and evaluation of the effectiveness of an exercise-based m-Health system for application in patients with Post-Acute COVID-19 Syndrome responds to a need.\n\nOur hypothesis is that a mobile health technology based on physical exercise recommendations for patients with Post-Acute COVID-19 Syndrome will improve fatigue, physical fitness, post-exertional dyspnea, pain intensity, anxiety, depression, cognitive function, and quality of life. Therefore, this project aims to evaluate the efficacy of the mobile health technology system (COVIDReApp) based on physical exercise recommendations for patients with COVID-19 Post-Acute Syndrome based on its results on fatigue, physical condition, post-exertional dyspnea, pain intensity, anxiety and depression, cognitive function and quality of life.\n\nThe achievement of the present project will serve to analyze the benefits of a physical exercise program in patients with COVID-19 Post-Acute Syndrome and identify those patients in whom the benefits will be greatest and whose implementation will have the highest priority.", "primary_outcomes": [ { "type": "primary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Fatigue (Fatigue Severity Scale (FSS))", "description": "The FSS consists of 9 items related to the interference of fatigue with specific activities and rates the perceived severity of fatigue on a 7-point scale (1 = \"strongly disagree\"; 7 = \"strongly agree\").", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "primary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Post-exertional dyspnoea (Dyspnoea-12)", "description": "Post-exertional dyspnea is assessed using the Dyspnea-12, a short questionnaire that takes into account both sensory and affective factors that may play a role in dyspnea. Each item in the questionnaire is scored from 0, if the symptom is mild, to 3, if it is severe, and the total score is the sum of the scores for all items. Six of the questions relate to sensory aspects and 6 to affective aspects of dyspnea. The total score ranges from 0 to 36, with 36 being the highest possible severity and 0 being the lowest.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "primary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Quality of life (SF-12v2)", "description": "The Short Form-12 (SF-12v2) will be administered to assess quality of life. This instrument contains 12 items that allow us to calculate the profile of 8 dimensions: (physical functioning, role-physical, bodily pain, general health perception, vitality, social functioning, role-emotional, and mental health) and two global scores: the physical health (PCS-12) and the mental health (MCS-12) component summary. Each global score ranges from 0 to 100, with higher scores indicating better health.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Pain intensity (Visual Analog Scale (VAS))", "description": "VAS is a scale used to rate the patient's pain intensity. The patient chooses a number from 0 to 10 (11-point numeric scale) that represents the best level of pain that the patient can imagine. A score of 0 represents no pain and 10 represents the worst pain imaginable.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Upper limb strength (Arm curl test)", "description": "The Arm Curl Test assesses upper body strength by determining the number of times a hand weight (2.3 kg) can be curled through a full range of motion in 30 seconds.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Lower limb strength (Chair stand test)", "description": "The chair stand test evaluates lower body muscular strength by counting the number of times a person can go from a sitting position to a standing position in 30 seconds.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Functional capacity and endurance (Two-minute walk test (2MWT))", "description": "The two-minute walk test (2MWT) assesses walking ability, functional endurance and functional capacity. It consists of measuring the distance the patient can walk for 2 minutes as fast as he or she can safely without assistance.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Depression and/or anxiety (Hospital Anxiety and Depression Scale (HADs)", "description": "Depression and anxiety are assessed using the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D).", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Cognitive function (Test Your Memory (TYM))", "description": "The Test Your Memory (TYM) screening test is used to assess cognitive function. This tool consists of 10 items with a total score ranging from 0 to 50, calculated on 10 cognitive dimensions: executive function, anterograde memory, visuospatial ability, naming, similarities, verbal fluency, calculation, retrograde memory, copying, orientation. The cut-off point is 42/50 (≤41 points indicates cognitive dysfunction) and a higher score indicates better cognitive performance.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Height, weight, and body mass index", "description": "Body measurements: height (standard height meter), weight, and body mass index (Tanita Model TBF-310 GS Weight Scale, Tanita Corporation of America, Inc., Arlington Heights, IL).", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Baseline of sociodemographic variables", "description": "A structured questionnaire will be used to collect sociodemographic data, including the following variables: gender, age, socioeconomic status, marital status, education level, employment status, clinical data, and use of alternative therapies.", "time_frame": "Baseline." }, { "type": "secondary", "measure": "Daily registry of the exercise difficulty (Borg Rating of Perceived Exertion Scale (RPE))", "description": "CovidReApp system will register the daily exercise, which allows us to know the exercise difficulty of each exercise.", "time_frame": "Only CovidReApp group: Daily." }, { "type": "secondary", "measure": "Daily registry of the adherence (CovidReApp log registration and self-reported)", "description": "The information is collected by the system only in the COVIDReApp group.", "time_frame": "Daily." } ], "outcome_measures": [ { "type": "primary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Fatigue (Fatigue Severity Scale (FSS))", "description": "The FSS consists of 9 items related to the interference of fatigue with specific activities and rates the perceived severity of fatigue on a 7-point scale (1 = \"strongly disagree\"; 7 = \"strongly agree\").", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "primary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Post-exertional dyspnoea (Dyspnoea-12)", "description": "Post-exertional dyspnea is assessed using the Dyspnea-12, a short questionnaire that takes into account both sensory and affective factors that may play a role in dyspnea. Each item in the questionnaire is scored from 0, if the symptom is mild, to 3, if it is severe, and the total score is the sum of the scores for all items. Six of the questions relate to sensory aspects and 6 to affective aspects of dyspnea. The total score ranges from 0 to 36, with 36 being the highest possible severity and 0 being the lowest.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "primary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Quality of life (SF-12v2)", "description": "The Short Form-12 (SF-12v2) will be administered to assess quality of life. This instrument contains 12 items that allow us to calculate the profile of 8 dimensions: (physical functioning, role-physical, bodily pain, general health perception, vitality, social functioning, role-emotional, and mental health) and two global scores: the physical health (PCS-12) and the mental health (MCS-12) component summary. Each global score ranges from 0 to 100, with higher scores indicating better health.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Pain intensity (Visual Analog Scale (VAS))", "description": "VAS is a scale used to rate the patient's pain intensity. The patient chooses a number from 0 to 10 (11-point numeric scale) that represents the best level of pain that the patient can imagine. A score of 0 represents no pain and 10 represents the worst pain imaginable.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Upper limb strength (Arm curl test)", "description": "The Arm Curl Test assesses upper body strength by determining the number of times a hand weight (2.3 kg) can be curled through a full range of motion in 30 seconds.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Lower limb strength (Chair stand test)", "description": "The chair stand test evaluates lower body muscular strength by counting the number of times a person can go from a sitting position to a standing position in 30 seconds.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Functional capacity and endurance (Two-minute walk test (2MWT))", "description": "The two-minute walk test (2MWT) assesses walking ability, functional endurance and functional capacity. It consists of measuring the distance the patient can walk for 2 minutes as fast as he or she can safely without assistance.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Depression and/or anxiety (Hospital Anxiety and Depression Scale (HADs)", "description": "Depression and anxiety are assessed using the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D).", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Cognitive function (Test Your Memory (TYM))", "description": "The Test Your Memory (TYM) screening test is used to assess cognitive function. This tool consists of 10 items with a total score ranging from 0 to 50, calculated on 10 cognitive dimensions: executive function, anterograde memory, visuospatial ability, naming, similarities, verbal fluency, calculation, retrograde memory, copying, orientation. The cut-off point is 42/50 (≤41 points indicates cognitive dysfunction) and a higher score indicates better cognitive performance.", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Longitudinal Change from Baseline up to 24 Weeks Follow-up in Height, weight, and body mass index", "description": "Body measurements: height (standard height meter), weight, and body mass index (Tanita Model TBF-310 GS Weight Scale, Tanita Corporation of America, Inc., Arlington Heights, IL).", "time_frame": "Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment." }, { "type": "secondary", "measure": "Baseline of sociodemographic variables", "description": "A structured questionnaire will be used to collect sociodemographic data, including the following variables: gender, age, socioeconomic status, marital status, education level, employment status, clinical data, and use of alternative therapies.", "time_frame": "Baseline." }, { "type": "secondary", "measure": "Daily registry of the exercise difficulty (Borg Rating of Perceived Exertion Scale (RPE))", "description": "CovidReApp system will register the daily exercise, which allows us to know the exercise difficulty of each exercise.", "time_frame": "Only CovidReApp group: Daily." }, { "type": "secondary", "measure": "Daily registry of the adherence (CovidReApp log registration and self-reported)", "description": "The information is collected by the system only in the COVIDReApp group.", "time_frame": "Daily." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05725538", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05706454", "title": "Phase 2/Phase 3 Study To Evaluate The Efficacy And Safety Of Ramatroban Along With The Standard Of Care In Subjects Hospitalized For COVID Pneumonia", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2023-01-31", "start_date": "2022-11-10", "completion_date": "2026-05-31", "primary_completion_date": "2024-07-01", "conditions_raw": [ "COVID-19 Pneumonia", "COVID-19 Respiratory Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Ramatroban" ], "sponsor": "KARE Biosciences", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection.\n\nApproximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups.\n\nGroup I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care.\n\nPhase 2\n\nPrimary Objective:\n\nTo evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.\n\nSecondary Objective:\n\nTo assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.\n\nPhase 3\n\nPrimary Objective:\n\nTo evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.\n\nSecondary Objective:\n\nTo evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects.\n\nLong COVID \\[Follow-up Phase- Objectives- (Phase 2 \\& 3)\\]\n\n1. To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment.\n2. To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC", "primary_outcomes": [ { "type": "primary", "measure": "Rate of Serious Adverse Events (SAE)", "description": "", "time_frame": "Baseline - Day 29" }, { "type": "primary", "measure": "Time to Clinical recovery (TTCR)", "description": "", "time_frame": "Baseline - Day 15" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Composite endpoint of death or need for mechanical ventilation or ECMO", "description": "", "time_frame": "Baseline - Day 29" }, { "type": "secondary", "measure": "Rate of mechanical ventilation or vasopressor therapy, or ECMO", "description": "", "time_frame": "Day 29" }, { "type": "secondary", "measure": "Ventilator free days", "description": "", "time_frame": "Baseline-Day 29" }, { "type": "secondary", "measure": "Duration of hospitalization", "description": "", "time_frame": "Baseline-Day 29" }, { "type": "secondary", "measure": "Duration of ICU stay", "description": "", "time_frame": "Baseline-Day 29" }, { "type": "secondary", "measure": "Number of subjects who had thrombotic events", "description": "", "time_frame": "Within Day 29" }, { "type": "secondary", "measure": "Mortality rate", "description": "", "time_frame": "Till Day 29" }, { "type": "secondary", "measure": "Change in hemoglobin, platelets, WBC, creatinine, need for renal replacement.", "description": "", "time_frame": "Baseline- Day 29" }, { "type": "secondary", "measure": "Occurrence of serious ventricular arrhythmia", "description": "", "time_frame": "censored at hospital discharge" }, { "type": "secondary", "measure": "Total red blood cell units transfused", "description": "", "time_frame": "Baseline -Day 29" }, { "type": "secondary", "measure": "Major or Clinically Significant Non-Major Bleeding", "description": "", "time_frame": "Baseline -Day 29" }, { "type": "secondary", "measure": "Change from baseline of inflammation and coagulation markers", "description": "", "time_frame": "Baseline- Day 29" } ], "outcome_measures": [ { "type": "primary", "measure": "Rate of Serious Adverse Events (SAE)", "description": "", "time_frame": "Baseline - Day 29" }, { "type": "primary", "measure": "Time to Clinical recovery (TTCR)", "description": "", "time_frame": "Baseline - Day 15" }, { "type": "secondary", "measure": "Composite endpoint of death or need for mechanical ventilation or ECMO", "description": "", "time_frame": "Baseline - Day 29" }, { "type": "secondary", "measure": "Rate of mechanical ventilation or vasopressor therapy, or ECMO", "description": "", "time_frame": "Day 29" }, { "type": "secondary", "measure": "Ventilator free days", "description": "", "time_frame": "Baseline-Day 29" }, { "type": "secondary", "measure": "Duration of hospitalization", "description": "", "time_frame": "Baseline-Day 29" }, { "type": "secondary", "measure": "Duration of ICU stay", "description": "", "time_frame": "Baseline-Day 29" }, { "type": "secondary", "measure": "Number of subjects who had thrombotic events", "description": "", "time_frame": "Within Day 29" }, { "type": "secondary", "measure": "Mortality rate", "description": "", "time_frame": "Till Day 29" }, { "type": "secondary", "measure": "Change in hemoglobin, platelets, WBC, creatinine, need for renal replacement.", "description": "", "time_frame": "Baseline- Day 29" }, { "type": "secondary", "measure": "Occurrence of serious ventricular arrhythmia", "description": "", "time_frame": "censored at hospital discharge" }, { "type": "secondary", "measure": "Total red blood cell units transfused", "description": "", "time_frame": "Baseline -Day 29" }, { "type": "secondary", "measure": "Major or Clinically Significant Non-Major Bleeding", "description": "", "time_frame": "Baseline -Day 29" }, { "type": "secondary", "measure": "Change from baseline of inflammation and coagulation markers", "description": "", "time_frame": "Baseline- Day 29" } ], "relevance_tags": [ "General", "Phase 2", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 324, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05706454", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04604704", "title": "Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2023-01-25", "start_date": "2021-01-28", "completion_date": "2023-01-23", "primary_completion_date": "2023-01-23", "conditions_raw": [ "Covid19", "Long COVID-19", "Post-COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Naltrexone", "Nad+" ], "sponsor": "AgelessRx", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+", "description": "Reduction of fatigue score from baseline as measured by the Chalder fatigue scale in post-COVID-19 syndrome by treatment with LDN and NAD+. The Chalder scale has a minimum value of 0 and a maximum value of 33, and the higher the score the more severe the fatigue symptoms are.", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+.", "description": "Improvement of quality of life scores from baseline as measured by the short form-36 (SF-36) survey in post-COVID-19 syndrome by treatment with LDN and NAD+. The SF-36 survey provides scores between 0-100 with lower scores representing more disability.", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+", "description": "Reduction of fatigue score from baseline as measured by the Chalder fatigue scale in post-COVID-19 syndrome by treatment with LDN and NAD+. The Chalder scale has a minimum value of 0 and a maximum value of 33, and the higher the score the more severe the fatigue symptoms are.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+.", "description": "Improvement of quality of life scores from baseline as measured by the short form-36 (SF-36) survey in post-COVID-19 syndrome by treatment with LDN and NAD+. The SF-36 survey provides scores between 0-100 with lower scores representing more disability.", "time_frame": "12 weeks" } ], "relevance_tags": [ "Immunomodulatory", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 36, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04604704", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05289154", "title": "Acupressure and Qigong in Chronic Fatigue Post COVID-19.", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-01-23", "start_date": "2022-06-14", "completion_date": "2023-10-01", "primary_completion_date": "2023-09-01", "conditions_raw": [ "COVID-19", "Post-COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Self- Applied Acupressure Plus Qigong Course Plus Advice Literature", "Advice Literature With Naturopathy" ], "sponsor": "Charite University, Berlin, Germany", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "International observational studies confirm the high incidence of post-infectious residual syndrome after infection with severe acute respiratory syndrome corona virus 2 (SARS-COV2), which can occur in 10-15% of all infected persons, regardless of the severity of the acute infection. Post corona virus disease 19 (postCOVID-19) patients suffer mostly from symptoms such as fatigue, muscle pain, problems to focus, depression and sleep disturbances.\n\nSo far, there are no results of interventional studies for the treatment of chronic fatigue post COVID-19, but there are indicators that post COVID-19 syndrome is a chronic subclinical inflammation, similar to Chronic Fatigue Syndrome / Myalgic Encephalomyelitis CSF/ME, which also often develops from a postviral syndrome. Previously tested and effective strategies for the treatment of chronic fatigue syndrome / myalgic encephalomyelitis (CFS/ME) will be tested in the treatment of chronic fatigue postCOVID-19, in this randomized controlled trial a combination of acupressure and Qigong.\n\nThe aim of this project is to evaluate an acupressure treatment plus a Qigong exercise series specifically tailored for chronic fatigue postCOVID-19 , used daily by the patients themselves and regularly supervised, in comparison to the advice literature on the treatment of PostCOVID-19 syndrome alone.", "primary_outcomes": [ { "type": "primary", "measure": "SF-36 Physical Function subscale", "description": "Primary study objective is to assess the changes in the mean score of the SF-36 Physical Function subscale between the two study arms assessing the degree of fatigue.", "time_frame": "week 8" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "EQ5D (EuroQoL 5 domains)", "description": "disease specific QoL", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "SF36 PFS (Short Form 36 physical function subscale)", "description": "changes in the mean score of the SF-36 Physical Function subscale- assessing the degree of fatigue", "time_frame": "week 16" }, { "type": "secondary", "measure": "Chalder Fatigue-Scale", "description": "Fatigue severity", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "VAS physical resilience (visual analogue scale)", "description": "visual analogue scale for subjective physical resilience", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "PHQ9 (Patient Health Questionnaire 9)", "description": "Patient Health Questionnaire assessing depression", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "VAS pain (visual analogue scale)", "description": "visual analogue scale for subjective pain", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "hand grip strength", "description": "hand grip strength", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "Spirometry", "description": "forced expiratory volume", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "autonomic dysfunction orthostasis test", "description": "heart rate and blood pressure analysis in orthostasis", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "d2- test", "description": "test for concentration- ability to focus", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "qualitative substudy", "description": "interviews regarding experience of illness and therapy", "time_frame": "week 8 and 16" } ], "outcome_measures": [ { "type": "primary", "measure": "SF-36 Physical Function subscale", "description": "Primary study objective is to assess the changes in the mean score of the SF-36 Physical Function subscale between the two study arms assessing the degree of fatigue.", "time_frame": "week 8" }, { "type": "secondary", "measure": "EQ5D (EuroQoL 5 domains)", "description": "disease specific QoL", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "SF36 PFS (Short Form 36 physical function subscale)", "description": "changes in the mean score of the SF-36 Physical Function subscale- assessing the degree of fatigue", "time_frame": "week 16" }, { "type": "secondary", "measure": "Chalder Fatigue-Scale", "description": "Fatigue severity", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "VAS physical resilience (visual analogue scale)", "description": "visual analogue scale for subjective physical resilience", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "PHQ9 (Patient Health Questionnaire 9)", "description": "Patient Health Questionnaire assessing depression", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "VAS pain (visual analogue scale)", "description": "visual analogue scale for subjective pain", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "hand grip strength", "description": "hand grip strength", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "Spirometry", "description": "forced expiratory volume", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "autonomic dysfunction orthostasis test", "description": "heart rate and blood pressure analysis in orthostasis", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "d2- test", "description": "test for concentration- ability to focus", "time_frame": "week 8 and 16" }, { "type": "secondary", "measure": "qualitative substudy", "description": "interviews regarding experience of illness and therapy", "time_frame": "week 8 and 16" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 200, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05289154", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04997395", "title": "Feasibility of Cannabidiol for the Treatment of Long COVID", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2023-01-19", "start_date": "2022-04-14", "completion_date": "2023-01-06", "primary_completion_date": "2023-01-06", "conditions_raw": [ "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Medicabilis Cannabis Sativa 50" ], "sponsor": "Bod Australia", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This is an open label, phase 2 clinical trial to assess the feasibility of a cannabidiol (CBD) dominant medicinal cannabis for the treatment of Long COVID. The primary aim is to assess the feasibility of recruiting and retaining individuals diagnosed with Long COVID into a treatment trial of medicinal cannabis, as well as assessing the safety and tolerability of a dominant medicinal cannabis in this population. The secondary aim is to determine the effect of a CBD dominant medicinal cannabis on symptoms associated with Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Recruitment rate", "description": "Recruiting individuals diagnosed with long COVID into a treatment trial of medicinal cannabis", "time_frame": "12 months (48 weeks)" }, { "type": "primary", "measure": "Tolerability for the treatment of long COVID", "description": "Retaining participants in a six month trial of medicinal cannabis using the proposed battery of assessments. Retention rate (%) of participants enrolled into the trial who complete the six-month protocol.", "time_frame": "6 months (24 weeks)" }, { "type": "primary", "measure": "Number of side effects", "description": "Adverse events, side effects", "time_frame": "6 months (24 weeks)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Long COVID symptoms", "description": "Assessed by the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS, Sivan et al., 2021). This scale includes: breathlessness, cough/ voice, swallowing/ nutrition, fatigue, continence, cognition, pain/discomfort, anxiety, depression, post-traumatic stress disorder, communication, mobility, personal care, activities of daily living, social role, perceived health status and family/carers views. The C19-YRS provides an overview of 3 outcomes: symptoms severity score, functional disability score and global health score.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Fatigue", "description": "Fatigue will be assessed using the nine item Fatigue Severity Scale (Krupp et al., 1989). This scale, which was initially designed for use in multiple sclerosis and systemic lupus erythematosus has been used extensively across multiple disorders and has bene demonstrated to have good reliability and validity. Each of the nine items in this scale is assessed on a seven-point scale from 1 (strongly disagree) to 7 (strongly agree). Thus, the composite scale ranges from 9 to 63 with higher ratings representing more severe fatigue.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Self-reported quality of life", "description": "The health-related quality of life instrument that will be used in this study is the EuroQol 5 Dimensions (EQ-5D; Devlin et al., 2017). It is a widely used, validated, and reliable tool that assesses the quality of life of patients in many disease areas through assessment of the severity of each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the five dimensions can be numerically summed into a single number, varying from 5 to 25 with higher numbers representing a lower quality of life. In addition, this measure contains a 100-point visual analogue which asks respondents to rate their current health with higher numbers representing better health.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Pain score", "description": "The Brief Pain Inventory Short Form (BPI-SF; Cleeland, 1989; Cleeland \\& Ryan, 1994), a 9 item self-administered questionnaire, will be used to evaluate the severity of a patient's pain and the interference of this pain on the patient's daily feeling and functioning. The patient rates their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10-point scale. The BPI scale defines pain as follows: 1-4=Mild Pain, 5-6=Moderate Pain, 7-10=Severe Pain. Thus, a mean of the items can be presented with higher ratings representing more severe pain. In addition, the mean of the 7 items assessing interference, each rated on a scale from 0 to 10, will be used as a measure of mean pain interference with higher numbers representing more interference.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Mood (anxiety)", "description": "The Generalised Anxiety Disorder Assessment (GAD-7; Spitzer et al., 2006) will be used to measure depression. The GAD-7 is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of their symptoms over the past two weeks. Response options include \"not at all\", \"several days\", \"more than half the days\" and \"nearly every day\". The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of \"not at all,\" \"several days,\" \"more than half the days,\" and \"nearly every day,\" respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Mood (depression)", "description": "The Patient Health Questionnaire (PHQ-9; Kroneke et al., 2001) will be used to measure mood/ depression. It is a reliable and valid measure of depression severity and is comprised of a 9-item self-rated instrument that has been validated in general populations, medical populations and psychiatric samples.\n\nIt is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of not at all, several days, more than half the days, and nearly every day, respectively. PHQ-9 total score for the nine items ranges from 0 to 27.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Sleep quality", "description": "Assessed using Pittsburgh self-report questionnaires and wearable technology. The Pittsburgh Sleep Quality Index (PSQI) includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a \"global\" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. Mean ratings on this global score will be used in our analyses. Furthermore, the wearable technology (i.e. Fitbit) will provide the patients' total time in sleep and time in sleep stages (light, deep and REM sleep), as well as a daily Sleep Score accessed via the Fitbit app. Seven day averages (means) of the Fitbit measures will be calculated for each participant across the duration of the study.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Resting heart rate (expressed as average beats per minute)", "description": "The wearable technology will provide 24/7 heart rate tracking and heart rate variability. We will have access to the daily resting heart rate and averages across discrete periods. We will analyse mean resting heart rate (beats per minute). Variation in the time between each heartbeat (heart rate variability) will be accessed via the Fitbit app. Seven day averages (means) of the Fitbit measures will be calculated for each participant across the duration of the study.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Activity levels (number of daily steps, distance walked, stairs climbed, active minutes and calories burned)", "description": "Activity levels assessed via wearable technology. The wearable technology (i.e. Fitbit) tracks all-day activity including number of steps walked, distance walked (expressed in kilometres), floors climbed, active minutes and calories burned. We will analyse the seven-day mean number of daily steps, distance walked, stairs climbed, active minutes and calories burned. Seven day averages (means) of the Fitbit measures will be calculated for each participant across the duration of the study.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Oxygen saturation (expressed as percentage saturation)", "description": "Oxygen saturation expressed as percentage saturation, with typical numbers being in the region of 95% will also be assessed via the Fitbit. Seven day averages (means) of the Fitbit measures will be calculated for each participant across the duration of the study.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Daily symptoms", "description": "Assessed using daily reports of key symptoms (breathlessness, fatigue, mood and pain) adapted from the COVID-19 Yorkshire Rehabilitation Scale. Each symptom will be scored out of 10 for a period of 7 days per 28 days, to produce an average score for each symptom.", "time_frame": "5 months (20 weeks)" } ], "outcome_measures": [ { "type": "primary", "measure": "Recruitment rate", "description": "Recruiting individuals diagnosed with long COVID into a treatment trial of medicinal cannabis", "time_frame": "12 months (48 weeks)" }, { "type": "primary", "measure": "Tolerability for the treatment of long COVID", "description": "Retaining participants in a six month trial of medicinal cannabis using the proposed battery of assessments. Retention rate (%) of participants enrolled into the trial who complete the six-month protocol.", "time_frame": "6 months (24 weeks)" }, { "type": "primary", "measure": "Number of side effects", "description": "Adverse events, side effects", "time_frame": "6 months (24 weeks)" }, { "type": "secondary", "measure": "Long COVID symptoms", "description": "Assessed by the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS, Sivan et al., 2021). This scale includes: breathlessness, cough/ voice, swallowing/ nutrition, fatigue, continence, cognition, pain/discomfort, anxiety, depression, post-traumatic stress disorder, communication, mobility, personal care, activities of daily living, social role, perceived health status and family/carers views. The C19-YRS provides an overview of 3 outcomes: symptoms severity score, functional disability score and global health score.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Fatigue", "description": "Fatigue will be assessed using the nine item Fatigue Severity Scale (Krupp et al., 1989). This scale, which was initially designed for use in multiple sclerosis and systemic lupus erythematosus has been used extensively across multiple disorders and has bene demonstrated to have good reliability and validity. Each of the nine items in this scale is assessed on a seven-point scale from 1 (strongly disagree) to 7 (strongly agree). Thus, the composite scale ranges from 9 to 63 with higher ratings representing more severe fatigue.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Self-reported quality of life", "description": "The health-related quality of life instrument that will be used in this study is the EuroQol 5 Dimensions (EQ-5D; Devlin et al., 2017). It is a widely used, validated, and reliable tool that assesses the quality of life of patients in many disease areas through assessment of the severity of each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the five dimensions can be numerically summed into a single number, varying from 5 to 25 with higher numbers representing a lower quality of life. In addition, this measure contains a 100-point visual analogue which asks respondents to rate their current health with higher numbers representing better health.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Pain score", "description": "The Brief Pain Inventory Short Form (BPI-SF; Cleeland, 1989; Cleeland \\& Ryan, 1994), a 9 item self-administered questionnaire, will be used to evaluate the severity of a patient's pain and the interference of this pain on the patient's daily feeling and functioning. The patient rates their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10-point scale. The BPI scale defines pain as follows: 1-4=Mild Pain, 5-6=Moderate Pain, 7-10=Severe Pain. Thus, a mean of the items can be presented with higher ratings representing more severe pain. In addition, the mean of the 7 items assessing interference, each rated on a scale from 0 to 10, will be used as a measure of mean pain interference with higher numbers representing more interference.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Mood (anxiety)", "description": "The Generalised Anxiety Disorder Assessment (GAD-7; Spitzer et al., 2006) will be used to measure depression. The GAD-7 is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of their symptoms over the past two weeks. Response options include \"not at all\", \"several days\", \"more than half the days\" and \"nearly every day\". The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of \"not at all,\" \"several days,\" \"more than half the days,\" and \"nearly every day,\" respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Mood (depression)", "description": "The Patient Health Questionnaire (PHQ-9; Kroneke et al., 2001) will be used to measure mood/ depression. It is a reliable and valid measure of depression severity and is comprised of a 9-item self-rated instrument that has been validated in general populations, medical populations and psychiatric samples.\n\nIt is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of not at all, several days, more than half the days, and nearly every day, respectively. PHQ-9 total score for the nine items ranges from 0 to 27.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Sleep quality", "description": "Assessed using Pittsburgh self-report questionnaires and wearable technology. The Pittsburgh Sleep Quality Index (PSQI) includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a \"global\" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. Mean ratings on this global score will be used in our analyses. Furthermore, the wearable technology (i.e. Fitbit) will provide the patients' total time in sleep and time in sleep stages (light, deep and REM sleep), as well as a daily Sleep Score accessed via the Fitbit app. Seven day averages (means) of the Fitbit measures will be calculated for each participant across the duration of the study.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Resting heart rate (expressed as average beats per minute)", "description": "The wearable technology will provide 24/7 heart rate tracking and heart rate variability. We will have access to the daily resting heart rate and averages across discrete periods. We will analyse mean resting heart rate (beats per minute). Variation in the time between each heartbeat (heart rate variability) will be accessed via the Fitbit app. Seven day averages (means) of the Fitbit measures will be calculated for each participant across the duration of the study.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Activity levels (number of daily steps, distance walked, stairs climbed, active minutes and calories burned)", "description": "Activity levels assessed via wearable technology. The wearable technology (i.e. Fitbit) tracks all-day activity including number of steps walked, distance walked (expressed in kilometres), floors climbed, active minutes and calories burned. We will analyse the seven-day mean number of daily steps, distance walked, stairs climbed, active minutes and calories burned. Seven day averages (means) of the Fitbit measures will be calculated for each participant across the duration of the study.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Oxygen saturation (expressed as percentage saturation)", "description": "Oxygen saturation expressed as percentage saturation, with typical numbers being in the region of 95% will also be assessed via the Fitbit. Seven day averages (means) of the Fitbit measures will be calculated for each participant across the duration of the study.", "time_frame": "5 months (20 weeks)" }, { "type": "secondary", "measure": "Daily symptoms", "description": "Assessed using daily reports of key symptoms (breathlessness, fatigue, mood and pain) adapted from the COVID-19 Yorkshire Rehabilitation Scale. Each symptom will be scored out of 10 for a period of 7 days per 28 days, to produce an average score for each symptom.", "time_frame": "5 months (20 weeks)" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 12, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04997395", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05107440", "title": "BREATHE: Virtual Self-management for Long COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-12-14", "start_date": "2022-01-03", "completion_date": "2022-10-13", "primary_completion_date": "2022-06-20", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Breathe" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "A mixed-methods evaluation of a virtual self-management program for people living with long COVID in Alberta.", "primary_outcomes": [ { "type": "primary", "measure": "Self-efficacy to manage symptoms", "description": "Total score on the 8-item short form, from the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions item bank. These PROMIS item banks include all include 8 items that are used to determine a T-score. A T-score of 50 represents the average of people managing chronic health conditions, and ten points is one standard deviation.", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "primary", "measure": "Self-efficacy to manage daily activities", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "primary", "measure": "Self-efficacy to manage emotions", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Self-efficacy to manage symptoms", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank. These PROMIS item banks include all include 8 items that are used to determine a T-score. A T-score of 50 represents the average of people managing chronic health conditions, and ten points is one standard deviation.", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Self-efficacy to manage daily activities", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Self-efficacy to manage emotions", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Fatigue severity (FACIT-F)", "description": "Total score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Fatigue severity (FACIT-F)", "description": "Total score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Medical Research Council (MRC) breathlessness scale grade", "description": "Modified according to recommendations for core outcomes for COVID-19 research.", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Medical Research Council (MRC) breathlessness scale grade", "description": "Modified according to recommendations for core outcomes for COVID-19 research.", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Scale (PCFS) grade", "description": "Post-COVID-19 Functional Scale (PCFS)", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Scale (PCFS) grade", "description": "Post-COVID-19 Functional Scale (PCFS)", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Recovery grade", "description": "Recommended core outcome measure", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Recovery grade", "description": "Recommended core outcome measure", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Physical functioning subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Physical functioning subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Role limitations due to physical health subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Role limitations due to physical health subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)." }, { "type": "secondary", "measure": "Role limitations due to emotional problems subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Role limitations due to emotional problems subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Emotional well-being subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Emotional well-being subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Social functioning subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Social functioning subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Energy/fatigue subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Energy/fatigue subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Pain subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Pain subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "General health subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "General health subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Physical component score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Physical component score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Mental component score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Mental component score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" } ], "outcome_measures": [ { "type": "primary", "measure": "Self-efficacy to manage symptoms", "description": "Total score on the 8-item short form, from the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions item bank. These PROMIS item banks include all include 8 items that are used to determine a T-score. A T-score of 50 represents the average of people managing chronic health conditions, and ten points is one standard deviation.", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "primary", "measure": "Self-efficacy to manage daily activities", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "primary", "measure": "Self-efficacy to manage emotions", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Self-efficacy to manage symptoms", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank. These PROMIS item banks include all include 8 items that are used to determine a T-score. A T-score of 50 represents the average of people managing chronic health conditions, and ten points is one standard deviation.", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Self-efficacy to manage daily activities", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Self-efficacy to manage emotions", "description": "Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Fatigue severity (FACIT-F)", "description": "Total score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Fatigue severity (FACIT-F)", "description": "Total score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Medical Research Council (MRC) breathlessness scale grade", "description": "Modified according to recommendations for core outcomes for COVID-19 research.", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Medical Research Council (MRC) breathlessness scale grade", "description": "Modified according to recommendations for core outcomes for COVID-19 research.", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Scale (PCFS) grade", "description": "Post-COVID-19 Functional Scale (PCFS)", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Post-COVID-19 Functional Scale (PCFS) grade", "description": "Post-COVID-19 Functional Scale (PCFS)", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Recovery grade", "description": "Recommended core outcome measure", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Recovery grade", "description": "Recommended core outcome measure", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Physical functioning subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Physical functioning subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Role limitations due to physical health subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Role limitations due to physical health subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)." }, { "type": "secondary", "measure": "Role limitations due to emotional problems subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Role limitations due to emotional problems subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Emotional well-being subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Emotional well-being subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Social functioning subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Social functioning subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Energy/fatigue subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Energy/fatigue subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Pain subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Pain subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "General health subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "General health subscale score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Physical component score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Physical component score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" }, { "type": "secondary", "measure": "Mental component score", "description": "36-Item Short-Form Health Survey", "time_frame": "Week 9 i.e. post-intervention (Change from Baseline)" }, { "type": "secondary", "measure": "Mental component score", "description": "36-Item Short-Form Health Survey", "time_frame": "3-month follow-up (Change from Baseline)" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 27, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05107440", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05279430", "title": "Effects of IMT on Functional Capacity in Patients With Chronic COVID After Hospital Discharge", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-12-13", "start_date": "2022-01-30", "completion_date": "2022-08-01", "primary_completion_date": "2022-07-31", "conditions_raw": [ "COVID-19 Pneumonia" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Inspiratory Muscle Training" ], "sponsor": "Fundación para la Investigación del Hospital Clínico de Valencia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Exercise intolerance and fatigue are the most common symptoms in patients with chronic COVID after hospital discharge. Muscle deconditioning, dysautonomia, and exercise hyperventilation have been proposed as potential mechanisms contributing to exercise functional capacity limitation in Long-COVID. Along this line, combined exercise training or inspiratory muscle training (IMT) alone have already been demonstrated to be feasible therapeutic options for Long-COVID patients. However, we do not have evidence about the effects of a home-based IMT program for 12-week on peak oxygen consumption (peakVO2). in patients chronic COVID (\\>3 months) after hospital discharge.\n\nThis is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a program of IMT that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12-week. Patients with chronic COVID (\\>3 months) after hospital discharge will be enrolled. A sample size estimation \\[alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +3 mL/kg/min (SD±2.5)\\] of 26 patients (13 per arm) would be necessary to test our hypothesis.", "primary_outcomes": [ { "type": "primary", "measure": "Peak oxygen consumption", "description": "Maximal functional capacity will be evaluated with incremental and symptom-limited cardiopulmonary exercise testing. Peak oxygen consumption (peakVO2) will be considered the highest value of VO2 during the last 20 seconds of exercise.", "time_frame": "12-week" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Peak oxygen consumption", "description": "Maximal functional capacity will be evaluated with incremental and symptom-limited cardiopulmonary exercise testing. Peak oxygen consumption (peakVO2) will be considered the highest value of VO2 during the last 20 seconds of exercise.", "time_frame": "12-week" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 26, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05279430", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05629793", "title": "Differential Diagnosis of Persistent COVID-19 by Artificial Intelligence", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-11-29", "start_date": "2022-12-14", "completion_date": "2023-11", "primary_completion_date": "2023-11", "conditions_raw": [ "COVID-19", "Fatigue", "Distress Respiratory Syndrome", "Cognitive Dysfunction", "COVID-19 Recurrent", "SARS CoV 2 Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Experimental Tests" ], "sponsor": "Fundacin Biomedica Galicia Sur", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The pandemic caused by SARS-CoV-2 infection has resulted, in addition to the well-known acute symptoms, in the emergence of persistent, diffuse and heterogeneous symptoms referred to as persistent COVID.\n\nCommon symptoms include fatigue, shortness of breath, and cognitive dysfunction, among others, and result in an impact on daily functioning. Symptoms may be new onset, appear after initial recovery from an acute episode of COVID-19, or persist after the initial illness. Cardiac variability (HRV) was initially used in COVID-19 to predict mortality in the acute setting. Dysautonomia which partly evaluates HRV is frequent in patients with persistent COVID. Several groups have used voice or other respiratory noise analysis for the diagnosis of acute COVID.\n\nPatients in the persistent COVID cohort will be able to be differentiated from an age, sex and vaccination status matched cohort of recovered COVID patients without sequelae by means of a model created by Machine Learning that will be trained using cardiac variability (HRV), skin conductance and acoustic analysis data. The primary objetive will be to obtain a classification algorithm by Machine Learning to differentiate the group of patients with persistent COVID diagnosis from the paired group of recovered COVID patients without sequelae.", "primary_outcomes": [ { "type": "primary", "measure": "Differences of the group of patients with a persistent diagnosis of COVID from the age-matched group, sex and vaccination status of patients recovered from COVID without sequelae.", "description": "Through an algorithm model created by Machine Learning that will be trained using cardic variability (HRV), skin conductance and acoustic analysis data.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Cardiac variability", "description": "Number of times a contraction of the heart occurs in one minute, expressed in beats per minute, by means of a Polar chest strap, model H10. A baseline recording of 5 minutes duration will be taken, with the patient in a seated position. At the end of each test, recording is continued for 2 minutes to demonstrate the speed and degree of recovery after stress.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Voice recording", "description": "Sounds produced by the patient at rest and after having performed the stress tests. The patient will be asked to take a deep breath and then pronounce the vowel /a/ in a sustained manner, in a comfortable tone and volume (3 times).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Skin conductance", "description": "micro Siemens \\[µS\\]. By means of the Bitalino electrodermal activity recording system. It will be recorded at rest, during the Cold Pressor test and once it is finished, for at least two minutes, to assess the normalization of the conductivity curve.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "6MWT", "description": "metres/min. The patient will walk the maximum distance they can in 6 minutes.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "1minSTST", "description": "Number of repetitions performed after sitting down and getting up from a chair without supporting the hands as many times as possible for 1 minute..", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Cold Pressor test", "description": "One hand is inserted into a container with water at 4-5ºC for 1 minute. Before and after the test, HRV, BP, and thermal conductance are recorded for 5 and 2 minutes -respectively- while lying supine.", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Differences of the group of patients with a persistent diagnosis of COVID from the age-matched group, sex and vaccination status of patients recovered from COVID without sequelae.", "description": "Through an algorithm model created by Machine Learning that will be trained using cardic variability (HRV), skin conductance and acoustic analysis data.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Cardiac variability", "description": "Number of times a contraction of the heart occurs in one minute, expressed in beats per minute, by means of a Polar chest strap, model H10. A baseline recording of 5 minutes duration will be taken, with the patient in a seated position. At the end of each test, recording is continued for 2 minutes to demonstrate the speed and degree of recovery after stress.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Voice recording", "description": "Sounds produced by the patient at rest and after having performed the stress tests. The patient will be asked to take a deep breath and then pronounce the vowel /a/ in a sustained manner, in a comfortable tone and volume (3 times).", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Skin conductance", "description": "micro Siemens \\[µS\\]. By means of the Bitalino electrodermal activity recording system. It will be recorded at rest, during the Cold Pressor test and once it is finished, for at least two minutes, to assess the normalization of the conductivity curve.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "6MWT", "description": "metres/min. The patient will walk the maximum distance they can in 6 minutes.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "1minSTST", "description": "Number of repetitions performed after sitting down and getting up from a chair without supporting the hands as many times as possible for 1 minute..", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Cold Pressor test", "description": "One hand is inserted into a container with water at 4-5ºC for 1 minute. Before and after the test, HRV, BP, and thermal conductance are recorded for 5 and 2 minutes -respectively- while lying supine.", "time_frame": "8 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 136, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05629793", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05629884", "title": "Efficacy of a Physical and Respiratory Rehabilitation Program for Patients With Persistent COVID-19 (SARS-CoV-2).", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-11-29", "start_date": "2022-12-14", "completion_date": "2023-11-14", "primary_completion_date": "2023-11-14", "conditions_raw": [ "SARS-CoV-2 Infection", "COVID-19 Recurrent", "Cognitive Dysfunction", "Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Coperia-Rehab" ], "sponsor": "Fundacin Biomedica Galicia Sur", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The pandemic caused by SARS-CoV-2 infection has resulted, in addition to the well-known acute symptoms, in the emergence of a plethora of persistent, diffuse and heterogeneous symptoms such as fatigue, shortness of breath and cognitive dysfunction among others, that have come to be called persistent COVID. Patients have reported that physical activity, stress and sleep disturbances often trigger exacerbations of their symptoms related by some authors to the so-called Post Exertional Malaise (PEM) characteristic of Myalgic Encephalomyelitis. Similarly, by analogy with other pathologies, it has been hypothesized that optimal exercise prescription would benefit these people with persistent COVID-19 symptoms but in practice, the rehabilitation of these patients runs the risk of collapsing respiratory and physical rehabilitation services.\n\nThis is why COPERIA proposes the construction of a platform for respiratory, cardiac and muscular telerehabilitation, to compare with face-to-face rehabilitation treatment and to try to predict the influence of physical activity in the prediction of PEM.", "primary_outcomes": [ { "type": "primary", "measure": "Six Minutes Walking test", "description": "The 6-min walk test is a standard in cardiac rehabilitation, serving both to ecologically determine the patient's functional status and to make recommendations regarding the intensity of rehabilitative exercise. The patient is asked to run the maximum distance he/she can in 6 minutes. The length of one of the hospital corridors has been previously measured so that by counting the number of times the patient walks the distance covered is determined. In addition to the number of meters, the heart rate is monitored by means of a pectoral band, and the saturation level by means of a pulse oximeter; the BP is evaluated before and after the test. In the context of functional assessment of Persistent COVID, it has been used for the evaluation of the impact of rehabilitation measures.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "mMRC dyspnea scale", "description": "The MRC shortness of breath scale consists of five statements that describe almost the entire range of respiratory disability, from none (Grade 1) to almost complete disability (Grade 5). It can be self-administered by asking subjects to choose the statement that best describes their condition, e.g., \"'I am only short of breath with strenuous exertion\" (Grade 1) or \"I am so short of breath that I cannot leave the house\" (Grade 5). Alternatively, it can be administered by an interviewer asking the questions, such as \"Are you short of breath when rushing on level ground or when climbing a gentle slope?\" (Grade 2). The score is the number that best matches the patient's activity level.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "SF-36 Health Questionnaire", "description": "The SF-36 Health Questionnaire is composed of 36 items that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical Function, Physical Role, Bodily Pain, General Health, Vitality, Social Function, Emotional Role, and Mental Health. Additionally, the SF-36 includes a transition item that asks about the change in general health status from the previous year.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Maximal Handgrip Strenght", "description": "Handgrip strength (HGS) is measured by a handgrip dynamometer and is considered an indicator of overall muscle strength. Low muscle strength, also known as dynapenia is an important indicator of health status, as well as an indicator of sarcopenia. Maximal grip strength is determined by performing three grip attempts at maximum power.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "1 Minute Sit to Stand test", "description": "Consists of sitting down and getting up from a chair without resting the hands as many times as possible for 1 minute with the patient connected to the saturator and monitored with a chest strap. The minute is timed, the number of repetitions performed is counted, the oxygen saturation value and heart rate are observed and the patient waits 1 minute after the exercise to record again the recovery of the basal parameters.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "P maximal inspiratory and P maximal expiratory", "description": "These tests will be performed by the Pneumology Service. The measurement of maximal inspiratory and expiratory pressures are well tolerated and relatively easy to perform, they allow estimating the neuromuscular function of the diaphragm, as well as the abdominal, intercostal and accessory muscles. In general terms, the Pimax test estimates the strength of inspiratory muscles (diaphragm) and the Pemax test estimates the strength of abdominal and intercostal muscles. The tests consist of the patient having to generate maximum inspiratory and expiratory pressures against an occluded mouthpiece.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Insomnia Severity Index.", "description": "This instrument for the assessment of insomnia consists of 7 questions that are rated between 0 and 4 points. It evaluates both the insomnia of conciliation, maintenance and early awakening, as well as its functional repercussions during the day.", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Six Minutes Walking test", "description": "The 6-min walk test is a standard in cardiac rehabilitation, serving both to ecologically determine the patient's functional status and to make recommendations regarding the intensity of rehabilitative exercise. The patient is asked to run the maximum distance he/she can in 6 minutes. The length of one of the hospital corridors has been previously measured so that by counting the number of times the patient walks the distance covered is determined. In addition to the number of meters, the heart rate is monitored by means of a pectoral band, and the saturation level by means of a pulse oximeter; the BP is evaluated before and after the test. In the context of functional assessment of Persistent COVID, it has been used for the evaluation of the impact of rehabilitation measures.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "mMRC dyspnea scale", "description": "The MRC shortness of breath scale consists of five statements that describe almost the entire range of respiratory disability, from none (Grade 1) to almost complete disability (Grade 5). It can be self-administered by asking subjects to choose the statement that best describes their condition, e.g., \"'I am only short of breath with strenuous exertion\" (Grade 1) or \"I am so short of breath that I cannot leave the house\" (Grade 5). Alternatively, it can be administered by an interviewer asking the questions, such as \"Are you short of breath when rushing on level ground or when climbing a gentle slope?\" (Grade 2). The score is the number that best matches the patient's activity level.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "SF-36 Health Questionnaire", "description": "The SF-36 Health Questionnaire is composed of 36 items that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical Function, Physical Role, Bodily Pain, General Health, Vitality, Social Function, Emotional Role, and Mental Health. Additionally, the SF-36 includes a transition item that asks about the change in general health status from the previous year.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Maximal Handgrip Strenght", "description": "Handgrip strength (HGS) is measured by a handgrip dynamometer and is considered an indicator of overall muscle strength. Low muscle strength, also known as dynapenia is an important indicator of health status, as well as an indicator of sarcopenia. Maximal grip strength is determined by performing three grip attempts at maximum power.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "1 Minute Sit to Stand test", "description": "Consists of sitting down and getting up from a chair without resting the hands as many times as possible for 1 minute with the patient connected to the saturator and monitored with a chest strap. The minute is timed, the number of repetitions performed is counted, the oxygen saturation value and heart rate are observed and the patient waits 1 minute after the exercise to record again the recovery of the basal parameters.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "P maximal inspiratory and P maximal expiratory", "description": "These tests will be performed by the Pneumology Service. The measurement of maximal inspiratory and expiratory pressures are well tolerated and relatively easy to perform, they allow estimating the neuromuscular function of the diaphragm, as well as the abdominal, intercostal and accessory muscles. In general terms, the Pimax test estimates the strength of inspiratory muscles (diaphragm) and the Pemax test estimates the strength of abdominal and intercostal muscles. The tests consist of the patient having to generate maximum inspiratory and expiratory pressures against an occluded mouthpiece.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Insomnia Severity Index.", "description": "This instrument for the assessment of insomnia consists of 7 questions that are rated between 0 and 4 points. It evaluates both the insomnia of conciliation, maintenance and early awakening, as well as its functional repercussions during the day.", "time_frame": "8 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 56, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05629884", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04742946", "title": "Digital Physiotherapy Practice in Long Covid-19 Patients", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-11-18", "start_date": "2021-12-15", "completion_date": "2022-12-30", "primary_completion_date": "2022-12-30", "conditions_raw": [ "Long COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Digital Physiotherapy Practice" ], "sponsor": "Universidad de Granada", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The COVID-19 can cause important sequels in the respiratory system by bilateral pneumonia and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Long COVID-19 has been defined as the condition occurring in individuals with a history of probable or confirmed SARS-CoV-2 infection, with related symptoms lasting at least 2 months and not explainable by an alternative diagnosis. The practice of digital physiotherapy presents itself as a promising complementary treatment method to standard physiotherapy, playing a key role in the recovery of function in subjects who have passed the disease and who maintain some symptomatology over time. The aims of this research are to explore the effect of a digital physiotherapy intervention on functional recovery in patients diagnosed with Long COVID-19 and to identify the level of adherence to the treatment carried out. Physiotherapy interventions acquires a fundamental role in the recovery of the functions and the quality of life. As secondary objectives, the aim is to identify the satisfaction and perception of patients with the intervention and the presence of barriers to its implementation (throught a qualitative research), as well as to evaluate the cost-effectiveness from the perspective of the health system. A quasi-experimental pre-post study assessed initially and at the end of the 4-week intervention the functional capacity (1-min STS and SPPB) and the adherence (software). The hypothesis of this research is that the implementation of a TR program presents positive results. If hypothesis is confirmed, that would be an opportunity to define new policies and interventions to address this disease and its consequences.", "primary_outcomes": [ { "type": "primary", "measure": "Functional Capacity", "description": "sit-to-stand test in 1 minute", "time_frame": "Baseline (T0)" }, { "type": "primary", "measure": "Functional Capacity", "description": "sit-to-stand test in 1 minute", "time_frame": "4 weeks (T1)" }, { "type": "primary", "measure": "Functional Capacity (SPBB) short performance physical battery test", "description": "(SPBB) short performance physical battery test", "time_frame": "Baseline (T0)" }, { "type": "primary", "measure": "Functional Capacity (SPBB) short performance physical battery test", "description": "(SPBB) short performance physical battery test", "time_frame": "Baseline 4 weeks (T1)" }, { "type": "primary", "measure": "The Short Form Health Survey SF-12", "description": "Quality of Live. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension).\n\na scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status).\n\n100 (the best health status)", "time_frame": "Baseline (T0)" }, { "type": "primary", "measure": "The Short Form Health Survey SF-12 Quality of Live", "description": "The SF-12 For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension).\n\na scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status).\n\n100 (the best health status)", "time_frame": "4 weeks (T1)" }, { "type": "primary", "measure": "European Quality of Life-5 Dimensions EQ-5D", "description": "Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).", "time_frame": "Baseline (T0)" }, { "type": "primary", "measure": "European Quality of Life-5 Dimensions EQ-5D", "description": "Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).", "time_frame": "4 weeks (T1)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Telemedicine Satisfaction Questionnaire (TSQ)", "description": "Telemedicine Satisfaction Questionnaire (TSQ). Perceived satisfaction comparing telemedicine to inperson in 26 Questions with likert scales", "time_frame": "4 weeks (T1)" }, { "type": "secondary", "measure": "Cost-effectiveness of the telerehabilitation intervention", "description": "Direct Costs", "time_frame": "4 weeks T1" }, { "type": "secondary", "measure": "Adherence to intervention", "description": "Automatic register by the digital physiotherapy software. Number of treatments and exercise acoording to PT prescription.", "time_frame": "4 weeks T1" }, { "type": "secondary", "measure": "Satisfaction and Perception with intervention", "description": "Qualitative interview", "time_frame": "4 weeks T1" } ], "outcome_measures": [ { "type": "primary", "measure": "Functional Capacity", "description": "sit-to-stand test in 1 minute", "time_frame": "Baseline (T0)" }, { "type": "primary", "measure": "Functional Capacity", "description": "sit-to-stand test in 1 minute", "time_frame": "4 weeks (T1)" }, { "type": "primary", "measure": "Functional Capacity (SPBB) short performance physical battery test", "description": "(SPBB) short performance physical battery test", "time_frame": "Baseline (T0)" }, { "type": "primary", "measure": "Functional Capacity (SPBB) short performance physical battery test", "description": "(SPBB) short performance physical battery test", "time_frame": "Baseline 4 weeks (T1)" }, { "type": "primary", "measure": "The Short Form Health Survey SF-12", "description": "Quality of Live. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension).\n\na scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status).\n\n100 (the best health status)", "time_frame": "Baseline (T0)" }, { "type": "primary", "measure": "The Short Form Health Survey SF-12 Quality of Live", "description": "The SF-12 For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension).\n\na scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status).\n\n100 (the best health status)", "time_frame": "4 weeks (T1)" }, { "type": "primary", "measure": "European Quality of Life-5 Dimensions EQ-5D", "description": "Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).", "time_frame": "Baseline (T0)" }, { "type": "primary", "measure": "European Quality of Life-5 Dimensions EQ-5D", "description": "Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).", "time_frame": "4 weeks (T1)" }, { "type": "secondary", "measure": "Telemedicine Satisfaction Questionnaire (TSQ)", "description": "Telemedicine Satisfaction Questionnaire (TSQ). Perceived satisfaction comparing telemedicine to inperson in 26 Questions with likert scales", "time_frame": "4 weeks (T1)" }, { "type": "secondary", "measure": "Cost-effectiveness of the telerehabilitation intervention", "description": "Direct Costs", "time_frame": "4 weeks T1" }, { "type": "secondary", "measure": "Adherence to intervention", "description": "Automatic register by the digital physiotherapy software. Number of treatments and exercise acoording to PT prescription.", "time_frame": "4 weeks T1" }, { "type": "secondary", "measure": "Satisfaction and Perception with intervention", "description": "Qualitative interview", "time_frame": "4 weeks T1" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 27, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04742946", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05597800", "title": "Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2022-10-28", "start_date": "2023-02-01", "completion_date": "2027-03-30", "primary_completion_date": "2026-12-31", "conditions_raw": [ "NSCLC Stage IV", "HIV", "HBV", "HCV", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Nivolumab And Ipilimumab" ], "sponsor": "Universita di Verona", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Study type: Phase 2 - Interventional Trial Number of patients to be enrolled: 105 Participating countries: Italy Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome The stratification factors are HBV/HCV positive (cohort A), HIV positive (cohort B), patients with Long Covid syndrome (Cohort C), histology (squamous vs non-squamous histology), and gender (male vs female).", "primary_outcomes": [ { "type": "primary", "measure": "Safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.", "description": "The primary objectives of the study are safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.", "time_frame": "3 years" }, { "type": "primary", "measure": "Objective Response Rate (ORR) measured as for RECIST 1.1 criteria", "description": "Activity in terms of objective response rate (ORR) of nivolumab plus ipilimumab in combination with platinum-based chemotherapy (2 cycles) in first-line advanced NSCLC patients with chronic viral infections.", "time_frame": "3 years" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Overall survival (OS)", "description": "Overall survival (OS) is defined as the time between the date of the randomization date and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.", "time_frame": "3 years" }, { "type": "secondary", "measure": "Progression-free survival (PFS)", "description": "Progression free survival (PFS), according to response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by local investigators, is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD is defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.", "time_frame": "3 years" }, { "type": "secondary", "measure": "Duration of response (DOR)", "description": "Duration of response (DOR) is defined as the time from date of first documentation of confirmed response (CR or PR) to date of first documentation of progression or symptomatic deterioration, or death due to any cause among patients who achieve, assessed at 6 and 12 months.", "time_frame": "3 years" } ], "outcome_measures": [ { "type": "primary", "measure": "Safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.", "description": "The primary objectives of the study are safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.", "time_frame": "3 years" }, { "type": "primary", "measure": "Objective Response Rate (ORR) measured as for RECIST 1.1 criteria", "description": "Activity in terms of objective response rate (ORR) of nivolumab plus ipilimumab in combination with platinum-based chemotherapy (2 cycles) in first-line advanced NSCLC patients with chronic viral infections.", "time_frame": "3 years" }, { "type": "secondary", "measure": "Overall survival (OS)", "description": "Overall survival (OS) is defined as the time between the date of the randomization date and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.", "time_frame": "3 years" }, { "type": "secondary", "measure": "Progression-free survival (PFS)", "description": "Progression free survival (PFS), according to response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by local investigators, is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD is defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.", "time_frame": "3 years" }, { "type": "secondary", "measure": "Duration of response (DOR)", "description": "Duration of response (DOR) is defined as the time from date of first documentation of confirmed response (CR or PR) to date of first documentation of progression or symptomatic deterioration, or death due to any cause among patients who achieve, assessed at 6 and 12 months.", "time_frame": "3 years" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 105, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05597800", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05228665", "title": "HEART Rate Variability Biofeedback in LOng COVID-19 (HEARTLOC)", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-10-24", "start_date": "2022-01-24", "completion_date": "2024-03-31", "primary_completion_date": "2023-12-31", "conditions_raw": [ "COVID-19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Heart Rate Variability Biofeedback" ], "sponsor": "University of Leeds", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long COVID is a common but highly debilitating illness which develops after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19). It is thought to affect as many as 1 in 7 people following COVID-19 infection. It can produce a vast array of symptoms including fatigue, breathlessness, fast heart rate, blood pressure disturbance, temperature disturbance, and dry mouth. Many of these symptoms could be explained by the nervous system being predominantly in a stress or 'fight or flight' response, also known as dysautonomia. One way of assessing whether this is the case is by measuring heart rate variability (HRV). This is the time variation between heart beats and is a marker of how stressed the nervous system is or how strong is the 'fight or flight' response. Heart rate variability can be measured using devices which are worn round the wrist or attach to the chest. An increased variability in heart rate corresponds with a more relaxed nervous system and decreased variability with a more stressed nervous system. Monitoring HRV in real-time and implementing interventions such as a breathing regime to maximise HRV is known as HRV biofeedback. The body can be trained out of the fight or flight response and into the 'rest and digest' mode response of the nervous system in this way and potentially significantly improve symptoms. We propose that for people with Long COVID, a programme of structured breathing exercises over 4 weeks whilst tracking HRV can demonstrate an improvement in HRV and consequently improve Long COVID symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Modified C19-YRS (COVID-19 Yorkshire Rehabilitation Scale)", "description": "The C19-YRSm will be completed by the patient every week for a total of 6 weeks. There will be a total of 7 C19-YRSm documents completed. The C19-YRSm consists of 17 items with each item rated on a 4-point numerical rating scale from 0 (no symptom) to 3 (life disturbing or affecting all aspects of daily life). The C19-YRSm is divided into four subscales (range of total score for each subscale): symptom severity score (0-30), functional disability score (0-15), other symptoms (0-25), and overall health (0-10). A higher score for the first 3 subscores represents higher severity. Conversely, a lower overall health score represents greater severity.", "time_frame": "Up to 6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "HRV (Heart Rate Variability) score", "description": "We will be collecting both medium and short term HRV data. Participants will wear a Fitbit for 6 weeks which will collect HRV data whilst sleeping each night, thus collecting 6 weeks of consecutive nocturnal HRV data. In addition they will wear a Polar H10 chest strap for 10 minutes twice daily whilst performing breathing exercises to collect frequent short-term HRV data. For both data sets an increase in HRV is expected as this denotes an improvement in heart rate variability.\n\nFitbit measures HRV in milliseconds on a scale from 0 to 100 (or more if HRV exceeds 100ms) A higher score represents more variability and therefore improvement.\n\nThe Elite HRV also provides a score of HRV on a scale from 0 to 100 with a higher score representing improvement. The score is derived from the root mean square of successive differences between heartbeats in milliseconds (rMSSD).", "time_frame": "Up to 6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Modified C19-YRS (COVID-19 Yorkshire Rehabilitation Scale)", "description": "The C19-YRSm will be completed by the patient every week for a total of 6 weeks. There will be a total of 7 C19-YRSm documents completed. The C19-YRSm consists of 17 items with each item rated on a 4-point numerical rating scale from 0 (no symptom) to 3 (life disturbing or affecting all aspects of daily life). The C19-YRSm is divided into four subscales (range of total score for each subscale): symptom severity score (0-30), functional disability score (0-15), other symptoms (0-25), and overall health (0-10). A higher score for the first 3 subscores represents higher severity. Conversely, a lower overall health score represents greater severity.", "time_frame": "Up to 6 weeks" }, { "type": "secondary", "measure": "HRV (Heart Rate Variability) score", "description": "We will be collecting both medium and short term HRV data. Participants will wear a Fitbit for 6 weeks which will collect HRV data whilst sleeping each night, thus collecting 6 weeks of consecutive nocturnal HRV data. In addition they will wear a Polar H10 chest strap for 10 minutes twice daily whilst performing breathing exercises to collect frequent short-term HRV data. For both data sets an increase in HRV is expected as this denotes an improvement in heart rate variability.\n\nFitbit measures HRV in milliseconds on a scale from 0 to 100 (or more if HRV exceeds 100ms) A higher score represents more variability and therefore improvement.\n\nThe Elite HRV also provides a score of HRV on a scale from 0 to 100 with a higher score representing improvement. The score is derived from the root mean square of successive differences between heartbeats in milliseconds (rMSSD).", "time_frame": "Up to 6 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05228665", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05152849", "title": "Efficacy, Safety, Tolerability of AXA1125 in Fatigue After COVID-19 Infection", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2022-10-20", "start_date": "2021-12-15", "completion_date": "2022-06-29", "primary_completion_date": "2022-06-21", "conditions_raw": [ "Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Axa1125" ], "sponsor": "Axcella Health, Inc", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving muscle function (metabolism) following moderate exercise in subjects with fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 as well as the safety and tolerability of AXA1125. Subjects will take one dose of AXA1125 or a placebo twice daily for 28 days.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS)", "description": "", "time_frame": "Baseline to 28 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS)", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Proportion of subjects with improvement in PCr recovery rate", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Change from baseline in serum lactate level after a 6-minute walk test", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Change from baseline in distance traveled during a 6MWT", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11", "description": "", "time_frame": "Baseline to14 days" }, { "type": "secondary", "measure": "Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 before and after a 6MWT", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Proportion of subjects with an improvement in fatigue score as assessed by CFQ-11 before and after a 6MWT", "description": "", "time_frame": "Baseline to 28 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS)", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS)", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Proportion of subjects with improvement in PCr recovery rate", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Change from baseline in serum lactate level after a 6-minute walk test", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Change from baseline in distance traveled during a 6MWT", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11", "description": "", "time_frame": "Baseline to14 days" }, { "type": "secondary", "measure": "Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 before and after a 6MWT", "description": "", "time_frame": "Baseline to 28 days" }, { "type": "secondary", "measure": "Proportion of subjects with an improvement in fatigue score as assessed by CFQ-11 before and after a 6MWT", "description": "", "time_frame": "Baseline to 28 days" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 41, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05152849", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05582603", "title": "Safety and Dosage of a Computerized Cognitive Training Program for Cognitive Dysfunction After COVID-19", "status": "UNKNOWN", "phase": "PHASE1", "last_updated": "2022-10-18", "start_date": "2022-10-18", "completion_date": "2022-11-30", "primary_completion_date": "2022-11-30", "conditions_raw": [ "Post-Acute COVID-19", "Post Acute COVID-19 Syndrome", "Cognitive Dysfunction", "Cognitive Impairment" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cct Long Covid" ], "sponsor": "Universidad Antonio de Nebrija", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this Phase I/II clinical trial is to assess the safety and maximum tolerated training time of a self-administered computerized cognitive training (CCT) in individuals with cognitive dysfunction as a consequence of COVID-19 infection.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Level Questionnaire", "description": "Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)", "time_frame": "In Phase I, after each iteration of a 15-minute training." }, { "type": "primary", "measure": "Fatigue Level Questionnaire", "description": "Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)", "time_frame": "In Phase II, on even days (rest days of the intervention protocol)." }, { "type": "primary", "measure": "Safety Level Questionnaire", "description": "Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.", "time_frame": "In Phase I, after each iteration of a 15-minute training." }, { "type": "primary", "measure": "Safety Level Questionnaire", "description": "Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.", "time_frame": "In Phase II, on even days (rest days of the intervention protocol)." }, { "type": "primary", "measure": "Classification of side effect or adverse events", "description": "Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).", "time_frame": "In Phase I, after each iteration of a 15-minute training, only in case side effects or adverse events have been reported in the Safety Questionnaire." }, { "type": "primary", "measure": "Classification of side effect or adverse events", "description": "Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).", "time_frame": "In Phase II, on even days (rest days of the intervention protocol), only in case side effects or adverse events have been reported in the Safety Questionnaire." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Computerized Cognitive Assessment", "description": "Complete cognitive evaluation based on Cognitive Assessment Battery (CogniFit Inc., San Francisco, USA).", "time_frame": "In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes)." }, { "type": "secondary", "measure": "Quality of Life Assessment", "description": "Short version of the self-perceived global physical and mental health scale from the Patient-Reported Outcomes Measurement Information System (PROMIS v.1.2).", "time_frame": "In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes)." }, { "type": "secondary", "measure": "Paper-and-pencil Cognitive Assessment", "description": "The Montreal Cognitive Assessment (MoCA).", "time_frame": "In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes)." } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Level Questionnaire", "description": "Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)", "time_frame": "In Phase I, after each iteration of a 15-minute training." }, { "type": "primary", "measure": "Fatigue Level Questionnaire", "description": "Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)", "time_frame": "In Phase II, on even days (rest days of the intervention protocol)." }, { "type": "primary", "measure": "Safety Level Questionnaire", "description": "Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.", "time_frame": "In Phase I, after each iteration of a 15-minute training." }, { "type": "primary", "measure": "Safety Level Questionnaire", "description": "Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.", "time_frame": "In Phase II, on even days (rest days of the intervention protocol)." }, { "type": "primary", "measure": "Classification of side effect or adverse events", "description": "Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).", "time_frame": "In Phase I, after each iteration of a 15-minute training, only in case side effects or adverse events have been reported in the Safety Questionnaire." }, { "type": "primary", "measure": "Classification of side effect or adverse events", "description": "Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).", "time_frame": "In Phase II, on even days (rest days of the intervention protocol), only in case side effects or adverse events have been reported in the Safety Questionnaire." }, { "type": "secondary", "measure": "Computerized Cognitive Assessment", "description": "Complete cognitive evaluation based on Cognitive Assessment Battery (CogniFit Inc., San Francisco, USA).", "time_frame": "In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes)." }, { "type": "secondary", "measure": "Quality of Life Assessment", "description": "Short version of the self-perceived global physical and mental health scale from the Patient-Reported Outcomes Measurement Information System (PROMIS v.1.2).", "time_frame": "In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes)." }, { "type": "secondary", "measure": "Paper-and-pencil Cognitive Assessment", "description": "The Montreal Cognitive Assessment (MoCA).", "time_frame": "In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes)." } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05582603", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04996212", "title": "Telerehabilitation Program in Persistent COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-10-17", "start_date": "2021-01-20", "completion_date": "2022-10-14", "primary_completion_date": "2022-10-14", "conditions_raw": [ "Coronavirus Infection", "Respiratory Disease" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Walking App Group", "Functional App Group" ], "sponsor": "University of Valencia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The syndrome characterized by the persistence of symptoms typical of COVID-19, beyond 4 weeks after discharge, is called long COVID. Long COVID affects a high percentage of patients who have suffered from COVID-19, regardless of its severity. The various symptoms present in that patients affect the functionality and physical, mental and psychological capacities of patients. Therefore, it is necessary to implement therapeutic programs, based on exercises and techniques of physiotherapy, to help affected people to resume their work, family, social and sports activities; prior to illness. Given the context in which these programs must be developed, telecare is positioned as the most recommended care method to carry out the rehabilitation of these patients. The general objective of this study is to evaluate the effectiveness of a cardiorespiratory tele-rehabilitation program in persistent COVID-19 patients. Study participants (n=60) will be randomly assigned to one of two intervention groups. Group 1 will combine breathing exercises with aerobic exercise: walk; and group 2 will perform functional exercises in addition to respiratory physiotherapy with. All participants will be evaluated at the beginning of the intervention, at the end of it.", "primary_outcomes": [ { "type": "primary", "measure": "Quality of life (EQ-5D-5L)", "description": "The EQ-5D-3L is a short and simple scale consisting of 2 parts. In the first of the pages, a total of 5 questions allow evaluating five different dimensions: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. In the second part, through a Visual Analogue Pain Scale (VAS), the patient can quantify, from 0 to 100, her perceived health status at the time of evaluation", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Quality of life (EQ-5D-5L) Change from Baseline PostCovid-19 Functional Satatus Scale at five months (PCFSS)", "description": "The PCFS items assess the functional limitations that post-COVID-19 patients The EQ-5D-3L is a short and simple scale consisting of 2 parts. In the first of the pages, a total of 5 questions allow evaluating five different dimensions: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. In the second part, through a Visual Analogue Pain Scale (VAS), the patient can quantify, from 0 to 100, her perceived health status at the time of evaluation", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Fatigue Assessment Scale (FAS)", "description": "The scale consists of 10 items through which the fatigue experienced by the subject can be assessed at two levels: physical and mental.\n\nParticipants in this study must answer how often the situations described in each item on the scale occur. To do this, they must quantify each statement with a number from 1 to 5, where 1 is never; and 5, always.", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "London Chest Activity of Daily Living Scale (LCADL)", "description": "The LCADL was designed with the purpose of assessing the level of dyspnea, reported by patients with pulmonary pathology, during the performance of ADL. The LCADL scale therefore makes it possible to assess and adequately monitor the functional deterioration that patients experience as a consequence of their dyspnea. Throughout its development, this scale explores 4 different dimensions: self-care, home activities, physical activity and leisure activities.", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "The HADS scale is a widely used instrument to assess the degree of emotional distress suffered by people with pathology. The scale consists of 14 items that consider cognitive, affective and behavioral aspects; but not somatic. The original version of the HADS has been validated and translated into different languages, including Spanish", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Perceived Stress Scale (PSS)", "description": "The PSS allows evaluating the level of stress perceived by patients during the last month It is made up of 14 items that explore the thoughts and feelings of the respondent that can be related to high levels of stress. The higher the score, the higher the level of perceived stress.", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Beck Depression Inventory (BDI-2)", "description": "The BDI-2, through its 21 items, aims to help the health professional to identify and measure the severity of symptoms, typical of a depressive process, in the adult population", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Exercise tolerance. Thirty Seconds Sit-To-Stand", "description": "Exercise tolerance will be assessed using the Thirty Seconds Sit-To-Stand test (30stst), as it has proven to be a useful test to evaluate the strength and endurance of the lower limbs and determine the patient's tolerance to physical activity", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Quality of life (EQ-5D-5L)", "description": "The EQ-5D-3L is a short and simple scale consisting of 2 parts. In the first of the pages, a total of 5 questions allow evaluating five different dimensions: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. In the second part, through a Visual Analogue Pain Scale (VAS), the patient can quantify, from 0 to 100, her perceived health status at the time of evaluation", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Quality of life (EQ-5D-5L) Change from Baseline PostCovid-19 Functional Satatus Scale at five months (PCFSS)", "description": "The PCFS items assess the functional limitations that post-COVID-19 patients The EQ-5D-3L is a short and simple scale consisting of 2 parts. In the first of the pages, a total of 5 questions allow evaluating five different dimensions: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. In the second part, through a Visual Analogue Pain Scale (VAS), the patient can quantify, from 0 to 100, her perceived health status at the time of evaluation", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Fatigue Assessment Scale (FAS)", "description": "The scale consists of 10 items through which the fatigue experienced by the subject can be assessed at two levels: physical and mental.\n\nParticipants in this study must answer how often the situations described in each item on the scale occur. To do this, they must quantify each statement with a number from 1 to 5, where 1 is never; and 5, always.", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "London Chest Activity of Daily Living Scale (LCADL)", "description": "The LCADL was designed with the purpose of assessing the level of dyspnea, reported by patients with pulmonary pathology, during the performance of ADL. The LCADL scale therefore makes it possible to assess and adequately monitor the functional deterioration that patients experience as a consequence of their dyspnea. Throughout its development, this scale explores 4 different dimensions: self-care, home activities, physical activity and leisure activities.", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "The HADS scale is a widely used instrument to assess the degree of emotional distress suffered by people with pathology. The scale consists of 14 items that consider cognitive, affective and behavioral aspects; but not somatic. The original version of the HADS has been validated and translated into different languages, including Spanish", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Perceived Stress Scale (PSS)", "description": "The PSS allows evaluating the level of stress perceived by patients during the last month It is made up of 14 items that explore the thoughts and feelings of the respondent that can be related to high levels of stress. The higher the score, the higher the level of perceived stress.", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Beck Depression Inventory (BDI-2)", "description": "The BDI-2, through its 21 items, aims to help the health professional to identify and measure the severity of symptoms, typical of a depressive process, in the adult population", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" }, { "type": "secondary", "measure": "Exercise tolerance. Thirty Seconds Sit-To-Stand", "description": "Exercise tolerance will be assessed using the Thirty Seconds Sit-To-Stand test (30stst), as it has proven to be a useful test to evaluate the strength and endurance of the lower limbs and determine the patient's tolerance to physical activity", "time_frame": "It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention" } ], "relevance_tags": [ "Persistence / Antiviral", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 70, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04996212", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05571852", "title": "Personalized Computerized Training Program for Cognitive Dysfunction After COVID-19", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-10-07", "start_date": "2021-12-01", "completion_date": "2022-02-28", "primary_completion_date": "2022-02-28", "conditions_raw": [ "Post-Acute COVID-19", "Long COVID" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Cognifit'S Cct Post Covid-19" ], "sponsor": "Universidad Antonio de Nebrija", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This before-and-after study aims to evaluate the usefulness and efficacy of a personalized computerized cognitive training (CCT) to improve cognitive function among people with post-acute sequelae of COVID-19 (PASC).", "primary_outcomes": [ { "type": "primary", "measure": "Cognitive Gains", "description": "The difference in scores between the initial and final assessments as evaluated by the Cognitive Assessment Battery (CAB)™ PRO", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Intensity of the training", "description": "Number of minutes dedicated to the CCT", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Cognitive Gains", "description": "The difference in scores between the initial and final assessments as evaluated by the Cognitive Assessment Battery (CAB)™ PRO", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Intensity of the training", "description": "Number of minutes dedicated to the CCT", "time_frame": "8 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 73, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05571852", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05483829", "title": "Digital Health Intervention Based on Artificial Intelligence to Support the Personalized Recovery of Long COVID Patients Affected by Fatigue (AIDA)", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-09-22", "start_date": "2022-08-01", "completion_date": "2022-08-28", "primary_completion_date": "2022-08-28", "conditions_raw": [ "Post Acute COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Adhera® Fatigue For Long Covid Program" ], "sponsor": "Adhera Health, Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The AIDA feasibility study builds upon mental health and technology acceptance theoretical frameworks. It examines the feasibility of a mobile-based digital program to support patients with long covid affected by fatigue. The program Adhera ® Fatigue Self-management is adapted for long covid patients.", "primary_outcomes": [ { "type": "primary", "measure": "Behavioral outcome: Usability", "description": "mHealth solution usability assessed with the System Usability Scale (SUS) questionnaire. SUS can range between 0 and 100 scores, with higher values representing higher usability.", "time_frame": "At week 4" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Behavioral outcome: Usability", "description": "mHealth solution usability assessed with the System Usability Scale (SUS) questionnaire. SUS can range between 0 and 100 scores, with higher values representing higher usability.", "time_frame": "At week 4" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 15, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05483829", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07398508", "title": "NORTHERA (DROXIDOPA) for Dysautonomia in Pediatric Survivors of Menkes Disease", "status": "RECRUITING", "phase": "PHASE1", "last_updated": "2026-10-05", "start_date": "2026-08-10", "completion_date": "2030-06-30", "primary_completion_date": "2030-06-30", "conditions_raw": [ "Menkes Disease" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Droxidopa Oral Product" ], "sponsor": "Stephen G. Kaler", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This clinical trial will evaluate the safety, tolerability, dosing, and efficacy of Northera (Droxidopa) in children with Menkes disease aged 7 to 17 years who survived the major neurodegenerative and neurocognitive effects of Menkes disease through early Copper Histidinate treatment. The investigator hypothesizes that Northera (Droxidopa) treatment in pediatric Menkes disease survivors with symptoms of dysautonomia (e.g., syncope, dizziness, orthostatic hypotension, abnormal sinoatrial conduction, and bowel or bladder dysfunction) from deficiency of the cuproenzyme, dopamine-beta-hydroxylase, will be safe and will correct or improve blood neurochemical levels, raise systolic blood pressure, and produce symptomatic improvement and a better quality of life. The investigator will test this hypothesis, in six to ten child or adolescent Menkes disease survivors through a placebo-controlled trial to evaluate adverse event rates and whether oral administration of Northera (Droxidopa) at doses established for individual subjects by careful dose titration improves plasma norepinephrine and dihydroxyphenylglycol (DHPG) levels, raises systolic blood pressure, and improves performance on tests of physical exertion. As an exploratory outcome measure, the study will validate the Orthostatic Hypotension Symptom Assessment (OHSA) questionnaire for this population for two four-week periods of either active or placebo treatment.\n\nAim 1. Determine the safety of Droxidopa in Menkes disease pediatric survivors.\n\nAim 2. Determine the efficacy of Droxidopa in Menkes disease survivors. The investigator hypothesizes that low-dose Droxidopa treatment in classic Menkes disease survivors aged 7 to 17 will improve orthostatic hypotension and ameliorate other signs and symptoms of dysautonomia. This pilot study will employ an ascending dose paradigm in a double-blind placebo-controlled randomized crossover design to optimize statistical power and rigorously discern treatment effects on 1) tilt table tests of orthostatic hypotension, 2) systolic and diastolic blood pressure, 3) plasma neurochemical levels and 4) tests of physical exertion. The trial will also validate the Orthostatic Hypotension Symptom Assessment (OHSA) questionnaire for this population of children and adolescents. This study addresses an important unmet clinical need for subjects with a rare disease, Menkes disease.", "primary_outcomes": [ { "type": "primary", "measure": "Incidence of SAEs", "description": "This is to measure safety and tolerability of study drug in children and adolescents with Menkes disease. The study will determine the adverse event profile of the formulation by comparing the time-to-event of serious adverse events (SAEs) and adverse events (AEs) between treatment and placebo arms as defined in the protocol.", "time_frame": "10 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in level of plasma norepinephrine and dihydroxyphenylglycol after Northera (Droxidopa)", "description": "Plasma L-DOPS levels: Levels of L-threo-3,4-dihydroxyphenylserine (L-DOPS, droxidopa) may be measured for comparison to the known pharmacokinetic (PK) profile of Northera (Droxidopa) (peak level at approximately 3 hrs). The assay for plasma LDOPS and plasma catecholamines (High Performance Liquid Chromatography with electrochemical detection) is the same. Measurements of L-DOPS may permit correlation between plasma L-DOPS and plasma norepinephrine levels.", "time_frame": "Baseline and post intervention at 4 weeks" }, { "type": "secondary", "measure": "Change in systolic blood pressure", "description": "Blood pressure (BP) will be measured using a standard blood pressure monitor while subjects are standing, and between supine and head-up tilt table positions after Northera (Droxidopa). Unit: mm Hg. Tilt Table testing involves positioning a patient onto the tilt table with feet resting on footplates. Continuous blood pressure monitors are then attached to the subject. The entire table can be tilted to move from 0˚ to 60˚angle in approximately 45s, allowing determination of changes in pulse and blood pressure based on supine (0˚) and standing (60˚) positions.", "time_frame": "Baseline and post intervention at 4 weeks" }, { "type": "secondary", "measure": "Average number of daily bowel movements", "description": "Gastrointestinal symptoms will be monitored using irritable bowel syndrome-diarrhea report. Decreased daily bowel movements counts as an improvement.", "time_frame": "Baseline, 4 weeks" }, { "type": "secondary", "measure": "Average time standing", "description": "This is to measure any improvement in physicality using performance of physical exertion tests. The longer the time standing, the greater the improvement. Unit: minutes.", "time_frame": "Baseline and post intervention at 4 weeks" }, { "type": "secondary", "measure": "Average 6-minute walk distance", "description": "This is to measure any improvement in physicality using performance of physical exertion tests. The further the distance, the greater the improvement. The primary measurement taken from a 6-minute walk test (6MWT) is the final distance someone manages to walk, which we refer to as the 6MWD (6-minute walk distance), which can be used to assess a patient's functional status. For everyday healthy people, the average distance walked during this test is between 400 and 700 meters.", "time_frame": "Baseline and post intervention at 4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Incidence of SAEs", "description": "This is to measure safety and tolerability of study drug in children and adolescents with Menkes disease. The study will determine the adverse event profile of the formulation by comparing the time-to-event of serious adverse events (SAEs) and adverse events (AEs) between treatment and placebo arms as defined in the protocol.", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "Change in level of plasma norepinephrine and dihydroxyphenylglycol after Northera (Droxidopa)", "description": "Plasma L-DOPS levels: Levels of L-threo-3,4-dihydroxyphenylserine (L-DOPS, droxidopa) may be measured for comparison to the known pharmacokinetic (PK) profile of Northera (Droxidopa) (peak level at approximately 3 hrs). The assay for plasma LDOPS and plasma catecholamines (High Performance Liquid Chromatography with electrochemical detection) is the same. Measurements of L-DOPS may permit correlation between plasma L-DOPS and plasma norepinephrine levels.", "time_frame": "Baseline and post intervention at 4 weeks" }, { "type": "secondary", "measure": "Change in systolic blood pressure", "description": "Blood pressure (BP) will be measured using a standard blood pressure monitor while subjects are standing, and between supine and head-up tilt table positions after Northera (Droxidopa). Unit: mm Hg. Tilt Table testing involves positioning a patient onto the tilt table with feet resting on footplates. Continuous blood pressure monitors are then attached to the subject. The entire table can be tilted to move from 0˚ to 60˚angle in approximately 45s, allowing determination of changes in pulse and blood pressure based on supine (0˚) and standing (60˚) positions.", "time_frame": "Baseline and post intervention at 4 weeks" }, { "type": "secondary", "measure": "Average number of daily bowel movements", "description": "Gastrointestinal symptoms will be monitored using irritable bowel syndrome-diarrhea report. Decreased daily bowel movements counts as an improvement.", "time_frame": "Baseline, 4 weeks" }, { "type": "secondary", "measure": "Average time standing", "description": "This is to measure any improvement in physicality using performance of physical exertion tests. The longer the time standing, the greater the improvement. Unit: minutes.", "time_frame": "Baseline and post intervention at 4 weeks" }, { "type": "secondary", "measure": "Average 6-minute walk distance", "description": "This is to measure any improvement in physicality using performance of physical exertion tests. The further the distance, the greater the improvement. The primary measurement taken from a 6-minute walk test (6MWT) is the final distance someone manages to walk, which we refer to as the 6MWD (6-minute walk distance), which can be used to assess a patient's functional status. For everyday healthy people, the average distance walked during this test is between 400 and 700 meters.", "time_frame": "Baseline and post intervention at 4 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 6, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07398508", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05493605", "title": "Cardiac Involvement in Wilson's Disease", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-10-01", "start_date": "2023-03-02", "completion_date": "2029-03", "primary_completion_date": "2029-03", "conditions_raw": [ "Wilson's Disease" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Delivery Of A Long-Term Holter 21 Days Or Placement Of An Implantable Holter From The Outset So Syncope" ], "sponsor": "Fondation Ophtalmologique Adolphe de Rothschild", "sponsor_type": "NETWORK", "primary_purpose": "N/A", "brief_summary": "Heart damage by copper accumulation has been reported in Wilson's Disease. However, the disease epidemiology is still poorly understood. A number of studies on pediatric populations have not shown any significant cardiac involvement apart from early dysautonomia. This could suggest that the clinical manifestations related to the copper accumulation in the heart appears with the duration of the disease. Case-control studies on adult populations have highlighted various electrocardiographic (ECG) abnormalities more frequent in patients with Wilson's Disease than in healthy volunteers, but all these studies involved small number of patients (maximum 60). The hypothesis is that there is cardiac involvement in Wilson's Disease, requiring screening, follow-up and appropriate support.", "primary_outcomes": [ { "type": "primary", "measure": "Contrast-enhanced cardiac MRI - Day 0", "description": "Percentage of patients with abnormal contrast-enhanced cardiac MRI results", "time_frame": "Day 0" }, { "type": "primary", "measure": "Contrast-enhanced cardiac MRI - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Transthoracic echocardiography - Day 0", "description": "Percentage of patients with abnormal transthoracic echocardiography results", "time_frame": "Day 0" }, { "type": "primary", "measure": "Transthoracic echocardiography - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Chest computed tomography scan without contrast - Day 0", "description": "Percentage of patients with abnormal coronary artery calcium score\n\nCalcium score : The higher the coronary calcium score, the greater the cardiovascular risk. A score of 0 (min) means that no calcium is seen in the heart. A score greater than 300 is a sign of very high to severe disease.", "time_frame": "Day 0" }, { "type": "primary", "measure": "Electrocardiogram - Day 0", "description": "Percentage of patients with abnormal electrocardiogram results", "time_frame": "Day 0" }, { "type": "primary", "measure": "Electrocardiogram - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Clinical examination - Day 0", "description": "Percentage of patients with abnormal clinical examination", "time_frame": "Day 0" }, { "type": "primary", "measure": "Clinical examination - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Blood and urine tests - Day 0", "description": "Percentage of patients with abnormal blood and urine tests results Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria", "time_frame": "Day 0" }, { "type": "primary", "measure": "Blood and urine tests - Day 0", "description": "Description of abnormalities (frequency and percentage) Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria", "time_frame": "Day 0" }, { "type": "primary", "measure": "Lying and standing blood pressure tests - Day 0", "description": "Percentage of patients with abnormal blood pressure tests results", "time_frame": "Day 0" }, { "type": "primary", "measure": "Lying and standing blood pressure tests - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Implantable loop recorder or ECG holter recorder- Day 21", "description": "Percentage of patients with abnormal implantable loop record (or ECG holter record) The device will record from Day 0 to Day 21 Implantable loop recorder assessment will be only performed on patients with syncope.", "time_frame": "Day 21" }, { "type": "primary", "measure": "Implantable loop recorder or ECG holter recorder- Day 21", "description": "Description of abnormalities (frequency and percentage) The device will record from Day 0 to Day 21 Implantable loop recorder assessment will be only performed on patients with syncope.", "time_frame": "Day 21" }, { "type": "primary", "measure": "Transthoracic echocardiography - Year 3", "description": "Percentage of patients with abnormal transthoracic echocardiography results", "time_frame": "Year 3" }, { "type": "primary", "measure": "Transthoracic echocardiography - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" }, { "type": "primary", "measure": "Contrast-enhanced cardiac MRI - Year 3", "description": "Percentage of patients with abnormal contrast-enhanced cardiac MRI results", "time_frame": "Year 3" }, { "type": "primary", "measure": "Contrast-enhanced cardiac MRI - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" }, { "type": "primary", "measure": "Chest computed tomography scan without contrast - Year 3", "description": "Percentage of patients with abnormal coronary artery calcium score\n\nCalcium score : The higher the coronary calcium score, the greater the cardiovascular risk. A score of 0 (min) means that no calcium is seen in the heart. A score greater than 300 is a sign of very high to severe disease.", "time_frame": "Year 3" }, { "type": "primary", "measure": "Electrocardiogram - Year 3", "description": "Percentage of patients with abnormal electrocardiogram results", "time_frame": "Year 3" }, { "type": "primary", "measure": "Electrocardiogram - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" }, { "type": "primary", "measure": "Clinical examination - Year 3", "description": "Percentage of patients with abnormal clinical examination", "time_frame": "Year 3" }, { "type": "primary", "measure": "Clinical examination - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" }, { "type": "primary", "measure": "Blood and urine tests - Year 3", "description": "Percentage of patients with abnormal blood or urine tests results Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria", "time_frame": "Year 3" }, { "type": "primary", "measure": "Blood and urine tests - Year 3", "description": "Description of abnormalities (frequency and percentage) Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria", "time_frame": "Year 3" }, { "type": "primary", "measure": "Lying and standing blood pressure tests - Year 3", "description": "Percentage of patients with abnormal blood pressure tests results", "time_frame": "Year 3" }, { "type": "primary", "measure": "Lying and standing blood pressure tests - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Contrast-enhanced cardiac MRI - Day 0", "description": "Percentage of patients with abnormal contrast-enhanced cardiac MRI results", "time_frame": "Day 0" }, { "type": "primary", "measure": "Contrast-enhanced cardiac MRI - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Transthoracic echocardiography - Day 0", "description": "Percentage of patients with abnormal transthoracic echocardiography results", "time_frame": "Day 0" }, { "type": "primary", "measure": "Transthoracic echocardiography - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Chest computed tomography scan without contrast - Day 0", "description": "Percentage of patients with abnormal coronary artery calcium score\n\nCalcium score : The higher the coronary calcium score, the greater the cardiovascular risk. A score of 0 (min) means that no calcium is seen in the heart. A score greater than 300 is a sign of very high to severe disease.", "time_frame": "Day 0" }, { "type": "primary", "measure": "Electrocardiogram - Day 0", "description": "Percentage of patients with abnormal electrocardiogram results", "time_frame": "Day 0" }, { "type": "primary", "measure": "Electrocardiogram - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Clinical examination - Day 0", "description": "Percentage of patients with abnormal clinical examination", "time_frame": "Day 0" }, { "type": "primary", "measure": "Clinical examination - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Blood and urine tests - Day 0", "description": "Percentage of patients with abnormal blood and urine tests results Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria", "time_frame": "Day 0" }, { "type": "primary", "measure": "Blood and urine tests - Day 0", "description": "Description of abnormalities (frequency and percentage) Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria", "time_frame": "Day 0" }, { "type": "primary", "measure": "Lying and standing blood pressure tests - Day 0", "description": "Percentage of patients with abnormal blood pressure tests results", "time_frame": "Day 0" }, { "type": "primary", "measure": "Lying and standing blood pressure tests - Day 0", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Day 0" }, { "type": "primary", "measure": "Implantable loop recorder or ECG holter recorder- Day 21", "description": "Percentage of patients with abnormal implantable loop record (or ECG holter record) The device will record from Day 0 to Day 21 Implantable loop recorder assessment will be only performed on patients with syncope.", "time_frame": "Day 21" }, { "type": "primary", "measure": "Implantable loop recorder or ECG holter recorder- Day 21", "description": "Description of abnormalities (frequency and percentage) The device will record from Day 0 to Day 21 Implantable loop recorder assessment will be only performed on patients with syncope.", "time_frame": "Day 21" }, { "type": "primary", "measure": "Transthoracic echocardiography - Year 3", "description": "Percentage of patients with abnormal transthoracic echocardiography results", "time_frame": "Year 3" }, { "type": "primary", "measure": "Transthoracic echocardiography - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" }, { "type": "primary", "measure": "Contrast-enhanced cardiac MRI - Year 3", "description": "Percentage of patients with abnormal contrast-enhanced cardiac MRI results", "time_frame": "Year 3" }, { "type": "primary", "measure": "Contrast-enhanced cardiac MRI - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" }, { "type": "primary", "measure": "Chest computed tomography scan without contrast - Year 3", "description": "Percentage of patients with abnormal coronary artery calcium score\n\nCalcium score : The higher the coronary calcium score, the greater the cardiovascular risk. A score of 0 (min) means that no calcium is seen in the heart. A score greater than 300 is a sign of very high to severe disease.", "time_frame": "Year 3" }, { "type": "primary", "measure": "Electrocardiogram - Year 3", "description": "Percentage of patients with abnormal electrocardiogram results", "time_frame": "Year 3" }, { "type": "primary", "measure": "Electrocardiogram - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" }, { "type": "primary", "measure": "Clinical examination - Year 3", "description": "Percentage of patients with abnormal clinical examination", "time_frame": "Year 3" }, { "type": "primary", "measure": "Clinical examination - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" }, { "type": "primary", "measure": "Blood and urine tests - Year 3", "description": "Percentage of patients with abnormal blood or urine tests results Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria", "time_frame": "Year 3" }, { "type": "primary", "measure": "Blood and urine tests - Year 3", "description": "Description of abnormalities (frequency and percentage) Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria", "time_frame": "Year 3" }, { "type": "primary", "measure": "Lying and standing blood pressure tests - Year 3", "description": "Percentage of patients with abnormal blood pressure tests results", "time_frame": "Year 3" }, { "type": "primary", "measure": "Lying and standing blood pressure tests - Year 3", "description": "Description of abnormalities (frequency and percentage)", "time_frame": "Year 3" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Network" ], "enrollment": 150, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05493605", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07468604", "title": "Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition", "status": "RECRUITING", "phase": "PHASE4", "last_updated": "2026-09-29", "start_date": "2026-05-19", "completion_date": "2027-09-01", "primary_completion_date": "2027-05-20", "conditions_raw": [ "Autonomic Dysfunction" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "5 Ml Of 0.25% Bupivacaine With Epinephrine" ], "sponsor": "University Health Network, Toronto", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Post-COVID Condition (PCC) affects roughly 2.1 million Canadians, carrying an annual economic burden of CAD $7.8-50.6 billion. It presents across multiple organ systems with symptoms including fatigue, brain fog, palpitations, and orthostatic intolerance, at an annual cost of CAD $1,675-$7,340 per case.\n\nA key mechanism underlying many treatment-resistant PCC symptoms appears to be dysautonomia abnormal autonomic nervous system function driven by immune-mediated sympathetic overactivity. Persistent inflammation (cytokine storms, T/B-cell dysfunction, microclots) sustains sympathetic hyperactivity, which in turn perpetuates systemic inflammation and \"sickness behaviors\" resembling PCC symptoms.\n\nCurrent treatments including beta blockers, ivabradine, fludrocortisone, and rehabilitation are limited by variable responses, side effects, and the complication of post-exertional symptom exacerbation. Emerging therapies (SSRIs, low-dose naltrexone, antihistamines, HBOT) show promise but lack robust trial evidence.\n\nCervicothoracic sympathetic chain block (CSB) a local anesthetic block of the cervical and upper thoracic sympathetic ganglia is a promising intervention that reduces sympathetic outflow, improves cerebral blood supply, and lowers pro-inflammatory cytokines. Small observational studies (16 studies, 224 patients) show benefit for PCC symptoms, but all lack placebo controls and have significant methodological heterogeneity.\n\nThe proposed study aims to fill this gap with a double-blind, placebo-controlled RCT to rigorously evaluate CSB's efficacy, magnitude of benefit, and durability in PCC patients.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in the Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) Symptom Severity subscale score", "description": "Description: The C19-YRSm Symptom Severity subscale is scored from 0 to 30, with higher scores indicating greater symptom burden. The outcome is the change from baseline in this score.", "time_frame": "Three months after the final injection." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "C19-YRSm Symptom Severity subscale score", "description": "The C19-YRSm Symptom Severity subscale is scored from 0 to 30, with higher scores indicating greater symptom burden. The outcome is the change from baseline in this score.", "time_frame": "One month and three months after the final injection." }, { "type": "secondary", "measure": "Autonomic symptom burden (COMPASS-31)", "description": "Weighted total score and the six domain scores (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, pupillomotor).", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Heart rate variability", "description": "Heart rate variability over a five-minute recording.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Heart rate and blood pressure responses to autonomic challenge", "description": "Valsalva manoeuvre, deep breathing, hyperventilation, and postural change (lying to sitting; sitting to standing).", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "One-minute sit-to-stand test.", "description": "sitting to standing heart rate and blood pressure responses to autonomic challenge", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Serum pro-inflammatory cytokines", "description": "Measurement of interleukin-1β (IL-1β), interleukin-6 (IL-6), tumour necrosis factor alpha (TNF-α).", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-7 (GAD-7)", "description": "The GAD-7 is a 7-item self-report questionnaire designed to screen for and measure the severity of generalized anxiety symptoms over the previous two weeks. Patients rate how often they have been bothered by symptoms such as excessive worry, nervousness, irritability, and difficulty relaxing. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a 9-item self-administered questionnaire used to screen for and assess the severity of depressive symptoms over the preceding two weeks. It evaluates symptoms including depressed mood, loss of interest or pleasure, sleep disturbances, fatigue, appetite changes, concentration difficulties, feelings of worthlessness, psychomotor changes, and suicidal ideation. Scores range from 0 to 27, with higher scores reflecting more severe depression.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "The HADS is a 14-item self-report instrument developed to assess anxiety and depression in medical and outpatient settings while minimizing the influence of physical symptoms related to medical illness. It consists of two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each containing 7 items. Scores for each subscale range from 0 to 21, with higher scores indicating greater symptom severity.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a standardized, preference-based measure of health-related quality of life developed by the EuroQol Group. It assesses health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels ranging from no problems to extreme problems/unable to perform activities. The questionnaire also includes a visual analogue scale (EQ VAS), on which participants rate their overall health from 0 (\"the worst health you can imagine\") to 100 (\"the best health you can imagine\"). Higher index and VAS scores indicate better perceived health-related quality of life.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Sleep Quality", "description": "Pittsburgh Sleep Quality Index (PSQI)\n\nThe Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire designed to assess subjective sleep quality and sleep disturbances over the previous month. The instrument comprises 19 items that generate seven component scores evaluating subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. These component scores are summed to produce a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global score greater than 5 is commonly used to identify clinically significant sleep disturbances.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Actigraphy-measured sleep-Monitoring sleep", "description": "Monitoring sleep onset latency, total sleep time, number of awakenings.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Actigraphy-measured sleep-Monitoring daytime activities", "description": "Time spent in sedentary, mild, moderate and vigorous activity.", "time_frame": "collected at screening, one month and three months after the final injection." } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in the Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) Symptom Severity subscale score", "description": "Description: The C19-YRSm Symptom Severity subscale is scored from 0 to 30, with higher scores indicating greater symptom burden. The outcome is the change from baseline in this score.", "time_frame": "Three months after the final injection." }, { "type": "secondary", "measure": "C19-YRSm Symptom Severity subscale score", "description": "The C19-YRSm Symptom Severity subscale is scored from 0 to 30, with higher scores indicating greater symptom burden. The outcome is the change from baseline in this score.", "time_frame": "One month and three months after the final injection." }, { "type": "secondary", "measure": "Autonomic symptom burden (COMPASS-31)", "description": "Weighted total score and the six domain scores (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, pupillomotor).", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Heart rate variability", "description": "Heart rate variability over a five-minute recording.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Heart rate and blood pressure responses to autonomic challenge", "description": "Valsalva manoeuvre, deep breathing, hyperventilation, and postural change (lying to sitting; sitting to standing).", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "One-minute sit-to-stand test.", "description": "sitting to standing heart rate and blood pressure responses to autonomic challenge", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Serum pro-inflammatory cytokines", "description": "Measurement of interleukin-1β (IL-1β), interleukin-6 (IL-6), tumour necrosis factor alpha (TNF-α).", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Generalized Anxiety Disorder-7 (GAD-7)", "description": "The GAD-7 is a 7-item self-report questionnaire designed to screen for and measure the severity of generalized anxiety symptoms over the previous two weeks. Patients rate how often they have been bothered by symptoms such as excessive worry, nervousness, irritability, and difficulty relaxing. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a 9-item self-administered questionnaire used to screen for and assess the severity of depressive symptoms over the preceding two weeks. It evaluates symptoms including depressed mood, loss of interest or pleasure, sleep disturbances, fatigue, appetite changes, concentration difficulties, feelings of worthlessness, psychomotor changes, and suicidal ideation. Scores range from 0 to 27, with higher scores reflecting more severe depression.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "The HADS is a 14-item self-report instrument developed to assess anxiety and depression in medical and outpatient settings while minimizing the influence of physical symptoms related to medical illness. It consists of two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each containing 7 items. Scores for each subscale range from 0 to 21, with higher scores indicating greater symptom severity.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)", "description": "The EQ-5D-5L is a standardized, preference-based measure of health-related quality of life developed by the EuroQol Group. It assesses health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels ranging from no problems to extreme problems/unable to perform activities. The questionnaire also includes a visual analogue scale (EQ VAS), on which participants rate their overall health from 0 (\"the worst health you can imagine\") to 100 (\"the best health you can imagine\"). Higher index and VAS scores indicate better perceived health-related quality of life.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Sleep Quality", "description": "Pittsburgh Sleep Quality Index (PSQI)\n\nThe Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire designed to assess subjective sleep quality and sleep disturbances over the previous month. The instrument comprises 19 items that generate seven component scores evaluating subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. These component scores are summed to produce a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global score greater than 5 is commonly used to identify clinically significant sleep disturbances.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Actigraphy-measured sleep-Monitoring sleep", "description": "Monitoring sleep onset latency, total sleep time, number of awakenings.", "time_frame": "collected at screening, one month and three months after the final injection." }, { "type": "secondary", "measure": "Actigraphy-measured sleep-Monitoring daytime activities", "description": "Time spent in sedentary, mild, moderate and vigorous activity.", "time_frame": "collected at screening, one month and three months after the final injection." } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Anti-inflammatory", "Phase 4", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 78, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07468604", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04137757", "title": "fMRI in Postural Tachycardia Syndrome", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-09-24", "start_date": "2022-02-18", "completion_date": "2027-12-01", "primary_completion_date": "2027-12-01", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Lower Body Negative Pressure" ], "sponsor": "Milton S. Hershey Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural tachycardia syndrome (POTS) is one of the most common forms of chronic orthostatic intolerance in the United States. This is a disabling disorder characterized by an excessive increase in heart rate upon standing that is accompanied by symptoms such as dizziness and fatigue. One of the most under appreciated and bothersome symptoms of POTS is impaired cognition or \"brain fog,\" which occurs to a level that interferes with daily activities such as work and education. Despite this high impact, the reasons why POTS patients have problems with cognition are not well understood. This project will test the overall hypothesis that \"brain fog\" in POTS is related to increased activation of cognitive brain regions during mental tasks when compared with healthy subjects, and that this activation is exacerbated by in the presence of orthostatic stress.", "primary_outcomes": [ { "type": "primary", "measure": "Cognitive Brain Region Activation", "description": "The change in activation of cognitive brain regions measured by blood oxygen dependent functional magnetic resonance imaging following cognitive tasks and orthostatic stress.", "time_frame": "60 minutes" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Brain Oxygen Perfusion", "description": "The change in brain oxygen perfusion measured by arterial spin labeling magnetic resonance imaging following cognitive tasks and orthostatic stress.", "time_frame": "60 minutes" }, { "type": "secondary", "measure": "Blood Pressure", "description": "The change in blood pressure following cognitive tasks and orthostatic stress.", "time_frame": "60 minutes" }, { "type": "secondary", "measure": "Heart Rate", "description": "The change in heart rate following cognitive tasks and orthostatic stress.", "time_frame": "60 minutes" }, { "type": "secondary", "measure": "Stroop Word-Color Score", "description": "The change in the Stroop word-color test score following orthostatic stress and sham stress. This test measure executive function. The scores are T-scores normalized to population averages based on age and education level from 0 to 100. A higher score indicates better executive function.", "time_frame": "10 minutes" } ], "outcome_measures": [ { "type": "primary", "measure": "Cognitive Brain Region Activation", "description": "The change in activation of cognitive brain regions measured by blood oxygen dependent functional magnetic resonance imaging following cognitive tasks and orthostatic stress.", "time_frame": "60 minutes" }, { "type": "secondary", "measure": "Brain Oxygen Perfusion", "description": "The change in brain oxygen perfusion measured by arterial spin labeling magnetic resonance imaging following cognitive tasks and orthostatic stress.", "time_frame": "60 minutes" }, { "type": "secondary", "measure": "Blood Pressure", "description": "The change in blood pressure following cognitive tasks and orthostatic stress.", "time_frame": "60 minutes" }, { "type": "secondary", "measure": "Heart Rate", "description": "The change in heart rate following cognitive tasks and orthostatic stress.", "time_frame": "60 minutes" }, { "type": "secondary", "measure": "Stroop Word-Color Score", "description": "The change in the Stroop word-color test score following orthostatic stress and sham stress. This test measure executive function. The scores are T-scores normalized to population averages based on age and education level from 0 to 100. A higher score indicates better executive function.", "time_frame": "10 minutes" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 21, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04137757", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07837804", "title": "RESET-POTS: Multimodal Phenotyping and Stellate Ganglion Block in Postural Orthostatic Tachycardia Syndrome", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-09-24", "start_date": "2026-10-01", "completion_date": "2027-12", "primary_completion_date": "2027-10-01", "conditions_raw": [ "POTS - Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Bilateral Sequential Stellate Ganglion Block" ], "sponsor": "University Medical Centre Ljubljana", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "RESET-POTS is a pilot study for adults with postural orthostatic tachycardia syndrome (POTS), a condition that can cause a rapid increase in heart rate, dizziness, weakness, fatigue and other symptoms when standing. The study has two parts. In the first part, patients with POTS and healthy volunteers will undergo several tests to better understand how POTS affects heart rate and blood pressure, the autonomic nervous system, hormones, metabolism, blood sugar regulation, brain and muscle oxygenation, and quality of life. In the second part, eligible patients with POTS will receive a stellate ganglion block, a procedure in which a local anaesthetic is injected near nerves in the neck that are involved in sympathetic nervous system activity. The procedure will be performed on the right and left sides on separate days. Participants will then be reassessed about 2 weeks and 3 months later. The main goals are to determine whether the study procedures are practical and well tolerated, whether the nerve block can be performed successfully and safely, and whether there are signs of changes in POTS-related body functions and symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Completion of the Core Phase 1 Phenotyping Protocol", "description": "Percentage of enrolled participants who complete the predefined core multidomain Phase 1 phenotyping protocol.", "time_frame": "End of Phase 1 phenotyping (before stellate ganglion block)" }, { "type": "primary", "measure": "Completeness of Phase 1 Phenotyping Data", "description": "Proportion of participants with complete and interpretable data across the predefined phenotyping domains. Data completeness will be assessed to determine the feasibility of using the multidomain assessment battery in a future randomized trial.", "time_frame": "End of Phase 1 phenotyping (before stellate ganglion block)" }, { "type": "primary", "measure": "Progression of Patients With POTS to the Interventional Phase", "description": "Percentage of eligible patients with POTS who proceed from Phase 1 phenotyping to Phase 2 and undergo stellate ganglion block.", "time_frame": "At initiation of Phase 2 (stellate ganglion block)" }, { "type": "primary", "measure": "Completion of Both Planned Stellate Ganglion Block Procedures", "description": "Percentage of participants entering Phase 2 who complete both the right and left stellate ganglion block procedures as planned.", "time_frame": "From the first stellate ganglion block to the second block, performed 3-7 days later" }, { "type": "primary", "measure": "Completion of First Follow-up", "description": "Percentage of participants undergoing bilateral stellate ganglion block who complete the planned early follow-up assessment.", "time_frame": "Approximately 14 days after completion of bilateral stellate ganglion block" }, { "type": "primary", "measure": "Completion of Second Follow-up", "description": "Percentage of participants undergoing bilateral stellate ganglion block who complete the planned final follow-up assessment.", "time_frame": "Approximately 3 months after completion of bilateral stellate ganglion block" }, { "type": "primary", "measure": "Incidence of Adverse Events", "description": "Number and percentage of participants experiencing adverse events during the interventional phase, including the type and severity of events and their relationship to stellate ganglion block. Procedure-related events of particular interest include dysphonia, dysphagia, hoarseness, brachial plexus block, phrenic nerve involvement, hematoma, vasovagal reaction, infection, allergic reaction, inadvertent intravascular injection, local anesthetic systemic toxicity, and pneumothorax.", "time_frame": "From the first stellate ganglion block through the final follow-up approximately 3 months after bilateral stellate ganglion block" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Technical Success of Stellate Ganglion Block", "description": "Percentage of performed stellate ganglion block procedures meeting the predefined criteria for technical success. Technical success will be based primarily on thermographic evidence of ipsilateral sympathetic blockade, supported by clinical signs where present.", "time_frame": "Within 30 minutes after each stellate ganglion block procedure" } ], "outcome_measures": [ { "type": "primary", "measure": "Completion of the Core Phase 1 Phenotyping Protocol", "description": "Percentage of enrolled participants who complete the predefined core multidomain Phase 1 phenotyping protocol.", "time_frame": "End of Phase 1 phenotyping (before stellate ganglion block)" }, { "type": "primary", "measure": "Completeness of Phase 1 Phenotyping Data", "description": "Proportion of participants with complete and interpretable data across the predefined phenotyping domains. Data completeness will be assessed to determine the feasibility of using the multidomain assessment battery in a future randomized trial.", "time_frame": "End of Phase 1 phenotyping (before stellate ganglion block)" }, { "type": "primary", "measure": "Progression of Patients With POTS to the Interventional Phase", "description": "Percentage of eligible patients with POTS who proceed from Phase 1 phenotyping to Phase 2 and undergo stellate ganglion block.", "time_frame": "At initiation of Phase 2 (stellate ganglion block)" }, { "type": "primary", "measure": "Completion of Both Planned Stellate Ganglion Block Procedures", "description": "Percentage of participants entering Phase 2 who complete both the right and left stellate ganglion block procedures as planned.", "time_frame": "From the first stellate ganglion block to the second block, performed 3-7 days later" }, { "type": "primary", "measure": "Completion of First Follow-up", "description": "Percentage of participants undergoing bilateral stellate ganglion block who complete the planned early follow-up assessment.", "time_frame": "Approximately 14 days after completion of bilateral stellate ganglion block" }, { "type": "primary", "measure": "Completion of Second Follow-up", "description": "Percentage of participants undergoing bilateral stellate ganglion block who complete the planned final follow-up assessment.", "time_frame": "Approximately 3 months after completion of bilateral stellate ganglion block" }, { "type": "primary", "measure": "Incidence of Adverse Events", "description": "Number and percentage of participants experiencing adverse events during the interventional phase, including the type and severity of events and their relationship to stellate ganglion block. Procedure-related events of particular interest include dysphonia, dysphagia, hoarseness, brachial plexus block, phrenic nerve involvement, hematoma, vasovagal reaction, infection, allergic reaction, inadvertent intravascular injection, local anesthetic systemic toxicity, and pneumothorax.", "time_frame": "From the first stellate ganglion block through the final follow-up approximately 3 months after bilateral stellate ganglion block" }, { "type": "secondary", "measure": "Technical Success of Stellate Ganglion Block", "description": "Percentage of performed stellate ganglion block procedures meeting the predefined criteria for technical success. Technical success will be based primarily on thermographic evidence of ipsilateral sympathetic blockade, supported by clinical signs where present.", "time_frame": "Within 30 minutes after each stellate ganglion block procedure" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07837804", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05618067", "title": "The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-09-16", "start_date": "2028-01", "completion_date": "2028-12", "primary_completion_date": "2028-12", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Breathing Exercise Training" ], "sponsor": "Virginia Commonwealth University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is being to see if participating in breathing exercise training and practicing this training will help with Postural tachycardia syndrome (POTS). The information may help doctors to learn more about how the different parts of people's brains communicate.", "primary_outcomes": [ { "type": "primary", "measure": "Change in periaqueductal gray region (PAG) activation - looming task", "description": "Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region during the looming task", "time_frame": "90 minutes" }, { "type": "primary", "measure": "Change in PAG activation - resting", "description": "Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region while at rest", "time_frame": "90 minutes" }, { "type": "primary", "measure": "Change in Heart Rate Variability (HRV)", "description": "HRV will be measured using an ear clip and/or wristband and results will be recorded automatically in the app", "time_frame": "Assessed for 2 days each week for the duration of the study (6 weeks)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Fatigue Severity Scale (FSS) score from baseline", "description": "The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue by asking participants to answer 9 statements that rate the severity of their fatigue symptoms in the past week by selecting their answer on a 1-7 point Likert scale. Sum scores range from 9-36. A low value (e.g., 1) indicates strong disagreement with the statement (lower symptom severity), whereas a high value (e.g., 7) indicates strong agreement (higher symptom severity).", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in Generalized Anxiety Disorder Scale (GAD-2) score from baseline", "description": "The Generalized Anxiety Disorder Scale (GAD-2) is a method of evaluating anxiety symptoms by asking participants to answer 2 statements that rate the severity of their anxiety symptoms in the past 2 weeks by selecting their answer a 0-3 point Likert scale (0- not at all, 1- several days, 2 - more than half the days, 3 - nearly every day). Sum scores range from 0-6. A low value (e.g., 0) indicates no or less severe anxiety symptoms, whereas a high value (e.g. 3), indicates more severe anxiety symptoms.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Differences in Adverse Childhood Experiences (ACE) scores between participants", "description": "The Adverse Childhood Experiences (ACE) questionnaire is a method of evaluating childhood adversities such as emotional, physical, and sexual abuse/neglect by asking participants to answer 10 statements that describe events that happened during the first 18 years of their life. Participants indicate if this event occurred by selecting a Yes or No answer. Sum scores range from 0-10. Less \"Yes\" responses indicate less ACE occurrences, and more \"Yes\" responses indicate more ACE occurrences.", "time_frame": "Assessed at baseline." }, { "type": "secondary", "measure": "Change in Pain Catastrophizing Scale (PCS) score from baseline", "description": "The Pain Catastrophizing Scale (PCS) is a method of evaluating pain catastrophizing, measuring pain-related cognitions and the dimensions of helplessness, rumination and magnification by asking participants to answer 13 items that describe different thoughts and feelings that may be associated with their pain. Participants rate how strong their feelings are about pain on a 5 point scale (0- Not at all, 1- To a slight degree, 2- To a moderate degree, 3- To a great degree, 4- All the time). Sum scores range from 0-52. Higher scores indicate higher levels of pain catastrophizing. A total PCS score of 30 represents a clinically relevant level of catastrophizing.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire (PHQ-9) score from baseline", "description": "The Patient Health Questionnaire (PHQ-9) objectifies and assesses degree of depression severity via questionnaire by asking participants to answer 9 items that rate the severity of depression symptoms over the past 2 weeks on a 0-3 point Likert scale (0- not at all, 1- several days, 2 - more than half the days, 3 - nearly every day). Sum scores range from 0-36. A low value (e.g., 0) indicates no or less severe depression symptoms, whereas a high value (e.g. 3), indicates more severe depression symptoms.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in Pittsburgh Sleep Quality Index (PSQI) from baseline", "description": "The Pittsburgh Sleep Quality Index (PSQI) measures quality and patterns of sleep in adults. It differentiates \"poor\" from \"good\" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the past month. Participants are asked to answer 19 items. 5 items are free response and ask questions about sleep duration. The remaining 14 items are answered on a 0-3 point Likert scale (0 - not during the past month, 1- less than once a week, 2- once or twice a week, 3- three or more times a week) that describe the frequency of the listed events. A global score is calculated from the sum of 7 component scores and ranges from 0-21, with lower scores indicating lower sleep dysfunction and higher scores indicating higher sleep dysfunction.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in PROMIS Physical Function (PROMIS 8b) from baseline", "description": "The PROMIS Physical Function (PROMIS 8b) instrument measures self-reported capability of physical activities by asking participants to respond to 8 items on a 5-point Likert scale. The scale for the first 4 items is as follows: 5- Without any difficulty, 4- With a little difficulty, 3- With some difficulty, 2- With much difficulty, 1- Unable to do. The scale for the last 4 items is as follows: 5- Not at all, 4- Very little, 3- Somewhat, 2- Quite a lot, 1- Cannot do. Raw sum scores range from 8-40 and are converted into a T-score ranging from 20.3 to 60.1, with higher scores indicating better physical function and lower scores indicating poorer physical function.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in the Perceived Stress Scale (PSS) from baseline", "description": "The Perceived Stress Scale (PSS) measures how different situations affect feelings and perceived stress. Participants are asked to answer 10 items that describe the frequency of their feelings and thoughts described in each item during the last month on a 0-4 point Likert scale (0 - never, 1- almost never, 2- sometimes, 3- fairly often, 4- very often). Sum scores range from 0-40, with lower scores indicating less perceived stress levels and higher scores indicating higher perceived stress levels.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in the PTSD Checklist (PCL-5) from baseline", "description": "The PCL-5 assesses the 20 DSM-5 symptoms of PTSD. Participants are asked to answer 5 free response questions about the worst \\& more stressful event to which they were exposed, then 20 items about the event on a 0-4 point Likert scale (0- not at all, 1- a little bit, 2- moderately, 3- quite a bit, 4- extremely). Sum scores of the 20 Likert-format items range from 0-80, with lower scores indicating less severe PTSD symptoms and higher scores indicating more severe PTSD symptoms.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in the Pain, Enjoyment of Life, and General Activity (PEG-3) from baseline", "description": "The Pain, Enjoyment of Life, and General Activity (PEG-3) scale assesses pain levels and interference with enjoyment of life and activity. Participants are asked to answer 3 items on a 0-10 point Likert scale. For item 1, the scale is as follows: 0- no pain, 10- pain as bad as you can imagine. For items 2-3, the scale is as follows: 0- does not interfere, 10- completely interferes. Sum scores range from 0-30, with lower scores indicating less pain and/or interference and higher scores indicating more pain and/or interference.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." } ], "outcome_measures": [ { "type": "primary", "measure": "Change in periaqueductal gray region (PAG) activation - looming task", "description": "Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region during the looming task", "time_frame": "90 minutes" }, { "type": "primary", "measure": "Change in PAG activation - resting", "description": "Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region while at rest", "time_frame": "90 minutes" }, { "type": "primary", "measure": "Change in Heart Rate Variability (HRV)", "description": "HRV will be measured using an ear clip and/or wristband and results will be recorded automatically in the app", "time_frame": "Assessed for 2 days each week for the duration of the study (6 weeks)." }, { "type": "secondary", "measure": "Change in Fatigue Severity Scale (FSS) score from baseline", "description": "The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue by asking participants to answer 9 statements that rate the severity of their fatigue symptoms in the past week by selecting their answer on a 1-7 point Likert scale. Sum scores range from 9-36. A low value (e.g., 1) indicates strong disagreement with the statement (lower symptom severity), whereas a high value (e.g., 7) indicates strong agreement (higher symptom severity).", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in Generalized Anxiety Disorder Scale (GAD-2) score from baseline", "description": "The Generalized Anxiety Disorder Scale (GAD-2) is a method of evaluating anxiety symptoms by asking participants to answer 2 statements that rate the severity of their anxiety symptoms in the past 2 weeks by selecting their answer a 0-3 point Likert scale (0- not at all, 1- several days, 2 - more than half the days, 3 - nearly every day). Sum scores range from 0-6. A low value (e.g., 0) indicates no or less severe anxiety symptoms, whereas a high value (e.g. 3), indicates more severe anxiety symptoms.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Differences in Adverse Childhood Experiences (ACE) scores between participants", "description": "The Adverse Childhood Experiences (ACE) questionnaire is a method of evaluating childhood adversities such as emotional, physical, and sexual abuse/neglect by asking participants to answer 10 statements that describe events that happened during the first 18 years of their life. Participants indicate if this event occurred by selecting a Yes or No answer. Sum scores range from 0-10. Less \"Yes\" responses indicate less ACE occurrences, and more \"Yes\" responses indicate more ACE occurrences.", "time_frame": "Assessed at baseline." }, { "type": "secondary", "measure": "Change in Pain Catastrophizing Scale (PCS) score from baseline", "description": "The Pain Catastrophizing Scale (PCS) is a method of evaluating pain catastrophizing, measuring pain-related cognitions and the dimensions of helplessness, rumination and magnification by asking participants to answer 13 items that describe different thoughts and feelings that may be associated with their pain. Participants rate how strong their feelings are about pain on a 5 point scale (0- Not at all, 1- To a slight degree, 2- To a moderate degree, 3- To a great degree, 4- All the time). Sum scores range from 0-52. Higher scores indicate higher levels of pain catastrophizing. A total PCS score of 30 represents a clinically relevant level of catastrophizing.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in Patient Health Questionnaire (PHQ-9) score from baseline", "description": "The Patient Health Questionnaire (PHQ-9) objectifies and assesses degree of depression severity via questionnaire by asking participants to answer 9 items that rate the severity of depression symptoms over the past 2 weeks on a 0-3 point Likert scale (0- not at all, 1- several days, 2 - more than half the days, 3 - nearly every day). Sum scores range from 0-36. A low value (e.g., 0) indicates no or less severe depression symptoms, whereas a high value (e.g. 3), indicates more severe depression symptoms.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in Pittsburgh Sleep Quality Index (PSQI) from baseline", "description": "The Pittsburgh Sleep Quality Index (PSQI) measures quality and patterns of sleep in adults. It differentiates \"poor\" from \"good\" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the past month. Participants are asked to answer 19 items. 5 items are free response and ask questions about sleep duration. The remaining 14 items are answered on a 0-3 point Likert scale (0 - not during the past month, 1- less than once a week, 2- once or twice a week, 3- three or more times a week) that describe the frequency of the listed events. A global score is calculated from the sum of 7 component scores and ranges from 0-21, with lower scores indicating lower sleep dysfunction and higher scores indicating higher sleep dysfunction.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in PROMIS Physical Function (PROMIS 8b) from baseline", "description": "The PROMIS Physical Function (PROMIS 8b) instrument measures self-reported capability of physical activities by asking participants to respond to 8 items on a 5-point Likert scale. The scale for the first 4 items is as follows: 5- Without any difficulty, 4- With a little difficulty, 3- With some difficulty, 2- With much difficulty, 1- Unable to do. The scale for the last 4 items is as follows: 5- Not at all, 4- Very little, 3- Somewhat, 2- Quite a lot, 1- Cannot do. Raw sum scores range from 8-40 and are converted into a T-score ranging from 20.3 to 60.1, with higher scores indicating better physical function and lower scores indicating poorer physical function.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in the Perceived Stress Scale (PSS) from baseline", "description": "The Perceived Stress Scale (PSS) measures how different situations affect feelings and perceived stress. Participants are asked to answer 10 items that describe the frequency of their feelings and thoughts described in each item during the last month on a 0-4 point Likert scale (0 - never, 1- almost never, 2- sometimes, 3- fairly often, 4- very often). Sum scores range from 0-40, with lower scores indicating less perceived stress levels and higher scores indicating higher perceived stress levels.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in the PTSD Checklist (PCL-5) from baseline", "description": "The PCL-5 assesses the 20 DSM-5 symptoms of PTSD. Participants are asked to answer 5 free response questions about the worst \\& more stressful event to which they were exposed, then 20 items about the event on a 0-4 point Likert scale (0- not at all, 1- a little bit, 2- moderately, 3- quite a bit, 4- extremely). Sum scores of the 20 Likert-format items range from 0-80, with lower scores indicating less severe PTSD symptoms and higher scores indicating more severe PTSD symptoms.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." }, { "type": "secondary", "measure": "Change in the Pain, Enjoyment of Life, and General Activity (PEG-3) from baseline", "description": "The Pain, Enjoyment of Life, and General Activity (PEG-3) scale assesses pain levels and interference with enjoyment of life and activity. Participants are asked to answer 3 items on a 0-10 point Likert scale. For item 1, the scale is as follows: 0- no pain, 10- pain as bad as you can imagine. For items 2-3, the scale is as follows: 0- does not interfere, 10- completely interferes. Sum scores range from 0-30, with lower scores indicating less pain and/or interference and higher scores indicating more pain and/or interference.", "time_frame": "Assessed at baseline, week 3, and week 6 (final visit)." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 12, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05618067", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05554107", "title": "The Effect of Physical Activity on Postural Orthostatic Tachycardia Syndrome", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-09-03", "start_date": "2022-11-02", "completion_date": "2028-10", "primary_completion_date": "2028-03", "conditions_raw": [ "POTS - Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Training Program" ], "sponsor": "Lund University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural orthostatic tachycardia syndrome (POTS) is a disorder of unknown origin characterized by orthostatic intolerance and increased heart rate (HR) of ≥ 30 beats/minute during orthostasis in the absence of orthostatic hypotension. In addition to the orthostatic intolerance and tachycardia, patients with POTS experience several debilitating symptoms including light-headedness, nausea, blurred vision, fatigue, mental confusion (\"brain-fog\"), chest pain and gastrointestinal problems. Several potential underlying mechanisms have been suggested for POTS including autonomic denervation, hypovolemia, hyperadrenergic stimulation and autoantibodies against adrenergic receptors. However, none of these proposed mechanisms has yet led to an effective treatment. Physical activity is recommended as a complimentary treatment in POTS in international guidelines. However, less is known regarding how physical activity could successfully be implemented in clinical practice in patients with POTS. Thus, in the current study, we aim to assess the effect of a 16-week specialized physical activity program in POTS.", "primary_outcomes": [ { "type": "primary", "measure": "POTS questionnaire", "description": "Subjective symptoms evaluated according to the Malmö POTS Symptom Score which has previously been described (Spahic et al. 2022). The questionnaire is based on patients' own perception of 12 commonly reported symptoms: five cardiac symptoms (palpitations, dizziness, presyncope, dyspnoea and chest pain) and seven non-cardiac symptoms (gastrointestinal symptoms, insomnia, concentration difficulties, headache, myalgia, nausea and fatigue) during the previous 7 days, graded on a scale from 0 (no symptoms) to 10 (very pronounced symptoms). The score ranges from 0 to a maximum score of 120 points.", "time_frame": "12 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Orthostatic hypotension questionnaire", "description": "Subjective symptoms evaluated according to the orthostatic hypotension questionnaire (OHQ). The OHQ is a questionnaire that has been previously validated and used for orthostatic hypotension but has also been used for quantification of POTS-related symptoms. Further details on the OHQ has previously been described in Kharraziha et al (2020).", "time_frame": "12 months" }, { "type": "secondary", "measure": "SF-36", "description": "Evaluation of 36-item Short Form Health Survey (SF-36). The SF-36 is a 36-item patient-reported questionnaire covering eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.", "time_frame": "12 months" }, { "type": "secondary", "measure": "Orthostatic tests", "description": "Hemodynamic measurements (pulse reaction) during orthostatic testing", "time_frame": "12 months" }, { "type": "secondary", "measure": "Maximal biking exercise", "description": "Physical capacity measured in watts", "time_frame": "12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "POTS questionnaire", "description": "Subjective symptoms evaluated according to the Malmö POTS Symptom Score which has previously been described (Spahic et al. 2022). The questionnaire is based on patients' own perception of 12 commonly reported symptoms: five cardiac symptoms (palpitations, dizziness, presyncope, dyspnoea and chest pain) and seven non-cardiac symptoms (gastrointestinal symptoms, insomnia, concentration difficulties, headache, myalgia, nausea and fatigue) during the previous 7 days, graded on a scale from 0 (no symptoms) to 10 (very pronounced symptoms). The score ranges from 0 to a maximum score of 120 points.", "time_frame": "12 months" }, { "type": "secondary", "measure": "Orthostatic hypotension questionnaire", "description": "Subjective symptoms evaluated according to the orthostatic hypotension questionnaire (OHQ). The OHQ is a questionnaire that has been previously validated and used for orthostatic hypotension but has also been used for quantification of POTS-related symptoms. Further details on the OHQ has previously been described in Kharraziha et al (2020).", "time_frame": "12 months" }, { "type": "secondary", "measure": "SF-36", "description": "Evaluation of 36-item Short Form Health Survey (SF-36). The SF-36 is a 36-item patient-reported questionnaire covering eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.", "time_frame": "12 months" }, { "type": "secondary", "measure": "Orthostatic tests", "description": "Hemodynamic measurements (pulse reaction) during orthostatic testing", "time_frame": "12 months" }, { "type": "secondary", "measure": "Maximal biking exercise", "description": "Physical capacity measured in watts", "time_frame": "12 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 200, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05554107", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07757555", "title": "Guanfacine and Cromolyn Sodium for POTS: The DBPOTS Trial", "status": "NOT_YET_RECRUITING", "phase": "EARLY_PHASE1", "last_updated": "2026-08-12", "start_date": "2026-08-15", "completion_date": "2028-02-02", "primary_completion_date": "2027-12-15", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)", "Dysautonomia", "Orthostatic Intolerance", "Autonomic Nervous System Diseases" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Guanfacine", "Cromolyn Sodium" ], "sponsor": "Johns Hopkins University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to learn whether guanfacine or cromolyn sodium can improve symptoms and physical functioning in adults with Postural Orthostatic Tachycardia Syndrome (POTS). Both medications are FDA-approved for other conditions but are investigational for the treatment of POTS.\n\nThe main questions this study aims to answer are:\n\nDoes treatment with guanfacine or cromolyn sodium improve physical functioning in adults with POTS compared with placebo? Does treatment with guanfacine or cromolyn sodium improve fatigue, cognitive function (\"brain fog\"), gastrointestinal symptoms, and overall symptom burden in adults with POTS?\n\nResearchers will compare guanfacine, cromolyn sodium, and placebo to determine whether either active treatment provides greater improvement in symptoms and physical functioning than placebo.\n\nParticipants will:\n\nBe randomly assigned to receive guanfacine, cromolyn sodium, and placebo during separate 4-week treatment periods in a randomized, double-blind crossover study.\n\nContinue standard non-drug POTS management, including recommendations for fluid and salt intake, exercise, compression garments, and other lifestyle measures.\n\nComplete questionnaires that measure physical function, fatigue, cognitive symptoms, gastrointestinal symptoms, and overall health throughout the study.\n\nAttend scheduled study visits for safety monitoring and assessment of study outcomes.\n\nProvide blood, urine, and sputum samples so researchers can evaluate biomarkers related to POTS and better understand how these treatments may work.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Physical Function as Measured by the PROMIS® Physical Function Scale", "description": "Scores are reported as T-scores based on a U.S. population average of 50, with a standard deviation of 10. Higher scores indicate better physical function.", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), week 10 (end of treatment), week 16 (end of treatment)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue", "description": "T-score (mean = 50, SD = 10). Higher T-scores indicate greater fatigue (worse outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), week 10 (end of treatment), week 16 (end of treatment)" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function", "description": "T-score (mean = 50, SD = 10). Higher T-scores indicate better cognitive function (better outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), Week 10 (end of treatment), Week 16 (end of treatment)" }, { "type": "secondary", "measure": "Clinical Global Impressions (CGI)", "description": "Score ranges from 1 to 7. Higher scores indicate greater illness severity or worsening (worse outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), Week 10 (end of treatment), Week 16 (end of treatment)" }, { "type": "secondary", "measure": "Malmö Postural Orthostatic Tachycardia Syndrome Symptom Score", "description": "Total score ranges from 0 to 120. Higher scores indicate greater POTS symptom burden (worse outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), Week 10 (end of treatment), and Week 16 (end of treatment)" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS®) Gastrointestinal Symptom Scale", "description": "T-score (mean = 50, SD = 10). Higher T-scores indicate more severe gastrointestinal symptoms (worse outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), Week 10 (end of treatment), Week 16 (end of treatment)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Physical Function as Measured by the PROMIS® Physical Function Scale", "description": "Scores are reported as T-scores based on a U.S. population average of 50, with a standard deviation of 10. Higher scores indicate better physical function.", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), week 10 (end of treatment), week 16 (end of treatment)" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue", "description": "T-score (mean = 50, SD = 10). Higher T-scores indicate greater fatigue (worse outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), week 10 (end of treatment), week 16 (end of treatment)" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function", "description": "T-score (mean = 50, SD = 10). Higher T-scores indicate better cognitive function (better outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), Week 10 (end of treatment), Week 16 (end of treatment)" }, { "type": "secondary", "measure": "Clinical Global Impressions (CGI)", "description": "Score ranges from 1 to 7. Higher scores indicate greater illness severity or worsening (worse outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), Week 10 (end of treatment), Week 16 (end of treatment)" }, { "type": "secondary", "measure": "Malmö Postural Orthostatic Tachycardia Syndrome Symptom Score", "description": "Total score ranges from 0 to 120. Higher scores indicate greater POTS symptom burden (worse outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), Week 10 (end of treatment), and Week 16 (end of treatment)" }, { "type": "secondary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS®) Gastrointestinal Symptom Scale", "description": "T-score (mean = 50, SD = 10). Higher T-scores indicate more severe gastrointestinal symptoms (worse outcome).", "time_frame": "Week 0 (baseline), Week 4 (end of treatment), Week 10 (end of treatment), Week 16 (end of treatment)" } ], "relevance_tags": [ "Neurological / Autonomic", "EARLY_Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 25, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07757555", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05400174", "title": "Blood Pressure Effects on Cognition and Brain Blood Flow in PD", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-08-07", "start_date": "2021-12-14", "completion_date": "2027-01-15", "primary_completion_date": "2026-12-15", "conditions_raw": [ "Parkinson Disease", "Orthostatic Hypotension", "Dysautonomia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Tilt Table" ], "sponsor": "University of California, San Diego", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Parkinson's disease (PD) is the second most common neurodegenerative disorder worldwide. Besides causing symptoms that impair movement, PD also causes non-motor symptoms, such as problems thinking and orthostatic hypotension (OH), i.e., low blood pressure (BP) when standing. About one-third of people with PD have OH, which can cause sudden, temporary symptoms while upright, including lightheadedness, dizziness, and fainting. People with PD and OH can also experience problems thinking that happen only while upright and not while sitting - this can occur without other symptoms, such as feeling dizzy or faint. However, the level of low BP that can affect thinking remains unknown, and no guidelines exist for treating OH when it happens without symptoms. This is significant because OH could be a treatable risk factor for thinking problems in PD, but OH is often not treated if people do not report obvious symptoms.\n\nThis project's goal is to determine how BP affects brain function in PD. The proposed experiments will measure BP and brain blood flow continuously in real-time using innovative wearable technology. Persons with PD with OH and without OH will undergo repeated cognitive tests while supine (lying down) and while upright. I will study the associations between BP, thinking abilities, and brain blood flow, and will compare groups with and without OH. These findings could be important because if a certain level of BP correlates with thinking abilities, then treating OH in PD may prevent thinking problems, which would improve health-related quality of life and reduce disability and healthcare costs.", "primary_outcomes": [ { "type": "primary", "measure": "Delis-Kaplan Executive Function System Verbal Fluency Test score (number of words per minute). Minimum: 0; Maximum: N/A; higher is better", "description": "Participant says as many words in 1 minute as possible each of several letter or category prompts.", "time_frame": "up to 30 months" }, { "type": "primary", "measure": "Oxygenated and deoxygenated hemoglobin change from baseline", "description": "Functional near-infrared spectroscopy will measure relative changes in oxygenated and deoxygenated hemoglobin variables", "time_frame": "up to 30 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Delis-Kaplan Executive Function System Verbal Fluency Test score (number of words per minute). Minimum: 0; Maximum: N/A; higher is better", "description": "Participant says as many words in 1 minute as possible each of several letter or category prompts.", "time_frame": "up to 30 months" }, { "type": "primary", "measure": "Oxygenated and deoxygenated hemoglobin change from baseline", "description": "Functional near-infrared spectroscopy will measure relative changes in oxygenated and deoxygenated hemoglobin variables", "time_frame": "up to 30 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05400174", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05043051", "title": "Autoimmune Basis for Postural Tachycardia Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-07-29", "start_date": "2022-01-14", "completion_date": "2026-07-15", "primary_completion_date": "2026-02-28", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Vagal Stimulation" ], "sponsor": "University of Oklahoma", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to test the hypothesis that an antibody-mediated autoimmune reaction will cause symptoms of autonomic dysfunction in some patients with postural tachycardia syndrome (POTS). The investigators further hypothesize that electrical stimulation of the vagus nerve will improve POTS symptoms, autoimmunity and inflammation.", "primary_outcomes": [ { "type": "primary", "measure": "Heart rate variability", "description": "Average of heart rate variability during the posture test", "time_frame": "5 minute" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Heart rate variability", "description": "Average of heart rate variability during the posture test", "time_frame": "5 minute" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05043051", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06593600", "title": "Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS)", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-07-21", "start_date": "2024-11-13", "completion_date": "2026-07-08", "primary_completion_date": "2026-05-06", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Regn7544" ], "sponsor": "Regeneron Pharmaceuticals", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This study is researching an experimental drug called REGN7544 (called \"study drug\"). The study is focused on participants with POTS.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug is.\n\nThe study is looking at several other research questions, including:\n\n* How the study drug changes heart rate and blood pressure in participants with POTS\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)\n* How the study drug affects symptoms associated with POTS", "primary_outcomes": [ { "type": "primary", "measure": "Change in Heart Rate (HR) from supine to standing (DeltaHR)", "description": "", "time_frame": "At Day 8" }, { "type": "primary", "measure": "Change from baseline in DeltaHR-avg", "description": "Only for Cohort B", "time_frame": "At day 29" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Occurrence of Treatment-Emergent Adverse Events (TEAEs)", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "Severity of TEAEs", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "DeltaHR", "description": "", "time_frame": "At Day 15 and 29" }, { "type": "secondary", "measure": "Supine HR", "description": "", "time_frame": "At Day 8, 15, and 29" }, { "type": "secondary", "measure": "Standing HR", "description": "", "time_frame": "At Day 8, 15, and 29" }, { "type": "secondary", "measure": "Supine blood pressure (BP)", "description": "", "time_frame": "At Day 8, 15, and 29" }, { "type": "secondary", "measure": "Standing BP", "description": "", "time_frame": "At Day 8, 15, and 29" }, { "type": "secondary", "measure": "Concentrations of REGN7544 in serum", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "Occurrence of anti-drug antibodies (ADAs) to REGN7544", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "Magnitude of ADAs to REGN7544", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "Change from baseline in Orthostatic Symptom Domain Scores of the Living with POTS Questionnaire (LWPQ)", "description": "Only for Cohort B", "time_frame": "At day 29" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Heart Rate (HR) from supine to standing (DeltaHR)", "description": "", "time_frame": "At Day 8" }, { "type": "primary", "measure": "Change from baseline in DeltaHR-avg", "description": "Only for Cohort B", "time_frame": "At day 29" }, { "type": "secondary", "measure": "Occurrence of Treatment-Emergent Adverse Events (TEAEs)", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "Severity of TEAEs", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "DeltaHR", "description": "", "time_frame": "At Day 15 and 29" }, { "type": "secondary", "measure": "Supine HR", "description": "", "time_frame": "At Day 8, 15, and 29" }, { "type": "secondary", "measure": "Standing HR", "description": "", "time_frame": "At Day 8, 15, and 29" }, { "type": "secondary", "measure": "Supine blood pressure (BP)", "description": "", "time_frame": "At Day 8, 15, and 29" }, { "type": "secondary", "measure": "Standing BP", "description": "", "time_frame": "At Day 8, 15, and 29" }, { "type": "secondary", "measure": "Concentrations of REGN7544 in serum", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "Occurrence of anti-drug antibodies (ADAs) to REGN7544", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "Magnitude of ADAs to REGN7544", "description": "", "time_frame": "Through 90 Days" }, { "type": "secondary", "measure": "Change from baseline in Orthostatic Symptom Domain Scores of the Living with POTS Questionnaire (LWPQ)", "description": "Only for Cohort B", "time_frame": "At day 29" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 82, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06593600", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03124355", "title": "Vagal Stimulation in POTS", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE1", "last_updated": "2026-07-13", "start_date": "2017-09-30", "completion_date": "2027-12", "primary_completion_date": "2027-06", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Pyridostigmine Pill", "Galantamine Pill", "Vagal Stimulation" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to investigate how the electrical stimulation of a nerve in the skin of the earlobe (transcutaneous vagal nerve stimulation), alone or in combination with two medications (galantamine and pyridostigmine), affects the way the autonomic (involuntary) nervous system controls heart rhythm, symptoms on standing, and inflammatory markers in female patients with postural tachycardia syndrome (POTS). The study consists of 2 parts: a screening (1-2 study days), and 3 testing days. The study will take 5 days total and about 16 participants will be screened for the study. The investigators estimate 13 will be eligible to participate in all of the study days.", "primary_outcomes": [ { "type": "primary", "measure": "High frequency variability of heart rate", "description": "Average of high frequency variability of heart rate during the head up tilt", "time_frame": "Up to 15 min of head up tilt" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "High frequency variability of heart rate", "description": "Average of high frequency variability of heart rate during the head up tilt", "time_frame": "Up to 15 min of head up tilt" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 11, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03124355", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04827992", "title": "Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-06-24", "start_date": "2021-08-23", "completion_date": "2025-10-31", "primary_completion_date": "2025-05-01", "conditions_raw": [ "Opioid Use", "Pain", "Marijuana Use" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Cannabis", "Prescription Opioid Taper Support" ], "sponsor": "Massachusetts General Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).", "primary_outcomes": [ { "type": "primary", "measure": "Mean Difference in Prescription Monitoring Program Verified Opioid Dose at Baseline and Week 24", "description": "Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.", "time_frame": "Week 24" }, { "type": "primary", "measure": "Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score Over Post-baseline to Week 24 Interval", "description": "The Pain, Enjoyment, General Activity (PEG) scale assesses pain intensity and interference. The scale ranges from 0 to 10, with a higher score indicating greater pain intensity and interference. PEG score was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Every post-baseline day until week 24" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Mean Difference in Self-Reported Opioid Dose Over Post-baseline to Week 24 Interval", "description": "Self-reported opioid dose in morphine milligram equivalents (MME) per day. Self-reported opioid dose was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Every post-baseline day until week 24" }, { "type": "secondary", "measure": "Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at Weeks 4, 8, 12, 16, 20, 24", "description": "Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form assesses changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life. Q-LES-SF score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 4, week 8, week 12, week 16, week 20, week 24" }, { "type": "secondary", "measure": "Mean Difference in PROMIS-29 Depression Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24", "description": "The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression. PROMIS-29 depression subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 4, week 8, week 12, week 16, week 20, week 24" }, { "type": "secondary", "measure": "Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24", "description": "The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety. PROMIS-29 anxiety subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 4, week 8, week 12, week 16, week 20, week 24" }, { "type": "secondary", "measure": "Mean Difference in Opioid Use Disorder Symptoms at Weeks 4, 8, 12, 16, 20, 24", "description": "Number of opioid use disorder (OUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. As all participants were taking prescribed opioids under the supervision of a clinician, symptom counts exclude tolerance and withdrawal. Number of symptoms range from 0 to 9. A score of 2 or more indicates a current opioid use disorder diagnosis. Number of opioid use disorder symptoms were assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 4, week 8, week 12, week 16, week 20, week 24" }, { "type": "secondary", "measure": "Mean Difference in Cannabis Use Disorder Symptoms at Weeks 12 and 24", "description": "Number of cannabis use disorder (CUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. Number of symptoms range from 0 to 11. A score of 2 or more indicates a current cannabis use disorder diagnosis. The number of cannabis use disorder symptoms were assessed at weeks 12 and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 12, Week 24" } ], "outcome_measures": [ { "type": "primary", "measure": "Mean Difference in Prescription Monitoring Program Verified Opioid Dose at Baseline and Week 24", "description": "Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.", "time_frame": "Week 24" }, { "type": "primary", "measure": "Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score Over Post-baseline to Week 24 Interval", "description": "The Pain, Enjoyment, General Activity (PEG) scale assesses pain intensity and interference. The scale ranges from 0 to 10, with a higher score indicating greater pain intensity and interference. PEG score was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Every post-baseline day until week 24" }, { "type": "secondary", "measure": "Mean Difference in Self-Reported Opioid Dose Over Post-baseline to Week 24 Interval", "description": "Self-reported opioid dose in morphine milligram equivalents (MME) per day. Self-reported opioid dose was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Every post-baseline day until week 24" }, { "type": "secondary", "measure": "Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at Weeks 4, 8, 12, 16, 20, 24", "description": "Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form assesses changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life. Q-LES-SF score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 4, week 8, week 12, week 16, week 20, week 24" }, { "type": "secondary", "measure": "Mean Difference in PROMIS-29 Depression Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24", "description": "The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression. PROMIS-29 depression subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 4, week 8, week 12, week 16, week 20, week 24" }, { "type": "secondary", "measure": "Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24", "description": "The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety. PROMIS-29 anxiety subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 4, week 8, week 12, week 16, week 20, week 24" }, { "type": "secondary", "measure": "Mean Difference in Opioid Use Disorder Symptoms at Weeks 4, 8, 12, 16, 20, 24", "description": "Number of opioid use disorder (OUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. As all participants were taking prescribed opioids under the supervision of a clinician, symptom counts exclude tolerance and withdrawal. Number of symptoms range from 0 to 9. A score of 2 or more indicates a current opioid use disorder diagnosis. Number of opioid use disorder symptoms were assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 4, week 8, week 12, week 16, week 20, week 24" }, { "type": "secondary", "measure": "Mean Difference in Cannabis Use Disorder Symptoms at Weeks 12 and 24", "description": "Number of cannabis use disorder (CUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. Number of symptoms range from 0 to 11. A score of 2 or more indicates a current cannabis use disorder diagnosis. The number of cannabis use disorder symptoms were assessed at weeks 12 and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.", "time_frame": "Week 12, Week 24" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 87, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04827992", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07585513", "title": "Beta-3 Enhanced Autonomic Therapy for POTS", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2026-05-13", "start_date": "2026-05", "completion_date": "2028-05", "primary_completion_date": "2028-05", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Mirabegron" ], "sponsor": "Cedars-Sinai Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor.", "description": "Patients pushes button when there are symptoms", "time_frame": "At baseline and again immediately after the completion of drug treatment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Malmö POTS Symptom Score", "description": "It is a 12-item questionnaire in which each symptom is rated from 0 to 10 using a visual analogue scale. The total score range is 0 (no symptom) to 120 (maximal symptom)", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "EQ-5D-5L quality of life score", "description": "calculated score, best = 1, worst = -0.573", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "Duke Activity Status Index", "description": "Scores range 0 to 58.2. The higher the score, the greater the individual's functional capacity.", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "Seattle Angina Questionnaire score", "description": "Measurement of Angina on a 0-100 scale. Higher score means better status and fewer symptoms.", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "OAB-q SF", "description": "Overactive bladder symptom measurements. best = 0, worst = 100.", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "PROMIS survey", "description": "PROMIS fatigue score range 30-80. Higher score = worse fatigue.", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "skin sympathetic nerve activity (SKNA) parameters", "description": "Average SKNA over 1 - minute windows, measured in μV. The higher the number, the higher the sympathetic nerve activity.", "time_frame": "At baseline and again immediately after the completion of drug treatment" } ], "outcome_measures": [ { "type": "primary", "measure": "Self-reported frequencies of cardiac-related symptoms as recorded by the number of pushbutton events per day on the monitor.", "description": "Patients pushes button when there are symptoms", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "Malmö POTS Symptom Score", "description": "It is a 12-item questionnaire in which each symptom is rated from 0 to 10 using a visual analogue scale. The total score range is 0 (no symptom) to 120 (maximal symptom)", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "EQ-5D-5L quality of life score", "description": "calculated score, best = 1, worst = -0.573", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "Duke Activity Status Index", "description": "Scores range 0 to 58.2. The higher the score, the greater the individual's functional capacity.", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "Seattle Angina Questionnaire score", "description": "Measurement of Angina on a 0-100 scale. Higher score means better status and fewer symptoms.", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "OAB-q SF", "description": "Overactive bladder symptom measurements. best = 0, worst = 100.", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "PROMIS survey", "description": "PROMIS fatigue score range 30-80. Higher score = worse fatigue.", "time_frame": "At baseline and again immediately after the completion of drug treatment" }, { "type": "secondary", "measure": "skin sympathetic nerve activity (SKNA) parameters", "description": "Average SKNA over 1 - minute windows, measured in μV. The higher the number, the higher the sympathetic nerve activity.", "time_frame": "At baseline and again immediately after the completion of drug treatment" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 36, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07585513", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07409363", "title": "Non-invasive Vagus Nerve Stimulation for Chronic Musculoskeletal Pain", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-05-11", "start_date": "2026-05-14", "completion_date": "2026-07-31", "primary_completion_date": "2026-07-09", "conditions_raw": [ "Chronic Musculoskeletal Pain", "Autonomic Dysfunction", "Dysautonomia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Active Vagus Nerve Stimulation" ], "sponsor": "University of Leeds", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic musculoskeletal (MSK) pain affects an estimated 20-33% of the global population and is frequently associated with autonomic nervous system dysfunction, characterised by symptoms such as orthostatic intolerance, palpitations, gastrointestinal dysmotility, and fatigue. Conventional treatments often fail to address this autonomic component, limiting their effectiveness. This pilot study investigates whether non-invasive vagus nerve stimulation (nVNS) using the gammaCore Sapphire device can reduce autonomic symptom severity and improve pain in adults with chronic MSK pain and confirmed autonomic dysfunction.\n\nRESTORE-MSK is a randomised, single-blind, sham-controlled, crossover pilot study. Twelve participants with chronic MSK pain (lasting 12 weeks or longer) and autonomic dysfunction (COMPASS-31 score of 17 or more) will be recruited from musculoskeletal clinics at Chapel Allerton Hospital, Leeds. Participants will be randomly allocated to receive either active nVNS or sham stimulation first, followed by a 2-week washout period, then crossover to the alternative treatment. Each treatment period lasts 14 days, with participants self-administering the device twice daily (morning and evening).\n\nThe primary outcome is change in autonomic symptom severity measured by the Composite Autonomic Symptom Score-31 (COMPASS-31). Secondary outcomes include physiological response to the NASA Lean Test, pain severity and interference (Brief Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (EQ-5D-5L), intervention acceptability, and recruitment feasibility.\n\nThis pilot study aims to establish feasibility and proof of concept for a larger randomised controlled trial investigating nVNS as a non-pharmacological treatment option for chronic MSK pain with autonomic dysfunction.", "primary_outcomes": [ { "type": "primary", "measure": "Composite Autonomic Symptom Score-31 (COMPASS-31) total score", "description": "Description: The COMPASS-31 is a validated 31-item self-administered questionnaire measuring autonomic symptom severity across six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor symptoms. Each item is scored based on severity and frequency, with domain scores weighted and summed to produce a total score ranging from 0 to 100. Higher scores indicate greater autonomic dysfunction. The questionnaire will be modified to assess symptoms over the preceding 2 weeks (rather than the standard 1 year) to capture treatment effects within the study timeframe.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.\n\nPrimary analysis will compare change from immediately pre-treatment to immediately post-treatment for active versus sham periods.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout/start of second treatment period (Day 28 ±2 days), and end of second treatment period/final visit (Day 43 ±2 days)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Positive overall response to the NASA Lean Test procedure", "description": "The NASA Lean Test procedure is a clinical assessment of autonomic function measuring cardiovascular response to postural change. It provides a single binary outcome of positive or negative response to the challenge.\n\nA positive response (indicating autonomic dysfunction) is defined as an increase in heart rate of more than 30 beats per minute (or more than 40 bpm in participants under 20 years) from supine to standing without a substantial drop in blood pressure, over the course of 10 minutes' observation.\n\nA negative response (indicating no evidence of autonomic dysfunction) is when the above criteria have not been met.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days, in-person visits only), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days, in-person visits only)." }, { "type": "secondary", "measure": "Maximum increase in heart rate during NASA Lean Test procedure", "description": "As part of the NASA Lean Test to identify a positive/negative response to the Lean Test challenge, heart rate is monitored continuously over a 10 minute period. We shall report the maximum increase in heart rate (beats per minute) from supine to standing, over the course of 10 minutes' observation, as an additional outcome measure that may offer insight on symptomatic individuals who do not meet the threshold for a positive Lean Test.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days, in-person visits only), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days, in-person visits only)." }, { "type": "secondary", "measure": "Brief Pain Inventory - Short Form (BPI-SF): Pain Severity Score", "description": "Description: The BPI-SF is a validated self-report questionnaire assessing pain intensity and interference. The Pain Severity Score is calculated as the mean of four items: worst pain in last 24 hours, least pain in last 24 hours, average pain, and pain right now. Each item is rated on a 0-10 numeric rating scale where 0 = no pain and 10 = pain as bad as you can imagine. The Pain Severity Score therefore ranges from 0 to 10, with higher scores indicating greater pain severity.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "Brief Pain Inventory - Short Form (BPI-SF): Pain Interference Score", "description": "Description: The Pain Interference Score is calculated as the mean of seven items assessing how much pain has interfered with: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item is rated on a 0-10 numeric rating scale where 0 = does not interfere and 10 = completely interferes. The Pain Interference Score therefore ranges from 0 to 10, with higher scores indicating greater interference with daily functioning.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS): Anxiety subscale score", "description": "Description: The HADS is a validated 14-item self-report questionnaire designed to assess anxiety and depression in medical populations. The Anxiety subscale comprises 7 items, each scored 0-3, producing a total anxiety score ranging from 0 to 21. Scores of 0-7 indicate non-cases, 8-10 indicate possible cases, and 11-21 indicate probable cases of anxiety disorder. Higher scores indicate greater anxiety symptom severity.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS): Depression subscale score", "description": "Description: The Depression subscale of the HADS comprises 7 items, each scored 0-3, producing a total depression score ranging from 0 to 21. Scores of 0-7 indicate non-cases, 8-10 indicate possible cases, and 11-21 indicate probable cases of depression. Higher scores indicate greater depression symptom severity.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "EuroQol EQ-5D-5L: Index value", "description": "Description: The EQ-5D-5L is a validated generic health-related quality of life instrument comprising five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of severity (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems). Responses are converted to a single index value using UK value set tariffs, ranging from negative values (states worse than dead) through 0 (dead) to 1 (full health). Higher values indicate better health-related quality of life.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "EuroQol EQ-5D-5L: Visual Analogue Scale (EQ-VAS)", "description": "Description: The EQ-VAS records the participant's self-rated health on a vertical visual analogue scale with endpoints labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). Participants mark their health state on the scale and record the corresponding number.\n\nMeasurement: Self-reported on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "Intervention acceptability: Theoretical Framework of Acceptability (TFA) questionnaire", "description": "Description: The TFA is a validated, theory-informed questionnaire assessing intervention acceptability across seven constructs: affective attitude (how the participant feels about the intervention), burden (perceived effort required), ethicality (fit with personal values), intervention coherence (understanding of how the intervention works), opportunity costs (extent to which benefits were given up), perceived effectiveness (perception that the intervention works), and self-efficacy (confidence in performing required behaviours). Each construct is assessed using a single item on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), plus one overall acceptability item. Higher scores indicate greater acceptability.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured once at final visit (Day 43 ±2 days)." } ], "outcome_measures": [ { "type": "primary", "measure": "Composite Autonomic Symptom Score-31 (COMPASS-31) total score", "description": "Description: The COMPASS-31 is a validated 31-item self-administered questionnaire measuring autonomic symptom severity across six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor symptoms. Each item is scored based on severity and frequency, with domain scores weighted and summed to produce a total score ranging from 0 to 100. Higher scores indicate greater autonomic dysfunction. The questionnaire will be modified to assess symptoms over the preceding 2 weeks (rather than the standard 1 year) to capture treatment effects within the study timeframe.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.\n\nPrimary analysis will compare change from immediately pre-treatment to immediately post-treatment for active versus sham periods.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout/start of second treatment period (Day 28 ±2 days), and end of second treatment period/final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "Positive overall response to the NASA Lean Test procedure", "description": "The NASA Lean Test procedure is a clinical assessment of autonomic function measuring cardiovascular response to postural change. It provides a single binary outcome of positive or negative response to the challenge.\n\nA positive response (indicating autonomic dysfunction) is defined as an increase in heart rate of more than 30 beats per minute (or more than 40 bpm in participants under 20 years) from supine to standing without a substantial drop in blood pressure, over the course of 10 minutes' observation.\n\nA negative response (indicating no evidence of autonomic dysfunction) is when the above criteria have not been met.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days, in-person visits only), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days, in-person visits only)." }, { "type": "secondary", "measure": "Maximum increase in heart rate during NASA Lean Test procedure", "description": "As part of the NASA Lean Test to identify a positive/negative response to the Lean Test challenge, heart rate is monitored continuously over a 10 minute period. We shall report the maximum increase in heart rate (beats per minute) from supine to standing, over the course of 10 minutes' observation, as an additional outcome measure that may offer insight on symptomatic individuals who do not meet the threshold for a positive Lean Test.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days, in-person visits only), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days, in-person visits only)." }, { "type": "secondary", "measure": "Brief Pain Inventory - Short Form (BPI-SF): Pain Severity Score", "description": "Description: The BPI-SF is a validated self-report questionnaire assessing pain intensity and interference. The Pain Severity Score is calculated as the mean of four items: worst pain in last 24 hours, least pain in last 24 hours, average pain, and pain right now. Each item is rated on a 0-10 numeric rating scale where 0 = no pain and 10 = pain as bad as you can imagine. The Pain Severity Score therefore ranges from 0 to 10, with higher scores indicating greater pain severity.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "Brief Pain Inventory - Short Form (BPI-SF): Pain Interference Score", "description": "Description: The Pain Interference Score is calculated as the mean of seven items assessing how much pain has interfered with: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item is rated on a 0-10 numeric rating scale where 0 = does not interfere and 10 = completely interferes. The Pain Interference Score therefore ranges from 0 to 10, with higher scores indicating greater interference with daily functioning.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS): Anxiety subscale score", "description": "Description: The HADS is a validated 14-item self-report questionnaire designed to assess anxiety and depression in medical populations. The Anxiety subscale comprises 7 items, each scored 0-3, producing a total anxiety score ranging from 0 to 21. Scores of 0-7 indicate non-cases, 8-10 indicate possible cases, and 11-21 indicate probable cases of anxiety disorder. Higher scores indicate greater anxiety symptom severity.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS): Depression subscale score", "description": "Description: The Depression subscale of the HADS comprises 7 items, each scored 0-3, producing a total depression score ranging from 0 to 21. Scores of 0-7 indicate non-cases, 8-10 indicate possible cases, and 11-21 indicate probable cases of depression. Higher scores indicate greater depression symptom severity.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "EuroQol EQ-5D-5L: Index value", "description": "Description: The EQ-5D-5L is a validated generic health-related quality of life instrument comprising five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of severity (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems). Responses are converted to a single index value using UK value set tariffs, ranging from negative values (states worse than dead) through 0 (dead) to 1 (full health). Higher values indicate better health-related quality of life.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "EuroQol EQ-5D-5L: Visual Analogue Scale (EQ-VAS)", "description": "Description: The EQ-VAS records the participant's self-rated health on a vertical visual analogue scale with endpoints labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). Participants mark their health state on the scale and record the corresponding number.\n\nMeasurement: Self-reported on paper or electronically via REDCap.", "time_frame": "Measured at baseline (Day 0), end of first treatment period (Day 15 ±2 days), end of washout (Day 28 ±2 days), and final visit (Day 43 ±2 days)." }, { "type": "secondary", "measure": "Intervention acceptability: Theoretical Framework of Acceptability (TFA) questionnaire", "description": "Description: The TFA is a validated, theory-informed questionnaire assessing intervention acceptability across seven constructs: affective attitude (how the participant feels about the intervention), burden (perceived effort required), ethicality (fit with personal values), intervention coherence (understanding of how the intervention works), opportunity costs (extent to which benefits were given up), perceived effectiveness (perception that the intervention works), and self-efficacy (confidence in performing required behaviours). Each construct is assessed using a single item on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), plus one overall acceptability item. Higher scores indicate greater acceptability.\n\nMeasurement: Self-reported questionnaire completed on paper or electronically via REDCap.", "time_frame": "Measured once at final visit (Day 43 ±2 days)." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 12, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07409363", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07579026", "title": "Effects of Breathing Retraining Exercises in Pregnant Females With Postural Orthostatic Tachycardia Syndrome.", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-05-11", "start_date": "2025-08-31", "completion_date": "2026-09", "primary_completion_date": "2026-09", "conditions_raw": [ "Orthostatic Hypotension", "Heart Rate", "Blood Pressure" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Diaphragmatic Breathing Exercise" ], "sponsor": "Riphah International University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural orthostatic tachycardia POTS is characterized by excessive increase in heart rate when moving from lying to standing position, often accompanied by symptoms such as dizziness, fatigue, brain fog, lightheadedness, rapid heartbeat and palpitation.it most commonly effects the females of reproductive age and can be triggered by events like viral infections, trauma and hormonal changes. During pregnancy females may experience worsening of symptoms in first trimester due to hormonal changes and decreased blood volume later on in second and third trimester the blood volume begins to increase. However, breathing exercises helps to regulate the nervous system, improves parasympathetic activity and reduce sympathetic activity.\n\nThe study will be randomized clinical trial and will be conducted at Bashir hospital Sialkot and Fatima hospital Sialkot. The study will be completed in 10 months of duration after the approval of synopsis. Non probability convenience sampling will be used and 44 participants will be included in the study after randomization. The subjects will be divided into two groups. Group A (experimental group) will receive diaphragmatic breathing exercises whereas Group B (control group) will receive educational retraining whereas both groups will receive baseline treatments which includes progressive muscle relaxation techniques. The tools used for the study will be Vanderbilt orthostatic symptom score VOSS to evaluate orthostatic intolerance, blood pressure will be measured using non-invasive blood pressure measurement and pulse oximetry will be used to access the heart rate. After data completion data will be analyzed by using SPSS version 21.", "primary_outcomes": [ { "type": "primary", "measure": "Vanderbilt Orthostatic symptom score", "description": "It describes the following nine symptoms: mental clouding, brain fog, shortness of breath, palpitations, tremor, headache, chest tightness, blurred vision, and nausea. VOSS will help to evaluate if the symptoms will get severe, after tilting back. Participants will be asked to rate the expression of their symptoms on a scale of 0 to 10.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Non-invasive blood pressure measurement", "description": "Non-invasive blood pressure (NIBP) measurement will be used by pressuring cuff around the arm or leg. The auscultatory approach will detect blood pressure by detecting the sound of the limb artery opening and closing. The oscillometer approach will measure the vibration of the cuff during pressurized air release. NIBP is considered as a gold standard test", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Pulse oximetry", "description": "Pulse oximeters are commonly used for the non-invasive, simultaneous measurement of hemoglobin oxygen saturation. They are reliable, accurate, relatively affordable, and portable. Pulse oximeters are commonly used to determine heart rate during rest and during activity", "time_frame": "6 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Vanderbilt Orthostatic symptom score", "description": "It describes the following nine symptoms: mental clouding, brain fog, shortness of breath, palpitations, tremor, headache, chest tightness, blurred vision, and nausea. VOSS will help to evaluate if the symptoms will get severe, after tilting back. Participants will be asked to rate the expression of their symptoms on a scale of 0 to 10.", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Non-invasive blood pressure measurement", "description": "Non-invasive blood pressure (NIBP) measurement will be used by pressuring cuff around the arm or leg. The auscultatory approach will detect blood pressure by detecting the sound of the limb artery opening and closing. The oscillometer approach will measure the vibration of the cuff during pressurized air release. NIBP is considered as a gold standard test", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Pulse oximetry", "description": "Pulse oximeters are commonly used for the non-invasive, simultaneous measurement of hemoglobin oxygen saturation. They are reliable, accurate, relatively affordable, and portable. Pulse oximeters are commonly used to determine heart rate during rest and during activity", "time_frame": "6 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 44, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07579026", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06208163", "title": "The Effects of Chiropractic in a Population With High Central Adiposity", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-05-08", "start_date": "2024-11-11", "completion_date": "2025-09-04", "primary_completion_date": "2025-09-04", "conditions_raw": [ "Abdominal Obesity" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Chiropractic" ], "sponsor": "Life University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Since 1980, the global prevalence of obesity, commonly defined as a body mass index (BMI) of 30 or higher, has doubled. Importantly, high levels of central adiposity (i.e., abdominal fat) is associated with numerous PNI-related sequelae, including increased levels of psychological distress, cognitive deficits, ANS dysfunction, and immune marker abnormalities. To our knowledge, rigorous investigation of chiropractic's impact on psychoneuroimmunological (PNI)-related outcomes in people with high central adiposity is lacking. Based on limited evidence to date, it is plausible that clinically important PNI-related dysfunctions (e.g., heightened stress levels, executive function impairments, dysautonomia, immune dysregulation) common in this population could be ameliorated via chiropractic care.", "primary_outcomes": [ { "type": "primary", "measure": "Proportion of Potential Participants Who Are Eligible.", "description": "The number of adults attending the on-site screening who are eligible to participate, divided to the total number of adults attending the on-site screening. This assesses 'Eligibility'", "time_frame": "From lab arrival to completion of on-site screening (up to 15 minutes)" }, { "type": "primary", "measure": "Proportion of Participants Complying With Pre-baseline Lifestyle Restrictions", "description": "The number of participants complying with 24hr and 3hr pre-baseline lifestyle restrictions, divided by the total number of participants. This assesses 'Compliance'.", "time_frame": "From start of lifestyle restriction window to lab arrival (up to 24 hours)" }, { "type": "primary", "measure": "Proportion of Participants Able to Tolerate the Assessments", "description": "The number of participants able to complete baseline assessments as directed, divided by the total number of participants. This assesses 'Tolerability'.", "time_frame": "From enrollment to completion of baseline assessments (up to 2 hours)" }, { "type": "primary", "measure": "Proportion of Participants Adhering to Their Prescribed Care Plan", "description": "The number of participants prescribed a chiropractic care plan that attended ≥80% of their chiropractic sessions, divided by the total number of participants prescribed a chiropractic care plan. This assesses 'Adherence'.", "time_frame": "From enrollment to end of treatment (up to 6 weeks)" }, { "type": "primary", "measure": "Proportion of Participants Retained in the Study", "description": "Number of participants enrolled who attend the final assessment session, divided by the total number of participants enrolled. This assesses 'Retention'.", "time_frame": "From enrollment to end of treatment (up to 6 weeks)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes in COMPASS-31 Raw Scores", "description": "Changes in self-reported autonomic function per the Composite Autonomic Symptom Score (COMPASS-31) survey. The COMPASS-31 is a 31-item questionnaire that evaluates ANS functioning across 6 domains: 1) orthostatic intolerance (4-items), 2) vasomotor (3-items), 3) secretomotor (4-items), 4) gastrointestinal (12-items), 5) bladder (3-items), and 6) pupillomotor (5-items). The domains are weighted, and the sum of the weighted sub-scores yields a total raw score ranging from 0-100. Higher scores indicate greater autonomic dysfunction with total raw scores ≥20 suggested to reflect moderate-to-severe autonomic dysfunction.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PSS-10 T-scores", "description": "Changes in perceived stress levels per the 10-item NIH Toolbox Perceived Stress Scale (PSS-10). NIH Toolbox negative emotion measures utilize a 7-day recall period, 5-point Likert scales (e.g., 1=never, 2=almost never, 3=sometimes, 4=fairly often, 5=very often). Total raw scores can range from 10 to 50. Raw scores are converted to standardized uncorrected T-scores (mean=50, SD=10) using conversion tables available in the online scoring instructions (https://www.healthmeasures.net/). Higher scores indicate greater levels of perceived stress with T-scores ≥60 deemed 'potentially problematic'.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PROMIS-Cog 8 T-scores", "description": "Changes in self-reported cognitive function per the 8-item PROMIS Cognitive Function (PROMIS-Cog 8) survey. It uses a 7-day recall period and relevant 5-point Likert scales (e.g., 1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Total raw scores can range from 8 to 40. Raw scores are converted to a standardized T-score (mean=50, SD=10) using conversion tables available in the scoring instructions at the PROMIS® website (https://www.healthmeasures.net/). Lower scores indicate greater functional impairment with standard benchmarks for mild (T-score = 40 to 45), moderate (T-score = 30 to 40), or severe (T-score \\<30) impairment.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PROMIS-29 Subscale T-scores", "description": "Changes in self-reported health per the T-scored PROMIS-29 subscales (physical function, social participation, anxiety, depression, fatigue, sleep disturbance). It uses a 7-day recall period and relevant 5-point Likert scales (e.g., 1=never, 2=rarely, 3=sometimes, 4=often, 5=always).Total raw scores can range from 4 to 20. Raw subscale scores are converted to a standardized T-score (mean=50, SD=10) using conversion tables available in the scoring instructions at the PROMIS® website (https://www.healthmeasures.net/). Lower scores on physical function, and social participation subscales indicate greater functional impairment with standard benchmarks for mild (T-score = 40 to 45), moderate (T-score = 30 to 40), or severe (T-score \\<30) impairment. Higher scores on the anxiety, depression, fatigue, and sleep disturbance subscales indicate greater severity of symptoms with standard benchmarks for mild (T-score = 55 to 60), moderate (T-score = 60 to 70), and severe (T-score \\>70) symptoms.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PROMIS-29 Subscale Raw Scores", "description": "Change in self-reported pain levels per the raw scored PROMIS-29 subscales (pain intensity). This subscale uses a 7-day recall period and is a single item scored on a 1 (no pain) to 10 (worst pain imaginable) scale.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in RMSSD", "description": "Changes in ECG-derived root mean square of successive differences (RMSSD) during rest, stress, and recovery. RMSSD is a time-domain heart rate variability (HRV) metric used to assess cardiac-related parasympathetic activity.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PEP", "description": "Changes in impedance cardiography (ICG)-derived pre-ejection period (PEP) during rest, stress, and recovery. PEP is a time-domain metric used to assess cardiac-related sympathetic activity.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in sIgA", "description": "Changes in salivary-derived secretory immunoglobulin A (sIgA) levels at rest. Salivary-derived sIgA is a measure of mucosal immune function.", "time_frame": "Baseline, 2 weeks, 6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Proportion of Potential Participants Who Are Eligible.", "description": "The number of adults attending the on-site screening who are eligible to participate, divided to the total number of adults attending the on-site screening. This assesses 'Eligibility'", "time_frame": "From lab arrival to completion of on-site screening (up to 15 minutes)" }, { "type": "primary", "measure": "Proportion of Participants Complying With Pre-baseline Lifestyle Restrictions", "description": "The number of participants complying with 24hr and 3hr pre-baseline lifestyle restrictions, divided by the total number of participants. This assesses 'Compliance'.", "time_frame": "From start of lifestyle restriction window to lab arrival (up to 24 hours)" }, { "type": "primary", "measure": "Proportion of Participants Able to Tolerate the Assessments", "description": "The number of participants able to complete baseline assessments as directed, divided by the total number of participants. This assesses 'Tolerability'.", "time_frame": "From enrollment to completion of baseline assessments (up to 2 hours)" }, { "type": "primary", "measure": "Proportion of Participants Adhering to Their Prescribed Care Plan", "description": "The number of participants prescribed a chiropractic care plan that attended ≥80% of their chiropractic sessions, divided by the total number of participants prescribed a chiropractic care plan. This assesses 'Adherence'.", "time_frame": "From enrollment to end of treatment (up to 6 weeks)" }, { "type": "primary", "measure": "Proportion of Participants Retained in the Study", "description": "Number of participants enrolled who attend the final assessment session, divided by the total number of participants enrolled. This assesses 'Retention'.", "time_frame": "From enrollment to end of treatment (up to 6 weeks)" }, { "type": "secondary", "measure": "Changes in COMPASS-31 Raw Scores", "description": "Changes in self-reported autonomic function per the Composite Autonomic Symptom Score (COMPASS-31) survey. The COMPASS-31 is a 31-item questionnaire that evaluates ANS functioning across 6 domains: 1) orthostatic intolerance (4-items), 2) vasomotor (3-items), 3) secretomotor (4-items), 4) gastrointestinal (12-items), 5) bladder (3-items), and 6) pupillomotor (5-items). The domains are weighted, and the sum of the weighted sub-scores yields a total raw score ranging from 0-100. Higher scores indicate greater autonomic dysfunction with total raw scores ≥20 suggested to reflect moderate-to-severe autonomic dysfunction.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PSS-10 T-scores", "description": "Changes in perceived stress levels per the 10-item NIH Toolbox Perceived Stress Scale (PSS-10). NIH Toolbox negative emotion measures utilize a 7-day recall period, 5-point Likert scales (e.g., 1=never, 2=almost never, 3=sometimes, 4=fairly often, 5=very often). Total raw scores can range from 10 to 50. Raw scores are converted to standardized uncorrected T-scores (mean=50, SD=10) using conversion tables available in the online scoring instructions (https://www.healthmeasures.net/). Higher scores indicate greater levels of perceived stress with T-scores ≥60 deemed 'potentially problematic'.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PROMIS-Cog 8 T-scores", "description": "Changes in self-reported cognitive function per the 8-item PROMIS Cognitive Function (PROMIS-Cog 8) survey. It uses a 7-day recall period and relevant 5-point Likert scales (e.g., 1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Total raw scores can range from 8 to 40. Raw scores are converted to a standardized T-score (mean=50, SD=10) using conversion tables available in the scoring instructions at the PROMIS® website (https://www.healthmeasures.net/). Lower scores indicate greater functional impairment with standard benchmarks for mild (T-score = 40 to 45), moderate (T-score = 30 to 40), or severe (T-score \\<30) impairment.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PROMIS-29 Subscale T-scores", "description": "Changes in self-reported health per the T-scored PROMIS-29 subscales (physical function, social participation, anxiety, depression, fatigue, sleep disturbance). It uses a 7-day recall period and relevant 5-point Likert scales (e.g., 1=never, 2=rarely, 3=sometimes, 4=often, 5=always).Total raw scores can range from 4 to 20. Raw subscale scores are converted to a standardized T-score (mean=50, SD=10) using conversion tables available in the scoring instructions at the PROMIS® website (https://www.healthmeasures.net/). Lower scores on physical function, and social participation subscales indicate greater functional impairment with standard benchmarks for mild (T-score = 40 to 45), moderate (T-score = 30 to 40), or severe (T-score \\<30) impairment. Higher scores on the anxiety, depression, fatigue, and sleep disturbance subscales indicate greater severity of symptoms with standard benchmarks for mild (T-score = 55 to 60), moderate (T-score = 60 to 70), and severe (T-score \\>70) symptoms.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PROMIS-29 Subscale Raw Scores", "description": "Change in self-reported pain levels per the raw scored PROMIS-29 subscales (pain intensity). This subscale uses a 7-day recall period and is a single item scored on a 1 (no pain) to 10 (worst pain imaginable) scale.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in RMSSD", "description": "Changes in ECG-derived root mean square of successive differences (RMSSD) during rest, stress, and recovery. RMSSD is a time-domain heart rate variability (HRV) metric used to assess cardiac-related parasympathetic activity.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in PEP", "description": "Changes in impedance cardiography (ICG)-derived pre-ejection period (PEP) during rest, stress, and recovery. PEP is a time-domain metric used to assess cardiac-related sympathetic activity.", "time_frame": "Baseline, 2 weeks, 6 weeks" }, { "type": "secondary", "measure": "Changes in sIgA", "description": "Changes in salivary-derived secretory immunoglobulin A (sIgA) levels at rest. Salivary-derived sIgA is a measure of mucosal immune function.", "time_frame": "Baseline, 2 weeks, 6 weeks" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 18, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06208163", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04271878", "title": "Hypercapnia and Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-05-07", "start_date": "2022-02-02", "completion_date": "2030-12-31", "primary_completion_date": "2029-12-31", "conditions_raw": [ "Postural Tachycardia Syndrome", "Orthostatic Intolerance" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Respiract™ System" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The mechanism behind postural orthostatic tachycardia syndrome (POTS) involves many causes including a sympathetic nervous system problem. Blood gases, like carbon dioxide (CO2), have an important effect on sympathetic activation.\n\nThe purpose of this research study is to determine if higher CO2 levels have any effect in lowering heart rate and reducing POTS symptoms when upright/standing. The investigators are also searching for the ideal CO2 concentration to achieve the most effective response", "primary_outcomes": [ { "type": "primary", "measure": "Heart Rate (HR) variation", "description": "Magnitude of ΔHR", "time_frame": "difference between HR from supine to peak HR during tilt test for each intervention (mean value HR between the 8th and 9th minute of supine; peak parameters, during HUTT, mean value during the first min and between the 3rd and 8th min)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Cerebral blood flow velocity (CBFv) variation", "description": "Magnitude of ΔCBFv", "time_frame": "difference between CBFv from supine to peak during tilt test for each intervention (mean value CBFv between the 8th and 9th min of supine; peak parameters, during HUTT, mean value CBFv during the first min and between the 3rd and 8th min)" }, { "type": "secondary", "measure": "VOSS symptom score", "description": "Vanderbilt Orthostatic Symptoms Score (VOSS) - patients will rate the severity of 9 symptoms on a scale of 0 to 10 (0 reflects absence of symptoms). The sum of the scores at each time point is used as a measure of symptom burden (lower score reflects reduced symptom burden). The 9 symptoms are mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea.", "time_frame": "VOSS will be accessed at the 8th minute of each HUTT, comparing the intensity of symptoms in each intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Heart Rate (HR) variation", "description": "Magnitude of ΔHR", "time_frame": "difference between HR from supine to peak HR during tilt test for each intervention (mean value HR between the 8th and 9th minute of supine; peak parameters, during HUTT, mean value during the first min and between the 3rd and 8th min)" }, { "type": "secondary", "measure": "Cerebral blood flow velocity (CBFv) variation", "description": "Magnitude of ΔCBFv", "time_frame": "difference between CBFv from supine to peak during tilt test for each intervention (mean value CBFv between the 8th and 9th min of supine; peak parameters, during HUTT, mean value CBFv during the first min and between the 3rd and 8th min)" }, { "type": "secondary", "measure": "VOSS symptom score", "description": "Vanderbilt Orthostatic Symptoms Score (VOSS) - patients will rate the severity of 9 symptoms on a scale of 0 to 10 (0 reflects absence of symptoms). The sum of the scores at each time point is used as a measure of symptom burden (lower score reflects reduced symptom burden). The 9 symptoms are mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea.", "time_frame": "VOSS will be accessed at the 8th minute of each HUTT, comparing the intensity of symptoms in each intervention" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 26, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04271878", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05924646", "title": "CAlgary SAlt for POTS", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-05-07", "start_date": "2024-05-07", "completion_date": "2028-12-31", "primary_completion_date": "2028-06-30", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Microcystalline Cellulose Capsules" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Many patients with postural orthostatic tachycardia syndrome (POTS) have decreased plasma volume. Current POTS guidelines recommend \\~10 g of salt and 2-3 L of fluid per day. Despite this recommendation, there is no long term data evaluating the use of salt in POTS. This randomized, placebo-controlled cross-over trial will evaluate a high salt diet, compared to a normal salt diet over a period of 3 months. Participants will complete 3 in lab evaluations including autonomic function testing, tilt table testing, blood volume and urine sodium evaluation, plasma catecholamine measurements and and cytokine measurements.", "primary_outcomes": [ { "type": "primary", "measure": "Upright Heart Rate", "description": "Upright heart rate measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm", "time_frame": "10 Minutes" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Vanderbilt Orthostatic Symptom Score (VOSS)", "description": "VOSS score measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm", "time_frame": "10 Minutes" }, { "type": "secondary", "measure": "Systolic Blood Pressure", "description": "Upright systolic blood pressure measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm", "time_frame": "10 Minutes" }, { "type": "secondary", "measure": "Diastolic Blood Pressure", "description": "Upright systolic blood pressure measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Stroke volume", "description": "Upright stroke volume measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate salt alone arm", "time_frame": "10 minutes" } ], "outcome_measures": [ { "type": "primary", "measure": "Upright Heart Rate", "description": "Upright heart rate measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm", "time_frame": "10 Minutes" }, { "type": "secondary", "measure": "Vanderbilt Orthostatic Symptom Score (VOSS)", "description": "VOSS score measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm", "time_frame": "10 Minutes" }, { "type": "secondary", "measure": "Systolic Blood Pressure", "description": "Upright systolic blood pressure measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm", "time_frame": "10 Minutes" }, { "type": "secondary", "measure": "Diastolic Blood Pressure", "description": "Upright systolic blood pressure measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Stroke volume", "description": "Upright stroke volume measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate salt alone arm", "time_frame": "10 minutes" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05924646", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04881318", "title": "Compression Garments in the Community With POTS", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-05-07", "start_date": "2021-05-17", "completion_date": "2026-12-31", "primary_completion_date": "2026-12-31", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Waist-High Compression Tights", "Abdominal Compression Garments", "Medications That Modulate Heart Rate And Blood Pressure" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Compression Garments are a commonly prescribed treatment in Postural Orthostatic Tachycardia Syndrome (POTS). The effectiveness of a proof-of-concept compression garment has been demonstrated in an acute laboratory setting. It is not known if commercially available compression garments that participants wear in their every day lives are effective at improving heart rate and reducing symptoms in POTS. This trial will evaluate the use of commercially available waist-high and abdominal compression garments in adults diagnosed with POTS in a community setting.", "primary_outcomes": [ { "type": "primary", "measure": "WHC Heart Rate", "description": "The primary outcome is the delta HR (standing HR - supine HR) in orthostatic vital signs (OVS) #1 (prior to the WHC) and OVS #2 (30min after WHC is applied), in the \"Without Medication\" phase.", "time_frame": "10 minutes" }, { "type": "primary", "measure": "AC Heart Rate", "description": "The primary outcome is the delta HR (standing HR - supine HR) in orthostatic vital signs (OVS) #1 (prior to the AC) and OVS #2 (30min after AC is applied), in the \"Without Medication\" phase.", "time_frame": "10 minutes" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Heart Rate - End of Study Day (WHC)", "description": "Delta HR measurement from OVS #3 (with WHC) compared to the delta HR from the OVS #4 (without WHC).", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Heart Rate - WHC and Medication", "description": "The delta HR from OVS #1 - OVS #2 in the \"With Medication\" phase, compared to the delta HR from OVS #1 - OVS #2 in the \"Without Medication\" phase .", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Heart Rate - WHC and AC", "description": "Delta HR from OVS #1 - OVS #2 on the WHC day, compared to OVS #1 - OVS #2 on the AC day, in the \"With Medication\" phase. This will provide an assessment of the differential efficacy of commercial WHC versus commercial AC in a home setting.", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Heart Rate - End of Study Day (AC)", "description": "Delta HR measurement from OVS #3 (with AC) compared to the delta HR from the OVS #4 (without AC). This will provide an assessment of the efficacy of commercial AC with prolonged use during the day.", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Heart Rate - AC and Medication", "description": "The delta HR from OVS #1 - OVS #2 in the \"With Medication\" phase, compared to the delta HR from OVS #1 - OVS #2 in the \"Without Medication\" phase. This will provide an assessment of the differential efficacy of commercial AC with and without POTS medications.", "time_frame": "10 minutes" } ], "outcome_measures": [ { "type": "primary", "measure": "WHC Heart Rate", "description": "The primary outcome is the delta HR (standing HR - supine HR) in orthostatic vital signs (OVS) #1 (prior to the WHC) and OVS #2 (30min after WHC is applied), in the \"Without Medication\" phase.", "time_frame": "10 minutes" }, { "type": "primary", "measure": "AC Heart Rate", "description": "The primary outcome is the delta HR (standing HR - supine HR) in orthostatic vital signs (OVS) #1 (prior to the AC) and OVS #2 (30min after AC is applied), in the \"Without Medication\" phase.", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Heart Rate - End of Study Day (WHC)", "description": "Delta HR measurement from OVS #3 (with WHC) compared to the delta HR from the OVS #4 (without WHC).", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Heart Rate - WHC and Medication", "description": "The delta HR from OVS #1 - OVS #2 in the \"With Medication\" phase, compared to the delta HR from OVS #1 - OVS #2 in the \"Without Medication\" phase .", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Heart Rate - WHC and AC", "description": "Delta HR from OVS #1 - OVS #2 on the WHC day, compared to OVS #1 - OVS #2 on the AC day, in the \"With Medication\" phase. This will provide an assessment of the differential efficacy of commercial WHC versus commercial AC in a home setting.", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Heart Rate - End of Study Day (AC)", "description": "Delta HR measurement from OVS #3 (with AC) compared to the delta HR from the OVS #4 (without AC). This will provide an assessment of the efficacy of commercial AC with prolonged use during the day.", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Heart Rate - AC and Medication", "description": "The delta HR from OVS #1 - OVS #2 in the \"With Medication\" phase, compared to the delta HR from OVS #1 - OVS #2 in the \"Without Medication\" phase. This will provide an assessment of the differential efficacy of commercial AC with and without POTS medications.", "time_frame": "10 minutes" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04881318", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05363514", "title": "Low Dose Naltrexone Use in Patients With POTS", "status": "NOT_YET_RECRUITING", "phase": "PHASE4", "last_updated": "2026-05-01", "start_date": "2026-07", "completion_date": "2030-12", "primary_completion_date": "2029-06", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Low Dose Naltrexone", "Microcrystalline Cellulose" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Many patients with Postural Orthostatic Tachycardia Syndrome (POTS) experience debilitating fatigue and this significantly impacts their daily lives. Unfortunately, there are no treatments to help POTS patients with their fatigue. One medication, called low dose naltrexone (LDN), has been tested as a treatment for fatigue in other medical conditions. In this other research, LDN helped patients feel less fatigue. Other research studies have shown that LDN can help reduce markers of inflammation called cytokines. Reducing these cytokines could help reduce symptoms as well. There have been no research studies testing LDN in POTS to date. We are planning to do a research study to test LDN as a treatment to see if it helps POTS patients feel less fatigue.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Visual Analogue Scale (VAS)", "description": "Change in Fatigue VAS from pre-treatment (baseline) to treatment (4 months). The score is measured from 0-100 (0 is no fatigue).", "time_frame": "4 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "RAND 36 Health Related Quality of Life Score", "description": "Change in RAND 36 Health Related Quality of Life Score from pre-treatment baseline to treatment (4 months).", "time_frame": "4 months" }, { "type": "secondary", "measure": "Cytokines", "description": "Change in plasma cytokine levels from pre-treatment baseline to treatment (4 months)", "time_frame": "4 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Visual Analogue Scale (VAS)", "description": "Change in Fatigue VAS from pre-treatment (baseline) to treatment (4 months). The score is measured from 0-100 (0 is no fatigue).", "time_frame": "4 months" }, { "type": "secondary", "measure": "RAND 36 Health Related Quality of Life Score", "description": "Change in RAND 36 Health Related Quality of Life Score from pre-treatment baseline to treatment (4 months).", "time_frame": "4 months" }, { "type": "secondary", "measure": "Cytokines", "description": "Change in plasma cytokine levels from pre-treatment baseline to treatment (4 months)", "time_frame": "4 months" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Anti-inflammatory", "Phase 4", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05363514", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05633693", "title": "Postural Sway and Counterpressure Maneuvers for Pediatric Syncope", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-04-23", "start_date": "2023-04-17", "completion_date": "2027-06", "primary_completion_date": "2027-05", "conditions_raw": [ "Syncope, Vasovagal", "Postural Orthostatic Tachycardia Syndrome", "Orthostatic Intolerance" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Counterpressure Maneuvers", "Baseline Stand" ], "sponsor": "Simon Fraser University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators are interested in whether discrete counterpressure maneuvers, or muscle movements in the lower body, will boost blood pressure and cardiovascular control in children who faint. We will record cardiovascular responses to maneuvers of exaggerated sway, leg crossing, crouching, and gluteal muscle tensing in children who faint (N=20), as well as their height, weight, muscularity, and pubertal (Tanner) stage. Autonomic cardiovascular control will be measured using a Valsalva manoeuvre (expiration against a closed airway for 20 seconds) and a supine-stand test. The primary outcomes are noninvasive measures of cardiovascular responses to the maneuvers (blood pressure, cerebral blood flow, and stroke volume (volume of blood pumped per heartbeat). Comparisons will be made across levels of sex, diagnosis, Tanner stage, muscularity, height, and degree of autonomic control.", "primary_outcomes": [ { "type": "primary", "measure": "Relationship between postural movement and stroke volume", "description": "We will correlate these two parameters using both time and frequency domain approaches. We will compare this between the five movement conditions using a one-way repeated measures ANOVA.", "time_frame": "Final minute of maneuver performance" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Relationship between anthropometry and response magnitude", "description": "We will evaluate the relationship between responses to the CPM and factors of muscle mass and height. We will evaluate this using correlation, regression, and AIC analyses.", "time_frame": "Final minute of maneuver performance" }, { "type": "secondary", "measure": "Relationship between tanner stage and response magnitude", "description": "We will compare responses across tanner stages using a 2-way repeated measures ANOVA. We will also consider sex differences in cardiovascular responses to the maneuver, again using a 2-way repeated measures ANOVA", "time_frame": "Final minute of maneuver performance" }, { "type": "secondary", "measure": "Relationship between autonomic control and response magnitude", "description": "We will use responses to the Valsalva maneuver and sit-stand test to determine participant autonomic control. Relationships between autonomic control will be evaluated using correlation/regression/AIC analyses. Comparisons between syncopal diagnoses will be made using a 2-way Repeated Measures ANOVA", "time_frame": "Final minute of maneuver performance, response to maneuver release." } ], "outcome_measures": [ { "type": "primary", "measure": "Relationship between postural movement and stroke volume", "description": "We will correlate these two parameters using both time and frequency domain approaches. We will compare this between the five movement conditions using a one-way repeated measures ANOVA.", "time_frame": "Final minute of maneuver performance" }, { "type": "secondary", "measure": "Relationship between anthropometry and response magnitude", "description": "We will evaluate the relationship between responses to the CPM and factors of muscle mass and height. We will evaluate this using correlation, regression, and AIC analyses.", "time_frame": "Final minute of maneuver performance" }, { "type": "secondary", "measure": "Relationship between tanner stage and response magnitude", "description": "We will compare responses across tanner stages using a 2-way repeated measures ANOVA. We will also consider sex differences in cardiovascular responses to the maneuver, again using a 2-way repeated measures ANOVA", "time_frame": "Final minute of maneuver performance" }, { "type": "secondary", "measure": "Relationship between autonomic control and response magnitude", "description": "We will use responses to the Valsalva maneuver and sit-stand test to determine participant autonomic control. Relationships between autonomic control will be evaluated using correlation/regression/AIC analyses. Comparisons between syncopal diagnoses will be made using a 2-way Repeated Measures ANOVA", "time_frame": "Final minute of maneuver performance, response to maneuver release." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05633693", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05555771", "title": "Paediatric Syncope in the Emergency Department", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-04-23", "start_date": "2022-09-03", "completion_date": "2027-09-30", "primary_completion_date": "2027-09-30", "conditions_raw": [ "Syncope, Vasovagal", "Postural Orthostatic Tachycardia Syndrome", "Orthostatic Intolerance" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Counterpressure Maneuvers" ], "sponsor": "Dr. Victoria Claydon", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators will assess the efficacy of clinically recommended counterpressure maneuvers (CPM) in preventing syncope for paediatric patients. Participants presenting to the emergency department (ED) will first provide written informed consent. In stage I, they will be asked to complete a brief survey documenting the presentation of their syncopal episode, and any prodromal symptoms they experienced. Participants that consent to the second stage of the study will either receive usual care (control arm) or training in counter pressure maneuvers alongside usual care (intervention arm; leg crossing, bending, arm tensing). These patients will be followed for one years time, and will be asked to complete monthly surveys detailing their syncopal and presyncopal recurrence. Medical records will be accessed over the duration of the study to identify any changes in medical diagnosis.", "primary_outcomes": [ { "type": "primary", "measure": "Number of patients with syncopal recurrence", "description": "Participant experiences an episode of syncope (transient loss of consciousness and postural tone followed by a spontaneous recovery) over the course of the one year follow up.", "time_frame": "One year, reported in monthly surveys." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Syncopal incidence", "description": "Report on the incidence of syncope in our cohort", "time_frame": "One year" }, { "type": "secondary", "measure": "Documentation of typical prodromal symptoms", "description": "Link the prodromal symptoms of the different types of syncope in the pediatric population with the final diagnosis after at least one year of follow-up.", "time_frame": "One year" }, { "type": "secondary", "measure": "Number of patients with exercise-related syncope", "description": "Determine the diagnosis of pediatric patients who may experience syncope that is temporally associated to exercise", "time_frame": "One year" }, { "type": "secondary", "measure": "Number of patients with syncope secondary to other causes", "description": "Report on predictive factors for syncope secondary to other causes", "time_frame": "One year" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of patients with syncopal recurrence", "description": "Participant experiences an episode of syncope (transient loss of consciousness and postural tone followed by a spontaneous recovery) over the course of the one year follow up.", "time_frame": "One year, reported in monthly surveys." }, { "type": "secondary", "measure": "Syncopal incidence", "description": "Report on the incidence of syncope in our cohort", "time_frame": "One year" }, { "type": "secondary", "measure": "Documentation of typical prodromal symptoms", "description": "Link the prodromal symptoms of the different types of syncope in the pediatric population with the final diagnosis after at least one year of follow-up.", "time_frame": "One year" }, { "type": "secondary", "measure": "Number of patients with exercise-related syncope", "description": "Determine the diagnosis of pediatric patients who may experience syncope that is temporally associated to exercise", "time_frame": "One year" }, { "type": "secondary", "measure": "Number of patients with syncope secondary to other causes", "description": "Report on predictive factors for syncope secondary to other causes", "time_frame": "One year" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 300, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05555771", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05618054", "title": "Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-04-21", "start_date": "2023-03-06", "completion_date": "2026-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Looming Task" ], "sponsor": "Virginia Commonwealth University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is being conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. The information may help doctors to learn more about how the different parts of people's brains communicate.", "primary_outcomes": [ { "type": "primary", "measure": "Periaqueductal gray region activation - looming task", "description": "Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task", "time_frame": "90 minutes" }, { "type": "primary", "measure": "Periaqueductal gray region activation - resting", "description": "Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest", "time_frame": "90 minutes" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Periaqueductal gray region activation - looming task", "description": "Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task", "time_frame": "90 minutes" }, { "type": "primary", "measure": "Periaqueductal gray region activation - resting", "description": "Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest", "time_frame": "90 minutes" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 36, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05618054", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05748015", "title": "Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-04-17", "start_date": "2021-03-04", "completion_date": "2027-05-30", "primary_completion_date": "2026-11-30", "conditions_raw": [ "Multiple Sclerosis" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Quantification Of Sensory And Autonomic Small Nerve Fibers By Punch Skin Biopsy", "Cardiovascular Reflexes Testing", "Administration Of Clinical Scales Evaluating Autonomic Symptoms, Pain Small Fiber Neuropathy Symptoms" ], "sponsor": "Istituti Clinici Scientifici Maugeri SpA", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this interventional non-pharmacological study is to evaluate the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis.\n\nThe main questions it aims to answer are:\n\n* Is it possible to define the characteristics of dysautonomia to improve treatment on patients with multiple sclerosis through the management of conditions such as orthostatic hypotension or thermoregulation disorders that inevitably condition the patient's life and the response to rehabilitation ?\n* Does the severity of the functional alterations correlate with impairment of small somatic and autonomic cutaneous nerve fibers in patients with multiple sclerosis ?\n* How much the involvement of the autonomic nervous system affects the clinical history and progression of the disease ?\n* Do different clinical variants of multiple sclerosis manifest with different patterns of involvement of the sensory-autonomic nervous system ?\n\nParticipants will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment. Patients will perform a sensory and autonomic functional study and a morphological analysis of cutaneous nerves through skin biopsy.\n\nResearchers will compare results between the two groups (relapsing-remitting and primary progressive) and between patients and data from control subjects.", "primary_outcomes": [ { "type": "primary", "measure": "Cardiovascular reflex test", "description": "Assessment of Cardiovascular reflex responses to physical challenges.", "time_frame": "At the recruitment" }, { "type": "primary", "measure": "Sudomotor function test", "description": "Assessment of postganglionic sudomotor function through dynamic sweat test", "time_frame": "At the recruitment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Quantification of peripheral autonomic nerve fibers", "description": "Quantification of sweat gland innervation (fiber length /um3) and arrector pili muscle (ff/mm).", "time_frame": "At the recruitment" }, { "type": "secondary", "measure": "Quantification of peripheral sensory nerve fibers", "description": "Quantification of sensory nerve fibers (Intraepidermal nerve fibers (ff/mm)).", "time_frame": "At the recruitment" } ], "outcome_measures": [ { "type": "primary", "measure": "Cardiovascular reflex test", "description": "Assessment of Cardiovascular reflex responses to physical challenges.", "time_frame": "At the recruitment" }, { "type": "primary", "measure": "Sudomotor function test", "description": "Assessment of postganglionic sudomotor function through dynamic sweat test", "time_frame": "At the recruitment" }, { "type": "secondary", "measure": "Quantification of peripheral autonomic nerve fibers", "description": "Quantification of sweat gland innervation (fiber length /um3) and arrector pili muscle (ff/mm).", "time_frame": "At the recruitment" }, { "type": "secondary", "measure": "Quantification of peripheral sensory nerve fibers", "description": "Quantification of sensory nerve fibers (Intraepidermal nerve fibers (ff/mm)).", "time_frame": "At the recruitment" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05748015", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04977388", "title": "NORTHERA (DROXIDOPA) for Dysautonomia in Adult Survivors of Menkes Disease and Occipital Horn Syndrome", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2026-04-13", "start_date": "2021-07-12", "completion_date": "2024-06-29", "primary_completion_date": "2023-10-30", "conditions_raw": [ "Menkes Disease", "Occipital Horn Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Droxidopa" ], "sponsor": "Stephen G. Kaler, MD", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to evaluate whether Northera (Droxidopa) is safe and effective in young adults with Menkes disease who survived the most severe complications of their illness or adults with occipital horn syndrome (OHS), who have trouble with intermittent low blood pressure and other symptoms of dysautonomia. The outcomes and information from this study may help adult survivors of Menkes disease and individuals with OHS lead more normal day-to-day lives.", "primary_outcomes": [ { "type": "primary", "measure": "Treatment Related Adverse Events as Assessed by CTCAE v4.0", "description": "Treatment related adverse events as assessed by CTCAE v 4.0 by study arm", "time_frame": "TEAEs in 6 week periods of either active drug (droxidopa) or placebo" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Mean Change in Systolic Blood Pressure in Tilt Position", "description": "Change in systolic BP in tilt position during each treatment arm (droxidopa and placebo) compared to baseline.", "time_frame": "Change in systolic BP in tilt position during each 6 week treatment arm (droxidopa and placebo) compared to baseline." }, { "type": "secondary", "measure": "Mean Change in Diastolic Blood Pressure in Tilt Position", "description": "The change in diastolic BP in tilt position during each treatment arm (droxidopa and placebo) compared to baseline.", "time_frame": "The change in diastolic BP in tilt position during each 6 week treatment arm (droxidopa and placebo) compared to baseline." }, { "type": "secondary", "measure": "Plasma Catechol Levels", "description": "Change in plasma catechols between placebo and droxidopa treatment arms", "time_frame": "Change in plasma catechols between each 6 week treatment arm (droxidopa and placebo)" }, { "type": "secondary", "measure": "Change From Baseline in Daily Bowel Movements", "description": "Change from baseline in daily bowel movements", "time_frame": "Change from baseline in daily bowel movements per day during each 6 week treatment arm (droxidopa and placebo)." }, { "type": "secondary", "measure": "Change From Baseline in Time Standing Duration", "description": "Change from baseline in Time standing duration", "time_frame": "Change from baseline in standing time duration during each 6 week treatment arm (droxidopa and placebo)." }, { "type": "secondary", "measure": "Change From Baseline in Timed Up and Go (TUG) Test Performance", "description": "Change from baseline in Timed Up and Go (TUG) test performance", "time_frame": "Change from baseline in TUG test performance during each 6 week treatment arm (droxidopa and placebo)" }, { "type": "secondary", "measure": "Change From Baseline in 6 Minute Walk Test Performance", "description": "Change from baseline in 6 minute walk test performance", "time_frame": "Change from baseline in the 6MW distance during each 6 week treatment arm (droxidopa and placebo)" }, { "type": "secondary", "measure": "Change From Baseline in Scores on the Orthostatic Hypotension Symptom Assessment (OHSA) Questionnaire", "description": "Change from baseline in scores on the Orthostatic Hypotension Symptom Assessment questionnaire. The scale rates the severity of OH symptoms from 0 to 10 ; with 10 defined as the worst possible.", "time_frame": "Change from baseline in OHSA score during each 6 week treatment arm (droxidopa and placebo)" } ], "outcome_measures": [ { "type": "primary", "measure": "Treatment Related Adverse Events as Assessed by CTCAE v4.0", "description": "Treatment related adverse events as assessed by CTCAE v 4.0 by study arm", "time_frame": "TEAEs in 6 week periods of either active drug (droxidopa) or placebo" }, { "type": "secondary", "measure": "Mean Change in Systolic Blood Pressure in Tilt Position", "description": "Change in systolic BP in tilt position during each treatment arm (droxidopa and placebo) compared to baseline.", "time_frame": "Change in systolic BP in tilt position during each 6 week treatment arm (droxidopa and placebo) compared to baseline." }, { "type": "secondary", "measure": "Mean Change in Diastolic Blood Pressure in Tilt Position", "description": "The change in diastolic BP in tilt position during each treatment arm (droxidopa and placebo) compared to baseline.", "time_frame": "The change in diastolic BP in tilt position during each 6 week treatment arm (droxidopa and placebo) compared to baseline." }, { "type": "secondary", "measure": "Plasma Catechol Levels", "description": "Change in plasma catechols between placebo and droxidopa treatment arms", "time_frame": "Change in plasma catechols between each 6 week treatment arm (droxidopa and placebo)" }, { "type": "secondary", "measure": "Change From Baseline in Daily Bowel Movements", "description": "Change from baseline in daily bowel movements", "time_frame": "Change from baseline in daily bowel movements per day during each 6 week treatment arm (droxidopa and placebo)." }, { "type": "secondary", "measure": "Change From Baseline in Time Standing Duration", "description": "Change from baseline in Time standing duration", "time_frame": "Change from baseline in standing time duration during each 6 week treatment arm (droxidopa and placebo)." }, { "type": "secondary", "measure": "Change From Baseline in Timed Up and Go (TUG) Test Performance", "description": "Change from baseline in Timed Up and Go (TUG) test performance", "time_frame": "Change from baseline in TUG test performance during each 6 week treatment arm (droxidopa and placebo)" }, { "type": "secondary", "measure": "Change From Baseline in 6 Minute Walk Test Performance", "description": "Change from baseline in 6 minute walk test performance", "time_frame": "Change from baseline in the 6MW distance during each 6 week treatment arm (droxidopa and placebo)" }, { "type": "secondary", "measure": "Change From Baseline in Scores on the Orthostatic Hypotension Symptom Assessment (OHSA) Questionnaire", "description": "Change from baseline in scores on the Orthostatic Hypotension Symptom Assessment questionnaire. The scale rates the severity of OH symptoms from 0 to 10 ; with 10 defined as the worst possible.", "time_frame": "Change from baseline in OHSA score during each 6 week treatment arm (droxidopa and placebo)" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 3, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04977388", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06524739", "title": "Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS", "status": "TERMINATED", "phase": "PHASE3", "last_updated": "2026-04-13", "start_date": "2024-08-28", "completion_date": "2025-07-11", "primary_completion_date": "2025-06-20", "conditions_raw": [ "Post-COVID Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Igpro20" ], "sponsor": "CSL Behring", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses of IgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatic tachycardia syndrome (post-Coronavirus Disease 2019 \\[COVID-19\\] POTS \\[post-COVID-POTS\\]).", "primary_outcomes": [ { "type": "primary", "measure": "Proportion of Participants No Longer Meeting Diagnostic Criteria of Post-COVID POTS as Measured by Standardized Standing Test (ie, No Longer Experiencing HR Increase of ≥30 Bpm, in the Absence of 20 mmHg Decrease of SBP [Orthostatic Hypotension])", "description": "The reported data reflect the percentage of participants who no longer met the diagnostic criteria for Post-Coronavirus Disease 2019 (COVID) Postural Orthostatic Tachycardia Syndrome (POTS), as assessed by a standardized standing test (i.e., no longer experiencing a heart-rate (HR) increase of \\>=30 bpm in the absence of a 20 mmHg decrease in systolic blood pressure \\[SBP; orthostatic hypotension\\]), among participants evaluated at that visit. The Baseline data represent the proportion of participants who were meeting the diagnostic criteria for post-COVID POTS.", "time_frame": "At Baseline and at Week 25" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change From Baseline in Orthostatic Intolerance (OI) Score of Composite Autonomic Symptom Score 31 (COMPASS-31)", "description": "The COMPASS-31 was a self-reported questionnaire that measures autonomic symptoms across six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. The OI domain assesses symptoms including faintness, dizziness, feeling \"goofy,\" or had difficulty thinking soon after standing up from a sitting or lying position, and generates a total score ranging from 0 to 40 with higher scores representing a higher symptom burden. The treatment effect of interest was the difference from baseline in OI score of COMPASS-31. A more negative change from baseline indicates a greater improvement in OI symptoms.", "time_frame": "At Baseline and at Week 25" }, { "type": "secondary", "measure": "Change From Baseline in COMPASS-31 Total Score", "description": "The COMPASS-31 was a self-reported questionnaire that measured autonomic symptoms related to six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. This questionnaire generated a weighted score ranging from 0 to 100, with higher scores representing a higher symptom burden. A COMPASS-31 score of \\>=40 indicated that participants had severe autonomic dysfunction. A more negative change from baseline indicates a greater improvement in autonomic symptoms.", "time_frame": "At Baseline and at Week 25" }, { "type": "secondary", "measure": "Change From Baseline in Heart Rate Increase Within 10 Minutes of Standing Test", "description": "Heart rate for the standing test was measured at the end of 10 minutes in the supine position and at 1, 3, 5, 7, and 10 minutes of standing. The change in heart rate during the standing test was calculated as the difference between the average of the two highest heart rate measurements (bpm) within 10 minutes of standing and the heart rate measurement (bpm) at the end of 10 minutes in the supine position.", "time_frame": "At Baseline and at Week 25" }, { "type": "secondary", "measure": "Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE", "description": "", "time_frame": "Up to Week 45" }, { "type": "secondary", "measure": "Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE", "description": "The participant data were rounded to one decimal place.", "time_frame": "Up to Week 45" }, { "type": "secondary", "measure": "Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities", "description": "", "time_frame": "Up to Week 45" }, { "type": "secondary", "measure": "Percentage of Participants With Clinically Significant ECG Abnormalities", "description": "", "time_frame": "Up to Week 45" }, { "type": "secondary", "measure": "Number of Participants With Change From Baseline in Clinically Significant ECG Abnormalities", "description": "", "time_frame": "From Baseline up to Week 45" }, { "type": "secondary", "measure": "Percentage of Participants With Change From Baseline in Clinically Significant ECG Abnormalities", "description": "", "time_frame": "From Baseline up to Week 45" } ], "outcome_measures": [ { "type": "primary", "measure": "Proportion of Participants No Longer Meeting Diagnostic Criteria of Post-COVID POTS as Measured by Standardized Standing Test (ie, No Longer Experiencing HR Increase of ≥30 Bpm, in the Absence of 20 mmHg Decrease of SBP [Orthostatic Hypotension])", "description": "The reported data reflect the percentage of participants who no longer met the diagnostic criteria for Post-Coronavirus Disease 2019 (COVID) Postural Orthostatic Tachycardia Syndrome (POTS), as assessed by a standardized standing test (i.e., no longer experiencing a heart-rate (HR) increase of \\>=30 bpm in the absence of a 20 mmHg decrease in systolic blood pressure \\[SBP; orthostatic hypotension\\]), among participants evaluated at that visit. The Baseline data represent the proportion of participants who were meeting the diagnostic criteria for post-COVID POTS.", "time_frame": "At Baseline and at Week 25" }, { "type": "secondary", "measure": "Change From Baseline in Orthostatic Intolerance (OI) Score of Composite Autonomic Symptom Score 31 (COMPASS-31)", "description": "The COMPASS-31 was a self-reported questionnaire that measures autonomic symptoms across six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. The OI domain assesses symptoms including faintness, dizziness, feeling \"goofy,\" or had difficulty thinking soon after standing up from a sitting or lying position, and generates a total score ranging from 0 to 40 with higher scores representing a higher symptom burden. The treatment effect of interest was the difference from baseline in OI score of COMPASS-31. A more negative change from baseline indicates a greater improvement in OI symptoms.", "time_frame": "At Baseline and at Week 25" }, { "type": "secondary", "measure": "Change From Baseline in COMPASS-31 Total Score", "description": "The COMPASS-31 was a self-reported questionnaire that measured autonomic symptoms related to six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. This questionnaire generated a weighted score ranging from 0 to 100, with higher scores representing a higher symptom burden. A COMPASS-31 score of \\>=40 indicated that participants had severe autonomic dysfunction. A more negative change from baseline indicates a greater improvement in autonomic symptoms.", "time_frame": "At Baseline and at Week 25" }, { "type": "secondary", "measure": "Change From Baseline in Heart Rate Increase Within 10 Minutes of Standing Test", "description": "Heart rate for the standing test was measured at the end of 10 minutes in the supine position and at 1, 3, 5, 7, and 10 minutes of standing. The change in heart rate during the standing test was calculated as the difference between the average of the two highest heart rate measurements (bpm) within 10 minutes of standing and the heart rate measurement (bpm) at the end of 10 minutes in the supine position.", "time_frame": "At Baseline and at Week 25" }, { "type": "secondary", "measure": "Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE", "description": "", "time_frame": "Up to Week 45" }, { "type": "secondary", "measure": "Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE", "description": "The participant data were rounded to one decimal place.", "time_frame": "Up to Week 45" }, { "type": "secondary", "measure": "Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities", "description": "", "time_frame": "Up to Week 45" }, { "type": "secondary", "measure": "Percentage of Participants With Clinically Significant ECG Abnormalities", "description": "", "time_frame": "Up to Week 45" }, { "type": "secondary", "measure": "Number of Participants With Change From Baseline in Clinically Significant ECG Abnormalities", "description": "", "time_frame": "From Baseline up to Week 45" }, { "type": "secondary", "measure": "Percentage of Participants With Change From Baseline in Clinically Significant ECG Abnormalities", "description": "", "time_frame": "From Baseline up to Week 45" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 3", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 16, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06524739", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06148311", "title": "Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia", "status": "ENROLLING_BY_INVITATION", "phase": "PHASE2", "last_updated": "2026-04-13", "start_date": "2024-07-01", "completion_date": "2027-09-01", "primary_completion_date": "2027-01-01", "conditions_raw": [ "Familial Dysautonomia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Dexmedetomidine" ], "sponsor": "NYU Langone Health", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this placebo controlled interventional study is to collect preliminary data on administering dexmedetomidine in patients with Familial Dysautonomia (FD) during a rapid cessation of autonomic crisis. The primary aims are to assess the feasibility and evaluate if measurements of heart rate, blood pressure and oxygen saturation can predict the start of an autonomic crisis.\n\nFunding Source- FDA OOPD", "primary_outcomes": [ { "type": "primary", "measure": "Percentage of patients with reduction of Autonomic crisis severity assessment scores (ACSAS) to ≤ 5 points", "description": "ACSAS tool will be used to measure objectively and record signs and symptoms of autonomic crisis, which includes documentation of blood pressure, heart rate, skin flushing and blotching, sweating, and behavioral changes. Scores are totaled at each timepoint (0 minutes, 15 min., 45 min., 1.5 hours, 2hr.) ranging from 0 (Normal) to 16 (most severe symptoms occurred).", "time_frame": "Up to 2 hours post administration" }, { "type": "primary", "measure": "Percentage of patients with 25% reduction in blood pressure", "description": "Patients will be monitored with a hospital-at-home (H@H) device to allow visualization of vital signs in real life. The H@H monitor (Biobeat™) is an FDA approved device and will be attached to the patient´s chest by an adhesive patch which will transmit blood pressure. Blood pressure will be monitored before taking each dose and up to 2 hours after.", "time_frame": "Up to 2 hours post administration" }, { "type": "primary", "measure": "Percentage of patients with >20% reduction in heart rate", "description": "Patients will be monitored with a hospital-at-home (H@H) device to allow visualization of vital signs in real life. The H@H monitor (Biobeat™) is an FDA approved device and will be attached to the patient´s chest by an adhesive patch which will transmit heart rate. Heart rate will be monitored before taking each dose and up to 2 hours after.", "time_frame": "Up to 2 hours post administration" }, { "type": "primary", "measure": "Percentage of patients with >50% reduction in vomiting/retching episodes", "description": "Patients will be monitored by their care givers for of episodes of vomiting/ retching before taking each dose and up to 2 hours after.", "time_frame": "Up to 2 hours post administration" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Percentage of patients with ≥ 20% reduction in hospitalizations", "description": "Study team will compare historical data to number of hospitalizations occurred after taking one or more doses.", "time_frame": "Up to 48 months" }, { "type": "secondary", "measure": "Percentage of patients with ≥ 20% reduction in hospital stay duration", "description": "Study team will compare historical data to number of days during hospital stay that occurred after taking one or more doses.", "time_frame": "Up to 48 months" }, { "type": "secondary", "measure": "Percentage of patients with ≥ 30% reduction in ICU stay duration", "description": "Study team will compare historical data to number of days at the ICU that occurred after taking one or more doses.", "time_frame": "Up to 48 months" }, { "type": "secondary", "measure": "Change in number of medical complications", "description": "Study team will compare historical data to number of medical complications of hospitalizations occurred after taking one or more doses.", "time_frame": "Baseline, up to 48 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Percentage of patients with reduction of Autonomic crisis severity assessment scores (ACSAS) to ≤ 5 points", "description": "ACSAS tool will be used to measure objectively and record signs and symptoms of autonomic crisis, which includes documentation of blood pressure, heart rate, skin flushing and blotching, sweating, and behavioral changes. Scores are totaled at each timepoint (0 minutes, 15 min., 45 min., 1.5 hours, 2hr.) ranging from 0 (Normal) to 16 (most severe symptoms occurred).", "time_frame": "Up to 2 hours post administration" }, { "type": "primary", "measure": "Percentage of patients with 25% reduction in blood pressure", "description": "Patients will be monitored with a hospital-at-home (H@H) device to allow visualization of vital signs in real life. The H@H monitor (Biobeat™) is an FDA approved device and will be attached to the patient´s chest by an adhesive patch which will transmit blood pressure. Blood pressure will be monitored before taking each dose and up to 2 hours after.", "time_frame": "Up to 2 hours post administration" }, { "type": "primary", "measure": "Percentage of patients with >20% reduction in heart rate", "description": "Patients will be monitored with a hospital-at-home (H@H) device to allow visualization of vital signs in real life. The H@H monitor (Biobeat™) is an FDA approved device and will be attached to the patient´s chest by an adhesive patch which will transmit heart rate. Heart rate will be monitored before taking each dose and up to 2 hours after.", "time_frame": "Up to 2 hours post administration" }, { "type": "primary", "measure": "Percentage of patients with >50% reduction in vomiting/retching episodes", "description": "Patients will be monitored by their care givers for of episodes of vomiting/ retching before taking each dose and up to 2 hours after.", "time_frame": "Up to 2 hours post administration" }, { "type": "secondary", "measure": "Percentage of patients with ≥ 20% reduction in hospitalizations", "description": "Study team will compare historical data to number of hospitalizations occurred after taking one or more doses.", "time_frame": "Up to 48 months" }, { "type": "secondary", "measure": "Percentage of patients with ≥ 20% reduction in hospital stay duration", "description": "Study team will compare historical data to number of days during hospital stay that occurred after taking one or more doses.", "time_frame": "Up to 48 months" }, { "type": "secondary", "measure": "Percentage of patients with ≥ 30% reduction in ICU stay duration", "description": "Study team will compare historical data to number of days at the ICU that occurred after taking one or more doses.", "time_frame": "Up to 48 months" }, { "type": "secondary", "measure": "Change in number of medical complications", "description": "Study team will compare historical data to number of medical complications of hospitalizations occurred after taking one or more doses.", "time_frame": "Baseline, up to 48 months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 15, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06148311", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06133075", "title": "Using Mirabegron to Increase BP in Patients With POTS", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-04-08", "start_date": "2023-12-22", "completion_date": "2025-07-25", "primary_completion_date": "2025-05-20", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome", "Chronic Orthostatic Intolerance", "Syncope" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Mirabegron 50 Mg", "Mirabegron 25 Mg" ], "sponsor": "Cedars-Sinai Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a pilot dose-finding study to test the hypothesis that mirabegron increases systolic blood pressure (BP), prevents syncope/presyncope, and improves the quality of life (QOL), functional capacity, chest pain, and overactive bladder (OAB) symptoms in patients with postural orthostatic tachycardia syndrome (POTS) who have a documented history of hypotension inadequately responsive to conventional treatments. The American Heart Association funds this study.", "primary_outcomes": [ { "type": "primary", "measure": "Blood Pressure", "description": "A 24-hr ambulatory blood pressure monitor (ABPM) was used to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP). The participants' average SBP is the primary outcome. We also report the average DBP in this Table. Due to technical reasons, only 7 participants in 50 mg group and 8 participants in 25 mg group had ABPM available for analysis.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Syncope", "description": "Change of frequencies of syncope and presyncope. Two of the initial 10 participants of each group exited the study early. So that we can compare the frequency of syncope at baseline with that at 8 weeks, we excluded those two patients from analysis. Therefore, we analyzed the 8 remaining participants in each group.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Hypotensive Episode", "description": "Change of the hypotensive (systolic BP \\< 90 mmHg) episodes during wake time using ABPM, which is available in 7 participants in the 50 mg group and 8 in the 25 mg group. They were used to compare between baseline and 8 weeks. Patients without complete data were excluded from analysis.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Duke Activity Status Index Questionnaire", "description": "Change of functional capacity score as measured by the Duke Activity Status index questionnaire. DASI (The Duke Activity Status Index): 0 to 58.2. The higher the score, the greater the individual's functional capacity.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "EQ-5D-5L Questionnaire", "description": "EuroQol 5-Dimension 5-Level, a questionnaire used to measure health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five response levels each, designed to be more sensitive than earlier versions. The 5-component scale includes mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D-5L: calculated score best = 1, worst = -0.573; EQ-5D-5L YHT (Your Health Today) score is self-reported by the patient on a 0-100 scale, with 100 being the best.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Seattle Angina Questionnaire (SAQ)", "description": "Change of QOL and symptoms of angina as measured by the SAQ based on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. Seattle Angina Questionnaire score on a 0-100 scale, with 100 being the best. SAQ subscales (physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale) all have a 0-100 scale, with 100 being the best. A total SAQ score can be calculated by averaging all domain scores.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Overactive Bladder Symptoms", "description": "Overactive Bladder Questionnaire Short Form (OAB-q SF) measures change in Overactive Bladder (OAB) symptoms. The severity score: best = 0, worst = 100. OAB-Q SF Health-Related quality of life (HRQoL) assessments evaluate the impact of OAB symptoms on a patient's quality of life. HRQoL best = 100, worst = 0", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Blood Pressure", "description": "A 24-hr ambulatory blood pressure monitor (ABPM) was used to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP). The participants' average SBP is the primary outcome. We also report the average DBP in this Table. Due to technical reasons, only 7 participants in 50 mg group and 8 participants in 25 mg group had ABPM available for analysis.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Syncope", "description": "Change of frequencies of syncope and presyncope. Two of the initial 10 participants of each group exited the study early. So that we can compare the frequency of syncope at baseline with that at 8 weeks, we excluded those two patients from analysis. Therefore, we analyzed the 8 remaining participants in each group.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Hypotensive Episode", "description": "Change of the hypotensive (systolic BP \\< 90 mmHg) episodes during wake time using ABPM, which is available in 7 participants in the 50 mg group and 8 in the 25 mg group. They were used to compare between baseline and 8 weeks. Patients without complete data were excluded from analysis.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Duke Activity Status Index Questionnaire", "description": "Change of functional capacity score as measured by the Duke Activity Status index questionnaire. DASI (The Duke Activity Status Index): 0 to 58.2. The higher the score, the greater the individual's functional capacity.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "EQ-5D-5L Questionnaire", "description": "EuroQol 5-Dimension 5-Level, a questionnaire used to measure health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five response levels each, designed to be more sensitive than earlier versions. The 5-component scale includes mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D-5L: calculated score best = 1, worst = -0.573; EQ-5D-5L YHT (Your Health Today) score is self-reported by the patient on a 0-100 scale, with 100 being the best.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Seattle Angina Questionnaire (SAQ)", "description": "Change of QOL and symptoms of angina as measured by the SAQ based on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. Seattle Angina Questionnaire score on a 0-100 scale, with 100 being the best. SAQ subscales (physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale) all have a 0-100 scale, with 100 being the best. A total SAQ score can be calculated by averaging all domain scores.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Overactive Bladder Symptoms", "description": "Overactive Bladder Questionnaire Short Form (OAB-q SF) measures change in Overactive Bladder (OAB) symptoms. The severity score: best = 0, worst = 100. OAB-Q SF Health-Related quality of life (HRQoL) assessments evaluate the impact of OAB symptoms on a patient's quality of life. HRQoL best = 100, worst = 0", "time_frame": "8 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06133075", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07182578", "title": "Programming Aquatic Therapy for POTS", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-04-03", "start_date": "2025-09-12", "completion_date": "2026-02-08", "primary_completion_date": "2026-02-08", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Aquatic Occupational Therapy" ], "sponsor": "California State University, Dominguez Hills", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this pilot study is to create, implement, and evaluate an aquatic therapy for Postural Orthostatic Tachycardia Syndrome (POTS) program feasibility and ability to improve quality of life as determined by reduced orthostatic tachycardia, reduced POTS symptoms, and improved quality of life measures.\n\nThe main questions it aims to answer are:\n\nDoes aquatic occupational therapy reduce orthostatic tachycardia and POTS symptoms? Does aquatic occupational therapy lead to higher quality of live measures for people with POTS? Is this aquatic occupational therapy program feasible for clinicians and people with POTS?\n\nThere is no comparison group for this pilot study.\n\nParticipants will complete:\n\nAn occupational Therapy evaluation before and after program completion (3 hours total) 30 minutes at home/remote 30 minutes on-site/in-person 30 minutes of individualized occupational therapy on land\n\nParticipate in 3 aquatic therapy sessions per week, 60 minutes each for 12 weeks", "primary_outcomes": [ { "type": "primary", "measure": "World Health Organization Quality of Life - Brief (WHOQOL-BREF)", "description": "The WHOQOL-BREF is a 26-item questionnaire that will be completed digitally. It is scored by first assigning numerical values (1-5) to each response, with higher scores generally indicating a better quality of life. Then, raw domain scores are calculated by averaging the responses within each domain (Physical, Psychological, Social, and Environmental). Finally, these raw domain scores are transformed into scaled scores ranging from 0 to 100 by multiplying by 4. Higher scores on the 0-100 scale indicate a higher quality of life.\n\nThe measure will be reported as a quality of life score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "primary", "measure": "The DePaul Symptom Questionnaire (Short Form) (DSQ-SF)", "description": "14-item-questionnaire which measures post-exertional malaise symptoms over the last 6 months. Each question requires two ratings, one for frequency (0 = none of the time and 4 = all of the time) and one for severity (0 = symptom not present and 4 = very severe). A frequency of at least 2 and a severity of at least 2 on any one of the 5 questions on the DSQ-SF subscale indicate that post exertional malaise is present. For each symptom, the frequency and severity scores are averaged, and then multiplied by 25 to create a composite score out of 100.\n\nThe measure will be reported as a post exertional malaise score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention." }, { "type": "primary", "measure": "Composite Autonomic Symptom Score-31", "description": "Measures neurodegenerative system symptoms through 31 patient-reported questions. Assessment is through six weighted domains: orthostatic intolerance \\[10 points\\]; vasomotor \\[6 points\\]; secretomotor \\[7 points\\]; gastrointestinal \\[28 points\\]; bladder \\[9 points\\] and pupillomotor \\[15 points\\]. A higher score indicates worse autonomic dysfunction. Simple yes or no questions are scored as 0 points for no and 1 point for yes. Questions about a specific site of symptoms or symptoms under specific circumstances are scored as 0 if not present and as 1 if present for each site or circumstance. All questions regarding the frequency of symptoms were scored as 0 points for rarely or never, 1 point for occasionally or sometimes, 2 points for frequently or \"a lot of the time,\" and 3 points for almost always or constantly. All questions regarding the severity of symptoms were scored as 1 point for mild, 2 points for moderate, and 3 points for severe.\n\nThe measure will be reported as a COMPASS score", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention." }, { "type": "primary", "measure": "Malmo POTS Scale (MAPS)", "description": "This 12-item questionnaire assesses the specific POTS symptom burden over the past 3 months. Each question uses a visual analog scale from 0-10, with a maximum score of 120. A score of 42 or higher is considered indicative of POTS.\n\nThe measure will be reported as a MAPS score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "primary", "measure": "ADLS, IADLS, and Vestibular Questionnaire", "description": "This is a 26-item questionnaire that will be filled out digitally. 21 questions cover about to participate in occupations listed in the Occupational Therapy Practice Framework using a scale from 1-10, where 1 is unable to complete the task, 5 is able to complete task with moderate difficulty (noticeable symptoms and extra effort is required) 10 is no problems/symptoms completing the task. It also contains 5 vestibular related questions using a scale from 1-7, with 1 being not at all dizzy, 4 being moderately dizzy, and 7 being extremely dizzy. The measure will be reported as an AIVQ score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "primary", "measure": "Active Stand Test", "description": "The patient will begin laying down in a relaxed and comfortable position. Blood pressure (BP) and heart rate (HR) are taken after 5 minutes. Next, the patient will be asked to stand promptly, and will have their BP and HR measured immediately. The therapist will note any comments like \"feeling dizzy\". The BP and HR will be taken again and documented after three minutes, and again after ten minutes of standing. If there is any event, such as severe dizziness, paleness, etc, the BP and HR will be taken and documented just before the patient sits down.\n\nThe measure will be reported as the position, time, and the correlated heart rate and blood pressure.", "time_frame": "From enrollment until the end of treatment at 12 weeks" }, { "type": "primary", "measure": "Single leg stance test", "description": "This test measures a person's ability to balance standing on one leg without assistance. The participant will stand on one leg with their hands on their hips while being timed. The test is repeated 3 times for each leg and averaged. The measure will be reported as time standing per leg.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "primary", "measure": "Heart Rate", "description": "Heart rate (HR) will be measured on land while the participant is laying down, sitting up, and standing. HR in the water will be taken while seated and standing. An aquatic HR maximum and HR zones will be calculated for each participant. This measure will be reported as a land-based and aquatic HR maximum.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "primary", "measure": "Borg's rate of perceived exertion scale", "description": "This scale is used to tell how tiring an activity feels. The scale ranges from 6 (no exertion at all), to 20 (maximal heaviness). This will be reported as the RPE score.", "time_frame": "From enrollment to the end of treatment at 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The Stroop Test", "description": "The Stroop Test is a measure of working memory and attention. A participant is asked to read words of various colors, say the color of the letters when they are the same, and when the colors don't match the words. They are timed and errors are tracked. This will be reported as the SCWT score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "secondary", "measure": "Trail Making Test Parts A & B", "description": "The participant is given a paper with numbers and letters, and is instructed to connect the letters and numbers in order (1-A-2-B-3-C, etc.), as quickly as possible, without lifting the pend or pencil from the paper. Errors will be pointed out immediately and the participant is allowed to correct it, but the time it takes to correct is still included in the completion time for the task. This will be reported as the TMT-A and TMT-B scores.", "time_frame": "From enrollment to the end of the intervention at 12 weeks" }, { "type": "secondary", "measure": "Enrollment", "description": "Total number of participants who complete the informed consent, evaluation session, and agree to participate in program according to schedule discussed with participant", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Attrition Rate", "description": "The number of enrolled participants who do not complete the program", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Session attendance rate", "description": "This will be calculated by the number of sessions attended out of the total number of sessions for the program.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Cost analysis", "description": "This measure will include resource tracking and total costs divided by the number of completers.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Health utilization changes", "description": "This will include a calculation of health utilization changes from before the program compared to after the program", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Satisfaction Analysis", "description": "Thematic analysis of open-ended feedback from participants and stakeholders will determine the most common themes and areas for improvement within the program.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Exercise self-efficacy", "description": "Measure will be completed before the program and compared to the result after, leading to an ESE score.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Goal Attainment Scaling", "description": "Goal attainment scaling is a method to turn individualized goals into a 5-point evaluation method, using a score of -2 to + 2 to quantify progress towards the specific goals. It measures the outcomes against expected results, where 0 is the expected outcome, -2 is much less than the expected outcome, and +2 is much more than the expected outcome.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Beighton Score", "description": "The Beighton score is a screener for hypermobility and can be done quickly and simply with no testing materials needed. It consists of a 5-point scale, requires 5 maneuvers. It involves the evaluation of only a small number of joints, so any hypermobile joints not in this group may be overlooked.", "time_frame": "From enrollment to the end of treatment at 12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "World Health Organization Quality of Life - Brief (WHOQOL-BREF)", "description": "The WHOQOL-BREF is a 26-item questionnaire that will be completed digitally. It is scored by first assigning numerical values (1-5) to each response, with higher scores generally indicating a better quality of life. Then, raw domain scores are calculated by averaging the responses within each domain (Physical, Psychological, Social, and Environmental). Finally, these raw domain scores are transformed into scaled scores ranging from 0 to 100 by multiplying by 4. Higher scores on the 0-100 scale indicate a higher quality of life.\n\nThe measure will be reported as a quality of life score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "primary", "measure": "The DePaul Symptom Questionnaire (Short Form) (DSQ-SF)", "description": "14-item-questionnaire which measures post-exertional malaise symptoms over the last 6 months. Each question requires two ratings, one for frequency (0 = none of the time and 4 = all of the time) and one for severity (0 = symptom not present and 4 = very severe). A frequency of at least 2 and a severity of at least 2 on any one of the 5 questions on the DSQ-SF subscale indicate that post exertional malaise is present. For each symptom, the frequency and severity scores are averaged, and then multiplied by 25 to create a composite score out of 100.\n\nThe measure will be reported as a post exertional malaise score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention." }, { "type": "primary", "measure": "Composite Autonomic Symptom Score-31", "description": "Measures neurodegenerative system symptoms through 31 patient-reported questions. Assessment is through six weighted domains: orthostatic intolerance \\[10 points\\]; vasomotor \\[6 points\\]; secretomotor \\[7 points\\]; gastrointestinal \\[28 points\\]; bladder \\[9 points\\] and pupillomotor \\[15 points\\]. A higher score indicates worse autonomic dysfunction. Simple yes or no questions are scored as 0 points for no and 1 point for yes. Questions about a specific site of symptoms or symptoms under specific circumstances are scored as 0 if not present and as 1 if present for each site or circumstance. All questions regarding the frequency of symptoms were scored as 0 points for rarely or never, 1 point for occasionally or sometimes, 2 points for frequently or \"a lot of the time,\" and 3 points for almost always or constantly. All questions regarding the severity of symptoms were scored as 1 point for mild, 2 points for moderate, and 3 points for severe.\n\nThe measure will be reported as a COMPASS score", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention." }, { "type": "primary", "measure": "Malmo POTS Scale (MAPS)", "description": "This 12-item questionnaire assesses the specific POTS symptom burden over the past 3 months. Each question uses a visual analog scale from 0-10, with a maximum score of 120. A score of 42 or higher is considered indicative of POTS.\n\nThe measure will be reported as a MAPS score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "primary", "measure": "ADLS, IADLS, and Vestibular Questionnaire", "description": "This is a 26-item questionnaire that will be filled out digitally. 21 questions cover about to participate in occupations listed in the Occupational Therapy Practice Framework using a scale from 1-10, where 1 is unable to complete the task, 5 is able to complete task with moderate difficulty (noticeable symptoms and extra effort is required) 10 is no problems/symptoms completing the task. It also contains 5 vestibular related questions using a scale from 1-7, with 1 being not at all dizzy, 4 being moderately dizzy, and 7 being extremely dizzy. The measure will be reported as an AIVQ score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "primary", "measure": "Active Stand Test", "description": "The patient will begin laying down in a relaxed and comfortable position. Blood pressure (BP) and heart rate (HR) are taken after 5 minutes. Next, the patient will be asked to stand promptly, and will have their BP and HR measured immediately. The therapist will note any comments like \"feeling dizzy\". The BP and HR will be taken again and documented after three minutes, and again after ten minutes of standing. If there is any event, such as severe dizziness, paleness, etc, the BP and HR will be taken and documented just before the patient sits down.\n\nThe measure will be reported as the position, time, and the correlated heart rate and blood pressure.", "time_frame": "From enrollment until the end of treatment at 12 weeks" }, { "type": "primary", "measure": "Single leg stance test", "description": "This test measures a person's ability to balance standing on one leg without assistance. The participant will stand on one leg with their hands on their hips while being timed. The test is repeated 3 times for each leg and averaged. The measure will be reported as time standing per leg.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "primary", "measure": "Heart Rate", "description": "Heart rate (HR) will be measured on land while the participant is laying down, sitting up, and standing. HR in the water will be taken while seated and standing. An aquatic HR maximum and HR zones will be calculated for each participant. This measure will be reported as a land-based and aquatic HR maximum.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "primary", "measure": "Borg's rate of perceived exertion scale", "description": "This scale is used to tell how tiring an activity feels. The scale ranges from 6 (no exertion at all), to 20 (maximal heaviness). This will be reported as the RPE score.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "The Stroop Test", "description": "The Stroop Test is a measure of working memory and attention. A participant is asked to read words of various colors, say the color of the letters when they are the same, and when the colors don't match the words. They are timed and errors are tracked. This will be reported as the SCWT score.", "time_frame": "From enrollment to the end of 12 weeks of aquatic occupational therapy intervention" }, { "type": "secondary", "measure": "Trail Making Test Parts A & B", "description": "The participant is given a paper with numbers and letters, and is instructed to connect the letters and numbers in order (1-A-2-B-3-C, etc.), as quickly as possible, without lifting the pend or pencil from the paper. Errors will be pointed out immediately and the participant is allowed to correct it, but the time it takes to correct is still included in the completion time for the task. This will be reported as the TMT-A and TMT-B scores.", "time_frame": "From enrollment to the end of the intervention at 12 weeks" }, { "type": "secondary", "measure": "Enrollment", "description": "Total number of participants who complete the informed consent, evaluation session, and agree to participate in program according to schedule discussed with participant", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Attrition Rate", "description": "The number of enrolled participants who do not complete the program", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Session attendance rate", "description": "This will be calculated by the number of sessions attended out of the total number of sessions for the program.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Cost analysis", "description": "This measure will include resource tracking and total costs divided by the number of completers.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Health utilization changes", "description": "This will include a calculation of health utilization changes from before the program compared to after the program", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Satisfaction Analysis", "description": "Thematic analysis of open-ended feedback from participants and stakeholders will determine the most common themes and areas for improvement within the program.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Exercise self-efficacy", "description": "Measure will be completed before the program and compared to the result after, leading to an ESE score.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Goal Attainment Scaling", "description": "Goal attainment scaling is a method to turn individualized goals into a 5-point evaluation method, using a score of -2 to + 2 to quantify progress towards the specific goals. It measures the outcomes against expected results, where 0 is the expected outcome, -2 is much less than the expected outcome, and +2 is much more than the expected outcome.", "time_frame": "From enrollment to the end of treatment at 12 weeks" }, { "type": "secondary", "measure": "Beighton Score", "description": "The Beighton score is a screener for hypermobility and can be done quickly and simply with no testing materials needed. It consists of a 5-point scale, requires 5 maneuvers. It involves the evaluation of only a small number of joints, so any hypermobile joints not in this group may be overlooked.", "time_frame": "From enrollment to the end of treatment at 12 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 5, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07182578", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06292377", "title": "Better Understanding of Fatigue After STroke", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-03-30", "start_date": "2024-06-07", "completion_date": "2027-12-31", "primary_completion_date": "2027-12-31", "conditions_raw": [ "Stroke" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Ecg", "Transthoracic Echography", "Blood Sampling" ], "sponsor": "Brugmann University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Stroke is worldwide the second most common cause of death following heart attack and the leading cause of disability. Post-stroke fatigue (PSF) is a common complication after stroke and can be defined as 'an overwhelming exhaustion or tiredness, not related to exertion, which does not typically improve with rest'. Fatigue following stroke can be divided into early (\\< 3 months) and late (\\> 3 months) fatigue. PSF can have a considerable impact on a person's everyday activities and quality of life, participation in the rehabilitation process and levels of caregiver burden. Yet no efficient treatment exists to prevent or cure PSF because the pathophysiology remains unclear and seems to be multifaceted.\n\nAutonomic dysfunction is a common complication after stroke, associated with higher morbidity and mortality. An easy tool to measure the function of the autonomic nervous system (ANS) is heart rate variability (HRV), which is defined as the beat-to-beat variation of the heart rate (= interbeat interval (IBI)). It is the result of alterations in the sympathetic and parasympathetic nervous system. In recent systematic reviews, authors stipulate that HRV can be regarded as a prognostic factor for short- and long-term stroke outcomes. HRV can be derived from 24 hours, 5 minutes (short-term) and \\< 5 minutes (ultra-short-term) measurements by applying time-domain and frequency-domain indices.\n\nAutonomic dysfunction has been related to chronic fatigue syndrome, in addition to fatigue in multiple sclerosis, Parkinson's disease and myasthenia gravis. However, to the best of our knowledge, the relationship between autonomic dysfunction and PSF has not yet been fully investigated.\n\nFatigue is also common in cardiovascular diseases, especially in patients with heart failure (HF). HF can contribute to fatigue after stroke, independently of stroke.\n\nCardiac complications after acute ischemic stroke (AIS), such as arrhythmias, cardiac dysfunction and myocardial injury, are frequent. The so-called 'stroke-heart syndrome', a concept introduced in 2018, describes a broad spectrum of cardiac changes observed in 10-20% of patients with AIS within the first month after stroke onset, with a peak in the first 72 hours. A dysregulation in the neural-cardiac control after stroke is suspected to be the cause of the cascade leading to cardiac complications, in which autonomic dysfunction and inflammation seem to be part of the underlying mechanism.\n\nBased on previous studies and by analogy with other neurological diseases, the investigators hypothesize that autonomic dysfunction following AIS contributes to PSF and that patients presenting heart failure as a complication following AIS have an increased risk of PSF.\n\nTo confirm this hypothesis, the investigators will conduct a prospective, interventional study where patients who are hospitalized at the Stroke Unit, within 72 hours after stroke symptom onset, will be included. Evaluation will take place of (a) the relationship between autonomic dysfunction (HRV) and early and late PSF, and of (b) the relationship between cardiac dysfunction and early PSF and late PSF.\n\nThere will also be an investigation into following elements:\n\n* the association between early and late PSF and (a) certain inflammatory markers at admission (CRP, NLR), (b) stroke localization and (c) baseline imaging markers of brain frailty.\n* the role of pre-existing fatigue + pre-existing or post-stroke newly diagnosed cognitive impairment, depression and sleep disturbances on the course of PSF.", "primary_outcomes": [ { "type": "primary", "measure": "Heart rate variability (HRV)", "description": "Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Heart rate variability (HRV)", "description": "Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Heart rate variability (HRV)", "description": "Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "Transthoracic echography (TTE)", "description": "Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Transthoracic echography (TTE)", "description": "Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Transthoracic echography (TTE)", "description": "Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "Fatigue Severity Scale (FSS-7)", "description": "The 7 items Fatigue Severity Scale (FSS-7) is a method of evaluating the impact of fatigue. The FSS-7 is a questionnaire with 7 statements rated from 1 (disagree) to 7 (agree). No official cut-off has been established, but most studies adopt the approach of using the average score: an average of ≥4 suggests clinically relevant fatigue, while an average \\<4 indicates low to moderate fatigue.", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Fatigue Severity Scale (FSS-7)", "description": "The 7 items Fatigue Severity Scale (FSS-7) is a method of evaluating the impact of fatigue. The FSS-7 is a questionnaire with 7 statements rated from 1 (disagree) to 7 (agree). No official cut-off has been established, but most studies adopt the approach of using the average score: an average of ≥4 suggests clinically relevant fatigue, while an average \\<4 indicates low to moderate fatigue.", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "N-terminal pro-brain natriuretic peptide (NT-proBNP)", "description": "NT-proBNP blood levels", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "N-terminal pro-brain natriuretic peptide (NT-proBNP)", "description": "NT-proBNP blood levels", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "N-terminal pro-brain natriuretic peptide (NT-proBNP)", "description": "NT-proBNP blood levels", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "cardiac troponin (cTnT)", "description": "cardiac troponin blood levels", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Non-Invasive Blood Pressure (NIBP)", "description": "Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Non-Invasive Blood Pressure (NIBP)", "description": "Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Non-Invasive Blood Pressure (NIBP)", "description": "Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "Baroreflex Sensitivity (BRS)", "description": "Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Baroreflex Sensitivity (BRS)", "description": "Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Baroreflex Sensitivity (BRS)", "description": "Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.", "time_frame": "12 months after baseline" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Blood CRP level", "description": "C-reactive protein (CRP) level in the blood (inflammatory marker)", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Blood neutrophil-to-lymphocyte ratio (NLR)", "description": "The neutrophil-to-lymphocyte ratio (NLR), calculated by dividing the neutrophil count by the lymphocyte count, is an inflammatory marker.", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Stroke localization in the brain", "description": "Manual segmentation of the acute ischemic lesion will be performed on the MRI of the brain", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Fazekas scale", "description": "The Fazekas scale is a widely used method to visually rate hyperintense white matter signal abnormalities in magnetic resonance imaging (MRI) data. It ranges from 0 (no lesions) to 3.", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Global cortical atrophy scale", "description": "Visual rating of cerebral atrophy on MRI images. Ranges from 0 (no lesions) to 39.", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)", "description": "The 26-item IQCODE questionnaire is completed by an informant to assess changes in cognitive function over the past 10 years in elderly individuals. Each item is rated on a 5-point scale from 1 (much improved) to 5 (much worse). The total score is calculated as the mean of all items, giving a range of 1-5. A mean score of ≥3.44 indicates significant cognitive decline.", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Presence for pre-existing fatigue (yes/no)", "description": "Questionnaire (did you experience fatigue before you had your stroke' (yes/no))", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Duration of pre-existing fatigue", "description": "Questionnaire ('how long did you experience fatigue' (\\< 1 week, \\< 3 months, 3-6 months and \\> 6 months)", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a 9-item questionnaire assessing the frequency of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), giving a total score range of 0-27. Total scores can be interpreted as follows:\n\n0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a 9-item questionnaire assessing the frequency of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), giving a total score range of 0-27. Total scores can be interpreted as follows:\n\n0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a 9-item questionnaire assessing the frequency of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), giving a total score range of 0-27. Total scores can be interpreted as follows:\n\n0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression", "time_frame": "12 months after baseline" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA) questionnaire", "description": "Questionnaire. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA) score", "description": "Questionnaire.MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.", "time_frame": "12 months after baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Insomnia will be assessed by using the Insomnia Severity Index (ISI). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Insomnia will be assessed by using the Insomnia Severity Index (ISI). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Insomnia will be assessed by using the Insomnia Severity Index (ISI). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "12 months after baseline" }, { "type": "secondary", "measure": "Complete blood count abnormalities: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Renal insufficiency: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Electrolyte imbalance: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Abnormal liver enzymes: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Dyslipidemia: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Diabetes: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Thyroid disorder: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Iron deficiency: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Epworth Sleepiness Scale (ESS)", "description": "Description and scoring: the ESS is a questionnaire consisting of 8 daily-life situations in which the patient rates their likelihood of falling asleep on a scale from 0 (would never doze) to 3 (high chance of dozing).\n\nTotal score = sum of the 8 items → possible range 0 to 24.\n\nCommon interpretation:\n\n0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Epworth Sleepiness Scale (ESS)", "description": "Description and scoring: the ESS is a questionnaire consisting of 8 daily-life situations in which the patient rates their likelihood of falling asleep on a scale from 0 (would never doze) to 3 (high chance of dozing).\n\nTotal score = sum of the 8 items → possible range 0 to 24.\n\nCommon interpretation:\n\n0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Epworth Sleepiness Scale (ESS)", "description": "Description and scoring: the ESS is a questionnaire consisting of 8 daily-life situations in which the patient rates their likelihood of falling asleep on a scale from 0 (would never doze) to 3 (high chance of dozing).\n\nTotal score = sum of the 8 items → possible range 0 to 24.\n\nCommon interpretation:\n\n0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)", "time_frame": "12 months after baseline" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder scale (GAD-7)", "description": "Description and scoring: the GAD-7 is a 7-item questionnaire assessing symptoms of generalized anxiety over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day).\n\nTotal score: sum of all 7 items → possible range 0-21.\n\nCommon interpretation:\n\n0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder scale (GAD-7)", "description": "Description and scoring: the GAD-7 is a 7-item questionnaire assessing symptoms of generalized anxiety over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day).\n\nTotal score: sum of all 7 items → possible range 0-21.\n\nCommon interpretation:\n\n0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder scale (GAD-7)", "description": "Description and scoring: the GAD-7 is a 7-item questionnaire assessing symptoms of generalized anxiety over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day).\n\nTotal score: sum of all 7 items → possible range 0-21.\n\nCommon interpretation:\n\n0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety", "time_frame": "12 months after baseline" } ], "outcome_measures": [ { "type": "primary", "measure": "Heart rate variability (HRV)", "description": "Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Heart rate variability (HRV)", "description": "Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Heart rate variability (HRV)", "description": "Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "Transthoracic echography (TTE)", "description": "Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Transthoracic echography (TTE)", "description": "Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Transthoracic echography (TTE)", "description": "Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "Fatigue Severity Scale (FSS-7)", "description": "The 7 items Fatigue Severity Scale (FSS-7) is a method of evaluating the impact of fatigue. The FSS-7 is a questionnaire with 7 statements rated from 1 (disagree) to 7 (agree). No official cut-off has been established, but most studies adopt the approach of using the average score: an average of ≥4 suggests clinically relevant fatigue, while an average \\<4 indicates low to moderate fatigue.", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Fatigue Severity Scale (FSS-7)", "description": "The 7 items Fatigue Severity Scale (FSS-7) is a method of evaluating the impact of fatigue. The FSS-7 is a questionnaire with 7 statements rated from 1 (disagree) to 7 (agree). No official cut-off has been established, but most studies adopt the approach of using the average score: an average of ≥4 suggests clinically relevant fatigue, while an average \\<4 indicates low to moderate fatigue.", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "N-terminal pro-brain natriuretic peptide (NT-proBNP)", "description": "NT-proBNP blood levels", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "N-terminal pro-brain natriuretic peptide (NT-proBNP)", "description": "NT-proBNP blood levels", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "N-terminal pro-brain natriuretic peptide (NT-proBNP)", "description": "NT-proBNP blood levels", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "cardiac troponin (cTnT)", "description": "cardiac troponin blood levels", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Non-Invasive Blood Pressure (NIBP)", "description": "Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Non-Invasive Blood Pressure (NIBP)", "description": "Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Non-Invasive Blood Pressure (NIBP)", "description": "Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.", "time_frame": "12 months after baseline" }, { "type": "primary", "measure": "Baroreflex Sensitivity (BRS)", "description": "Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.", "time_frame": "Baseline (hospital admission)" }, { "type": "primary", "measure": "Baroreflex Sensitivity (BRS)", "description": "Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.", "time_frame": "3 months after baseline" }, { "type": "primary", "measure": "Baroreflex Sensitivity (BRS)", "description": "Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.", "time_frame": "12 months after baseline" }, { "type": "secondary", "measure": "Blood CRP level", "description": "C-reactive protein (CRP) level in the blood (inflammatory marker)", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Blood neutrophil-to-lymphocyte ratio (NLR)", "description": "The neutrophil-to-lymphocyte ratio (NLR), calculated by dividing the neutrophil count by the lymphocyte count, is an inflammatory marker.", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Stroke localization in the brain", "description": "Manual segmentation of the acute ischemic lesion will be performed on the MRI of the brain", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Fazekas scale", "description": "The Fazekas scale is a widely used method to visually rate hyperintense white matter signal abnormalities in magnetic resonance imaging (MRI) data. It ranges from 0 (no lesions) to 3.", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Global cortical atrophy scale", "description": "Visual rating of cerebral atrophy on MRI images. Ranges from 0 (no lesions) to 39.", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)", "description": "The 26-item IQCODE questionnaire is completed by an informant to assess changes in cognitive function over the past 10 years in elderly individuals. Each item is rated on a 5-point scale from 1 (much improved) to 5 (much worse). The total score is calculated as the mean of all items, giving a range of 1-5. A mean score of ≥3.44 indicates significant cognitive decline.", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Presence for pre-existing fatigue (yes/no)", "description": "Questionnaire (did you experience fatigue before you had your stroke' (yes/no))", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Duration of pre-existing fatigue", "description": "Questionnaire ('how long did you experience fatigue' (\\< 1 week, \\< 3 months, 3-6 months and \\> 6 months)", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a 9-item questionnaire assessing the frequency of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), giving a total score range of 0-27. Total scores can be interpreted as follows:\n\n0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a 9-item questionnaire assessing the frequency of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), giving a total score range of 0-27. Total scores can be interpreted as follows:\n\n0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire-9 (PHQ-9)", "description": "The PHQ-9 is a 9-item questionnaire assessing the frequency of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), giving a total score range of 0-27. Total scores can be interpreted as follows:\n\n0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression", "time_frame": "12 months after baseline" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA) questionnaire", "description": "Questionnaire. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment (MoCA) score", "description": "Questionnaire.MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.", "time_frame": "12 months after baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Insomnia will be assessed by using the Insomnia Severity Index (ISI). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Insomnia will be assessed by using the Insomnia Severity Index (ISI). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "Insomnia will be assessed by using the Insomnia Severity Index (ISI). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).", "time_frame": "12 months after baseline" }, { "type": "secondary", "measure": "Complete blood count abnormalities: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Renal insufficiency: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Electrolyte imbalance: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Abnormal liver enzymes: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Dyslipidemia: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Diabetes: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Thyroid disorder: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Iron deficiency: yes/no", "description": "Clinical decision based on the analysis of the blood sample results", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Epworth Sleepiness Scale (ESS)", "description": "Description and scoring: the ESS is a questionnaire consisting of 8 daily-life situations in which the patient rates their likelihood of falling asleep on a scale from 0 (would never doze) to 3 (high chance of dozing).\n\nTotal score = sum of the 8 items → possible range 0 to 24.\n\nCommon interpretation:\n\n0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Epworth Sleepiness Scale (ESS)", "description": "Description and scoring: the ESS is a questionnaire consisting of 8 daily-life situations in which the patient rates their likelihood of falling asleep on a scale from 0 (would never doze) to 3 (high chance of dozing).\n\nTotal score = sum of the 8 items → possible range 0 to 24.\n\nCommon interpretation:\n\n0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Epworth Sleepiness Scale (ESS)", "description": "Description and scoring: the ESS is a questionnaire consisting of 8 daily-life situations in which the patient rates their likelihood of falling asleep on a scale from 0 (would never doze) to 3 (high chance of dozing).\n\nTotal score = sum of the 8 items → possible range 0 to 24.\n\nCommon interpretation:\n\n0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)", "time_frame": "12 months after baseline" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder scale (GAD-7)", "description": "Description and scoring: the GAD-7 is a 7-item questionnaire assessing symptoms of generalized anxiety over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day).\n\nTotal score: sum of all 7 items → possible range 0-21.\n\nCommon interpretation:\n\n0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety", "time_frame": "Baseline (hospital admission)" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder scale (GAD-7)", "description": "Description and scoring: the GAD-7 is a 7-item questionnaire assessing symptoms of generalized anxiety over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day).\n\nTotal score: sum of all 7 items → possible range 0-21.\n\nCommon interpretation:\n\n0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety", "time_frame": "3 months after baseline" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder scale (GAD-7)", "description": "Description and scoring: the GAD-7 is a 7-item questionnaire assessing symptoms of generalized anxiety over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day).\n\nTotal score: sum of all 7 items → possible range 0-21.\n\nCommon interpretation:\n\n0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety", "time_frame": "12 months after baseline" } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 250, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06292377", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04050410", "title": "Autonomic Determinants of POTS - Pilot1", "status": "ACTIVE_NOT_RECRUITING", "phase": "EARLY_PHASE1", "last_updated": "2026-03-27", "start_date": "2019-08-27", "completion_date": "2026-12-31", "primary_completion_date": "2025-12-31", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Moxonidine" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly otherwise healthy young women. It is the cause of significant disability and an impairment in quality of life. These patients have high heart rate and symptoms during standing. Many of these patients are disabled and have a poor quality of life. The sympathetic nerves are part of the nervous system that helps to maintain normal blood pressures and heart rates during activities of daily life. The purpose of this study is to determine the importance of sympathetic activation as a cause of orthostatic symptoms. The investigators will assess the effects of a blood pressure medication (Moxonidine) on the symptoms during standing. Moxonidine lowers sympathetic activity. The investigators believe patients with high resting sympathetic activity might benefit from Moxonidine. It might reduce high heart rate and improve symptoms during standing. This study should help clinicians and the growing population of patients with POTS gain a better understanding of this disorder and find more personalized treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Orthostatic Symptom Burden [delta (delta VOSS)]", "description": "VOSS is a validated questionnaire that consists of 9 items: mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. Each item is scored on a 0 to 10 scale (with 0 reflecting absence of symptoms), and the change of the total scores (range: 0-90) from supine to upright postures (delta VOSS) will be used as a measure of orthostatic symptom burden. The primary outcome measure will be the difference in orthostatic symptom burden \\[delta (delta VOSS)\\] following placebo vs. moxonidine administration.", "time_frame": "after 30 min supine to after 15 min upright (delta VOSS), 2-3 hours after placebo or moxonidine intake [delta (delta VOSS)]." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Orthostatic Change in Heart Rate [delta (delta HR)]", "description": "Difference in heart rate change from supine to upright postures (delta HR) following placebo vs. moxonidine administration.", "time_frame": "after 30 min supine to after 15 min upright (delta HR), 2-3 hours after placebo or moxonidine intake [delta (delta HR)]." } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Orthostatic Symptom Burden [delta (delta VOSS)]", "description": "VOSS is a validated questionnaire that consists of 9 items: mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. Each item is scored on a 0 to 10 scale (with 0 reflecting absence of symptoms), and the change of the total scores (range: 0-90) from supine to upright postures (delta VOSS) will be used as a measure of orthostatic symptom burden. The primary outcome measure will be the difference in orthostatic symptom burden \\[delta (delta VOSS)\\] following placebo vs. moxonidine administration.", "time_frame": "after 30 min supine to after 15 min upright (delta VOSS), 2-3 hours after placebo or moxonidine intake [delta (delta VOSS)]." }, { "type": "secondary", "measure": "Change in Orthostatic Change in Heart Rate [delta (delta HR)]", "description": "Difference in heart rate change from supine to upright postures (delta HR) following placebo vs. moxonidine administration.", "time_frame": "after 30 min supine to after 15 min upright (delta HR), 2-3 hours after placebo or moxonidine intake [delta (delta HR)]." } ], "relevance_tags": [ "Neurological / Autonomic", "EARLY_Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 48, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04050410", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04140721", "title": "Autonomic Determinants of POTS - Pilot 2", "status": "ACTIVE_NOT_RECRUITING", "phase": "EARLY_PHASE1", "last_updated": "2026-03-27", "start_date": "2021-08-31", "completion_date": "2026-12-31", "primary_completion_date": "2025-12-31", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Moxonidine Pill" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly otherwise healthy young women. These patients have high heart rate and disabling symptoms during standing. Quality of life may be poor. The sympathetic nerves in the autonomic nervous system help to maintain normal blood pressures and heart rates during activities of daily life.\n\nThe purpose of this study is to determine the importance of sympathetic activation as a cause of orthostatic symptoms. The investigators will assess the effects of a blood pressure medication (Moxonidine) on the symptoms during standing. Moxonidine lowers sympathetic activity. The investigators believe patients with high resting sympathetic activity might benefit from Moxonidine. It might reduce high heart rate and improve symptoms during standing. This study should help clinicians and the growing population of patients with POTS gain a better understanding of this disorder and find more personalized treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Orthostatic Symptom Burden [delta (delta VOSS)]", "description": "VOSS is a validated questionnaire that consists of 9 items: mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. Each item is scored on a 0 to 10 scale (with 0 reflecting absence of symptoms), and the change of the total scores (range: 0-90) from supine to upright postures (delta VOSS) will be used as a measure of orthostatic symptom burden. The primary outcome measure will be the difference in orthostatic symptom burden \\[delta (delta VOSS)\\] following 4 weeks of placebo vs. moxonidine treatment.", "time_frame": "after 30 min supine to after 15 min of 60 degrees upright tilt (delta VOSS), 2-3 hours after a dose of the treatment assigned for the previous period." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Orthostatic Change in Heart Rate [delta (delta HR)]", "description": "Difference in heart rate change from supine to upright postures (delta HR) following 4 weeks of placebo vs. moxonidine treatment \\[delta (delta HR)\\].", "time_frame": "after 30 min supine to after 15 min of 60 degrees upright tilt (delta HR), 2-3 hours after a dose of the treatment assigned for the previous period." } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Orthostatic Symptom Burden [delta (delta VOSS)]", "description": "VOSS is a validated questionnaire that consists of 9 items: mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. Each item is scored on a 0 to 10 scale (with 0 reflecting absence of symptoms), and the change of the total scores (range: 0-90) from supine to upright postures (delta VOSS) will be used as a measure of orthostatic symptom burden. The primary outcome measure will be the difference in orthostatic symptom burden \\[delta (delta VOSS)\\] following 4 weeks of placebo vs. moxonidine treatment.", "time_frame": "after 30 min supine to after 15 min of 60 degrees upright tilt (delta VOSS), 2-3 hours after a dose of the treatment assigned for the previous period." }, { "type": "secondary", "measure": "Change in Orthostatic Change in Heart Rate [delta (delta HR)]", "description": "Difference in heart rate change from supine to upright postures (delta HR) following 4 weeks of placebo vs. moxonidine treatment \\[delta (delta HR)\\].", "time_frame": "after 30 min supine to after 15 min of 60 degrees upright tilt (delta HR), 2-3 hours after a dose of the treatment assigned for the previous period." } ], "relevance_tags": [ "Neurological / Autonomic", "EARLY_Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 48, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04140721", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02281097", "title": "Transdermal Vagal Stimulation for POTS", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-03-27", "start_date": "2013-06", "completion_date": "2026-12-31", "primary_completion_date": "2017-04", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Stimulation" ], "sponsor": "Vanderbilt University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Some patients experience high heart rates and symptoms of light-headedness, fatigue, headache during standing despite well maintained blood pressure.\n\nThese patient are disabled and can't be in upright position for a longer time. The purpose of this study is to test whether electrical stimulation of a nerve through a skin of the ear may improve heart rate response and reduce disabling symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Heart Rate (average of 1 minute)", "description": "Upright heart rate and heart rate change from supine measured during graded tilt with 15 degrees increments each 5 minutes till 30 min of 75 degrees or abort.", "time_frame": "[-5,0,5,10,15,20,..,50 min] relative time from tilt" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Orthostatic Symptoms (Subjective analog symptoms scale (0-100)", "description": "Subjective analog symptoms scale (0-100)", "time_frame": "[-5,0,5,10,15,20,..,50 min] relative time from tilt" }, { "type": "secondary", "measure": "Orthostatic Tolerance (Maximal tolerated time in upright position)", "description": "Maximal tolerated time in upright position", "time_frame": "[0-50 min] relative time from tilt" } ], "outcome_measures": [ { "type": "primary", "measure": "Heart Rate (average of 1 minute)", "description": "Upright heart rate and heart rate change from supine measured during graded tilt with 15 degrees increments each 5 minutes till 30 min of 75 degrees or abort.", "time_frame": "[-5,0,5,10,15,20,..,50 min] relative time from tilt" }, { "type": "secondary", "measure": "Orthostatic Symptoms (Subjective analog symptoms scale (0-100)", "description": "Subjective analog symptoms scale (0-100)", "time_frame": "[-5,0,5,10,15,20,..,50 min] relative time from tilt" }, { "type": "secondary", "measure": "Orthostatic Tolerance (Maximal tolerated time in upright position)", "description": "Maximal tolerated time in upright position", "time_frame": "[0-50 min] relative time from tilt" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 18, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02281097", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07478172", "title": "Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-03-17", "start_date": "2026-03-10", "completion_date": "2031-01-07", "primary_completion_date": "2030-12-31", "conditions_raw": [ "Neuromuscular Diseases (NMD)", "Amyotrophic Lateral Sclerosis", "Myasthenia Gravis", "Lambert-eaton Myasthenic Syndrome", "Primary Lateral Sclerosis", "Spinal Muscular Atrophy", "Charcot Marie Tooth Disease (CMT)", "Fascioscapulohumeral Muscular Dystrophy", "Inclusion Body Myositis", "Mitochondrial Myopathy", "Nemaline Myopathy", "Centronuclear Myopathy", "Postpolio Syndrome", "Pompe Disease (Late-onset)", "Chronic Inflammatory Demyelinating Polyneuropathy", "Hereditary Spastic Paraplegia", "Postural Orthostatic Tachycardia Syndrome (POTS)", "Progressive Muscular Atrophy" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Whole-Body Electrical Muscle Stimulation Exercise" ], "sponsor": "University of Missouri-Columbia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This single-arm pilot study evaluates the effects of whole-body electrical muscle stimulation (WB-EMS) exercise on neuromuscular and physical function in adults with neuromuscular disease (NMD). Due to motor unit impairments, NMD patients often cannot tolerate traditional exercise. WB-EMS bypasses voluntary activation limits by directly stimulating muscle contractions. Up to 50 adults with conditions like ALS, SMA, and MG will undergo 20-minute supervised WB-EMS sessions (1-2 times weekly for 4-8 weeks) using the Katalyst system. Outcomes include neural excitability (TMS), motor unit behavior (EMG, NCS), functional tests (walk, balance, strength), and patient-reported fatigue, pain, and quality of life. Strict safety monitoring and exclusion criteria are in place. This study will provide preliminary data on WB-EMS as a potential exercise modality for NMD.", "primary_outcomes": [ { "type": "primary", "measure": "Mean change from baseline in motor unit firing rates using decomposition electromyography (dEMG)", "description": "Decomposition electromyography (dEMG) is a measurement of motor unit activity; a surface electrode will be placed over the vastus lateralis in the thigh and participants will be asked to activate that muscle. Participants will take standardized positions, sitting with knee at a 75-degree angle. Participants will perform three 5-second maximal voluntary isometric contractions (MVC); this will be followed by 2 contractions each at 35%, 50% and 70% MVC using a trapezoidal force matching protocol.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "primary", "measure": "Mean change from baseline in motor evoked potentials using transcranial magnetic stimulation (TMS)", "description": "Motor evoked potentials are a measure of neural excitability. They are generated by placing a magnetic coil over the skull. The output will be measured from surface electrodes over the vastus lateralis muscle in the quadriceps. We will be assessing the corticospinal pathway. Participants will take standardized positions, sitting with knee at a 75-degree angle. Participants will perform six contractions at 10% MVC, and four contractions each at 30%, 50% and 70% MVC. Magnetic pulses will be applied during each contraction.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "primary", "measure": "Mean change from baseline in compound muscle action potential ampliutde using standard nerve conduction study technique", "description": "A small amount of electrical stimulation (enough to ensure that the largest possible response is elicited) will be applied to the skin surface over the femoral nerve at the anterior hip. Surface recording electrodes will be placed over the vastus lateralis in the thigh to read out the muscle's response to the nerve stimulation; this is the compound muscle action potential. It is a measure of motor unit health.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "primary", "measure": "Mean change from baseline in timed functional tests", "description": "To capture changes in time to perform common functional movements relevant to maintenance of independence for adults with neuromuscular disease, the investigators will collect data on 10-meter walk/run test, timed up and go test (rise from a chair, walk 3 meters, turn around, and return to sitting in chair at comfortable and fast speeds), 5-time sit-to-stand test (perform 5 times consecutively sitting to standing to sitting again), and 4-stair ascent and descent test (climb 4 stairs and descend 4 stairs with and without handrails).", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Mean change from baseline in perceived fatigue on a person's life", "description": "The Fatigue Severity Scale (FSS) is a patient-reported outcome that assesses the impact of perceived fatigue on a person's life over the prior 7-day period. It consists of 9 statements rated on a 1-7 scale with 1 indicating \"strongly disagree\" with the statement and 7 indicating \"strongly agree\". The max score is 63 where higher values indicate more impact of perceived fatigue", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "secondary", "measure": "Mean change from baseline in severity of pain and impact of pain on daily life", "description": "The Brief Pain Inventory (BPI) is a patient-reported outcome that assesses the severity of pain and impact of pain on daily life over the prior 7-day period. It consists of 9 statements rated on a 1-10 scale with 1 indicating \"no pain\" or \"no interference\"and 10 indicating \"pain as bad as you can imagine\" or \"completely interferes\".", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "secondary", "measure": "Mean change from baseline in the impact of the participant's neuromuscular condition", "description": "The Individualized Neuromuscular Quality of Life Questionnaire (INQoL) is a patient-reported outcome that assesses how the participant's neuromuscular condition affects them. There are questions about symptoms, physical ability, independence, relationships, emotional state, body image, and treatments. It consists of 45 items across 10 sections using a scale of 0-6 or 1-7. Raw scores from items in each section are summed, transformed, and converted into a 0-100 score where higher scores indicate worse quality of life.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "secondary", "measure": "Mean change from baseline on the broad jump test", "description": "The broad jump test is a measure of lower extremity power. Participants will perform a two-legged jump for distance. Three trials are performed and averaged.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "secondary", "measure": "Mean change from baseline in the multidirectional lunge test", "description": "The multidirectional lunge test is a measure of dynamic balance. Participants will stand in the center of an asterisk star shape taped on the floor. Participants will lunge in each of 8 directions and return to two feet in the center of the star with a single push. The distance lunged in each direction is recorded. Three trials are performed on each foot and the data averaged.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." } ], "outcome_measures": [ { "type": "primary", "measure": "Mean change from baseline in motor unit firing rates using decomposition electromyography (dEMG)", "description": "Decomposition electromyography (dEMG) is a measurement of motor unit activity; a surface electrode will be placed over the vastus lateralis in the thigh and participants will be asked to activate that muscle. Participants will take standardized positions, sitting with knee at a 75-degree angle. Participants will perform three 5-second maximal voluntary isometric contractions (MVC); this will be followed by 2 contractions each at 35%, 50% and 70% MVC using a trapezoidal force matching protocol.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "primary", "measure": "Mean change from baseline in motor evoked potentials using transcranial magnetic stimulation (TMS)", "description": "Motor evoked potentials are a measure of neural excitability. They are generated by placing a magnetic coil over the skull. The output will be measured from surface electrodes over the vastus lateralis muscle in the quadriceps. We will be assessing the corticospinal pathway. Participants will take standardized positions, sitting with knee at a 75-degree angle. Participants will perform six contractions at 10% MVC, and four contractions each at 30%, 50% and 70% MVC. Magnetic pulses will be applied during each contraction.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "primary", "measure": "Mean change from baseline in compound muscle action potential ampliutde using standard nerve conduction study technique", "description": "A small amount of electrical stimulation (enough to ensure that the largest possible response is elicited) will be applied to the skin surface over the femoral nerve at the anterior hip. Surface recording electrodes will be placed over the vastus lateralis in the thigh to read out the muscle's response to the nerve stimulation; this is the compound muscle action potential. It is a measure of motor unit health.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "primary", "measure": "Mean change from baseline in timed functional tests", "description": "To capture changes in time to perform common functional movements relevant to maintenance of independence for adults with neuromuscular disease, the investigators will collect data on 10-meter walk/run test, timed up and go test (rise from a chair, walk 3 meters, turn around, and return to sitting in chair at comfortable and fast speeds), 5-time sit-to-stand test (perform 5 times consecutively sitting to standing to sitting again), and 4-stair ascent and descent test (climb 4 stairs and descend 4 stairs with and without handrails).", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "secondary", "measure": "Mean change from baseline in perceived fatigue on a person's life", "description": "The Fatigue Severity Scale (FSS) is a patient-reported outcome that assesses the impact of perceived fatigue on a person's life over the prior 7-day period. It consists of 9 statements rated on a 1-7 scale with 1 indicating \"strongly disagree\" with the statement and 7 indicating \"strongly agree\". The max score is 63 where higher values indicate more impact of perceived fatigue", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "secondary", "measure": "Mean change from baseline in severity of pain and impact of pain on daily life", "description": "The Brief Pain Inventory (BPI) is a patient-reported outcome that assesses the severity of pain and impact of pain on daily life over the prior 7-day period. It consists of 9 statements rated on a 1-10 scale with 1 indicating \"no pain\" or \"no interference\"and 10 indicating \"pain as bad as you can imagine\" or \"completely interferes\".", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "secondary", "measure": "Mean change from baseline in the impact of the participant's neuromuscular condition", "description": "The Individualized Neuromuscular Quality of Life Questionnaire (INQoL) is a patient-reported outcome that assesses how the participant's neuromuscular condition affects them. There are questions about symptoms, physical ability, independence, relationships, emotional state, body image, and treatments. It consists of 45 items across 10 sections using a scale of 0-6 or 1-7. Raw scores from items in each section are summed, transformed, and converted into a 0-100 score where higher scores indicate worse quality of life.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "secondary", "measure": "Mean change from baseline on the broad jump test", "description": "The broad jump test is a measure of lower extremity power. Participants will perform a two-legged jump for distance. Three trials are performed and averaged.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." }, { "type": "secondary", "measure": "Mean change from baseline in the multidirectional lunge test", "description": "The multidirectional lunge test is a measure of dynamic balance. Participants will stand in the center of an asterisk star shape taped on the floor. Participants will lunge in each of 8 directions and return to two feet in the center of the star with a single push. The distance lunged in each direction is recorded. Three trials are performed on each foot and the data averaged.", "time_frame": "Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11)." } ], "relevance_tags": [ "Metabolic", "Mitochondrial", "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07478172", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07455994", "title": "Dysautonomia in Children With Type 1 Diabetes", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-03-06", "start_date": "2025-12-22", "completion_date": "2027-05", "primary_completion_date": "2026-12", "conditions_raw": [ "Dysautonomia in Children With Type 1 Diabetes", "Healthy Volunteer" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Neurocoach® And Sudoscan®" ], "sponsor": "Centre Hospitalier Universitaire de Saint Etienne", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Some physiological factors, such as physical activity, or pathological factors, such as sepsis or diabetes, are known to modulate the overall autonomic activity and the individual's intrinsic capacity to regulate their sympathetic and parasympathetic balance. These conditions can alter the physiological autonomic balance, sometimes with positive consequences on the FC-breathing control and blood pressure adjustment, depending on the individual's position and the status of blood volume, but sometimes with deleterious effects, such as poor regulation of sinus cardiac activity and respiration rate.\n\nCardiovascular autonomic neuropathy is a major complication of type 1 diabetes. Several studies have described autonomic dysfunction in patients with type 1 diabetes, but these data are derived from cohorts of adults and adolescents or short ECG recordings at rest. Moreover, there are often confounding factors such as sedentary/physical activity, overweight, exposure to post-pubertal hormonal peaks, toxic drugs, or cardiac therapy.\n\nThese factors don't greatly influence children's autonomic physiological maturation, whereas diabetes can sometimes exist for several years. In this population, the search for cardiac dysautonomia is entirely appropriate.", "primary_outcomes": [ { "type": "primary", "measure": "HF ECG index value", "description": "HF index value (ms2/Hz) of high-frequency heart rate variability in the frequency domain", "time_frame": "During 24 hours" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Sympathetic and parasympathetic indices of heart rate variability", "description": "Secondary endpoints: Sympathetic and parasympathetic indices of heart rate variability in the linear frequency domains (Ptot, VLF, LF, LF/HF ratio), time domains (SDNN, pNN30, pNN50, rMSSD), and nonlinear domains (Approximate entropy, SD1, SD2, chaos).\n\nQuantifying the Mean ESC value (µS) of the hands and feet.", "time_frame": "During 24 hours" } ], "outcome_measures": [ { "type": "primary", "measure": "HF ECG index value", "description": "HF index value (ms2/Hz) of high-frequency heart rate variability in the frequency domain", "time_frame": "During 24 hours" }, { "type": "secondary", "measure": "Sympathetic and parasympathetic indices of heart rate variability", "description": "Secondary endpoints: Sympathetic and parasympathetic indices of heart rate variability in the linear frequency domains (Ptot, VLF, LF, LF/HF ratio), time domains (SDNN, pNN30, pNN50, rMSSD), and nonlinear domains (Approximate entropy, SD1, SD2, chaos).\n\nQuantifying the Mean ESC value (µS) of the hands and feet.", "time_frame": "During 24 hours" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07455994", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00409435", "title": "A Study of Pyridostigmine in Postural Tachycardia Syndrome", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-03-05", "start_date": "2006-10", "completion_date": "2027-02", "primary_completion_date": "2027-02", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Pyridostigmine" ], "sponsor": "Mayo Clinic", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a 3-day study comparing pyridostigmine versus placebo in the treatment of postural tachycardia syndrome (POTS). The researchers expect pyridostigmine to improve tachycardia and stabilize blood pressure.", "primary_outcomes": [ { "type": "primary", "measure": "Change in orthostatic symptoms using Composite Autonomic Symptom Scale (COMPASS) change", "description": "", "time_frame": "3 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Heart rate response to head-up tilt", "description": "", "time_frame": "3 days" }, { "type": "secondary", "measure": "Plasma norepinephrine change", "description": "", "time_frame": "3 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in orthostatic symptoms using Composite Autonomic Symptom Scale (COMPASS) change", "description": "", "time_frame": "3 days" }, { "type": "secondary", "measure": "Heart rate response to head-up tilt", "description": "", "time_frame": "3 days" }, { "type": "secondary", "measure": "Plasma norepinephrine change", "description": "", "time_frame": "3 days" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT00409435", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06128356", "title": "Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2026-03-04", "start_date": "2024-06-01", "completion_date": "2028-12", "primary_completion_date": "2028-09", "conditions_raw": [ "Familial Dysautonomia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Dexmedetomidine Sublingual" ], "sponsor": "NYU Langone Health", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a pilot open-label study to evaluate the feasibility of conducting a clinical trial using sublingual dexmedetomidine sublingual film to treat hyperadrenergic autonomic crises in patients with Familial Dysautonomia at home. The primary aims are to examine the feasibility of performing a clinical trial using dexmedetomidine at home to terminate autonomic crisis, and refine the interventions and assessments used to evaluate autonomic crisis termination.", "primary_outcomes": [ { "type": "primary", "measure": "Number of subjects screened per month", "description": "", "time_frame": "Month 6" }, { "type": "primary", "measure": "Number of subjects enrolled per month", "description": "", "time_frame": "Month 6" }, { "type": "primary", "measure": "Number of completed crises treated at home within the protocol", "description": "", "time_frame": "Month 6" }, { "type": "primary", "measure": "Number of subjects that underwent an autonomic crisis per month", "description": "", "time_frame": "Month 6" }, { "type": "primary", "measure": "Average duration of the study from visit 1 to the last visit of the last patient", "description": "", "time_frame": "From enrollment to end of treatment (up to 6 months)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Length of time from autonomic crisis onset to the initiation of the video recording", "description": "", "time_frame": "Up to 2 hours" }, { "type": "secondary", "measure": "Length of time from autonomic crisis onset to administration of the medication", "description": "", "time_frame": "Up to 2 hours" }, { "type": "secondary", "measure": "Length of time from autonomic crisis onset to crisis resolution", "description": "", "time_frame": "Up to 24 hours" }, { "type": "secondary", "measure": "Length of time it took to complete assessments from start of autonomic crisis", "description": "", "time_frame": "Up to 24 hours" }, { "type": "secondary", "measure": "Percentage of completion of all rating scales", "description": "The scales required to be completed is the Autonomic Crisis Symptom Assessment Scale (ACSAS), the study safety assessments and the Richmond Agitation-Sedation Scale.", "time_frame": "Month 6" }, { "type": "secondary", "measure": "Change in blood pressure", "description": "", "time_frame": "Pre-dose, up to 2 hours post-dose" }, { "type": "secondary", "measure": "Change in heart rate", "description": "", "time_frame": "Pre-dose, up to 2 hours post-dose" }, { "type": "secondary", "measure": "Change in number of vomiting episodes", "description": "", "time_frame": "Pre-dose, up to 2 hours post-dose" }, { "type": "secondary", "measure": "Change in number of retching episodes", "description": "", "time_frame": "Pre-dose, up to 2 hours post-dose" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of subjects screened per month", "description": "", "time_frame": "Month 6" }, { "type": "primary", "measure": "Number of subjects enrolled per month", "description": "", "time_frame": "Month 6" }, { "type": "primary", "measure": "Number of completed crises treated at home within the protocol", "description": "", "time_frame": "Month 6" }, { "type": "primary", "measure": "Number of subjects that underwent an autonomic crisis per month", "description": "", "time_frame": "Month 6" }, { "type": "primary", "measure": "Average duration of the study from visit 1 to the last visit of the last patient", "description": "", "time_frame": "From enrollment to end of treatment (up to 6 months)" }, { "type": "secondary", "measure": "Length of time from autonomic crisis onset to the initiation of the video recording", "description": "", "time_frame": "Up to 2 hours" }, { "type": "secondary", "measure": "Length of time from autonomic crisis onset to administration of the medication", "description": "", "time_frame": "Up to 2 hours" }, { "type": "secondary", "measure": "Length of time from autonomic crisis onset to crisis resolution", "description": "", "time_frame": "Up to 24 hours" }, { "type": "secondary", "measure": "Length of time it took to complete assessments from start of autonomic crisis", "description": "", "time_frame": "Up to 24 hours" }, { "type": "secondary", "measure": "Percentage of completion of all rating scales", "description": "The scales required to be completed is the Autonomic Crisis Symptom Assessment Scale (ACSAS), the study safety assessments and the Richmond Agitation-Sedation Scale.", "time_frame": "Month 6" }, { "type": "secondary", "measure": "Change in blood pressure", "description": "", "time_frame": "Pre-dose, up to 2 hours post-dose" }, { "type": "secondary", "measure": "Change in heart rate", "description": "", "time_frame": "Pre-dose, up to 2 hours post-dose" }, { "type": "secondary", "measure": "Change in number of vomiting episodes", "description": "", "time_frame": "Pre-dose, up to 2 hours post-dose" }, { "type": "secondary", "measure": "Change in number of retching episodes", "description": "", "time_frame": "Pre-dose, up to 2 hours post-dose" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 5, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06128356", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06073886", "title": "Personalized Brain Stimulation to Treat Chronic Concussive Symptoms", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-02-24", "start_date": "2024-03-06", "completion_date": "2027-01", "primary_completion_date": "2026-07", "conditions_raw": [ "Post-Concussion Syndrome", "Concussion, Brain", "Mild Traumatic Brain Injury", "Head Injury", "Headache", "Dizziness", "Cognitive Symptom", "Dysautonomia", "Anxiety", "Irritability; Syndrome", "Depression", "Post-traumatic Stress Disorder" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Active Ctbs", "Imaginal Exposure" ], "sponsor": "University of California, Los Angeles", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS).\n\nThe investigators intend to answer the questions:\n\n1. Does personalized TMS improve brain connectivity after concussion?\n2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms?\n3. Do the improvements last up to 2 months post-treatment?\n4. Are there predictors of treatment response, or who might respond the best?\n\nParticipants will undergo 14 total visits to University of California Los Angeles (UCLA):\n\n1. One for the baseline symptom assessments and magnetic resonance imaging (MRI)\n2. Ten for TMS administration\n3. Three for post-treatment symptom assessments and MRIs\n\nParticipants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.", "primary_outcomes": [ { "type": "primary", "measure": "Central target engagement, modulation, and durability", "description": "Using resting-state functional magnetic resonance connectivity in the target frontoamygdala circuit", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "primary", "measure": "Peripheral target engagement, modulation, and durability", "description": "Using heart rate variability as measured by electrocardiogram", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "primary", "measure": "Persistent post-concussive symptoms modulation and durability", "description": "Using the Modified Rivermead Post Concussion Symptoms Questionnaire where higher scores are worse. Scores range from 0-64.", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "primary", "measure": "Fear avoidance modulation and durability", "description": "Using the Fear Avoidance Behavior Questionnaire for Traumatic Brain Injury where higher scores are worse. Scores range from 0-48.", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Nightly Sleep Score from Oura Ring", "description": "Using sleep quality metric, called Sleep Score, from the Oura Ring where higher scores are better, ranging from 0-100.", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "secondary", "measure": "Daily heart rate variability", "description": "Using heart rate variability metric from the Oura Ring", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "secondary", "measure": "Weekly avoidance behavior", "description": "Using a single item question \"I avoid activities that might make my symptoms worse\" where higher ratings are worse. Ratings range from 1-10.", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Central target engagement, modulation, and durability", "description": "Using resting-state functional magnetic resonance connectivity in the target frontoamygdala circuit", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "primary", "measure": "Peripheral target engagement, modulation, and durability", "description": "Using heart rate variability as measured by electrocardiogram", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "primary", "measure": "Persistent post-concussive symptoms modulation and durability", "description": "Using the Modified Rivermead Post Concussion Symptoms Questionnaire where higher scores are worse. Scores range from 0-64.", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "primary", "measure": "Fear avoidance modulation and durability", "description": "Using the Fear Avoidance Behavior Questionnaire for Traumatic Brain Injury where higher scores are worse. Scores range from 0-48.", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "secondary", "measure": "Nightly Sleep Score from Oura Ring", "description": "Using sleep quality metric, called Sleep Score, from the Oura Ring where higher scores are better, ranging from 0-100.", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "secondary", "measure": "Daily heart rate variability", "description": "Using heart rate variability metric from the Oura Ring", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" }, { "type": "secondary", "measure": "Weekly avoidance behavior", "description": "Using a single item question \"I avoid activities that might make my symptoms worse\" where higher ratings are worse. Ratings range from 1-10.", "time_frame": "Change from baseline across all subsequent time points until completion of the study, an average of 4 months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 75, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06073886", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06863207", "title": "Autonomic Reactivity and Personalized Neurostimulation", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-02-13", "start_date": "2025-01-24", "completion_date": "2029-06", "primary_completion_date": "2028-12", "conditions_raw": [ "Functional Gastrointestinal Disorders (FGIDs)", "Cyclic Vomiting Syndrome", "Functional Dyspepsia", "Dysautonomia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Percutaneous Electrical Nerve Field Stimulation", "Hypnotherapy" ], "sponsor": "Medical College of Wisconsin", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Disorders of gut-brain interaction (DGBI) affect up to 25% of U.S. children. Patients often suffer from disabling, multisystem comorbidities that suggest a common root (sleep disturbances, fatigue, anxiety, etc). Yet, DGBI are defined and treated based on GI symptom origin (cyclic vomiting, dyspepsia, irritable bowel) rather than underlying pathophysiology. Many patients manifest comorbidities suggesting an underlying autonomic nervous system (ANS) dysregulation (palpitations, dizziness, cognitive dysfunction). Unfortunately, due to common features of anxiety and visceral hyperreactivity and lack of obvious pathology, children with DGBI are frequently diagnosed with psychosomatic or 'benign, functional disorders' and treated with empiric antidepressants despite lack of scientific support and risks of serious side effects. Little is known about the underlying brain-gut mechanisms linking these comorbidities. A lack of targeted treatment options naturally follows the paucity of mechanistic data. A dysregulated ANS response circuit via brainstem nuclei is linked to visceral hypersensitivity. As the team's prior research has shown, ANS regulation can be non-invasively measured via several validated indices of cardiac vagal tone. Using the novel vagal efficiency (VE) metric, the investigators have demonstrated inefficient vagal regulation in cyclic vomiting syndrome and pain-related DGBI and that low VE predicts response to non-invasive, auricular percutaneous electrical nerve field stimulation (PENFS) therapy. PENFS targets brainstem vagal afferent pathways and, along with brain-gut interventions such as hypnotherapy, are the only therapies currently proven effective for pediatric DGBI. Individualizing neurostimulation based on sensory thresholds while assessing dynamic ANS reactivity offers a path towards personalized medicine using the most effective therapies to date. This proposal will test the feasibility of an ANS tracking software in assessing real-time, autonomic regulation and providing individualized neurostimulation in children with nausea/vomiting and ANS imbalance.", "primary_outcomes": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile-37", "description": "Validated quality of life instrument assessing physical, emotional, and psychosocial functioning in children across 6 domains (subscales). Scores range from 0 (minimum) to 5 (maximum). A lower score indicates improved quality of life for the Anxiety, Depression, Fatigue and Pain Interference domains/subscales. A higher scores indicates improvement in the Physical Function and Peer Relationships subscales. Scores are converted to a T-score where a score of 50 represents the mean.", "time_frame": "From enrollment to end of treatment at 6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "2. Patient Assessment of upper GastroIntestinal Symptom Severity Index", "description": "Upper gastrointestinal symptoms including symptoms of gastroparesis will be assessed via this 20-item instrument with scores ranging from 0 (minimum) to 5 (maximum). Higher scores indicate worse outcome.", "time_frame": "From enrollment to the end of treatment at 6 weeks." } ], "outcome_measures": [ { "type": "primary", "measure": "Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile-37", "description": "Validated quality of life instrument assessing physical, emotional, and psychosocial functioning in children across 6 domains (subscales). Scores range from 0 (minimum) to 5 (maximum). A lower score indicates improved quality of life for the Anxiety, Depression, Fatigue and Pain Interference domains/subscales. A higher scores indicates improvement in the Physical Function and Peer Relationships subscales. Scores are converted to a T-score where a score of 50 represents the mean.", "time_frame": "From enrollment to end of treatment at 6 weeks" }, { "type": "secondary", "measure": "2. Patient Assessment of upper GastroIntestinal Symptom Severity Index", "description": "Upper gastrointestinal symptoms including symptoms of gastroparesis will be assessed via this 20-item instrument with scores ranging from 0 (minimum) to 5 (maximum). Higher scores indicate worse outcome.", "time_frame": "From enrollment to the end of treatment at 6 weeks." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06863207", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05212129", "title": "Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-02-13", "start_date": "2021-04-05", "completion_date": "2026-12-31", "primary_completion_date": "2026-12-31", "conditions_raw": [ "Functional Gastrointestinal Disorders", "Hypermobile Ehlers-Danlos Syndrome", "Postural Orthostatic Tachycardia Syndrome", "Autonomic Nervous System Disease", "Autonomic Nervous System Imbalance" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Percutaneous Vagal Nerve Stimulation (Pvns) Device", "Acoustic Vagal Nerve Stimulation (Avns) Treatment" ], "sponsor": "Medical College of Wisconsin", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Hypermobile Ehlers-Danlos Syndrome (hEDS) is a connective tissue disorder characterized by hyperextensible skin, joint hypermobility and additional connective tissue manifestations. For unclear reasons, hEDS is associated with many gastrointestinal (GI) and autonomic nervous system (ANS) complaints such as postural orthostatic tachycardia syndrome (POTS). This study will address the clinical relationship between hEDS/Hypermobile Spectrum Disorders and autonomic regulation and see if there is a benefit of two forms of non-invasive vagal nerve stimulation therapies to reduce GI symptoms in hEDS and POTS. The study will also investigate plausible effects of these nerve stimulation therapies on gastric function and autonomic signaling.", "primary_outcomes": [ { "type": "primary", "measure": "Change in gastrointestinal symptoms as assessed by the instrument Patient Assessment of upper Gastrointestinal Symptom Severity Index (PAGI-SYM)", "description": "Instrument assessing upper gastrointestinal symptoms including symptoms of gastroparesis; score range 0-100 with higher scores indicating worse symptoms", "time_frame": "Change from baseline total PAGI-SYM score at end of therapy (6 weeks)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in gastric motor function as assessed by gastric MRI", "description": "Dynamic gastric MRI measure of gastric accomodation as measured by gastric volume change in response to test meal. A greater gastric volume change indicates improved gastric accomodation.", "time_frame": "Change from baseline at end of therapy (6 weeks)" }, { "type": "secondary", "measure": "Change in Body Perception Questionnaire (BPQ) total score", "description": "Instrument assessing symptoms of autonomic reactivity; raw score range 0-130 with higher score indicating greater autonomic reactivity", "time_frame": "Change from baseline at end of therapy (6 weeks)" }, { "type": "secondary", "measure": "Change in vagal efficiency measurements", "description": "Metrics of vagal tone extracted from ECG R-R interval data measurements during postural challenges", "time_frame": "Change from baseline at end of therapy (6 weeks)" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in gastrointestinal symptoms as assessed by the instrument Patient Assessment of upper Gastrointestinal Symptom Severity Index (PAGI-SYM)", "description": "Instrument assessing upper gastrointestinal symptoms including symptoms of gastroparesis; score range 0-100 with higher scores indicating worse symptoms", "time_frame": "Change from baseline total PAGI-SYM score at end of therapy (6 weeks)" }, { "type": "secondary", "measure": "Change in gastric motor function as assessed by gastric MRI", "description": "Dynamic gastric MRI measure of gastric accomodation as measured by gastric volume change in response to test meal. A greater gastric volume change indicates improved gastric accomodation.", "time_frame": "Change from baseline at end of therapy (6 weeks)" }, { "type": "secondary", "measure": "Change in Body Perception Questionnaire (BPQ) total score", "description": "Instrument assessing symptoms of autonomic reactivity; raw score range 0-130 with higher score indicating greater autonomic reactivity", "time_frame": "Change from baseline at end of therapy (6 weeks)" }, { "type": "secondary", "measure": "Change in vagal efficiency measurements", "description": "Metrics of vagal tone extracted from ECG R-R interval data measurements during postural challenges", "time_frame": "Change from baseline at end of therapy (6 weeks)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 90, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05212129", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01988883", "title": "Modafinil and Cognitive Function in POTS", "status": "ACTIVE_NOT_RECRUITING", "phase": "EARLY_PHASE1", "last_updated": "2026-01-15", "start_date": "2014-10", "completion_date": "2026-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Modafinil", "Propranolol" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "A common complaint among patients with Postural Tachycardia Syndrome (POTS) is \"brain fog\" or difficulty concentrating. This problem is poorly understood.\n\nThe purpose of this study is to better understand the cognitive dysfunction associated POTS, and to determine optimal treatment strategies for this condition. In this study, the investigators will test the hypothesis that acute administration of the psychostimulant drug modafinil can improve seated measures of cognitive function in patients with POTS.", "primary_outcomes": [ { "type": "primary", "measure": "Visual Attention Performance Speed", "description": "This outcome will be assessed using the CogState Identification Task which provides a continuous variable for visual attention performance speed.", "time_frame": "2.5 hours post study medication" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Executive Function", "description": "This outcome will be assessed by the CogState Groton Maze Learning and Set-Shifting Tasks which provides continuous variables for speed and accuracy measures of executive function.", "time_frame": "2.5 hours post study medication" }, { "type": "secondary", "measure": "Blood Pressure", "description": "This outcome will be assessed using an automated sphygmomanometer arm cuff.", "time_frame": "Baseline and up to 4 hours after drug administration" }, { "type": "secondary", "measure": "Heart Rate", "description": "This outcome will be assessed using an automated sphygmomanometer arm cuff.", "time_frame": "Baseline and up to 4 hours after drug administration" } ], "outcome_measures": [ { "type": "primary", "measure": "Visual Attention Performance Speed", "description": "This outcome will be assessed using the CogState Identification Task which provides a continuous variable for visual attention performance speed.", "time_frame": "2.5 hours post study medication" }, { "type": "secondary", "measure": "Executive Function", "description": "This outcome will be assessed by the CogState Groton Maze Learning and Set-Shifting Tasks which provides continuous variables for speed and accuracy measures of executive function.", "time_frame": "2.5 hours post study medication" }, { "type": "secondary", "measure": "Blood Pressure", "description": "This outcome will be assessed using an automated sphygmomanometer arm cuff.", "time_frame": "Baseline and up to 4 hours after drug administration" }, { "type": "secondary", "measure": "Heart Rate", "description": "This outcome will be assessed using an automated sphygmomanometer arm cuff.", "time_frame": "Baseline and up to 4 hours after drug administration" } ], "relevance_tags": [ "Neurological / Autonomic", "EARLY_Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01988883", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01783288", "title": "Aldosterone & Sodium Regulation in Postural Tachycardia Syndrome - Screening", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-01-13", "start_date": "2013-02", "completion_date": "2026-12", "primary_completion_date": "2026-12", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Autonomic Function Testing", "Posture Study", "Measurement Of Total Blood Volume", "Exercise Capacity Test" ], "sponsor": "Vanderbilt University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of the study is to determine whether patients meet criteria for Postural Tachycardia Syndrome (or not) and have reduced blood volume (or not). Both of these are important screening elements to Aim 3 of a National Institutes of Health Grant. The purposes of Aim 3 are to determine 1. whether a high dietary sodium level appropriately expands plasma volume in Postural Orthostatic Tachycardia, 2. whether plasma renin activity and aldosterone are modified appropriately by changes in dietary sodium in Postural Tachycardia Syndrome and 3. whether patients with Postural Tachycardia Syndrome have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.", "primary_outcomes": [ { "type": "primary", "measure": "blood volume deviation (%) from individual predicted volumes", "description": "Compare blood volume deviations using the 131-I-Albumin method. Deviations will be reported as a percentage deviation from an individual's predicted value. These values will be compared between POTS patients and healthy control groups.", "time_frame": "2 days" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "blood volume deviation (%) from individual predicted volumes", "description": "Compare blood volume deviations using the 131-I-Albumin method. Deviations will be reported as a percentage deviation from an individual's predicted value. These values will be compared between POTS patients and healthy control groups.", "time_frame": "2 days" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 110, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01783288", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07029191", "title": "Screening for Alterations in the Autonomic Nervous System", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-12-24", "start_date": "2025-11-21", "completion_date": "2025-12-12", "primary_completion_date": "2025-12-12", "conditions_raw": [ "Dysautonomia", "ACCUVEIN", "Superficial Veins", "Sympathetic Nervous System", "Standing Test" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Progressive Standing Test" ], "sponsor": "University Hospital, Angers", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "Dysautonomia is an alteration of the autonomic nervous system that manifests itself in different forms, some of which are very disabling. Dysautonomia accompanies many pathologies. Its importance in public health is illustrated by an incidence of 20-70% in diabetes. It affects between 400,000 and 1.4 million patients in the French diabetic population alone. Dysautonomia is mainly investigated through alterations in the cardiovascular system's reactivity to various maneuvers. It involves a methodology that evaluates the functionality of the sympathetic nervous system. This methodology is reserved for specialized laboratories, limiting access to diagnosis. Dysautonomia is therefore commonly overlooked for lack of a simple, effective diagnostic tool.\n\nACCUVEIN is an augmented-reality venipuncture device. It projects the network of superficial veins onto the patient's skin. Our aim is to show that ACCUVEIN is capable of objectivizing the venoconstriction caused by activation of the sympathetic system in a healthy subject, such as when moving to a standing position. If ACCUVEIN has this capability, it would then represent a simple and rapid diagnostic tool for objectifying a venoconstriction defect in patients with dysautonomia.", "primary_outcomes": [ { "type": "primary", "measure": "Progressive standing test", "description": "If the subject's resting ECG is normal, the experimental session then begins with a progressive uprighting test of the subject in increments starting at 0° (the horizontal position) then moving on to 15°, then 30°, then 45° and finally 70°, the maximum upright head-up position, i.e. a total of 5 increments). Progressive verticalization is performed on a verticalization table used in standard autonomic nervous system assessment procedures. Three thoracic electrocardiographic electrodes and the blood pressure measurement finger pad on the right middle finger are positioned, then the left upper limb is stripped and held at heart level by a suitable support throughout the experimental procedure. The subject then lies down on the examination table. Each level is maintained for 5 minutes. At the end of the last 70° stop, the examination table is returned to the horizontal position.", "time_frame": "Day 1" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Blood pressure recording", "description": "Recording of blood pressure by the Finapres Nova system begins after 5 minutes' rest in the supine position, to allow the body to adapt to this position. The standing test then begins.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Heart rate recording", "description": "Heart rate recording by the Finapres Nova system begins after 5 minutes' rest in the supine position, to allow the body to adapt to this position. The standing test then begins.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "ACCUVEIN", "description": "A photograph of the forearm, with the superficial veins highlighted by the ACCUVEIN device, is taken during the last minute of each stage.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Breathing test", "description": "To confirm the absence of dysautonomia, two very short tests are performed. These tests involve asking the subject to breathe according to the experimenter's instructions (inflate lungs, deflate lungs), who then imposes a normal breathing rhythm of 12 cycles per minute for one minute. The subject is then asked to stand up on his own and maintain this posture for 30 seconds.", "time_frame": "Day 1" } ], "outcome_measures": [ { "type": "primary", "measure": "Progressive standing test", "description": "If the subject's resting ECG is normal, the experimental session then begins with a progressive uprighting test of the subject in increments starting at 0° (the horizontal position) then moving on to 15°, then 30°, then 45° and finally 70°, the maximum upright head-up position, i.e. a total of 5 increments). Progressive verticalization is performed on a verticalization table used in standard autonomic nervous system assessment procedures. Three thoracic electrocardiographic electrodes and the blood pressure measurement finger pad on the right middle finger are positioned, then the left upper limb is stripped and held at heart level by a suitable support throughout the experimental procedure. The subject then lies down on the examination table. Each level is maintained for 5 minutes. At the end of the last 70° stop, the examination table is returned to the horizontal position.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Blood pressure recording", "description": "Recording of blood pressure by the Finapres Nova system begins after 5 minutes' rest in the supine position, to allow the body to adapt to this position. The standing test then begins.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Heart rate recording", "description": "Heart rate recording by the Finapres Nova system begins after 5 minutes' rest in the supine position, to allow the body to adapt to this position. The standing test then begins.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "ACCUVEIN", "description": "A photograph of the forearm, with the superficial veins highlighted by the ACCUVEIN device, is taken during the last minute of each stage.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Breathing test", "description": "To confirm the absence of dysautonomia, two very short tests are performed. These tests involve asking the subject to breathe according to the experimenter's instructions (inflate lungs, deflate lungs), who then imposes a normal breathing rhythm of 12 cycles per minute for one minute. The subject is then asked to stand up on his own and maintain this posture for 30 seconds.", "time_frame": "Day 1" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other Gov" ], "enrollment": 12, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07029191", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00962728", "title": "Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-12-22", "start_date": "2009-07", "completion_date": "2026-12", "primary_completion_date": "2026-11", "conditions_raw": [ "Postural Tachycardia Syndrome", "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Inspiratory Threshold Device" ], "sponsor": "Alfredo Gamboa", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease heart rate increases on standing in patients with postural tachycardia syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Magnitude of orthostatic heart rate increase on upright posture", "description": "", "time_frame": "10 min" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptoms rating with upright posture", "description": "", "time_frame": "10 min" }, { "type": "secondary", "measure": "Hemodynamic changes on upright posture", "description": "", "time_frame": "10 min" } ], "outcome_measures": [ { "type": "primary", "measure": "Magnitude of orthostatic heart rate increase on upright posture", "description": "", "time_frame": "10 min" }, { "type": "secondary", "measure": "Symptoms rating with upright posture", "description": "", "time_frame": "10 min" }, { "type": "secondary", "measure": "Hemodynamic changes on upright posture", "description": "", "time_frame": "10 min" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00962728", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07197905", "title": "Restoring Iron Deficiency in POTS", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2025-12-11", "start_date": "2025-11-24", "completion_date": "2026-12", "primary_completion_date": "2026-10", "conditions_raw": [ "POTS - Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Intravenous Iron" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "People with postural orthostatic tachycardia syndrome (POTS) often have low red blood cell volumes and low ferritin in their blood (a marker of iron storage in the body). The purpose of this pilot study is to investigate whether giving iron to people with POTS who have low ferritin levels will increase the red blood cell volume and improve POTS symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Orthostatic tachycardia", "description": "Orthostatic tachycardia, defined as the difference between upright and supine heart rates, will be assessed during a 10-minute head-up tilt test.", "time_frame": "Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Orthostatic tachycardia", "description": "Orthostatic tachycardia, defined as the difference between upright and supine heart rates, will be assessed during a 10-minute head-up tilt test.", "time_frame": "Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 12, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07197905", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05375968", "title": "Splanchnic Venous Capacitance in Postural Tachycardia Syndrome", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2025-12-05", "start_date": "2023-02-25", "completion_date": "2028-06-01", "primary_completion_date": "2027-05-31", "conditions_raw": [ "Postural Tachycardia Syndrome (POTS)" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Compare Change Is Svc And Sma Flow Due To Gip Antagonist Gip(3-30)Nh2", "Compare Change Is Svc And Sma Flow Due To Saline" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural tachycardia syndrome (POTS) affects ≈3 million young people, characterized by chronic presyncopal symptoms characterized by dizziness, lightheadedness, and orthostatic tachycardia that occur while standing. Across-sectional survey found that 25% of these patients complains that meals rich in carbohydrates are among the factors that further exacerbate POTS's symptoms and cause a myriad of gastrointestinal symptoms.\n\nThe splanchnic circulation is the largest blood volume reservoir of the human body, storing ≈25% of the total blood volume and contributing to sudden, and large, fluctuations in the stroke volume (SV). The orthostatic changes in systemic hemodynamics are particularly magnified after meals, due to increased blood volume sequestration triggered by the release of gastrointestinal peptides with vasodilatory properties. The purpose of this study is to determine if the worsening orthostatic tachycardia and symptoms after glucose ingestion in POTS patients are due to a greater increase in splanchnic venous capacitance and excessive blood pooling on standing as compare to Healthy controls.\n\nThe study will also determine if glucose-induced GIP secretion increases splanchnic venous capacitance, orthostatic tachycardia and worsening POTS postprandial symptoms. For this purpose subjects will be further randomized to either saline versus GIP(3-30)NH2 acute infusion, to measure the changes their splanchnic venous capacitance and superior mesenteric arterial flow before and after a 75-g oral glucose challenge during supine and 45-degree head-up tilt positions (orthostatic challenge) for up to 3 hours.", "primary_outcomes": [ { "type": "primary", "measure": "Change in splanchnic venous capacitance in Postural Orthostatic Tachycardia Syndrome", "description": "The changes in splanchnic venous capacitance and superior mesenteric arterial flow will be measured, before and after a 75 gram of oral glucose challenge. It will compared in POTS and Healthy controls.\n\nWhile segmental bio impedance is monitored, continuous positive airway pressure (CPAP) will be applied sequentially at 0, 4, 8, 12 and 16 cm H2O for about 30 seconds each; this positive airway pressure will increase the intrathoracic pressure, which is transmitted to the venous circulation. Pressure (CPAP pressure, x-axis) - volume (splanchnic vascular volume measured by segmental impedance and expressed as % change from baseline, y-axis) relationships are then constructed to assess for splanchnic venous capacitance.", "time_frame": "Baseline up to 180 minutes post glucose challenge" }, { "type": "primary", "measure": "Effect of glucose-induced GIP secretion on splanchnic venous capacitance", "description": "25 participants with POTS diagnosis, will be randomized them to either saline versus GIP antagonist (GIP(3-30)NH2) acute infusion. We will measure changes in their splanchnic venous capacitance and superior mesenteric arterial flow before and after a 75-g oral glucose challenge during supine and 45-degree head-up tilt positions (orthostatic challenge) for up to 3 hr", "time_frame": "0-180 mins" }, { "type": "primary", "measure": "Effect of glucose-induced GIP secretion on POTS postprandial symptoms.", "description": "Compare the post prandial symptoms on the participants who got infused with GIP antagonist GIP(3-30)NH2 and compare it with Saline infused participants at baseline and 45 degree head tilt. Total of 25 participants with diagnosis of POTS will randomized at visit 2, as 1:1 saline vs GIP antagonist GIP(3-30)NH2 At visit 3, the subjects who received Saline, will get GIP antagonist GIP(3-30)NH2 , vice versa.", "time_frame": "0-90 mins" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Measure Glucose-dependent Insulinotropic polypeptide (GIP) hormone level in POTS patients and Controls after 75 grams of glucose ingestion", "description": "Measure and compare various GIP hormones (GLP-1, GLP-2, GIP, Vasoactive Intestinal Peptide(VIP)and glucagon) after ingesting 75-gram glucose for up to 180 minutes in POTS patients and healthy controls of similar age and BMI.\n\nSequential blood draw will done to measure GIP hormones", "time_frame": "Baseline up to 180 minutes post glucose challenge" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in splanchnic venous capacitance in Postural Orthostatic Tachycardia Syndrome", "description": "The changes in splanchnic venous capacitance and superior mesenteric arterial flow will be measured, before and after a 75 gram of oral glucose challenge. It will compared in POTS and Healthy controls.\n\nWhile segmental bio impedance is monitored, continuous positive airway pressure (CPAP) will be applied sequentially at 0, 4, 8, 12 and 16 cm H2O for about 30 seconds each; this positive airway pressure will increase the intrathoracic pressure, which is transmitted to the venous circulation. Pressure (CPAP pressure, x-axis) - volume (splanchnic vascular volume measured by segmental impedance and expressed as % change from baseline, y-axis) relationships are then constructed to assess for splanchnic venous capacitance.", "time_frame": "Baseline up to 180 minutes post glucose challenge" }, { "type": "primary", "measure": "Effect of glucose-induced GIP secretion on splanchnic venous capacitance", "description": "25 participants with POTS diagnosis, will be randomized them to either saline versus GIP antagonist (GIP(3-30)NH2) acute infusion. We will measure changes in their splanchnic venous capacitance and superior mesenteric arterial flow before and after a 75-g oral glucose challenge during supine and 45-degree head-up tilt positions (orthostatic challenge) for up to 3 hr", "time_frame": "0-180 mins" }, { "type": "primary", "measure": "Effect of glucose-induced GIP secretion on POTS postprandial symptoms.", "description": "Compare the post prandial symptoms on the participants who got infused with GIP antagonist GIP(3-30)NH2 and compare it with Saline infused participants at baseline and 45 degree head tilt. Total of 25 participants with diagnosis of POTS will randomized at visit 2, as 1:1 saline vs GIP antagonist GIP(3-30)NH2 At visit 3, the subjects who received Saline, will get GIP antagonist GIP(3-30)NH2 , vice versa.", "time_frame": "0-90 mins" }, { "type": "secondary", "measure": "Measure Glucose-dependent Insulinotropic polypeptide (GIP) hormone level in POTS patients and Controls after 75 grams of glucose ingestion", "description": "Measure and compare various GIP hormones (GLP-1, GLP-2, GIP, Vasoactive Intestinal Peptide(VIP)and glucagon) after ingesting 75-gram glucose for up to 180 minutes in POTS patients and healthy controls of similar age and BMI.\n\nSequential blood draw will done to measure GIP hormones", "time_frame": "Baseline up to 180 minutes post glucose challenge" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05375968", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02725060", "title": "Autoimmune Basis for Postural Tachycardia Syndrome", "status": "ENROLLING_BY_INVITATION", "phase": "NA", "last_updated": "2025-11-12", "start_date": "2016-02", "completion_date": "2026-12", "primary_completion_date": "2026-10", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome", "Postural Tachycardia Syndrome", "Tachycardia", "Arrhythmias, Cardiac", "Autonomic Nervous System Diseases", "Orthostatic Intolerance", "Cardiovascular Diseases", "Primary Dysautonomias" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Phenylephrine", "Isoproterenol", "25 Micro-Ci Of Radiation", "24-Hour Heart Rhythm And Blood Pressure Monitoring", "Quantitative Axonal Sudomotor Reflex Testing", "Autonomic Function Tests", "Rebreathing Test", "Assessment Of Splanchnic Capacitance", "Microneurography" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to see if some people with postural tachycardia syndrome (POTS) have higher levels of immune proteins (autoantibodies) directed against receptors of the autonomic nervous system, and if these autoantibodies make a difference in their POTS symptoms. The investigators also want to see if the levels of these autoantibodies stay the same over time.", "primary_outcomes": [ { "type": "primary", "measure": "Autoantibody levels", "description": "Blood samples collected while supine during the posture study will be analyzed for autoantibody positivity in POTS patients and control subjects.", "time_frame": "up to 10 minutes" }, { "type": "primary", "measure": "Blood pressure after phenylephrine boluses", "description": "", "time_frame": "1-2 minutes after bolus injections" }, { "type": "primary", "measure": "Heart rate after isoproterenol boluses", "description": "", "time_frame": "1-2 minutes after bolus injections" }, { "type": "primary", "measure": "Orthostatic change in heart rate", "description": "Difference between standing and supine heart rates.", "time_frame": "up to 10 minutes" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Blood pressure response during phase IV of the Valsalva maneuver", "description": "", "time_frame": "up to 10 minutes" }, { "type": "secondary", "measure": "Hear rate response during phase IV of the Valsalva maneuver", "description": "", "time_frame": "up to 10 minutes" } ], "outcome_measures": [ { "type": "primary", "measure": "Autoantibody levels", "description": "Blood samples collected while supine during the posture study will be analyzed for autoantibody positivity in POTS patients and control subjects.", "time_frame": "up to 10 minutes" }, { "type": "primary", "measure": "Blood pressure after phenylephrine boluses", "description": "", "time_frame": "1-2 minutes after bolus injections" }, { "type": "primary", "measure": "Heart rate after isoproterenol boluses", "description": "", "time_frame": "1-2 minutes after bolus injections" }, { "type": "primary", "measure": "Orthostatic change in heart rate", "description": "Difference between standing and supine heart rates.", "time_frame": "up to 10 minutes" }, { "type": "secondary", "measure": "Blood pressure response during phase IV of the Valsalva maneuver", "description": "", "time_frame": "up to 10 minutes" }, { "type": "secondary", "measure": "Hear rate response during phase IV of the Valsalva maneuver", "description": "", "time_frame": "up to 10 minutes" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 58, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02725060", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06268288", "title": "Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-10-31", "start_date": "2024-02-14", "completion_date": "2024-10-05", "primary_completion_date": "2024-10-05", "conditions_raw": [ "Postural Tachycardia Syndrome", "Autonomic Dysfunction", "Postural Orthostatic Tachycardia Syndrome", "POTS - Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Gammacore Intervention", "Steps Management Protocol" ], "sponsor": "Mayo Clinic", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management.", "primary_outcomes": [ { "type": "primary", "measure": "The Change in Composite Autonomic Symptom Score (COMPASS-31)", "description": "The change in COMPASS-31 score from baseline to 8 weeks. COMPASS-31 measures autonomic dysfunction in patients with neurodegenerative diseases. It consists of 31 patient-reported questions assessing various symptoms, including orthostatic intolerance, vasomotor symptoms, and gastrointestinal issues. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.", "time_frame": "Baseline; 8 Weeks" }, { "type": "primary", "measure": "The Change in Child Functional Disability Inventory Scores", "description": "The change in Child Functional Disability Inventory scores from baseline to eight weeks. The Child Functional Disability Inventory assesses the physical and psychosocial functioning of children due to their physical health. It consists of 15 items that measure activity limitations due to being sick or not feeling well. The total scores range from 0 to 60 with higher scores indicating greater perceived functional disability.", "time_frame": "Baseline; 8 Weeks" }, { "type": "primary", "measure": "The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests", "description": "The change in heart rate, measured in beats per minute (BPM), in the head up tilt table test (HUTT) from baseline to 8 weeks.", "time_frame": "Baseline; 8 Weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in the Number of Headaches Experienced by Adolescent Patients With POTS", "description": "The change in the number of headaches from baseline to 8 weeks experienced by adolescent patients with POTS.", "time_frame": "Baseline; 8 Weeks" }, { "type": "secondary", "measure": "Change in Exercise Duration (Minutes) in Adolescent Patients With POTS", "description": "The change in the exercise duration (minutes) in adolescent patients with POTS from baseline to 8 weeks.", "time_frame": "Baseline; 8 Weeks" }, { "type": "secondary", "measure": "Change in PHQ-9 Scores in Adolescent Patients With POTS", "description": "The change in the Patient Health Questionnaire 9-item (PHQ-9) scale score from baseline to 8 weeks. PHQ-9 is used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of \"not at all,\" \"several days,\" \"more than half the days,\" and \"nearly every day.\" Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.", "time_frame": "Baseline; 8 Weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "The Change in Composite Autonomic Symptom Score (COMPASS-31)", "description": "The change in COMPASS-31 score from baseline to 8 weeks. COMPASS-31 measures autonomic dysfunction in patients with neurodegenerative diseases. It consists of 31 patient-reported questions assessing various symptoms, including orthostatic intolerance, vasomotor symptoms, and gastrointestinal issues. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.", "time_frame": "Baseline; 8 Weeks" }, { "type": "primary", "measure": "The Change in Child Functional Disability Inventory Scores", "description": "The change in Child Functional Disability Inventory scores from baseline to eight weeks. The Child Functional Disability Inventory assesses the physical and psychosocial functioning of children due to their physical health. It consists of 15 items that measure activity limitations due to being sick or not feeling well. The total scores range from 0 to 60 with higher scores indicating greater perceived functional disability.", "time_frame": "Baseline; 8 Weeks" }, { "type": "primary", "measure": "The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests", "description": "The change in heart rate, measured in beats per minute (BPM), in the head up tilt table test (HUTT) from baseline to 8 weeks.", "time_frame": "Baseline; 8 Weeks" }, { "type": "secondary", "measure": "Change in the Number of Headaches Experienced by Adolescent Patients With POTS", "description": "The change in the number of headaches from baseline to 8 weeks experienced by adolescent patients with POTS.", "time_frame": "Baseline; 8 Weeks" }, { "type": "secondary", "measure": "Change in Exercise Duration (Minutes) in Adolescent Patients With POTS", "description": "The change in the exercise duration (minutes) in adolescent patients with POTS from baseline to 8 weeks.", "time_frame": "Baseline; 8 Weeks" }, { "type": "secondary", "measure": "Change in PHQ-9 Scores in Adolescent Patients With POTS", "description": "The change in the Patient Health Questionnaire 9-item (PHQ-9) scale score from baseline to 8 weeks. PHQ-9 is used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of \"not at all,\" \"several days,\" \"more than half the days,\" and \"nearly every day.\" Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.", "time_frame": "Baseline; 8 Weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06268288", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06953661", "title": "Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-10-15", "start_date": "2025-10-13", "completion_date": "2026-11", "primary_completion_date": "2026-11", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Stellate Ganglion Block", "Ropivacaine", "Normal Saline" ], "sponsor": "Stanford University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This single-center study aims to evaluate both immediate and long-term outcomes of stellate ganglion block (SGB) in a cohort of rigorously phenotyped patients with Postural Tachycardia Syndrome (POTS). By assessing the effects of SGB, this study seeks to determine its viability as an intervention for symptom control in POTS.", "primary_outcomes": [ { "type": "primary", "measure": "COMPASS 31 total score", "description": "The change in Composite Autonomic Symptom Score 31 (COMPASS-31) from baseline to first follow-up visit. The COMPASS-31 scale measures autonomic dysfunctions through 31 patient-reported questions. A higher score indicates worse autonomic dysfunction.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Magnitude of postural tachycardia", "description": "Change in magnitude of postural tachycardia (a heart rate increase within the first 10 minutes of standing) from baseline to first and second follow up visit.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Heart rate variability (HRV)", "description": "Change in heart rate variability (HRV) metrics (time and frequency domains) from baseline to first and second follow up visit", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Plasma catecholamine levels", "description": "Measure the change in plasma catecholamine levels from baseline to first and second follow up visits", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Survey of Postural Orthostatic Tachycardia Syndrome Symptoms (SPOTS)", "description": "SPOTS evaluates the frequency and severity of common POTS symptoms, The higher the score, the greater the symptom burden. A reduction in SPOTS score suggests clinical improvement. SPOTS scores at 1st and 2nd FU are compared to baseline SPOTS scores.", "time_frame": "Baseline (day -21 to -1 before intervention) to 1-2 weeks, then day 74 to 94 following study intervention" }, { "type": "secondary", "measure": "VOSS score", "description": "Change in VOSS score at 1st and 2nd FU compared to baseline. The Vanderbilt Orthostatic Symptom Score (VOSS) is a tool used to assess and track the severity of symptoms associated with postural orthostatic tachycardia syndrome (POTS). It helps quantify a patient's symptom burden by having them rate the severity of 9 symptoms (mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea) on a scale of 0 to 10, where 0 indicates no symptoms.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "FSS score", "description": "Change in FSS score at 1st and 2nd FU compared to baseline. The Fatigue Severity Scale (FSS) is a questionnaire used to measure the severity of fatigue and its impact on daily activities. It's a 9-item scale where respondents rate their agreement with statements about fatigue using a 7-point scale, with 1 being \"strongly disagree\" and 7 being \"strongly agree\". The total FSS score is calculated by summing the responses, with a higher score indicating greater fatigue severity.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "PROMIS Cognitive Function Short Form 6a", "description": "Change in the PROMIS Cognitive Function Short Form 6a score at 1st and 2nd FU compared to baseline. Short Form 6a is a six-item sub-set scale of the PROMIS (Patient Reported Outcomes Measurement Information System) Cognitive Function item bank that assesses patient-perceived cognitive deficits. The questions use a 5-point response scale, ranging from \"Not at all\" to \"Very much\". A higher score generally indicates better perceived cognitive ability.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "EQ-5D score", "description": "Change in EQ-5D score at 1st and 2nd FU compared to baseline. The EQ-5D is a questionnaire for measuring patient-reported outcomes which assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 to 1, where 1 represents perfect health, 0 represents a state as bad as death, and values between 0 and 1 represent different levels of health, with higher values indicating better health.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "PGI-S rating", "description": "The PGI-S (Patient Global Impression of Severity) is a single-item, 7-point scale used to assess a patient's perception of the current severity of their condition. A rating of 1 indicates \"normal, not at all ill,\" while a rating of 7 indicates \"among the most extremely ill patients.\" This self-reported measure provides a global assessment of illness severity from the patient's perspective and is commonly used in clinical trials to gauge baseline condition or monitor progression over time.", "time_frame": "Baseline (day -21 to -1 before intervention)" }, { "type": "secondary", "measure": "PGI-C rating", "description": "The PGI-C (Patient Global Impression of Change) is a 7-point scale used to assess a patient's perceived change in their health or condition after an intervention. A rating of 1 indicates \"very much improved,\" while a rating of 7 indicates \"very much worse\". It's a self-reported measure that reflects a patient's belief about the efficacy of treatment.", "time_frame": "First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "CGI-S rating", "description": "The CGI-S (Clinical Global Impression of Severity) is a 7-point scale used by clinicians to assess the severity of a patient's illness at a given point in time. A rating of 1 indicates \"normal, not at all ill,\" while a rating of 7 indicates \"among the most extremely ill patients.\" This clinician-rated measure provides an overall impression of the patient's current condition, based on clinical judgment and all available information, including patient history, symptoms, and behavior.", "time_frame": "Baseline (day -21 to -1 before intervention)" }, { "type": "secondary", "measure": "CGI-C rating", "description": "The Clinical Global Impression of Change (CGI-C) is a scale used to assess the clinical change or improvement in a patient's condition over time. CGI-C scores range from 1 (very much improved) through to 7 (very much worse).", "time_frame": "First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "BAI score", "description": "Reduction in anxiety and depression symptoms as measured by the BAI score. Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to assess the severity of anxiety symptoms. Each item is rated on a 4-point scale (0 = not at all to 3 = severely). The total score ranges from 0 to 63. Higher scores indicate greater severity of anxiety symptoms.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "BDI score", "description": "Reduction in anxiety and depression symptoms as measured by the BDI score. Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. The total score ranges from 0 to 63. Higher total scores indicate more severe depressive symptoms.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Adrenergic G-protein-coupled receptor autoantibody activity", "description": "Measure the change in adrenergic G-protein-coupled receptor autoantibody concentrations from baseline to first and second follow up visits from stored serum samples.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Inflammatory markers (including but not limited to IL1, IL6, IL8, TNF)", "description": "Measure the change in inflammatory markers concentrations (including but not limited to IL1, IL6, IL8, TNF) from baseline to first and second follow up visits from stored serum samples", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Horner's syndrome", "description": "Proportion of patients achieving Horner's syndrome post-SGB as a measure of block success", "time_frame": "Within 10 minutes after the procedure" }, { "type": "secondary", "measure": "Facial skin temperature", "description": "Measure the change in facial skin temperature (C°) post-procedure", "time_frame": "Within 10 minutes after the procedure" }, { "type": "secondary", "measure": "Facial sweating", "description": "Sweat testing will be performed following the procedure. The patient is coated with a moisture-sensitive powder that changes color following the increase in facial blood flow following the intervention.", "time_frame": "Within 10 minutes after the procedure" } ], "outcome_measures": [ { "type": "primary", "measure": "COMPASS 31 total score", "description": "The change in Composite Autonomic Symptom Score 31 (COMPASS-31) from baseline to first follow-up visit. The COMPASS-31 scale measures autonomic dysfunctions through 31 patient-reported questions. A higher score indicates worse autonomic dysfunction.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Magnitude of postural tachycardia", "description": "Change in magnitude of postural tachycardia (a heart rate increase within the first 10 minutes of standing) from baseline to first and second follow up visit.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Heart rate variability (HRV)", "description": "Change in heart rate variability (HRV) metrics (time and frequency domains) from baseline to first and second follow up visit", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Plasma catecholamine levels", "description": "Measure the change in plasma catecholamine levels from baseline to first and second follow up visits", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Survey of Postural Orthostatic Tachycardia Syndrome Symptoms (SPOTS)", "description": "SPOTS evaluates the frequency and severity of common POTS symptoms, The higher the score, the greater the symptom burden. A reduction in SPOTS score suggests clinical improvement. SPOTS scores at 1st and 2nd FU are compared to baseline SPOTS scores.", "time_frame": "Baseline (day -21 to -1 before intervention) to 1-2 weeks, then day 74 to 94 following study intervention" }, { "type": "secondary", "measure": "VOSS score", "description": "Change in VOSS score at 1st and 2nd FU compared to baseline. The Vanderbilt Orthostatic Symptom Score (VOSS) is a tool used to assess and track the severity of symptoms associated with postural orthostatic tachycardia syndrome (POTS). It helps quantify a patient's symptom burden by having them rate the severity of 9 symptoms (mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea) on a scale of 0 to 10, where 0 indicates no symptoms.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "FSS score", "description": "Change in FSS score at 1st and 2nd FU compared to baseline. The Fatigue Severity Scale (FSS) is a questionnaire used to measure the severity of fatigue and its impact on daily activities. It's a 9-item scale where respondents rate their agreement with statements about fatigue using a 7-point scale, with 1 being \"strongly disagree\" and 7 being \"strongly agree\". The total FSS score is calculated by summing the responses, with a higher score indicating greater fatigue severity.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "PROMIS Cognitive Function Short Form 6a", "description": "Change in the PROMIS Cognitive Function Short Form 6a score at 1st and 2nd FU compared to baseline. Short Form 6a is a six-item sub-set scale of the PROMIS (Patient Reported Outcomes Measurement Information System) Cognitive Function item bank that assesses patient-perceived cognitive deficits. The questions use a 5-point response scale, ranging from \"Not at all\" to \"Very much\". A higher score generally indicates better perceived cognitive ability.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "EQ-5D score", "description": "Change in EQ-5D score at 1st and 2nd FU compared to baseline. The EQ-5D is a questionnaire for measuring patient-reported outcomes which assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 to 1, where 1 represents perfect health, 0 represents a state as bad as death, and values between 0 and 1 represent different levels of health, with higher values indicating better health.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "PGI-S rating", "description": "The PGI-S (Patient Global Impression of Severity) is a single-item, 7-point scale used to assess a patient's perception of the current severity of their condition. A rating of 1 indicates \"normal, not at all ill,\" while a rating of 7 indicates \"among the most extremely ill patients.\" This self-reported measure provides a global assessment of illness severity from the patient's perspective and is commonly used in clinical trials to gauge baseline condition or monitor progression over time.", "time_frame": "Baseline (day -21 to -1 before intervention)" }, { "type": "secondary", "measure": "PGI-C rating", "description": "The PGI-C (Patient Global Impression of Change) is a 7-point scale used to assess a patient's perceived change in their health or condition after an intervention. A rating of 1 indicates \"very much improved,\" while a rating of 7 indicates \"very much worse\". It's a self-reported measure that reflects a patient's belief about the efficacy of treatment.", "time_frame": "First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "CGI-S rating", "description": "The CGI-S (Clinical Global Impression of Severity) is a 7-point scale used by clinicians to assess the severity of a patient's illness at a given point in time. A rating of 1 indicates \"normal, not at all ill,\" while a rating of 7 indicates \"among the most extremely ill patients.\" This clinician-rated measure provides an overall impression of the patient's current condition, based on clinical judgment and all available information, including patient history, symptoms, and behavior.", "time_frame": "Baseline (day -21 to -1 before intervention)" }, { "type": "secondary", "measure": "CGI-C rating", "description": "The Clinical Global Impression of Change (CGI-C) is a scale used to assess the clinical change or improvement in a patient's condition over time. CGI-C scores range from 1 (very much improved) through to 7 (very much worse).", "time_frame": "First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "BAI score", "description": "Reduction in anxiety and depression symptoms as measured by the BAI score. Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to assess the severity of anxiety symptoms. Each item is rated on a 4-point scale (0 = not at all to 3 = severely). The total score ranges from 0 to 63. Higher scores indicate greater severity of anxiety symptoms.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "BDI score", "description": "Reduction in anxiety and depression symptoms as measured by the BDI score. Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. The total score ranges from 0 to 63. Higher total scores indicate more severe depressive symptoms.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Adrenergic G-protein-coupled receptor autoantibody activity", "description": "Measure the change in adrenergic G-protein-coupled receptor autoantibody concentrations from baseline to first and second follow up visits from stored serum samples.", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Inflammatory markers (including but not limited to IL1, IL6, IL8, TNF)", "description": "Measure the change in inflammatory markers concentrations (including but not limited to IL1, IL6, IL8, TNF) from baseline to first and second follow up visits from stored serum samples", "time_frame": "Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention)" }, { "type": "secondary", "measure": "Horner's syndrome", "description": "Proportion of patients achieving Horner's syndrome post-SGB as a measure of block success", "time_frame": "Within 10 minutes after the procedure" }, { "type": "secondary", "measure": "Facial skin temperature", "description": "Measure the change in facial skin temperature (C°) post-procedure", "time_frame": "Within 10 minutes after the procedure" }, { "type": "secondary", "measure": "Facial sweating", "description": "Sweat testing will be performed following the procedure. The patient is coated with a moisture-sensitive powder that changes color following the increase in facial blood flow following the intervention.", "time_frame": "Within 10 minutes after the procedure" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06953661", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01000350", "title": "Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-10-08", "start_date": "2009-10", "completion_date": "2028-06", "primary_completion_date": "2028-06", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Saline" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).", "primary_outcomes": [ { "type": "primary", "measure": "Difference in VO2max between saline day and placebo day", "description": "VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.", "time_frame": "Within 2 week" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Exercise capacity/Maximal Load (Watts) during peak VO2", "description": "Maximal exercise load will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.", "time_frame": "Less than 2 weeks" }, { "type": "secondary", "measure": "Cardiac output between exercise tests (inert gas rebreathing technique)", "description": "", "time_frame": "2-10 Days between exercise tests" } ], "outcome_measures": [ { "type": "primary", "measure": "Difference in VO2max between saline day and placebo day", "description": "VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.", "time_frame": "Within 2 week" }, { "type": "secondary", "measure": "Exercise capacity/Maximal Load (Watts) during peak VO2", "description": "Maximal exercise load will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.", "time_frame": "Less than 2 weeks" }, { "type": "secondary", "measure": "Cardiac output between exercise tests (inert gas rebreathing technique)", "description": "", "time_frame": "2-10 Days between exercise tests" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01000350", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00608725", "title": "Pathophysiology of Orthostatic Intolerance", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-10-08", "start_date": "1996-12", "completion_date": "2029-12", "primary_completion_date": "2029-12", "conditions_raw": [ "Tachycardia", "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Daxor", "Qsweat", "Intrinsic Heart Rate" ], "sponsor": "Satish R. Raj", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to describe the mechanism of orthostatic intolerance, relying on cardiovascular physiological studies. The syndrome is of undetermined etiology, but the syndrome causes impairment of a number of young adults, females more than males, with symptoms of tachycardia, fatigue, lightheadedness, palpitations, blurred vision, chest discomfort, difficulty concentrating, and dizziness with the upright posture. It is believed that many different pathophysiological processes can give rise to this disorder.", "primary_outcomes": [ { "type": "primary", "measure": "Physiological abnormalities in orthostatic intolerance", "description": "varied metrics used here", "time_frame": "1 day" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "blood volume", "description": "Blood volume as measured by DAXOR technique", "time_frame": "1 day" }, { "type": "secondary", "measure": "intrinsic heart rate", "description": "Heart rate after IV propranolol and IV atropine", "time_frame": "1 hour" }, { "type": "secondary", "measure": "quantitative sweat testing", "description": "sweat volumes after a QSweat test", "time_frame": "2 hours" }, { "type": "secondary", "measure": "residual sympathetic function after pharmacological autonomic blockade", "description": "changes in BP after trimethaphan infusions", "time_frame": "3 hours" }, { "type": "secondary", "measure": "norepinephrine spillover", "description": "tritiated norepunephrine spillover data", "time_frame": "3 hours" } ], "outcome_measures": [ { "type": "primary", "measure": "Physiological abnormalities in orthostatic intolerance", "description": "varied metrics used here", "time_frame": "1 day" }, { "type": "secondary", "measure": "blood volume", "description": "Blood volume as measured by DAXOR technique", "time_frame": "1 day" }, { "type": "secondary", "measure": "intrinsic heart rate", "description": "Heart rate after IV propranolol and IV atropine", "time_frame": "1 hour" }, { "type": "secondary", "measure": "quantitative sweat testing", "description": "sweat volumes after a QSweat test", "time_frame": "2 hours" }, { "type": "secondary", "measure": "residual sympathetic function after pharmacological autonomic blockade", "description": "changes in BP after trimethaphan infusions", "time_frame": "3 hours" }, { "type": "secondary", "measure": "norepinephrine spillover", "description": "tritiated norepunephrine spillover data", "time_frame": "3 hours" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 260, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT00608725", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00962949", "title": "The Renin-Aldosterone Axis in Postural Tachycardia Syndrome", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2025-09-16", "start_date": "2009-04", "completion_date": "2012-12", "primary_completion_date": "2012-12", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Angiotensin Ii" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder.", "primary_outcomes": [ { "type": "primary", "measure": "Mean Arterial Blood Pressure Change", "description": "Change in MAP from baseline to after 1h of infusion.", "time_frame": "1 hour" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Plasma Renin Activity", "description": "Change in plasma renin activity from baseline to after 1h of infusion.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Aldosterone Level", "description": "Change in aldosterone blood level from baseline to after 1h of infusion.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Cortisol Level", "description": "Change in cortisol blood level from baseline to after 1h of infusion.", "time_frame": "1 hour" } ], "outcome_measures": [ { "type": "primary", "measure": "Mean Arterial Blood Pressure Change", "description": "Change in MAP from baseline to after 1h of infusion.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Plasma Renin Activity", "description": "Change in plasma renin activity from baseline to after 1h of infusion.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Aldosterone Level", "description": "Change in aldosterone blood level from baseline to after 1h of infusion.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Cortisol Level", "description": "Change in cortisol blood level from baseline to after 1h of infusion.", "time_frame": "1 hour" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 28, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00962949", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07077278", "title": "Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome", "status": "NOT_YET_RECRUITING", "phase": "PHASE4", "last_updated": "2025-07-25", "start_date": "2025-10-01", "completion_date": "2027-09", "primary_completion_date": "2027-09", "conditions_raw": [ "Idiopathic Hypersomnia", "POTS - Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Low Sodium Oxybate" ], "sponsor": "Stanford University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators hope to learn if low sodium oxybate (LXB) is an effective treatment for symptoms of idiopathic hypersomnia (IH) and postural tachycardia syndrome (POTS). Previous research has shown that patients with IH also report having symptoms associated with POTS. The researchers have observed that in patients with both IH and POTS, when patients' sleep quality improves, so do their POTS symptoms. The goal of this study is to test this in a controlled way by using LXB as a treatment for both IH and POTS in patients that have been diagnosed with both conditions.", "primary_outcomes": [ { "type": "primary", "measure": "Overall COMPASS-31 Score as a measure of direct comparison between the two conditions across the two-week randomized withdrawal period.", "description": "The Composite Autonomic Symptom Severity Scale-31 (COMPASS-31) is an overall assessment of autonomic symptom severity. The scale measures neurodegenerative system symptoms through 31 patient-reported questions. Assessment is through six weighted domains: orthostatic intolerance \\[10 points\\]; vasomotor \\[6 points\\]; secretomotor \\[7 points\\]; gastrointestinal \\[28 points\\]; bladder \\[9 points\\] and pupillomotor \\[15 points\\]. Weighted scores are summed. A higher score indicates worse autonomic dysfunction.", "time_frame": "At the end of the two-week randomized withdrawal period" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Overall COMPASS-31 Score as a measure of direct comparison between the two conditions across the two-week randomized withdrawal period.", "description": "The Composite Autonomic Symptom Severity Scale-31 (COMPASS-31) is an overall assessment of autonomic symptom severity. The scale measures neurodegenerative system symptoms through 31 patient-reported questions. Assessment is through six weighted domains: orthostatic intolerance \\[10 points\\]; vasomotor \\[6 points\\]; secretomotor \\[7 points\\]; gastrointestinal \\[28 points\\]; bladder \\[9 points\\] and pupillomotor \\[15 points\\]. Weighted scores are summed. A higher score indicates worse autonomic dysfunction.", "time_frame": "At the end of the two-week randomized withdrawal period" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 4", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 25, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07077278", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07019519", "title": "POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-06-13", "start_date": "2025-03-15", "completion_date": "2026-09-30", "primary_completion_date": "2026-06-30", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)", "Healthy" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Gipr Antagonist", "Glp-1R Antagonist", "Cck Agonist" ], "sponsor": "University of Copenhagen", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will describe the interplay between the gut hormones GIP and CCK and their regulation of blood flow to the large vessels in patients with Postural Orthostatic Tachycardia Syndrome (POTS) and GIP, CCK and GLP-1 in healthy. This is addressed by hormone infusions during MR-scans of the abdomen and intake of oral glucose.", "primary_outcomes": [ { "type": "primary", "measure": "Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR)", "description": "Blood flow in the superior mesenteric artery measured with MR ml/min", "time_frame": "Continuously for 80 minutes/during infusions" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Blood flow in portal vein", "description": "Blood flow in the portal vein measured with MR-scans in ml/min", "time_frame": "Continuously for 80 minutes/during infusions" }, { "type": "secondary", "measure": "Blood Flow in celiac trunk", "description": "Blood flow in the celiac trunk measured with MR-scans in ml/min", "time_frame": "Continuously for 80 minutes/during infusions" }, { "type": "secondary", "measure": "Blood Flow in the hepatic artery", "description": "Blood flow in the hepatic artery measured with MR-scans in ml/min", "time_frame": "Continuously for 80 minutes/during infusions" }, { "type": "secondary", "measure": "Blood samples for hormones", "description": "Blood samples of hormones types:\n\nGLP-1(7-36 NH2), GLP-2(1-33), GIP(1-42), Exendin(9-39)NH2, GLP-2(3-33), GIP(3-30)NH2, Glucagon, Insulin/C-peptid, CCK", "time_frame": "Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)" }, { "type": "secondary", "measure": "Gastric emptying/Blood sample of paracetamol", "description": "Uptake/amount of paracetamol in the blood over time as a measure of gastric emptying", "time_frame": "Every 10-20 minutes before, during and after the infusions and MRI scans (120 minutes)" }, { "type": "secondary", "measure": "Symptomscoring", "description": "Symptomscoring of autonome dysfunction with VOSS (Vanderbilt Orthostatic Symptom Score) questionnaire: this consists of 10 symptoms: lightheadedness, brain fog, shortness of breath, palpitations, tremor, headache, tightness in chest, blurred vision, nausea and sleepiness rated from 0-10 where 0 is not ocurring and 10 is worts experienced.", "time_frame": "Continously before and during the infusions (120 minutes)" }, { "type": "secondary", "measure": "Blood samples for genes", "description": "Genes analyzed from buffycoat:\n\nGLP-1R: NM\\_002062, GLP-2R: NM\\_004246, GIPR: NM\\_000164 and NM\\_001308418, CCKR: NM\\_000730 and NM\\_176875,", "time_frame": "One measurement at baseline visit" }, { "type": "secondary", "measure": "Blood sample for glucose", "description": "Glucose measurements", "time_frame": "Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)" }, { "type": "secondary", "measure": "Blood samples for autoantibodies", "description": "Autoantibodies:\n\nAngiotensin-II-receptor-1 AT1R-ab, Endothelin-receptor-A ETAR-ab, Alpha1 adrenergic-receptor-ab, Alpha2 adrenergic-receptor-ab, Beta1 adrenergic-receptor-ab, Beta2 adrenergic-receptor-ab, Muscarinic cholinergic M1-receptor-ab, Muscarinic cholinergic M2-receptor-ab, Muscarinic cholinergic M3-receptor-ab, Muscarinic cholinergic M4-receptor-ab, Muscarinic cholinergic M5-receptor-ab", "time_frame": "One measurement at baseline visit" } ], "outcome_measures": [ { "type": "primary", "measure": "Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR)", "description": "Blood flow in the superior mesenteric artery measured with MR ml/min", "time_frame": "Continuously for 80 minutes/during infusions" }, { "type": "secondary", "measure": "Blood flow in portal vein", "description": "Blood flow in the portal vein measured with MR-scans in ml/min", "time_frame": "Continuously for 80 minutes/during infusions" }, { "type": "secondary", "measure": "Blood Flow in celiac trunk", "description": "Blood flow in the celiac trunk measured with MR-scans in ml/min", "time_frame": "Continuously for 80 minutes/during infusions" }, { "type": "secondary", "measure": "Blood Flow in the hepatic artery", "description": "Blood flow in the hepatic artery measured with MR-scans in ml/min", "time_frame": "Continuously for 80 minutes/during infusions" }, { "type": "secondary", "measure": "Blood samples for hormones", "description": "Blood samples of hormones types:\n\nGLP-1(7-36 NH2), GLP-2(1-33), GIP(1-42), Exendin(9-39)NH2, GLP-2(3-33), GIP(3-30)NH2, Glucagon, Insulin/C-peptid, CCK", "time_frame": "Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)" }, { "type": "secondary", "measure": "Gastric emptying/Blood sample of paracetamol", "description": "Uptake/amount of paracetamol in the blood over time as a measure of gastric emptying", "time_frame": "Every 10-20 minutes before, during and after the infusions and MRI scans (120 minutes)" }, { "type": "secondary", "measure": "Symptomscoring", "description": "Symptomscoring of autonome dysfunction with VOSS (Vanderbilt Orthostatic Symptom Score) questionnaire: this consists of 10 symptoms: lightheadedness, brain fog, shortness of breath, palpitations, tremor, headache, tightness in chest, blurred vision, nausea and sleepiness rated from 0-10 where 0 is not ocurring and 10 is worts experienced.", "time_frame": "Continously before and during the infusions (120 minutes)" }, { "type": "secondary", "measure": "Blood samples for genes", "description": "Genes analyzed from buffycoat:\n\nGLP-1R: NM\\_002062, GLP-2R: NM\\_004246, GIPR: NM\\_000164 and NM\\_001308418, CCKR: NM\\_000730 and NM\\_176875,", "time_frame": "One measurement at baseline visit" }, { "type": "secondary", "measure": "Blood sample for glucose", "description": "Glucose measurements", "time_frame": "Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)" }, { "type": "secondary", "measure": "Blood samples for autoantibodies", "description": "Autoantibodies:\n\nAngiotensin-II-receptor-1 AT1R-ab, Endothelin-receptor-A ETAR-ab, Alpha1 adrenergic-receptor-ab, Alpha2 adrenergic-receptor-ab, Beta1 adrenergic-receptor-ab, Beta2 adrenergic-receptor-ab, Muscarinic cholinergic M1-receptor-ab, Muscarinic cholinergic M2-receptor-ab, Muscarinic cholinergic M3-receptor-ab, Muscarinic cholinergic M4-receptor-ab, Muscarinic cholinergic M5-receptor-ab", "time_frame": "One measurement at baseline visit" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07019519", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01791816", "title": "Mechanisms of Vasovagal Syncope", "status": "COMPLETED", "phase": "EARLY_PHASE1", "last_updated": "2025-05-23", "start_date": "2013-02", "completion_date": "2022-12", "primary_completion_date": "2022-12", "conditions_raw": [ "Vasovagal Syncope", "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Phenylephrine", "L-Ng-Monomethyl Arginine" ], "sponsor": "New York Medical College", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Vasovagal Syncope (simple postural faint) is the most common cause of acute loss of consciousness. Postural tachycardia syndrome(POTS) is the most common chronic form of postural lightheadedness. Together they afflict many Americans, mostly young women, who are prevented from gainful employ or school attendance. The underlying mechanism is not known. Our past work suggests that a simple molecule, nitric oxide, acts to subvert normal blood flow controls causing blood to pool in the gut when standing. Our proposal will show the mechanism behind this problem and will indicate effective medical treatments. Patients will be compared to healthy control subjects.", "primary_outcomes": [ { "type": "primary", "measure": "Heart rate and blood pressure in response to Lower Body Negative Pressure(LBNP)", "description": "", "time_frame": "1 year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Adrenergic neurotransmission as measured by Muscle Sympathetic Nerve Activity(MSNA), doppler ultrasound blood flow, venous Norepinephrine in response to Phenylephrine infusion", "description": "", "time_frame": "1 year" } ], "outcome_measures": [ { "type": "primary", "measure": "Heart rate and blood pressure in response to Lower Body Negative Pressure(LBNP)", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "Adrenergic neurotransmission as measured by Muscle Sympathetic Nerve Activity(MSNA), doppler ultrasound blood flow, venous Norepinephrine in response to Phenylephrine infusion", "description": "", "time_frame": "1 year" } ], "relevance_tags": [ "Neurological / Autonomic", "EARLY_Phase 1", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 90, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01791816", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02558972", "title": "Northera Improves Postural Tachycardia Syndrome (POTS) and Postural Vasovagal Syncope (VVS)", "status": "TERMINATED", "phase": "PHASE2", "last_updated": "2025-05-23", "start_date": "2015-09", "completion_date": "2022-12", "primary_completion_date": "2022-12", "conditions_raw": [ "Postural Tachycardia Syndrome (POTS)", "Vasovagal Syncope (VVS)", "Fainting" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Northera" ], "sponsor": "New York Medical College", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Vasovagal syncope (VVS, simple faint) is the most common cause of transient loss of consciousness and represents the acute episodic form of orthostatic intolerance (OI). Postural tachycardia syndrome (POTS) is the common chronic form of OI. Both are defined by debilitating symptoms and signs while upright relieved by recumbency. Northera should therefore improve both sympathetic splanchnic arterial vasoconstriction and sympathetic splanchnic venoconstriction in POTS and VVS, and may represent an ideal drug to improve the orthostatic response in POTS and VVS.", "primary_outcomes": [ { "type": "primary", "measure": "Study #1 and Study #2 - Splanchnic and lower extremity pooling (physiological parameter)", "description": "Splanchnic and lower extremity pooling will be measured before, during, and after upright tilt. The investigators will use both venous occlusion plethysmography and impedance plethysmography. Venous occlusion plethysmography are made in ml/min by rapidly inflating cuffs to a pressure of 45mmHg and then computing the slope of the time dependent increase in cross limb section. During impedance plethysmography, a Tetrapolar High Resolution Impedance monitor 4-channel digital IPG is used to detect changes in regional blood volume and blood flow in ml/min", "time_frame": "2 weeks" }, { "type": "primary", "measure": "Study #2 -Quality of Life measured by self reporting questionnaire (RAND-36)", "description": "The investigators will test whether chronic administration of Northera (Droxidopa) in escalating dose improves quality of life. Quality of life will be measured by the RAND-36 questionnaire. The RAND-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. (2-4)", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Study #2 -Quality of Life measured by self reporting questionnaire (COMPASS 31)", "description": "The investigators will test whether chronic administration of Northera (Droxidopa) in escalating dose improves quality of life. Quality of life will be measured by the RAND-36 questionnaire (as shown in the above primary outcome) as well as the COMPASS 31 questionnaire. The COMPASS 31 \"was developed as a self-assessment instrument of autonomic symptoms and function that is up-to-date, broadly applicable, easy to administer in a short amount of time, and based on a scientific approach. It was designed to provide a global autonomic severity score and domain scores that are both clinically and scientifically meaningful.\" \"COMPASS 31 is based on the well-established ASP \\[Autonomic Symptom Profile\\], a comprehensive questionnaire assessing autonomic symptoms across multiple domains.\" (1)", "time_frame": "6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Study #1 and Study #2 -Blood pressure (BP)", "description": "During laboratory testing, blood pressure will be continuously monitored in mmHg", "time_frame": "2 weeks" }, { "type": "secondary", "measure": "Study #1 and Study #2 -Heart rate (HR)", "description": "During laboratory testing, heart rate will be continuously monitored in beats/minute.", "time_frame": "2 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Study #1 and Study #2 - Splanchnic and lower extremity pooling (physiological parameter)", "description": "Splanchnic and lower extremity pooling will be measured before, during, and after upright tilt. The investigators will use both venous occlusion plethysmography and impedance plethysmography. Venous occlusion plethysmography are made in ml/min by rapidly inflating cuffs to a pressure of 45mmHg and then computing the slope of the time dependent increase in cross limb section. During impedance plethysmography, a Tetrapolar High Resolution Impedance monitor 4-channel digital IPG is used to detect changes in regional blood volume and blood flow in ml/min", "time_frame": "2 weeks" }, { "type": "primary", "measure": "Study #2 -Quality of Life measured by self reporting questionnaire (RAND-36)", "description": "The investigators will test whether chronic administration of Northera (Droxidopa) in escalating dose improves quality of life. Quality of life will be measured by the RAND-36 questionnaire. The RAND-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. (2-4)", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Study #2 -Quality of Life measured by self reporting questionnaire (COMPASS 31)", "description": "The investigators will test whether chronic administration of Northera (Droxidopa) in escalating dose improves quality of life. Quality of life will be measured by the RAND-36 questionnaire (as shown in the above primary outcome) as well as the COMPASS 31 questionnaire. The COMPASS 31 \"was developed as a self-assessment instrument of autonomic symptoms and function that is up-to-date, broadly applicable, easy to administer in a short amount of time, and based on a scientific approach. It was designed to provide a global autonomic severity score and domain scores that are both clinically and scientifically meaningful.\" \"COMPASS 31 is based on the well-established ASP \\[Autonomic Symptom Profile\\], a comprehensive questionnaire assessing autonomic symptoms across multiple domains.\" (1)", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Study #1 and Study #2 -Blood pressure (BP)", "description": "During laboratory testing, blood pressure will be continuously monitored in mmHg", "time_frame": "2 weeks" }, { "type": "secondary", "measure": "Study #1 and Study #2 -Heart rate (HR)", "description": "During laboratory testing, heart rate will be continuously monitored in beats/minute.", "time_frame": "2 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02558972", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06936319", "title": "Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-05-02", "start_date": "2025-01-15", "completion_date": "2025-12-31", "primary_completion_date": "2025-12-31", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Best Clinical Practice Plus Cpm-Biofeedback Training", "Best Clinical Practice" ], "sponsor": "Medical University Innsbruck", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The present study evaluates whether performing a 14-days counter pressure maneuvers (CPM)-biofeedback training improves the symptomatic burden (primary objective) and secondarily the interference of POTS symptoms with daily activities, fatigue, and health-related quality of life of individuals with POTS compared to best clinical practice non-pharmacological measures. Secondary in-laboratory objectives are to assess the influence of CPM on the supine-to-standing heart rate (HR) and blood pressure (BP) changes as well as on the severity of orthostatic intolerance after performing CPM for two minutes compared to a baseline (intervention-free) active standing test, and to assess the safety and tolerability of CPM-biofeedback training in individuals with POTS.\n\nThis is a monocentric, proof-of-concept, 1:1 randomized, controlled trial with rater-blinded evaluation of the hemodynamic effect of CPM in 40 individuals suffering from POTS.\n\nAll study participants will receive detailed counselling on CPM and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life and will be invited to practice them regularly (best clinical practice). Participants randomized to the interventional arm will receive a CPM-biofeedback training session in the autonomic function laboratory at the Department of Neurology of the Innsbruck Medical University to learn four different CPM under continuous HR and BP monitoring. The CPM-biofeedback training will consist of a baseline 2-minutes active standing and the following four different physical maneuver: leg crossing and muscle tensing, heel raises (10 tiptoeing per minute), squatting, unilateral handgrip (20 times a minute).\n\nThe trial foresees three study visits for both the interventional and the control arm (screening and baseline on-site, as well as a telephone visit 14 days later). For the interventional trial arm, two additional visits are planned (CPM-biofeedback training session in the autonomic function laboratory and a follow-up telephone visit 7 days later).\n\nTo evaluate the baseline to day-14 change in symptom severity, the Malmö POTS Score (MAPS) total score (primary endpoint) and the MAPS single items, Vanderbilt Orthostatic Symptom Score, Orthostatic Grading Scale, Fatigue Severity Scale and Health-related Quality of Life Questionnaire (EuroQol -EQ-5D-5L ) will be administered.", "primary_outcomes": [ { "type": "primary", "measure": "Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS)", "description": "Baseline to day-14 change in the total score from 0 to 120. Higher scores means more symptoms and higher symptom severity.", "time_frame": "Baseline to day-14" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Severity of orthostatic intolerance (on a 0 - 10 points scale)", "description": "Secondary in-laboratory endpoint, orthostatic intolerance after two minutes upon standing and performing counterpressure maneuvers compared to a baseline active standing for two minutes; higher score means more severe symptoms of orthostatic intolerance.", "time_frame": "After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3." }, { "type": "secondary", "measure": "Absolute heart rate", "description": "Absolute heart rate compared to baseline active standing.", "time_frame": "At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver practiced upon standing , at day 1 +/-3." }, { "type": "secondary", "measure": "Absolute systolic and diastolic blood pressure", "description": "Absolute systolic and diastolic blood pressure at 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing compared to baseline active standing.", "time_frame": "At 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing, , at day 1 +/-3." }, { "type": "secondary", "measure": "Supine-to-standing change in heart rate", "description": "Supine-to-standing change in heart rate at 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver compared to baseline active standing (same timepoints)", "time_frame": "At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3." }, { "type": "secondary", "measure": "Supine-to-standing change in systolic and diastolic blood pressure", "description": "Supine-to-standing change in systolic and diastolic blood pressure compared to baseline active standing at 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers", "time_frame": "At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3." }, { "type": "secondary", "measure": "Single items of the Malmö POTS Score (MAPS)", "description": "Baseline to day-14 change in twelve single items of the Malmö POTS Score (MAPS) from 0-10. Higher scores indicate more severe symptoms.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Vanderbilt Orthostatic Symptom Score (VOSS)", "description": "Baseline to day-14 change in the 9 items Vanderbilt Orthostatic Symptom Score (VOSS, score range: 0-90). A higher score means more pronounced symptoms.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Orthostatic Grading Scale (OGS)", "description": "Baseline to day-14 change in the 5-items Orthostatic Grading Scale (OGS, score range: 0-20). Higher scores mean more interference of daily life due to symptoms.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS) - german Version", "description": "Baseline to day-14 change in the 9-items Fatigue Severity Scale (FSS) - german Version (score range: 1 to 63). Higher scores mean pronounced symptoms and worse outcome.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "European Quality of Life, 5 Dimensions, 5 Levels (EuroQol -EQ-5D-5L - german Version)", "description": "Baseline to day-14 change in the 5-items EuroQol -EQ-5D-5L - german Version and a 0-100 visual analogue scale. Higher scores means better outcome and self-estimated health, 100= best, 0= worse health.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Estimated number and preferred choice of counterpressure maneuvers in daily life", "description": "Baseline to day-14 estimated number and preferred choice of counterpressure maneuver in daily life. Higher numbers indicate that a given counterpressure maneouver was performed more frequently, and stand for a better compliance.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Overall usefulness of counterpressure maneuvers", "description": "Overall usefulness of counterpressure maneuvers on a Likert scale 0-10. Higher scores indicate higher subjective usefulness of a given counterpressure maneouver.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Adverse events", "description": "Any adverse event from screening to day-14.", "time_frame": "Screening-Visit to day-14" }, { "type": "secondary", "measure": "Barriers to counterpressure maneuver application in daily life", "description": "Barriers to counterpressure maneuver application in daily life in the opinion of the study participants. Open answers possible.", "time_frame": "Baseline to day-14" } ], "outcome_measures": [ { "type": "primary", "measure": "Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS)", "description": "Baseline to day-14 change in the total score from 0 to 120. Higher scores means more symptoms and higher symptom severity.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Severity of orthostatic intolerance (on a 0 - 10 points scale)", "description": "Secondary in-laboratory endpoint, orthostatic intolerance after two minutes upon standing and performing counterpressure maneuvers compared to a baseline active standing for two minutes; higher score means more severe symptoms of orthostatic intolerance.", "time_frame": "After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3." }, { "type": "secondary", "measure": "Absolute heart rate", "description": "Absolute heart rate compared to baseline active standing.", "time_frame": "At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver practiced upon standing , at day 1 +/-3." }, { "type": "secondary", "measure": "Absolute systolic and diastolic blood pressure", "description": "Absolute systolic and diastolic blood pressure at 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing compared to baseline active standing.", "time_frame": "At 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing, , at day 1 +/-3." }, { "type": "secondary", "measure": "Supine-to-standing change in heart rate", "description": "Supine-to-standing change in heart rate at 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver compared to baseline active standing (same timepoints)", "time_frame": "At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3." }, { "type": "secondary", "measure": "Supine-to-standing change in systolic and diastolic blood pressure", "description": "Supine-to-standing change in systolic and diastolic blood pressure compared to baseline active standing at 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers", "time_frame": "At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3." }, { "type": "secondary", "measure": "Single items of the Malmö POTS Score (MAPS)", "description": "Baseline to day-14 change in twelve single items of the Malmö POTS Score (MAPS) from 0-10. Higher scores indicate more severe symptoms.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Vanderbilt Orthostatic Symptom Score (VOSS)", "description": "Baseline to day-14 change in the 9 items Vanderbilt Orthostatic Symptom Score (VOSS, score range: 0-90). A higher score means more pronounced symptoms.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Orthostatic Grading Scale (OGS)", "description": "Baseline to day-14 change in the 5-items Orthostatic Grading Scale (OGS, score range: 0-20). Higher scores mean more interference of daily life due to symptoms.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Fatigue Severity Scale (FSS) - german Version", "description": "Baseline to day-14 change in the 9-items Fatigue Severity Scale (FSS) - german Version (score range: 1 to 63). Higher scores mean pronounced symptoms and worse outcome.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "European Quality of Life, 5 Dimensions, 5 Levels (EuroQol -EQ-5D-5L - german Version)", "description": "Baseline to day-14 change in the 5-items EuroQol -EQ-5D-5L - german Version and a 0-100 visual analogue scale. Higher scores means better outcome and self-estimated health, 100= best, 0= worse health.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Estimated number and preferred choice of counterpressure maneuvers in daily life", "description": "Baseline to day-14 estimated number and preferred choice of counterpressure maneuver in daily life. Higher numbers indicate that a given counterpressure maneouver was performed more frequently, and stand for a better compliance.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Overall usefulness of counterpressure maneuvers", "description": "Overall usefulness of counterpressure maneuvers on a Likert scale 0-10. Higher scores indicate higher subjective usefulness of a given counterpressure maneouver.", "time_frame": "Baseline to day-14" }, { "type": "secondary", "measure": "Adverse events", "description": "Any adverse event from screening to day-14.", "time_frame": "Screening-Visit to day-14" }, { "type": "secondary", "measure": "Barriers to counterpressure maneuver application in daily life", "description": "Barriers to counterpressure maneuver application in daily life in the opinion of the study participants. Open answers possible.", "time_frame": "Baseline to day-14" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06936319", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06817707", "title": "Evaluation of Urinary Dysfunction in CANVAS Patients", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-03-26", "start_date": "2025-03-21", "completion_date": "2027-03", "primary_completion_date": "2027-03", "conditions_raw": [ "Cerebellar Ataxia", "Neuropathy", "Vestibular Areflexia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Evaluation Of Urinary Dysfunction In Patients With Canvas" ], "sponsor": "Centre Hospitalier Universitaire de Nice", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigator wishes to evaluate the prevalence of urinary symptoms in patients diagnosed with Cerebellar Ataxia, Neuropathy, Vestibular Areflexia Syndrome (CANVAS).\n\nAs much as one third of patients living with CANVAS experience symptoms of urinary system dysfunction. The primary objective of this study is to evaluate the incidence of urinary symptoms in these patients, as well as the potential complications that might occur at the level of the upper and lower urinary system. The investigator also wishes to analyse the connection between the severity of the neurological deficits, the presence of dysautonomia and the presence of urinary dysfunction. To that end, the data collected in the study will concern : a detailed neurological examination including SARA (Scale for the assessement and rating of ataxia) scale assessement, laboratory tests of the renal function, dysautonomia tests with Sudoscan and research of orthostatic hypotension, urinary function questionnaires, dysautonomia questionnaire, urodynamic tests and urinary system ultrasound.", "primary_outcomes": [ { "type": "primary", "measure": "Evaluate the prevalence of urinary dysfunctions in patients with CANVAS genetically confirmed", "description": "The percentage of participants with urinary symptoms will be calculated by multiplying the number of participants with a USP (Urinary Symptom Profile) score greater than of equal to 1 by the total number of subjects included in the study, multiplied by 100. USP self-questionnaire was developped by the French Association of Urology. It aims to assess the symptoms of low urinary tract symptoms (LUTS) in men and women. It contains 13 items that assess stress urinary incontinence, bladder hyperreactivity and dysuria.", "time_frame": "at inclusion" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Characterise the type of urinary dysfunctions", "description": "To characterize the type of urinary dysfunctions (urinary incontinence, dysuria, bladder hyperactivity (urgent or pollakiuria)), we will use the answers to the USP (Urinary Symptom Profile) self-questionnaire. USP self-questionnaire was developped by the French Association of Urology. It aims to assess the symptoms of low urinary tract symptoms (LUTS) in men and women. It contains 13 items that assess stress urinary incontinence, bladder hyperreactivity and dysuria.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Characterise the severity of each type of urinary dysfunctions", "description": "To characterize the degree of severity of urinary dysfunctions (mild, moderate, severe), we will use the answers to the IPSS (International Prostate Symptom Score) self-questionnaire. This questionnaire is a screening tool, which helps with the diagnosis and monitoring of symptoms of benign prostatic hypertrophy (BPH). It consists of 7 questions on urinary difficulties and one question on quality of life. Questions include: incomplete bladder emptying, frequency of urination, intermittent urination (stop and restart), urge to urinate (feeling \"urgent\"), low jet, effort to urinate (force or push), nycturia.\n\nEach question refers to the last month and has a score of 1 to 5, for a total of 35 points maximum.\n\nPatients can be classified according to the severity of symptoms: from 0 to 7 = low symptomatic; 8 to 19 = moderately symptomatic; from 20 to 35 = severe symptoms.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Characterise the impact of urinary dysfunctions on patient's quality of life", "description": "To characterize the impact of urinary dysfunctions on patient's quality of life, we will use the SF-Qualiveen urological self-questionnaire. This questionnaire was developed to specifically and rapidly assess the impact on quality of life of urinary disorders in patients with a neurological bladder. Its initial validation was performed in patients with multiple sclerosis. This rapid form of the Qualiveen scale has 8 items evaluating 4 domains: discomfort, constraints, fears and patient experience. Each item is rated from 0 to 4", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the prevalence of different types of urinary dysfunctions", "description": "To calculate the prevalence of each type of urinary dysfunctions (urinary incontinence, dysuria, bladder hyperactivity (urgent or pollakiuria)), the percentage of participants with each type of impairment will be calculated as the ratio between the number of subjects in each group of impairment and the total number of participants with a USP score greater than or equal to 1, multiplied by 100.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the prevalence of biological complications in the upper urinary tract", "description": "To calculate the prevalence of biological complications in the upper urinary tract, the percentage of subjects with abnormal renal function at the biological balance will be calculated by the ratio of the number of subjects with glomerular filtration rate (GFR) \\< 90 mL/min/1,73 m2 and the total number of participants with a USP score greater than or equal to 1, multiplied by 100.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the prevalence of structural complications in the upper urinary tract", "description": "To calculate the prevalence of structural complications in the upper urinary tract, the percentage of subjects with structural abnormalities of the urinary system will be calculated by the ratio of the number of subjects with pyelocalicial dilation, renal lithiasis or abnormal bladder wall on renal ultrasound and the total number of participants with a USP score greater than or equal to 1, multiplied by 100.", "time_frame": "within 6 months after inclusion" }, { "type": "secondary", "measure": "Assess prevalence of urinary flow malfunction", "description": "To calculate the prevalence of urinary flow malfunction, the percentage of subjects with functional urinary anomalies will be calculated by the ratio of the number of subjects with a deviation from the bladder emptying curve, or a maximum flow rate \\< 15 mL at urinary flow, or a post-micturition residue greater than 100 mL and the total number of participants with USP greater than or equal to 1, multiplied by 100.", "time_frame": "within 6 months after inclusion" }, { "type": "secondary", "measure": "Assess prevalence of dysautonomia", "description": "To assess the prevalence of dysautonomia, the percentage of subjects with dysautonomia will be calculated by the ratio of participants with a positive Sudoscan or orthostatic hypotension test and the total number of participants, multiplied by 100.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the prevalence of dysautonomia symptoms", "description": "To calculate the prevalence of dysautonomia symptoms, the percentage of subjects with dysautonomia symptoms will be calculated as the ratio between the number of subjects with an abnormal response to the SCOPA-AUT (Scales for outcome in Parkinson's disease - Autonomic dysfunction) questionnaire and the total number of participants, multiplied by 100. The SCOPA-AUT is a validated scale developed to assess symptoms of dysautonomia in patients with Parkinson's disease and multisystemic atrophy. It allows to evaluate the symptoms of digestive, urinary, sexual, thermoregulatory, pupillary and cardiovascular dysfunction. It is composed of 26 questions. Each question refers to the last month and has a score of 1 to 4 or 5.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the relationship between urinary dysfunction and presence of dysautonomia", "description": "To assess the association between urinary dysfunction and dysautonomia, we will compare the percentage of participants with a UPS score greater than or equal to 1 among participants who have dysautonomia (following the SCOPA-AUT questionnaire, the SUDOSCAN test or the search for orthostatic hypotension), and the percentage of participants with a USP score greater than or equal to 1 among participants without dysautonomia.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the relationship between severity of neurological dysfunction and dysautonomia", "description": "To assess the relationship between severity of neurological dysfunction and dysautonomia, we will calculate the SARA (Scale for the assessement and rating of ataxia) score for each participant and divide patients into 3 subgroups: Group 1 (SARA score \\< 15), Group 2 (SARA score between 15 - 25) and Group 3 (SARA score \\> 25). The SARA score was developed to evaluate the various deficits resulting from cerebellum dysfunction. It is divided into 8 categories with a cumulative score of 0 (without ataxia) to 40 (the most severe form of ataxia): walking, standing, sitting, speaking, finger hunting, nose test - quick alternate hand movements, heel slip - ankle. For items 5 to 8, the assessment is done bilaterally and then the average value is calculated to obtain the final score.\n\nWe will then calculate and compare the percentage of subjects with dysautonomia (following SCOPA AUT questionnaire, SUDOSCAN test or search for orthostatic hypotension) in each SARA score group.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the relationship between urinary dysfunction and severity of neurological dysfunction", "description": "To assess the relationship between urinary dysfunction and severity of neurological dysfunction, we will calculate and compare the percentage of subjects with urological symptoms or a USP score greater than or equal to 1 in each SARA score group.", "time_frame": "at inclusion" } ], "outcome_measures": [ { "type": "primary", "measure": "Evaluate the prevalence of urinary dysfunctions in patients with CANVAS genetically confirmed", "description": "The percentage of participants with urinary symptoms will be calculated by multiplying the number of participants with a USP (Urinary Symptom Profile) score greater than of equal to 1 by the total number of subjects included in the study, multiplied by 100. USP self-questionnaire was developped by the French Association of Urology. It aims to assess the symptoms of low urinary tract symptoms (LUTS) in men and women. It contains 13 items that assess stress urinary incontinence, bladder hyperreactivity and dysuria.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Characterise the type of urinary dysfunctions", "description": "To characterize the type of urinary dysfunctions (urinary incontinence, dysuria, bladder hyperactivity (urgent or pollakiuria)), we will use the answers to the USP (Urinary Symptom Profile) self-questionnaire. USP self-questionnaire was developped by the French Association of Urology. It aims to assess the symptoms of low urinary tract symptoms (LUTS) in men and women. It contains 13 items that assess stress urinary incontinence, bladder hyperreactivity and dysuria.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Characterise the severity of each type of urinary dysfunctions", "description": "To characterize the degree of severity of urinary dysfunctions (mild, moderate, severe), we will use the answers to the IPSS (International Prostate Symptom Score) self-questionnaire. This questionnaire is a screening tool, which helps with the diagnosis and monitoring of symptoms of benign prostatic hypertrophy (BPH). It consists of 7 questions on urinary difficulties and one question on quality of life. Questions include: incomplete bladder emptying, frequency of urination, intermittent urination (stop and restart), urge to urinate (feeling \"urgent\"), low jet, effort to urinate (force or push), nycturia.\n\nEach question refers to the last month and has a score of 1 to 5, for a total of 35 points maximum.\n\nPatients can be classified according to the severity of symptoms: from 0 to 7 = low symptomatic; 8 to 19 = moderately symptomatic; from 20 to 35 = severe symptoms.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Characterise the impact of urinary dysfunctions on patient's quality of life", "description": "To characterize the impact of urinary dysfunctions on patient's quality of life, we will use the SF-Qualiveen urological self-questionnaire. This questionnaire was developed to specifically and rapidly assess the impact on quality of life of urinary disorders in patients with a neurological bladder. Its initial validation was performed in patients with multiple sclerosis. This rapid form of the Qualiveen scale has 8 items evaluating 4 domains: discomfort, constraints, fears and patient experience. Each item is rated from 0 to 4", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the prevalence of different types of urinary dysfunctions", "description": "To calculate the prevalence of each type of urinary dysfunctions (urinary incontinence, dysuria, bladder hyperactivity (urgent or pollakiuria)), the percentage of participants with each type of impairment will be calculated as the ratio between the number of subjects in each group of impairment and the total number of participants with a USP score greater than or equal to 1, multiplied by 100.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the prevalence of biological complications in the upper urinary tract", "description": "To calculate the prevalence of biological complications in the upper urinary tract, the percentage of subjects with abnormal renal function at the biological balance will be calculated by the ratio of the number of subjects with glomerular filtration rate (GFR) \\< 90 mL/min/1,73 m2 and the total number of participants with a USP score greater than or equal to 1, multiplied by 100.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the prevalence of structural complications in the upper urinary tract", "description": "To calculate the prevalence of structural complications in the upper urinary tract, the percentage of subjects with structural abnormalities of the urinary system will be calculated by the ratio of the number of subjects with pyelocalicial dilation, renal lithiasis or abnormal bladder wall on renal ultrasound and the total number of participants with a USP score greater than or equal to 1, multiplied by 100.", "time_frame": "within 6 months after inclusion" }, { "type": "secondary", "measure": "Assess prevalence of urinary flow malfunction", "description": "To calculate the prevalence of urinary flow malfunction, the percentage of subjects with functional urinary anomalies will be calculated by the ratio of the number of subjects with a deviation from the bladder emptying curve, or a maximum flow rate \\< 15 mL at urinary flow, or a post-micturition residue greater than 100 mL and the total number of participants with USP greater than or equal to 1, multiplied by 100.", "time_frame": "within 6 months after inclusion" }, { "type": "secondary", "measure": "Assess prevalence of dysautonomia", "description": "To assess the prevalence of dysautonomia, the percentage of subjects with dysautonomia will be calculated by the ratio of participants with a positive Sudoscan or orthostatic hypotension test and the total number of participants, multiplied by 100.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the prevalence of dysautonomia symptoms", "description": "To calculate the prevalence of dysautonomia symptoms, the percentage of subjects with dysautonomia symptoms will be calculated as the ratio between the number of subjects with an abnormal response to the SCOPA-AUT (Scales for outcome in Parkinson's disease - Autonomic dysfunction) questionnaire and the total number of participants, multiplied by 100. The SCOPA-AUT is a validated scale developed to assess symptoms of dysautonomia in patients with Parkinson's disease and multisystemic atrophy. It allows to evaluate the symptoms of digestive, urinary, sexual, thermoregulatory, pupillary and cardiovascular dysfunction. It is composed of 26 questions. Each question refers to the last month and has a score of 1 to 4 or 5.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the relationship between urinary dysfunction and presence of dysautonomia", "description": "To assess the association between urinary dysfunction and dysautonomia, we will compare the percentage of participants with a UPS score greater than or equal to 1 among participants who have dysautonomia (following the SCOPA-AUT questionnaire, the SUDOSCAN test or the search for orthostatic hypotension), and the percentage of participants with a USP score greater than or equal to 1 among participants without dysautonomia.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the relationship between severity of neurological dysfunction and dysautonomia", "description": "To assess the relationship between severity of neurological dysfunction and dysautonomia, we will calculate the SARA (Scale for the assessement and rating of ataxia) score for each participant and divide patients into 3 subgroups: Group 1 (SARA score \\< 15), Group 2 (SARA score between 15 - 25) and Group 3 (SARA score \\> 25). The SARA score was developed to evaluate the various deficits resulting from cerebellum dysfunction. It is divided into 8 categories with a cumulative score of 0 (without ataxia) to 40 (the most severe form of ataxia): walking, standing, sitting, speaking, finger hunting, nose test - quick alternate hand movements, heel slip - ankle. For items 5 to 8, the assessment is done bilaterally and then the average value is calculated to obtain the final score.\n\nWe will then calculate and compare the percentage of subjects with dysautonomia (following SCOPA AUT questionnaire, SUDOSCAN test or search for orthostatic hypotension) in each SARA score group.", "time_frame": "at inclusion" }, { "type": "secondary", "measure": "Assess the relationship between urinary dysfunction and severity of neurological dysfunction", "description": "To assess the relationship between urinary dysfunction and severity of neurological dysfunction, we will calculate and compare the percentage of subjects with urological symptoms or a USP score greater than or equal to 1 in each SARA score group.", "time_frame": "at inclusion" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06817707", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04170725", "title": "Muscular and Cutaneous Dysfunction in POTS", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-03-10", "start_date": "2020-01-10", "completion_date": "2025-03-03", "primary_completion_date": "2025-03-03", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Patient And Healthy Volunteers Training Protocol" ], "sponsor": "Insel Gruppe AG, University Hospital Bern", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "POTS patients seem to experience orthostasis-dependent muscle weakness and pain as well as increased muscle fatigue upon physical activity, which can be improved by regular aerobic exercise. However, reduced sweat production of the extremities with limited control of the body temperature leads to exercise intolerance, so that sticking to a training program becomes a challenge for most patients. Recordings of MVRCs provide a new tool to assess muscle membrane dysfunction, depending on ischemia, surface temperature and training. As muscle dysfunction is assumed to be present in the majority of POTS patients but has not yet been scientifically studied the present study aims at understanding the muscular and cutaneous functioning in POTS using MVRC recordings, dependent both on orthostatic stress and exercise training as well as body temperature regulation. Our main hypothesis is that POTS patients experience functional muscle dysfunction that may be linked to altered muscle perfusion or body temperature regulation.\n\nThe purpose of this study is to examine muscular and cutaneous dysfunction in POTS in order to i) better understand the underlying pathology for symptoms and to ii) ultimately improve treatment options.", "primary_outcomes": [ { "type": "primary", "measure": "Change of early supernormality in%", "description": "Change of early super normality as the most important parameter of MVRC measurements during HUT and fatigue in patients with neuropathic POTS compared to healthy subjects.", "time_frame": "Day 14" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change of relative refractory period in msec", "description": "During HUT and muscle fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Change of late supernormality period in %", "description": "During HUT and muscle fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Change of early supernormality % after Muscle endurance training", "description": "Muscle endurance training induced changes of MVRC measurements", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Change of relative refractory period in msec after Muscle endurance training", "description": "Muscle endurance training induced changes of MVRC measurements", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Change of late supernormality in % after Muscle endurance training", "description": "Muscle endurance training induced changes of MVRC measurements", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Area of palmar sweat production (in cm2)", "description": "Qualitative sweat production", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Area of plantar sweat production (in cm2)", "description": "Qualitative sweat production", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Skin wrinkling grade", "description": "Skin wrinkling grade", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Intramuscular and skin temperature change", "description": "Intramuscular and skin temperature changes during HUT and fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Recapillarization time at the lower extremities", "description": "Recapillarization time at the lower extremities before and during HUT", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Heart rate changes", "description": "Heart rate changes during HUT and fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Blood pressure changes", "description": "Blood pressure changes during HUT and fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Maximal Tibialis Anterior peak force and endurance time", "description": "Maximal Tibialis Anterior peak force and endurance time before and after training", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Circumference of the lower legs", "description": "Circumference of the lower legs before and after training", "time_frame": "Day 14" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of early supernormality in%", "description": "Change of early super normality as the most important parameter of MVRC measurements during HUT and fatigue in patients with neuropathic POTS compared to healthy subjects.", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Change of relative refractory period in msec", "description": "During HUT and muscle fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Change of late supernormality period in %", "description": "During HUT and muscle fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Change of early supernormality % after Muscle endurance training", "description": "Muscle endurance training induced changes of MVRC measurements", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Change of relative refractory period in msec after Muscle endurance training", "description": "Muscle endurance training induced changes of MVRC measurements", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Change of late supernormality in % after Muscle endurance training", "description": "Muscle endurance training induced changes of MVRC measurements", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Area of palmar sweat production (in cm2)", "description": "Qualitative sweat production", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Area of plantar sweat production (in cm2)", "description": "Qualitative sweat production", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Skin wrinkling grade", "description": "Skin wrinkling grade", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Intramuscular and skin temperature change", "description": "Intramuscular and skin temperature changes during HUT and fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Recapillarization time at the lower extremities", "description": "Recapillarization time at the lower extremities before and during HUT", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Heart rate changes", "description": "Heart rate changes during HUT and fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Blood pressure changes", "description": "Blood pressure changes during HUT and fatigue", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Maximal Tibialis Anterior peak force and endurance time", "description": "Maximal Tibialis Anterior peak force and endurance time before and after training", "time_frame": "Day 14" }, { "type": "secondary", "measure": "Circumference of the lower legs", "description": "Circumference of the lower legs before and after training", "time_frame": "Day 14" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 15, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04170725", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05454137", "title": "A Shared Medical Appointment Intervention for Quality of Life Improvement in POTS", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-03-05", "start_date": "2023-11-01", "completion_date": "2024-12-01", "primary_completion_date": "2024-08-01", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Shared Medical Appointment" ], "sponsor": "University of Arizona", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural orthostatic tachycardia syndrome (POTS) is a clinical syndrome encompassing a myriad of debilitating symptoms that does not have any FDA approved drug therapies. We propose a shared medical appointment intervention where participants will learn lifestyle management therapies and integrative practices that may improve quality of life.", "primary_outcomes": [ { "type": "primary", "measure": "Recruitment and retention rate", "description": "Percentage of participants who consent to study participation, attend sessions, and complete the program and scheduled outcome assessments", "time_frame": "at 4 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in COMPASS overall score", "description": "The Composite Autonomic Symptom Score is a self-assessment of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor.", "time_frame": "Baseline and 4 months" }, { "type": "secondary", "measure": "Change on Short Form Survey (SF-36) overall score", "description": "The 36-Item Short Form Survey (SF-36), is a self assessment of vitality, physical functioning, bodily pain, health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health", "time_frame": "Baseline and 4 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Recruitment and retention rate", "description": "Percentage of participants who consent to study participation, attend sessions, and complete the program and scheduled outcome assessments", "time_frame": "at 4 months" }, { "type": "secondary", "measure": "Change in COMPASS overall score", "description": "The Composite Autonomic Symptom Score is a self-assessment of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor.", "time_frame": "Baseline and 4 months" }, { "type": "secondary", "measure": "Change on Short Form Survey (SF-36) overall score", "description": "The 36-Item Short Form Survey (SF-36), is a self assessment of vitality, physical functioning, bodily pain, health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health", "time_frame": "Baseline and 4 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 10, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05454137", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06795750", "title": "The Effect of Neural Therapy on Heart Rate Recovery, Cardiac Parameters and Pain in Fibromyalgia", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-01-28", "start_date": "2023-11-01", "completion_date": "2024-05-30", "primary_completion_date": "2024-04-30", "conditions_raw": [ "Fibromyalgia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Neural Therapy", "Exercise" ], "sponsor": "Uşak University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Background: Autonomic dysfunction has been observed in patients with fibromyalgia and is associated with symptoms and arrhythmia development in such patients.The investigators can analyze dysautonomia using heart rate recovery (HRR). Studies have reported that impaired HRR improves after exercise in fibromyalgia patients. Although previous theories have suggested that neural therapy benefits fibromyalgia patients by regulating autonomic dysfunction, there are no studies in the literature reporting that neural therapy improves autonomic dysfunction.\n\nAims: The purpose of the present study was to compare whether neural therapy + exercise therapy provided more improvement in impaired HRR, cardiac parameters, and pain levels than exercise alone therapy in fibromyalgia patients with autonomic dysfunction.\n\nMethods: The study included sixty female patients diagnosed with fibromyalgia and impaired HRR, all over the age of 18. The investigators divided the patients into two groups: the exercise-alone group and the neural therapy + exercise group.", "primary_outcomes": [ { "type": "primary", "measure": "Changes in impaired heart rate recovery", "description": "Heart rate recovery (HRR) can be calculated by subtracting the heart rate at the 30th second or 1st, 2nd, 3rd, 4th, 5th, and 10th minutes during the post-exercise recovery period from the maximum heart rate during the treadmill exercise test (the most commonly used is the 1st minute \\[HRR60 s\\] and the 2nd minute \\[HRR120\\]). An abnormal HRR index was defined as a drop in the heart rate of less than 12 beats in the first minute and 22 beats in the second minute during the resting period (HRR60 s \\<12) (HRR120 s \\<22).", "time_frame": "From enrollment to the end of treatment at 5 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes in pain levels in fibromiyalgia patients", "description": "The pain level was assessed with the Visual Analog Scale (VAS) using a 10-cm ruler. All patients were told that no pain corresponded to 0, the most severe pain to 10, and moderate pain to five points and asked to describe their pain accordingly.", "time_frame": "From enrollment to the end of treatment at 5 weeks" }, { "type": "secondary", "measure": "Changes in heart rate", "description": "Heart rate number of cardiac cycles in beats per min.", "time_frame": "From enrollment to the end of treatment at 5 weeks" }, { "type": "secondary", "measure": "Changes in blood pressure", "description": "BP measurement was performed using the Omron HEM 907 oscillometric monitor (Omron Healthcare) with a cuff size appropriate for the arm. The monitor was programmed such that the cuff did not start to inflate until the participant rested quietly for 5 minutes in a seated position with the arm at the level of the heart.", "time_frame": "From enrollment to the end of treatment at 5 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Changes in impaired heart rate recovery", "description": "Heart rate recovery (HRR) can be calculated by subtracting the heart rate at the 30th second or 1st, 2nd, 3rd, 4th, 5th, and 10th minutes during the post-exercise recovery period from the maximum heart rate during the treadmill exercise test (the most commonly used is the 1st minute \\[HRR60 s\\] and the 2nd minute \\[HRR120\\]). An abnormal HRR index was defined as a drop in the heart rate of less than 12 beats in the first minute and 22 beats in the second minute during the resting period (HRR60 s \\<12) (HRR120 s \\<22).", "time_frame": "From enrollment to the end of treatment at 5 weeks" }, { "type": "secondary", "measure": "Changes in pain levels in fibromiyalgia patients", "description": "The pain level was assessed with the Visual Analog Scale (VAS) using a 10-cm ruler. All patients were told that no pain corresponded to 0, the most severe pain to 10, and moderate pain to five points and asked to describe their pain accordingly.", "time_frame": "From enrollment to the end of treatment at 5 weeks" }, { "type": "secondary", "measure": "Changes in heart rate", "description": "Heart rate number of cardiac cycles in beats per min.", "time_frame": "From enrollment to the end of treatment at 5 weeks" }, { "type": "secondary", "measure": "Changes in blood pressure", "description": "BP measurement was performed using the Omron HEM 907 oscillometric monitor (Omron Healthcare) with a cuff size appropriate for the arm. The monitor was programmed such that the cuff did not start to inflate until the participant rested quietly for 5 minutes in a seated position with the arm at the level of the heart.", "time_frame": "From enrollment to the end of treatment at 5 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06795750", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05796154", "title": "POTS Stroke Volume", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2024-12-19", "start_date": "2025-06-01", "completion_date": "2026-12-31", "primary_completion_date": "2025-12-31", "conditions_raw": [ "POTS" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Ear Blood Pressure Monitor" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "the investigators propose studies of a tiny, wearable, wireless, beat-to-beat blood pressure monitor that will be both a transformative research platform and an enabler of patient self-care in the diagnosis, investigation, and management of POTS.", "primary_outcomes": [ { "type": "primary", "measure": "the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.", "description": "that stroke volume can be accurately estimated based on ambulatory blood pressure and heart rate sequences and will diagnose POTS in patients at home, reflect clinical status, and be suitable for multicenter studies.", "time_frame": "10 minutes pre-intervention (Cardiac MRI)" }, { "type": "primary", "measure": "the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.", "description": "that stroke volume can be accurately estimated based on ambulatory blood pressure and heart rate sequences and will diagnose POTS in patients at home, reflect clinical status, and be suitable for multicenter studies.", "time_frame": "10 minutes post-intervention( cardiac MRI)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.", "description": "that stroke volume can be accurately estimated based on ambulatory blood pressure and heart rate sequences and will diagnose POTS in patients at home, reflect clinical status, and be suitable for multicenter studies.", "time_frame": "10 minutes pre-intervention (Cardiac MRI)" }, { "type": "primary", "measure": "the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.", "description": "that stroke volume can be accurately estimated based on ambulatory blood pressure and heart rate sequences and will diagnose POTS in patients at home, reflect clinical status, and be suitable for multicenter studies.", "time_frame": "10 minutes post-intervention( cardiac MRI)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05796154", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05664711", "title": "Effect of Stellate Ganglion Block on ME/CFS", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2024-12-06", "start_date": "2023-03-15", "completion_date": "2024-01-15", "primary_completion_date": "2023-12-21", "conditions_raw": [ "Encephalomyelitis, Myalgic", "Chronic Fatigue Syndrome", "Chronic Fatigue Disorder", "Chronic Fatigue and Immune Dysfunction Syndrome", "Myalgic Encephalomyelitis", "Postviral Fatigue Syndrome", "Systemic Exertion Intolerance Disease", "Infectious Mononucleosis-Like Syndrome, Chronic", "Chronic Fatigue-Fibromyalgia Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Bupivacaine Injection" ], "sponsor": "Neuroversion, Inc.", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to study the effects of stellate ganglion block (SGB) in participants with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The main questions it aims to answer are:\n\nDoes SGB treatment improve symptoms of ME/CFS (e.g. brain fog, fatigue)? Do changes in symptoms go along with changes in blood or saliva?\n\nParticipants will receive a total of six blocks over three weeks (one block on each side, one day apart, per week). Prior to treatment and at two points following treatment, participants will complete surveys, take a cognitive (puzzle type) test, and provide blood and saliva for analysis. Participants will measure their heart rate daily using a free smart phone app.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Subjective Rating of Symptoms at 2 Weeks", "description": "The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two weeks for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation).", "time_frame": "2 weeks" }, { "type": "primary", "measure": "Change in Subjective Rating of Symptoms at 2 Months", "description": "The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two months for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation).", "time_frame": "2 months" }, { "type": "primary", "measure": "Change in Cognitive Function at 2 Weeks", "description": "The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces \"brain fog\" as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two weeks post-treatment.", "time_frame": "2 weeks" }, { "type": "primary", "measure": "Change in Cognitive Function at 2 Months", "description": "The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces \"brain fog\" as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two months post-treatment.", "time_frame": "2 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Orthostatic Tolerance at 2 Weeks", "description": "The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used to measure hemodynamic changes during orthostatic challenge (lying down vs. standing up). The study will measure change from baseline at 2 weeks post-treatment.", "time_frame": "2 weeks" }, { "type": "secondary", "measure": "Change in Orthostatic Tolerance at 2 Months", "description": "The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used to measure hemodynamic changes during orthostatic challenge (lying down vs. standing up). The study will measure change from baseline at 2 months post-treatment.", "time_frame": "2 months" }, { "type": "secondary", "measure": "Change in Autonomic Tone at 2 Weeks", "description": "A wearable device (a ring worn on a finger at night) will be used to measure resting heart rate (beats per minute), heart rate variability (milliseconds), and blood oxygenation (percentage oxygen aka SpO2) during the night and for 5 minutes upon awakening, in combination with a smart phone app, at baseline and two weeks after treatment. These parameters reflect the balance between sympathetic and parasympathetic nervous systems (aka \"autonomic tone\"). ME/CFS patients are known to have excessive sympathetic tone. Within normal levels, better outcomes are indicated by lower resting heart rate, increased heart rate variability, and increased blood oxygenation.", "time_frame": "2 weeks" }, { "type": "secondary", "measure": "Change in Autonomic Tone at 2 Months", "description": "A wearable device (a ring worn on a finger at night) will be used to measure resting heart rate (beats per minute), heart rate variability (milliseconds), and blood oxygenation (percentage oxygen aka SpO2) during the night and for 5 minutes upon awakening, in combination with a smart phone app, at baseline and two months after treatment. These parameters reflect the balance between sympathetic and parasympathetic nervous systems (aka \"autonomic tone\"). ME/CFS patients are known to have excessive sympathetic tone. Within normal levels, better outcomes are indicated by lower resting heart rate, increased heart rate variability, and increased blood oxygenation compared to baseline.", "time_frame": "2 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Subjective Rating of Symptoms at 2 Weeks", "description": "The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two weeks for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation).", "time_frame": "2 weeks" }, { "type": "primary", "measure": "Change in Subjective Rating of Symptoms at 2 Months", "description": "The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment improves the subjective rating of symptoms (severity and frequency) and the amount of limitations to activities. We will measure the change from baseline scores at two months for the DePaul Symptom Questionnaire to measure the frequency and severity of symptoms (on a scale of 0 to 4 in which a higher score indicates more frequent or more severe) and the Rand Short Form-36-Physical Fatigue subscale (SF-36PF) to measure the amount of limitations due to symptoms (on a scale of 1-3 in which a higher score indicates less limitation).", "time_frame": "2 months" }, { "type": "primary", "measure": "Change in Cognitive Function at 2 Weeks", "description": "The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces \"brain fog\" as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two weeks post-treatment.", "time_frame": "2 weeks" }, { "type": "primary", "measure": "Change in Cognitive Function at 2 Months", "description": "The primary objective of the clinical trial is to evaluate whether stellate ganglion block treatment reduces \"brain fog\" as measured by computerized neurocognitive tests for attention, executive function, and memory. Scores are standardized and scaled to adjust for age and the device on which tests are taken. Scores range from 0 to 200, in which the average score (corresponding to the 50th percentile) is set to 100, and higher scores indicate better cognitive function. Scores are obtained for attention, executive function, and memory. Scores at baseline will be compared to scores at two months post-treatment.", "time_frame": "2 months" }, { "type": "secondary", "measure": "Change in Orthostatic Tolerance at 2 Weeks", "description": "The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used to measure hemodynamic changes during orthostatic challenge (lying down vs. standing up). The study will measure change from baseline at 2 weeks post-treatment.", "time_frame": "2 weeks" }, { "type": "secondary", "measure": "Change in Orthostatic Tolerance at 2 Months", "description": "The 10-minute National Aeronautics and Space Administration (NASA) lean test will be used to measure hemodynamic changes during orthostatic challenge (lying down vs. standing up). The study will measure change from baseline at 2 months post-treatment.", "time_frame": "2 months" }, { "type": "secondary", "measure": "Change in Autonomic Tone at 2 Weeks", "description": "A wearable device (a ring worn on a finger at night) will be used to measure resting heart rate (beats per minute), heart rate variability (milliseconds), and blood oxygenation (percentage oxygen aka SpO2) during the night and for 5 minutes upon awakening, in combination with a smart phone app, at baseline and two weeks after treatment. These parameters reflect the balance between sympathetic and parasympathetic nervous systems (aka \"autonomic tone\"). ME/CFS patients are known to have excessive sympathetic tone. Within normal levels, better outcomes are indicated by lower resting heart rate, increased heart rate variability, and increased blood oxygenation.", "time_frame": "2 weeks" }, { "type": "secondary", "measure": "Change in Autonomic Tone at 2 Months", "description": "A wearable device (a ring worn on a finger at night) will be used to measure resting heart rate (beats per minute), heart rate variability (milliseconds), and blood oxygenation (percentage oxygen aka SpO2) during the night and for 5 minutes upon awakening, in combination with a smart phone app, at baseline and two months after treatment. These parameters reflect the balance between sympathetic and parasympathetic nervous systems (aka \"autonomic tone\"). ME/CFS patients are known to have excessive sympathetic tone. Within normal levels, better outcomes are indicated by lower resting heart rate, increased heart rate variability, and increased blood oxygenation compared to baseline.", "time_frame": "2 months" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 10, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05664711", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04943276", "title": "A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-10-08", "start_date": "2022-02-27", "completion_date": "2023-11-03", "primary_completion_date": "2023-11-03", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Embr Device" ], "sponsor": "Stanford University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators hope to learn the feasibility and preliminary efficacy of the Embr device for improving thermal comfort in individuals with POTS and impaired thermoregulation. Feasibility will be assessed via usage of the Embr device and participant feedback. Preliminary efficacy measures will include temperature-related symptoms and temperature- related quality of life in individuals with POTS and impaired thermoregulation.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in Compass-31 survey at study endpoint", "description": "Compass 31 score ranges in value from 0 to 100. A score of 0 indicates no autonomic symptoms, while more-severe autonomic symptoms correspond to higher values.", "time_frame": "Baseline and end of study ( 4 weeks)" }, { "type": "primary", "measure": "Change from baseline in Pittsburg Sleep Quality Index (PSQI) at study endpoint", "description": "PSQI score ranges in value from 0 to 21. A score of 0 indicates no sleep difficulties, while more-severe sleep difficulties correspond to higher values.", "time_frame": "Baseline and end of study ( 4 weeks)" }, { "type": "primary", "measure": "Change from baseline in Insomnia Severity Scale Index (ISI) at study endpoint", "description": "Scale range is 0-28, with 0 indicating absence of insomnia and 28 indicating severe insomnia.", "time_frame": "Baseline and end of study ( 4 weeks)" }, { "type": "primary", "measure": "Temperature Quality of life Questionnaire", "description": "", "time_frame": "Week 1,2,3,4" }, { "type": "primary", "measure": "Temperature related daily interference scale", "description": "Scale range is 0-100, with a higher score indicating more problems with thermoregulation.", "time_frame": "Week 1,2,3,4" }, { "type": "primary", "measure": "OCEAN Temperature Related Psychogenic Questionnaire", "description": "", "time_frame": "Week 1,2,3,4" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in Compass-31 survey at study endpoint", "description": "Compass 31 score ranges in value from 0 to 100. A score of 0 indicates no autonomic symptoms, while more-severe autonomic symptoms correspond to higher values.", "time_frame": "Baseline and end of study ( 4 weeks)" }, { "type": "primary", "measure": "Change from baseline in Pittsburg Sleep Quality Index (PSQI) at study endpoint", "description": "PSQI score ranges in value from 0 to 21. A score of 0 indicates no sleep difficulties, while more-severe sleep difficulties correspond to higher values.", "time_frame": "Baseline and end of study ( 4 weeks)" }, { "type": "primary", "measure": "Change from baseline in Insomnia Severity Scale Index (ISI) at study endpoint", "description": "Scale range is 0-28, with 0 indicating absence of insomnia and 28 indicating severe insomnia.", "time_frame": "Baseline and end of study ( 4 weeks)" }, { "type": "primary", "measure": "Temperature Quality of life Questionnaire", "description": "", "time_frame": "Week 1,2,3,4" }, { "type": "primary", "measure": "Temperature related daily interference scale", "description": "Scale range is 0-100, with a higher score indicating more problems with thermoregulation.", "time_frame": "Week 1,2,3,4" }, { "type": "primary", "measure": "OCEAN Temperature Related Psychogenic Questionnaire", "description": "", "time_frame": "Week 1,2,3,4" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 23, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04943276", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03365414", "title": "A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS", "status": "WITHDRAWN", "phase": "PHASE3", "last_updated": "2024-09-19", "start_date": "2022-01", "completion_date": "2024-03", "primary_completion_date": "2023-10", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Albumin (Human) 5%, Usp" ], "sponsor": "University of Alberta", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "POTS is a relatively common condition that affects millions of patients around the globe. It has an estimated prevalence of 170/100,000 with approximately 80% of patients being women of childbearing age. POTS is characterized by an excessive heart rate increase on assuming an upright posture, either standing or even sitting and leading to disabling palpitations, light-headedness, and even in syncope in severe cases. More than 95% patients with POTS have pronounced cardiovascular deconditioning and show marked exercise intolerance. The severity of POTS is variable. In mild cases the affected patient may continue with routine activities with minimal limitations. Severe form of the disease precludes most normal life activities, such as sitting upright, walking or standing to perform even basic house chores. An estimated 40% of patients with POTS have a resistant form of the condition that is nonresponsive or mildly responsive to all treatments resulting in continued functional limitations in the long term.\n\nMany of the currently available treatments in POTS are geared towards increasing blood pressure. These include compression stockings, increased daily fluid intake and increased salt ingestion. Saline infusions may be helpful in certain patients in the short term, though many do not respond. The effectiveness of medications varies greatly, with many patient failing to improve.\n\nA small series of clinical patients suffering from severe POTS have shown robust response to weekly albumin therapy, which supports the hypothesis that periodic albumin infusions will provide significant and sustained symptomatic relief to patients with severe POTS.\n\nThis pilot study will explore the effectiveness of albumin infusions as a treatment for POTS. Eligible patients will receive weekly intravenous infusions of 5% Albumin or Saline in a double blinded fashion for 4 weeks and will crossover to the other infusion for 4 weeks after an intervening 4-week washout period. The participants will be required to maintain a daily diary of their symptoms during the screening, the study and washout periods. Any possible adverse effects as the result of infusions will be documented. Outcome measures will be quantified and validated at the end of each study period and the percentage reduction of tachycardia will be determined at the completion of each study arm.", "primary_outcomes": [ { "type": "primary", "measure": "Severity of Orthostatic Intolerance", "description": "Self-reported severity of orthostatic intolerance assessed by the Orthostatic Symptom Grading Scale (OSGS) scores. Recorded daily. Each item is scored 0-4 (0= lowest severity; 4=greatest severity), yielding a total between 0 and 25.", "time_frame": "Change in Orthostatic Symptom Grading Scale (OSGS) scores from baseline to end of first arm (1-4 weeks), from end of washout (5-8 weeks) to end of second arm (9-12 weeks) and at end of study (16 week duration)." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Disability Assessment", "description": "The Health Assessment Questionnaire (HAQ) score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).", "time_frame": "Weekly through study completion, 16 week duration" }, { "type": "secondary", "measure": "Degree of cardiovascular improvement - Heart rate", "description": "Degree of improvement from baseline in the severity of tachycardia (beats per minute) on a 10-minute head up tilt table test (HUTT). The tilt table test will be performed at baseline and at the end-points of each arm of the study to measure degree of heart rate increment and pulse pressure reduction within 10 minutes of assuming an upright posture.", "time_frame": "Changes in heart rate (BPM) from baseline to end of first arm (1-4 weeks), from end of washout (5-8 weeks) to end of second arm (9-12 weeks) and at end of study (16 week duration)." }, { "type": "secondary", "measure": "Degree of cardiovascular improvement - Pulse", "description": "Degree of improvement from baseline in the pulse pressure (mm Hg) on a 10-minute head up tilt table test (HUTT). The tilt table test will be performed at baseline and at the end-points of each arm of the study to measure degree of heart rate increment and pulse pressure reduction within 10 minutes of assuming an upright posture.", "time_frame": "Changes in blood pressure (mm Hg) from baseline to end of first arm (1-4 weeks), from end of washout (5-8 weeks) to end of second arm (9-12 weeks) and at end of study (16 week duration)." }, { "type": "secondary", "measure": "Change in maximal exercise capacity - Cardiopulmonary exercise testing", "description": "Cardiopulmonary exercise testing (CPX) using breath by breath gas-analysis measures variables related to cardiorespiratory function, including expiratory ventilation and pulmonary gas exchange (oxygen uptake (VO2) and carbon dioxide (VCO2).The standard expression of aerobic working capacity is the maximum VO2.\n\nVO2 max reached during a symptom-limited incremental CPX protocol is commonly expressed as O2 per kg-1 per min -1.", "time_frame": "Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration)." }, { "type": "secondary", "measure": "Change in maximal exercise capacity - Electrocardiogram", "description": "Electrocardiogram (ECG) measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise.", "time_frame": "Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration)." }, { "type": "secondary", "measure": "Change in maximal exercise capacity - Heart rate", "description": "Pulse measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise.", "time_frame": "Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration)." }, { "type": "secondary", "measure": "Change in maximal exercise capacity - Blood Pressure", "description": "Blood pressure measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise.", "time_frame": "Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration)." } ], "outcome_measures": [ { "type": "primary", "measure": "Severity of Orthostatic Intolerance", "description": "Self-reported severity of orthostatic intolerance assessed by the Orthostatic Symptom Grading Scale (OSGS) scores. Recorded daily. Each item is scored 0-4 (0= lowest severity; 4=greatest severity), yielding a total between 0 and 25.", "time_frame": "Change in Orthostatic Symptom Grading Scale (OSGS) scores from baseline to end of first arm (1-4 weeks), from end of washout (5-8 weeks) to end of second arm (9-12 weeks) and at end of study (16 week duration)." }, { "type": "secondary", "measure": "Disability Assessment", "description": "The Health Assessment Questionnaire (HAQ) score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).", "time_frame": "Weekly through study completion, 16 week duration" }, { "type": "secondary", "measure": "Degree of cardiovascular improvement - Heart rate", "description": "Degree of improvement from baseline in the severity of tachycardia (beats per minute) on a 10-minute head up tilt table test (HUTT). The tilt table test will be performed at baseline and at the end-points of each arm of the study to measure degree of heart rate increment and pulse pressure reduction within 10 minutes of assuming an upright posture.", "time_frame": "Changes in heart rate (BPM) from baseline to end of first arm (1-4 weeks), from end of washout (5-8 weeks) to end of second arm (9-12 weeks) and at end of study (16 week duration)." }, { "type": "secondary", "measure": "Degree of cardiovascular improvement - Pulse", "description": "Degree of improvement from baseline in the pulse pressure (mm Hg) on a 10-minute head up tilt table test (HUTT). The tilt table test will be performed at baseline and at the end-points of each arm of the study to measure degree of heart rate increment and pulse pressure reduction within 10 minutes of assuming an upright posture.", "time_frame": "Changes in blood pressure (mm Hg) from baseline to end of first arm (1-4 weeks), from end of washout (5-8 weeks) to end of second arm (9-12 weeks) and at end of study (16 week duration)." }, { "type": "secondary", "measure": "Change in maximal exercise capacity - Cardiopulmonary exercise testing", "description": "Cardiopulmonary exercise testing (CPX) using breath by breath gas-analysis measures variables related to cardiorespiratory function, including expiratory ventilation and pulmonary gas exchange (oxygen uptake (VO2) and carbon dioxide (VCO2).The standard expression of aerobic working capacity is the maximum VO2.\n\nVO2 max reached during a symptom-limited incremental CPX protocol is commonly expressed as O2 per kg-1 per min -1.", "time_frame": "Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration)." }, { "type": "secondary", "measure": "Change in maximal exercise capacity - Electrocardiogram", "description": "Electrocardiogram (ECG) measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise.", "time_frame": "Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration)." }, { "type": "secondary", "measure": "Change in maximal exercise capacity - Heart rate", "description": "Pulse measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise.", "time_frame": "Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration)." }, { "type": "secondary", "measure": "Change in maximal exercise capacity - Blood Pressure", "description": "Blood pressure measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise.", "time_frame": "Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration)." } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 3", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT03365414", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03919773", "title": "IVIG (Gamunex-C) Treatment Study for POTS Subjects", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2024-09-19", "start_date": "2018-10-29", "completion_date": "2023-12-01", "primary_completion_date": "2023-06-26", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "IVIG (Intravenous Immunoglobulin)", "Albumin" ], "sponsor": "University of Texas Southwestern Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this trial is to evaluate the symptomatic benefits of immunomodulatory treatment with IVIG for POTS (postural tachycardia syndrome) patients with evidence of autoimmunity.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Symptoms Measured by Change in COMPASS-31 Score (After Initial Treatment Phase)", "description": "Primary outcome was change in autonomic symptom burden, assessed by total COMPASS-31 (sum of scaled subscores), comparing assessment at week 13 (2 weeks after final infusion) minus the assessment at baseline. This questionnaire generates a weighted score from 0 to 100, and questions fall into one of six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor function. A COMPASS-31 (Composite Autonomic Symptom Score-31) score of ≥20 suggests moderate-to-severe autonomic dysfunction.\n\nHigher scores indicate more severe symptoms. A reduction in score (negative change over time) indicates better outcome or response to treatment.", "time_frame": "Baseline,13 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Number of Participants With Clinical Improvement", "description": "The count of participants with clinical improvement at 13 weeks is being reported here. Clinical improvement was defined as a reduction of the COMPASS-31 total score by 20% or more. Lower scores are associated with improvement and a 20% reduction was used as a meaningful change in previous studies of POTS", "time_frame": "13 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Symptoms Measured by Change in COMPASS-31 Score (After Initial Treatment Phase)", "description": "Primary outcome was change in autonomic symptom burden, assessed by total COMPASS-31 (sum of scaled subscores), comparing assessment at week 13 (2 weeks after final infusion) minus the assessment at baseline. This questionnaire generates a weighted score from 0 to 100, and questions fall into one of six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor function. A COMPASS-31 (Composite Autonomic Symptom Score-31) score of ≥20 suggests moderate-to-severe autonomic dysfunction.\n\nHigher scores indicate more severe symptoms. A reduction in score (negative change over time) indicates better outcome or response to treatment.", "time_frame": "Baseline,13 weeks" }, { "type": "secondary", "measure": "Number of Participants With Clinical Improvement", "description": "The count of participants with clinical improvement at 13 weeks is being reported here. Clinical improvement was defined as a reduction of the COMPASS-31 total score by 20% or more. Lower scores are associated with improvement and a 20% reduction was used as a meaningful change in previous studies of POTS", "time_frame": "13 weeks" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03919773", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05409651", "title": "Phenotyping Mitochondrial and Immune Dysfunction in POTS With Targeted Clinical Intervention.", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-08-20", "start_date": "2022-07-01", "completion_date": "2025-06", "primary_completion_date": "2024-05-10", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Time Restricted Eating" ], "sponsor": "University of California, San Diego", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The mechanisms underlying POTS are not well understood. Though heterogeneous in nature, patients often present with symptoms that include fatigue, orthostatic lightheadedness and tachycardia, \"brain fog\", shortness of breath, and sleep disruption. The central mediator that links observations in disease entities similar to POTS is energy use and balance driven by mitochondrial health. Mitochondrial dysfunction (i.e. respiration defects, reactive oxygen species (ROS) generation, and structural abnormalities) are hallmarks of currently defined syndromes that resemble POTS symptomatology. Many patients with POTS have underlying immune system dysfunction, which, when treated, may improve the patient's overall health. Though autoimmunity has been demonstrated in POTS, overall immune dysregulation may be broader and include immune cell exhaustion and persistent inflammatory cytokine responses. Immune dysfunction including cellular exhaustion and persistent inflammation has been linked to mitochondrial function. Therefore, we hypothesize that a unifying feature of POTS results from latent or continued mitochondrial/immune dysfunction which then impacts multi-organ energy imbalance and immune homeostasis. Understanding and targeting mitochondria utilizing established, novel, and directed approaches including time-restricted eating (TRE) will help to unravel common etiologies and help us to better diagnose, manage, and treat POTS.", "primary_outcomes": [ { "type": "primary", "measure": "Conduct a pilot clinical trial with POTS patients to assess if TRE can improve Quality of Life.", "description": "Intervention with TRE will significantly improve quality of life (QOL). We will conduct a 12-week intervention with POTS patients to assess the impact of TRE on QOL (primary endpoint) utilizing the quality of life questionnaire SF-36..", "time_frame": "Change from Baseline quality of life questionnaire at 14 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Conduct a pilot clinical trial with POTS patients to assess if TRE can improve Quality of Life.", "description": "Intervention with TRE will significantly improve quality of life (QOL). We will conduct a 12-week intervention with POTS patients to assess the impact of TRE on QOL (primary endpoint) utilizing the quality of life questionnaire SF-36..", "time_frame": "Change from Baseline quality of life questionnaire at 14 weeks" } ], "relevance_tags": [ "Metabolic", "Immunomodulatory", "Mitochondrial", "Neurological / Autonomic", "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 25, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05409651", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06554834", "title": "Effects of Osteopathic Technique on Autonomic Nervous System Activity", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-08-16", "start_date": "2024-06-20", "completion_date": "2024-11-10", "primary_completion_date": "2024-10-20", "conditions_raw": [ "Healthy", "Dysautonomia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Cv4 + Rr", "Cv4", "Eeg/Hrv/Rsa (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring Using Infiniti System" ], "sponsor": "SomaticMed", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Cranial osteopathic manipulation technique for brain and cranial nerve function, known as the fourth ventricle compression (CV4), has been recognized. Rib raising (RR), aimed at reducing rib restriction and conditions associated with sympathetic hypertonia, is also employed. This study aimed to assess, in about 109 healthy individuals, the effects of osteopathic techniques (CV4 and RR) on autonomic nervous system (ANS) activity, as measured by heart rate variability (HRV).", "primary_outcomes": [ { "type": "primary", "measure": "Heart Rate Variability (HRV)", "description": "Changes in Heart Rate Variability will be assessed to evaluate the overall autonomic nervous system (ANS) function. HRV will be measured using the standard deviation of normal-to-normal intervals (SDNN) and other relevant time-domain and frequency-domain parameters. Measurements will be taken before the intervention, immediately after the third session, and one month after the final session to evaluate both immediate and sustained effects.", "time_frame": "Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up)." }, { "type": "primary", "measure": "High-Frequency Power (HF)", "description": "The HF component of HRV, which reflects parasympathetic (vagal) activity, will be measured. Changes in HF power will indicate the impact of the osteopathic techniques on parasympathetic regulation. HF power will be expressed in absolute units (ms²) and as a normalized unit.", "time_frame": "Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up)." }, { "type": "primary", "measure": "Low-Frequency Power (LF", "description": "The LF component of HRV, associated with both sympathetic and parasympathetic activity, will be assessed. LF power will be measured to understand its modulation through the interventions. LF power will be reported in absolute units (ms²) and as a normalized unit.", "time_frame": "Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up)." }, { "type": "primary", "measure": "LF/HF Ratio", "description": "The ratio of LF to HF power (LF/HF) will be analyzed as an indicator of the balance between sympathetic and parasympathetic nervous system activity. This measure will help determine the relative predominance of each branch of the autonomic nervous system in response to the osteopathic interventions.", "time_frame": "Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up)." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Heart Rate Variability (HRV)", "description": "Changes in Heart Rate Variability will be assessed to evaluate the overall autonomic nervous system (ANS) function. HRV will be measured using the standard deviation of normal-to-normal intervals (SDNN) and other relevant time-domain and frequency-domain parameters. Measurements will be taken before the intervention, immediately after the third session, and one month after the final session to evaluate both immediate and sustained effects.", "time_frame": "Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up)." }, { "type": "primary", "measure": "High-Frequency Power (HF)", "description": "The HF component of HRV, which reflects parasympathetic (vagal) activity, will be measured. Changes in HF power will indicate the impact of the osteopathic techniques on parasympathetic regulation. HF power will be expressed in absolute units (ms²) and as a normalized unit.", "time_frame": "Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up)." }, { "type": "primary", "measure": "Low-Frequency Power (LF", "description": "The LF component of HRV, associated with both sympathetic and parasympathetic activity, will be assessed. LF power will be measured to understand its modulation through the interventions. LF power will be reported in absolute units (ms²) and as a normalized unit.", "time_frame": "Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up)." }, { "type": "primary", "measure": "LF/HF Ratio", "description": "The ratio of LF to HF power (LF/HF) will be analyzed as an indicator of the balance between sympathetic and parasympathetic nervous system activity. This measure will help determine the relative predominance of each branch of the autonomic nervous system in response to the osteopathic interventions.", "time_frame": "Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up)." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 109, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06554834", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06017232", "title": "Telerehabilitation for Dysautonomia in Parkinson's Disease", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-05-23", "start_date": "2023-06-13", "completion_date": "2024-04-30", "primary_completion_date": "2024-04-30", "conditions_raw": [ "Parkinson Disease" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Hybrid Telerehabilitation Program" ], "sponsor": "Université de Sherbrooke", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "People diagnosed with Parkinson's Disease (PD) exhibit a combination of motor and non-motor symptoms, with the latter posing challenges in terms of identification and management. These non-motor symptoms tend to manifest before the motor symptoms and progressively worsen over time, significantly impacting the symptoms and everyday life activities of those affected. However, there remains a noticeable lack of scientific literature addressing the assessment and rehabilitation of cardiovascular dysautonomia in PD patients. Thus, our research aims to address this gap by pursuing the following objectives: 1) assess the feasibility, acceptability, and potential effectiveness of a hybrid telerehabilitation program designed to target cardiovascular health in individuals with Parkinson's disease; and 2) characterize cardiovascular dysautonomia using non-invasive measurements of cardiovascular and autonomic nervous system (ANS) function and self-reported symptom assessments.", "primary_outcomes": [ { "type": "primary", "measure": "Feasibility of the implementation", "description": "This will be evaluated by the percentage of participants that accepted to participate in the study (recruitment rate), percentage who completed the intervention (retention rate) and number of completed session in relation to the anticipated number of sessions (adherence).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Acceptability", "description": "The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Dysautonomia Symptoms", "description": "Scale for Outcomes in Parkinson's disease for Autonomic symptoms (SCOPA-AUT) with maximum score 69, with the score for each item ranging from 0 (never experiencing the symptom) to 3 (often experiencing the symptom).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Impact of dysautonomia symptoms", "description": "Orthostatic Hypotension Questionnaire (OHQ): The questionnaire is divided into 2 parts: Part I, Symptom Assessment (OHSA), consisted of 6 questions, each rat-ing the intensity of one characteristic symptom \\[ 1. Dizziness, lightheadedness, feeling faint, or feeling Iike you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; 6. Head/neck dis-comfort\\] and Part Il, Daily Activity Scale (OHDAS), consisted of 4 questions that assessed the impact of NOH symptoms on daily activities.\n\nItems scored on an 11-point scale (0 to 10), with O indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. The composite OHQ score is calculated by averaging the OHSAS and the OHDAS.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Exercise capacity", "description": "Six-minute walk test (performance and physiological responses)", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Severity of pain and impact on functioning", "description": "Brief Pain Inventory: Participants are asked to rate their current symptoms, their average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 0 to 10. A total pain severity score can be found by averaging these items or a single item can be treated as the primary outcome measure.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Type of pain", "description": "Neuropathic pain DN4 Questionnaire: Items are scored based on a yes (1 point) /no (0 points) answer. This leads to a score range of 0-10 when the symptoms (range 0-7 points) as well as the signs (range 0-3 points) items are included.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Perceived quality of life", "description": "Parkinson's Disease Questionnaire 8 items (PDQ-8, scored 0-32, higher score indicating the worst quality of life)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Lower-limb function", "description": "Lower Extremity Functional Scale (LEFS, scored 0-32, higher score indicating less difficulty)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Mobility in the community", "description": "Life-space mobility (French-Canadian version) (partial scores are summed to produce a composite score 0-120, higher score indicating more mobility)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Mobility", "description": "Timed Up and Go", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Balance", "description": "Berg balance scale (scored 0-56, higher score indicating more balance)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Walking capacity", "description": "10-meter walk test", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Lower-limb strength and power", "description": "5-repetition sit to stand test", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Cardiovascular health", "description": "24-hour ambulatory blood pressure monitoring (Mobil-O-Graph® 24hr ABPM) (systolic and diastolic blood pressure)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Sympathetic nervous innervation of the skin", "description": "Electrodermal activity (Galvanic skin response) with PowerLab ADInstruments: Results are presented as the difference between the maximum of the electrodermal response (or of sweating, therefore of skin conductivity) and the minimum of the electrodermal response (delta values).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Autonomic modulation", "description": "Heart rate variability (HRV) (supine 6 minutes and upright position 6 minutes)", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Feasibility of the implementation", "description": "This will be evaluated by the percentage of participants that accepted to participate in the study (recruitment rate), percentage who completed the intervention (retention rate) and number of completed session in relation to the anticipated number of sessions (adherence).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Acceptability", "description": "The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Dysautonomia Symptoms", "description": "Scale for Outcomes in Parkinson's disease for Autonomic symptoms (SCOPA-AUT) with maximum score 69, with the score for each item ranging from 0 (never experiencing the symptom) to 3 (often experiencing the symptom).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Impact of dysautonomia symptoms", "description": "Orthostatic Hypotension Questionnaire (OHQ): The questionnaire is divided into 2 parts: Part I, Symptom Assessment (OHSA), consisted of 6 questions, each rat-ing the intensity of one characteristic symptom \\[ 1. Dizziness, lightheadedness, feeling faint, or feeling Iike you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; 6. Head/neck dis-comfort\\] and Part Il, Daily Activity Scale (OHDAS), consisted of 4 questions that assessed the impact of NOH symptoms on daily activities.\n\nItems scored on an 11-point scale (0 to 10), with O indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. The composite OHQ score is calculated by averaging the OHSAS and the OHDAS.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Exercise capacity", "description": "Six-minute walk test (performance and physiological responses)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Severity of pain and impact on functioning", "description": "Brief Pain Inventory: Participants are asked to rate their current symptoms, their average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 0 to 10. A total pain severity score can be found by averaging these items or a single item can be treated as the primary outcome measure.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Type of pain", "description": "Neuropathic pain DN4 Questionnaire: Items are scored based on a yes (1 point) /no (0 points) answer. This leads to a score range of 0-10 when the symptoms (range 0-7 points) as well as the signs (range 0-3 points) items are included.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Perceived quality of life", "description": "Parkinson's Disease Questionnaire 8 items (PDQ-8, scored 0-32, higher score indicating the worst quality of life)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Lower-limb function", "description": "Lower Extremity Functional Scale (LEFS, scored 0-32, higher score indicating less difficulty)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Mobility in the community", "description": "Life-space mobility (French-Canadian version) (partial scores are summed to produce a composite score 0-120, higher score indicating more mobility)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Mobility", "description": "Timed Up and Go", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Balance", "description": "Berg balance scale (scored 0-56, higher score indicating more balance)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Walking capacity", "description": "10-meter walk test", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Lower-limb strength and power", "description": "5-repetition sit to stand test", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Cardiovascular health", "description": "24-hour ambulatory blood pressure monitoring (Mobil-O-Graph® 24hr ABPM) (systolic and diastolic blood pressure)", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Sympathetic nervous innervation of the skin", "description": "Electrodermal activity (Galvanic skin response) with PowerLab ADInstruments: Results are presented as the difference between the maximum of the electrodermal response (or of sweating, therefore of skin conductivity) and the minimum of the electrodermal response (delta values).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Autonomic modulation", "description": "Heart rate variability (HRV) (supine 6 minutes and upright position 6 minutes)", "time_frame": "12 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 16, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06017232", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04186286", "title": "Crossover Study of Propranolol vs Ivabradine in POTS", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2024-05-09", "start_date": "2021-02-01", "completion_date": "2026-12-31", "primary_completion_date": "2025-12-31", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Ivabradine 4-Week Course", "Propranolol 4-Week Course" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "1.0 BACKGROUND Postural tachycardia syndrome (POTS) is a disorder of chronic orthostatic intolerance characterized by symptoms of palpitations, lightheadedness, chest discomfort, shortness of breath, blurred vision, and mental clouding. These symptoms occur during standing and are associated with a marked increase in heart rate (HR) in the absence of hypotension, which typically resolve when sitting or lying down. Most importantly, POTS is associated with a very poor quality of life and significant functional disability. POTS patients commonly experience mental clouding (\"brain fog\") even while lying down or seated, which poses significant limitations to daily activities .\n\nUnfortunately, there is a relative paucity in the literature assessing therapies for POTS patients. Given that excessive tachycardia on standing is a fundamental component of this syndrome, a handful of studies have evaluated medications that reduce HR. Ivabradine is newer drug that is a selective If channel blocker that reduces HR without affecting other cardiovascular functions.\n\n2.0 RATIONALE / STUDY PURPOSE The investigators propose to compare the efficacy of propranolol and ivabradine on HR response to standing, and symptom burden in patients with POTS.\n\n3.0 Study Design This will be a single-center double-blind placebo-controlled randomized crossover trial conducted in patients with POTS to compare effects of (1) oral ivabradine 5 mg bid plus placebo BID (to fill out a QID schedule); (2) oral propranolol 10 mg qid; and (3) oral placebo qid in POTS patients. After a baseline screening assessment following a washout period of 7 days, participants will be randomized to start with a 4-week course of either ivabradine, propranolol or placebo. The other two treatments will be given in separate 4-week courses with a 7-day washout period between phases, with each participant acting as his or her own control. At the end of each 4-week phase, participants will complete the symptom-rating and HRQOL questionnaires, and also undergo tilt table testing to assess the change in HR at 10 min with head up tilt.\n\nParticipants will undergo POTS testing at baseline and at the end of each 4-week treatment course. This will involve a total of 4 separate study visits.", "primary_outcomes": [ { "type": "primary", "measure": "Change in HR", "description": "the ∆HR from supine to standing on head-up tilt at 10 minutes after the 4 weeks each of patient taking Ivabradine, Propranolol and Placebo", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Vanderbilt Orthostatic Symptoms Score", "description": "change in symptom burden quantified by the VOSS at 10 minutes of head-up tilt after the 4 weeks each of patient taking Ivabradine, Propranolol and Placebo", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in HR", "description": "the ∆HR from supine to standing on head-up tilt at 10 minutes after the 4 weeks each of patient taking Ivabradine, Propranolol and Placebo", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Vanderbilt Orthostatic Symptoms Score", "description": "change in symptom burden quantified by the VOSS at 10 minutes of head-up tilt after the 4 weeks each of patient taking Ivabradine, Propranolol and Placebo", "time_frame": "4 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04186286", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04652843", "title": "Single-center Pathophysiological Study of the Role of Inflammation, Changes in the Intestinal Epithelial Barrier and the Intestinal Microbiota in Parkinson's Disease", "status": "TERMINATED", "phase": "NA", "last_updated": "2024-02-01", "start_date": "2020-12-17", "completion_date": "2024-01-12", "primary_completion_date": "2024-01-12", "conditions_raw": [ "Parkinson's Disease" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Rectosignoidoscopy", "Coloscopy" ], "sponsor": "Nantes University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Converging evidence from the literature suggests that digestive inflammation may play a role in the development of Parkinson's disease (PD). The investigators showed in the laboratory in a pilot study that PD patients have digestive inflammation and that the level of inflammation was inversely related to the length of the disease course. This digestive inflammation could be at the origin of an increased intestinal permeability in a subpopulation of parkinsonian patients, cause or consequence of modifications of the intestinal microbiota, thus offering a potential portal of entry for a pathogen according to Braak's theory. To opponents of this theory, it could also reflect the spread of inflammation from the Central nervous System to the Enteral Nervous System (ENS), via the brain-gut axis.\n\nInvestigators' hypothesis is that digestive inflammation occurs very early in Parkinson's disease and that it is associated with hyperpermeability of the intestinal epithelial barrier and a change in the intestinal microbiota composition. The investigators propose to study the inflammation markers in the ENS of patients with a pre-motor form of PD (idiopathic Rapid Eye Movement (REM) sleep behavior disorder, n = 20), early-stage PD (\\<5 years, without dopatherapy, n = 20), more advanced PD (\\> 5 years, n = 20) and control subjects (n = 20), on colonic biopsies taken during a rectosigmoidoscopy or a coloscopy. Intestinal permeability will be measured by ex-vivo techniques (in a Ussing chamber), the composition of the microbiota will be established by sequencing 16s RNA and the lesional load of phosphorylated alpha-synuclein will be evaluated by immunohistochemistry. All of these parameters will be correlated with clinical data on the severity of PD: duration of development, age, total Unified Parkinson's Disease Rating Scale (UPDRS) motor score and axial sub-score, cognitive tests (Montreal Cognitive Assessment, MoCA), existence of a probable idiopathic REM sleep behavior disorder (REM Sleep Behavior Disorder Screening Questionnaire RBDSQ), olfactory tests, complaint of dysautonomia (SCales for Outcomes in Parkinson's disease - autonomic dysfunction, SCOPA-Aut).\n\nThe analysis of inflammation markers, the intestinal barrier and the microbiota could be a first step making it possible to formulate physiopathological hypotheses on the development of PD, to propose predictive biomarkers of the disease and its severity and to design early interventions in the hope of modifying the evolutionary course of the pathological process.", "primary_outcomes": [ { "type": "primary", "measure": "TNF-α", "description": "TNF-α in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "IFN-γ", "description": "IFN-γ in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-6", "description": "IL-6 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-1β", "description": "IL-1β in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IFN-α2", "description": "IFN-α2 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "MCP-1 (CCL2)", "description": "MCP-1 (CCL2) in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-8 (CXCL8)", "description": "IL-8 (CXCL8) in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-10", "description": "IL-10 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-12p70", "description": "IL-12p70 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-17A", "description": "IL-17A in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-18", "description": "IL-18 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-23", "description": "IL-23 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-33", "description": "IL-33 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Permeability slopes for sulfonic acid", "description": "Permeability slopes for sulfonic acid (low molecular weight) and dextran (high molecular weight) measured in a Ussing chamber", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Diversity of the intestinal microbiota", "description": "Bacterial diversity in each group by genetic sequencing of 16s RNA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Relative abundance of the intestinal microbiota", "description": "Relative abundance of different families or genera or bacterial species in each group by genetic sequencing of 16s RNA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Quantification of phosphorylated alpha-synuclein", "description": "Presence or absence of inclusion of phosphorylated alpha-synuclein, if presence: quantification (in thioflavin fluorescence intensity and amplification time in minutes)", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Duration of progression", "description": "Disease duration of progression as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Age", "description": "Age as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Total Unified Parkinson Disease Rating Scale motor score", "description": "Total Unified Parkinson Disease Rating Scale motor score as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Unified Parkinson Disease Rating Scale axial sub-score", "description": "Unified Parkinson Disease Rating Scale axial sub-score as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment score", "description": "Montreal Cognitive Assessment score as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Presence or absence of a probable Idiopathic REM sleep behavior disorders", "description": "Presence or absence of a probable Idiopathic REM sleep behavior disorders (REM Sleep Behavior Disorder Screening Questionnaire score ≥ 5) as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Olfactory tests", "description": "Olfactory tests (Sniffin 'sticks test score) as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction score", "description": "Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction score as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" } ], "outcome_measures": [ { "type": "primary", "measure": "TNF-α", "description": "TNF-α in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IFN-γ", "description": "IFN-γ in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-6", "description": "IL-6 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-1β", "description": "IL-1β in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IFN-α2", "description": "IFN-α2 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "MCP-1 (CCL2)", "description": "MCP-1 (CCL2) in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-8 (CXCL8)", "description": "IL-8 (CXCL8) in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-10", "description": "IL-10 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-12p70", "description": "IL-12p70 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-17A", "description": "IL-17A in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-18", "description": "IL-18 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-23", "description": "IL-23 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "IL-33", "description": "IL-33 in colonic biopsies measured by ELISA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Permeability slopes for sulfonic acid", "description": "Permeability slopes for sulfonic acid (low molecular weight) and dextran (high molecular weight) measured in a Ussing chamber", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Diversity of the intestinal microbiota", "description": "Bacterial diversity in each group by genetic sequencing of 16s RNA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Relative abundance of the intestinal microbiota", "description": "Relative abundance of different families or genera or bacterial species in each group by genetic sequencing of 16s RNA", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Quantification of phosphorylated alpha-synuclein", "description": "Presence or absence of inclusion of phosphorylated alpha-synuclein, if presence: quantification (in thioflavin fluorescence intensity and amplification time in minutes)", "time_frame": "In the three months following the inclusion" }, { "type": "secondary", "measure": "Duration of progression", "description": "Disease duration of progression as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Age", "description": "Age as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Total Unified Parkinson Disease Rating Scale motor score", "description": "Total Unified Parkinson Disease Rating Scale motor score as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Unified Parkinson Disease Rating Scale axial sub-score", "description": "Unified Parkinson Disease Rating Scale axial sub-score as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Montreal Cognitive Assessment score", "description": "Montreal Cognitive Assessment score as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Presence or absence of a probable Idiopathic REM sleep behavior disorders", "description": "Presence or absence of a probable Idiopathic REM sleep behavior disorders (REM Sleep Behavior Disorder Screening Questionnaire score ≥ 5) as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Olfactory tests", "description": "Olfactory tests (Sniffin 'sticks test score) as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" }, { "type": "secondary", "measure": "Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction score", "description": "Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction score as Parkinson's disease clinical severity parameter", "time_frame": "At inclusion" } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 77, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04652843", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03930914", "title": "Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-12-18", "start_date": "2019-11-04", "completion_date": "2021-12-07", "primary_completion_date": "2020-03-02", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Parasym (Tm) Transcutaneous Electrical Nerve Stimulation (Tens) Device" ], "sponsor": "University of Oklahoma", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural orthostatic tachycardia (POTS) is characterized by abnormalities in the autonomic nervous system in the body. The autonomic nervous system controls and regulates body functions such as heart rate, breathing, digestion, and more.\n\nThe investigator has shown that patients with POTS have higher cardiovascular and adrenergic activating autoantibodies (AAb), which likely changes the normal make-up of POTS. There are autoantibodies that have been suggested by a few reports of their presence in POTS, but their role different aspects of POTS is unknown. The study will look at the body's responses in patients with POTS. The crossover study design is to have half of the patients will start with sham followed by active stimulation and half will start by active followed by sham stimulation. It is anticipated that results will provide a potential therapeutic approach based on the understanding of POTS.", "primary_outcomes": [ { "type": "primary", "measure": "Average change in orthostatic heart rate", "description": "We will measure the average change in heart rate between supine and standing using continuous ECG after two and four months of daily vagal nerve stimulation", "time_frame": "2 and 4 months" }, { "type": "primary", "measure": "Long term effects on M2 muscarinic autoantibody levels", "description": "The average change in M2 muscarinic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.", "time_frame": "2 and 4 months" }, { "type": "primary", "measure": "Long term effects on beta 1-adrenergic autoantibody levels", "description": "The average change in beta 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.", "time_frame": "2 and 4 months" }, { "type": "primary", "measure": "Long term effects on alpha 1-adrenergic autoantibody levels", "description": "The average change in alpha 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.", "time_frame": "2 and 4 months" }, { "type": "primary", "measure": "Average change in heart rate variability", "description": "We will measure the average change in heart rate variability based on 5 minute ECG after two and four months of daily vagal nerve stimulation", "time_frame": "2 and 4 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Average change in orthostatic heart rate", "description": "We will measure the average change in heart rate between supine and standing using continuous ECG after two and four months of daily vagal nerve stimulation", "time_frame": "2 and 4 months" }, { "type": "primary", "measure": "Long term effects on M2 muscarinic autoantibody levels", "description": "The average change in M2 muscarinic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.", "time_frame": "2 and 4 months" }, { "type": "primary", "measure": "Long term effects on beta 1-adrenergic autoantibody levels", "description": "The average change in beta 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.", "time_frame": "2 and 4 months" }, { "type": "primary", "measure": "Long term effects on alpha 1-adrenergic autoantibody levels", "description": "The average change in alpha 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation.", "time_frame": "2 and 4 months" }, { "type": "primary", "measure": "Average change in heart rate variability", "description": "We will measure the average change in heart rate variability based on 5 minute ECG after two and four months of daily vagal nerve stimulation", "time_frame": "2 and 4 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 5, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03930914", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05469477", "title": "Increasing Seat Belt Wearing and Decreasing Handheld Phone Use While Driving", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-10-03", "start_date": "2023-03-12", "completion_date": "2023-06-29", "primary_completion_date": "2023-06-29", "conditions_raw": [ "Distracted Driving", "Impaired Driving", "Driving Behaviors" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Woop", "Customized Habit Tips", "Raffle Financial Incentive", "Shared Pot Financial Incentive", "Weekly Sms Support Text", "Weekly Sms Encouragement" ], "sponsor": "University of Pennsylvania", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The study team is proposing to conduct a randomized controlled trial to determine the effectiveness of behavioral and financial incentives on phone use while driving and seat belt adherence. Each arm will receive a support text if their app is not collecting data. The behavioral engagement intervention includes persuasive education, mental contrasting with implementation intentions, customized habit tips, weekly feedback about participants' streaks, and encouraging SMS texts. The two financial incentive interventions add on weekly raffles or shared pots for participants with perfect streaks.", "primary_outcomes": [ { "type": "primary", "measure": "Proportion of trips with seat belt use", "description": "Calculated as the number of trips during which a driver's seat belt click was detected, divided by total number of trips (defined as 1/10 of a mile or greater).", "time_frame": "105 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Seconds of active (handheld) phone use per hour of driving", "description": "This is a composite outcome that measures the proportion of total trip time in which the driver is engaged in handheld phone call use or non-call handheld use (e.g. texting, swiping, and typing), as measured by the Way to Drive app.", "time_frame": "105 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Proportion of trips with seat belt use", "description": "Calculated as the number of trips during which a driver's seat belt click was detected, divided by total number of trips (defined as 1/10 of a mile or greater).", "time_frame": "105 days" }, { "type": "secondary", "measure": "Seconds of active (handheld) phone use per hour of driving", "description": "This is a composite outcome that measures the proportion of total trip time in which the driver is engaged in handheld phone call use or non-call handheld use (e.g. texting, swiping, and typing), as measured by the Way to Drive app.", "time_frame": "105 days" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Very Large (1000+ participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 1139, "enrollment_type": "ACTUAL", "size_category": "Very Large (1000+ participants)", "link": "https://clinicaltrials.gov/study/NCT05469477", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05923840", "title": "Chemoreflex and Baroreflex Alterations Causing Postural Tachycardia Syndrome With Orthostatic Hyperpnea and Hypocapnia", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-06-28", "start_date": "2022-09-23", "completion_date": "2024-08-31", "primary_completion_date": "2023-08-31", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome", "Hypocapnia", "Hyperventilation" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Chemoreflex Testing", "Baroreflex Testing", "Orthostatic Stress Testing" ], "sponsor": "New York Medical College", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural tachycardia syndrome (POTS) is the most common chronic cause of postural lightheadedness, and upright confusion afflicting many Americans, mostly young women. Many POTS patients hyperventilate by increasing their depth of breathing that produces tachycardia, alters blood flow and blood pooling in the body and importantly reduces brain blood flow causing \"brain fog\". In this proposal the investigators will demonstrate in young women that abnormal repeated brief impairment of blood pressure and brain flow just after standing sensitizes the body's oxygen sensor in POTS to respond as if it were in a low oxygen environment causing hyperventilation and its consequences. In this project the investigators will use various drugs that will help to understand the mechanisms that cause POTS in this unique subset of POTS patients who hyperventilate.", "primary_outcomes": [ { "type": "primary", "measure": "Orthostatic tachycardia", "description": "Heart rate (beats per minute) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Blood Pressure Changes", "description": "Blood pressure (mmHg) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Changes in Systemic Vascular Resistance", "description": "Systemic vascular resistance (mmHg⋅min⋅mL-1) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Blood Volume Changes", "description": "Central Blood Volume in liters (L) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Changes in Segmental Blood Flow", "description": "Segmental Blood Flows (ml•min-1•100 ml tissue-1) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Changes in Cerebral Blood Flow", "description": "Cerebral Blood Flow (cm/s) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostasis Induced Rate of Breathing", "description": "Changes in the rate of breathing (breaths per minute) will be determined in all subjects before and after being tilted upright on a tilt table.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostasis Induced Depth of Breathing", "description": "Changes in the depth of breathing (L of inhaled air per minute) will be determined in all subjects before and after being tilted upright on a tilt table.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Measurement of chemoreflex sensitivity carotid body chemoreflex and central chemoreflex", "description": "Paired hypoxia and isocapnic hyperoxia determine the carotid body chemoreflex sensitivity; measurements of ventilation and sympathetic activation using Muscle Sympathetic Nerve Activity (MSNA - mean burst frequency and normalized mean burst area and expressed as arbitrary units (AU) per minute) define the responses. Similarly, measurement of during isocapnic hyperoxia and hypercapnic hyperoxia determine central chemoreflex stressors - measure sympathetic activity as responses.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Effects of chemoreflex activation on baroreflexfunction and the effects of baroreflex on chemoreflex sensitivity", "description": "Supine chemoreflex activation using controlled gas conditions which are: isocapnic hypoxia and isocapnic hyperoxia to measure carotid body reflex; hyperoxic isocapnia and hyperoxic hypercapnia to measure central chemoreflexes. Hyperoxia silences peripheral chemoreceptors and will normalize baroreflex and tilt responses) should alter baroreflex function measured as the change in RR Interval (reciprocal of heart rate) in milliseconds per millimeter of mercury change in systolic blood pressure). This will be performed both supine and during 45 degree tilting which will activate the baroreflexes and reduce chemoreflex responses.", "time_frame": "Baseline in all subjects" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Systemic changes in leg blood volumes during orthostatic testing.", "description": "The investigators will measure changes in leg blood volume using impedance plethysmography methods which measures changes in electrical resistance (in Ohms) of the legs before and after tilt table testing which is expressed as ml•min-1•100 ml tissue-1.", "time_frame": "Baseline in all subjects" }, { "type": "secondary", "measure": "Systemic changes in abdominal blood volumes during orthostatic testing.", "description": "The investigators will measure changes in abdominal blood volume using impedance plethysmography methods which measures changes in electrical resistance (in Ohms) of the abdomin before and after tilt table testing which is expressed as ml•min-1•100 ml tissue-1.", "time_frame": "Baseline in all subjects" } ], "outcome_measures": [ { "type": "primary", "measure": "Orthostatic tachycardia", "description": "Heart rate (beats per minute) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Blood Pressure Changes", "description": "Blood pressure (mmHg) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Changes in Systemic Vascular Resistance", "description": "Systemic vascular resistance (mmHg⋅min⋅mL-1) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Blood Volume Changes", "description": "Central Blood Volume in liters (L) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Changes in Segmental Blood Flow", "description": "Segmental Blood Flows (ml•min-1•100 ml tissue-1) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostatic Changes in Cerebral Blood Flow", "description": "Cerebral Blood Flow (cm/s) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostasis Induced Rate of Breathing", "description": "Changes in the rate of breathing (breaths per minute) will be determined in all subjects before and after being tilted upright on a tilt table.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Orthostasis Induced Depth of Breathing", "description": "Changes in the depth of breathing (L of inhaled air per minute) will be determined in all subjects before and after being tilted upright on a tilt table.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Measurement of chemoreflex sensitivity carotid body chemoreflex and central chemoreflex", "description": "Paired hypoxia and isocapnic hyperoxia determine the carotid body chemoreflex sensitivity; measurements of ventilation and sympathetic activation using Muscle Sympathetic Nerve Activity (MSNA - mean burst frequency and normalized mean burst area and expressed as arbitrary units (AU) per minute) define the responses. Similarly, measurement of during isocapnic hyperoxia and hypercapnic hyperoxia determine central chemoreflex stressors - measure sympathetic activity as responses.", "time_frame": "Baseline in all subjects" }, { "type": "primary", "measure": "Effects of chemoreflex activation on baroreflexfunction and the effects of baroreflex on chemoreflex sensitivity", "description": "Supine chemoreflex activation using controlled gas conditions which are: isocapnic hypoxia and isocapnic hyperoxia to measure carotid body reflex; hyperoxic isocapnia and hyperoxic hypercapnia to measure central chemoreflexes. Hyperoxia silences peripheral chemoreceptors and will normalize baroreflex and tilt responses) should alter baroreflex function measured as the change in RR Interval (reciprocal of heart rate) in milliseconds per millimeter of mercury change in systolic blood pressure). This will be performed both supine and during 45 degree tilting which will activate the baroreflexes and reduce chemoreflex responses.", "time_frame": "Baseline in all subjects" }, { "type": "secondary", "measure": "Systemic changes in leg blood volumes during orthostatic testing.", "description": "The investigators will measure changes in leg blood volume using impedance plethysmography methods which measures changes in electrical resistance (in Ohms) of the legs before and after tilt table testing which is expressed as ml•min-1•100 ml tissue-1.", "time_frame": "Baseline in all subjects" }, { "type": "secondary", "measure": "Systemic changes in abdominal blood volumes during orthostatic testing.", "description": "The investigators will measure changes in abdominal blood volume using impedance plethysmography methods which measures changes in electrical resistance (in Ohms) of the abdomin before and after tilt table testing which is expressed as ml•min-1•100 ml tissue-1.", "time_frame": "Baseline in all subjects" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05923840", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03681080", "title": "Concentration and Attentional Deficits in POTS and Other Autonomic Neuropathies", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-06-26", "start_date": "2017-04-01", "completion_date": "2023-05-30", "primary_completion_date": "2021-05-30", "conditions_raw": [ "Autonomic Failure", "Dysautonomia", "Cognitive Impairment", "Ehlers-Danlos Syndrome", "Postural Tachycardia Syndrome", "Pure Autonomic Failure" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Leg Crossing" ], "sponsor": "RWTH Aachen University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "People with POTS, autoimmune autonomic neuropathy (AAN), pure autonomic failure (PAF), SFN and Ehlers Danlos Syndrome (EDS) do not only suffer from orthostatic symptoms such as dizziness, headache, neck pain, blurred vision or (pre-) syncope. They also experience deficits in attention and concentration (more precisely deficits in selective perspective, operating speed, executive functions and memory performance) mainly in upright position. Only few studies concerning cognitive impairment in autonomic neuropathies, their frequency, aetiology and therapy exist. Many patients concerned, especially with POTS, report attention deficits and \"brain fog\" with problems in their everyday life and work, predominantly in upright posture. Specific symptomatic or medical therapies do not exist. Medical treatment with Modafinil is discussed and part of a current study at Vanderbilt Autonomic Dysfunction Centre (1-5). The investigators want to investigate if problems of concentration, attention and/or cognitive dysfunction exist in people with POTS, AAN, SFN and EDS compared to healthy controls (HC). Thus the investigators use detailed clinical, autonomic and neuropsychological tests in different body positions (lying, sitting and standing) as also acute therapy (leg crossing).", "primary_outcomes": [ { "type": "primary", "measure": "cognitive function: Stroop, TMT A und B", "description": "Change of results of cognitive function tests lying compared to standing and leg crossing", "time_frame": "during intervention (Leg crossing)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "blood pressure Change (mmHg)", "description": "Change between blood pressure lying compared to compared to standing and leg crossing", "time_frame": "during intervention (Leg crossing)" }, { "type": "secondary", "measure": "Heart frequency Change (B/min)", "description": "Change between heart frequency lying compared to compared to standing and leg crossing", "time_frame": "during intervention (Leg crossing)" }, { "type": "secondary", "measure": "cerebral blood flow velocity", "description": "Change between cerebral blood flow compared to compared to standing and leg crossing", "time_frame": "during intervention (Leg crossing)" } ], "outcome_measures": [ { "type": "primary", "measure": "cognitive function: Stroop, TMT A und B", "description": "Change of results of cognitive function tests lying compared to standing and leg crossing", "time_frame": "during intervention (Leg crossing)" }, { "type": "secondary", "measure": "blood pressure Change (mmHg)", "description": "Change between blood pressure lying compared to compared to standing and leg crossing", "time_frame": "during intervention (Leg crossing)" }, { "type": "secondary", "measure": "Heart frequency Change (B/min)", "description": "Change between heart frequency lying compared to compared to standing and leg crossing", "time_frame": "during intervention (Leg crossing)" }, { "type": "secondary", "measure": "cerebral blood flow velocity", "description": "Change between cerebral blood flow compared to compared to standing and leg crossing", "time_frame": "during intervention (Leg crossing)" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 110, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03681080", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04855266", "title": "Iron Sucrose in Patients With Iron Deficiency and POTS", "status": "WITHDRAWN", "phase": "PHASE2", "last_updated": "2023-06-13", "start_date": "2021-04", "completion_date": "2023-05", "primary_completion_date": "2023-05", "conditions_raw": [ "Iron-deficiency", "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Sucrose", "Tilt Table Test" ], "sponsor": "Mayo Clinic", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS).", "primary_outcomes": [ { "type": "primary", "measure": "Change in autonomic dysfunction symptoms", "description": "Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction", "time_frame": "Baseline, 7 days, 6 months" }, { "type": "primary", "measure": "Change in postural heart rate increase", "description": "Heart rate change during tilt table test measured in beats per minute", "time_frame": "Baseline, 7 days" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Change in autonomic dysfunction symptoms", "description": "Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction", "time_frame": "Baseline, 7 days, 6 months" }, { "type": "primary", "measure": "Change in postural heart rate increase", "description": "Heart rate change during tilt table test measured in beats per minute", "time_frame": "Baseline, 7 days" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT04855266", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02669056", "title": "Brainstem and Prematurity", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-05-16", "start_date": "2015-12-17", "completion_date": "2023-05-12", "primary_completion_date": "2019-01-01", "conditions_raw": [ "Very Premature Infants" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "5-Ht Measurement", "Cerebral Mri", "Video Recording", "Eeg", "Growth Curves" ], "sponsor": "Assistance Publique Hopitaux De Marseille", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Although significant advances in neonatal care have increased survival rates of preterm infants born before 28 weeks gestation, a concomitant decrease in neuro developmental disorders has not been achieved. Cerebral injuries, well documented during the previous years, in preterm babies are particularly deleterious since they occur in a developing brain. They affect both white and grey matter by complex mechanisms and the principal targets are the developing oligodendrocytes and neurons of the subplate. All these criteria define the encephalopathy of prematurity. Nevertheless, the consequences of prematurity at the level of the brainstem are not very well known and may explain neuro-developmental disorders with normal MRI.\n\nThe assessment of the motor repertoire is complementary to the neurological examination and may represent a diagnostic tool for cerebral palsy, mild motor deficits and delayed acquisition in children. The newborn have a rich motor repertoire. GMs play a key role in the development due to the feedback that they send to cortical neurons and reflect the maturational stage of the Central Nervous System (CNS). Lesions of the brainstem caused by prematurity may induce alterations of the motor repertoire.\n\nDysautonomic disorders, such as bradycardia, apneas, feeding problems, that occur frequently in very preterm babies reflect brainstem abnormalities. These symptoms are also described in other pathologies, in Rett syndrome and sudden infant death syndrome (SIDS). In these pathologies deficits of the 5-HT system have been described and associated with dysautonomia. It would then be interesting to evaluate 5-hydroxytryptamine (5-HT) levels in very preterm babies.\n\nThe serotonergic system develops very early during gestation and is one of the first neurotransmitter to appear in the developing brain. The main 5-HT nuclei are located within the brainstem. 5-HT plays an important role in the homeostasis and the modulation of the respiratory network. Moreover, previous studies have shown that 5-HT projections to the spinal cord are involved in posture and in the coordination. It is tempting to think that 5-HT deficits may have some repercussions on the development of the CNS, changing activity dependent processes, such as spontaneous activity recorded at the spinal level in rodents.\n\nIn this project, the 5-HT platelet levels in preterm infants born before 28 weeks will be compared with newborns. a correlation between the levels of 5-HT with MRI of the posterior fossa, GMs and dysautonomia different parameters such as heart rate variability, suction-swallowing and different breathing techniques will be established", "primary_outcomes": [ { "type": "primary", "measure": "5-HT levels", "description": "5-HT platelets levels will be measured in very preterm and in term infants and compared (5-HT platelets level reflect the central 5HT level.", "time_frame": "term age (37 weeks)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Posterior fossa injury", "description": "MRI will be performed at term age to analyse preterm cerebral structure focusing on the posterior fossa", "time_frame": "at term age (37 weeks)" }, { "type": "secondary", "measure": "General movements (GMs) assesment", "description": "GMs will be video taped at during the writing movements period and fidgety period and analyzed to detect abnormal GMs", "time_frame": "3 times in the hospitalization period and at 3 month post-term age" }, { "type": "secondary", "measure": "R-R variability assesment", "description": "The autonomic nervous system activity level will be assessed by R-R variability analyze during polysomnographic recordings", "time_frame": "at 36 weeks" }, { "type": "secondary", "measure": "Respiratory pattern assessment", "description": "Respiratory pattern assessment will be analyzed during polysomnographic recordings to detect apneas, sighs…", "time_frame": "at 36 weeks" }, { "type": "secondary", "measure": "Ages and Stages Questionnaires (ASQ)", "description": "ASQ questionnaire as neurodevelopmental assessment will be send to parents", "time_frame": "12 and 24 month post-term age" }, { "type": "secondary", "measure": "weight and statural growth assessment", "description": "", "time_frame": "until 24 month postterm age" }, { "type": "secondary", "measure": "statural growth assessment", "description": "", "time_frame": "until 24 month postterm age" }, { "type": "secondary", "measure": "Hospitalization duration", "description": "", "time_frame": "6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "5-HT levels", "description": "5-HT platelets levels will be measured in very preterm and in term infants and compared (5-HT platelets level reflect the central 5HT level.", "time_frame": "term age (37 weeks)" }, { "type": "secondary", "measure": "Posterior fossa injury", "description": "MRI will be performed at term age to analyse preterm cerebral structure focusing on the posterior fossa", "time_frame": "at term age (37 weeks)" }, { "type": "secondary", "measure": "General movements (GMs) assesment", "description": "GMs will be video taped at during the writing movements period and fidgety period and analyzed to detect abnormal GMs", "time_frame": "3 times in the hospitalization period and at 3 month post-term age" }, { "type": "secondary", "measure": "R-R variability assesment", "description": "The autonomic nervous system activity level will be assessed by R-R variability analyze during polysomnographic recordings", "time_frame": "at 36 weeks" }, { "type": "secondary", "measure": "Respiratory pattern assessment", "description": "Respiratory pattern assessment will be analyzed during polysomnographic recordings to detect apneas, sighs…", "time_frame": "at 36 weeks" }, { "type": "secondary", "measure": "Ages and Stages Questionnaires (ASQ)", "description": "ASQ questionnaire as neurodevelopmental assessment will be send to parents", "time_frame": "12 and 24 month post-term age" }, { "type": "secondary", "measure": "weight and statural growth assessment", "description": "", "time_frame": "until 24 month postterm age" }, { "type": "secondary", "measure": "statural growth assessment", "description": "", "time_frame": "until 24 month postterm age" }, { "type": "secondary", "measure": "Hospitalization duration", "description": "", "time_frame": "6 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 34, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02669056", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02669212", "title": "Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-04-18", "start_date": "2016-10-10", "completion_date": "2022-01-11", "primary_completion_date": "2022-01-11", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Cardiopulmonary Exercise Test" ], "sponsor": "National Institute of Neurological Disorders and Stroke (NINDS)", "sponsor_type": "NIH", "primary_purpose": "N/A", "brief_summary": "Background:\n\nPost-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to long-lasting and disabling fatigue or malaise, inability to recover after exercise, and physical and emotional discomfort that may occur after a person has an infection. Researchers want to learn more about its causes.\n\nObjective:\n\nTo learn more about PI-ME/CFS.\n\nEligibility:\n\nAdults ages 18-60 years who have finished at least 7th grade education and either:\n\nhave ME/CFS that started after an infection\n\nOR had Lyme disease, were treated, and returned to normal health\n\nOR are healthy volunteers\n\nDesign:\n\nParticipants will initially have a 2-5 day inpatient visit at the National Institutes of Health Clinical Center in Bethesda. During the visit, participants will have:\n\nMedical history\n\nPhysical exam\n\nIntravenous (IV) line. A thin plastic tube is inserted into a vein.\n\nBlood and urine collected\n\nMagnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They may get a dye through their IV.\n\nGrip strength tested\n\nSaliva, cheek swab, and stool collected\n\nTilt table test with measures of body functions such as sweating and breathing, blood pressure, and heart rate and blood and urine sample collection\n\nCollection of blood cells. Participants can choose to have the blood drawn through the IV or through a machine that filters blood cells and returns the liquid blood back into the participant s vein.\n\nLumbar puncture. Fluid will be removed by placement of a needle between the back bones.\n\nHeart monitoring\n\nSleep study for participants with PI ME/CFS\n\nQuestions about the participant s life and how they are feeling\n\nQuestions from a neuropsychologist\n\nQuestions from an occupational therapist for participants with PI ME/CFS\n\nQuestinos from a nutritionist\n\nAfter the initial visit participants will return home. Participants evaluated for PI-ME/CFS during the first visit will have their information reviewed by an adjudication panel of experts in the diagnosis and care of ME/CFS to determine if they are eligible to participate in the second study visit.\n\nEligible participants will be invited back for a second study visit. If a participant was taking certain medications during the first visit, they may be asked to taper off of them prior to the second visit and report any problems. They will also receive an activity monitor, fatigue diary, and nutrition log to use for at least one week prior to their second visit.\n\nParticipants who are eligible will return for a 5-10 day inpatient hospital visit at the National Institutes of Health Clinical Center. During the visit, participants will undergo measurements before and up to 96 hours after performing a stationary bike exercise test. The purpose of the exercise test is to provoke ME/CFS symptoms (post-exertional malaise). Tests will be performed before and after exercise testing. These include:\n\nSleeping in a room that measures how the body uses energy with EEG monitoring\n\nEating a controlled diet\n\nPerforming vigorous exercise for 10-15 minutes\n\nQuestions about how participants are feeling\n\nQuestions about what participants usually eat\n\nSamples of saliva, blood, urine and stool\n\nWearing an activity monitor\n\nHaving an Xray that measures body composition\n\nThinking and memory tests\n\nHeart monitoring\n\nTranscranial magnetic stimulation. A brief electrical current to the scalp creates a magnetic pulse that affects brain activity.\n\nMagnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They will do thinking and exercise tasks during the MRI.\n\nLumbar puncture. Fluid will be removed by placement of a needle between the back bones.", "primary_outcomes": [ { "type": "primary", "measure": "Cardiopulmonary Exercise Test (CPET) - ATVO2rel", "description": "The Relative Volume of Oxygen at the Anaerobic Threshold (ATVO2rel) was determined during a cardiopulmonary exercise test (CPET). ATVO2rel represents the volume of oxygen being consumed when a participant reaches AT, adjusted for their weight during the CPET. Results compared Healthy Volunteer Participants to ME/CFS Participants.", "time_frame": "At time of AT during CPET" }, { "type": "primary", "measure": "Cardiopulmonary Exercise Test (CPET) - RER", "description": "The Respiratory Exchange Ratio (VCO2/VO2) was determined during a cardiopulmonary exercise test (CPET). VCO2/VO2 is calculated by measuring the volume of carbon dioxide and oxygen the participant breathes during CPET. When the volume of carbon dioxide exceeds that of oxygen, it reflects a change from aerobic metabolism to anaerobic metabolism. When a participant has a Respiratory Exchange Ratio (RER) during CPET that is equal or greater than 1.1 it is considered a sufficient exercise effort. Results compared Healthy Volunteer Participants to ME/CFS Participants.", "time_frame": "At time of AT during CPET" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Cardiopulmonary Exercise Test (CPET) - ATVO2rel", "description": "The Relative Volume of Oxygen at the Anaerobic Threshold (ATVO2rel) was determined during a cardiopulmonary exercise test (CPET). ATVO2rel represents the volume of oxygen being consumed when a participant reaches AT, adjusted for their weight during the CPET. Results compared Healthy Volunteer Participants to ME/CFS Participants.", "time_frame": "At time of AT during CPET" }, { "type": "primary", "measure": "Cardiopulmonary Exercise Test (CPET) - RER", "description": "The Respiratory Exchange Ratio (VCO2/VO2) was determined during a cardiopulmonary exercise test (CPET). VCO2/VO2 is calculated by measuring the volume of carbon dioxide and oxygen the participant breathes during CPET. When the volume of carbon dioxide exceeds that of oxygen, it reflects a change from aerobic metabolism to anaerobic metabolism. When a participant has a Respiratory Exchange Ratio (RER) during CPET that is equal or greater than 1.1 it is considered a sufficient exercise effort. Results compared Healthy Volunteer Participants to ME/CFS Participants.", "time_frame": "At time of AT during CPET" } ], "relevance_tags": [ "Metabolic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Nih" ], "enrollment": 52, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02669212", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03903666", "title": "Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-03-02", "start_date": "2019-10-14", "completion_date": "2022-05-23", "primary_completion_date": "2022-03-25", "conditions_raw": [ "Down Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Nocturnal Gaz Exchanges Measurement" ], "sponsor": "Institut Jerome Lejeune", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Recently, retrospective studies have shown that Down Syndrome children have a higher CO2 (carbone dioxide) sleep pressure than the general pediatric population. This increase does not seem to be always related to sleep apnea. The Investigators wish to confirm these results prospectively. The investigators hypothesize that this alveolar hypoventilation may be due to ventilatory control disorders caused by dysautonomia, but also to a decrease in the strength of the respiratory muscles within the framework of the global muscular hypotonia described in children with Down syndrome. .", "primary_outcomes": [ { "type": "primary", "measure": "Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings", "description": "", "time_frame": "2 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Percentage of total sleep time with a PtcCO2 in mmHg higher than 50; mean, maximum and minimum SpO2 in %", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Number of patients with low mean, minimum and maximum SpO2 (oyxygen saturation) and/or % of Total sleep time spent with a PtcCO2 higher than 50 mmHg, higher than 20%, as measured by nocturnal gas exchange recordings.", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders assed by the Dysautonomia questionnaire", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by Hand Grip assessment", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by OSA (Obstructive Sleep Apnea) assessment questionnaire", "description": "", "time_frame": "2 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Percentage of total sleep time with a PtcCO2 in mmHg higher than 50; mean, maximum and minimum SpO2 in %", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Number of patients with low mean, minimum and maximum SpO2 (oyxygen saturation) and/or % of Total sleep time spent with a PtcCO2 higher than 50 mmHg, higher than 20%, as measured by nocturnal gas exchange recordings.", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders assed by the Dysautonomia questionnaire", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by Hand Grip assessment", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by OSA (Obstructive Sleep Apnea) assessment questionnaire", "description": "", "time_frame": "2 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 48, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03903666", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03032328", "title": "Vitamin D Deficiency and Dysautonomia", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-01-27", "start_date": "2016-06", "completion_date": "2022-12-21", "primary_completion_date": "2022-12-21", "conditions_raw": [ "Vitamin D Deficiency", "Orthostatic Intolerance", "Nausea" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Vitamin D Supplement" ], "sponsor": "Wake Forest University Health Sciences", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In previous work the investigator identified a group of children between the ages of 10-18 years whose diagnostic workup for chronic nausea unexplained by conventional diagnostic tests has unexpectedly revealed underlying cardiovascular instability manifesting as orthostatic intolerance, primary defined as postural orthostatic tachycardia syndrome (POTS) (88%). While this is an atypical initial presentation for orthostatic intolerance in general, the investigator believes that the cardiovascular problem is serious and represents a cause of the nausea in a majority of these individuals, as treatment of the POTS with fludrocortisone reduced the symptoms of nausea. While fludrocortisone treatment abrogates the fall in baroreflex sensitivity (BRS) during tilt in part, it did not completely correct the tachycardia symptoms or the BRS suppression during HUT. Furthermore it caused an elevation in MAP in supine position, which may lead to future cardiovascular problems such as early onset hypertension and cardiac hypertrophy. This argues for a different treatment approach. The investigator presents preliminary data in this application revealing that OI subjects tend to have lower 25-hydroxy vitamin D (25(OH)D) compared to non OI subjects.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement of orthostatic intolerance symptoms usint tilt table test", "description": "assessment of orthostatic intolerance will be done using tilt table test", "time_frame": "2 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "improvement of nausea symptoms", "description": "assessment of nausea symptoms will be done using nausea questionaire", "time_frame": "2 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Improvement of orthostatic intolerance symptoms usint tilt table test", "description": "assessment of orthostatic intolerance will be done using tilt table test", "time_frame": "2 months" }, { "type": "secondary", "measure": "improvement of nausea symptoms", "description": "assessment of nausea symptoms will be done using nausea questionaire", "time_frame": "2 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 31, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03032328", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05404672", "title": "Breathing Exercises With And Without Aerobic Training In Patients With Postural Orthostatic Tachycardia Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-01-25", "start_date": "2022-06-01", "completion_date": "2023-01-15", "primary_completion_date": "2022-12-31", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Aerobic Training", "Conventional Treatment" ], "sponsor": "Riphah International University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural orthostatic tachycardia syndrome (POTS) is a chronic, multifactorial syndrome with complex symptoms of orthostatic intolerance. Of the major complaints are breathlessness and exercise intolerance. The aim is to explore the potential impact of a physiotherapy intervention involving education and breathing control on dysfunctional breathing and improving exercise intolerance in POTS. The study would be a randomised controlled trial. Duration would be 4 week. Patients will be randomly divided into two groups by lottery method. Data will be collected through questionnaire from enrolled subjects in physical therapy department of Liaqat Hospital, Lahore. Experimental group will be treated by Progressive Breathing Retraining Exercise Program-2 times a day for 15 minutes, initially Controlled Nasal Breathing with progressively increasing the Controlled Pause, 4 times a day for 15 minutes, then both techniques will be performed together. In addition to this Aerobic training will be assigned to both the groups. Aerobic training will include cycling and treadmill- for 30 minutes\\\\day for 5 days\\\\week for 1 month. Total 20 sessions. While the controlled group will receive only aerobic training which will include cycling and treadmill for 30 minutes\\\\day for 5 days\\\\week for 1 month. Total 20 sessions. The dysfunctional breathing and exercise intolerance will be assessed through Nijmegen Questionnaire and Veterans Questionnaire respectively at 0 week, after 2 week and after 4 week. The data will be analyzed by spss version 25.", "primary_outcomes": [ { "type": "primary", "measure": "Nijmen Questionnaire ….dysfunctional breathing", "description": "This questionnaire is a self-report 16-symptom scale. The frequency of symptoms can be indicated by the following options (score): never (0), rarely (1), sometimes (2), often (3), and very often (4). This questionnaire was developed to screen individuals complaining of shortness of breath with several signs and symptoms of hyperventilation syndrome, such as tense feeling, dizziness, fast and deep breathing, feeling of tightness around the mouth, and anxiety.\n\nReadings will be at 0 week, after 2 week and after 4 week", "time_frame": "4 week." }, { "type": "primary", "measure": "Veterans specific activity questionnaire (VSAQ):", "description": "The Veterans Specific Activity Questionnaire (VSAQ) is a 13-item self-administered symptom questionnaire that estimates aerobic fitness expressed in metabolic equivalents (METs). Aerobic capacity is measured in METs by the VSAQ.\n\nReadings will be at 0 week, after 2 week and after 4 week", "time_frame": "4 week" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Nijmen Questionnaire ….dysfunctional breathing", "description": "This questionnaire is a self-report 16-symptom scale. The frequency of symptoms can be indicated by the following options (score): never (0), rarely (1), sometimes (2), often (3), and very often (4). This questionnaire was developed to screen individuals complaining of shortness of breath with several signs and symptoms of hyperventilation syndrome, such as tense feeling, dizziness, fast and deep breathing, feeling of tightness around the mouth, and anxiety.\n\nReadings will be at 0 week, after 2 week and after 4 week", "time_frame": "4 week." }, { "type": "primary", "measure": "Veterans specific activity questionnaire (VSAQ):", "description": "The Veterans Specific Activity Questionnaire (VSAQ) is a 13-item self-administered symptom questionnaire that estimates aerobic fitness expressed in metabolic equivalents (METs). Aerobic capacity is measured in METs by the VSAQ.\n\nReadings will be at 0 week, after 2 week and after 4 week", "time_frame": "4 week" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 28, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05404672", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03674541", "title": "The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2022-11-08", "start_date": "2020-01-14", "completion_date": "2021-12-20", "primary_completion_date": "2021-12-05", "conditions_raw": [ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome", "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis", "Exercise Intolerance", "Dysautonomia", "Low Ventricular Filling Pressures (Preload Failure)", "Postural Orthostatic Tachycardia Syndrome", "Orthostatic Hypotension", "Fibromyalgia" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Pyridostigmine Bromide" ], "sponsor": "Brigham and Women's Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Myalgic encephalomyelitis/Chronic fatigue syndrome (ME/CFS), otherwise known as Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME), is an under-recognized disorder whose cause is not yet understood. Suggested theories behind the pathophysiology of this condition include autoimmune causes, an inciting viral illness, and a dysfunctional autonomic nervous system caused by a small fiber polyneuropathy. Symptoms include fatigue, cognitive impairments, gastrointestinal changes, exertional dyspnea, and post-exertional malaise. The latter two symptoms are caused in part by abnormal cardiopulmonary hemodynamics during exercise thought to be due to a small fiber polyneuropathy. This manifests as low biventricular filling pressures throughout exercise seen in patients undergoing an invasive cardiopulmonary exercise test (iCPET) along with small nerve fiber atrophy seen on skin biopsy.\n\nAfter diagnosis, patients are often treated with pyridostigmine (off-label use of this medication) to enhance cholinergic stimulation of norepinephrine release at the post-ganglionic synapse. This is thought to improve venoconstriction at the site of exercising muscles, leading to improved return of blood to the heart and increasing filling of the heart to more appropriate levels during peak exercise. Retrospective studies have shown that noninvasive measurements of exercise capacity, such as oxygen uptake, end-tidal carbon dioxide, and ventilatory efficiency, improve after treatment with pyridostigmine. To date, there are no studies that assess invasive hemodynamics after pyridostigmine administration.\n\nIt is estimated that four million people suffer from ME/CFS worldwide, a number that is thought to be a gross underestimate of disease prevalence. However, despite its potential for debilitating symptoms, loss of productivity, and worldwide burden, the pathophysiology behind ME/CFS remains unknown and its treatment unclear. By evaluating the exercise response to cholinergic stimulation, this study will shed further light on the link between the autonomic nervous system and cardiopulmonary hemodynamics, potentially leading to new therapeutic targets.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Peak Oxygen Uptake (Peak VO2) Between the First and Second iCPET", "description": "Define the response of oxygen uptake to pyridostigmine expressed both as mL/min and mL/min/kg. The difference in peak oxygen uptake from first iCPET to second iCPET. Research has shown that ME/CFS patients have inability to reproduce results on two consecutive cardiopulmonary exercise tests(CPET). Traditionally this is demonstrated with a two-day CPET protocol, but in this study we investigate the acute effects of pyridostigmine administration on the early stages of post exertional malaise(PEM).", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Peak-Rest Oxygen Uptake (VO2)", "description": "Peak versus rest changes in oxygen uptake between first and second CPETs expressed as mL/min.", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak Cardiac Output (Qc)", "description": "Arterial and mixed-venous blood gases and pH are measured at peak exercise and Qc is calculated using the direct Fick principle Qc=VO2/(Ca-Cv). Change in peak Qc between first and second iCPETs is measured in L/min.", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak-Rest Cardiac Output (Qc)", "description": "Peak versus rest change in cardiac output expressed in L/min between first and second iCPETs. Cardiac output is determined using the direct Fick principle.", "time_frame": "First iCPET up to 30 min, 50 minutes rest, second iCPET up to 30 minutes" }, { "type": "secondary", "measure": "Peak Right Atrial Pressure (RAP)", "description": "Difference in peak RAP between first and second iCPETs measured in mmHg.", "time_frame": "First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak-Rest Right Atrial Pressure (RAP)", "description": "Peak versus rest changes in RAP between first and second iCPETs measured in mmHg", "time_frame": "First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak Pulmonary Arterial Wedge Pressure (PAWP)", "description": "Difference in peak PAWP between first and second iCPETs measured in mmHg", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak Stroke Volume (SV)", "description": "Difference in peak SV between first and second iCPETs measured in mL", "time_frame": "First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak (Ca-vO2)/[Hgb]", "description": "Difference in peak arterial-venous oxygen content difference normalized to hemoglobin (Ca-vO2)/\\[Hgb\\] between first and second iCPETs", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Ventilatory Efficiency (VE/VCO2)", "description": "Difference in ventilatory efficiency between first and second iCPETs", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Borg Fatigue Scale", "description": "Difference in perception of fatigue at peak exercise between first and second iCPETs. Used Borg Scale 0 (minimal) to 10 (maximal).", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Borg Dyspnea Scale", "description": "Difference in perceived dyspnea at peak exercise between first and second iCPETs. Used Borg Scale 0 (minimal) to 10 (maximal).", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Peak Oxygen Uptake (Peak VO2) Between the First and Second iCPET", "description": "Define the response of oxygen uptake to pyridostigmine expressed both as mL/min and mL/min/kg. The difference in peak oxygen uptake from first iCPET to second iCPET. Research has shown that ME/CFS patients have inability to reproduce results on two consecutive cardiopulmonary exercise tests(CPET). Traditionally this is demonstrated with a two-day CPET protocol, but in this study we investigate the acute effects of pyridostigmine administration on the early stages of post exertional malaise(PEM).", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak-Rest Oxygen Uptake (VO2)", "description": "Peak versus rest changes in oxygen uptake between first and second CPETs expressed as mL/min.", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak Cardiac Output (Qc)", "description": "Arterial and mixed-venous blood gases and pH are measured at peak exercise and Qc is calculated using the direct Fick principle Qc=VO2/(Ca-Cv). Change in peak Qc between first and second iCPETs is measured in L/min.", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak-Rest Cardiac Output (Qc)", "description": "Peak versus rest change in cardiac output expressed in L/min between first and second iCPETs. Cardiac output is determined using the direct Fick principle.", "time_frame": "First iCPET up to 30 min, 50 minutes rest, second iCPET up to 30 minutes" }, { "type": "secondary", "measure": "Peak Right Atrial Pressure (RAP)", "description": "Difference in peak RAP between first and second iCPETs measured in mmHg.", "time_frame": "First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak-Rest Right Atrial Pressure (RAP)", "description": "Peak versus rest changes in RAP between first and second iCPETs measured in mmHg", "time_frame": "First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak Pulmonary Arterial Wedge Pressure (PAWP)", "description": "Difference in peak PAWP between first and second iCPETs measured in mmHg", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak Stroke Volume (SV)", "description": "Difference in peak SV between first and second iCPETs measured in mL", "time_frame": "First iCPEt up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Peak (Ca-vO2)/[Hgb]", "description": "Difference in peak arterial-venous oxygen content difference normalized to hemoglobin (Ca-vO2)/\\[Hgb\\] between first and second iCPETs", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Ventilatory Efficiency (VE/VCO2)", "description": "Difference in ventilatory efficiency between first and second iCPETs", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Borg Fatigue Scale", "description": "Difference in perception of fatigue at peak exercise between first and second iCPETs. Used Borg Scale 0 (minimal) to 10 (maximal).", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." }, { "type": "secondary", "measure": "Borg Dyspnea Scale", "description": "Difference in perceived dyspnea at peak exercise between first and second iCPETs. Used Borg Scale 0 (minimal) to 10 (maximal).", "time_frame": "First iCPET up to 30 minutes, 50 minutes rest, second iCPET up to 30 minutes." } ], "relevance_tags": [ "Immunomodulatory", "Repurposed", "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 45, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03674541", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04845737", "title": "Electrophysiological Findings in Fibromyalgia Patients", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-10-13", "start_date": "2021-06-07", "completion_date": "2022-08-20", "primary_completion_date": "2022-07-20", "conditions_raw": [ "Fibromyalgia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Sympathetic Skin Response Measurement" ], "sponsor": "Abant Izzet Baysal University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Fibromyalgia Syndrome (FMS); It is a chronic condition characterized by widespread body pain, sleep disturbance, fatigue, impaired cognitive functions, and anxiety (1). FMS; chronic fatigue syndrome, interstitial cystitis, irritable bowel syndrome, temperomandibular joint dysfunction, myofascial pain, functional dyspepsia, restless leg syndrome and posttraumatic stress disorder are among central sensitization syndromes (2,3).", "primary_outcomes": [ { "type": "primary", "measure": "Sympathetic Skin Response", "description": "Sympathetic Skin Response (SSR) measurement will be made at room temperature of 25 ºC, while the patients are resting in the supine position.For upper extremity SSR evaluation, the active (-) electrode will be placed in the palmar area, the reference electrode (+) in the dorsum of the hand, and the ground electrode in the forearm. Similarly, in the lower extremity, the active electrode will be placed on the sole of the foot and the reference electrode will be placed on the back of the foot. The same side median nerve will be stimulated from the second finger, and the SSR obtained from the right upper and lower extremities will be evaluated. The duration of the warning will be adjusted to be 0.1 ms and the intensity of the warning to be 15-20 mA. In order to prevent habituation, warnings will be given at different intervals and with\\> 30 seconds between warning. A maximum of 5 unilateral stimulation will be applied to each patient.", "time_frame": "10 minutes" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Visual analogue scale", "description": "It is used to convert some values that cannot be measured numerically into numerical ones. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line.", "time_frame": "45 seconds" }, { "type": "secondary", "measure": "Fibromyalgia Impact Questionnaire", "description": "It measures 10 different characteristics: physical function, feeling unwell, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Except for the sense of well-being, lower scores indicate improvement or less affected by the disease. The Fibromyalgia Impact Questionnaire is filled out by the patient. The maximum possible score for each subtitle is 10 points. Thus the total maximum score is 100 points", "time_frame": "60 seconds" } ], "outcome_measures": [ { "type": "primary", "measure": "Sympathetic Skin Response", "description": "Sympathetic Skin Response (SSR) measurement will be made at room temperature of 25 ºC, while the patients are resting in the supine position.For upper extremity SSR evaluation, the active (-) electrode will be placed in the palmar area, the reference electrode (+) in the dorsum of the hand, and the ground electrode in the forearm. Similarly, in the lower extremity, the active electrode will be placed on the sole of the foot and the reference electrode will be placed on the back of the foot. The same side median nerve will be stimulated from the second finger, and the SSR obtained from the right upper and lower extremities will be evaluated. The duration of the warning will be adjusted to be 0.1 ms and the intensity of the warning to be 15-20 mA. In order to prevent habituation, warnings will be given at different intervals and with\\> 30 seconds between warning. A maximum of 5 unilateral stimulation will be applied to each patient.", "time_frame": "10 minutes" }, { "type": "secondary", "measure": "Visual analogue scale", "description": "It is used to convert some values that cannot be measured numerically into numerical ones. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line.", "time_frame": "45 seconds" }, { "type": "secondary", "measure": "Fibromyalgia Impact Questionnaire", "description": "It measures 10 different characteristics: physical function, feeling unwell, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Except for the sense of well-being, lower scores indicate improvement or less affected by the disease. The Fibromyalgia Impact Questionnaire is filled out by the patient. The maximum possible score for each subtitle is 10 points. Thus the total maximum score is 100 points", "time_frame": "60 seconds" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04845737", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03261570", "title": "Cardiovagal Baroreflex Deficits Impair Neurovascular Coupling and Cognition in POTS", "status": "COMPLETED", "phase": "EARLY_PHASE1", "last_updated": "2022-09-28", "start_date": "2017-07-01", "completion_date": "2022-06-01", "primary_completion_date": "2022-06-01", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome (POTS)", "POTS", "Orthostatic Intolerance" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Pyridostigmine", "Digoxin" ], "sponsor": "New York Medical College", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural tachycardia syndrome (POTS), is the chronic form of orthostatic intolerance associated with excessive upright tachycardia, and occurs predominantly in young females (\\>85%). Among its most troubling symptoms are lightheadedness, fatigue, and decreased memory often called \"brain fog\" by patients. Task-related neurovascular coupling (NVC) links neural activity to an increase in CBF known as \"functional hyperemia\". Although memory task performance and NVC deteriorated with angle of tilt in POTS but not healthy controls, cerebral blood flow (CBF) remained similar to control. Instead, the investigators observed extensive narrow band low frequency (0.07-0.13 Hz) oscillations in BP (OBP) that entrained and amplified oscillations in CBF (OCBF). OBP and OCBF increased with tilt angle and caused impaired working memory and reduced functional hyperemia. The cardiovagal baroreflex couples BP to HR to buffer BP changes. The investigators hypothesize that the cardiovagal baroreflex becomes progressively impaired with orthostasis in POTS, but not in healthy volunteers, and accounts for OBP, OCBF, and loss of NVC; further, improving the baroreflex reduces OBP, OCBF and Brain Fog in POTS.", "primary_outcomes": [ { "type": "primary", "measure": "Cardiovagal Baroreflex during orthostatic stress", "description": "Cardiovagal Baroreflex during orthostatic stress in unmedicated POTS patients compared to unmedicated control subjects during each angle of incremental tilt. The unmedicated baroreflex measurement will be repeated in POTS patients to similar measurements after treatment with placebo, pyridostigmine or digoxin. Baroreflex measurements will be obtained using the standard \"modified Oxford\" technique.", "time_frame": "1 year" }, { "type": "primary", "measure": "Cognitive ability during orthostatic stress", "description": ". Cognitive ability during orthostatic stress in unmedicated POTS patients compared to unmedicated control subjects during each angle of incremental tilt. Cognitive ability will be repeated in POTS patients to similar measurements after treatment with placebo, pyridostigmine or digoxin. Cognitive ability will be assessed with a standard 2-Back test in which patients identify identical alphabetic characters appearing 2 characters before the current displayed character in a sequence of 29 characters.", "time_frame": "1 year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Cardiac output measure by inert gas breathing technique", "description": "Cardiac output measure by inert gas breathing technique. Cardiac output is the amount of blood pumped by the heart in one minute. The technique uses the Innocor system in which the relative levels of two inert gases - one blood soluble and one insoluble component - are measured over a few respirations (about 5 breaths or 15 seconds). The rate of disappearance of the soluble gas from the alveolar space is proportional to the flow of blood perfusing the lungs and equals the cardiac output.", "time_frame": "1 year" }, { "type": "secondary", "measure": "Arterial blood pressure, and mean arterial pressure defined by the time average blood pressure over the cardiac cycle", "description": "Arterial blood pressure in mmHg over each cardiac cycle will be collected using finger photoplethysmography. The arterial pressure is reported as an aggregate of 3 extracted quantities: the systolic blood pressure which is the maximum blood pressure over a cardiac cycle; the diastolic blood pressure which is the minimum blood pressure over a cardiac cycle; and the mean blood pressure which is the average blood pressure over a cardiac cycle.", "time_frame": "1 year" }, { "type": "secondary", "measure": "Heart rate", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "systemic vascular resistance defined by the ratio of mean arterial pressure to cardiac output", "description": "", "time_frame": "1 year" } ], "outcome_measures": [ { "type": "primary", "measure": "Cardiovagal Baroreflex during orthostatic stress", "description": "Cardiovagal Baroreflex during orthostatic stress in unmedicated POTS patients compared to unmedicated control subjects during each angle of incremental tilt. The unmedicated baroreflex measurement will be repeated in POTS patients to similar measurements after treatment with placebo, pyridostigmine or digoxin. Baroreflex measurements will be obtained using the standard \"modified Oxford\" technique.", "time_frame": "1 year" }, { "type": "primary", "measure": "Cognitive ability during orthostatic stress", "description": ". Cognitive ability during orthostatic stress in unmedicated POTS patients compared to unmedicated control subjects during each angle of incremental tilt. Cognitive ability will be repeated in POTS patients to similar measurements after treatment with placebo, pyridostigmine or digoxin. Cognitive ability will be assessed with a standard 2-Back test in which patients identify identical alphabetic characters appearing 2 characters before the current displayed character in a sequence of 29 characters.", "time_frame": "1 year" }, { "type": "secondary", "measure": "Cardiac output measure by inert gas breathing technique", "description": "Cardiac output measure by inert gas breathing technique. Cardiac output is the amount of blood pumped by the heart in one minute. The technique uses the Innocor system in which the relative levels of two inert gases - one blood soluble and one insoluble component - are measured over a few respirations (about 5 breaths or 15 seconds). The rate of disappearance of the soluble gas from the alveolar space is proportional to the flow of blood perfusing the lungs and equals the cardiac output.", "time_frame": "1 year" }, { "type": "secondary", "measure": "Arterial blood pressure, and mean arterial pressure defined by the time average blood pressure over the cardiac cycle", "description": "Arterial blood pressure in mmHg over each cardiac cycle will be collected using finger photoplethysmography. The arterial pressure is reported as an aggregate of 3 extracted quantities: the systolic blood pressure which is the maximum blood pressure over a cardiac cycle; the diastolic blood pressure which is the minimum blood pressure over a cardiac cycle; and the mean blood pressure which is the average blood pressure over a cardiac cycle.", "time_frame": "1 year" }, { "type": "secondary", "measure": "Heart rate", "description": "", "time_frame": "1 year" }, { "type": "secondary", "measure": "systemic vascular resistance defined by the ratio of mean arterial pressure to cardiac output", "description": "", "time_frame": "1 year" } ], "relevance_tags": [ "Neurological / Autonomic", "EARLY_Phase 1", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 51, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03261570", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03186027", "title": "Coenzyme Q10 Plus NADH Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-09-21", "start_date": "2017-06-28", "completion_date": "2021-09-01", "primary_completion_date": "2020-05-28", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Coenzyme Q10 Plus Nadh", "Phosphoserine Plus Vitamin C" ], "sponsor": "Hospital Universitari Vall d'Hebron Research Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The main aim of the study is to examine the effect of oral CoQ10 plus NADH (Reconnect®) supplementation twice daily for 8-weeks on the changes in fatigue perception, sleep disturbances, autonomic dysfunction and HRQoL assessed by patient-reported outcome measures in CFS/ME.", "primary_outcomes": [ { "type": "primary", "measure": "Effect of oral Reconnect ® (CoQ10 plus NADH) supplementation on the changes in core symptoms during 8-weeks in CFS/ME subjects.", "description": "Evaluate the effect of oral Reconnect ® supplementation on the changes in fatigue perception measured by the Fatigue Index Scale-40 (40 items) in all study participants. Items Rate: 0 (no fatigue) to 4 (severe fatigue).", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Demographic data and clinical parameters", "description": "Sex", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Age of onset of symptoms", "description": "Age at onset of fatigue", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Concomitant conditions", "description": "Comorbid illnesses associated with ME/CFS", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Height will be measured and reported", "description": "Height in meters", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Weight will be measured and reported", "description": "Weight in kilograms", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Body Mass Index (BMI)", "description": "Height and Weight will be combined to report BMI in kg/m\\^2", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Sleep Quality", "description": "Pittsburgh Quality of Sleep Index (18 items) for non-refreshing sleep", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Autonomic Function", "description": "COMPASS-31 Questionnaire (31-items) to assess autonomic dysfunction", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Heart Rate Variability (HRV) recording device", "description": "Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50(NN50/total number of all NN). Frequency domain - TP (the variance of NN intervals over the temporal segment), VLF(power in very low frequency range; \\< 0.04 Hz), LF (Power in low frequency range; 0.04\\~0.15 Hz), HF(Power in high frequency range; 0.15\\~0.4 Hz).", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Health-Related Quality of Life SF36 survey", "description": "Short Form-36 Health Survey (36-items) to measure quality of life of participants.", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" } ], "outcome_measures": [ { "type": "primary", "measure": "Effect of oral Reconnect ® (CoQ10 plus NADH) supplementation on the changes in core symptoms during 8-weeks in CFS/ME subjects.", "description": "Evaluate the effect of oral Reconnect ® supplementation on the changes in fatigue perception measured by the Fatigue Index Scale-40 (40 items) in all study participants. Items Rate: 0 (no fatigue) to 4 (severe fatigue).", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Demographic data and clinical parameters", "description": "Sex", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Age of onset of symptoms", "description": "Age at onset of fatigue", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Concomitant conditions", "description": "Comorbid illnesses associated with ME/CFS", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Height will be measured and reported", "description": "Height in meters", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Weight will be measured and reported", "description": "Weight in kilograms", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Body Mass Index (BMI)", "description": "Height and Weight will be combined to report BMI in kg/m\\^2", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Sleep Quality", "description": "Pittsburgh Quality of Sleep Index (18 items) for non-refreshing sleep", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Autonomic Function", "description": "COMPASS-31 Questionnaire (31-items) to assess autonomic dysfunction", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Heart Rate Variability (HRV) recording device", "description": "Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50(NN50/total number of all NN). Frequency domain - TP (the variance of NN intervals over the temporal segment), VLF(power in very low frequency range; \\< 0.04 Hz), LF (Power in low frequency range; 0.04\\~0.15 Hz), HF(Power in high frequency range; 0.15\\~0.4 Hz).", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" }, { "type": "secondary", "measure": "Health-Related Quality of Life SF36 survey", "description": "Short Form-36 Health Survey (36-items) to measure quality of life of participants.", "time_frame": "At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)" } ], "relevance_tags": [ "Mitochondrial", "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 282, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT03186027", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02460445", "title": "Phlebotomy and Polycystic Ovary Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-07-27", "start_date": "2015-01", "completion_date": "2020-06", "primary_completion_date": "2020-06", "conditions_raw": [ "Hyperandrogenism", "Metabolic Cardiovascular Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Phlebotomy", "Cyproterone Acetate" ], "sponsor": "Manuel Luque Ramírez", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk factors in patients with functional hyperandrogenism (polycystic ovary syndrome \\& idiopathic hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to usual clinical practice.\n\nMETHODOLOGY\n\nOpen label, controlled, parallel, prospective study of 12 months of duration, with 2 randomized arms of follow-up:\n\ni) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to perform scheduled phlebotomies from the third month of treatment to the end of the study (3 times with a 3-month interval between them).\n\nii) Control Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to follow-up without bloodletting.\n\nThe whole group of patients will undergo a comprehensive anthropometric and hormonal assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory and office blood pressure monitoring, proinflammatory profile, oxidative stress status, autonomic function assessment, and iron-related metabolism parameters at baseline, after 3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention Group of patients, and throughout follow-up under treatment with COC in the Control Group of patients. If a significant relationship between circulating hepcidin levels and elevated ferritin concentrations is observed, a study of the potential influence of mutations/polymorphic variants of hepcidin gene on ferritin values will be performed as well.", "primary_outcomes": [ { "type": "primary", "measure": "Change in the Matsuda index from the circulating glucose and insulin concentrations during and standard oral glucose tolerance test.", "description": "", "time_frame": "one year" }, { "type": "primary", "measure": "Percentage of patients with Hb < 12 g/dl or hematocrit <36% throughout the study", "description": "", "time_frame": "one year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in the percentage of patients with undiagnosed prediabetes/diabetes between month 0 and 12 of follow-up", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Change in the Disposition index between month 0 and 12 of follow-up", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Change in the lipid profile between month 0 and 12 of follow-up", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Changes in the blood pressure recordings between month 0 and 12 of follow-up", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Percentage of patients with ferropenia throughout the study", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Percentage of patients with a hypovolemic event during blood donation", "description": "", "time_frame": "one year" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in the Matsuda index from the circulating glucose and insulin concentrations during and standard oral glucose tolerance test.", "description": "", "time_frame": "one year" }, { "type": "primary", "measure": "Percentage of patients with Hb < 12 g/dl or hematocrit <36% throughout the study", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Change in the percentage of patients with undiagnosed prediabetes/diabetes between month 0 and 12 of follow-up", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Change in the Disposition index between month 0 and 12 of follow-up", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Change in the lipid profile between month 0 and 12 of follow-up", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Changes in the blood pressure recordings between month 0 and 12 of follow-up", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Percentage of patients with ferropenia throughout the study", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Percentage of patients with a hypovolemic event during blood donation", "description": "", "time_frame": "one year" } ], "relevance_tags": [ "Metabolic", "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 37, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02460445", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05454683", "title": "Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-07-12", "start_date": "2022-09-05", "completion_date": "2024-12-31", "primary_completion_date": "2024-09-30", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Melatonin Plus Zinc", "Isomaltose And Magnesium Stearate" ], "sponsor": "Laboratorios Viñas, S.A.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The aim of the study is to investigate the effects of oral melatonin and zinc supplementation on core features in individuals with ME/CFS", "primary_outcomes": [ { "type": "primary", "measure": "Self-reported fatigue as assessed by the 40-item Fatigue Impact Scale (FIS-40) over the baseline in the study participants.", "description": "The FIS-40 includes three subscales of the perceived impact of fatigue: cognitive (10 items), physical (10 items) and psychosocial functions (20 items), each item being scored from 0 (no fatigue) to 4 (severe fatigue). The total score is calculated by adding together the responses from the 40 questions (range 0-160). Higher scores indicate more functional limitations due to fatigue.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The health-related quality of life (HRQoL) as assessed by the Short-Form 36-Item Health Survey (SF-36) over the baseline in the study participants.", "description": "The SF-36 is a broadly-based self-reported survey on health-related physical and mental functioning status. It assesses functioning on eight subscales, including domains of physical functioning, physical role, bodily pain, general health, social functioning, vitality, emotional role and mental health, and two general subscales covering the physical and mental health domains on a 0-100 score. Lower scores indicate a more negative impact of an individual's health on functioning.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleep disturbances as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire over the baseline in the study participants.", "description": "The PSQI is the self-administered 19-item questionnaire. PSQI scores are obtained on each of seven components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep perturbations, use of sleeping medication and daytime dysfunction. Each item is scored from 0 to 3 (0 = no sleep problems and 3 = severe sleep problems). The global PSQI score ranges from 0 to 21 points, with scores of \\>5 indicating poorer sleep quality.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleepiness as assessed by the Epworth Sleepiness Scale (ESS) over the baseline in the study participants.", "description": "The ESS is a short, self-administered questionnaire that consists of eight questions asking to rate how likely it is to fall asleep in everyday situations (each question can be scored from 0 to 3 points: '0' indicates no sleepiness, and '3' indicates significant sleepiness). It provides a total score which has been shown to relate to the subject's level of daytime sleepiness (total score is ranging from 0 to 24 points).", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleep latency as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device was programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables were recorded and stored in the device's memory for data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleep onset as assessed by an actigraph sensor over the baseline in the study participants", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleep efficiency as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Total sleep time as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Wake time as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Number of awakenings as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Heart rate variability (HRV) as recorded by the FitLab software over the baseline in the study participants.", "description": "Changes in the cardiovagal autonomic dysfuntion will be continuously assessed and recorded for the R-R intervals over 5-min periods at rest and in the supine position on different days using the FitLab software.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Orthostatic intolerance as assessed by the active standing test (10-minute NASA Lean test) over the baseline in the study participants.", "description": "The 10-minute NLT is a well-established non-invasive procedure used to assess impaired cardiovascular responses to standing and to diagnose OI phenotypes. It records objective hemodynamic parameters (blood pressure and heart rate). The participants will be first asked to lie down during 5 minutes and then to stand and lean against a wall, with heels 6-8 inches from the wall. Throughout the recording, participants will be asked to remain motionless, quiet and any talking or movement will be discouraged, except for reporting any symptoms of concern.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Pain intensity as assessed by a visual analog scale (VAS) over the baseline in the study participants.", "description": "The pain VAS is a continuous and unidimensional measure of pain intensity. It comprised of a horizontal line of 10-centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. \"No pain\" (score of 0) and \"pain as bad as it could be\" or \"worst imaginable pain\"(score of 10).", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Anxiety and depression symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS) over the baseline in the study participants.", "description": "The HADS is a validated self-reported tool composed of 14 items (seven related to anxiety symptoms and seven to depression). Each item is scored from 0-3, and thus, scores range from 0 to 21; scores of 0-7 are interpreted as normal, 8-10 as mild, 11-14 as moderate, and 15-21 as severe for either anxiety or depression. The total HADS score ranges from 0 (no anxiety or depression) to 42 (severe anxiety and depression).", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Side effect of treatment", "description": "Treatment side effects will be collected from each participant during clinical trial.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" } ], "outcome_measures": [ { "type": "primary", "measure": "Self-reported fatigue as assessed by the 40-item Fatigue Impact Scale (FIS-40) over the baseline in the study participants.", "description": "The FIS-40 includes three subscales of the perceived impact of fatigue: cognitive (10 items), physical (10 items) and psychosocial functions (20 items), each item being scored from 0 (no fatigue) to 4 (severe fatigue). The total score is calculated by adding together the responses from the 40 questions (range 0-160). Higher scores indicate more functional limitations due to fatigue.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "The health-related quality of life (HRQoL) as assessed by the Short-Form 36-Item Health Survey (SF-36) over the baseline in the study participants.", "description": "The SF-36 is a broadly-based self-reported survey on health-related physical and mental functioning status. It assesses functioning on eight subscales, including domains of physical functioning, physical role, bodily pain, general health, social functioning, vitality, emotional role and mental health, and two general subscales covering the physical and mental health domains on a 0-100 score. Lower scores indicate a more negative impact of an individual's health on functioning.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleep disturbances as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire over the baseline in the study participants.", "description": "The PSQI is the self-administered 19-item questionnaire. PSQI scores are obtained on each of seven components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep perturbations, use of sleeping medication and daytime dysfunction. Each item is scored from 0 to 3 (0 = no sleep problems and 3 = severe sleep problems). The global PSQI score ranges from 0 to 21 points, with scores of \\>5 indicating poorer sleep quality.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleepiness as assessed by the Epworth Sleepiness Scale (ESS) over the baseline in the study participants.", "description": "The ESS is a short, self-administered questionnaire that consists of eight questions asking to rate how likely it is to fall asleep in everyday situations (each question can be scored from 0 to 3 points: '0' indicates no sleepiness, and '3' indicates significant sleepiness). It provides a total score which has been shown to relate to the subject's level of daytime sleepiness (total score is ranging from 0 to 24 points).", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleep latency as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device was programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables were recorded and stored in the device's memory for data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleep onset as assessed by an actigraph sensor over the baseline in the study participants", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Sleep efficiency as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Total sleep time as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Wake time as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Number of awakenings as assessed by an actigraph sensor over the baseline in the study participants.", "description": "An actigraph (Actiwatch Spectrum Plus® from Philips Respironics, Linton Instrumentation, UK) on the wrist of the non-dominant arm is continuously recording for seven days. The same device is programmed to collect data on motor activity (accelerometer) and light type/intensity (lux) at one minute intervals. These variables will be recorded and stored in the device's memory for further data analysis.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Heart rate variability (HRV) as recorded by the FitLab software over the baseline in the study participants.", "description": "Changes in the cardiovagal autonomic dysfuntion will be continuously assessed and recorded for the R-R intervals over 5-min periods at rest and in the supine position on different days using the FitLab software.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Orthostatic intolerance as assessed by the active standing test (10-minute NASA Lean test) over the baseline in the study participants.", "description": "The 10-minute NLT is a well-established non-invasive procedure used to assess impaired cardiovascular responses to standing and to diagnose OI phenotypes. It records objective hemodynamic parameters (blood pressure and heart rate). The participants will be first asked to lie down during 5 minutes and then to stand and lean against a wall, with heels 6-8 inches from the wall. Throughout the recording, participants will be asked to remain motionless, quiet and any talking or movement will be discouraged, except for reporting any symptoms of concern.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Pain intensity as assessed by a visual analog scale (VAS) over the baseline in the study participants.", "description": "The pain VAS is a continuous and unidimensional measure of pain intensity. It comprised of a horizontal line of 10-centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. \"No pain\" (score of 0) and \"pain as bad as it could be\" or \"worst imaginable pain\"(score of 10).", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Anxiety and depression symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS) over the baseline in the study participants.", "description": "The HADS is a validated self-reported tool composed of 14 items (seven related to anxiety symptoms and seven to depression). Each item is scored from 0-3, and thus, scores range from 0 to 21; scores of 0-7 are interpreted as normal, 8-10 as mild, 11-14 as moderate, and 15-21 as severe for either anxiety or depression. The total HADS score ranges from 0 (no anxiety or depression) to 42 (severe anxiety and depression).", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" }, { "type": "secondary", "measure": "Side effect of treatment", "description": "Treatment side effects will be collected from each participant during clinical trial.", "time_frame": "During 4 months of treatment and 8 weeks after discontinuation of dietary therapy" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 106, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05454683", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03253120", "title": "Alterations of Attention in POTS Depending on Body Position and Hydration", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-07-06", "start_date": "2017-09-11", "completion_date": "2022-07-05", "primary_completion_date": "2022-04-14", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Water" ], "sponsor": "Insel Gruppe AG, University Hospital Bern", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The Postural Tachycardia-Syndrome (POTS) is a form of autonomic dysregulation, typically accompanied by symptoms of orthostatic intolerance (OI). OI is defined by the inability to tolerate the upright position and is improved by lying down. POTS is considered a syndrome that may include a number of several disorders. Symptoms should be persistent for at least 6 months to reach a diagnosis. It is characterized by a sustained heart rate (HR) increment of 30 beats/min or more within 10 min of standing or head-up tilt (HUT) in adults, in the absence of orthostatic hypotension and with the presence of symptoms of OI. In children and adolescents a diagnosis requests a HR increment of at least 40 beats/min. The increment in HR when moving to an upright posture is often a response to a reduction in venous return, causing excessive blood pooling in the lower limbs. The symptoms present in POTS vary greatly. Typical symptoms are lightheadedness, dizziness, blurred vision, mental clouding (\"brain fog\") or cognitive dysfunction. Other symptoms may present as palpitations or chest pain. Additional symptoms consist of postural headaches, nausea, sleep disturbances, fatigue and gastrointestinal dysfunction. The manifestation of symptoms in POTS varies in severity, frequency and combination, resulting in POTS being a very heterogenous and subjective disorder. Symptoms can be severe and often make simple daily activities difficult to an extent that compromises the patients quality of life. Typically symptoms exacerbate in the mornings, after physical activity, after eating and during menstruation.\n\nThis study objective is to examine the occurrence, mechanisms and causes of impaired attention in POTS as well as to test the effect of acute water ingestion for attention in POTS. The investigators therefore conduct a study including patients with POTS and healthy volunteers.\n\nAll participants will receive a dossier of five self-assessment questionnaires after giving informed consent. Clinical examination includes 2 HUT-tests while standing for 15 minutes, conventional measuring of blood pressure, continuous recording of NIRS signals during testing, determination of pupil size, the diameter of the optic nerve and Neuropsychological testing (Test of Attentional Performance, mobility version\" (TAP-M), Go/NoGo Test, Divided Attention Test)", "primary_outcomes": [ { "type": "primary", "measure": "Numerical variables reaction time and/or hits resp. misses in the subtests \"alertness\" from the automated test battery \"Test of Attentional Performance, mobility version\"", "description": "\"Alertness\" is designed to assess tonic alertness, which is defined as the ability to maintain a high level of responsiveness in anticipation of a test stimulus. The alertness test measures the simple reaction time in response to a visual stimulus (a cross presented on the monitor)", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "primary", "measure": "Numerical variables reaction time and/or hits resp. misses in the subtest \"Go/NoGo\" from the automated test battery \"Test of Attentional Performance, mobility version\"", "description": "The \"Go/NoGo\" task for assessing the specific ability of subjects to suppress undesired responses. Reaction times and errors are recorded in a simple test with two stimuli", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "primary", "measure": "Numerical variables reaction time and/or hits resp. misses in the subtest \"divided attention\" from the automated test battery \"Test of Attentional Performance, mobility version\"", "description": "In the Test of Attentional Performance a visual and an auditory task must be processed in parallel", "time_frame": "After change body position and 5dl of water, up to 30 minutes" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Diameter of the optic nerve", "description": "The diameter of the optic nerve is measured with a 7-15 MHz linear array transducer in transorbital B-mode ultrasound .", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "secondary", "measure": "Brain perfusion measured with NIRS", "description": "All parameters of brain perfusion will be assessed using NIRS.", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "secondary", "measure": "Heart rate", "description": "For autonomic function testing, beat-to-beat BP and HR are measured with the Finometer device.", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "secondary", "measure": "Blood pressure", "description": "For autonomic function testing, beat-to-beat BP and HR are measured with the Finometer device.", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "secondary", "measure": "Pupil diameter", "description": "Determination of pupil size will be performed with a rubber cup covering the measured eye and the operator's hand covering the nonmeasured eye. A brief 2- to 3-second pause allows the pupil to dilate briefly at which time the measurement will be taken. Pupil size is the average diameter for the entire measurement time, which is typically 3 to 4 seconds.", "time_frame": "After change body position and 5dl of water, up to 30 minutes" } ], "outcome_measures": [ { "type": "primary", "measure": "Numerical variables reaction time and/or hits resp. misses in the subtests \"alertness\" from the automated test battery \"Test of Attentional Performance, mobility version\"", "description": "\"Alertness\" is designed to assess tonic alertness, which is defined as the ability to maintain a high level of responsiveness in anticipation of a test stimulus. The alertness test measures the simple reaction time in response to a visual stimulus (a cross presented on the monitor)", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "primary", "measure": "Numerical variables reaction time and/or hits resp. misses in the subtest \"Go/NoGo\" from the automated test battery \"Test of Attentional Performance, mobility version\"", "description": "The \"Go/NoGo\" task for assessing the specific ability of subjects to suppress undesired responses. Reaction times and errors are recorded in a simple test with two stimuli", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "primary", "measure": "Numerical variables reaction time and/or hits resp. misses in the subtest \"divided attention\" from the automated test battery \"Test of Attentional Performance, mobility version\"", "description": "In the Test of Attentional Performance a visual and an auditory task must be processed in parallel", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "secondary", "measure": "Diameter of the optic nerve", "description": "The diameter of the optic nerve is measured with a 7-15 MHz linear array transducer in transorbital B-mode ultrasound .", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "secondary", "measure": "Brain perfusion measured with NIRS", "description": "All parameters of brain perfusion will be assessed using NIRS.", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "secondary", "measure": "Heart rate", "description": "For autonomic function testing, beat-to-beat BP and HR are measured with the Finometer device.", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "secondary", "measure": "Blood pressure", "description": "For autonomic function testing, beat-to-beat BP and HR are measured with the Finometer device.", "time_frame": "After change body position and 5dl of water, up to 30 minutes" }, { "type": "secondary", "measure": "Pupil diameter", "description": "Determination of pupil size will be performed with a rubber cup covering the measured eye and the operator's hand covering the nonmeasured eye. A brief 2- to 3-second pause allows the pupil to dilate briefly at which time the measurement will be taken. Pupil size is the average diameter for the entire measurement time, which is typically 3 to 4 seconds.", "time_frame": "After change body position and 5dl of water, up to 30 minutes" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03253120", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04632134", "title": "Long-term Effects of Transcutaneous Vagal Nerve Stimulation on Postural Orthostatic Tachycardia Syndrome (POTS)", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-06-30", "start_date": "2019-11-10", "completion_date": "2022-12-30", "primary_completion_date": "2022-06-30", "conditions_raw": [ "Orthostatic Intolerance", "Postural Tachycardia Syndrome", "Syncope, Postural", "Physical Disability", "Autonomic Dysfunction" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Transcutaneous Vagal Nerve Stimulation", "Home Daily Transcutaneous Vagal Nerve Stimulation" ], "sponsor": "Istituto Clinico Humanitas", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural Orthostatic Tachycardia Syndrome (POTS) is characterized by symptoms of chronic orthostatic intolerance such as fatigue, lightheadedness, dizziness, palpitations and by pronounced tachycardia upon standing.\n\nThe aims of the present research study are to test whether a daily transcutaneous vagal nerve stimulation (tVNS) performed for 14 consecutive days may improve heart rate response and reduce disabling symptoms while standing.", "primary_outcomes": [ { "type": "primary", "measure": "Change of Autonomic symptoms", "description": "Autonomic symptoms will be assessed by the Composite Autonomic Symptom Scale (COMPASS 31) questionnaire. This is based on 31 items and a score ranging from 0 to100, 0 being the absence of symptom and 100 the greatest symptom intensity. The COMPASS 31 will be used to quantify the following autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, urinary and pupillomotor dysfunction symptoms.", "time_frame": "Change from baseline Autonomic symptoms at 14 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Heart rate", "description": "Change of Cardiovascular autonomic profile", "time_frame": "Change from baseline cardiovascular autonomic profile at 14 days" }, { "type": "secondary", "measure": "Change in blood pressure", "description": "Change of Cardiovascular autonomic profile", "time_frame": "Change from baseline cardiovascular autonomic profile at 14 days" }, { "type": "secondary", "measure": "Change in respiration rate", "description": "Change of Cardiovascular autonomic profile", "time_frame": "Change from baseline cardiovascular autonomic profile at 14 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of Autonomic symptoms", "description": "Autonomic symptoms will be assessed by the Composite Autonomic Symptom Scale (COMPASS 31) questionnaire. This is based on 31 items and a score ranging from 0 to100, 0 being the absence of symptom and 100 the greatest symptom intensity. The COMPASS 31 will be used to quantify the following autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, urinary and pupillomotor dysfunction symptoms.", "time_frame": "Change from baseline Autonomic symptoms at 14 days" }, { "type": "secondary", "measure": "Change in Heart rate", "description": "Change of Cardiovascular autonomic profile", "time_frame": "Change from baseline cardiovascular autonomic profile at 14 days" }, { "type": "secondary", "measure": "Change in blood pressure", "description": "Change of Cardiovascular autonomic profile", "time_frame": "Change from baseline cardiovascular autonomic profile at 14 days" }, { "type": "secondary", "measure": "Change in respiration rate", "description": "Change of Cardiovascular autonomic profile", "time_frame": "Change from baseline cardiovascular autonomic profile at 14 days" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 23, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04632134", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03724370", "title": "Using Telehealth to Improve Outcomes in Veterans at Risk for Suicide", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-05-06", "start_date": "2018-12-14", "completion_date": "2023-12-31", "primary_completion_date": "2023-12-31", "conditions_raw": [ "Suicide" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Telehealth Monitoring System", "Vha-Srm" ], "sponsor": "VA Pittsburgh Healthcare System", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "Overview. The investigators will randomize 120 Veterans in this 3-site trial over 16 months. Eligible Veterans will include those to be discharged for a hospitalization for suicidal ideation. Baseline data collection and randomization will occur at discharge. The 3 month intervention will have study assessments at 2, 4, 8, and 12 weeks post-discharge. The study's primary outcome measure is suicidal ideation (measured with the Beck Scale for Suicidal Ideation\\[BSS\\] and secondarily with the Columbia Scale for Suicidality C-SSRS).\n\nIntervention Components. The control condition will consist of Veterans randomized to VHA-SRM (Suicide Risk Monitoring). The experimental condition will be the telehealth system (TES) + VHA-SRM (Suicide Risk Monitoring) intervention. Veterans randomized to the telehealth system will receive the Interactive Voice Response (IVR) system monitoring in addition to VHA-SRM and will receive training on how to use the TES from the research coordinator. Veterans can access the IVR as a telephonic device accessed by a local or toll-free number and can use a 'plain old telephone system' (POTS), Cellular phone or Internet phone connected to their phone service provider. Participants will be instructed to interact daily with the TES system daily. Because of safety concerns, questions pertaining to suicidal behavior will be asked daily; to avoid repetition, all other questions will be asked every 3rd day. Once participants complete the questions on the telehealth device, their responses will be automatically uploaded and checked by trained VA Pittsburgh Healthcare System (VAPHS) nurses every 4 hours, during regular daytime hours of 9-5. VAPHS will serve as the central site retrieving downloads for all sites. Color-coded risk triage level designations based on potential responses, provide guidance regarding next steps. The protocol for assessing suicidal patients will follow standard VA procedures, outlined in each medical center's safety plan for suicidal patients.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Beck Scale for Suicidal Ideation (BSS). Aaron T. Beck, copyright 1991.", "description": "Continuous scale assessing suicidal ideation. Scores will range from 0 to 42, with lower scores indicating less suicidal ideation.", "time_frame": "At every visit: screen, baseline(s), week 2,4,6,8,12; timeframe is the past week, including today." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Columbia Suicide Severity Rating Scale (C-SSRS). Posner, K; Brent, D; Lucas, c; Gould, M; Stanley, B; Brown, G; Fisher, P; Zelazny, J; Burke, A; Oquendo, M; Mann, J.", "description": "Scale assessing suicidal ideation, attempts and behaviors. Mean change in suicidal behavior minimum total score 0, maximum total score 5, higher total scores indicate more suicidal behavior.", "time_frame": "At every visit: screen, baseline(s), week 2,4,6,8,12; time frame includes lifetime and since last visit." } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Beck Scale for Suicidal Ideation (BSS). Aaron T. Beck, copyright 1991.", "description": "Continuous scale assessing suicidal ideation. Scores will range from 0 to 42, with lower scores indicating less suicidal ideation.", "time_frame": "At every visit: screen, baseline(s), week 2,4,6,8,12; timeframe is the past week, including today." }, { "type": "secondary", "measure": "Change in Columbia Suicide Severity Rating Scale (C-SSRS). Posner, K; Brent, D; Lucas, c; Gould, M; Stanley, B; Brown, G; Fisher, P; Zelazny, J; Burke, A; Oquendo, M; Mann, J.", "description": "Scale assessing suicidal ideation, attempts and behaviors. Mean change in suicidal behavior minimum total score 0, maximum total score 5, higher total scores indicate more suicidal behavior.", "time_frame": "At every visit: screen, baseline(s), week 2,4,6,8,12; time frame includes lifetime and since last visit." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Fed" ], "enrollment": 180, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03724370", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01764711", "title": "Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-03-31", "start_date": "2013-01", "completion_date": "2020-12-31", "primary_completion_date": "2020-12-31", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Cosyntropin Administration" ], "sponsor": "Vanderbilt University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is to determine different chemical levels in the blood during a low salt diet. This study will compare normal volunteers to those with Postural Tachycardia Syndrome (POTS)", "primary_outcomes": [ { "type": "primary", "measure": "Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH).", "description": "To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.", "time_frame": "30 minutes after injection of ACTH" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH).", "description": "To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.", "time_frame": "30 minutes after injection of ACTH" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 13, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01764711", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04603157", "title": "Remote Self-training Program for Patients With Postural Orthostatic Tachycardia Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-03-15", "start_date": "2020-01-01", "completion_date": "2022-02-18", "primary_completion_date": "2022-02-18", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Hybrid Exercise Training" ], "sponsor": "Mayo Clinic", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this research is to evaluate if a hybrid semi-supervised remote exercise training program can reduce symptoms and improve quality of life and physical fitness in individuals with postural orthostatic tachycardia syndrome (POTS) and determine if this program is more effective than current standard of care.", "primary_outcomes": [ { "type": "primary", "measure": "Change Peak Oxygen consumption at 3 months", "description": "peak oxygen consumption measured from maximal cardiopulmonary exercise testing", "time_frame": "baseline and following 3 month intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Composite Autonomic Symptom Score (COMPASS 31) at 3 months", "description": "Composite Autonomic Symptom Score a questionnaire of autonomic symptoms severity in 6 domains. Total score ranges from 0-100. Higher score means more severe autonomic symptoms.", "time_frame": "baseline and following 3 month intervention" }, { "type": "secondary", "measure": "Change in Functional Ability Score at 3 months", "description": "Functional Ability Score asking patient to report their degree of limitation from 0-100% in 10% increments. 100% would be no limitation, feel normal, 10% is completely bedridden.", "time_frame": "baseline and following 3 month intervention" }, { "type": "secondary", "measure": "Change in 36-Item Short Form Health Survey questionnaire (SF-36) at 3 months", "description": "36-Item Short Form Health Survey questionnaire to evaluate quality of life and degree of health specifically focusing on the reported physical and mental components. Scores range from 0-100, where a higher score indicated better health.", "time_frame": "baseline and following 3 month intervention" }, { "type": "secondary", "measure": "Change in heart rate with 10-min Stand test at 3 months", "description": "Change in heart rate in response to standing from supine to standing for 10 minutes", "time_frame": "baseline and following 3 month intervention" }, { "type": "secondary", "measure": "Change in blood volume at 3 months", "description": "change in blood volume", "time_frame": "baseline and following 3 month intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Change Peak Oxygen consumption at 3 months", "description": "peak oxygen consumption measured from maximal cardiopulmonary exercise testing", "time_frame": "baseline and following 3 month intervention" }, { "type": "secondary", "measure": "Change in Composite Autonomic Symptom Score (COMPASS 31) at 3 months", "description": "Composite Autonomic Symptom Score a questionnaire of autonomic symptoms severity in 6 domains. Total score ranges from 0-100. Higher score means more severe autonomic symptoms.", "time_frame": "baseline and following 3 month intervention" }, { "type": "secondary", "measure": "Change in Functional Ability Score at 3 months", "description": "Functional Ability Score asking patient to report their degree of limitation from 0-100% in 10% increments. 100% would be no limitation, feel normal, 10% is completely bedridden.", "time_frame": "baseline and following 3 month intervention" }, { "type": "secondary", "measure": "Change in 36-Item Short Form Health Survey questionnaire (SF-36) at 3 months", "description": "36-Item Short Form Health Survey questionnaire to evaluate quality of life and degree of health specifically focusing on the reported physical and mental components. Scores range from 0-100, where a higher score indicated better health.", "time_frame": "baseline and following 3 month intervention" }, { "type": "secondary", "measure": "Change in heart rate with 10-min Stand test at 3 months", "description": "Change in heart rate in response to standing from supine to standing for 10 minutes", "time_frame": "baseline and following 3 month intervention" }, { "type": "secondary", "measure": "Change in blood volume at 3 months", "description": "change in blood volume", "time_frame": "baseline and following 3 month intervention" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04603157", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01547117", "title": "Dietary Salt in Postural Tachycardia Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-02-22", "start_date": "2012-03", "completion_date": "2021-12", "primary_completion_date": "2020-12", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Blood Volume", "Total Blood Volume", "Exercise Capacity Test - Bicycle", "Posture Study" ], "sponsor": "Vanderbilt University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Patients with POTS may not adequately expand their plasma volume in response to a high-sodium (Na+) diet. Mechanisms involved in the regulation of plasma volume, such as the renin-angiotensin-aldosterone system and renal dopamine, may be impaired in POTS and may respond inappropriately to changes in dietary sodium.The purpose of this study is to determine (1) whether a high dietary sodium level appropriately expands plasma volume in POTS; (2) whether plasma renin activity and aldosterone are modified appropriately by changes in dietary sodium in POTS; and (3) whether patients with POTS have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.", "primary_outcomes": [ { "type": "primary", "measure": "Plasma Volume", "description": "Plasma volume (PV) was determined by the indicator tracer-dilution technique, using the DAXOR Blood Volume Analyzer (BVA)-100 system (DAXOR Corporation), on Day 7 of the low sodium and high sodium dietary interventions. Outcome data are the absolute values for PV on Day 7 for each diet.", "time_frame": "after 7 days of each dietary sodium level" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Magnitude of Suppression of Plasma Renin Activity (From Low Sodium to High Sodium Diets)", "description": "Whether upright plasma renin activity was modified appropriately by changes in dietary sodium in POTS \\& healthy controls. Outcome data are the absolute values for upright plasma renin activity on Day 7 of each diet.", "time_frame": "Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Plasma Volume", "description": "Plasma volume (PV) was determined by the indicator tracer-dilution technique, using the DAXOR Blood Volume Analyzer (BVA)-100 system (DAXOR Corporation), on Day 7 of the low sodium and high sodium dietary interventions. Outcome data are the absolute values for PV on Day 7 for each diet.", "time_frame": "after 7 days of each dietary sodium level" }, { "type": "secondary", "measure": "Magnitude of Suppression of Plasma Renin Activity (From Low Sodium to High Sodium Diets)", "description": "Whether upright plasma renin activity was modified appropriately by changes in dietary sodium in POTS \\& healthy controls. Outcome data are the absolute values for upright plasma renin activity on Day 7 of each diet.", "time_frame": "Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium intervention" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 38, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01547117", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02553265", "title": "Carbidopa for the Treatment of Excessive Blood Pressure Variability", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2022-02-09", "start_date": "2015-09", "completion_date": "2019-05-10", "primary_completion_date": "2019-05-10", "conditions_raw": [ "Dysautonomia, Familial", "Baroreflex Failure Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Carbidopa Low-Dose", "Carbidopa High-Dose" ], "sponsor": "NYU Langone Health", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension and normalize or reduce the exaggerated blood pressure variability in patients with familial dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or Riley-Day syndrome). Funding Source- FDA OOPD.", "primary_outcomes": [ { "type": "primary", "measure": "Number of Participants Who Reported Adverse Events Related to Study Drug", "description": "Adverse events defined as: a change in a patient's baseline condition including intercurrent illnesses irrespective of the relationship to carbidopa treatment. This will be monitored primarily with phone calls at weekly intervals. In addition, patients will be asked about adverse events while at the office. Patients will also fill a daily diary with a specific prompts to note any adverse events.", "time_frame": "Up to 90 days" }, { "type": "primary", "measure": "Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study.", "description": "Body mass measured in kg", "time_frame": "Up to 90 days" }, { "type": "primary", "measure": "Number of Participants With Abnormal Electrocardiographic Interval Patterns", "description": "Clinically significant changes in the intervals of characteristic electrocardiographic patterns", "time_frame": "Up to 90 days" }, { "type": "primary", "measure": "Average Systolic Blood Pressure Variability (Daytime)", "description": "Patients with FD undergo ambulatory BP monitoring while keeping a detailed log of their activities (sleep/meal-times/medications/posture/symptoms). Variability in blood pressure overtime will be measured by the standard deviation during awake hours", "time_frame": "up to Week 14" }, { "type": "primary", "measure": "Highest Systolic Blood Pressure", "description": "Maximum blood pressure captured on 24-h ambulatory monitoring", "time_frame": "Day 1 of treatment period" }, { "type": "primary", "measure": "Systolic Blood Pressure", "description": "SBP measured in the seated position", "time_frame": "up to Week 14" }, { "type": "primary", "measure": "Heart Rate", "description": "Heart rate in the seated position", "time_frame": "up to Week 14" }, { "type": "primary", "measure": "Number of Participants Who Displayed Clinical Significant Laboratory Values on CBC or Metabolic Panel", "description": "Clinically significant laboratory values include complete blood count (CMC) and metabolic panel related to treatment with carbidopa", "time_frame": "Up to 90 days" }, { "type": "primary", "measure": "Number of Participants Who Displayed Clinically Significant Values in Urine Safety Parameters", "description": "Clinically significant values on urinalysis, urine safety parameters related to treatment with carbidopa", "time_frame": "Up to 90 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Severity of Hypotension During an Active Stand Test", "description": "Lowest blood pressure captured during 3 minutes of standing", "time_frame": "up to Week 14" }, { "type": "secondary", "measure": "Number of Participants Who Reported Worsening of OH Symptoms or Dropped Out Because of Worsening OH While on Active Study Drug", "description": "", "time_frame": "Up to 90 days" }, { "type": "secondary", "measure": "Frequency of Worsening Symptoms Noted in the Patient's Diary", "description": "A tailored questionnaire to examine symptoms over the treatment period and the used of as needed medications. Each day will have a designated page. Since nausea/vomiting and hypertension occur together in FD we will use a diary consisting of a simplified version of the Rhodes Index 44 symptoms of nausea/retching, with items addressing vomiting/throwing up omitted, as most participants will have had anti-reflux surgery to prevent vomiting (fundoplication), graded on a 5-point scale (appendix 2). The diary will also include space to write down any adverse events on a daily basis.", "time_frame": "Up to 90 Days" }, { "type": "secondary", "measure": "24-h Urinary Norepinephrine Excretion", "description": "Norepinephrine concentration determined from a 24-hour urine sample in a bottle shielded from light containing preservative. Patients will be instructed to refrigerate their sample and bring it on the morning of their visit in a cool bag.", "time_frame": "up to Week 14" }, { "type": "secondary", "measure": "Coefficient of Systolic BP Variability (Daytime)", "description": "The measurement of blood pressure variability based on the standard deviation that also takes into account the underlying level of BP.", "time_frame": "up to Week 14" }, { "type": "secondary", "measure": "Morning Surge in Systolic BP on Awakening From Sleep (24-h)", "description": "The morning surge will be calculated as the difference between the mean systolic blood pressure during the hour that included the lowest blood pressure during sleep and maximum value detected within 2-h of awakening from sleep", "time_frame": "up to Week 14" } ], "outcome_measures": [ { "type": "primary", "measure": "Number of Participants Who Reported Adverse Events Related to Study Drug", "description": "Adverse events defined as: a change in a patient's baseline condition including intercurrent illnesses irrespective of the relationship to carbidopa treatment. This will be monitored primarily with phone calls at weekly intervals. In addition, patients will be asked about adverse events while at the office. Patients will also fill a daily diary with a specific prompts to note any adverse events.", "time_frame": "Up to 90 days" }, { "type": "primary", "measure": "Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study.", "description": "Body mass measured in kg", "time_frame": "Up to 90 days" }, { "type": "primary", "measure": "Number of Participants With Abnormal Electrocardiographic Interval Patterns", "description": "Clinically significant changes in the intervals of characteristic electrocardiographic patterns", "time_frame": "Up to 90 days" }, { "type": "primary", "measure": "Average Systolic Blood Pressure Variability (Daytime)", "description": "Patients with FD undergo ambulatory BP monitoring while keeping a detailed log of their activities (sleep/meal-times/medications/posture/symptoms). Variability in blood pressure overtime will be measured by the standard deviation during awake hours", "time_frame": "up to Week 14" }, { "type": "primary", "measure": "Highest Systolic Blood Pressure", "description": "Maximum blood pressure captured on 24-h ambulatory monitoring", "time_frame": "Day 1 of treatment period" }, { "type": "primary", "measure": "Systolic Blood Pressure", "description": "SBP measured in the seated position", "time_frame": "up to Week 14" }, { "type": "primary", "measure": "Heart Rate", "description": "Heart rate in the seated position", "time_frame": "up to Week 14" }, { "type": "primary", "measure": "Number of Participants Who Displayed Clinical Significant Laboratory Values on CBC or Metabolic Panel", "description": "Clinically significant laboratory values include complete blood count (CMC) and metabolic panel related to treatment with carbidopa", "time_frame": "Up to 90 days" }, { "type": "primary", "measure": "Number of Participants Who Displayed Clinically Significant Values in Urine Safety Parameters", "description": "Clinically significant values on urinalysis, urine safety parameters related to treatment with carbidopa", "time_frame": "Up to 90 days" }, { "type": "secondary", "measure": "Severity of Hypotension During an Active Stand Test", "description": "Lowest blood pressure captured during 3 minutes of standing", "time_frame": "up to Week 14" }, { "type": "secondary", "measure": "Number of Participants Who Reported Worsening of OH Symptoms or Dropped Out Because of Worsening OH While on Active Study Drug", "description": "", "time_frame": "Up to 90 days" }, { "type": "secondary", "measure": "Frequency of Worsening Symptoms Noted in the Patient's Diary", "description": "A tailored questionnaire to examine symptoms over the treatment period and the used of as needed medications. Each day will have a designated page. Since nausea/vomiting and hypertension occur together in FD we will use a diary consisting of a simplified version of the Rhodes Index 44 symptoms of nausea/retching, with items addressing vomiting/throwing up omitted, as most participants will have had anti-reflux surgery to prevent vomiting (fundoplication), graded on a 5-point scale (appendix 2). The diary will also include space to write down any adverse events on a daily basis.", "time_frame": "Up to 90 Days" }, { "type": "secondary", "measure": "24-h Urinary Norepinephrine Excretion", "description": "Norepinephrine concentration determined from a 24-hour urine sample in a bottle shielded from light containing preservative. Patients will be instructed to refrigerate their sample and bring it on the morning of their visit in a cool bag.", "time_frame": "up to Week 14" }, { "type": "secondary", "measure": "Coefficient of Systolic BP Variability (Daytime)", "description": "The measurement of blood pressure variability based on the standard deviation that also takes into account the underlying level of BP.", "time_frame": "up to Week 14" }, { "type": "secondary", "measure": "Morning Surge in Systolic BP on Awakening From Sleep (24-h)", "description": "The morning surge will be calculated as the difference between the mean systolic blood pressure during the hour that included the lowest blood pressure during sleep and maximum value detected within 2-h of awakening from sleep", "time_frame": "up to Week 14" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 22, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02553265", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01563107", "title": "Dietary Sodium's Effect on Urinary Sodium and Dopamine Excretion in Patients With Postural Tachycardia Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-01-25", "start_date": "2012-03", "completion_date": "2020-12", "primary_completion_date": "2020-12", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Plasma Volume", "Exercise Capacity Test - Bicycle", "Posture Study" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Patients with Postural Tachycardia Syndrome (POTS) may not adequately expand their plasma volume in response to a high sodium diet. Mechanisms involved in the regulation of plasma volume, such as the renin-angiotensin-aldosterone system and renal dopamine (DA), may be impaired in POTS and may respond inappropriately to changes in dietary sodium. The investigators propose that the changes in urinary sodium and dopamine excretion caused by consuming low-sodium and high-sodium diets will be different between patients with POTS and healthy volunteers. The purpose of this study is to determine (1) whether changes in dietary sodium level appropriately influence sodium excretion in POTS; (2) whether changes in dietary sodium level appropriately influence DA excretion in POTS; (3) whether a high dietary sodium level appropriately expands plasma volume in POTS; and (4) whether patients with POTS have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.", "primary_outcomes": [ { "type": "primary", "measure": "24hr Urinary Sodium", "description": "Amount of sodium excreted in urine over 24hr ending on Day 7", "time_frame": "Day 6 am - Day 7 am for each dietary sodium level" }, { "type": "primary", "measure": "24hr Urinary Dopamine", "description": "Amount of dopamine excreted in urine over 24 hours ending on Day 7", "time_frame": "Between Day 6 am - Day 7 am of each dietary sodium level" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Plasma Volume", "description": "Plasma volume (PV) was determined by the indicator tracer-dilution technique, using the DAXOR Blood Volume Analyzer (BVA)-100 system (DAXOR Corporation), on Day 7 of the low sodium and high sodium dietary interventions.", "time_frame": "after 7 days of each dietary sodium level" }, { "type": "secondary", "measure": "Magnitude of Orthostatic Tachycardia", "description": "Whether the magnitude of the heart rate increase that occurs in patients with POTS when moving from a supine to an upright position is attenuated by a High Sodium diet relative to a Low Sodium diet.\n\nHeart rate was assessed after overnight rest and fasting after midnight, following at least 60 minutes of lying quietly. Heart rate was then measured at intervals after subjects had been standing for up to 30 minutes (as tolerated). Differences between supine and standing values are presented for 5 minutes standing (or maximal stand if \\<5 minutes) since several patients were unable to stand for 10 minutes.\n\nData in POTS patients were compared to that of Healthy Controls.", "time_frame": "Supine and upright heart rate were measured after 6 days of each dietary sodium level" }, { "type": "secondary", "measure": "Upright Symptom Score", "description": "Whether upright symptoms were improved in patients with POTS on a High Sodium diet relative to a Low Sodium diet.\n\nPatients were asked to report their standing symptom burden at the end of the Stand portion of the posture study, using the Vanderbilt Orthostatic Symptoms Scale (VOSS). They rated the severity of nine symptoms (palpitations, lightheadedness, mental confusion, blurred vision, shortness of breath, tremulousness, chest discomfort, headache, and nausea) on a scale ranging from a minimum of 0 (reflecting an absence of symptoms) to a maximum score of 10. The sum of the individual symptom scores was used to calculate orthostatic symptom burden for each participant. The lowest possible total score was 0, if a participant scored all 9 questions as 0, and the highest possible score was 90, if a participant scored all 9 questions as 10. Higher scores indicated worse symptoms.", "time_frame": "Upright symptoms were assessed on the 6th day of low or high sodium diet." }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 1-2", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 2 of each diet phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days1-2", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 2 of each dietary sodium phase" }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 2-3", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 3 of each diet phase" }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 3-4", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 4 of each diet phase" }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 4-5", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets", "time_frame": "24 hour collections ending on Day 5 of each diet phase" }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 5-6", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 6 of each diet phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days 2-3", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 3 of each dietary sodium phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days 3-4", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 4 of each dietary sodium phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days 4-5", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 5 of each dietary sodium phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days 5-6", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 6 of each dietary sodium phase" } ], "outcome_measures": [ { "type": "primary", "measure": "24hr Urinary Sodium", "description": "Amount of sodium excreted in urine over 24hr ending on Day 7", "time_frame": "Day 6 am - Day 7 am for each dietary sodium level" }, { "type": "primary", "measure": "24hr Urinary Dopamine", "description": "Amount of dopamine excreted in urine over 24 hours ending on Day 7", "time_frame": "Between Day 6 am - Day 7 am of each dietary sodium level" }, { "type": "secondary", "measure": "Plasma Volume", "description": "Plasma volume (PV) was determined by the indicator tracer-dilution technique, using the DAXOR Blood Volume Analyzer (BVA)-100 system (DAXOR Corporation), on Day 7 of the low sodium and high sodium dietary interventions.", "time_frame": "after 7 days of each dietary sodium level" }, { "type": "secondary", "measure": "Magnitude of Orthostatic Tachycardia", "description": "Whether the magnitude of the heart rate increase that occurs in patients with POTS when moving from a supine to an upright position is attenuated by a High Sodium diet relative to a Low Sodium diet.\n\nHeart rate was assessed after overnight rest and fasting after midnight, following at least 60 minutes of lying quietly. Heart rate was then measured at intervals after subjects had been standing for up to 30 minutes (as tolerated). Differences between supine and standing values are presented for 5 minutes standing (or maximal stand if \\<5 minutes) since several patients were unable to stand for 10 minutes.\n\nData in POTS patients were compared to that of Healthy Controls.", "time_frame": "Supine and upright heart rate were measured after 6 days of each dietary sodium level" }, { "type": "secondary", "measure": "Upright Symptom Score", "description": "Whether upright symptoms were improved in patients with POTS on a High Sodium diet relative to a Low Sodium diet.\n\nPatients were asked to report their standing symptom burden at the end of the Stand portion of the posture study, using the Vanderbilt Orthostatic Symptoms Scale (VOSS). They rated the severity of nine symptoms (palpitations, lightheadedness, mental confusion, blurred vision, shortness of breath, tremulousness, chest discomfort, headache, and nausea) on a scale ranging from a minimum of 0 (reflecting an absence of symptoms) to a maximum score of 10. The sum of the individual symptom scores was used to calculate orthostatic symptom burden for each participant. The lowest possible total score was 0, if a participant scored all 9 questions as 0, and the highest possible score was 90, if a participant scored all 9 questions as 10. Higher scores indicated worse symptoms.", "time_frame": "Upright symptoms were assessed on the 6th day of low or high sodium diet." }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 1-2", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 2 of each diet phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days1-2", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 2 of each dietary sodium phase" }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 2-3", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 3 of each diet phase" }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 3-4", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 4 of each diet phase" }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 4-5", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets", "time_frame": "24 hour collections ending on Day 5 of each diet phase" }, { "type": "secondary", "measure": "Urinary Sodium Following Change in Dietary Sodium Days 5-6", "description": "Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 6 of each diet phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days 2-3", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 3 of each dietary sodium phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days 3-4", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 4 of each dietary sodium phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days 4-5", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 5 of each dietary sodium phase" }, { "type": "secondary", "measure": "Urinary Dopamine Following Change in Dietary Sodium Days 5-6", "description": "Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.", "time_frame": "24 hour collections ending on Day 6 of each dietary sodium phase" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 38, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01563107", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00685919", "title": "Peripheral Dopamine in Postural Tachycardia Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2022-01-24", "start_date": "2008-05", "completion_date": "2021-12", "primary_completion_date": "2020-07", "conditions_raw": [ "Postural Tachycardia Syndrome", "Orthostatic Intolerance" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Carbidopa" ], "sponsor": "Vanderbilt University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of the proposed research is to determine how changes in kidney dopamine (DA) activity influence urinary sodium excretion. We will decrease DA activity in the kidney by inhibiting DA synthesis via carbidopa administration. We want to compare findings in normal volunteers and in patients with postural tachycardia syndrome (POTS). We will test the null hypothesis (Ho) that the effects of oral carbidopa administration on urinary sodium excretion will not differ between patients with POTS and healthy volunteers.", "primary_outcomes": [ { "type": "primary", "measure": "24 Hour Urinary Sodium Excretion During Treatment Normalized to Creatinine", "description": "Urine was collected for 24hr during treatment. Urinary volume was measured and the urine was analyzed for sodium and creatinine concentrations. Total amounts of sodium and creatinine excreted over the 24 hr were calculated and results expressed as ratio of sodium:creatinine.", "time_frame": "Immediately before the 1st dose of placebo or carbidopa to immediately before the 5th dose (approximately 24 hours)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Systolic Blood Pressure Measured at 8 Hours After the Last Dose of Placebo or Carbidopa", "description": "Systolic blood pressure was measured once using a Dinamap non-invasive oscillometric blood pressure monitor, 2-4 hours after lunch and after at least 30 minutes of resting supine.", "time_frame": "8 hours after the last dose of placebo or carbidopa" }, { "type": "secondary", "measure": "Plasma Catecholamines (Norepinephrine) After the Last Dose of Placebo or Carbidopa", "description": "Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.", "time_frame": "8 hours after the last dose of placebo or carbidopa" }, { "type": "secondary", "measure": "Plasma Catecholamines (DOPA) After the Last Dose of Placebo or Carbidopa", "description": "Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.", "time_frame": "8 hours after the last dose of placebo or carbidopa" }, { "type": "secondary", "measure": "24 Hour Urinary Catecholamine (DOPA) Excretion During Treatment Normalized to Creatinine", "description": "Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.", "time_frame": "Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)" }, { "type": "secondary", "measure": "24 Hour Urinary Catecholamine (Dopamine) Excretion During Treatment Normalized to Creatinine", "description": "Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.", "time_frame": "Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)" }, { "type": "secondary", "measure": "Supine Plasma Renin Activity 2 Hours After the Last Dose of Placebo or Carbidopa", "description": "Blood samples were collected while resting supine for at least 30 minutes and 1 1/2 to 2 hours after breakfast. Samples were processed and sent to the Vanderbilt Clinic Laboratory for assay.", "time_frame": "2 hours after the last dose of placebo or carbidopa" }, { "type": "secondary", "measure": "Plasma Sodium After the Last Dose of Placebo or Carbidopa", "description": "Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. Samples were processed and sent to the Vanderbilt Clinical Laboratory for assay.", "time_frame": "8 hours after the last dose of placebo or carbidopa" } ], "outcome_measures": [ { "type": "primary", "measure": "24 Hour Urinary Sodium Excretion During Treatment Normalized to Creatinine", "description": "Urine was collected for 24hr during treatment. Urinary volume was measured and the urine was analyzed for sodium and creatinine concentrations. Total amounts of sodium and creatinine excreted over the 24 hr were calculated and results expressed as ratio of sodium:creatinine.", "time_frame": "Immediately before the 1st dose of placebo or carbidopa to immediately before the 5th dose (approximately 24 hours)" }, { "type": "secondary", "measure": "Systolic Blood Pressure Measured at 8 Hours After the Last Dose of Placebo or Carbidopa", "description": "Systolic blood pressure was measured once using a Dinamap non-invasive oscillometric blood pressure monitor, 2-4 hours after lunch and after at least 30 minutes of resting supine.", "time_frame": "8 hours after the last dose of placebo or carbidopa" }, { "type": "secondary", "measure": "Plasma Catecholamines (Norepinephrine) After the Last Dose of Placebo or Carbidopa", "description": "Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.", "time_frame": "8 hours after the last dose of placebo or carbidopa" }, { "type": "secondary", "measure": "Plasma Catecholamines (DOPA) After the Last Dose of Placebo or Carbidopa", "description": "Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.", "time_frame": "8 hours after the last dose of placebo or carbidopa" }, { "type": "secondary", "measure": "24 Hour Urinary Catecholamine (DOPA) Excretion During Treatment Normalized to Creatinine", "description": "Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.", "time_frame": "Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)" }, { "type": "secondary", "measure": "24 Hour Urinary Catecholamine (Dopamine) Excretion During Treatment Normalized to Creatinine", "description": "Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.", "time_frame": "Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)" }, { "type": "secondary", "measure": "Supine Plasma Renin Activity 2 Hours After the Last Dose of Placebo or Carbidopa", "description": "Blood samples were collected while resting supine for at least 30 minutes and 1 1/2 to 2 hours after breakfast. Samples were processed and sent to the Vanderbilt Clinic Laboratory for assay.", "time_frame": "2 hours after the last dose of placebo or carbidopa" }, { "type": "secondary", "measure": "Plasma Sodium After the Last Dose of Placebo or Carbidopa", "description": "Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. Samples were processed and sent to the Vanderbilt Clinical Laboratory for assay.", "time_frame": "8 hours after the last dose of placebo or carbidopa" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 32, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00685919", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01550315", "title": "Effect of Dietary Sodium Intake on Vascular Endothelium", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-01-05", "start_date": "2012-04", "completion_date": "2021-09", "primary_completion_date": "2020-12", "conditions_raw": [ "Postural Tachycardia Syndrome (POTS)" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Pulsitile Arterial Tonometry (Pat) Protocol", "Calf Blood Flow In Reactive Hyperemia", "Evaluation Of Forearm-Mediated Dilation" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators will test the hypothesis that markers of vascular endothelial dysfunction will be exaggerated acutely with an extreme high sodium diet compared to an extreme low-sodium diet. The investigators will compare patients with postural orthostatic tachycardia (POTS) to healthy control subjects.", "primary_outcomes": [ { "type": "primary", "measure": "FMD (% Change)", "description": "The primary analysis will involve a non-parametric, paired, Signed Rank test of flow mediated dilation (FMD) between all subjects (POTS \\& control subjects) on the high sodium diet vs low sodium diet", "time_frame": "FMD was assessed on the morning of day 7, after 6 days of being on either a high salt diet or a low salt diet." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "FMD (% Change)", "description": "The primary analysis will involve a non-parametric, paired, Signed Rank test of flow mediated dilation (FMD) between all subjects (POTS \\& control subjects) on the high sodium diet vs low sodium diet", "time_frame": "FMD was assessed on the morning of day 7, after 6 days of being on either a high salt diet or a low salt diet." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 27, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01550315", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04702217", "title": "Physical Activity as a Complementary Treatment in POTS", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2021-12-06", "start_date": "2021-10-01", "completion_date": "2022-12-01", "primary_completion_date": "2022-07-01", "conditions_raw": [ "POTS" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Training Program" ], "sponsor": "Lund University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural orthostatic tachycardia syndrome (POTS) is a disorder of unknown origin characterized by orthostatic intolerance and increased heart rate (HR) of ≥ 30 beats/minute during orthostasis in the absence of orthostatic hypotension. In addition to the orthostatic intolerance and tachycardia, patients with POTS experience several debilitating symptoms including light-headedness, nausea, blurred vision, fatigue, mental confusion (\"brain-fog\"), chest pain and gastrointestinal problems. Several potential underlying mechanisms have been suggested for POTS including autonomic denervation, hypovolemia, hyperadrenergic stimulation and autoantibodies against adrenergic receptors. However, none of these proposed mechanisms has yet led to an effective treatment. Physical activity is recommended as a complimentary treatment in POTS in international guidelines. However, less is known regarding how physical activity could successfully be implemented in clinical practice in patients with POTS. Thus, in the current study, we aim to assess the effect of a 16-week specialized physical activity program in POTS.", "primary_outcomes": [ { "type": "primary", "measure": "POTS questionnaire", "description": "Subjective symptoms evaluated according to the POTS questionnaire.", "time_frame": "6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Orthostatic hypotension questionnaire", "description": "Subjective symptoms evaluated according to the orthostatic hypotension questionnaire.", "time_frame": "6 months" }, { "type": "secondary", "measure": "SF-36", "description": "Evaluation of the SF-36 (general health questionnaire).", "time_frame": "6 months" }, { "type": "secondary", "measure": "Orthostatic tests", "description": "Hemodynamic measurements (pulse reaction) during orthostatic testing.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Submaximal biking exercise", "description": "Physical capacity measured in watts.", "time_frame": "6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "POTS questionnaire", "description": "Subjective symptoms evaluated according to the POTS questionnaire.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Orthostatic hypotension questionnaire", "description": "Subjective symptoms evaluated according to the orthostatic hypotension questionnaire.", "time_frame": "6 months" }, { "type": "secondary", "measure": "SF-36", "description": "Evaluation of the SF-36 (general health questionnaire).", "time_frame": "6 months" }, { "type": "secondary", "measure": "Orthostatic tests", "description": "Hemodynamic measurements (pulse reaction) during orthostatic testing.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Submaximal biking exercise", "description": "Physical capacity measured in watts.", "time_frame": "6 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT04702217", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03484273", "title": "Hemodynamic Effects of Compression in POTS", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-10-22", "start_date": "2018-07-12", "completion_date": "2021-01-26", "primary_completion_date": "2020-04-01", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Lifewrap Compression Garment" ], "sponsor": "University of Calgary", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "When an individual with Postural Tachycardia Syndrome (POTS) stands up, their heart rate increases significantly (\\>30BPM) and they may experience symptoms such as lightheadedness, dizziness, shortness of breath, nausea and mental confusion.\n\nOne commonly prescribed treatment for POTS is compression garments. Compression garments squeeze veins to help return blood back to the heart, which may decrease heart rate and symptoms on standing. However, there is little research about the effectiveness of compression in adults with POTS.\n\nIn this study, the investigators will use the Lifewrap garment, which compresses the abdomen, pelvis and lower extremities, to evaluate the effectiveness of compression in POTS. The investigators will use a head up tilt (HUT) which will simulate standing. The study participant will participate in 4x 10 minute HUTs wearing 4 different compression configurations:\n\n1. full abdomen and lower extremity compression\n2. abdominal only compression\n3. leg only compression\n4. No compression\n\nThe investigators hypothesize that with full compression, the participant's heart rate increase from lying down to upright will be lower than when they are not wearing any compression. The investigators will also ask the participant about their symptoms when they are upright.\n\nThe results of this study could demonstrate the potential benefits of compression and what configuration is most effective. These findings could rapidly translate to the clinical setting, providing improved care.", "primary_outcomes": [ { "type": "primary", "measure": "Orthostatic Heart Rate (HR) Change", "description": "The primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.", "time_frame": "Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Maximum Upright Heart Rate", "description": "The maximum heart rate during minutes 5-10 of each HUT. The maximum heart rate during each of the study arms will be compared.", "time_frame": "During minutes 5-10 of the HUT" }, { "type": "secondary", "measure": "Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating", "description": "Subjective symptom scoring as reported by participant during each study arm. The VOSS evaluates 9 symptoms on a 0 to 10 scale with 0 being no symptom to 10 being worst ever symptom. The total score ranges from 0-90, with a higher score being more severe symptoms.\n\nThe 9 symptoms are mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. The participant's VOSS score will be compared across the 4 arms of this study.\n\nThe VOSS score has been previously used in multiple publications", "time_frame": "After t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms)" }, { "type": "secondary", "measure": "Change in Systolic Blood Pressure (SBP)", "description": "Change in continuous systolic blood pressure between supine and HUT during each study arm.", "time_frame": "During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals." }, { "type": "secondary", "measure": "Changes in Stroke Volume", "description": "Change in Stroke Volume from supine to HUT in each of the study arms.", "time_frame": "During the baseline before the HUT and the SV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals." }, { "type": "secondary", "measure": "Change in Cardiac Output (CO)", "description": "Change in Cardiac Output from supine to HUT in each of the study arms.", "time_frame": "During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals." }, { "type": "secondary", "measure": "Change in Systemic Vascular Resistance (SVR)", "description": "Change in Systemic Vascular Resistance from supine to HUT in each of the study arms.", "time_frame": "During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals." }, { "type": "secondary", "measure": "Change in Cerebral Blood Flow Velocity (CBFV)", "description": "Change in cerebral blood flow from supine to HUT in each of the study arms.", "time_frame": "During the baseline before the HUT and the CBFV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals." } ], "outcome_measures": [ { "type": "primary", "measure": "Orthostatic Heart Rate (HR) Change", "description": "The primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.", "time_frame": "Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR" }, { "type": "secondary", "measure": "Maximum Upright Heart Rate", "description": "The maximum heart rate during minutes 5-10 of each HUT. The maximum heart rate during each of the study arms will be compared.", "time_frame": "During minutes 5-10 of the HUT" }, { "type": "secondary", "measure": "Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating", "description": "Subjective symptom scoring as reported by participant during each study arm. The VOSS evaluates 9 symptoms on a 0 to 10 scale with 0 being no symptom to 10 being worst ever symptom. The total score ranges from 0-90, with a higher score being more severe symptoms.\n\nThe 9 symptoms are mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. The participant's VOSS score will be compared across the 4 arms of this study.\n\nThe VOSS score has been previously used in multiple publications", "time_frame": "After t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms)" }, { "type": "secondary", "measure": "Change in Systolic Blood Pressure (SBP)", "description": "Change in continuous systolic blood pressure between supine and HUT during each study arm.", "time_frame": "During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals." }, { "type": "secondary", "measure": "Changes in Stroke Volume", "description": "Change in Stroke Volume from supine to HUT in each of the study arms.", "time_frame": "During the baseline before the HUT and the SV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals." }, { "type": "secondary", "measure": "Change in Cardiac Output (CO)", "description": "Change in Cardiac Output from supine to HUT in each of the study arms.", "time_frame": "During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals." }, { "type": "secondary", "measure": "Change in Systemic Vascular Resistance (SVR)", "description": "Change in Systemic Vascular Resistance from supine to HUT in each of the study arms.", "time_frame": "During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals." }, { "type": "secondary", "measure": "Change in Cerebral Blood Flow Velocity (CBFV)", "description": "Change in cerebral blood flow from supine to HUT in each of the study arms.", "time_frame": "During the baseline before the HUT and the CBFV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 32, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03484273", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03182725", "title": "Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2021-06-29", "start_date": "2018-02-06", "completion_date": "2020-05-08", "primary_completion_date": "2020-05-08", "conditions_raw": [ "Postural Orthostatic Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Ivabradine" ], "sponsor": "University of California, San Diego", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans, but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating tachycardia upon postural changes such as standing that impairs their quality of life. Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120 beats/min within the first ten minutes of a diagnostic tilt table test without postural hypotension. There are currently no effective treatment methods for POTS. However, several studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has been also used for treatment of inappropriate sinus tachycardia with good benefit. The hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve functional status in patients with POTS.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Heart Rate", "description": "Orthostatic heart rate monitoring will be used to gauge heart rate changes.", "time_frame": "Baseline and one month post-treatment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Quality of Life Via SF-36 Survey", "description": "Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) The SF-36 has 36 questions and is an indicator of overall health status and is well-validated. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. The total score on the SF-36 ranges from 0 - 100 Lower scores = more disability, higher scores = less disability\n\nSections:\n\nVitality Physical functioning Bodily pain General health perceptions Physical role functioning Emotional role functioning Social role functioning Mental health", "time_frame": "Baseline and one month post-treatment" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Heart Rate", "description": "Orthostatic heart rate monitoring will be used to gauge heart rate changes.", "time_frame": "Baseline and one month post-treatment" }, { "type": "secondary", "measure": "Change in Quality of Life Via SF-36 Survey", "description": "Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) The SF-36 has 36 questions and is an indicator of overall health status and is well-validated. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. The total score on the SF-36 ranges from 0 - 100 Lower scores = more disability, higher scores = less disability\n\nSections:\n\nVitality Physical functioning Bodily pain General health perceptions Physical role functioning Emotional role functioning Social role functioning Mental health", "time_frame": "Baseline and one month post-treatment" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 3", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 37, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03182725", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01210430", "title": "Local Vasoconstriction in Postural Tachycardia Syndrome", "status": "COMPLETED", "phase": "EARLY_PHASE1", "last_updated": "2021-06-10", "start_date": "2010-07", "completion_date": "2015-06", "primary_completion_date": "2015-06", "conditions_raw": [ "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Losartan", "Ascorbic Acid", "Normal Saline" ], "sponsor": "New York Medical College", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators study will determine how often blood flow regulation abnormalities and abnormalities of sympathetic regulation produced by nitric oxide, angiotensin-II, and oxidative stress occur in POTS and the mechanism(s) of POTS in individual patients. Specific causes for POTS may vary from patient to patient. Patients will be compared to healthy control subjects. There is a treatment arm with a medication (losartan) that reduces the binding of angiotensin and increases NO. If the investigators know the specific biochemical mechanism the investigators may be able to offer further specific treatments to specific patients.", "primary_outcomes": [ { "type": "primary", "measure": "Orthostatic tolerance measured by the heart rate and blood pressure response to upright tilt", "description": "", "time_frame": "2 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Sympathetic activation and blood flow measured by sympathetic nerve recordings and Doppler blood flow in the leg", "description": "", "time_frame": "2 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Orthostatic tolerance measured by the heart rate and blood pressure response to upright tilt", "description": "", "time_frame": "2 months" }, { "type": "secondary", "measure": "Sympathetic activation and blood flow measured by sympathetic nerve recordings and Doppler blood flow in the leg", "description": "", "time_frame": "2 months" } ], "relevance_tags": [ "Neurological / Autonomic", "EARLY_Phase 1", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 74, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01210430", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02854683", "title": "Reducing Orthostatic Intolerance With Oral Rehydration in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients", "status": "UNKNOWN", "phase": "PHASE1", "last_updated": "2021-06-10", "start_date": "2016-02", "completion_date": "2021-12", "primary_completion_date": "2021-12", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis", "Systemic Exertion Intolerance Disease (SEID)", "Postural Tachycardia Syndrome (POTS)", "Neurally Mediated Syncope (NMS)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Normal Saline", "Oral Rehydration Solution" ], "sponsor": "New York Medical College", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "We and others have shown that many younger patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have orthostatic intolerance (OI), i.e., they can't tolerate prolonged standing. OI in ME/CFS is often accompanied by either postural tachycardia syndrome (POTS) in which standing results in an excessive heart rate, and neurally mediated hypotension (NMH) in which standing causes a fall in blood pressure and fainting. Intravenous fluids can alleviate these symptoms, but is difficult to administer; oral fluids fail to provide the same benefit. We would therefore like to test the effectiveness of an oral rehydration solution (ORS, W.H.O. formula) making use of co-transport of glucose and sodium, to reverse these symptoms in ME/CFS subjects with POTS or NMS, and will compare these results with healthy control subjects.", "primary_outcomes": [ { "type": "primary", "measure": "To test whether 1 Liter volumes of intravenous or oral rehydration solution increase total blood volume and cardiac output, comparably improving the threshold for orthostatic intolerance", "description": "We will measure total blood volume, cardiorespiratory properties, plasma osmolarity and electrolytes before and after 1 hour after completing an intravenous infusion of normal saline. Hematocrit will be measure every 10 minutes for changes in blood volume. On a second day, we will measure total blood volume, cardiorespiratory properties, plasma osmolarity and electrolytes before and after 1 hour after ingesting 1 liter of oral rehydration solution. Hematocrit will be measure every 10 minutes for changes in blood volume.", "time_frame": "1 week" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "To test whether 1 Liter volumes of intravenous or oral rehydration solution increase total blood volume and cardiac output, comparably improving the threshold for orthostatic intolerance", "description": "We will measure total blood volume, cardiorespiratory properties, plasma osmolarity and electrolytes before and after 1 hour after completing an intravenous infusion of normal saline. Hematocrit will be measure every 10 minutes for changes in blood volume. On a second day, we will measure total blood volume, cardiorespiratory properties, plasma osmolarity and electrolytes before and after 1 hour after ingesting 1 liter of oral rehydration solution. Hematocrit will be measure every 10 minutes for changes in blood volume.", "time_frame": "1 week" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 45, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02854683", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03990142", "title": "Study of Abnormalities of the Nervous System in the Occurrence of Intradialytic Arterial Hypotension", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-06-02", "start_date": "2019-06-25", "completion_date": "2021-05-11", "primary_completion_date": "2020-05-31", "conditions_raw": [ "Hemodialysis Complication" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Cutaneous Conductance To Chlorine By Sudoscan" ], "sponsor": "Fondation Hôpital Saint-Joseph", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Intradialytic hypotension is a common complication of hemodialysis sessions in patients with chronic renal failure, with an estimated prevalence of 10 to 30%. This hypotensopn is classically defined by a decrease in systolic blood pressure greater than 30 mmHg associated with clinical signs (cramps, abdominal pain, unconsciousness, convulsions). Its repetition is correlated with cardiovascular events, neurological events and excess mortality. Several clinical factors have been proposed to predict the risk of intradialytic hypotension such as age, certain comorbidities (diabetes, ischemic heart disease...), dialysis modalities (hemodialysis), ultrafiltration, conductivity but also alterations of the autonomic nervous system (especially the sympathetic system).\n\nIn recent years, the study of vegetative functions has been facilitated by the use of SUDOSCAN® (Impeto, Paris, France) which is a simple, non-invasive tool that allows the study of Chlorine conductance directly reflecting the activity of small non-myelinated C fibers that innervate the sweat glands. SUDOSCAN® has shown good sensitivity and specificity in the diagnosis of vegetative damage in diabetic patients and also a good correlation with cardiac autonomic neuropathy. More recently, SUDOSCAN® has shown good sensitivity in the detection of neuropathies small fibers especially in diabetic patients. This sensitivity is comparable to QST-type quantitative tests and the correlation with cardiovascular dysautonomia tests is good. This test, simple and fast realization, does not require the active participation of the patient. There is a good correlation between the results of SUDOSCAN® and the reduction of intra-dermal fiber density at cutaneous biopsy.\n\nHemodialysis patients are at risk of peripheral neurological involvement not only because of an increasing incidence of diabetes (30-40%) but also because of the abnormal production and elimination of certain uremic toxins. Few studies exist on the anomalies of the vegetative system in hemodialysis. A recent publication has suggested a difference in nerve excitability depending on the type of hemodialysis suggesting nerve changes secondary to ionic changes. The identification of patients at risk of intradialytic hypotension during dialysis sessions could be useful for adapting hemodialysis protocols.\n\nPatients will be classified into 2 groups according to the occurrence of intradialytic hypotension. Group 1 corresponds to patients with intradialytic hypotension and group 2 corresponds to patients without intradialytic hypotension.", "primary_outcomes": [ { "type": "primary", "measure": "Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis", "description": "This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts before hemodialysis.", "time_frame": "Day 1" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Cutaneous conductance to chlorine by SUDOSCAN after hemiodialysis", "description": "This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts after hemodialysis.", "time_frame": "Day 1" } ], "outcome_measures": [ { "type": "primary", "measure": "Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis", "description": "This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts before hemodialysis.", "time_frame": "Day 1" }, { "type": "secondary", "measure": "Cutaneous conductance to chlorine by SUDOSCAN after hemiodialysis", "description": "This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts after hemodialysis.", "time_frame": "Day 1" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 176, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03990142", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04121338", "title": "Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2021-05-19", "start_date": "2019-12-09", "completion_date": "2021-05-15", "primary_completion_date": "2021-05-15", "conditions_raw": [ "Dysautonomia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Celiac Ganglion Block", "Liposomal Bupivacaine" ], "sponsor": "Johns Hopkins University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Dysautonomia is malfunction of the autonomic nervous system. It usually results from overactivity of the sympathetic portion and over-secretion of acetylcholine. Symptoms depend on the organ involved by this sympathetic overstimulation. Involvement of the gastrointestinal system results in chronic dysmotility, nausea, vomiting, food intolerance, weight loss and need for feeding tube placement and/or parenteral feeding. Autonomic celiac ganglia resection has been shown to alleviate symptoms as it interrupts the sympathetic stimulation to the gastrointestinal (GI) system, however there is no pre surgery test to confirm the diagnosis. The investigators' objective is to temporarily block the celiac ganglion with a long acting anesthetic (liposomal bupivacaine). If symptoms abate the diagnosis is confirmed and patient will proceed to surgery.", "primary_outcomes": [ { "type": "primary", "measure": "Amount of solid food intake by mouth per day", "description": "Over the 2 days post Celiac Ganglion block, the investigators will monitor the patient (outpatient) for amount of solid food intake (grams) per day.", "time_frame": "2 days post celiac ganglion block" }, { "type": "primary", "measure": "Change in abdominal pain as assessed by patient reported pain on scale 1-10 (10 worse)", "description": "Patients with GI involvement of dysautonomia have abdominal pain which is worse with solid food intake. The patient's ability to take solid food without pain will be evaluated on scale 1-10 with 10 being worse pain.", "time_frame": "Baseline and 2 days post-celiac ganglion block" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Number of episodes of nausea/vomiting per day", "description": "The frequency of nausea/vomiting will be tabulated.", "time_frame": "2 days post celiac ganglion block" }, { "type": "secondary", "measure": "Change in amount of analgesic medications used", "description": "Patients with GI dysautonomia have chronic abdominal pain and take almost daily analgesic medication. The investigators shall evaluate the use of analgesic medication for the duration of the Celiac Ganglion block.", "time_frame": "Baseline and 2 days post celiac ganglion block" } ], "outcome_measures": [ { "type": "primary", "measure": "Amount of solid food intake by mouth per day", "description": "Over the 2 days post Celiac Ganglion block, the investigators will monitor the patient (outpatient) for amount of solid food intake (grams) per day.", "time_frame": "2 days post celiac ganglion block" }, { "type": "primary", "measure": "Change in abdominal pain as assessed by patient reported pain on scale 1-10 (10 worse)", "description": "Patients with GI involvement of dysautonomia have abdominal pain which is worse with solid food intake. The patient's ability to take solid food without pain will be evaluated on scale 1-10 with 10 being worse pain.", "time_frame": "Baseline and 2 days post-celiac ganglion block" }, { "type": "secondary", "measure": "Number of episodes of nausea/vomiting per day", "description": "The frequency of nausea/vomiting will be tabulated.", "time_frame": "2 days post celiac ganglion block" }, { "type": "secondary", "measure": "Change in amount of analgesic medications used", "description": "Patients with GI dysautonomia have chronic abdominal pain and take almost daily analgesic medication. The investigators shall evaluate the use of analgesic medication for the duration of the Celiac Ganglion block.", "time_frame": "Baseline and 2 days post celiac ganglion block" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 15, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04121338", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04875949", "title": "Anti-Cholinergic Receptors Antibodies, Autonomic Profile and Dysautonomia Symptoms in PAF, ALS and POTS (DISAUT-AB)", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-05-06", "start_date": "2016-04", "completion_date": "2019-04", "primary_completion_date": "2019-01", "conditions_raw": [ "Pure Autonomic Failure", "Amyotrophic Lateral Sclerosis", "Postural Orthostatic Tachycardia Syndrome", "Anti-Cholinergic Receptors Antibodies" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Immunoabsorption/Plasmapheresis Procedure" ], "sponsor": "Istituto Clinico Humanitas", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Anti alfa-3 and alfa-7 ganglionic cholinergic receptors (anti-AChRs) antibodies (Abs) plasma removal by plasmapheresis (1,2) acutely improved dysautonomia symptoms in case reports with Pure Autonomic Failure (PAF) (3). We shall assess the prevalence of anti-AChRs Ab and the relationship among Ab titer, cardiovascular autonomic profile and symptoms in neurodegenerative diseases characterized by similar dysautonomia symptoms such as PAF, Amyotrophic Lateral Sclerosis (ALS) and Postural Orthostatic Tachycardia Syndrome (POTS) (4). Ab positive patients will undergo selective immunoabsorption once a week up to achievement of Ab titer lower than 65% of baseline followed by immunosuppressive therapy with prednisone. Both Ab positive and negative groups will undergo anti-AChR Abs, autonomic profile and dysautonomia symptoms assessment, every 4 months up to 3 years. Evidence of correlation among reduced Ab titer and autonomic profile and symptoms improvement may result in new effective therapy.", "primary_outcomes": [ { "type": "primary", "measure": "Prevalence of plasma anti-AChR Abs in PAF, ALS and POTS", "description": "Number of patients with plasma anti-AChR Abs", "time_frame": "3 years" }, { "type": "primary", "measure": "Effects of anti-AChR Abs removal on dysautonomic symptoms", "description": "COMPASS31 scores (range 0-100; 0 best -100 worst)", "time_frame": "3 years" }, { "type": "primary", "measure": "Time course of dysautonomia symptoms", "description": "COMPASS31 scores (range: 0-100; 0 best-100 worst)", "time_frame": "3 years" }, { "type": "primary", "measure": "Time course of orthostatic tolerance", "description": "Orthostatic tolerance (minutes)", "time_frame": "3 years" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Prevalence of plasma anti-AChR Abs in PAF, ALS and POTS", "description": "Number of patients with plasma anti-AChR Abs", "time_frame": "3 years" }, { "type": "primary", "measure": "Effects of anti-AChR Abs removal on dysautonomic symptoms", "description": "COMPASS31 scores (range 0-100; 0 best -100 worst)", "time_frame": "3 years" }, { "type": "primary", "measure": "Time course of dysautonomia symptoms", "description": "COMPASS31 scores (range: 0-100; 0 best-100 worst)", "time_frame": "3 years" }, { "type": "primary", "measure": "Time course of orthostatic tolerance", "description": "Orthostatic tolerance (minutes)", "time_frame": "3 years" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 75, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04875949", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03602482", "title": "Standing Cognition and Co-morbidities of POTS Evaluation", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-04-14", "start_date": "2018-06-23", "completion_date": "2019-12-17", "primary_completion_date": "2019-12-17", "conditions_raw": [ "Postural Tachycardia Syndrome", "Ehlers-Danlos Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Standing", "Supine" ], "sponsor": "Milton S. Hershey Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to evaluate cognition in patients with postural tachycardia syndrome (POTS) while lying down and standing and to assess the prevalence of hypermobile Ehlers-Danlos Syndrome in POTS.", "primary_outcomes": [ { "type": "primary", "measure": "Executive Function (Stroop Word-color Test)", "description": "Testing scores are normalized using T-scores for predicted values based on age and education for each participant. Scores range from 0 to 100. Higher numbers indicate better cognition. Testing will be performed while participants are supine and standing.", "time_frame": "1 hour" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Attention Score Using Cogstate Identification Task", "description": "Scores are measured as speed to complete task with lower numbers indicating faster reaction time. Testing will be performed while participants are supine and standing.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)", "description": "hEDS was evaluated using the Diagnostic Criteria for hEDS checklist. The number of participants who fulfill the diagnostic criteria on the checklist are reported.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Heart Rate Standing Minus Heart Rate Supine", "description": "Heart rate (HR) will be measured using an arm blood pressure cuff while participants are in supine and standing postures. The difference in heart rate (HR standing - HR supine) was calculated for each participant.", "time_frame": "1 hour" } ], "outcome_measures": [ { "type": "primary", "measure": "Executive Function (Stroop Word-color Test)", "description": "Testing scores are normalized using T-scores for predicted values based on age and education for each participant. Scores range from 0 to 100. Higher numbers indicate better cognition. Testing will be performed while participants are supine and standing.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Attention Score Using Cogstate Identification Task", "description": "Scores are measured as speed to complete task with lower numbers indicating faster reaction time. Testing will be performed while participants are supine and standing.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)", "description": "hEDS was evaluated using the Diagnostic Criteria for hEDS checklist. The number of participants who fulfill the diagnostic criteria on the checklist are reported.", "time_frame": "1 hour" }, { "type": "secondary", "measure": "Heart Rate Standing Minus Heart Rate Supine", "description": "Heart rate (HR) will be measured using an arm blood pressure cuff while participants are in supine and standing postures. The difference in heart rate (HR standing - HR supine) was calculated for each participant.", "time_frame": "1 hour" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 139, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03602482", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01607073", "title": "Verapamil as Therapy for Children and Young Adults With Dravet Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2021-04-13", "start_date": "2012-04", "completion_date": "2015-01", "primary_completion_date": "2015-01", "conditions_raw": [ "Dravet Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Verapamil" ], "sponsor": "Gillette Children's Specialty Healthcare", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will assess how well the drug verapamil can improve control of seizures and dysautonomia symptoms in children and young adults diagnosed with Dravet syndrome. The safety of verapamil when given with all concomitant medications will also be assessed.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit", "description": "The primary study endpoint is the change in number of seizures from baseline. Since we only had one participant finish the study, the endpoint was changed to Week 12 visit. Participants were on verapamil for 4 weeks at Week 12.", "time_frame": "Week 8 (baseline) to Week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Number of Myoclonic Seizures From Week 8 (Baseline) to Week 12", "description": "The secondary outcome is the change in number of myoclonic seizures between baseline Week 8 visit and Week 12 visit.", "time_frame": "Week 8 (baseline) to Week 12" }, { "type": "secondary", "measure": "Change in Number of Absence Seizures From Week 8 (Baseline) to Week 12", "description": "The secondary outcome measure is the change in number of absence seizures from Week 8 (Baseline) to Week 12", "time_frame": "Week 8 to Week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit", "description": "The primary study endpoint is the change in number of seizures from baseline. Since we only had one participant finish the study, the endpoint was changed to Week 12 visit. Participants were on verapamil for 4 weeks at Week 12.", "time_frame": "Week 8 (baseline) to Week 12" }, { "type": "secondary", "measure": "Change in Number of Myoclonic Seizures From Week 8 (Baseline) to Week 12", "description": "The secondary outcome is the change in number of myoclonic seizures between baseline Week 8 visit and Week 12 visit.", "time_frame": "Week 8 (baseline) to Week 12" }, { "type": "secondary", "measure": "Change in Number of Absence Seizures From Week 8 (Baseline) to Week 12", "description": "The secondary outcome measure is the change in number of absence seizures from Week 8 (Baseline) to Week 12", "time_frame": "Week 8 to Week 12" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 2, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01607073", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02276716", "title": "The Nutritional Supplement Phosphatidylserine in Patients With Familial Dysautonomia", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2021-02-21", "start_date": "2011-11", "completion_date": "2019-08-01", "primary_completion_date": "2019-08-01", "conditions_raw": [ "Familial Dysautonomia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Phosphatidylserine" ], "sponsor": "NYU Langone Health", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Familial dysautonomia (FD) is a devastating hereditary disease in which the development of selective neuronal populations is impaired because of a deficiency of the protein IKAP (Slaugenhaupt, 2002). There is no known cure. Treatments are supportive, often ineffective and around half of all patients die before reaching age 40 (Axelrod et al., 2002).\n\nPhosphatidylserine is an FDA approved food supplement that was shown recently to correct the genetic abnormality and restore IKAP protein levels in cell lines derived from patients with FD (Keren et al., 2011) and a humanized mouse model of the disease (Bochner et al., 2013). Despite its safety and efficacy in this fragile population being unknown, many patients with FD are currently taking phosphatidylserine\n\nThe investigators propose to conduct a safety, tolerability and early proof of concept efficacy study of phosphatidylserine in patients with FD. The study will be divided into two independent arms. The first phase of the study will be an open-label dose titration study to determine the safety and optimal dose of phosphatidylserine and its effect of normal IKBKAP mRNA levels in 40 patients with FD. The second phase will be a longitudinal observational study in which we will follow, on a yearly basis, patients with FD of all ages who opt to take phosphatidylserine. In this study, we will evaluate the long-term safety of phosphatidylserine in patients with FD and hope to determine whether phosphatidylserine has any impact on the clinical evolution of the disorder.\n\nOur long-term goal is to find an effective therapy that will improve the quality of life for patients with FD and alter disease prognosis. We believe that the promise of phosphatidylserine and its availability in health food shops warrants a controlled safety, tolerability and efficacy study to determine whether it should be taken by patients with FD. This study is not intended to determine whether phosphatidylserine has a new indication to treat FD.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in blood lab values at every 2 month interval", "description": "blood lab values, CBC, metabolic panel,physical exam, vital signs, 12 lead ECG", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" }, { "type": "primary", "measure": "Change from baseline in adverse events measures at every 2 month interval", "description": "number of participants with adverse events", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" }, { "type": "primary", "measure": "Change from baseline in physical exam measures at every 2 month interval", "description": "change from baseline in physical exam", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" }, { "type": "primary", "measure": "Change from baseline in 12 lead ECG measures at every 2 month interval", "description": "change from baseline in 12 lead ECG", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" }, { "type": "primary", "measure": "Change from baseline in vital signs measures at every 2 month interval", "description": "change from baseline in sitting blood pressure, body temperature", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from baseline in efficacy measures", "description": "Change from baseline in IKBKP mRNA blood levels at each 2 month intervals", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in blood lab values at every 2 month interval", "description": "blood lab values, CBC, metabolic panel,physical exam, vital signs, 12 lead ECG", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" }, { "type": "primary", "measure": "Change from baseline in adverse events measures at every 2 month interval", "description": "number of participants with adverse events", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" }, { "type": "primary", "measure": "Change from baseline in physical exam measures at every 2 month interval", "description": "change from baseline in physical exam", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" }, { "type": "primary", "measure": "Change from baseline in 12 lead ECG measures at every 2 month interval", "description": "change from baseline in 12 lead ECG", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" }, { "type": "primary", "measure": "Change from baseline in vital signs measures at every 2 month interval", "description": "change from baseline in sitting blood pressure, body temperature", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" }, { "type": "secondary", "measure": "Change from baseline in efficacy measures", "description": "Change from baseline in IKBKP mRNA blood levels at each 2 month intervals", "time_frame": "measurements will be taken at baseline and at two months intervals for the first 6 months, then at yearly intervals for up to 5 years" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 26, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02276716", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07655375", "title": "Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-09-10", "start_date": "2026-08-18", "completion_date": "2028-04", "primary_completion_date": "2027-10", "conditions_raw": [ "IBS (Irritable Bowel Syndrome)" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Sample Collection" ], "sponsor": "Guy Boeckxstaens", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Study evaluating the effect of UCB8600 on mast cell activation in the human gut:\n\nIBS is a disease characterized by abdominal pain and a change in stool. Treatment is limited to an adapted life style, dietary changes and medication to lessen cramps (spasmolytica), all of which have seen limited to no clinical success.\n\nRecently, we were able to demonstrate that mast cells play an active role in IBS symptoms. More specifically, they set histamine free when activated which heightens nerve sensitivity in the intestines which probably contributes to the abdominal pain. A new product called \"UCB8600\" is hypothesized to be able to counteract this by causing less mast cells to be activated. In this study we'll test this by administering UCB8600 on intestinal tissue and see if there is less mast cell activation. If the study produces good results, this new product could potentially be used as a treatment for IBS in the future.", "primary_outcomes": [ { "type": "primary", "measure": "Total percentage of degranulated mast cells, detected using fluorescence microscopy", "description": "Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified", "time_frame": "After finishing the essay, approximately on day 2" }, { "type": "primary", "measure": "Total corrected cellular fluorescence (TCCF) per mast cell", "description": "Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified", "time_frame": "After finishing the essay, approximately on day 2" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Total percentage of degranulated mast cells, detected using fluorescence microscopy", "description": "Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified", "time_frame": "After finishing the essay, approximately on day 2" }, { "type": "primary", "measure": "Total corrected cellular fluorescence (TCCF) per mast cell", "description": "Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified", "time_frame": "After finishing the essay, approximately on day 2" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07655375", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07675876", "title": "Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer", "status": "NOT_YET_RECRUITING", "phase": "PHASE1", "last_updated": "2026-07-01", "start_date": "2026-08", "completion_date": "2027-08", "primary_completion_date": "2027-06", "conditions_raw": [ "Locally Advanced Non-Small Cell Lung Cancer", "Lung Adenocarcinoma" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Cromolyn Sodium" ], "sponsor": "Carcinex Inc", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Brief Summary\n\nThis prospective, open-label pilot study is designed to evaluate the safety, tolerability, feasibility, and preliminary clinical activity of inhaled cromolyn sodium administered by dry powder inhalation in participants with locally advanced lung cancer.\n\nCromolyn sodium is an FDA-approved mast cell stabilizer with an established safety profile in respiratory disease. Increasing evidence suggests that inflammatory signaling, mast cell activation, and stromal remodeling contribute to tumor progression, immune dysregulation, and resistance to therapy within the lung tumor microenvironment. Modulation of these pathways may represent a novel therapeutic strategy in lung cancer.\n\nApproximately 5 to 10 participants with locally advanced lung cancer will receive inhaled cromolyn sodium according to the study protocol. Participants will undergo clinical assessments, safety monitoring, laboratory evaluations, and radiographic imaging in accordance with protocol-defined procedures and standard oncologic care.\n\nThe primary objective of this pilot study is to evaluate the safety, tolerability, and feasibility of inhaled Cromolyn sodium administration in this patient population. Secondary objectives include exploratory assessment of radiographic response, clinical outcomes, biomarker trends, and potential signals of biological activity. Data generated from this study are intended to support the development of future clinical investigations evaluating the role of mast cell stabilization and tumor microenvironment modulation in lung cancer.", "primary_outcomes": [ { "type": "primary", "measure": "Safety and Tolerability of Inhaled Cromolyn Sodium", "description": "Incidence, severity, and frequency of treatment-emergent adverse events and serious adverse events during study participation.", "time_frame": "Up to 12 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Radiographic Tumor Response", "description": "Exploratory assessment of changes in tumor burden based on clinically obtained imaging studies.", "time_frame": "Baseline through 12 months" }, { "type": "secondary", "measure": "Feasibility of Treatment Administration", "description": "Assessment of participant completion of protocol-defined treatment and study procedures.", "time_frame": "Up to 12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Safety and Tolerability of Inhaled Cromolyn Sodium", "description": "Incidence, severity, and frequency of treatment-emergent adverse events and serious adverse events during study participation.", "time_frame": "Up to 12 months" }, { "type": "secondary", "measure": "Radiographic Tumor Response", "description": "Exploratory assessment of changes in tumor burden based on clinically obtained imaging studies.", "time_frame": "Baseline through 12 months" }, { "type": "secondary", "measure": "Feasibility of Treatment Administration", "description": "Assessment of participant completion of protocol-defined treatment and study procedures.", "time_frame": "Up to 12 months" } ], "relevance_tags": [ "Immunomodulatory", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 10, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07675876", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05652907", "title": "Safety and Efficacy of FSD201 for the Treatment of Chronic Pain Associated With Idiopathic MCAS (MCAD)", "status": "TERMINATED", "phase": "PHASE2", "last_updated": "2026-04-21", "start_date": "2023-01-19", "completion_date": "2023-05-24", "primary_completion_date": "2023-05-24", "conditions_raw": [ "Mast Cell Activation Syndrome", "Mast Cell Activation Disorder Idiopathic" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Fsd201" ], "sponsor": "Quantum Biopharma", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "This study will determine if FSD201 reduces the average daily 24-hour recall pain intensity after 28 and 56 days of treatment in adults with chronic widespread musculoskeletal nociplastic pain.", "primary_outcomes": [ { "type": "primary", "measure": "Targeted Treatment Effect of 30% Decrease From Baseline to Day 28 in the Average Daily Pain Intensity", "description": "Targeted treatment effect of 30% decrease from baseline to Day 28 in the average daily pain intensity score measured by an 11-point numerical pain rating scale (NPRS). NPRS is an 11-point scale from 0 to10 where the higher number indicates worse pain.\n\nAverages will be calculated as follows: Baseline: calculated weekly average from Day -7 to Day -1 Day 28: calculated weekly average from Day 22 to Day 28", "time_frame": "Day 28" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Targeted Treatment Effect of 30% Decrease From Baseline to Day 28 in the Average Daily Pain Intensity", "description": "Targeted treatment effect of 30% decrease from baseline to Day 28 in the average daily pain intensity score measured by an 11-point numerical pain rating scale (NPRS). NPRS is an 11-point scale from 0 to10 where the higher number indicates worse pain.\n\nAverages will be calculated as follows: Baseline: calculated weekly average from Day -7 to Day -1 Day 28: calculated weekly average from Day 22 to Day 28", "time_frame": "Day 28" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 2, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05652907", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07526558", "title": "Mast Cell Treatment in Post-tick Bite Illness (PTBI)", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2026-04-13", "start_date": "2026-04-30", "completion_date": "2027-01", "primary_completion_date": "2027-01", "conditions_raw": [ "Post-tick Bite Illness", "Mast Cell Stabilizer" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Ketotifen", "Fexofenadine", "Cromolyn Sodium" ], "sponsor": "University of North Carolina, Chapel Hill", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a Phase II double-blinded study to assess the safety, tolerability, and feasibility of the mast cell stabilizing medications ketotifen and cromolyn compared to participants receiving standard of care treatment with fexofenadine alone in participants who have persistent symptoms of mast cell activation following a documented tick-borne illness (Ehrlichiosis, Rocky Mountain Spotted Fever, Alpha-gal Syndrome).", "primary_outcomes": [ { "type": "primary", "measure": "Change in Mast Cell Activation Symptom Score", "description": "Symptoms will be assessed using the mast cell activity symptom scale, which is based on the American Academy of Allergy, Asthma and Immunology scale but with modifications to include neuro/psych symptoms. The construct is a Likert metric with participants ranking symptoms based on categories of frequency, severity and impact to daily life (\"bothersome\"). Each item is rated on a 4-point scale from 1 (\"not at all\") to 4 (\"extremely\") resulting in a range of 63 - 252. Higher scores are correlated with worse symptoms.", "time_frame": "Baseline, after 4 months of intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in General Symptoms Questionnaire-30 (GSQ-30) Total Score", "description": "The General Symptoms Questionnaire-30 (GSQ-30) is a 30-item patient-reported outcome measure designed to assess multi-system symptom burden. Each item is rated on a 5-point Likert scale from 0 (\"not at all\") to 4 (\"very much\"), resulting in a total score ranging from 0 to 120. Higher scores indicate greater symptom burden.", "time_frame": "Baseline, after 4 months of intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Mast Cell Activation Symptom Score", "description": "Symptoms will be assessed using the mast cell activity symptom scale, which is based on the American Academy of Allergy, Asthma and Immunology scale but with modifications to include neuro/psych symptoms. The construct is a Likert metric with participants ranking symptoms based on categories of frequency, severity and impact to daily life (\"bothersome\"). Each item is rated on a 4-point scale from 1 (\"not at all\") to 4 (\"extremely\") resulting in a range of 63 - 252. Higher scores are correlated with worse symptoms.", "time_frame": "Baseline, after 4 months of intervention" }, { "type": "secondary", "measure": "Change in General Symptoms Questionnaire-30 (GSQ-30) Total Score", "description": "The General Symptoms Questionnaire-30 (GSQ-30) is a 30-item patient-reported outcome measure designed to assess multi-system symptom burden. Each item is rated on a 5-point Likert scale from 0 (\"not at all\") to 4 (\"very much\"), resulting in a total score ranging from 0 to 120. Higher scores indicate greater symptom burden.", "time_frame": "Baseline, after 4 months of intervention" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07526558", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01912313", "title": "Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-03-20", "start_date": "2013-08", "completion_date": "2026-12", "primary_completion_date": "2026-12", "conditions_raw": [ "IBS", "Healthy" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Rectal Biopsies From Ibs Patients Or Healthy Subjects Will Be Taken During Proctoscopy" ], "sponsor": "KU Leuven", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Rectal biopsies from IBS patients or healthy subjects will be taken.\n\nBiopsies will be used for:\n\n1. the isolation of submucosal plexus to perform: 1.1 live nerve recordings and Calcium imaging; 1.2 immunohistochemistry; 1.3 mRNA (Messenger ribonucleic acids) isolation and real time PCR (Polymerase chain reaction);\n2. culturing biopsies\n\nOn the basis of these observations, the general aim of the study is to move a significant step forward in the current knowledge on human ENS (enteric nervous system) in IBS by establishing a live imaging method to record enteric nerves activity in small intestinal biopsies from humans. This development is unique in its kind as not other research groups have reported successful live recordings with calcium imaging in this preparation.\n\nIn particular, the investigators aim:\n\n1. to develop and validate the technique to measure activity in human enteric nerves in the submucous plexus isolated from rectal biopsies from healthy subjects and IBS patients;\n2. to characterize this nerve activity in healthy subjects and IBS patients using both calcium imaging to evaluate the effect of different neuromodulators, immunohistochemistry and rtPCR to determine receptor expression levels and identify neurons and glial cells in the submucous ganglia;\n3. to investigate whether the biopsies of IBS patients secrete more modulators/cytokines compared to healthy subjects and their potential to activate neurons.\n4. to evaluate the influence of different food constituents (cow\"s milk, wheat, yeast, gluten and soy) on the local reaction of the rectal mucosa and evaluate mast cell activation/degranulation in biopsies of IBS patients compared to healthy subjects.\n5. To evaluate the amount of inflammatory mediators/metabolites in urine samples of IBS patients and healthy volunteers by the use of metabolic profiling", "primary_outcomes": [ { "type": "primary", "measure": "nerve activity in healthy subjects and IBS patients", "description": "Measuring nerve activity in healthy subjects and IBS patients using both calcium imaging to evaluate the effect of different neuromodulators, immunohistochemistry and rtPCR to determine receptor expression levels and identify neurons and glial cells in the submucous ganglia.", "time_frame": "Starting from the moment biopsies are collected untill nerve activity in samples is lost (approximately 5 hours)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "nerve activity in healthy subjects and IBS patients", "description": "Measuring nerve activity in healthy subjects and IBS patients using both calcium imaging to evaluate the effect of different neuromodulators, immunohistochemistry and rtPCR to determine receptor expression levels and identify neurons and glial cells in the submucous ganglia.", "time_frame": "Starting from the moment biopsies are collected untill nerve activity in samples is lost (approximately 5 hours)" } ], "relevance_tags": [ "Metabolic", "NA", "Very Large (1000+ participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 99999999, "enrollment_type": "ESTIMATED", "size_category": "Very Large (1000+ participants)", "link": "https://clinicaltrials.gov/study/NCT01912313", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06097572", "title": "Improved Diagnostics in Food Allergy Study", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-03-28", "start_date": "2023-10-18", "completion_date": "2025-07-31", "primary_completion_date": "2025-07-31", "conditions_raw": [ "Food Allergy" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Intranasal Food Challenge", "Mast Cell Activation Test" ], "sponsor": "Imperial College London", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators will conduct low-dose intranasal allergen challenges on children and young people with an indeterminate diagnosis of food allergy to cow's milk or peanut. Blood samples will also be taken, for conventional blood allergy diagnostics (allergy-specific Immunoglobulin E) and mast cell activation test (MAT). The data will be used to determine the diagnostic accuracy of two complementary, novel approaches to diagnose food allergy, in a representative clinical cohort.", "primary_outcomes": [ { "type": "primary", "measure": "Test performance", "description": "Comparison of test performance characteristics (sensitivity, specificity, measured according to standard statistical methods) for each of the following diagnostic tests, compared to a formal oral food challenge (FC) as the reference standard:\n\ni. Intranasal FC (InFC) ii. Skin prick testing iii. Characterisation of serum-specific IgE to whole allergen, components and molecular components iv. Mast cell activation test (MAT) v. Basophil activation test (BAT) (peanut only)", "time_frame": "1 day" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Adverse events", "description": "Number of participants who experience a non-allergic adverse event, and/or have symptoms of a systemic allergic reaction) associated with the intranasal food challenge.", "time_frame": "1 day" } ], "outcome_measures": [ { "type": "primary", "measure": "Test performance", "description": "Comparison of test performance characteristics (sensitivity, specificity, measured according to standard statistical methods) for each of the following diagnostic tests, compared to a formal oral food challenge (FC) as the reference standard:\n\ni. Intranasal FC (InFC) ii. Skin prick testing iii. Characterisation of serum-specific IgE to whole allergen, components and molecular components iv. Mast cell activation test (MAT) v. Basophil activation test (BAT) (peanut only)", "time_frame": "1 day" }, { "type": "secondary", "measure": "Adverse events", "description": "Number of participants who experience a non-allergic adverse event, and/or have symptoms of a systemic allergic reaction) associated with the intranasal food challenge.", "time_frame": "1 day" } ], "relevance_tags": [ "Immunomodulatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 166, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06097572", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05309772", "title": "The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-09-06", "start_date": "2023-01-13", "completion_date": "2025-07", "primary_completion_date": "2025-07", "conditions_raw": [ "Food Allergy", "Food Allergy in Infants", "Food Allergy in Children", "Food Allergen Sensitisation", "Milk Allergy", "Egg Allergy", "Nut Allergy" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Basophil Activation Test", "Oral Food Challenge" ], "sponsor": "King's College London", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The BAT Impact study is a prospective multicentre study in the UK using a biomarker-led study design to compare the incidence of adverse events (defined as allergic reactions during oral food challenges) in a randomized-controlled trial. Patients will either follow the standard-of-care (i.e. an oral food challenge in case of equivocal SPT/sIgE) or follow a basophil activation test (BAT)/mast cell activation test (MAT)-based strategy, i.e. patients with a positive BAT or MAT are dispensed of an oral food challenge (OFC) and patients with a negative BAT/MAT undergo an OFC.", "primary_outcomes": [ { "type": "primary", "measure": "The proportion of positive oral food challenges in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm", "description": "Comparison of the ratio of positive oral food challenges in the biomarker arm compared to the standard-of-care arm.", "time_frame": "Up to 1 year" }, { "type": "primary", "measure": "Number of OFCs in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm", "description": "Comparison of the ratio of OFCs in the biomarker arm compared to the standard-of-care arm.", "time_frame": "Up to 1 year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The quality of life of children and parents at the start and at the end of the diagnostic work-up for food allergy as assessed by the Food Allergy Quality of Life Questionnaire.", "description": "Change in quality of life score at the start and end of diagnostic work-up.", "time_frame": "Up to 1.5 years" }, { "type": "secondary", "measure": "Anxiety levels of parents and children before and after diagnostic work-up as assessed by the Hospital Anxiety and Depression Questionnaire.", "description": "Change in anxiety score before and after diagnostic work-up.", "time_frame": "Up to 1.5 years" }, { "type": "secondary", "measure": "Anxiety levels of parents and children before and after diagnostic work-up as assessed by the State Trait Anxiety Inventory.", "description": "Change in anxiety score before and after diagnostic work-up.", "time_frame": "Up to 1.5 years" }, { "type": "secondary", "measure": "NHS and societal costs of food allergies during the diagnostic assessment, as measured through a bespoke form.", "description": "NHS and societal costs during the six weeks before and six weeks after diagnostic work-up.", "time_frame": "Up to 1.5 years" } ], "outcome_measures": [ { "type": "primary", "measure": "The proportion of positive oral food challenges in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm", "description": "Comparison of the ratio of positive oral food challenges in the biomarker arm compared to the standard-of-care arm.", "time_frame": "Up to 1 year" }, { "type": "primary", "measure": "Number of OFCs in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm", "description": "Comparison of the ratio of OFCs in the biomarker arm compared to the standard-of-care arm.", "time_frame": "Up to 1 year" }, { "type": "secondary", "measure": "The quality of life of children and parents at the start and at the end of the diagnostic work-up for food allergy as assessed by the Food Allergy Quality of Life Questionnaire.", "description": "Change in quality of life score at the start and end of diagnostic work-up.", "time_frame": "Up to 1.5 years" }, { "type": "secondary", "measure": "Anxiety levels of parents and children before and after diagnostic work-up as assessed by the Hospital Anxiety and Depression Questionnaire.", "description": "Change in anxiety score before and after diagnostic work-up.", "time_frame": "Up to 1.5 years" }, { "type": "secondary", "measure": "Anxiety levels of parents and children before and after diagnostic work-up as assessed by the State Trait Anxiety Inventory.", "description": "Change in anxiety score before and after diagnostic work-up.", "time_frame": "Up to 1.5 years" }, { "type": "secondary", "measure": "NHS and societal costs of food allergies during the diagnostic assessment, as measured through a bespoke form.", "description": "NHS and societal costs during the six weeks before and six weeks after diagnostic work-up.", "time_frame": "Up to 1.5 years" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 398, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05309772", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05449444", "title": "Masitinib for the Treatment of Severe Mast Cell Activation Syndrome", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2023-02-06", "start_date": "2022-07-01", "completion_date": "2024-12-31", "primary_completion_date": "2024-12-31", "conditions_raw": [ "Mast Cell Activation Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Masitinib 4.5 Mg/Kg/Day", "Best Supportive Care", "Masitinib 6.0 Mg/Kg/Day" ], "sponsor": "AB Science", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "To evaluate the efficacy and safety of two dosing schemes of oral masitinib versus matching placebo in the treatment of patients suffering from severe MCAS with handicap unresponsive to optimal symptomatic treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Confirmed response at 50%", "description": "Confirmed response at 50%, defined as an improvement with respect to the baseline values of 50% for Pruritus, Flushes and Depression (HAMD-17 score) which should be confirmed from the previous visit.\n\nHandicaps at baseline defined as: pruritus score ≥ 9; number of flushes per week ≥ 8; HAMD-17 score ≥ 19.", "time_frame": "24 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Cumulative response", "description": "Cumulative (every patient visit) response at 75% on 3 handicaps (pruritus, flush, depression) from week 8 to week 24. Analysis will be performed using Generalized Estimating Equations (GEE) model with stratification.", "time_frame": "week 8 to week 24" }, { "type": "secondary", "measure": "Confirmed response (75%)", "description": "Confirmed response at 75%, defined as an an improvement with respect to the baseline values of 75% for Pruritus, Flushes and Depression (Hamilton Depression Rating Scale) which should be confirmed from the previous visit. The Hamilton Depression Rating Scale (HAMD-17) has 17 items and is scored between 0 and 4 points. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52.", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Patient-Reported Outcome for Symptom Severity (PROSS)", "description": "Changes in MCAS symptom severity will also be assessed using the Patient-Reported Outcome for Symptom Severity (PROSS) questionnaire. Total and individual symptom scores will be determined at baseline and at every visit until Week 24.The PROSS questionnaire has 11 items and is scored between 0 and 10 points. A score of 0 is an absence of the symptom and a score of 10 is very severe; the maximum score being 110.", "time_frame": "24 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Confirmed response at 50%", "description": "Confirmed response at 50%, defined as an improvement with respect to the baseline values of 50% for Pruritus, Flushes and Depression (HAMD-17 score) which should be confirmed from the previous visit.\n\nHandicaps at baseline defined as: pruritus score ≥ 9; number of flushes per week ≥ 8; HAMD-17 score ≥ 19.", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Cumulative response", "description": "Cumulative (every patient visit) response at 75% on 3 handicaps (pruritus, flush, depression) from week 8 to week 24. Analysis will be performed using Generalized Estimating Equations (GEE) model with stratification.", "time_frame": "week 8 to week 24" }, { "type": "secondary", "measure": "Confirmed response (75%)", "description": "Confirmed response at 75%, defined as an an improvement with respect to the baseline values of 75% for Pruritus, Flushes and Depression (Hamilton Depression Rating Scale) which should be confirmed from the previous visit. The Hamilton Depression Rating Scale (HAMD-17) has 17 items and is scored between 0 and 4 points. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52.", "time_frame": "24 weeks" }, { "type": "secondary", "measure": "Patient-Reported Outcome for Symptom Severity (PROSS)", "description": "Changes in MCAS symptom severity will also be assessed using the Patient-Reported Outcome for Symptom Severity (PROSS) questionnaire. Total and individual symptom scores will be determined at baseline and at every visit until Week 24.The PROSS questionnaire has 11 items and is scored between 0 and 10 points. A score of 0 is an absence of the symptom and a score of 10 is very severe; the maximum score being 110.", "time_frame": "24 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 72, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05449444", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04978740", "title": "Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-12-01", "start_date": "2021-07-30", "completion_date": "2021-09-03", "primary_completion_date": "2021-09-03", "conditions_raw": [ "Mast Cell Activation Disease", "Mast Cell Activation Syndrome", "Mast Cell Disease", "Urticaria Pigmentosa" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Ophthalmological Examination" ], "sponsor": "Poitiers University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Mastocytosis is a rare condition characterized by an accumulation of mast cell cells in one or more organs such as the liver, bone marrow, spleen and intestines. Its prevalence in the general population is 1 in 10,000.\n\nThis pathology is due to the proliferation of a mast cell clone and the excessive release of inflammatory mediators which lead to abnormal tissue infiltration.\n\nTo date, there are only a few cases reporting ocular and orbital manifestations of mastocytosis.\n\nOur prospective, interventional and single-center study consist in describing the ocular functional manifestations and ocular surface abnormalities of patients with systemic and cutaneous mastocytosis.", "primary_outcomes": [ { "type": "primary", "measure": "Proportion of Subjects with mastocytosis presenting eye abnormalities", "description": "Number of patients with functional complaints or abnormalities of the surface, orbit, anterior and posterior segment of the eyeball.", "time_frame": "up to 2 hours" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Nature and Frequency of eye abnormalities", "description": "Details of functional complaints, abnormalities of various specialized examinations such as ocular tonometry to determine intraocular pressure, Refraction assessment, Retina examination, Slit lamp examination, Visual acuity, Schirmer's test, Corneal topography, Funduscopic examination, Optical coherence tomography", "time_frame": "up to 2 hours" }, { "type": "secondary", "measure": "Risk factor of eye abnormalities", "description": "Significative association with a mastocytosis subtype or certain organ involvements or biological abnormalities", "time_frame": "up to 2 hours" } ], "outcome_measures": [ { "type": "primary", "measure": "Proportion of Subjects with mastocytosis presenting eye abnormalities", "description": "Number of patients with functional complaints or abnormalities of the surface, orbit, anterior and posterior segment of the eyeball.", "time_frame": "up to 2 hours" }, { "type": "secondary", "measure": "Nature and Frequency of eye abnormalities", "description": "Details of functional complaints, abnormalities of various specialized examinations such as ocular tonometry to determine intraocular pressure, Refraction assessment, Retina examination, Slit lamp examination, Visual acuity, Schirmer's test, Corneal topography, Funduscopic examination, Optical coherence tomography", "time_frame": "up to 2 hours" }, { "type": "secondary", "measure": "Risk factor of eye abnormalities", "description": "Significative association with a mastocytosis subtype or certain organ involvements or biological abnormalities", "time_frame": "up to 2 hours" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 21, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04978740", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02316132", "title": "Confocal Laser Endomicroscopy, IBS and Stress", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2022-07-06", "start_date": "2014-12", "completion_date": "2016-07", "primary_completion_date": "2016-06", "conditions_raw": [ "Irritable Bowel Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Stress" ], "sponsor": "University Hospital Schleswig-Holstein", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation.\n\nInitial CLE baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal mucosa.\n\nThereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according to randomisation) will be injected intravenously. Endoscopist and assistant staff will be blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space.\n\nPost procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers.\n\nThe procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. A study outline is presented in figure 1.\n\nSamples taken are the same amount as done in the previous food associated study.", "primary_outcomes": [ { "type": "primary", "measure": "visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.", "description": "", "time_frame": "immediate" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.", "description": "", "time_frame": "immediate" } ], "relevance_tags": [ "General", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT02316132", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05084872", "title": "Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2021-10-20", "start_date": "2021-10", "completion_date": "2024-01", "primary_completion_date": "2024-01", "conditions_raw": [ "Mastocytosis" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Hydroxychloroquine" ], "sponsor": "University Hospital, Toulouse", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The treatment of systemic mastocytosis has two main axes:\n\n* Control of mast cell activation symptoms and\n* The control of proliferation (accumulation) of mast cells.\n\nThere is no standard treatment and no treatment has a marketing authorization for the treatment of monoclonal indolent mastocytosis.", "primary_outcomes": [ { "type": "primary", "measure": "Change of mast cell activation symptoms", "description": "The primary endpoint of this study is the change of mast cell activation symptoms as pruritus between the start of treatment and 12 months later. Skin pruritus will be assessed by the visual analogue scale from 0 to 10 at each visit.", "time_frame": "12 month" }, { "type": "primary", "measure": "Change of mast cell activation symptoms", "description": "The primary endpoint of this study is the change of mast cell activation symptoms as flushes between the start of treatment and 12 months later. The skin flush will be evaluated according to the absolute number of flushes / week at each visit", "time_frame": "12 month" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Difference on mast cell burden - serum tryptase level", "description": "The difference on mast cell burden between the start of treatment and 12 months later will be evaluated by variation of the level serum tryptase l expressed in μg / L.", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference on skin mast cell burden - mast cells/mm²", "description": "The difference on mast cell burden between the start of treatment and 12 months later will be assessed by variation of the number of mast cells / mm² identified on the skin biopsies.", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference of mast cell activation symptoms : diarrhea", "description": "The difference of diarrhea between the start of treatment and 12 months later evaluated by the absolute number of stools / day for diarrhea", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference of mast cell activation symptoms : pollakiuria", "description": "The difference of pollakiuria between the start of treatment and 12 months later assessed by the absolute number of urinations / day for pollakiuria.", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference of mast cell activation symptoms : arthralgia", "description": "The difference of arthralgia between the start of treatment and 12 months later evaluated by the absolute number of painful joints / day and the intensity of joint pain assessed by the visual analogue scale from 0 to 10 for arthralgia.", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference of mast cell activation symptoms : discomfort", "description": "The difference of discomfort between the start of treatment and 12 months later evaluated by the absolute number of faintness / week", "time_frame": "12 month" }, { "type": "secondary", "measure": "The safety of hydroxychloroquine treatment.", "description": "The safety of hydroxychloroquine treatment will be done by evaluation of adverse events", "time_frame": "12 month" }, { "type": "secondary", "measure": "effectiveness of treatment", "description": "The correlation between the efficacy of treatment with the hydroxychloroquine and level of serum HCQ will be performed by the Bland-Altman test.", "time_frame": "12 month" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of mast cell activation symptoms", "description": "The primary endpoint of this study is the change of mast cell activation symptoms as pruritus between the start of treatment and 12 months later. Skin pruritus will be assessed by the visual analogue scale from 0 to 10 at each visit.", "time_frame": "12 month" }, { "type": "primary", "measure": "Change of mast cell activation symptoms", "description": "The primary endpoint of this study is the change of mast cell activation symptoms as flushes between the start of treatment and 12 months later. The skin flush will be evaluated according to the absolute number of flushes / week at each visit", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference on mast cell burden - serum tryptase level", "description": "The difference on mast cell burden between the start of treatment and 12 months later will be evaluated by variation of the level serum tryptase l expressed in μg / L.", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference on skin mast cell burden - mast cells/mm²", "description": "The difference on mast cell burden between the start of treatment and 12 months later will be assessed by variation of the number of mast cells / mm² identified on the skin biopsies.", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference of mast cell activation symptoms : diarrhea", "description": "The difference of diarrhea between the start of treatment and 12 months later evaluated by the absolute number of stools / day for diarrhea", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference of mast cell activation symptoms : pollakiuria", "description": "The difference of pollakiuria between the start of treatment and 12 months later assessed by the absolute number of urinations / day for pollakiuria.", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference of mast cell activation symptoms : arthralgia", "description": "The difference of arthralgia between the start of treatment and 12 months later evaluated by the absolute number of painful joints / day and the intensity of joint pain assessed by the visual analogue scale from 0 to 10 for arthralgia.", "time_frame": "12 month" }, { "type": "secondary", "measure": "Difference of mast cell activation symptoms : discomfort", "description": "The difference of discomfort between the start of treatment and 12 months later evaluated by the absolute number of faintness / week", "time_frame": "12 month" }, { "type": "secondary", "measure": "The safety of hydroxychloroquine treatment.", "description": "The safety of hydroxychloroquine treatment will be done by evaluation of adverse events", "time_frame": "12 month" }, { "type": "secondary", "measure": "effectiveness of treatment", "description": "The correlation between the efficacy of treatment with the hydroxychloroquine and level of serum HCQ will be performed by the Bland-Altman test.", "time_frame": "12 month" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05084872", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03789422", "title": "Tranexamic Acid and Spontaneous Chronic Urticaria", "status": "UNKNOWN", "phase": "PHASE4", "last_updated": "2021-04-28", "start_date": "2019-12-10", "completion_date": "2022-09", "primary_completion_date": "2022-09", "conditions_raw": [ "Chronic Spontaneous Urticaria" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Association Of Levocetirizine And Tranexamic Acid", "Levocetirizine Only" ], "sponsor": "University Hospital, Grenoble", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Spontaneous chronic urticaria (UCS) is a disease that affects 1% of the general population with a potentially severe impact on quality of life. Most patients respond favorably to long-term antihistamine treatment, but sometimes it is necessary to give a high dose (4 times the formal dose, Berlin consensus 2016). These high doses are often accompanied by side effects requiring cessation of treatment. The therapeutic alternative is then omalizumab, an expensive biotherapy. UCS is secondary to non-specific mast cell activation. It has been shown to be associated with activation of fibrinolysis that correlates with the severity of symptoms. Patients with UCS resistant to levocetirizine were shown to have higher D-dimer levels than patients who responded to antihistamines. Tranexamic acid is a molecule with antifibrinolytic propertiesSeveral cases of severe chronic urticaria responding favorably to treatment with tranexamic acid have been reported. In our department, Investigators also noticed the improvement of some of their patients on tranexamic acid. The combination of these two treatments appears to be synergistic: action on histamine receptors and control of fibrinolysis.\n\nThe investigators propose to evaluate the association of tranexamic acid and levocetirizine for the treatment of chronic spontaneous urticaria.", "primary_outcomes": [ { "type": "primary", "measure": "Evolution of the Urticaria Activity Score 7 (UAS7)", "description": "Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. To calculate the score, the patient rates the number of papules and itching intensity from 0 to 3 daily for 7 days. 0 corresponds to no papules and no itching, 3 corresponds to more than 50 papules per 24h and intense itching that can cause daily life. This makes a score of 0 to 6 per day accumulated over 7 days, ranging from 0 to 42.", "time_frame": "28 days" }, { "type": "primary", "measure": "Tolerance of the association tranexamic acid and levocetirizine", "description": "Number of adverse events", "time_frame": "28 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "To demonstrate the non-inferiority of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine alone 20mg / day in terms of efficacy on the Angioedema Activity Score (AAS)", "description": "Evolution of the AAS score between the beginning (J0) and the end (J28) of the end of treatment. The AAS score is a The AAS consists of 5 questions as well as an opening question. A score between 0 and 3 is assigned to every answer field. The question scores are summed up to an AAS day sum score, 7 AAS day sum scores to an AAS week sum score (AAS7). Accordingly, the minimum and maximum possible AAS scores are 0-15 (AAS day sum score), 0-105 (AAS7).", "time_frame": "28 days" }, { "type": "secondary", "measure": "Clinical characteristics of responders", "description": "Identify the clinical characteristics of responders to the combination rather than antihistamines alone.", "time_frame": "28 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Evolution of the Urticaria Activity Score 7 (UAS7)", "description": "Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. To calculate the score, the patient rates the number of papules and itching intensity from 0 to 3 daily for 7 days. 0 corresponds to no papules and no itching, 3 corresponds to more than 50 papules per 24h and intense itching that can cause daily life. This makes a score of 0 to 6 per day accumulated over 7 days, ranging from 0 to 42.", "time_frame": "28 days" }, { "type": "primary", "measure": "Tolerance of the association tranexamic acid and levocetirizine", "description": "Number of adverse events", "time_frame": "28 days" }, { "type": "secondary", "measure": "To demonstrate the non-inferiority of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine alone 20mg / day in terms of efficacy on the Angioedema Activity Score (AAS)", "description": "Evolution of the AAS score between the beginning (J0) and the end (J28) of the end of treatment. The AAS score is a The AAS consists of 5 questions as well as an opening question. A score between 0 and 3 is assigned to every answer field. The question scores are summed up to an AAS day sum score, 7 AAS day sum scores to an AAS week sum score (AAS7). Accordingly, the minimum and maximum possible AAS scores are 0-15 (AAS day sum score), 0-105 (AAS7).", "time_frame": "28 days" }, { "type": "secondary", "measure": "Clinical characteristics of responders", "description": "Identify the clinical characteristics of responders to the combination rather than antihistamines alone.", "time_frame": "28 days" } ], "relevance_tags": [ "General", "Phase 4", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03789422", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04821882", "title": "Intravesical Injection of Dextrose to Improve Lower Urinary Tract Symptoms Caused by Chronic Cystitis", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-04-05", "start_date": "2019-05-01", "completion_date": "2020-10-11", "primary_completion_date": "2020-09-11", "conditions_raw": [ "Bladder Pain Syndrome", "Interstitial Cystitis" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Dextrose" ], "sponsor": "National Defense Medical Center, Taiwan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The pathogenesis of bladder pain syndrome/interstitial cystitis (BPS/IC) is currently unclear. Scholars have put forward different hypotheses, including the function of the extracellular matrix surface of the glycosaminoglycan (GAG) layer, downregulation of tight junction protein, increased urothelial permeability, mast cell activation, neurogenic inflammation, and psychosomatic factors. The symptoms are very similar to severe bladder pain syndrome/interstitial cystitis, and the patients respond to existing medications. In 1956, Dr. George Hackett created a method for treating damaged ligaments and tendons called prolotherapy (proliferation therapy). Prolotherapy is defined as an alternative therapy for musculoskeletal and arthritic pain, including the treatment of irritating substances (such as dextrose, also known as d-glucose) injected into ligaments or tendons to promote the growth of new tissues. There are many clinical trials confirming that proliferation therapy can effectively treat painful musculoskeletal problems. For example, in patients with lateral epicondylitis treated with a solution with a final concentration of 10% dextrose, compared with patients treated with placebo (normal saline), pain and isometric muscle strength improved significantly. A recent literature review also tells that hypertonic glucose proliferation therapy can effectively treat a variety of musculoskeletal diseases.\n\nHence, this research suggests that dextrose prolotherapy is an affordable and effective pain management strategy in dealing with musculoskeletal neuroinflammation pain in BPS/IC. In order to begin to understand prolotherapy and its therapeutic utility, this study should begin to elucidate the immediate response of prolotherapy in the urology field by investigating the impact of dextrose.\n\nThis project is expected to accommodate subjects with BPS/IC, by injecting 10% dextrose into the bladder lining muscles of IC patients and performing various urodynamic tests and questionnaires to evaluate the patient's urinary voiding symptoms and urinary bladder function recovery. Afterward, the expressions of growth factors and cytokines in the urine samples were investigated in an attempt to reveal the mechanism of dextrose prolotherapy in BPS/IC disease.", "primary_outcomes": [ { "type": "primary", "measure": "Urinary Voiding Symptoms Analysis", "description": "Patients were asked to provide a three-day voiding frequency volume chart prior the treatment to record episodes of urinary voiding symptoms including urinary frequency, urgency, and nocturia.", "time_frame": "3 days" }, { "type": "primary", "measure": "Global Response Assessment (GRA)", "description": "GRA examined the overall response to treatment. Patients were requested to rate symptoms on a seven-point centered scale from markedly-, moderately-, and slightly- worse, no change, slightly-, moderately-, and markedly-improved.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "International Prostate Symptom Score (IPSS)", "description": "The severity of voiding symptoms was evaluated by using the International Prostate Symptom Score (IPSS-TOTAL), and the IPSS-voiding (IPSS-V) and IPSS-storage (IPSS-S) sub-scores were also recorded. There were 7 questions including questions of IPSS-V and IPSS-S.\n\nThe IPSS-V is the sum of the answers to question 1 (incomplete emptying), question 3 (intermittency), question 5 (weak stream), and question 6 (straining to void). Oppositely, the IPSS-S is the sum of the answers to question 2 (frequency), question 4 (urgency), and question 7 (nocturia). The IPSS subscore can be used to evaluate symptom severity or the results of treatment.\n\nIPSS-TOTAL then took into account the total score from the answers of the questions that can therefore range from 0 to 35 (0-7 mild symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic).", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "Visual Analogue Scale (VAS)", "description": "VAS is a pain rating scale which its scores are based on patient self-assessment measures of symptoms that are recorded with a single handwritten mark placed at one point of 10-point along the length of a 10-cm line. The line represents the pain condition, the left end of line scale (0 cm) represents \"no pain\" and the right end of the scale (10 cm) shows the \"worst pain\".", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "O'Leary-Sant Score (OSS)", "description": "OSS indexes have eight questions assessing pain and voiding symptoms. OSS is obtained from O'Leary Sant instrument which evaluates a Symptom Index (ICSI with range: 0-20 points) and a Problem Index (ICPI with range: 0-16 points), each of which contains four questions related to urinary and pain symptoms. For each index, the score is calculated by summing the points for each item. A maximal index score of 36 reflects maximal symptom and problem severity.\n\nThe Symptom Index covers various areas, including whether the patient feels the need to urinate with little or no warning, has to urinate more frequently than every 2 hours, needs to get up during the night to urinate, and has pain in the bladder. The Problem Index evaluates other aspects, such as urinary frequency during the day, the urinary frequency at night, the need to urinate with little or no warning, and burning, pain, discomfort, or pressure on the bladder. Both indices evaluate the situation over the previous month.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "5-Item Brief Symptom Rating Scale (BSRS-5)", "description": "BSRS-5 evaluated the quality of life of patients. It contained five items of a self-administered questionnaire that is derived from the 50-item brief symptom rating scale. The score for each item ranges from 0 to 4 (from not at all to extremely). A total score on the BSRS-5 above 14, between 10 and 14, and between 6 and 9 indicated severe, moderate, and mild symptoms, respectively.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "5-item Female Sexual Function Index (FSFI-5)", "description": "FSFI-5 was performed to assess the sexual dysfunction possibility of female patients. FSFI-5 contained item-by-item combinations of the 5 domains of sexual \"desire\", \"arousal\", \"lubrication\", \"orgasm\", and \"satisfaction\". The 5 items were derived from 19 items of FSFI questionnaire.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "Luminex Assay of Growth Factors", "description": "Urine samples were collected and stored at 4°C until analysis. Samples were analyzed for the presences of 4 analytes: epidermal growth factor (EGF), hepatocyte growth factor (HGF), placental growth factor-1 (PIGF-1), and vascular endothelial growth factor-D (VEGF-D). Their concentration was measured using a Growth Factor 11-Plex Human ProcartaPlex™ Panel assay kit with magnetic beads (EPX110-12170-901, Thermo Fisher Scientific, MA, USA) and examined with an automated immunoassay analyzer (Luminex™ 100 IS System, Luminex, TX, USA) and the accompanying ProcartaPlex Analyst Software 1.0 (Thermo Fisher Scientific, MA, USA) according to the manufacturer's instructions.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "Luminex Assay of Cytokine Assay", "description": "The levels of serum cytokines \\[interleukin-6 (IL-6), IL-10, IL-12p70, IL-13, IL-17F, and IL-27\\] in blood samples were detected using a magnetic bead-based multiplex immunoassay MILLIPLEX MAP Human Th17 Magnetic Bead Panel (Merck KGaA, Darmstadt, Germany) according to the manufacturer's protocol. The MAGPIX® System reader was used to acquire the data of cytokines, which was output as concentration (pg/mL) using the Belysa™ Immunoassay Curve Fitting Software (Merck KGaA, Darmstadt, Germany).", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "Statistics Analysis", "description": "Urinary voiding symptoms analysis, the score of questionnaires (GRA, IPSS-TOTAL, IPSS-V, IPSS-S, VAS, ICSI, ICPI, BSRS5, and FSFI5), Luminex assay result of growth factors and cytokines assay were compared between and after treatment. Results are presented as mean values plus or minus standard deviations. Statistical comparisons between the groups were tested using a chi-square test for categorical variables, and an independent t test or a Wilcoxon test for nonparametric data was used for multiple comparisons. The correlation analysis and coefficient statistical method were performed for comparing VAS questionnaire and growth factor relation. A P value of \\<0.05 was considered statistically significant. Statistical analyses were performed using SPSS 18.0 statistical software (SPSS Inc., IL, USA).", "time_frame": "Up to 7 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Urinary Voiding Symptoms Analysis", "description": "Patients were asked to provide a three-day voiding frequency volume chart prior the treatment to record episodes of urinary voiding symptoms including urinary frequency, urgency, and nocturia.", "time_frame": "3 days" }, { "type": "primary", "measure": "Global Response Assessment (GRA)", "description": "GRA examined the overall response to treatment. Patients were requested to rate symptoms on a seven-point centered scale from markedly-, moderately-, and slightly- worse, no change, slightly-, moderately-, and markedly-improved.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "International Prostate Symptom Score (IPSS)", "description": "The severity of voiding symptoms was evaluated by using the International Prostate Symptom Score (IPSS-TOTAL), and the IPSS-voiding (IPSS-V) and IPSS-storage (IPSS-S) sub-scores were also recorded. There were 7 questions including questions of IPSS-V and IPSS-S.\n\nThe IPSS-V is the sum of the answers to question 1 (incomplete emptying), question 3 (intermittency), question 5 (weak stream), and question 6 (straining to void). Oppositely, the IPSS-S is the sum of the answers to question 2 (frequency), question 4 (urgency), and question 7 (nocturia). The IPSS subscore can be used to evaluate symptom severity or the results of treatment.\n\nIPSS-TOTAL then took into account the total score from the answers of the questions that can therefore range from 0 to 35 (0-7 mild symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic).", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "Visual Analogue Scale (VAS)", "description": "VAS is a pain rating scale which its scores are based on patient self-assessment measures of symptoms that are recorded with a single handwritten mark placed at one point of 10-point along the length of a 10-cm line. The line represents the pain condition, the left end of line scale (0 cm) represents \"no pain\" and the right end of the scale (10 cm) shows the \"worst pain\".", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "O'Leary-Sant Score (OSS)", "description": "OSS indexes have eight questions assessing pain and voiding symptoms. OSS is obtained from O'Leary Sant instrument which evaluates a Symptom Index (ICSI with range: 0-20 points) and a Problem Index (ICPI with range: 0-16 points), each of which contains four questions related to urinary and pain symptoms. For each index, the score is calculated by summing the points for each item. A maximal index score of 36 reflects maximal symptom and problem severity.\n\nThe Symptom Index covers various areas, including whether the patient feels the need to urinate with little or no warning, has to urinate more frequently than every 2 hours, needs to get up during the night to urinate, and has pain in the bladder. The Problem Index evaluates other aspects, such as urinary frequency during the day, the urinary frequency at night, the need to urinate with little or no warning, and burning, pain, discomfort, or pressure on the bladder. Both indices evaluate the situation over the previous month.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "5-Item Brief Symptom Rating Scale (BSRS-5)", "description": "BSRS-5 evaluated the quality of life of patients. It contained five items of a self-administered questionnaire that is derived from the 50-item brief symptom rating scale. The score for each item ranges from 0 to 4 (from not at all to extremely). A total score on the BSRS-5 above 14, between 10 and 14, and between 6 and 9 indicated severe, moderate, and mild symptoms, respectively.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "5-item Female Sexual Function Index (FSFI-5)", "description": "FSFI-5 was performed to assess the sexual dysfunction possibility of female patients. FSFI-5 contained item-by-item combinations of the 5 domains of sexual \"desire\", \"arousal\", \"lubrication\", \"orgasm\", and \"satisfaction\". The 5 items were derived from 19 items of FSFI questionnaire.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "Luminex Assay of Growth Factors", "description": "Urine samples were collected and stored at 4°C until analysis. Samples were analyzed for the presences of 4 analytes: epidermal growth factor (EGF), hepatocyte growth factor (HGF), placental growth factor-1 (PIGF-1), and vascular endothelial growth factor-D (VEGF-D). Their concentration was measured using a Growth Factor 11-Plex Human ProcartaPlex™ Panel assay kit with magnetic beads (EPX110-12170-901, Thermo Fisher Scientific, MA, USA) and examined with an automated immunoassay analyzer (Luminex™ 100 IS System, Luminex, TX, USA) and the accompanying ProcartaPlex Analyst Software 1.0 (Thermo Fisher Scientific, MA, USA) according to the manufacturer's instructions.", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "Luminex Assay of Cytokine Assay", "description": "The levels of serum cytokines \\[interleukin-6 (IL-6), IL-10, IL-12p70, IL-13, IL-17F, and IL-27\\] in blood samples were detected using a magnetic bead-based multiplex immunoassay MILLIPLEX MAP Human Th17 Magnetic Bead Panel (Merck KGaA, Darmstadt, Germany) according to the manufacturer's protocol. The MAGPIX® System reader was used to acquire the data of cytokines, which was output as concentration (pg/mL) using the Belysa™ Immunoassay Curve Fitting Software (Merck KGaA, Darmstadt, Germany).", "time_frame": "Up to 7 months" }, { "type": "primary", "measure": "Statistics Analysis", "description": "Urinary voiding symptoms analysis, the score of questionnaires (GRA, IPSS-TOTAL, IPSS-V, IPSS-S, VAS, ICSI, ICPI, BSRS5, and FSFI5), Luminex assay result of growth factors and cytokines assay were compared between and after treatment. Results are presented as mean values plus or minus standard deviations. Statistical comparisons between the groups were tested using a chi-square test for categorical variables, and an independent t test or a Wilcoxon test for nonparametric data was used for multiple comparisons. The correlation analysis and coefficient statistical method were performed for comparing VAS questionnaire and growth factor relation. A P value of \\<0.05 was considered statistically significant. Statistical analyses were performed using SPSS 18.0 statistical software (SPSS Inc., IL, USA).", "time_frame": "Up to 7 months" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 29, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04821882", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03784339", "title": "Effect of Designated Education Session on Patellofemoral Pain", "status": "COMPLETED", "phase": "NA", "last_updated": "2020-02-26", "start_date": "2019-03-02", "completion_date": "2019-11-29", "primary_completion_date": "2019-08-13", "conditions_raw": [ "Knee Cap" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Physiotherapy" ], "sponsor": "Manchester Metropolitan University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Feasibility study: Does a designated education session change levels of catastrophizing, kinesiophobia and pain beliefs in patients with patellofemoral pain? Design: Single site feasibility Study Aim: Aims are to identify if a formal education session (intervention) improves patient outcomes and to assess if it is possible to test the intervention for efficacy in a larger study.\n\nOutcome Measures: The primary outcome measure is the Knee Osteoarthritis Outcome Score-Patellofemoral) KOOS-PF. The original KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of Life (QOL). The KOOS-PF was developed to evaluate individuals or samples of individuals who present with anterior knee pain/patellofemoral pain and/or patellofemoral osteoarthritis (OA), or who are at risk of developing patellofemoral pain or OA.\n\nSecondary Outcome Measures are Pain Catastrophizing Scale and The Tampa Scale for Kinesiophobia.\n\nPatients who are eligible for inclusion in the study will be identified from the Musculoskeletal Clinical Assessment Service (MCAS) by Band 6's and 7's and approved by a Band 8 Physiotherapist the South Liverpool Treatment Centre.\n\nIntervention: The intervention will comprise a 1:1, 30 minute education session delivered by a specialist musculoskeletal physiotherapist with over ten years' experience who has an interest in patellofemoral pain.\n\nThe education session will be based on a schedule formed from the most recent research on patellofemoral pain PFP which considers psychosocial factors (Robertson et al 2017). Crepitus is a word used to describe any grinding, creaking, cracking, grating, crunching or popping that occurs when the patellofemoral joint moves (Robertson et al 2017). The psychological factors, specifically patients' beliefs about crepitus, avoiding crepitus and the influence of others will be discussed.\n\nThe intervention will be supported by the leaflet 'managing my patellofemoral pain' developed by Barton and Rathleff (2016) on the basis of international opinion from 21 international experts and subsequent review by 20 patients diagnosed with PFP to ensure clarity.\n\nDuration: Within the time constraints of a Masters Degree, patients will be recruited over a four month period. There will be four months for follow up and a further four months for write up, total study duration 12 months.", "primary_outcomes": [ { "type": "primary", "measure": "Knee Osteoarthritis Outcome Score - Patellofemoral (KOOS-PF)", "description": "The KOOS-PF is an 11 item, patient reported outcome measure of pain and function where a maximum score of 100 indicates no problems and a minimum score of 0 indicates extreme problems.", "time_frame": "12 weeks following baseline visit" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Tampa Scale for Kinesiophobia (TSK)", "description": "The TSK is a 17-item patient reported outcome measure of fear of movement. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.", "time_frame": "12 weeks following baseline visit" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "The PCS is a 13 item patient reported outcome measure where the PCS total score is computed by summing the responses to all 13 items. PCS total scores range from 0 - 52, with higher scores indicating greater pain catastrophizing", "time_frame": "12 weeks following baseline visit" } ], "outcome_measures": [ { "type": "primary", "measure": "Knee Osteoarthritis Outcome Score - Patellofemoral (KOOS-PF)", "description": "The KOOS-PF is an 11 item, patient reported outcome measure of pain and function where a maximum score of 100 indicates no problems and a minimum score of 0 indicates extreme problems.", "time_frame": "12 weeks following baseline visit" }, { "type": "secondary", "measure": "Tampa Scale for Kinesiophobia (TSK)", "description": "The TSK is a 17-item patient reported outcome measure of fear of movement. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.", "time_frame": "12 weeks following baseline visit" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "The PCS is a 13 item patient reported outcome measure where the PCS total score is computed by summing the responses to all 13 items. PCS total scores range from 0 - 52, with higher scores indicating greater pain catastrophizing", "time_frame": "12 weeks following baseline visit" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 24, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03784339", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01713725", "title": "Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2017-10-24", "start_date": "2012-03", "completion_date": "2017-06", "primary_completion_date": "2016-02", "conditions_raw": [ "Chronic Urticaria" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Omalizumab" ], "sponsor": "Clinica Universidad de Navarra, Universidad de Navarra", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic urticaria can be defined as the occurrence of widespread daily or almost daily wheals for at least 6 weeks, which may be accompanied by angioedema. While the wheals are transient, the resolution of angioedema is slower than wheals and could take up to 72 hours. The natural course of chronic urticaria is self-limited, with spontaneous remissions and occasional relapses. The investigators calculated a 0.6% (95% CI(Confidence Interval): 0.4-0.8) prevalence in a population study. It has a great impact on patients' quality of life. In a recent national survey on patients attending Allergy Department, chronic urticaria was the disease with greater impact on mental quality of life out of all allergic diseases.\n\nIn spite of the high morbidity of this disease and the impact in quality of life, there is no available treatment. Last guidelines recommend initiating treatment with antihistamine and if there is no response to increase the dose off-label up to four-fold; systemic corticosteroids are also recommended in short tapering and if no response, the only treatment with clinical evidence to be employed is cyclosporine. As additional data, the treatment cost of this disease has been calculated in 2047$/year.\n\nIn past years it has been employed the monoclonal humanized anti-Immunoglobulin IgE (iGE) antibody (Omalizumab) to treat moderate to severe asthma with good results. The rationale for this approach in chronic urticaria is that Omalizumab inhibits the binding of IgE to the high affinity IgE receptor (FceRI) which decreases the FceRI expression on the surface of mast cells and basophils so that immunoglobulin G cross linking of the alpha subunit and basophil degranulation is prevented.The hypothesis the investigators are working on is that monoclonal IgE antibody Omalizumab could be effective in controlling chronic urticaria symptoms in patients non respondent to conventional therapy. The investigators hypothesize that Omalizumab is able to revert the basophil or mast cell activation present in chronic urticaria.", "primary_outcomes": [ { "type": "primary", "measure": "Symptom's control as measured by the UAS7", "description": "The Urticaria Activity Score 7 measures number the weekly average of hives and pruritus measured twice a day. It scores from 0 to 42", "time_frame": "One year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Use of Medication", "description": "Two antihistamines and corticosteroids are allowed as rescue medication that would be recorded by the patient.", "time_frame": "One year" }, { "type": "secondary", "measure": "Quality of life score (CU-Q2oL)", "description": "Specific QOL score for chronic urticaria.It includes 23 items categorized under the following scales: limits looks, swelling/eating, functioning, sleep, mental status, and itching/embarrassment.", "time_frame": "One year" } ], "outcome_measures": [ { "type": "primary", "measure": "Symptom's control as measured by the UAS7", "description": "The Urticaria Activity Score 7 measures number the weekly average of hives and pruritus measured twice a day. It scores from 0 to 42", "time_frame": "One year" }, { "type": "secondary", "measure": "Use of Medication", "description": "Two antihistamines and corticosteroids are allowed as rescue medication that would be recorded by the patient.", "time_frame": "One year" }, { "type": "secondary", "measure": "Quality of life score (CU-Q2oL)", "description": "Specific QOL score for chronic urticaria.It includes 23 items categorized under the following scales: limits looks, swelling/eating, functioning, sleep, mental status, and itching/embarrassment.", "time_frame": "One year" } ], "relevance_tags": [ "Immunomodulatory", "Repurposed", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01713725", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01316718", "title": "Mesalazine for the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D)", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2014-01-17", "start_date": "2011-03", "completion_date": "2013-09", "primary_completion_date": "2013-09", "conditions_raw": [ "Irritable Bowel Syndrome With Diarrhoea" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Mesalazine" ], "sponsor": "University of Nottingham", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of the trial is to define the clinical benefit and possible mediators of the benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea.\n\nThe investigators will therefore evaluate symptoms (primarily bowel frequency) and markers reflecting mast cell activation and small bowel tone.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in average stool frequency during weeks 11 and 12.", "description": "Clinical Endpoint", "time_frame": "Week 0 and week 12" }, { "type": "primary", "measure": "Change from baseline of number of mast cell per mm2 at week 12", "description": "Mechanistic endpoint", "time_frame": "Week 0 and week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Average daily severity of abdominal pain on a 0-10 scale", "description": "Clinical Endpoint", "time_frame": "Week 0 to week 12" }, { "type": "secondary", "measure": "Days with urgency", "description": "Clinical Endpoint", "time_frame": "weeks 11-12" }, { "type": "secondary", "measure": "Mean stool consistency using Bristol Stool Form Score", "description": "Clinical Endpoint", "time_frame": "Week 0 to week 12" }, { "type": "secondary", "measure": "Global satisfaction with control of IBS symptoms", "description": "as assessed from the answer to the question \"Have you had satisfactory relief of your IBS symptoms this week? Yes / No. \"", "time_frame": "Week 0 to week 12" }, { "type": "secondary", "measure": "Mast cell tryptase release during 6 hour biopsy incubation", "description": "Mechanistic endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "IL-1β, TNF-a, histamine and serotonin secretion during same incubation", "description": "Mechanistic endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Small bowel tone assessed by volume of fasting small bowel water", "description": "Mechanistic endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Euro-Qol Score", "description": "Ancillary endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Centres for disease control and prevention health related quality of life healthy days core module score", "description": "Ancillary endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Hospital Anxiety Depression Scale Score", "description": "Ancillary endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Patient Health Questionnaire -15", "description": "Ancillary endpoint", "time_frame": "Week 0 and week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in average stool frequency during weeks 11 and 12.", "description": "Clinical Endpoint", "time_frame": "Week 0 and week 12" }, { "type": "primary", "measure": "Change from baseline of number of mast cell per mm2 at week 12", "description": "Mechanistic endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Average daily severity of abdominal pain on a 0-10 scale", "description": "Clinical Endpoint", "time_frame": "Week 0 to week 12" }, { "type": "secondary", "measure": "Days with urgency", "description": "Clinical Endpoint", "time_frame": "weeks 11-12" }, { "type": "secondary", "measure": "Mean stool consistency using Bristol Stool Form Score", "description": "Clinical Endpoint", "time_frame": "Week 0 to week 12" }, { "type": "secondary", "measure": "Global satisfaction with control of IBS symptoms", "description": "as assessed from the answer to the question \"Have you had satisfactory relief of your IBS symptoms this week? Yes / No. \"", "time_frame": "Week 0 to week 12" }, { "type": "secondary", "measure": "Mast cell tryptase release during 6 hour biopsy incubation", "description": "Mechanistic endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "IL-1β, TNF-a, histamine and serotonin secretion during same incubation", "description": "Mechanistic endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Small bowel tone assessed by volume of fasting small bowel water", "description": "Mechanistic endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Euro-Qol Score", "description": "Ancillary endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Centres for disease control and prevention health related quality of life healthy days core module score", "description": "Ancillary endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Hospital Anxiety Depression Scale Score", "description": "Ancillary endpoint", "time_frame": "Week 0 and week 12" }, { "type": "secondary", "measure": "Patient Health Questionnaire -15", "description": "Ancillary endpoint", "time_frame": "Week 0 and week 12" } ], "relevance_tags": [ "General", "Phase 4", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 108, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01316718", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07842302", "title": "Fighting Fatigue in Multiple Sclerosis: TMS vs. tDCS Efficacy.", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-09-25", "start_date": "2026-09", "completion_date": "2029-09", "primary_completion_date": "2029-05", "conditions_raw": [ "Multiple Sclerosis" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Tms", "Tdcs" ], "sponsor": "Universitat Oberta de Catalunya", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Multiple Sclerosis (MS) is a chronic neurological disease impacting 2.8 million individuals globally, with fatigue being its most debilitating symptom, reported by 75% of patients. Despite its prevalence, the pathophysiology of MS-related fatigue remains poorly understood, and current pharmacological treatments have limited effectiveness. This research addresses this critical gap by investigating two non-invasive brain stimulation (NIBS) techniquestranscranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS)as innovative, effective and scalable therapeutic approaches for MS fatigue.\n\nThe study employs a parallel, randomized, triple-blind, multicentric, sham-controlled design to assess and compare the short- and long-term efficacy of TMS and tDCS in addressing MS-related fatigue. 80 participants will be recruited from multiple centers in Spain and randomly assigned to one of four experimental groups: TMS, tDCS, Sham-TMS, Sham-tDCS. Each intervention will consist of 20 sessions, conducted daily from Monday to Friday, over 4 weeks. The left dorsolateral prefrontal cortex (DLPFC, F3 following the 10/20 system for EEG) was selected as the stimulation site based on its involvement in MS-related self-reported fatigue and in cognitive fatigability. For TMS experimental groups, intermittent theta-burst protocol (iTBS) will be used to increase the cortical excitability of the stimulated area. iTBS delivers a total of 600 pulses, organised into 50 Hz triplets repeated at 5 Hz, with 2second blocks of pulses, interleaved with 8 seconds of rest, repeated 20 times (total duration: 190s). The intensity of stimulation will be individually tailored based on the active motor threshold (aMT), setting it at 80% of the aMT. The sham stimulation will follow the same protocol, but using a sham coil (placebo). For tDCS experimental groups anodal tDCS will be applied (increasing cortical excitability) with the anode over the left DLPFC (F3), and the cathode over the contralateral supraorbital area. The intensity will be 2mA, and the duration of the stimulation will be 20min per session. For tDCS placebo condition, the sham option available on the device will be selected.\n\nPrimary outcomes include changes in fatigue levels measured through MS validated self-report scales (Modified Fatigue Impact Scale-MFIS; Fatigue Scale for Motor and Cognitive Functions-FSMC); secondary outcomes include depression (Beck Depression Inventory-II, BDI-II), quality of life (Multiple Sclerosis Quality of Life, MSQOL-54), functional independence (Functional Independence Measure, FIM), and cognitive fatigability (Symbol Digit Modalities Test, SDMT). All the outcomes will be assessed at baseline, at the end of the intervention, and six months after the end of the treatment (6 months follow-up).\n\nThis project promotes personalized precision medicine and innovative new treatment methods. This research is expected to expand scientific knowledge on NIBS efficacy in MS, establish evidence-based clinical practices, and set the foundation for cost-effective, patient-centered therapies. The study also addresses gender-specific responses to treatment, ensuring inclusive therapeutic strategies. Furthermore, it has the potential to benefit other neurological conditions characterized by fatigue, such as stroke, chronic fatigue syndrome or Parkinsons disease, showing significant social, clinical, and economic impact.", "primary_outcomes": [ { "type": "primary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "The MFIS is a 21-item self-report questionnaire designed to assess how fatigue impacts the daily lives of people living with Multiple Sclerosis (MS). It consists of 21 items divided into three subscales: Physical subscale (9 items)Cognitive subscale (10 items)Psychosocial subscale (2 items). Items are rated based on the patient's experiences over the past 4 weeks using a 5-point Likert scale (from 0 = \"Never\" to 4 = \"Almost always\"). Total score ranges from 0 to 84, with higher score indicating more severe fatigue.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "primary", "measure": "Fatigue Scale for Motor and Cognitive Functions (FSMC)", "description": "It is a 20-item scale assessing two dimensions of MS-related fatigue: cognitive and motor. Patients rank statements on a scale from \"Does not apply\" to \"Applies completely\". Cut-off values were used to classify patients as experiencing mild, moderate or severe fatigue. Higher scores indicating a greater impact of fatigue.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "primary", "measure": "Multiple sclerosis fatigue severity scale (MSFSS)", "description": "It is a 9-item (7-point Likert scale), self-report, questionnaire designed to measure the severity of fatigue and its impact on daily activities. It is one of the most widely used and validated scales for patients with Multiple Sclerosis. Higher score Indicates more severe fatigue and interference with the patient's daily responsibilities, work, or social life.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "primary", "measure": "Symbol Digit Modalities Test (SDMT)", "description": "The SDMT measures information processing speed, visual scanning, working memory, and sustained attention. It is widely considered the gold standard for detecting and tracking cognitive impairment in patients with Multiple Sclerosis. The total score ranges from 0 to 110, with higher score indicating better cognitive performance.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Multiple Sclerosis Quality of Life (MSQOL-54)", "description": "It is a highly comprehensive, disease-specific health-related quality of life instrument designed for patients with Multiple Sclerosis. It consists of 54 items divided into 12 distinct subscales alongside 2 single items.The 12 Subscales: Physical function, role limitations (physical), role limitations (emotional), pain, emotional well-being, energy/fatigue, health perceptions, social function, cognitive function, health distress, sexual function, and satisfaction with sexual function. Total score ranges from 0 to 100, where higher scores indicate a better quality of life.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Functional Independence Measure (FIM)", "description": "It is an 18-item clinician-administered assessment designed to measure a patient's level of disability and track their functional changes during rehabilitation. It quantifies how much assistance a person requires to perform essential activities of daily living safely. It is divided into two main subscales: Motor Subscale (13 items): Covers self-care, sphincter control, transfers, and locomotion; and Cognitive Subscale (5 items): Covers communication and social cognition (problem-solving, memory). Total score ranges from 18 to 126. Higher scores indicate greater functional independence.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Barther Index", "description": "The Barthel Index is an internationally recognized, clinician-administered or self-report rating scale used to measure a patient's performance in activities of daily living. It consists of 10 items evaluating basic self-care and mobility tasks. The 10 Items: Feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers (bed to chair), mobility (on level surfaces), and stairs. Total score ranges from 0 to 100; higher scores indicate greater independence.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Selective reminding test (SRT)", "description": "The SRT is a highly sensitive neuropsychological verbal memory test designed to assess verbal learning and long-term memory. It is uniquely structured to differentiate between a patient's ability to store information over the long term versus their ability to retrieve it at any given moment. It is widely used to detect cognitive impairment in Multiple Sclerosis. It consists of 6 consecutive learning trials, followed by a delayed recall trial (administered 15 to 30 minutes later) and a final recognition trial. Instead of a single final number, the SRT generates multiple crucial metrics: Long-Term Storage (LTS): The number of words that have entered long-term memory.Consistent Long-Term Retrieval (CLTR): The words consistently recalled across consecutive trials without being reminded.Short-Term Storage (STS): Words recalled only after just being read. Higher scores in all indices indicate better verbal memory and learning capacity.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Spatial recall test (10/36 SPART)", "description": "The 10/36 SPART is a highly sensitive neuropsychological test used to evaluate visuospatial learning and long-term visual memory. It includes two different scores: immediate recall ranges from 0 to 30; and delayed recall ranges from 0 to 10. Higher scores always indicate better visuospatial memory.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Paced auditory serial addition task (PASAT)", "description": "The PASAT is used to assess auditory information processing speed, sustained attention, divided attention, and working memory. The final score ranges from 0 to 60, with higher scores indicate better processing speed and working memory.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Word List Generation Test (WLG)", "description": "The WLG is a brief, widely used verbal fluency test designed to assess a patient's spontaneous word production, executive functioning, and mental flexibility. It includes both phonemic (phonetic) and semantic (categorical) verbal fluency tasks. The final score is simply the total number of correct, unique words produced within the time limit. Higher scores indicate better verbal fluency and executive functioning.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Stroop test", "description": "The Stroop Test is used to evaluate executive functioning, specifically selective attention, cognitive flexibility, and processing speed. It measures a person's ability to inhibit an automatic response (reading a word) in favor of a novel, controlled response (naming the ink color). The standard clinical version consists of three separate trials, each presented on a page with columns of items:Word Page (W): Color words (e.g., RED, GREEN, BLUE) printed in black ink. The patient reads the words as fast as possible.Color Page (C): Rows of symbols (like XXXX) printed in colored ink. The patient names the ink colors as fast as possible.Color-Word Page (CW / Interference): Color words printed in conflicting ink colors (e.g., the word RED printed in BLUE ink). The patient must name the color of the ink and ignore the written word. The Interference Score indicate resistance to interferences, with higher scores indicating better cognitive control and stronger resistance to interference.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Trail making test (A and B)", "description": "The Trail Making Test (TMT) is a widely used neuropsychological assessment designed to evaluate visuospatial scanning, processing speed, and executive functioning (specifically cognitive flexibility and set-shifting).\n\nPart A (TMT-A): The patient is presented with a sheet containing the numbers 1 through 25 scattered inside circles. They must draw a continuous line connecting the numbers in sequential order (1-2-3-4...). It primarily measures visual scanning, motor speed, and basic processing speed.\n\nPart B (TMT-B): The patient is presented with numbers (1 to 13) and letters (A to L) scattered inside circles. They must draw a continuous line alternating between numbers and letters in ascending order (1-A-2-B-3-C...). It measures complex executive control, working memory, and cognitive flexibility (set-shifting).\n\nThe score for each part is the total time in seconds taken to complete the task. Lower times indicate better cognitive performance (faster speed and efficiency).", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Hospital anxiety and depression scale (HADS)", "description": "The HADS is a widely used 14-item (rated on a 4-point Likert scale, 0 to 3) self-report questionnaire designed to screen for anxiety and depression in patients with physical medical conditions. Its primary methodological advantage is that it strictly excludes somatic symptoms (such as fatigue, pain, or sleep disturbances). This prevents a patient's physical illness-such as Multiple Sclerosis-from artificially inflating their psychological scores.\n\nIt features two independent subscales of 7 items each:HADS-A (Anxiety): Evaluates cognitive and emotional states of tension, worry, and panic.HADS-D (Depression): Heavily focused on anhedonia (the loss of the ability to enjoy things) rather than physical lethargy.\n\nEach subscale is calculated separately and ranges from 0 to 21. Higher scores indicate worse psychological distress.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" } ], "outcome_measures": [ { "type": "primary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "The MFIS is a 21-item self-report questionnaire designed to assess how fatigue impacts the daily lives of people living with Multiple Sclerosis (MS). It consists of 21 items divided into three subscales: Physical subscale (9 items)Cognitive subscale (10 items)Psychosocial subscale (2 items). Items are rated based on the patient's experiences over the past 4 weeks using a 5-point Likert scale (from 0 = \"Never\" to 4 = \"Almost always\"). Total score ranges from 0 to 84, with higher score indicating more severe fatigue.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "primary", "measure": "Fatigue Scale for Motor and Cognitive Functions (FSMC)", "description": "It is a 20-item scale assessing two dimensions of MS-related fatigue: cognitive and motor. Patients rank statements on a scale from \"Does not apply\" to \"Applies completely\". Cut-off values were used to classify patients as experiencing mild, moderate or severe fatigue. Higher scores indicating a greater impact of fatigue.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "primary", "measure": "Multiple sclerosis fatigue severity scale (MSFSS)", "description": "It is a 9-item (7-point Likert scale), self-report, questionnaire designed to measure the severity of fatigue and its impact on daily activities. It is one of the most widely used and validated scales for patients with Multiple Sclerosis. Higher score Indicates more severe fatigue and interference with the patient's daily responsibilities, work, or social life.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "primary", "measure": "Symbol Digit Modalities Test (SDMT)", "description": "The SDMT measures information processing speed, visual scanning, working memory, and sustained attention. It is widely considered the gold standard for detecting and tracking cognitive impairment in patients with Multiple Sclerosis. The total score ranges from 0 to 110, with higher score indicating better cognitive performance.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Multiple Sclerosis Quality of Life (MSQOL-54)", "description": "It is a highly comprehensive, disease-specific health-related quality of life instrument designed for patients with Multiple Sclerosis. It consists of 54 items divided into 12 distinct subscales alongside 2 single items.The 12 Subscales: Physical function, role limitations (physical), role limitations (emotional), pain, emotional well-being, energy/fatigue, health perceptions, social function, cognitive function, health distress, sexual function, and satisfaction with sexual function. Total score ranges from 0 to 100, where higher scores indicate a better quality of life.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Functional Independence Measure (FIM)", "description": "It is an 18-item clinician-administered assessment designed to measure a patient's level of disability and track their functional changes during rehabilitation. It quantifies how much assistance a person requires to perform essential activities of daily living safely. It is divided into two main subscales: Motor Subscale (13 items): Covers self-care, sphincter control, transfers, and locomotion; and Cognitive Subscale (5 items): Covers communication and social cognition (problem-solving, memory). Total score ranges from 18 to 126. Higher scores indicate greater functional independence.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Barther Index", "description": "The Barthel Index is an internationally recognized, clinician-administered or self-report rating scale used to measure a patient's performance in activities of daily living. It consists of 10 items evaluating basic self-care and mobility tasks. The 10 Items: Feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers (bed to chair), mobility (on level surfaces), and stairs. Total score ranges from 0 to 100; higher scores indicate greater independence.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Selective reminding test (SRT)", "description": "The SRT is a highly sensitive neuropsychological verbal memory test designed to assess verbal learning and long-term memory. It is uniquely structured to differentiate between a patient's ability to store information over the long term versus their ability to retrieve it at any given moment. It is widely used to detect cognitive impairment in Multiple Sclerosis. It consists of 6 consecutive learning trials, followed by a delayed recall trial (administered 15 to 30 minutes later) and a final recognition trial. Instead of a single final number, the SRT generates multiple crucial metrics: Long-Term Storage (LTS): The number of words that have entered long-term memory.Consistent Long-Term Retrieval (CLTR): The words consistently recalled across consecutive trials without being reminded.Short-Term Storage (STS): Words recalled only after just being read. Higher scores in all indices indicate better verbal memory and learning capacity.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Spatial recall test (10/36 SPART)", "description": "The 10/36 SPART is a highly sensitive neuropsychological test used to evaluate visuospatial learning and long-term visual memory. It includes two different scores: immediate recall ranges from 0 to 30; and delayed recall ranges from 0 to 10. Higher scores always indicate better visuospatial memory.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Paced auditory serial addition task (PASAT)", "description": "The PASAT is used to assess auditory information processing speed, sustained attention, divided attention, and working memory. The final score ranges from 0 to 60, with higher scores indicate better processing speed and working memory.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Word List Generation Test (WLG)", "description": "The WLG is a brief, widely used verbal fluency test designed to assess a patient's spontaneous word production, executive functioning, and mental flexibility. It includes both phonemic (phonetic) and semantic (categorical) verbal fluency tasks. The final score is simply the total number of correct, unique words produced within the time limit. Higher scores indicate better verbal fluency and executive functioning.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Stroop test", "description": "The Stroop Test is used to evaluate executive functioning, specifically selective attention, cognitive flexibility, and processing speed. It measures a person's ability to inhibit an automatic response (reading a word) in favor of a novel, controlled response (naming the ink color). The standard clinical version consists of three separate trials, each presented on a page with columns of items:Word Page (W): Color words (e.g., RED, GREEN, BLUE) printed in black ink. The patient reads the words as fast as possible.Color Page (C): Rows of symbols (like XXXX) printed in colored ink. The patient names the ink colors as fast as possible.Color-Word Page (CW / Interference): Color words printed in conflicting ink colors (e.g., the word RED printed in BLUE ink). The patient must name the color of the ink and ignore the written word. The Interference Score indicate resistance to interferences, with higher scores indicating better cognitive control and stronger resistance to interference.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Trail making test (A and B)", "description": "The Trail Making Test (TMT) is a widely used neuropsychological assessment designed to evaluate visuospatial scanning, processing speed, and executive functioning (specifically cognitive flexibility and set-shifting).\n\nPart A (TMT-A): The patient is presented with a sheet containing the numbers 1 through 25 scattered inside circles. They must draw a continuous line connecting the numbers in sequential order (1-2-3-4...). It primarily measures visual scanning, motor speed, and basic processing speed.\n\nPart B (TMT-B): The patient is presented with numbers (1 to 13) and letters (A to L) scattered inside circles. They must draw a continuous line alternating between numbers and letters in ascending order (1-A-2-B-3-C...). It measures complex executive control, working memory, and cognitive flexibility (set-shifting).\n\nThe score for each part is the total time in seconds taken to complete the task. Lower times indicate better cognitive performance (faster speed and efficiency).", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" }, { "type": "secondary", "measure": "Hospital anxiety and depression scale (HADS)", "description": "The HADS is a widely used 14-item (rated on a 4-point Likert scale, 0 to 3) self-report questionnaire designed to screen for anxiety and depression in patients with physical medical conditions. Its primary methodological advantage is that it strictly excludes somatic symptoms (such as fatigue, pain, or sleep disturbances). This prevents a patient's physical illness-such as Multiple Sclerosis-from artificially inflating their psychological scores.\n\nIt features two independent subscales of 7 items each:HADS-A (Anxiety): Evaluates cognitive and emotional states of tension, worry, and panic.HADS-D (Depression): Heavily focused on anhedonia (the loss of the ability to enjoy things) rather than physical lethargy.\n\nEach subscale is calculated separately and ranges from 0 to 21. Higher scores indicate worse psychological distress.", "time_frame": "Baseline, post-treatment (1 month), and 6 months follow-up" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07842302", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06739720", "title": "RCT of Efficacy and Safety of CP003 on CFS/ME or Post COVID-19 Fatigue", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2026-09-21", "start_date": "2025-01-02", "completion_date": "2026-12-31", "primary_completion_date": "2026-01-15", "conditions_raw": [ "Chronic Fatigue Syndrome (CFS)", "Post-COVID ME/CFS" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Lingzhi Capsule" ], "sponsor": "The University of Hong Kong", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to test if a Lingzhi supplement (CP003) helps people with chronic fatigue or post-COVID fatigue feel better. It will also check if the supplement is safe to use. The main questions it aims to answer are:\n\nDoes the Lingzhi supplement reduce fatigue symptoms? Is it safe to take? How does it affect the body's immune system and inflammation?\n\nThe investigators will compare people taking the Lingzhi supplement to those who do not receive any treatment (waitlist group) to see if it works.\n\nParticipants will:\n\n* Take 5 capsules once daily for 6 weeks (or wait to start treatment if in waitlist group)\n* Visit the clinic 2 times for blood tests (before and after taking the supplement)\n* Complete questionnaires 3 times about their fatigue and quality of life (4 times participants in the waitlist group)", "primary_outcomes": [ { "type": "primary", "measure": "Mean difference in Chalder Fatigue Score", "description": "Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue", "time_frame": "From baseline to 6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Mean difference in Chalder Fatigue Score", "description": "Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue", "time_frame": "From baseline to 12 weeks" }, { "type": "secondary", "measure": "Mean difference in 36-Item Short-Form Health Survey", "description": "ranging 0-100, with higher scores indicating better health status", "time_frame": "from baseline to 6 week and 12 week" }, { "type": "secondary", "measure": "Mean difference in Fatigue Severity Score", "description": "Likert score 1-7 for 9 items, ranging 9-63, where higher scores indicate more severe fatigue", "time_frame": "from baseline to 6 week and 12 week" }, { "type": "secondary", "measure": "mean difference in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form 7A survey", "description": "a 5-point Likert scale of 7 items, ranging 0-35, with higher scores indicating greater fatigue", "time_frame": "from baseline to 6 week and 12 week" }, { "type": "secondary", "measure": "Mean difference in hospital anxiety and depression scale", "description": "ranging 0-21, with higher scores indicating more severe symptoms", "time_frame": "from baseline to 6 week and 12 week" }, { "type": "secondary", "measure": "Mean difference in Pittsburgh sleep quality index", "description": "ranging 0-21, with higher scores indicating worse sleep quality", "time_frame": "from baseline to 6 week and 12 week visit." } ], "outcome_measures": [ { "type": "primary", "measure": "Mean difference in Chalder Fatigue Score", "description": "Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue", "time_frame": "From baseline to 6 weeks" }, { "type": "secondary", "measure": "Mean difference in Chalder Fatigue Score", "description": "Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue", "time_frame": "From baseline to 12 weeks" }, { "type": "secondary", "measure": "Mean difference in 36-Item Short-Form Health Survey", "description": "ranging 0-100, with higher scores indicating better health status", "time_frame": "from baseline to 6 week and 12 week" }, { "type": "secondary", "measure": "Mean difference in Fatigue Severity Score", "description": "Likert score 1-7 for 9 items, ranging 9-63, where higher scores indicate more severe fatigue", "time_frame": "from baseline to 6 week and 12 week" }, { "type": "secondary", "measure": "mean difference in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form 7A survey", "description": "a 5-point Likert scale of 7 items, ranging 0-35, with higher scores indicating greater fatigue", "time_frame": "from baseline to 6 week and 12 week" }, { "type": "secondary", "measure": "Mean difference in hospital anxiety and depression scale", "description": "ranging 0-21, with higher scores indicating more severe symptoms", "time_frame": "from baseline to 6 week and 12 week" }, { "type": "secondary", "measure": "Mean difference in Pittsburgh sleep quality index", "description": "ranging 0-21, with higher scores indicating worse sleep quality", "time_frame": "from baseline to 6 week and 12 week visit." } ], "relevance_tags": [ "Immunomodulatory", "Anti-inflammatory", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 130, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06739720", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06472622", "title": "Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort", "status": "RECRUITING", "phase": "EARLY_PHASE1", "last_updated": "2026-09-18", "start_date": "2025-04-09", "completion_date": "2034-06-30", "primary_completion_date": "2034-06-30", "conditions_raw": [ "Fatigue Syndrome, Chronic" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Thermal Pain Stimulation", "Physical Effort Stimulation" ], "sponsor": "National Institute of Neurological Disorders and Stroke (NINDS)", "sponsor_type": "NIH", "primary_purpose": "N/A", "brief_summary": "Background:\n\nThe way the brain processes rewards and punishments may play a role in some disorders of the nervous system. People with chronic overlapping pain conditions (such as myalgic encephalomyelitis/chronic fatigue syndrome \\[ME/CFS\\]) may have heightened responses to unpleasant, punishing sensations. Some of these conditions may also cause heightened responses to effort; this is an unpleasant sensation felt during physical and mental exertion.\n\nObjective:\n\nTo learn more about how the brain processes different unpleasant sensations.\n\nEligibility:\n\nPeople aged 18 to 50 years with ME/CFS. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 3 visits in 1 to 5 weeks.\n\nVisit 1: Participants may have a neurologic exam. They will have a mock magnetic resonance imaging (MRI) scan. They will lie on a bed in a wooden tube while they practice 2 tasks:\n\nThermal pain rating: A device that creates mild to moderate heat will be placed on one leg.\n\nPhysical effort rating: Participants will squeeze a plastic bar with different levels of force.\n\nVisit 2: Participants will have a real MRI scan. They will lie on a table that slides into a large tube.\n\nVisit 3: Participants will have another MRI scan. They will repeat the thermal pain and physical effort tasks while in the scanner. Sensors will be placed on 1 arm to measure how the muscles function as they squeeze the bar.\n\nTheir heart rate will be tested: They will hold their finger against a camera lens for 1 minute. They will do 2 other tasks: 1 requires repeatedly pressing a key on a keyboard, and the other requires squeezing a bar.", "primary_outcomes": [ { "type": "primary", "measure": "Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain.", "description": "SVN regions in which activity is significantly associated with unpleasantness of pain.", "time_frame": "The measurement will be assessed concurrently with thermal pain stimulus administration during the fMRI procedure associated with one of the study visits, 1-31 days following the visit for the first session." }, { "type": "primary", "measure": "Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort.", "description": "The SVN has been hypothesized to play a role in producing the unpleasantness of negative experiences including effort.", "time_frame": "The measurement will be assessed concurrently with physical effort stimulus administration during the fMRI associated with one of the study visits, 1-31 days following the visit for the first session." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain.", "description": "SVN regions in which activity is significantly associated with unpleasantness of pain.", "time_frame": "The measurement will be assessed concurrently with thermal pain stimulus administration during the fMRI procedure associated with one of the study visits, 1-31 days following the visit for the first session." }, { "type": "primary", "measure": "Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort.", "description": "The SVN has been hypothesized to play a role in producing the unpleasantness of negative experiences including effort.", "time_frame": "The measurement will be assessed concurrently with physical effort stimulus administration during the fMRI associated with one of the study visits, 1-31 days following the visit for the first session." } ], "relevance_tags": [ "General", "EARLY_Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Nih" ], "enrollment": 47, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06472622", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04308278", "title": "Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection", "status": "RECRUITING", "phase": "PHASE4", "last_updated": "2026-08-31", "start_date": "2021-01-22", "completion_date": "2028-08-30", "primary_completion_date": "2028-08-22", "conditions_raw": [ "EBV Infection" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "2Lebv® / 2Lxfs®" ], "sponsor": "Labo'Life", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Worldwide, 95% of adults are infected with Epstein-Barr Virus (EBV). These infections may cause different diseases. In most cases, EBV infection is asymptomatic because of a highly effective host immune response. Some individuals develop infectious mononucleosis (a self-limiting lymphoproliferative disorder in adolescents and young adults that is considered to be the primary infection), while others develop chronic fatigue syndrome, EBV-associated lymphoid, or epithelial malignancies.\n\nToday, there is no available treatment to treat and destroy EBV. The treatment is essentially symptomatic (treatment of the symptoms and not of the virus itself) with analgesics for pain for example.\n\nThe studied drugs are 2LEBV® and 2LXFS®, from Labo'Life company, and the treatment schema is the same for the two drugs: it consists in taking the content of one capsule per day, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment.\n\nThe duration of treatment will be of 6 months of continuous intake of the content of 1 capsule/day.\n\nThe aim of this study is to provide additional information on effectiveness on the 2LEBV® and 2LXFS®in the treatment of EBV chronic and acute infections, and in particular to demonstrate their effectiveness versus placebo in the reduction of asthenia and other symptoms in EBV infection.", "primary_outcomes": [ { "type": "primary", "measure": "Measure of the general fatigue scale of the Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire at the end of the treatment.", "description": "Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome.\n\nGeneral Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.", "time_frame": "6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Comparison of the efficacy of the treatment on physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group", "description": "Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome.\n\nPhysical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Comparison of the efficacy of the treatment on general fatigue and other dimensions of the MFI-20 questionnaire between the 2LEBV® and the 2LXFS®/2LEBV® group versus the placebo group.", "description": "Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome.\n\nGeneral Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Comparison of the efficacy of the treatment on general fatigue and other dimensions of the MFI-20 questionnaire between the 2LEBV® and the 2LXFS®/2LEBV® group versus the placebo group.", "description": "Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome.\n\nGeneral Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.", "time_frame": "12 months" }, { "type": "secondary", "measure": "Comparisons of the efficacy of the treatment on others symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Comparisons of the efficacy of the treatment on others symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.", "description": "", "time_frame": "12 months" }, { "type": "secondary", "measure": "Comparison of the evolution of the lymphocytes typing between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.", "description": "", "time_frame": "12 months" }, { "type": "secondary", "measure": "Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Comparisons of the efficacy of the treatment on others symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.", "description": "", "time_frame": "3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Measure of the general fatigue scale of the Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire at the end of the treatment.", "description": "Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome.\n\nGeneral Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Comparison of the efficacy of the treatment on physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group", "description": "Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome.\n\nPhysical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Comparison of the efficacy of the treatment on general fatigue and other dimensions of the MFI-20 questionnaire between the 2LEBV® and the 2LXFS®/2LEBV® group versus the placebo group.", "description": "Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome.\n\nGeneral Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.", "time_frame": "3 months" }, { "type": "secondary", "measure": "Comparison of the efficacy of the treatment on general fatigue and other dimensions of the MFI-20 questionnaire between the 2LEBV® and the 2LXFS®/2LEBV® group versus the placebo group.", "description": "Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome.\n\nGeneral Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20.", "time_frame": "12 months" }, { "type": "secondary", "measure": "Comparisons of the efficacy of the treatment on others symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Comparisons of the efficacy of the treatment on others symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.", "description": "", "time_frame": "12 months" }, { "type": "secondary", "measure": "Comparison of the evolution of the lymphocytes typing between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.", "description": "", "time_frame": "12 months" }, { "type": "secondary", "measure": "Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "Comparisons of the efficacy of the treatment on others symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.", "description": "", "time_frame": "3 months" } ], "relevance_tags": [ "Immunomodulatory", "Phase 4", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 88, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04308278", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07285473", "title": "Low-Dose Naltrexone For ME/CFS: Dose-Finding", "status": "NOT_YET_RECRUITING", "phase": "PHASE2", "last_updated": "2026-08-21", "start_date": "2026-10-01", "completion_date": "2028-04-01", "primary_completion_date": "2028-04-01", "conditions_raw": [ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Low-Dose Naltrexone (LDN)" ], "sponsor": "University of Alabama at Birmingham", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama.", "primary_outcomes": [ { "type": "primary", "measure": "PROMIS Fatigue Short Form 7a", "description": "This will be measured using weekly surveys.", "time_frame": "10 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "PROMIS Fatigue Short Form 7a", "description": "This will be measured using weekly surveys.", "time_frame": "10 months" } ], "relevance_tags": [ "Immunomodulatory", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 75, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07285473", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07621068", "title": "Hyperbaric Oxygen Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-08-21", "start_date": "2026-07-19", "completion_date": "2027-06", "primary_completion_date": "2027-06", "conditions_raw": [ "Chronic Fatigue Syndrome", "ME/CFS" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Hyperbaric Oxygen Therapy (HBOT)" ], "sponsor": "Assaf-Harofeh Medical Center", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "This study evaluates the effects of hyperbaric oxygen therapy (HBOT) in patients with mild to moderate CFS/ME. Participants will undergo 60 HBOT sessions over 3 months with a 3-month follow-up, including physical, cognitive, imaging, and laboratory assessments.", "primary_outcomes": [ { "type": "primary", "measure": "Cardiopulmonary exercise test (CPET)", "description": "Physical performance evaluated by cardiopulmonary exercise test (CPET) on a bicycle or a treadmill. CPET will be used to determine the peak oxygen consumption (Peak VO2), first ventilatory threshold (VT1) and if possible, the second ventilatory threshold (VT2).\n\nThe day after each CPET an FUNCAP55 questionnaire will be filled to assess the functional capacity.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "DePaul Post-Exertional Malaise Questionnaire (DPEMQ)", "description": "A self-report instrument assessing the frequency and severity of post-exertional malaise symptoms in individuals with ME/CFS.\n\nTotal scores typically range from the minimum value (no symptoms) to the maximum value (most severe and frequent symptoms), with higher scores indicating worse post-exertional malaise.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Short Form-36 Health Survey (SF-36)", "description": "A self-reported measure of health-related quality of life across eight domains. Each SF-36 scale is transformed to a 0 to 100 score, where 0 represents the worst health status and 100 represents the best health status.\n\nHigher scores indicate better health-related quality of life.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "a self-report questionnaire that assesses sleep quality and disturbances over the previous month.\n\nThe measure consists of 19 individual items, creating 7 components that produce one global score.\n\nThe score ranges from 0 to 21, with higher scores indicating poorer sleep quality.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Brief Symptom Inventory-18 (BSI-18)", "description": "The BSI-18 will be used to evaluate psychological distress. An 18 item self-report questionnaire which generates a global stress index (GSI), and three subscales: depression, anxiety, and somatization.\n\nEach item is rated on a 5-point scale, with distress ratings ranging from 0 (not at all) to 4 (extremely).\n\nHigher scores indicate greater psychological distress.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "NeuroTrax", "description": "NeuroTrax (NeuroTrax Corp., Houston, TX) is a computerized neurocognitive battery of tests used to assess brain wellness across multiple cognitive domains, including memory, executive function, visual spatial perception, verbal function, attention, information processing speed, and motor skills", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Brain MRI", "description": "Images will be acquired on MAGNETOM Vida 3T Scanner, T1-weighted images will be used for gray matter and hippocampal volumetric measurement.\n\nStatistical parametric mapping software SPM12, will be used for brain segmentation.\n\nVoxel-based morphometry (VBM) procedure to calculate the whole-brain volumes.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Brain EEG", "description": "Resting-state and task-related brain EEG measures.\n\nEEG will be recorded using a high-density dry-electrode system (115 channels, EEG-Sense, Israel).\n\nRecordings will include eyes-open rest (3 minutes), eyes-closed rest (3 minutes), and 20 minutes of cognitive tasks (N-Back, Stroop, Flanker, and multiple-object tracking).\n\nEEG data will undergo standard preprocessing (filtering, line-noise and artifact removal, and down-sampling).\n\nPrimary EEG outcomes will include spectral measures (peak frequency and relative power; alpha, beta, theta, and delta band power), power spectral distribution, and functional connectivity indices.\n\nEvent-related potentials will be extracted for the cognitive tasks, including event-related synchronization and desynchronization (ERS/ERD), with averages computed across artifact-free trials.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Sleep EEG", "description": "Physiological sleep EEG signals will be collected using a home wearable EEG headband (Muse S) paired with a mobile application.\n\nMulti-channel EEG will be recorded from frontal and temporal locations, together with inertial sensors to capture movement and head position.\n\nPrimary sleep EEG outcomes will include validated sleep-wake classification and sleep staging metrics (percent time in light, deep, and REM sleep), sleep timing (bedtime, sleep onset, awakenings, final wake time), and sleep continuity indices (wake after sleep onset and sleep efficiency).\n\nSecondary analyses will include signal-level EEG features such as spectral power in conventional frequency bands and spindle-like activity.\n\nHigher sleep efficiency and higher proportions of deep (slow-wave) sleep will be interpreted as better sleep quality.", "time_frame": "Baseline (3 consecutive nights within 2 weeks before treatment), post-treatment (3 consecutive nights within 21±7 days after last HBOT/Sham session), and at the end of the 3-month follow-up period (3 consecutive nights)" }, { "type": "secondary", "measure": "Orthostatic Intolerance - 10-min NASA Lean Test (NLT)", "description": "The 10-min NASA Lean Test (NLT) will be performed by asking the subject to lay supine for 10 min and then leaning against a wall for 10 min, while blood pressure and heart rate are measured", "time_frame": "Baseline, monthly during treatment (3 months), at the post-treatment evaluation (within 21±7 days after last HBOT/Sham session), monthly during follow-up (3 months), at the end of the follow-up period (end of study evaluation)." }, { "type": "secondary", "measure": "Body Composition", "description": "Body composition will be assessed using the seca mBCA Ultra, a clinically validated segmental multi-frequency bioelectrical impedance analysis (SMF-BIA) system.\n\nThe device estimates fat mass, fat-free mass, skeletal muscle mass, and total body water based on multi-frequency impedance measurements across body segments.\n\nOutcomes will include absolute values (kg or liters) and relative values (percentage of body weight) for each compartment. Higher fat mass and body fat percentage indicate greater adiposity, whereas higher fat-free mass and skeletal muscle mass indicate greater lean tissue.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Hand Grip test", "description": "Quick, non invasive assessment of the maximal force generated when squeezing a hand dynamometer. Reflecting strength of the hand and forearm muscles and serving as a proxy for overall muscle weakness, fatigability, and disease severity", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Peripheral blood biomarkers", "description": "Whole blood and plasma will be collected and stored for future biomarker analysis", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Muscle biopsy", "description": "A voluntary test. Participants will undergo a muscle biopsy using a 0.3mm Trucut needle in an aseptic technique. Muscle sample will be analysed using the Oxygraph (Oroboros Inc, Austria) for oxygen respiratory function, as well as staining for mitochondrial proteins and Mitochondrial DNA.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session." }, { "type": "secondary", "measure": "FUNCAP55 - a 55-item functional capacity questionnaire", "description": "Reliable for assessing functional capacity. May assist in diagnosis and follow-up.", "time_frame": "The day after each CPET. and once a month during the study" }, { "type": "secondary", "measure": "Urine Test", "description": "Taken and stored for future analysis.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" } ], "outcome_measures": [ { "type": "primary", "measure": "Cardiopulmonary exercise test (CPET)", "description": "Physical performance evaluated by cardiopulmonary exercise test (CPET) on a bicycle or a treadmill. CPET will be used to determine the peak oxygen consumption (Peak VO2), first ventilatory threshold (VT1) and if possible, the second ventilatory threshold (VT2).\n\nThe day after each CPET an FUNCAP55 questionnaire will be filled to assess the functional capacity.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "DePaul Post-Exertional Malaise Questionnaire (DPEMQ)", "description": "A self-report instrument assessing the frequency and severity of post-exertional malaise symptoms in individuals with ME/CFS.\n\nTotal scores typically range from the minimum value (no symptoms) to the maximum value (most severe and frequent symptoms), with higher scores indicating worse post-exertional malaise.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Short Form-36 Health Survey (SF-36)", "description": "A self-reported measure of health-related quality of life across eight domains. Each SF-36 scale is transformed to a 0 to 100 score, where 0 represents the worst health status and 100 represents the best health status.\n\nHigher scores indicate better health-related quality of life.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "a self-report questionnaire that assesses sleep quality and disturbances over the previous month.\n\nThe measure consists of 19 individual items, creating 7 components that produce one global score.\n\nThe score ranges from 0 to 21, with higher scores indicating poorer sleep quality.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Brief Symptom Inventory-18 (BSI-18)", "description": "The BSI-18 will be used to evaluate psychological distress. An 18 item self-report questionnaire which generates a global stress index (GSI), and three subscales: depression, anxiety, and somatization.\n\nEach item is rated on a 5-point scale, with distress ratings ranging from 0 (not at all) to 4 (extremely).\n\nHigher scores indicate greater psychological distress.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "NeuroTrax", "description": "NeuroTrax (NeuroTrax Corp., Houston, TX) is a computerized neurocognitive battery of tests used to assess brain wellness across multiple cognitive domains, including memory, executive function, visual spatial perception, verbal function, attention, information processing speed, and motor skills", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Brain MRI", "description": "Images will be acquired on MAGNETOM Vida 3T Scanner, T1-weighted images will be used for gray matter and hippocampal volumetric measurement.\n\nStatistical parametric mapping software SPM12, will be used for brain segmentation.\n\nVoxel-based morphometry (VBM) procedure to calculate the whole-brain volumes.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Brain EEG", "description": "Resting-state and task-related brain EEG measures.\n\nEEG will be recorded using a high-density dry-electrode system (115 channels, EEG-Sense, Israel).\n\nRecordings will include eyes-open rest (3 minutes), eyes-closed rest (3 minutes), and 20 minutes of cognitive tasks (N-Back, Stroop, Flanker, and multiple-object tracking).\n\nEEG data will undergo standard preprocessing (filtering, line-noise and artifact removal, and down-sampling).\n\nPrimary EEG outcomes will include spectral measures (peak frequency and relative power; alpha, beta, theta, and delta band power), power spectral distribution, and functional connectivity indices.\n\nEvent-related potentials will be extracted for the cognitive tasks, including event-related synchronization and desynchronization (ERS/ERD), with averages computed across artifact-free trials.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Sleep EEG", "description": "Physiological sleep EEG signals will be collected using a home wearable EEG headband (Muse S) paired with a mobile application.\n\nMulti-channel EEG will be recorded from frontal and temporal locations, together with inertial sensors to capture movement and head position.\n\nPrimary sleep EEG outcomes will include validated sleep-wake classification and sleep staging metrics (percent time in light, deep, and REM sleep), sleep timing (bedtime, sleep onset, awakenings, final wake time), and sleep continuity indices (wake after sleep onset and sleep efficiency).\n\nSecondary analyses will include signal-level EEG features such as spectral power in conventional frequency bands and spindle-like activity.\n\nHigher sleep efficiency and higher proportions of deep (slow-wave) sleep will be interpreted as better sleep quality.", "time_frame": "Baseline (3 consecutive nights within 2 weeks before treatment), post-treatment (3 consecutive nights within 21±7 days after last HBOT/Sham session), and at the end of the 3-month follow-up period (3 consecutive nights)" }, { "type": "secondary", "measure": "Orthostatic Intolerance - 10-min NASA Lean Test (NLT)", "description": "The 10-min NASA Lean Test (NLT) will be performed by asking the subject to lay supine for 10 min and then leaning against a wall for 10 min, while blood pressure and heart rate are measured", "time_frame": "Baseline, monthly during treatment (3 months), at the post-treatment evaluation (within 21±7 days after last HBOT/Sham session), monthly during follow-up (3 months), at the end of the follow-up period (end of study evaluation)." }, { "type": "secondary", "measure": "Body Composition", "description": "Body composition will be assessed using the seca mBCA Ultra, a clinically validated segmental multi-frequency bioelectrical impedance analysis (SMF-BIA) system.\n\nThe device estimates fat mass, fat-free mass, skeletal muscle mass, and total body water based on multi-frequency impedance measurements across body segments.\n\nOutcomes will include absolute values (kg or liters) and relative values (percentage of body weight) for each compartment. Higher fat mass and body fat percentage indicate greater adiposity, whereas higher fat-free mass and skeletal muscle mass indicate greater lean tissue.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Hand Grip test", "description": "Quick, non invasive assessment of the maximal force generated when squeezing a hand dynamometer. Reflecting strength of the hand and forearm muscles and serving as a proxy for overall muscle weakness, fatigability, and disease severity", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Peripheral blood biomarkers", "description": "Whole blood and plasma will be collected and stored for future biomarker analysis", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" }, { "type": "secondary", "measure": "Muscle biopsy", "description": "A voluntary test. Participants will undergo a muscle biopsy using a 0.3mm Trucut needle in an aseptic technique. Muscle sample will be analysed using the Oxygraph (Oroboros Inc, Austria) for oxygen respiratory function, as well as staining for mitochondrial proteins and Mitochondrial DNA.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session." }, { "type": "secondary", "measure": "FUNCAP55 - a 55-item functional capacity questionnaire", "description": "Reliable for assessing functional capacity. May assist in diagnosis and follow-up.", "time_frame": "The day after each CPET. and once a month during the study" }, { "type": "secondary", "measure": "Urine Test", "description": "Taken and stored for future analysis.", "time_frame": "Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other Gov" ], "enrollment": 74, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07621068", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07523113", "title": "ME/CFS Brain Fog: Cognitive Rehabilitation Trial", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-08-14", "start_date": "2026-06-23", "completion_date": "2028-06", "primary_completion_date": "2027-06", "conditions_raw": [ "ME/CFS", "ME/CFS Following EBV-associated Infectious Mononucleosis", "ME/CFS Following COVID-19", "Chronic Fatigue", "Chronic Fatigue Syndrome (CFS)", "Brain Fog", "Cognitive Impairment", "Cognitive Dysfunction" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Processing Speed Training", "In-Session Instrumental Activities Of Daily Living Training", "Transfer Package", "Follow Up Phone Calls", "Trans-Auricular Vagus Nerve Stimulation: High Intensity", "In-Session Brain Health Training", "Reaction Time Training", "Trans-Auricular Vagus Nerve Stimulation: Low Intensity" ], "sponsor": "University of Alabama at Birmingham", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer \"games\" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer \"games\" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.", "primary_outcomes": [ { "type": "primary", "measure": "Canadian Occupational Performance Measure (COPM)", "description": "The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview commonly used to measure the real-world outcome of rehabilitation procedures that span both motor and cognitive functions after stroke. The Performance Scale assesses how well a participant performs five activities in their daily life, i.e., outside the lab, that are important to the participant. Activities, for this purpose, will be restricted to those with an important cognitive component ,i.e., IADL. The 10-point response scale ranges from 1 (not able to do the activity at all) to 10 (able to do the activity extremely well). Performance Scale scores from the participant will be the primary outcome.", "time_frame": "Change from Day 30 to Day 60 (i.e., change from Pre- to Post-treatment)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Canadian Occupational Performance Measure (COPM)", "description": "The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview commonly used to measure the real-world outcome of rehabilitation procedures that span both motor and cognitive functions after stroke. The Performance Scale assesses how well a participant performs five activities in their daily life, i.e., outside the lab, that are important to the participant. Activities, for this purpose, will be restricted to those with an important cognitive component ,i.e., IADL. The 10-point response scale ranges from 1 (not able to do the activity at all) to 10 (able to do the activity extremely well). Performance Scale scores from the participant will be the primary outcome.", "time_frame": "Change from Day 30 to Day 60 (i.e., change from Pre- to Post-treatment)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07523113", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07753122", "title": "Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-08-07", "start_date": "2026-08-15", "completion_date": "2027-07", "primary_completion_date": "2027-07", "conditions_raw": [ "Chronic Fatigue Syndrome (CFS)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Molecular Hydrogen Produced By A Metallic Magnesium Tablet, Consumed 3X A Day Dissolved In Water. Treatment Duration Is 16 Weeks." ], "sponsor": "Fred Friedberg", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME/CFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination. The HRV biomarker hypothesis is based on a finding that High Frequency HRV (cardio-parasympathetic measure) biologically separated improvers and non-improvers in my previous ME/CFS observational study.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "Self-report measure of the effect of fatigue on functioning.", "time_frame": "2 weeks." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "SF-36 Physical Function Subscale", "description": "Self-report measure of how much health limits your ability to perform various types of physical activities.", "time_frame": "30 days" }, { "type": "secondary", "measure": "Depression, Anxiety and Stress Scale", "description": "Self-report measures three related negative emotional states of depression, anxiety, and tension/stress.", "time_frame": "30 days" }, { "type": "secondary", "measure": "Hassles and Uplifts Scale", "description": "Self-report measure of chronic minor stressors and positive everyday experiences.", "time_frame": "2 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "Self-report measure of the effect of fatigue on functioning.", "time_frame": "2 weeks." }, { "type": "secondary", "measure": "SF-36 Physical Function Subscale", "description": "Self-report measure of how much health limits your ability to perform various types of physical activities.", "time_frame": "30 days" }, { "type": "secondary", "measure": "Depression, Anxiety and Stress Scale", "description": "Self-report measures three related negative emotional states of depression, anxiety, and tension/stress.", "time_frame": "30 days" }, { "type": "secondary", "measure": "Hassles and Uplifts Scale", "description": "Self-report measure of chronic minor stressors and positive everyday experiences.", "time_frame": "2 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07753122", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07546539", "title": "Photobiomodulation in Chronic Fatigue Syndrome", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-06-24", "start_date": "2026-06-15", "completion_date": "2026-09", "primary_completion_date": "2026-07-15", "conditions_raw": [ "Chronic Fatigue Syndrome (CFS)", "Quality of Life" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Photobiomodulation" ], "sponsor": "University of Lahore", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to evaluate whether photobiomodulation therapy (low-level laser therapy) can reduce fatigue and improve quality of life in patients with chronic fatigue syndrome (CFS). The study will include adults aged 18-60 years diagnosed with chronic fatigue syndrome.\n\nThe main questions it aims to answer are:\n\nDoes photobiomodulation therapy significantly reduce fatigue levels as measured by the Fatigue Severity Scale (FSS) and Multidimensional Fatigue Inventory (MFI-20)? Does photobiomodulation therapy improve pain, functional capacity, sleep quality, and psychological well-being in patients with chronic fatigue syndrome?\n\nResearchers will compare the low-level laser therapy group with a placebo (sham laser) group to determine whether photobiomodulation therapy leads to greater improvements in fatigue, pain, and overall quality of life.\n\nParticipants will:\n\nReceive either active low-level laser therapy or placebo treatment three times per week for eight weeks Undergo assessments of fatigue, pain, functional capacity, quality of life, sleep quality, and psychological well-being at baseline and follow-up intervals (3, 6, and 12 months)", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Improvement", "description": "Fatigue will be assessed using validated self-reported instruments to evaluate the effect of photobiomodulation therapy on chronic fatigue symptoms.\n\nThe Fatigue Severity Scale (Fatigue Severity Scale) is a 9-item questionnaire that measures the impact of fatigue on daily functioning. Each item is scored on a 7-point Likert scale, and the final score is calculated as the mean of all items, with higher scores indicating greater fatigue severity.\n\nThe Multidimensional Fatigue Inventory (Multidimensional Fatigue Inventory) is a 20-item instrument assessing five dimensions: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each domain is scored on a 5-point Likert scale, with higher scores indicating increased fatigue.", "time_frame": "Baseline to Week 8-12 (end of intervention)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Health Related Quality of Life", "description": "Quality of life will be assessed using either the Medical Outcomes Study 36-Item Short Form Health Survey (Short Form-36 Health Survey) or the World Health Organization Quality of Life Brief Version (World Health Organization Quality of Life-BREF).\n\nThe Short Form-36 Health Survey evaluates eight domains including physical functioning, bodily pain, vitality, and mental health. Scores range from 0 to 100, with higher scores indicating better quality of life.\n\nThe World Health Organization Quality of Life-BREF consists of 26 items covering physical, psychological, social, and environmental domains, with higher scores indicating better perceived quality of life.", "time_frame": "Baseline to Week 8-12" }, { "type": "secondary", "measure": "Functional Capacity", "description": "Functional capacity will be assessed using the Six-Minute Walk Test (Six-Minute Walk Test). This test measures the total distance (in meters) a participant can walk in six minutes on a flat surface and reflects submaximal aerobic capacity and endurance.", "time_frame": "Baseline to Week 8-12 (end of intervention)" }, { "type": "secondary", "measure": "Pain Intensity", "description": "Pain intensity will be measured using the Visual Analog Scale (Visual Analog Scale), a 10-centimeter horizontal line ranging from \"no pain\" to \"worst imaginable pain.\" Scores are recorded in centimeters, with higher scores indicating greater pain intensity.", "time_frame": "Baseline to Week 8-12" }, { "type": "secondary", "measure": "Sleep Quality", "description": "Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index). This 19-item questionnaire assesses sleep quality over the past month across seven components. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.", "time_frame": "Baseline to Week 8-12" }, { "type": "secondary", "measure": "Psychological Well-Being", "description": "Psychological well-being will be assessed using either the Hospital Anxiety and Depression Scale (Hospital Anxiety and Depression Scale) or the Beck Depression Inventory (Beck Depression Inventory).\n\nThe Hospital Anxiety and Depression Scale includes 14 items divided into anxiety and depression subscales, each scored from 0 to 21.\n\nThe Beck Depression Inventory is a 21-item self-report questionnaire with scores ranging from 0 to 63, where higher scores indicate more severe depressive symptoms.", "time_frame": "Baseline to Week 8-12" }, { "type": "secondary", "measure": "Sustained Effects", "description": "Follow-up assessments will be conducted to determine whether improvements in fatigue, pain, and functional capacity are sustained after completion of the intervention.", "time_frame": "Week 16 and Week 24 follow-up" }, { "type": "secondary", "measure": "Safety and Tolerability", "description": "Safety and tolerability will be assessed by monitoring participant-reported discomfort, skin irritation, or other minor side effects occurring during or after Photobiomodulation therapy sessions.", "time_frame": "Throughout Week 8-12 intervention period" }, { "type": "secondary", "measure": "Adverse Effects and Safety Profile", "description": "All adverse events will be recorded and categorized by type, severity, duration, and relationship to the intervention. Serious adverse events will be reported immediately in accordance with regulatory requirements.", "time_frame": "From baseline through Week 24 (study completion)" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Improvement", "description": "Fatigue will be assessed using validated self-reported instruments to evaluate the effect of photobiomodulation therapy on chronic fatigue symptoms.\n\nThe Fatigue Severity Scale (Fatigue Severity Scale) is a 9-item questionnaire that measures the impact of fatigue on daily functioning. Each item is scored on a 7-point Likert scale, and the final score is calculated as the mean of all items, with higher scores indicating greater fatigue severity.\n\nThe Multidimensional Fatigue Inventory (Multidimensional Fatigue Inventory) is a 20-item instrument assessing five dimensions: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each domain is scored on a 5-point Likert scale, with higher scores indicating increased fatigue.", "time_frame": "Baseline to Week 8-12 (end of intervention)" }, { "type": "secondary", "measure": "Health Related Quality of Life", "description": "Quality of life will be assessed using either the Medical Outcomes Study 36-Item Short Form Health Survey (Short Form-36 Health Survey) or the World Health Organization Quality of Life Brief Version (World Health Organization Quality of Life-BREF).\n\nThe Short Form-36 Health Survey evaluates eight domains including physical functioning, bodily pain, vitality, and mental health. Scores range from 0 to 100, with higher scores indicating better quality of life.\n\nThe World Health Organization Quality of Life-BREF consists of 26 items covering physical, psychological, social, and environmental domains, with higher scores indicating better perceived quality of life.", "time_frame": "Baseline to Week 8-12" }, { "type": "secondary", "measure": "Functional Capacity", "description": "Functional capacity will be assessed using the Six-Minute Walk Test (Six-Minute Walk Test). This test measures the total distance (in meters) a participant can walk in six minutes on a flat surface and reflects submaximal aerobic capacity and endurance.", "time_frame": "Baseline to Week 8-12 (end of intervention)" }, { "type": "secondary", "measure": "Pain Intensity", "description": "Pain intensity will be measured using the Visual Analog Scale (Visual Analog Scale), a 10-centimeter horizontal line ranging from \"no pain\" to \"worst imaginable pain.\" Scores are recorded in centimeters, with higher scores indicating greater pain intensity.", "time_frame": "Baseline to Week 8-12" }, { "type": "secondary", "measure": "Sleep Quality", "description": "Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index). This 19-item questionnaire assesses sleep quality over the past month across seven components. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.", "time_frame": "Baseline to Week 8-12" }, { "type": "secondary", "measure": "Psychological Well-Being", "description": "Psychological well-being will be assessed using either the Hospital Anxiety and Depression Scale (Hospital Anxiety and Depression Scale) or the Beck Depression Inventory (Beck Depression Inventory).\n\nThe Hospital Anxiety and Depression Scale includes 14 items divided into anxiety and depression subscales, each scored from 0 to 21.\n\nThe Beck Depression Inventory is a 21-item self-report questionnaire with scores ranging from 0 to 63, where higher scores indicate more severe depressive symptoms.", "time_frame": "Baseline to Week 8-12" }, { "type": "secondary", "measure": "Sustained Effects", "description": "Follow-up assessments will be conducted to determine whether improvements in fatigue, pain, and functional capacity are sustained after completion of the intervention.", "time_frame": "Week 16 and Week 24 follow-up" }, { "type": "secondary", "measure": "Safety and Tolerability", "description": "Safety and tolerability will be assessed by monitoring participant-reported discomfort, skin irritation, or other minor side effects occurring during or after Photobiomodulation therapy sessions.", "time_frame": "Throughout Week 8-12 intervention period" }, { "type": "secondary", "measure": "Adverse Effects and Safety Profile", "description": "All adverse events will be recorded and categorized by type, severity, duration, and relationship to the intervention. Serious adverse events will be reported immediately in accordance with regulatory requirements.", "time_frame": "From baseline through Week 24 (study completion)" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07546539", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04542161", "title": "Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome", "status": "ACTIVE_NOT_RECRUITING", "phase": "PHASE2", "last_updated": "2026-06-22", "start_date": "2020-09-01", "completion_date": "2027-04-30", "primary_completion_date": "2027-04-30", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "N-Acetylcysteine (NAC)" ], "sponsor": "Weill Medical College of Cornell University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS) is an unexplained multisymptom/multisystem disorder for which there are currently no validated treatments. The present exploratory clinical trial aims to advance our understand of the mechanisms of in situ GSH synthesis control through assessment of the response of brain GSH and plasma markers of oxidative stress to different doses of NAC in comparison to placebo, as a potential treatment for ME/CFS that would provide neuroprotection against oxidative stress by restoring cortical GSH reserves. If successful, this exploratory clinical trial would address a significant public health concern by shedding new light onto the mechanisms of action of NAC in brain GSH restoration, which could open a new avenue for the development of potentially effective treatments for a disorder, ME/CFS, that currently has none.", "primary_outcomes": [ { "type": "primary", "measure": "Change in GSH levels of treatment response: measure 1", "description": "Levels of occipital cortex GSH, as measured in vivo with 1H MRS", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "primary", "measure": "Change in GSH levels of treatment response: measure 2", "description": "Levels of striatal GSH, as measured in vivo with 1H MRS", "time_frame": "pre/post 4 weeks of NAC supplementation" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change of levels of ventricular CSF lactate of treatment response", "description": "Levels of ventricular CSF lactate, as measured in vivo with 1H MRS", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change of regional cerebral blood flow (rCBF) of treatment response", "description": "Regional cerebral blood flow (rCBF), as measured in vivo with perfusion MRI", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 1", "description": "Level of F2-isoprostanes, a marker of oxidative stress, in plasma samples obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 2", "description": "Level of 8-hydroxy-2-deoxy guanosine (8-OH-2dG), a DNA damage marker, in plasma samples obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 3", "description": "Level of reduced (GSH) glutathione, an antioxidant capacity and redox state marker, in plasma obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 4", "description": "Level of oxidized (GSSG) glutathione, an antioxidant capacity and redox state marker, in plasma obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 5", "description": "Level of GSH peroxidase, an antioxidant enzyme activity marker, in plasma obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 6", "description": "Level of protein carbonyls, a protein damage marker, in plasma obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in GSH levels of treatment response: measure 1", "description": "Levels of occipital cortex GSH, as measured in vivo with 1H MRS", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "primary", "measure": "Change in GSH levels of treatment response: measure 2", "description": "Levels of striatal GSH, as measured in vivo with 1H MRS", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change of levels of ventricular CSF lactate of treatment response", "description": "Levels of ventricular CSF lactate, as measured in vivo with 1H MRS", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change of regional cerebral blood flow (rCBF) of treatment response", "description": "Regional cerebral blood flow (rCBF), as measured in vivo with perfusion MRI", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 1", "description": "Level of F2-isoprostanes, a marker of oxidative stress, in plasma samples obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 2", "description": "Level of 8-hydroxy-2-deoxy guanosine (8-OH-2dG), a DNA damage marker, in plasma samples obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 3", "description": "Level of reduced (GSH) glutathione, an antioxidant capacity and redox state marker, in plasma obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 4", "description": "Level of oxidized (GSSG) glutathione, an antioxidant capacity and redox state marker, in plasma obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 5", "description": "Level of GSH peroxidase, an antioxidant enzyme activity marker, in plasma obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" }, { "type": "secondary", "measure": "Change in Oxidative stress levels of treatment response: measure 6", "description": "Level of protein carbonyls, a protein damage marker, in plasma obtained", "time_frame": "pre/post 4 weeks of NAC supplementation" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 95, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04542161", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05947136", "title": "PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and/or Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-06-11", "start_date": "2024-01-19", "completion_date": "2029-09-14", "primary_completion_date": "2028-06-14", "conditions_raw": [ "Multiple Myeloma", "Complication" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Interpretation Of The Results From The Detection Visit", "Explaining Detection Results And Referrals To The Patient", "Early Medical Care Through The Network" ], "sponsor": "Centre Leon Berard", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a prospective, multicentre, phase III, randomised, controlled intervention study.\n\nTwo groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).\n\nEach patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).\n\n\\- PASCA interventional group\n\nFor both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary.\n\n\\- Control group\n\nFor the 7 complications of interest (primary objective) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management.\n\n=\\> For all patients, regardless of group\n\nAll patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications:\n\n* Visit No.1 (T1), 1-2 months after the autologous haematopoietic stem cell transplantation (aHSCT), corresponding to the patient's visit to his or her Multiple Myeloma (MM) monitoring consultation and/or the start of his or her consolidation treatment.\n* Visit No.2 (T2), 4 months after aHSCT, corresponding to a patient's visit for the end of consolidation treatment;\n* Visit No.3 (T3), 14 months after the last aHSCT, corresponding to a visit by the patient during his or her maintenance treatment;\n* Visit No.4 (T4), 24 months after the last aHSCT, corresponding to a visit by the patient for a MM monitoring consultation.", "primary_outcomes": [ { "type": "primary", "measure": "change from Baseline high blood pressure", "description": "blood pressure ≥ 140/90 mmHg measured in the investigating center and persisting over time", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline chronic kidney failure incidence at 24 months", "description": "diagnosed on the basis of 2 blood tests carried out within 3 months with the same technique showing either:\n\n* a decrease in GFR to \\< 60ml/min/1.73m2, estimated from serum creatinine using the CKD-EPI equation (Chronic Kidney Disease EPIdemiology collaboration, Levey, 2009),\n* positive proteinuria or albuminuria (albuminuria/creatinine ratio),\n* haematuria with a GR \\> 10/mm3 or 10,000/ml (after eliminating a urological cause),\n* leucocyturia with a WBC \\>10/mm3 or 10,000/ml (in the absence of infection),\n* a morphological abnormality on renal ultrasound: size asymmetry, bumpy contours, small kidneys or large polycystic kidneys, nephrocalcinosis, cyst.\n\nThe evolutionary character corresponds to one of the following situations:\n\n* Annual decline in GFR ≥ 5 ml/min/1.73 m²/year: GFR year n - GFR year n+1\n* Presence of albuminuria,\n* Poorly controlled arterial hypertension", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline chronic pain incidence at 60 months", "description": "pain felt for more than 3 months by the patient with an intensity on the Visual Analogue Scale (VAS) ≥ 3", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline sexual disorders incidence at 24 months", "description": "at least one perceived problem among the following:\n\n* disorders of desire,\n* arousal/erection disorders in men,\n* arousal disorders (insufficiency) in women,\n* Orgasm disorders in women", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline osteoporosis incidence at 24 months", "description": "T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur", "time_frame": "month 2, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline chronic fatigue incidence at 24 months", "description": "Questionnaire \"MFI-20\" (Multidimensional Fatigue Inventory)", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline severe anxiety disorder incidence at 24 months", "description": "Questionnaire \"HADS-D\" (Hospital Anxiety and Depression scale)", "time_frame": "month 2, month 4, month 14 and month 24" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from Baseline depressive events incidence at 24 months", "description": "Defined by at least two main depressive symptoms, associated with at least two symptoms additional information, according to the 2017 HAS recommendation \"Characterized depressive episode in adults\n\n: care in first resort\".", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline physical deconditioning incidence at 24 months", "description": "Defined by at least two tests among the 6 min Walk Test (TDM6), Handgrip-test, 60s Sit-to-stand, Flamingo test, with usual values below the norms defined by their authors, according to age and sex", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline cognitive problems incidence at 24 months", "description": "Positive score on at least one of the sub-dimensions of the Functional questionnaire Cancer Therapy Assessment - Cognitive Function (FACT-COG)", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline hypogonadism incidence at 24 months", "description": "Presence of clinical signs as defined by the International Society for Sexual Medicine\n\nA value below the lower limit on at least one of the following blood assay:\n\n* level of total testosterone\n* level of bioavailable testosterone", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline obesity incidence at 24 months", "description": "BMI value:\n\n* \\[25-30\\[ kg/m2 with a waist circumference above the norm (≥ 94cm for men or\n\n ≥ 80cm for women)\n* ≥ 30 kg/m2", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline hypothyroidism incidence at 24 months", "description": "* level of thyroid-stimulating hormone\n* level of total thyroxine", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline dyslipidemias incidence at 24 months", "description": "hypercholesterolemia (LDL) ≥ 1.6 g/L estimated by the Friedewald formula and/or a hypertriglyceridemia ≥ 4 g/L", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline Heart failure markers incidence at 24 months", "description": "NT-proBNP and/or troponin I level above the threshold values.", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline Atrial fibrillation incidence at 24 months", "description": "equivocal electrocardiogram, interpreted by an experienced physician", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline of respiratory failure markers incidence at 24 months", "description": "FVC, FVC, FEV1, FEF25-75, FEF50, FEF25 (established by spirometric test) ≤ 80% of the predicted values (abacus on age, sex, height and origin ethnic)", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline return to work issues incidence at 24 months", "description": "Diagnosed by a social worker", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline of Lifestyle risk factors ( tobacco, alcohol, and cannabis) incidence at 24 months", "description": "consumption :\n\n* smoking and/or active cannabis\n* alcohols higher than the latest recommendations", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "secondary", "measure": "Change from baseline Myelodysplastic syndromes and secondary acute leukemia incidence at 24 months", "description": "confirmed by the reference diagnosis", "time_frame": "month 4, month 14 and month 24" } ], "outcome_measures": [ { "type": "primary", "measure": "change from Baseline high blood pressure", "description": "blood pressure ≥ 140/90 mmHg measured in the investigating center and persisting over time", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline chronic kidney failure incidence at 24 months", "description": "diagnosed on the basis of 2 blood tests carried out within 3 months with the same technique showing either:\n\n* a decrease in GFR to \\< 60ml/min/1.73m2, estimated from serum creatinine using the CKD-EPI equation (Chronic Kidney Disease EPIdemiology collaboration, Levey, 2009),\n* positive proteinuria or albuminuria (albuminuria/creatinine ratio),\n* haematuria with a GR \\> 10/mm3 or 10,000/ml (after eliminating a urological cause),\n* leucocyturia with a WBC \\>10/mm3 or 10,000/ml (in the absence of infection),\n* a morphological abnormality on renal ultrasound: size asymmetry, bumpy contours, small kidneys or large polycystic kidneys, nephrocalcinosis, cyst.\n\nThe evolutionary character corresponds to one of the following situations:\n\n* Annual decline in GFR ≥ 5 ml/min/1.73 m²/year: GFR year n - GFR year n+1\n* Presence of albuminuria,\n* Poorly controlled arterial hypertension", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline chronic pain incidence at 60 months", "description": "pain felt for more than 3 months by the patient with an intensity on the Visual Analogue Scale (VAS) ≥ 3", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline sexual disorders incidence at 24 months", "description": "at least one perceived problem among the following:\n\n* disorders of desire,\n* arousal/erection disorders in men,\n* arousal disorders (insufficiency) in women,\n* Orgasm disorders in women", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline osteoporosis incidence at 24 months", "description": "T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur", "time_frame": "month 2, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline chronic fatigue incidence at 24 months", "description": "Questionnaire \"MFI-20\" (Multidimensional Fatigue Inventory)", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "primary", "measure": "Change from Baseline severe anxiety disorder incidence at 24 months", "description": "Questionnaire \"HADS-D\" (Hospital Anxiety and Depression scale)", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline depressive events incidence at 24 months", "description": "Defined by at least two main depressive symptoms, associated with at least two symptoms additional information, according to the 2017 HAS recommendation \"Characterized depressive episode in adults\n\n: care in first resort\".", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline physical deconditioning incidence at 24 months", "description": "Defined by at least two tests among the 6 min Walk Test (TDM6), Handgrip-test, 60s Sit-to-stand, Flamingo test, with usual values below the norms defined by their authors, according to age and sex", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline cognitive problems incidence at 24 months", "description": "Positive score on at least one of the sub-dimensions of the Functional questionnaire Cancer Therapy Assessment - Cognitive Function (FACT-COG)", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline hypogonadism incidence at 24 months", "description": "Presence of clinical signs as defined by the International Society for Sexual Medicine\n\nA value below the lower limit on at least one of the following blood assay:\n\n* level of total testosterone\n* level of bioavailable testosterone", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline obesity incidence at 24 months", "description": "BMI value:\n\n* \\[25-30\\[ kg/m2 with a waist circumference above the norm (≥ 94cm for men or\n\n ≥ 80cm for women)\n* ≥ 30 kg/m2", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline hypothyroidism incidence at 24 months", "description": "* level of thyroid-stimulating hormone\n* level of total thyroxine", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline dyslipidemias incidence at 24 months", "description": "hypercholesterolemia (LDL) ≥ 1.6 g/L estimated by the Friedewald formula and/or a hypertriglyceridemia ≥ 4 g/L", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline Heart failure markers incidence at 24 months", "description": "NT-proBNP and/or troponin I level above the threshold values.", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline Atrial fibrillation incidence at 24 months", "description": "equivocal electrocardiogram, interpreted by an experienced physician", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline of respiratory failure markers incidence at 24 months", "description": "FVC, FVC, FEV1, FEF25-75, FEF50, FEF25 (established by spirometric test) ≤ 80% of the predicted values (abacus on age, sex, height and origin ethnic)", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline return to work issues incidence at 24 months", "description": "Diagnosed by a social worker", "time_frame": "month 2, month 14 and month 24" }, { "type": "secondary", "measure": "Change from Baseline of Lifestyle risk factors ( tobacco, alcohol, and cannabis) incidence at 24 months", "description": "consumption :\n\n* smoking and/or active cannabis\n* alcohols higher than the latest recommendations", "time_frame": "month 2, month 4, month 14 and month 24" }, { "type": "secondary", "measure": "Change from baseline Myelodysplastic syndromes and secondary acute leukemia incidence at 24 months", "description": "confirmed by the reference diagnosis", "time_frame": "month 4, month 14 and month 24" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 204, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT05947136", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07491315", "title": "Is Post-exertional Symptom Exacerbation Specific to Patients With Myalgic Encephalomyelitis / Chronic Fatigue Syndrome? A Study Comparing Patients With Myalgic Encephalomyelitis / Chronic Fatigue Syndrome and Patients With Cardiac Diseases Who Underwent an Exercise Test.", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-06-08", "start_date": "2025-06-24", "completion_date": "2026-12-24", "primary_completion_date": "2026-12-24", "conditions_raw": [ "Fatigue Syndrome, Chronic", "Cardiovascular Diseases" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Exercise Test On Ergocycle", "Near Infrared Spectroscopy" ], "sponsor": "Hôpital Européen Marseille", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) is a disease characterized by persistent and unexplained fatigue associated with diffuse pain, sleep disorders, neurocognitive and autonomic symptoms, musculoskeletal manifestations and digestive symptoms. A central feature of this disease is post-exertional symptom exacerbation, also referred to as post-exertional malaise, defined as the worsening or the appearance of symptoms after physical or mental exertion, sometimes even minimal.\n\nSeveral studies have described post-exertional malaise in populations of patients with ME/CFS following a standardized exercise test performed over one or two consecutive days. These studies confirmed the presence of post-exertional malaise in ME/CFS patients compared with healthy controls or patients with multiple sclerosis.\n\nHowever, no data are available evaluating the impact of an exercise test on symptoms in patients referred to cardiology for this examination. Patients with cardiac diseases may also present symptoms such as fatigue, dyspnea or exercise intolerance.\n\nThis study aims to compare post-exertional symptoms in two populations: patients with ME/CFS and patients with cardiac diseases undergoing an exercise test as part of routine clinical evaluation. The study also aims to measure variations in muscle oxyhemoglobin and deoxyhemoglobin concentrations before, during and after exercise using Near Infrared Spectroscopy (NIRS).", "primary_outcomes": [ { "type": "primary", "measure": "Time to onset of symptoms after completion of the exercise test on an ergocycle in both groups.", "description": "Type of symptoms reported by participants after the exercise test.", "time_frame": "From immediately after the exercise test up to Day 7." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptoms observed during the 7 days following the exercise test in both groups", "description": "Type of symptoms reported by participants after the exercise test.", "time_frame": "From immediately after the exercise test up to Day 7." }, { "type": "secondary", "measure": "Duration of symptoms after the exercise test in both groups.", "description": "Type of symptoms reported by participants after the exercise test.", "time_frame": "From immediately after the exercise test up to Day 7." }, { "type": "secondary", "measure": "Intensity of post-exercise symptoms measured in both groups.", "description": "Type of symptoms reported by participants after the exercise test.", "time_frame": "From immediately after the exercise test up to Day 7." }, { "type": "secondary", "measure": "Characterization of symptoms experienced before the exercise test in both groups.", "description": "Baseline symptom characterization using the DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM). The DSQ-PEM evaluates the frequency and severity of post-exertional malaise symptoms. A frequency score and a severity score ≥ 2 for at least one of items 1-5 are indicative of post-exertional malaise. For diagnostic classification, either item 7 or item 8 must be positive, and item 9 must indicate a duration of symptoms greater than 14 hours. Higher frequency and severity scores indicate greater symptom burden.", "time_frame": "Day 0 (prior to the exercise test)." }, { "type": "secondary", "measure": "Variations in oxyhemoglobin and deoxyhemoglobin concentrations measured by Near Infrared Spectroscopy (NIRS) at the muscular level before, during and after exercise.", "description": "Measurement of changes in oxyhaemoglobin and deoxyhaemoglobin concentrations in muscle tissue using Near-Infrared Spectroscopy (NIRS).", "time_frame": "Before, during, and up to 10 minutes after the exercise test." } ], "outcome_measures": [ { "type": "primary", "measure": "Time to onset of symptoms after completion of the exercise test on an ergocycle in both groups.", "description": "Type of symptoms reported by participants after the exercise test.", "time_frame": "From immediately after the exercise test up to Day 7." }, { "type": "secondary", "measure": "Symptoms observed during the 7 days following the exercise test in both groups", "description": "Type of symptoms reported by participants after the exercise test.", "time_frame": "From immediately after the exercise test up to Day 7." }, { "type": "secondary", "measure": "Duration of symptoms after the exercise test in both groups.", "description": "Type of symptoms reported by participants after the exercise test.", "time_frame": "From immediately after the exercise test up to Day 7." }, { "type": "secondary", "measure": "Intensity of post-exercise symptoms measured in both groups.", "description": "Type of symptoms reported by participants after the exercise test.", "time_frame": "From immediately after the exercise test up to Day 7." }, { "type": "secondary", "measure": "Characterization of symptoms experienced before the exercise test in both groups.", "description": "Baseline symptom characterization using the DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM). The DSQ-PEM evaluates the frequency and severity of post-exertional malaise symptoms. A frequency score and a severity score ≥ 2 for at least one of items 1-5 are indicative of post-exertional malaise. For diagnostic classification, either item 7 or item 8 must be positive, and item 9 must indicate a duration of symptoms greater than 14 hours. Higher frequency and severity scores indicate greater symptom burden.", "time_frame": "Day 0 (prior to the exercise test)." }, { "type": "secondary", "measure": "Variations in oxyhemoglobin and deoxyhemoglobin concentrations measured by Near Infrared Spectroscopy (NIRS) at the muscular level before, during and after exercise.", "description": "Measurement of changes in oxyhaemoglobin and deoxyhaemoglobin concentrations in muscle tissue using Near-Infrared Spectroscopy (NIRS).", "time_frame": "Before, during, and up to 10 minutes after the exercise test." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07491315", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03807973", "title": "Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.", "status": "SUSPENDED", "phase": "PHASE1", "last_updated": "2026-06-02", "start_date": "2021-10-05", "completion_date": "2028-10", "primary_completion_date": "2028-10", "conditions_raw": [ "Fibromyalgia", "Chronic Fatigue Syndrome", "Multiple Sclerosis", "Healthy" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "[Zr-89]Oxine-Labeled Leukocytes Pet/Mri" ], "sponsor": "University of Alabama at Birmingham", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) and an investigational radioactive drug called \\[Zr-89\\]oxine to track the location of white blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled white blood cells and determine if they enter the central nervous system in conditions associated with brain inflammation (also called neuroinflammation). By better understanding the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.", "primary_outcomes": [ { "type": "primary", "measure": "Regional brain distribution of radiolabeled white blood cells", "description": "Descriptive statistics (means and standard deviations) of standardized uptake values (SUVs) will be presented for the patient groups and healthy controls in the following regions: whole brain, gray matter, white matter, atlas-based regions of interest, and lesions (MS patients only). Normality of the SUV distribution will be tested using Shapiro-Wilk tests, and the data will be transformed to normal distribution if necessary.", "time_frame": "3 years" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Regional brain distribution of radiolabeled white blood cells", "description": "Descriptive statistics (means and standard deviations) of standardized uptake values (SUVs) will be presented for the patient groups and healthy controls in the following regions: whole brain, gray matter, white matter, atlas-based regions of interest, and lesions (MS patients only). Normality of the SUV distribution will be tested using Shapiro-Wilk tests, and the data will be transformed to normal distribution if necessary.", "time_frame": "3 years" } ], "relevance_tags": [ "Immunomodulatory", "Anti-inflammatory", "Phase 1", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03807973", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03759522", "title": "Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.", "status": "RECRUITING", "phase": "PHASE1", "last_updated": "2026-06-02", "start_date": "2019-02-03", "completion_date": "2028-04", "primary_completion_date": "2028-04", "conditions_raw": [ "Fibromyalgia", "Chronic Fatigue Syndrome", "Multiple Sclerosis", "Healthy" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Dpa-714 Pet/Mri" ], "sponsor": "University of Alabama at Birmingham", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical \\[F-18\\]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer \\[F-18\\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with \\[F-18\\]DPA-714-PET/MRI.", "primary_outcomes": [ { "type": "primary", "measure": "Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.", "description": "Quantitative PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be compared between healthy volunteers and symptomatic study participants with pain and/or fatigue.", "time_frame": "3 years" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.", "description": "Quantitative PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be compared between healthy volunteers and symptomatic study participants with pain and/or fatigue.", "time_frame": "3 years" } ], "relevance_tags": [ "Metabolic", "Mitochondrial", "Anti-inflammatory", "Phase 1", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03759522", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07573709", "title": "Functional and Affective Effects of a Brief tDCS Intervention in Fibromyalgia and Chronic Fatigue Syndrome", "status": "TERMINATED", "phase": "NA", "last_updated": "2026-05-07", "start_date": "2025-01-01", "completion_date": "2025-05-30", "primary_completion_date": "2025-05-01", "conditions_raw": [ "Fibromyalgia (FM)", "Chronic Fatigue Syndrome (CFS)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Transcraneal Direct Current Electric Stimulation", "Transcranial Direct Current Electric Stimulation" ], "sponsor": "Hospital Donostia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Functional and Affective Effects of a brief tDCS Intervention in Fibromyalgia and Chronic Fatigue Syndrome Fibromyalgia (FM) and chronic fatigue syndrome (CFS) are characterized by persistent, multidimensional symptoms arising from complex brain-body interactions that impair functioning and quality of life. Noninvasive neuromodulation techniques such as transcranial direct current stimulation (tDCS) have been proposed as adjunctive approaches to support short-term functional changes within distributed neural systems, although evidence remains limited and heterogeneous. The objective is to examine immediate pre-post changes in multidimensional clinical outcomes following a standardized tDCS protocol in patients with FM and CFS, and to explore potential diagnosis-related response patterns.", "primary_outcomes": [ { "type": "primary", "measure": "Visual Pain Scores (VAS)", "description": "It is measured before and inmediately after the treatment ( tDCS) is applied. (0-10) Higher scores mean more pain.", "time_frame": "From enrollment to the end of treatment at 2 weeks" }, { "type": "primary", "measure": "Fibromyalgia Impact Questionnaire (FIQ)", "description": "It measures the impact of fibromyalgia (Scores: 0-100) The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person.", "time_frame": "From enrollment to the end of treatment at 2 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Visual Pain Scores (VAS)", "description": "It is measured before and inmediately after the treatment ( tDCS) is applied. (0-10) Higher scores mean more pain.", "time_frame": "From enrollment to the end of treatment at 2 weeks" }, { "type": "primary", "measure": "Fibromyalgia Impact Questionnaire (FIQ)", "description": "It measures the impact of fibromyalgia (Scores: 0-100) The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person.", "time_frame": "From enrollment to the end of treatment at 2 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07573709", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06978582", "title": "Effectiveness and Safety of a Tele-Rehabilitation Program on Fatigue and Related Variables in Chronic Fatigue Syndrome and Post COVID Syndrome", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2026-04-28", "start_date": "2025-10-01", "completion_date": "2027-03-30", "primary_completion_date": "2026-12-30", "conditions_raw": [ "Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)", "Post COVID Syndrome" ], "mapped_conditions": [ "Long COVID / PASC", "ME/CFS" ], "agents": [ "Mindful And Conscious Movement-Based Exercise", "Conventional Exercise" ], "sponsor": "University of Seville", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a randomized, single-blind clinical trial that aims to evaluate the effectiveness of a tele-rehabilitation program based on mindful and conscious movement-based exercise (including adapted yoga, breathing exercises, and body awareness) compared to conventional exercise (low-intensity strength and aerobic training) and usual medical care (control group) over twelve weeks. The study is for people diagnosed with Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) or Post-Covid Syndrome (PCS).\n\nWe will also look at how the program affects the autonomic nervous system by measuring heart rate variability (HRV).\n\nAll sessions will be delivered remotely via Telehealth, so participants can take part from home. Assessments will be completed online at the beginning of the study, after three months (at the end of the intervention), and again three months later.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue will be measured through the Spanish version of the Chadler Fatigue Scale. It is a 14-item psychometric questionnaire designed to assess the subjective perception of physical and mental fatigue over the past few weeks. Items are rated on a 4-point Likert scale (0 = never, 1 = sometimes, 2 = often, 3 = always). The total score ranges from 0 to 42, with higher scores indicating greater levels of fatigue.", "time_frame": "From baseline to three months after intervention completion" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Heart Rate Variability", "description": "Welltory Mobile Application (v.4.16.100) is a mobile application that uses photoplethysmography through the phone's camera to measure resting heart rate. Based on these data, it estimates heart rate variability (HRV) parameters, including autonomic balance indicators such as RMSSD and SSDN. The tool has been validated in previous studies for assessing resting HRV, showing a significant correlation with reference medical devices such as electrocardiograms and heart rate monitors (intraclass correlation coefficient \\> 0.90).", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Perceived pain", "description": "Perceived pain will be assessed through the Spanish version of the Brief Pain Inventory (BPI), which is a self-administered instrument composed of two sections: pain intensity and the degree of interference in daily activities (such as sleep, mood, work, among others). It consists of 9 items, each rated on a numerical scale from 0 to 10, where higher scores indicate greater pain intensity and/or interference.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Perceived Quality of life", "description": "Perceived quality of life will be assessed through the completion of the Spanish version of the SF-36 Health Questionary. It is a widely used tool for measuring health-related quality of life. This instrument consists of 36 items grouped into eight dimensions: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are transformed to a scale from 0 to 100 for each dimension, with higher scores indicating a better perceived health status in that domain.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Physical function", "description": "Physical function will be quantified through the Sit-To-Stand Test. This test is a functional test that measures lower limb muscular endurance. It involves recording the number of repetitions of standing up from and sitting down on a standard armless chair over a 60-second period. The participant must keep their arms crossed over the chest and perform the movement as quickly as possible while maintaining proper technique. This test is a reliable indicator of functional strength and muscular endurance, widely used in both healthy populations and individuals with chronic conditions.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Interoceptive awareness", "description": "Interoceptive awareness will be quantified through the Spanish version of the Multidimensional Assessment of Interoceptive Awareness. This is a self-administered 32-item questionnaire that measures interoceptive awareness across eight dimensions, such as attention to internal bodily sensations, emotional regulation through bodily signals, and interoceptive confidence. Each item is rated on a Likert scale from 0 (never) to 5 (always), with higher scores indicating greater interoceptive awareness.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Anxiety and depression levels", "description": "Anxiety and depression levels will be measured with the Hospital Anxiety and Depression Scale (HADS) which is a brief questionnaire composed of 14 items divided into two subscales: anxiety (7 items) and depression (7 items). Each item is rated on a scale from 0 to 3, with total scores ranging from 0 to 21 for each subscale. A cutoff score of ≥8 is considered indicative of clinically significant levels of anxiety or depression.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Perceived sleep quality", "description": "Perceived sleep quality will be measured with the Pittsburg Sleep Quality Index (PSQI). This is a self-administered questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, and the total score ranges from 0 to 21. Scores greater than 5 indicate significant sleep problems.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Fear of movement", "description": "Fear of movement will be measured through the Tampa Scale for Kinesiophobia. The Tampa Scale for Kinesiophobia assesses fear of movement related to pain through 17 items rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Somatic vigilance", "description": "Somatic vigilance will be evaluated using the Anxiety Sensitivity Index (ASI; Spanish version). The ASI consists on 16 items (total score 0-64) assessing fear of anxiety-related bodily sensations, with higher scores denoting greater sensitivity.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Treatment feasibility", "description": "Treatment feasibility will be measured through quantification of adherence to treatment and adverse events. An individual digital diary will be used to record this data.", "time_frame": "From baseline to the end of treatment at 3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue", "description": "Fatigue will be measured through the Spanish version of the Chadler Fatigue Scale. It is a 14-item psychometric questionnaire designed to assess the subjective perception of physical and mental fatigue over the past few weeks. Items are rated on a 4-point Likert scale (0 = never, 1 = sometimes, 2 = often, 3 = always). The total score ranges from 0 to 42, with higher scores indicating greater levels of fatigue.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Heart Rate Variability", "description": "Welltory Mobile Application (v.4.16.100) is a mobile application that uses photoplethysmography through the phone's camera to measure resting heart rate. Based on these data, it estimates heart rate variability (HRV) parameters, including autonomic balance indicators such as RMSSD and SSDN. The tool has been validated in previous studies for assessing resting HRV, showing a significant correlation with reference medical devices such as electrocardiograms and heart rate monitors (intraclass correlation coefficient \\> 0.90).", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Perceived pain", "description": "Perceived pain will be assessed through the Spanish version of the Brief Pain Inventory (BPI), which is a self-administered instrument composed of two sections: pain intensity and the degree of interference in daily activities (such as sleep, mood, work, among others). It consists of 9 items, each rated on a numerical scale from 0 to 10, where higher scores indicate greater pain intensity and/or interference.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Perceived Quality of life", "description": "Perceived quality of life will be assessed through the completion of the Spanish version of the SF-36 Health Questionary. It is a widely used tool for measuring health-related quality of life. This instrument consists of 36 items grouped into eight dimensions: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are transformed to a scale from 0 to 100 for each dimension, with higher scores indicating a better perceived health status in that domain.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Physical function", "description": "Physical function will be quantified through the Sit-To-Stand Test. This test is a functional test that measures lower limb muscular endurance. It involves recording the number of repetitions of standing up from and sitting down on a standard armless chair over a 60-second period. The participant must keep their arms crossed over the chest and perform the movement as quickly as possible while maintaining proper technique. This test is a reliable indicator of functional strength and muscular endurance, widely used in both healthy populations and individuals with chronic conditions.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Interoceptive awareness", "description": "Interoceptive awareness will be quantified through the Spanish version of the Multidimensional Assessment of Interoceptive Awareness. This is a self-administered 32-item questionnaire that measures interoceptive awareness across eight dimensions, such as attention to internal bodily sensations, emotional regulation through bodily signals, and interoceptive confidence. Each item is rated on a Likert scale from 0 (never) to 5 (always), with higher scores indicating greater interoceptive awareness.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Anxiety and depression levels", "description": "Anxiety and depression levels will be measured with the Hospital Anxiety and Depression Scale (HADS) which is a brief questionnaire composed of 14 items divided into two subscales: anxiety (7 items) and depression (7 items). Each item is rated on a scale from 0 to 3, with total scores ranging from 0 to 21 for each subscale. A cutoff score of ≥8 is considered indicative of clinically significant levels of anxiety or depression.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Perceived sleep quality", "description": "Perceived sleep quality will be measured with the Pittsburg Sleep Quality Index (PSQI). This is a self-administered questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, and the total score ranges from 0 to 21. Scores greater than 5 indicate significant sleep problems.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Fear of movement", "description": "Fear of movement will be measured through the Tampa Scale for Kinesiophobia. The Tampa Scale for Kinesiophobia assesses fear of movement related to pain through 17 items rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Somatic vigilance", "description": "Somatic vigilance will be evaluated using the Anxiety Sensitivity Index (ASI; Spanish version). The ASI consists on 16 items (total score 0-64) assessing fear of anxiety-related bodily sensations, with higher scores denoting greater sensitivity.", "time_frame": "From baseline to three months after intervention completion" }, { "type": "secondary", "measure": "Treatment feasibility", "description": "Treatment feasibility will be measured through quantification of adherence to treatment and adverse events. An individual digital diary will be used to record this data.", "time_frame": "From baseline to the end of treatment at 3 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 147, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06978582", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03844412", "title": "Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2026-03-19", "start_date": "2019-11-04", "completion_date": "2024-05-30", "primary_completion_date": "2024-03-13", "conditions_raw": [ "Vestibulodynia", "Temporomandibular Disorder", "Fibromyalgia Syndrome", "Irritable Bowel Syndrome", "Migraines", "Tension Headache", "Endometriosis", "Interstitial Cystitis", "Back Pain", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Nortriptyline" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Vestibulodynia (VBD) is a complex chronic vulvar pain condition that impairs the psychological, physical, and sexual health of 1 in 6 reproductive aged women in the United States. Here, the investigators plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to 1) compare the efficacy of peripheral (lidocaine/estradiol cream), centrally-targeted (nortriptyline), and combined treatments in alleviating pain and improving patient-reported outcomes and 2) determine cytokine and microRNA biomarkers that predict treatment response in women with distinct VBD subtypes. Positive findings from this study will readily translate to improved patient care, permitting the millions of women with VBD, their partners, and their clinicians to make more informed decisions about pain management.", "primary_outcomes": [ { "type": "primary", "measure": "Pain Score During the Tampon Test", "description": "The Tampon Test will provide a self-reported numeric rating scale of pain with self-tampon insertion, performed by the patient and reported to the research nurse. Participants will be asked to verbally rate the pain on a scale of 0-10, with 0 meaning no pain and 10 meaning the worst possible pain.", "time_frame": "Baseline, 16 weeks" }, { "type": "primary", "measure": "Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ)", "description": "The SF-MPQ consists of 15 descriptors which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The total score ranges from 0 to 45, where a higher score indicates greater pain. A negative change score indicates a decrease in pain over time.", "time_frame": "Baseline, 16 weeks" }, { "type": "primary", "measure": "Self-reported Physical Health Via SF-12 Health Survey (SF12v2)", "description": "The SF-12 physical health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.", "time_frame": "Prior to randomization" }, { "type": "primary", "measure": "Self-reported Mental Health Via SF-12 Health Survey (SF12v2)", "description": "The SF-12 mental health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.", "time_frame": "Prior to randomization" }, { "type": "primary", "measure": "Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS)", "description": "The PROMIS score is based on a 96-item form developed by the NIH that measures 11 domains of biopsychosocial function and includes an assessment of sexual function measures (e.g., desire, frequency, fear, and pain) related to sexual intercourse. The PROMIS Sexual Function and Satisfaction (SexFS) measures produce a T-score that summarizes a person's sexual health. The T-score is a standardized score that ranges from 0 to 100, where 50 indicates the population mean with a standard deviation of 10. Higher scores indicate greater satisfaction.", "time_frame": "Baseline, 16 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Pain Level as Measured by Vaginal Vestibule Pressure Pain Intensities (PPI)", "description": "Vaginal Vestibule PPIs will be determined using a cotton swab applied to externally-accessed sites (at 10, 6, and 2 o'clock on the vestibule) for 1-2 seconds. Upon application of cotton swab at each site, participants will rate their pain intensity on a scale from 0-10, where 0 = no pain and 10 = the worst pain possible. Reported as a composite mean score.", "time_frame": "Baseline, 8 weeks, and 16 weeks" }, { "type": "secondary", "measure": "Change in Levator Muscle Complex Pressure Pain Threshold (PPT)", "description": "Levator Muscle Complex PPTs will be determined using a digital vestibular algometer applied internally to the left puborectalis levator muscles site (7 o'clock) just lateral to the perineum. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation.", "time_frame": "Baseline, 16 weeks" }, { "type": "secondary", "measure": "Change in Pain Level as Measured by Remote Bodily PPTs", "description": "Remote Bodily PPTs will be determined by applying the algometer to 3 'neutral' non-pelvic body sites (deltoid, shin, and trapezius), right and left, beginning at 1N and increasing until the participant's first sensation of pain. PPT scores are rated on a scale of 0-10, where 0 meaning no pain and 10 meaning the worst pain possible. Reported as a composite mean score.", "time_frame": "Baseline, 8 weeks, and 16 weeks" }, { "type": "secondary", "measure": "Somatic Awareness Via Pennebaker Index of Limbic Languidness (PILL)", "description": "Pennebaker Index of Limbic Languidness (PILL) is used to create a summary score of somatic symptoms (e.g., itchy eyes, dizziness). Symptom frequency is recorded on a five-point Likert scale ranging from \"never\" (0) to \"more than once a week\" (4). The total score ranges from 0 to 216, where greater scores indicate greater frequency of symptoms.", "time_frame": "Baseline, 8 weeks, and 16 weeks" }, { "type": "secondary", "measure": "Change in Sleep as Measured by the Sleep Scale", "description": "The sleep scale is a 12-item scale that measures amount of sleep and ease/difficulty of initiating and maintaining sleep.", "time_frame": "Baseline, 8 weeks, 16 weeks, and 24 weeks" }, { "type": "secondary", "measure": "Change in Perceived Stress Via Perceived Stress Scale (PSS)", "description": "The Perceived stress scale (PSS) is a 10-item scale that measures the impact of personal stress on thoughts and feelings.", "time_frame": "Baseline, 8 weeks, 16 weeks, and 24 weeks" }, { "type": "secondary", "measure": "Change in Mood as Measured by the Symptom Checklist-27 (SCL-27)", "description": "Symptom Check List 27 (SCL-27) questionnaire will be used to measure a broad range of psychological symptoms (e.g., anxiety and depression).", "time_frame": "Baseline, 8 weeks, 16 weeks, and 24 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Pain Score During the Tampon Test", "description": "The Tampon Test will provide a self-reported numeric rating scale of pain with self-tampon insertion, performed by the patient and reported to the research nurse. Participants will be asked to verbally rate the pain on a scale of 0-10, with 0 meaning no pain and 10 meaning the worst possible pain.", "time_frame": "Baseline, 16 weeks" }, { "type": "primary", "measure": "Change in Self-reported Pain Via the Short Form- McGill Pain Questionnaire (SF-MPQ)", "description": "The SF-MPQ consists of 15 descriptors which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The total score ranges from 0 to 45, where a higher score indicates greater pain. A negative change score indicates a decrease in pain over time.", "time_frame": "Baseline, 16 weeks" }, { "type": "primary", "measure": "Self-reported Physical Health Via SF-12 Health Survey (SF12v2)", "description": "The SF-12 physical health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.", "time_frame": "Prior to randomization" }, { "type": "primary", "measure": "Self-reported Mental Health Via SF-12 Health Survey (SF12v2)", "description": "The SF-12 mental health score has a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.", "time_frame": "Prior to randomization" }, { "type": "primary", "measure": "Sexual Health Via Patient-Reported Outcomes Measurement Information System (PROMIS)", "description": "The PROMIS score is based on a 96-item form developed by the NIH that measures 11 domains of biopsychosocial function and includes an assessment of sexual function measures (e.g., desire, frequency, fear, and pain) related to sexual intercourse. The PROMIS Sexual Function and Satisfaction (SexFS) measures produce a T-score that summarizes a person's sexual health. The T-score is a standardized score that ranges from 0 to 100, where 50 indicates the population mean with a standard deviation of 10. Higher scores indicate greater satisfaction.", "time_frame": "Baseline, 16 weeks" }, { "type": "secondary", "measure": "Change in Pain Level as Measured by Vaginal Vestibule Pressure Pain Intensities (PPI)", "description": "Vaginal Vestibule PPIs will be determined using a cotton swab applied to externally-accessed sites (at 10, 6, and 2 o'clock on the vestibule) for 1-2 seconds. Upon application of cotton swab at each site, participants will rate their pain intensity on a scale from 0-10, where 0 = no pain and 10 = the worst pain possible. Reported as a composite mean score.", "time_frame": "Baseline, 8 weeks, and 16 weeks" }, { "type": "secondary", "measure": "Change in Levator Muscle Complex Pressure Pain Threshold (PPT)", "description": "Levator Muscle Complex PPTs will be determined using a digital vestibular algometer applied internally to the left puborectalis levator muscles site (7 o'clock) just lateral to the perineum. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation.", "time_frame": "Baseline, 16 weeks" }, { "type": "secondary", "measure": "Change in Pain Level as Measured by Remote Bodily PPTs", "description": "Remote Bodily PPTs will be determined by applying the algometer to 3 'neutral' non-pelvic body sites (deltoid, shin, and trapezius), right and left, beginning at 1N and increasing until the participant's first sensation of pain. PPT scores are rated on a scale of 0-10, where 0 meaning no pain and 10 meaning the worst pain possible. Reported as a composite mean score.", "time_frame": "Baseline, 8 weeks, and 16 weeks" }, { "type": "secondary", "measure": "Somatic Awareness Via Pennebaker Index of Limbic Languidness (PILL)", "description": "Pennebaker Index of Limbic Languidness (PILL) is used to create a summary score of somatic symptoms (e.g., itchy eyes, dizziness). Symptom frequency is recorded on a five-point Likert scale ranging from \"never\" (0) to \"more than once a week\" (4). The total score ranges from 0 to 216, where greater scores indicate greater frequency of symptoms.", "time_frame": "Baseline, 8 weeks, and 16 weeks" }, { "type": "secondary", "measure": "Change in Sleep as Measured by the Sleep Scale", "description": "The sleep scale is a 12-item scale that measures amount of sleep and ease/difficulty of initiating and maintaining sleep.", "time_frame": "Baseline, 8 weeks, 16 weeks, and 24 weeks" }, { "type": "secondary", "measure": "Change in Perceived Stress Via Perceived Stress Scale (PSS)", "description": "The Perceived stress scale (PSS) is a 10-item scale that measures the impact of personal stress on thoughts and feelings.", "time_frame": "Baseline, 8 weeks, 16 weeks, and 24 weeks" }, { "type": "secondary", "measure": "Change in Mood as Measured by the Symptom Checklist-27 (SCL-27)", "description": "Symptom Check List 27 (SCL-27) questionnaire will be used to measure a broad range of psychological symptoms (e.g., anxiety and depression).", "time_frame": "Baseline, 8 weeks, 16 weeks, and 24 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 209, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT03844412", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07242573", "title": "Effect of Physical Exercise and Neuromodulation on Pain, Sleep and Fatigue in Patients With Fibromyalgia", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-02-24", "start_date": "2025-11-01", "completion_date": "2027-12-15", "primary_completion_date": "2027-02-20", "conditions_raw": [ "Fibromyalgia", "Chronic Fatigue Syndrome (CFS)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Physical Training Program", "Nesa X-Signal", "Conventional Physiotherapy" ], "sponsor": "National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland", "sponsor_type": "NETWORK", "primary_purpose": "N/A", "brief_summary": "Fibromyalgia (FMS) is a chronic, multifactorial syndrome characterized by widespread pain, fatigue, and cognitive disturbances. This interventional study evaluates the impact of structured physical training using diagnostic-training devices (Zebris treadmill and Alfa balance platform) and transcutaneous neuromodulation (NESA X-Signal) on pain, sleep quality, and overall health status in patients with fibromyalgia and chronic fatigue symptom.\n\nParticipants are allocated into three groups:\n\n1. Physical training + conventional physiotherapy,\n2. Transcutaneous neuromodulation + conventional physiotherapy,\n3. Control (conventional physiotherapy only). The results will support the development of evidence-based rehabilitation protocols for fibromyalgia patients.", "primary_outcomes": [ { "type": "primary", "measure": "Change in pain intensity (Visual Analogue Scale - VAS 0-10)", "description": "Difference in visual analogue scale, pain score between baseline and post-intervention across study arms. In which 0 means no pain, and 10 means excruciating pain.", "time_frame": "Baseline to 6 weeks (post-intervention)" }, { "type": "primary", "measure": "Change in sleep quality (Pittsburgh Sleep Quality Index - PSQI)", "description": "Change in PSQI global score from baseline to post-intervention across study arms.", "time_frame": "Baseline to 6 weeks (post-intervention)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in depressive symptoms (Beck Depression Inventory - BDI)", "description": "Change in BDI total score from baseline to post-intervention.", "time_frame": "Baseline to 6 weeks" }, { "type": "secondary", "measure": "Change in Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)", "description": "Change in ACR diagnostic components (WPI and SSS) between baseline and post-intervention.", "time_frame": "Baseline to 6 weeks" }, { "type": "secondary", "measure": "Change in fatigue severity (Fatigue Severity Scale - FSS)", "description": "Change in FSS total score from baseline to post-intervention.", "time_frame": "Baseline to 6 weeks" }, { "type": "secondary", "measure": "Change in fatigue impact (Fatigue Impact Scale - FIS)", "description": "Change in FIS total score assessing functional impact of fatigue.", "time_frame": "Baseline to 6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in pain intensity (Visual Analogue Scale - VAS 0-10)", "description": "Difference in visual analogue scale, pain score between baseline and post-intervention across study arms. In which 0 means no pain, and 10 means excruciating pain.", "time_frame": "Baseline to 6 weeks (post-intervention)" }, { "type": "primary", "measure": "Change in sleep quality (Pittsburgh Sleep Quality Index - PSQI)", "description": "Change in PSQI global score from baseline to post-intervention across study arms.", "time_frame": "Baseline to 6 weeks (post-intervention)" }, { "type": "secondary", "measure": "Change in depressive symptoms (Beck Depression Inventory - BDI)", "description": "Change in BDI total score from baseline to post-intervention.", "time_frame": "Baseline to 6 weeks" }, { "type": "secondary", "measure": "Change in Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)", "description": "Change in ACR diagnostic components (WPI and SSS) between baseline and post-intervention.", "time_frame": "Baseline to 6 weeks" }, { "type": "secondary", "measure": "Change in fatigue severity (Fatigue Severity Scale - FSS)", "description": "Change in FSS total score from baseline to post-intervention.", "time_frame": "Baseline to 6 weeks" }, { "type": "secondary", "measure": "Change in fatigue impact (Fatigue Impact Scale - FIS)", "description": "Change in FIS total score assessing functional impact of fatigue.", "time_frame": "Baseline to 6 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Network" ], "enrollment": 75, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07242573", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07363655", "title": "Effects of a Rehabilitation Programme Focused on Energy Management in People With Myalgic Encephalomyelitis / Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2026-01-28", "start_date": "2024-10-09", "completion_date": "2025-03-09", "primary_completion_date": "2025-02-23", "conditions_raw": [ "Myalgic Encephalomyelitis (ME)", "Chronic Fatigue Syndrome (CFS)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Intervention Group" ], "sponsor": "Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The study focuses on rehabilitation nursing care for adults diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in a home setting. The objective is to evaluate the effects of an individualised rehabilitation programme, which aims to empower participants to manage their energy effectively, observing the impacts on functionality and fatigue.", "primary_outcomes": [ { "type": "primary", "measure": "Functional Assessment", "description": "Short Form Health Survey: SF 36 v2 (physical dimension)", "time_frame": "Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention." }, { "type": "primary", "measure": "Quality of Life Measure", "description": "Quality-of-life measure: EuroQoL 5D-5L", "time_frame": "Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention." }, { "type": "primary", "measure": "Fatigue Assessment", "description": "Application of the Chalder Fatigue Scale", "time_frame": "Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Functional Assessment", "description": "Short Form Health Survey: SF 36 v2 (physical dimension)", "time_frame": "Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention." }, { "type": "primary", "measure": "Quality of Life Measure", "description": "Quality-of-life measure: EuroQoL 5D-5L", "time_frame": "Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention." }, { "type": "primary", "measure": "Fatigue Assessment", "description": "Application of the Chalder Fatigue Scale", "time_frame": "Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention." } ], "relevance_tags": [ "Metabolic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 13, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT07363655", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07357688", "title": "The Effect of Acupuncture Therapy on Cognitive Function in Post-COVID-19 Myalgic Encephalomyelitis/Chronic Fatigue Syndrome", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2026-01-22", "start_date": "2026-05", "completion_date": "2027-12", "primary_completion_date": "2027-12", "conditions_raw": [ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Acupuncture" ], "sponsor": "Xi Wu", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Background of study:\n\nMyalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a common sequela after SARS-CoV-2 infection(COVID-19). Cognitive dysfunction is one of the most common debilitating symptoms in ME/CFS. Currently, standardized therapy for ME/CFS has not been established. Some treatments, such as cognitive behavioral therapy (CBT) and graded exercise therapy (GET), mainly exert effects on physical symptoms, whereas the influence on cognitive problems is not significant. Acupuncture is an important complementary and alternative therapy for ME/CFS. However, However, research focused on the impact of acupuncture on cognitive functions in ME/CFS is rare. Additionally, no study has evaluated the efficacy and mechanism of acupuncture treatment in improving cognitive functions for post-COVID-19 ME/CFS.\n\nObjective of the study:\n\nThe first objective of this study is to assess the efficacy of acupuncture treatment in improving cognitive function for post-COVID-19 ME/CFS. The second objective is to explore whether acupuncture improves cognitive ability in patients with post-COVID-19 ME/CFS through modulating hippocampal connectivity and metabolites using multimodal magnetic resonance imaging(MRI).\n\nStudy design:\n\nA prospective, three-armed, randomized controlled trial with resting-state functional MRI(rs-fMRI) and magnetic resonance spectroscopy(MRS). Adults with post-COVID-19 ME/CFS will be randomly assigned to acupuncture, sham acupuncture, or waitlist control group in a 1:1:1 ratio, receiving 8-week intervention or waiting. Cognitive functions and resting-state functional connectivity(RSFC) and the levels of metabolites for each hippocampus will be examined at baseline and 8th week.\n\nStudy population:\n\nPatients fulfilling 2015 National Academy of Medicine (NAM) criteria for ME/CFS following COVID-19.", "primary_outcomes": [ { "type": "primary", "measure": "Change of Symbol Digit Modality Test score from baseline to the end of 8 weeks", "description": "Symbol Digit Modality Test assesses attention through measuring the number of correct responses within 90 seconds. The minimum score is 0, and the maximum score is 110. Higher score indicates better attention.", "time_frame": "Baseline and 8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes of Digit Span Test scores from baseline to the end of 8 weeks", "description": "Digit Span Test consists of forward and backward subtests, that respectively assess attention and executive function through measuring the number of correct digit sequences. The minimum score is 0 , and the maximum scores are respectively 10 and 9 for forward and backward subtests. Higher scores indicate better attention and executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Trail Making Test scores from baseline to the end of 8 weeks", "description": "Trail Making Test includes Part A(TMT-A) and Part B(TMT-B), that respectively evaluates attention and executive function via measuring the time in seconds required for completion of each part of the test. Higher scores indicate worse attention and executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Rey Auditory Verbal Learning Test scores from baseline to the end of 8 weeks", "description": "Rey Auditory Verbal Learning Test evaluates different aspects of verbal memory through measuring total learning, repetitions, delayed recall, retroactive interference, and proactive interference. Higher scores for total learning and delayed recall indicate better memory, while higher scores for repetitions, retroactive interference, and proactive interference indicate worse memory.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Stroop Test scores from baseline to the end of 8 weeks", "description": "Stroop test consists of Stroop word test(Part A), Stroop color test(Part B) and Stroop color word test(Part C), that assess executive function through measuring the time in second required to complete each part and the number of errors for each part. Higher score for each part indicates worse executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Rey-Osterrieth Complex Figure Test scores from baseline to the end of 8 weeks", "description": "Rey-Osterrieth Complex Figure Test evaluates visuospatial construction ability through measuring the accuracy of copy, and evaluates visual memory via measuring the accuracies of immediate and delayed recalls. Higher scores indicate better visuospatial construction and visual memory.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Verbal Fluency Test Scores from baseline to the end of 8 weeks.", "description": "Verbal Fluency Test includes Phonemic Fluency Test, Category Fluency Test and Action Fluency Test, that evaluate language. Verbal Fluency Test measures the number of correct words produced under restricted search conditions of phonemic(letter F), category(animals) and action(kitchen actions). Higher score for each subtest indicates better language.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Boston Naming Test from baseline to the end of 8 weeks", "description": "Boston Naming Test includes 30 items and evaluates language through measuring the total of correct responses. The minimum score is 0, and the maximum score is 30. Higher score indicates better language.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Multidimensional Fatigue Inventory score from baseline to the end of 8 weeks", "description": "Multidimensional Fatigue Inventory is a self-report instrument consisting of 20-item devised to evaluate fatigue through measuring the dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. The minimum score is 20 ,and the maximum score is 100. Higher score indicate greater severity of fatigue.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Pittsburgh Sleep Quality Index from baseline to the end of 8 weeks", "description": "Pittsburgh Sleep Quality Index is a self-report questionnaire with 19 items, that assesses general sleep quality within 1 month through measuring the components of Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medication, and Daytime Dysfunction. The total score ranges from 0 to 21. Higher score indicates worse sleep quality.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of the Generalized Anxiety Disorde-7 score from baseline to the end of 8 weeks", "description": "Generalized Anxiety Disorde-7 is a self-report questionnaire with 7 items, that assesses the level of anxiety in the past two week. The minimum score is 0, and the maximum score is 21. Higher score indicates greater severity of anxiety.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Hamilton Depression Scale from baseline to the end of 8 weeks", "description": "Hamilton Depression Scale is the most commonly used instrument for the assessment of depression in clinical practice. It includes 24 items and assesses the level of depression through measuring factors of Anxiety/Somatization, Weight, Cognitive Impairment, Diurnal Variation, Retardation, Sleep Disturbance, and Hopelessness. The total score range is 0 to 76. Higher total score indicates greater level of depression.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of the MOS Item Short From Health Survey from baseline to the end of 8 weeks", "description": "The MOS Item Short From Health Survey is a self-report instrument with 36 items, that assesses quality of life through measuring subscales of Physical Function, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Higher subscores indicate better quality of life.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of N-acetylaspartate(NAA)at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of NAA will be represented as the NAA to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS).", "time_frame": "Baseline and 8 weeks." }, { "type": "secondary", "measure": "The change in level of choline(Cho)at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of Cho will be represented as the Cho to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of glutamate (Glu) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of Glu will be represented as the Glu to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of glutamine (Gln) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of Gln will be represented as the Gln to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of lactate (Lac) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of Lac will be represented as the Lac to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of myo-inositol (mI) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of mI will be represented as the mI to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of glycerophosphorylcholine (GPC) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of GPC will be represented as the GPC to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of glutathione (GSH) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of GSH will be represented as the GSH to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change of resting-state functional connectivity(RSFC) at each hippocampus from baseline to the end of 8 weeks.", "description": "The RSFC for each hippocampus will be examined with functional Magnetic Resonance Imaging(fMRI).", "time_frame": "Baseline and 8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of Symbol Digit Modality Test score from baseline to the end of 8 weeks", "description": "Symbol Digit Modality Test assesses attention through measuring the number of correct responses within 90 seconds. The minimum score is 0, and the maximum score is 110. Higher score indicates better attention.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Digit Span Test scores from baseline to the end of 8 weeks", "description": "Digit Span Test consists of forward and backward subtests, that respectively assess attention and executive function through measuring the number of correct digit sequences. The minimum score is 0 , and the maximum scores are respectively 10 and 9 for forward and backward subtests. Higher scores indicate better attention and executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Trail Making Test scores from baseline to the end of 8 weeks", "description": "Trail Making Test includes Part A(TMT-A) and Part B(TMT-B), that respectively evaluates attention and executive function via measuring the time in seconds required for completion of each part of the test. Higher scores indicate worse attention and executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Rey Auditory Verbal Learning Test scores from baseline to the end of 8 weeks", "description": "Rey Auditory Verbal Learning Test evaluates different aspects of verbal memory through measuring total learning, repetitions, delayed recall, retroactive interference, and proactive interference. Higher scores for total learning and delayed recall indicate better memory, while higher scores for repetitions, retroactive interference, and proactive interference indicate worse memory.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Stroop Test scores from baseline to the end of 8 weeks", "description": "Stroop test consists of Stroop word test(Part A), Stroop color test(Part B) and Stroop color word test(Part C), that assess executive function through measuring the time in second required to complete each part and the number of errors for each part. Higher score for each part indicates worse executive function.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Changes of Rey-Osterrieth Complex Figure Test scores from baseline to the end of 8 weeks", "description": "Rey-Osterrieth Complex Figure Test evaluates visuospatial construction ability through measuring the accuracy of copy, and evaluates visual memory via measuring the accuracies of immediate and delayed recalls. Higher scores indicate better visuospatial construction and visual memory.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Verbal Fluency Test Scores from baseline to the end of 8 weeks.", "description": "Verbal Fluency Test includes Phonemic Fluency Test, Category Fluency Test and Action Fluency Test, that evaluate language. Verbal Fluency Test measures the number of correct words produced under restricted search conditions of phonemic(letter F), category(animals) and action(kitchen actions). Higher score for each subtest indicates better language.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Boston Naming Test from baseline to the end of 8 weeks", "description": "Boston Naming Test includes 30 items and evaluates language through measuring the total of correct responses. The minimum score is 0, and the maximum score is 30. Higher score indicates better language.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Multidimensional Fatigue Inventory score from baseline to the end of 8 weeks", "description": "Multidimensional Fatigue Inventory is a self-report instrument consisting of 20-item devised to evaluate fatigue through measuring the dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. The minimum score is 20 ,and the maximum score is 100. Higher score indicate greater severity of fatigue.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Pittsburgh Sleep Quality Index from baseline to the end of 8 weeks", "description": "Pittsburgh Sleep Quality Index is a self-report questionnaire with 19 items, that assesses general sleep quality within 1 month through measuring the components of Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medication, and Daytime Dysfunction. The total score ranges from 0 to 21. Higher score indicates worse sleep quality.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of the Generalized Anxiety Disorde-7 score from baseline to the end of 8 weeks", "description": "Generalized Anxiety Disorde-7 is a self-report questionnaire with 7 items, that assesses the level of anxiety in the past two week. The minimum score is 0, and the maximum score is 21. Higher score indicates greater severity of anxiety.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of Hamilton Depression Scale from baseline to the end of 8 weeks", "description": "Hamilton Depression Scale is the most commonly used instrument for the assessment of depression in clinical practice. It includes 24 items and assesses the level of depression through measuring factors of Anxiety/Somatization, Weight, Cognitive Impairment, Diurnal Variation, Retardation, Sleep Disturbance, and Hopelessness. The total score range is 0 to 76. Higher total score indicates greater level of depression.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "Change of the MOS Item Short From Health Survey from baseline to the end of 8 weeks", "description": "The MOS Item Short From Health Survey is a self-report instrument with 36 items, that assesses quality of life through measuring subscales of Physical Function, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Higher subscores indicate better quality of life.", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of N-acetylaspartate(NAA)at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of NAA will be represented as the NAA to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS).", "time_frame": "Baseline and 8 weeks." }, { "type": "secondary", "measure": "The change in level of choline(Cho)at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of Cho will be represented as the Cho to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of glutamate (Glu) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of Glu will be represented as the Glu to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of glutamine (Gln) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of Gln will be represented as the Gln to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of lactate (Lac) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of Lac will be represented as the Lac to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of myo-inositol (mI) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of mI will be represented as the mI to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of glycerophosphorylcholine (GPC) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of GPC will be represented as the GPC to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change in level of glutathione (GSH) at each hippocampus from baseline to the end of 8 weeks.", "description": "The level of GSH will be represented as the GSH to total creatine (Cr) ratio which is measured by Proton Magnetic Resonance Spectroscopy(MRS)", "time_frame": "Baseline and 8 weeks" }, { "type": "secondary", "measure": "The change of resting-state functional connectivity(RSFC) at each hippocampus from baseline to the end of 8 weeks.", "description": "The RSFC for each hippocampus will be examined with functional Magnetic Resonance Imaging(fMRI).", "time_frame": "Baseline and 8 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 99, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07357688", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07352254", "title": "OutreAch MediCal Care for HousEbound Patients With Post-COVID-19 Syndrome or ME/CFS of Any Cause (ACCESS)", "status": "RECRUITING", "phase": "NA", "last_updated": "2026-01-21", "start_date": "2026-01", "completion_date": "2028-12", "primary_completion_date": "2028-10", "conditions_raw": [ "ME/CFS" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Online Visit" ], "sponsor": "Hannover Medical School", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The significance of the Post-COVID Syndrome (PCS) has been widely acknowledged. Various efforts are made to find out about the pathomechanisms behind PCS and to establish therapies. One sub-group of PCS-patients, however, is generally excluded from any studies, and that are those who are unable to visit outpatient clinics or hospitals for diagnostic work up or participation in clinical trials, as they are unable to leave their home and to seek medical support on their own physical and mental capabilities. They are housebound, mostly or totally bedridden. Similar cases are known from myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) of any cause and are graded as moderate to very severe ME/CFS according to the Canadian Consensus criteria. The patients are usually seen by their family doctor and have no access to medical specialists.\n\nThe planned project aims to find out about the prevalence of this most severe manifestation of PCS, the clinical characteristics, the prevalence of mimics, risk factors and impact of the disease on the patients' life and their family/caregivers. Individual care and treatment plans will be developed and the effect of monthly consultation hours for patients and caregivers upon the patients' health status and the caregiver burden will be evaluated in a randomized controlled trial. The project will be performed in close cooperation between patients, caregivers, the patient's family doctor and a board of experts from internal medicine, neurology, psychosomatic medicine and general medicine at Hannover Medical School.\n\nWe expect an improvement of the patients' and caregivers wellbeing with intensified medical care. We are aware, however, that intensification of the patient-doctor interaction carries the risk to exacerbate the patients' symptoms. The results of our study will show how current models of care for PCS and ME/CFS patients should be modified to fit to the individual patient's aims and capacities.", "primary_outcomes": [ { "type": "primary", "measure": "Short Form (SF)-36 health survey, physical score", "description": "Short-Form (SF-36) health survey to assess health related quality of life, here the physical score. Higher values indicate better health status. The range depends on age, gender and education.", "time_frame": "1 year" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Short Form (SF)-36 health survey, physical score", "description": "Short-Form (SF-36) health survey to assess health related quality of life, here the physical score. Higher values indicate better health status. The range depends on age, gender and education.", "time_frame": "1 year" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07352254", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07320937", "title": "Effects of Yiqi Fuyuan Paste Formula in Chronic Fatigue Syndrome: A Randomized Double-Blind Controlled Clinical Trial.", "status": "ENROLLING_BY_INVITATION", "phase": "NA", "last_updated": "2026-01-06", "start_date": "2025-12-29", "completion_date": "2026-11-18", "primary_completion_date": "2026-08-18", "conditions_raw": [ "CFS" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "\"Yiqi Fuyuan Paste Formula\" Test Group" ], "sponsor": "ShuGuang Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to learn if \"Yiqi Fuyuan Paste Formula\" (a traditional Chinese medicinal paste made from medicinal and edible Chinese medicines and health food like Ginseng Radix et Rhizoma, Astragali Radix et Rhizoma, Codonopsis Radix, Atractylodis Macrocephalae Rhizoma, Poria Cocos, Coicis Semen, Dioscoreae Rhizoma, Nelumbinis Semen, Angelicae Sinensis Radix, Lycii Fructus, Citri Reticulatae Pericarpium, Juglandis Semen, Longan Arillus, Sesami Nigri Semen, Jujubae Fructus, Glycyrrhizae Radix et Rhizoma, and fine ingredients) works to ease Chronic Fatigue Syndrome (CFS) symptoms in adults. It will also learn about the safety of \"Yiqi Fuyuan Paste Formula\". The main questions it aims to answer are:\n\n1. Does \"Yiqi Fuyuan Paste Formula\" help reduce CFS-related fatigue (measured by the Fatigue Assessment Instrument, FAI)\n2. What underlying bodily changes (shown in blood tests) might explain its effects.\n\nResearchers will compare \"Yiqi Fuyuan Paste Formula\" to a placebo (a look-alike substance that contains no drug) to see if \"Yiqi Fuyuan Paste Formula\" works to ease CFS symptoms.\n\nParticipants will:\n\n1. Take \"Yiqi Fuyuan Paste Formula\" or a placebo every day for 2 months\n2. Visit the clinic before and after the intervention for checkups and tests\n3. Keep a diary of their symptoms", "primary_outcomes": [ { "type": "primary", "measure": "FAI (Fatigue Assessment Instrument)", "description": "", "time_frame": "week4" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "SF-36 (The MOS 36-Item Short-Form Health Survey)", "description": "", "time_frame": "week4" }, { "type": "secondary", "measure": "QDC（Qi deficiency constitution score）", "description": "", "time_frame": "week4" } ], "outcome_measures": [ { "type": "primary", "measure": "FAI (Fatigue Assessment Instrument)", "description": "", "time_frame": "week4" }, { "type": "secondary", "measure": "SF-36 (The MOS 36-Item Short-Form Health Survey)", "description": "", "time_frame": "week4" }, { "type": "secondary", "measure": "QDC（Qi deficiency constitution score）", "description": "", "time_frame": "week4" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07320937", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04740736", "title": "Cardiovascular Analysis of PEM", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-12-18", "start_date": "2021-08-31", "completion_date": "2025-07-11", "primary_completion_date": "2025-07-11", "conditions_raw": [ "Myalgic Encephalomyelitis", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Saline Infusion" ], "sponsor": "Icahn School of Medicine at Mount Sinai", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to examine cardiopulmonary function in Chronic Fatigue Syndrome (CFS) patients and determine how it relates to the common symptom of Post-exertional malaise (PEM). Subjects will complete a maximal exercise test on 2 subsequent days. Total blood volume will be measured prior to each exercise test, and patient with hypovolemia on day 1, will be randomized to either a saline or sham infusion prior to the 2nd exercise test. A total of 80 CFS patients will be enrolled.", "primary_outcomes": [ { "type": "primary", "measure": "CPET testing", "description": "To assess VO2VT and peak VO2", "time_frame": "2 days" }, { "type": "primary", "measure": "Total Blood Volume", "description": "To measure Total Blood Volume (TBV) before each exercise test", "time_frame": "2 days" }, { "type": "primary", "measure": "Hypovolemia", "description": "Patients with reduced Total Blood Volume on day #1 CPET will be randomized in a 1:1 fashion to either a one hour infusion of a liter of isotonic saline prior to day #2 CPET or a sham infusion", "time_frame": "1 day" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "CPET testing", "description": "To assess VO2VT and peak VO2", "time_frame": "2 days" }, { "type": "primary", "measure": "Total Blood Volume", "description": "To measure Total Blood Volume (TBV) before each exercise test", "time_frame": "2 days" }, { "type": "primary", "measure": "Hypovolemia", "description": "Patients with reduced Total Blood Volume on day #1 CPET will be randomized in a 1:1 fashion to either a one hour infusion of a liter of isotonic saline prior to day #2 CPET or a sham infusion", "time_frame": "1 day" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 106, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04740736", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07259902", "title": "FMRI Study on DC/TMD Patients", "status": "NOT_YET_RECRUITING", "phase": "NA", "last_updated": "2025-12-02", "start_date": "2026-01-01", "completion_date": "2031-01-01", "primary_completion_date": "2030-01-01", "conditions_raw": [ "TMJ Disorder" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Fmri" ], "sponsor": "University of Milan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Temporomandibular disorders (TMD) are among the most common causes of chronic pain worldwide. It is estimated that about 5-12% of the global population is affected, and some conditions, such as arthritis, may be causative factors. Depending on severity, the joints involved can affect multiple functions of the masticatory system, such as the ability to speak, chew, swallow, limit facial expressions, and even breathe. Moreover, most patients with TMD may report painful conditions in other parts of the body, with comorbidities including chronic fatigue syndrome, chronic headache, endometriosis, fibromyalgia, interstitial cystitis, irritable bowel syndrome, back pain, sleep disorders, and vulvodynia. Another significant condition that frequently occurs alongside TMD is psychological distress in the form of anxiety and/or depression.\n\nThe study proposed by this research protocol aims to investigate the presence of TMD and associated psychological/psychiatric disorders such as anxiety and depression. The innovative value of the research lies in evaluating whether the association between these disorders may lead to neuroplastic changes at the brain level, which could guide targeted therapies. Only a few studies in the literature have explored this possible association, with inconclusive and conflicting results.\n\nThe study will be prospective in design, based on reference clinical/diagnostic criteria and functional neuroimaging.", "primary_outcomes": [ { "type": "primary", "measure": "fmri Blood Oxygen Level-Dependent (BOLD)", "description": "Oxygenation concentration (referred to as BOLD). Bold is primarily used on the other hand to conduct function brain mapping. The degree of BOLD is a measure of the neuronal activity.", "time_frame": "end of the fmri" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "fmri Blood Oxygen Level-Dependent (BOLD)", "description": "Oxygenation concentration (referred to as BOLD). Bold is primarily used on the other hand to conduct function brain mapping. The degree of BOLD is a measure of the neuronal activity.", "time_frame": "end of the fmri" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07259902", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05236465", "title": "A 3-day Course for CFS/ME", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-11-26", "start_date": "2022-03-21", "completion_date": "2028-12-01", "primary_completion_date": "2027-01-01", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "A 3-Day Course", "Waiting List" ], "sponsor": "Norwegian University of Science and Technology", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome/Myalgic encephalomyelitis (CFS/ME) can be a serious and disabling condition with a heavy symptom burden and low function. Work disability is common, and social life dramatically affected. CFS/ME is a challenging health problem as well as a societal problem.\n\nIn recent years, a doubling of the number of patients with a CFS/ME diagnoses has been reported in Norway. The patient group represents a challenge for the health care system, the municipality, and the Norwegian Labour and Welfare Organization (NAV). According to new figures, the NAV pays 100 million Norwegian Kroner (NOK) each month in permanently incapacitated expenses for people with CFS/ME. Municipalities have expenses in form of care, rehabilitation and other measures.\n\nThere is a lack of effective treatment for CFS/ME. Evidence-based knowledge is highly needed.\n\nIf the 3-day course shows promising effects, this could have positive consequences for patients, relatives and health personnel, but also financially for the society and the municipality.", "primary_outcomes": [ { "type": "primary", "measure": "Physical function", "description": "Measured through the Short Form Health Survey (SF-36), physical function, a scale that measures physical function with questions relating to ability to perform physical activity. The instrument contains 10 items with three options on each question. The score range is 0 -100, where 100 is equivalent to no disability.", "time_frame": "10 weeks after the 3-day course" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue", "description": "Measured through the Chalder Fatigue Questionnaire, an instrument that measures fatigue severity, both on mental and physical fatigue in the last month. The instrument contains 11 items with four different response options in each question. The scale ranges from 0-33, where higher score indicates greater fatigue.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Pain on a daily basis", "description": "Measured through the Brief Pain Inventory, an instrument measuring pain and its allied aspects. The instrument contains 11 items with numeric rating from 0-10, where higher score indicates more severe pain.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "Measured through A Brief Questionnaire to Assess Post-Exertional Malaise, an instrument that measures symptoms after activity. The instrument contains 10 items, with options ranging from 0-4, where a higher score indicates more severity.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Mental wellbeing", "description": "Measured trough the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), an instrument that measures mental wellbeing. The instrument contains 14 items, with 5 response categories, summed to provide a single score. Higher score indicates better wellbeing.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Overall improvement", "description": "Measured through the Patient Global Impression of Change (PGIC) with one single item that measures change in function, symptoms and quality of life. The instrument has seven possible options ranging from very much better to very much worse.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Sick leave", "description": "Register data from the Norwegian Labour and Welfare Administration (NAV) on sick leave, benefits, diagnoses from 12 months before the 3-day course and 24 months after the 3-day course.", "time_frame": "24 months after the 3-day course" } ], "outcome_measures": [ { "type": "primary", "measure": "Physical function", "description": "Measured through the Short Form Health Survey (SF-36), physical function, a scale that measures physical function with questions relating to ability to perform physical activity. The instrument contains 10 items with three options on each question. The score range is 0 -100, where 100 is equivalent to no disability.", "time_frame": "10 weeks after the 3-day course" }, { "type": "secondary", "measure": "Fatigue", "description": "Measured through the Chalder Fatigue Questionnaire, an instrument that measures fatigue severity, both on mental and physical fatigue in the last month. The instrument contains 11 items with four different response options in each question. The scale ranges from 0-33, where higher score indicates greater fatigue.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Pain on a daily basis", "description": "Measured through the Brief Pain Inventory, an instrument measuring pain and its allied aspects. The instrument contains 11 items with numeric rating from 0-10, where higher score indicates more severe pain.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Post-Exertional Malaise", "description": "Measured through A Brief Questionnaire to Assess Post-Exertional Malaise, an instrument that measures symptoms after activity. The instrument contains 10 items, with options ranging from 0-4, where a higher score indicates more severity.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Mental wellbeing", "description": "Measured trough the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), an instrument that measures mental wellbeing. The instrument contains 14 items, with 5 response categories, summed to provide a single score. Higher score indicates better wellbeing.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Overall improvement", "description": "Measured through the Patient Global Impression of Change (PGIC) with one single item that measures change in function, symptoms and quality of life. The instrument has seven possible options ranging from very much better to very much worse.", "time_frame": "6 months after the 3-day course" }, { "type": "secondary", "measure": "Sick leave", "description": "Register data from the Norwegian Labour and Welfare Administration (NAV) on sick leave, benefits, diagnoses from 12 months before the 3-day course and 24 months after the 3-day course.", "time_frame": "24 months after the 3-day course" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05236465", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06245642", "title": "Compound Ciwujia Granules Treat Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2025-09-23", "start_date": "2024-03-19", "completion_date": "2025-01-16", "primary_completion_date": "2025-01-16", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Compound Ciwujia Granules, Guipi Granules" ], "sponsor": "Heilongjiang Quanle Pharmaceutical Co., Ltd.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "To observe the improvement of Chalder scale score in patients with chronic fatigue syndrome treated by Compound Ciwujia Granules. Improvement =\\[(baseline score - post-treatment score)/baseline score\\]\\*100%", "primary_outcomes": [ { "type": "primary", "measure": "The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment", "description": "Based on the results of a multicenter RCT on CFS conducted earlier, it was found that the higher the baseline Chalder scale score, the greater the decrease in the score after treatment. Therefore, to reduce the differences in efficacy caused by the baseline, we used the nimodipine efficacy calculation method to evaluate the improvement in Chalder scale scores.\n\nCalculation method: Improvement = \\[(Baseline score - Post-treatment score) / Baseline score\\] \\* 100%", "time_frame": "Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes in Chalder scale scores and sub-scores", "description": "", "time_frame": "Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)" }, { "type": "secondary", "measure": "Changes in TCM syndrome scores and sub-scores", "description": "", "time_frame": "Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)" }, { "type": "secondary", "measure": "Changes in scores of EQ-5D-5L Quality of Life questionnaire", "description": "", "time_frame": "Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)" } ], "outcome_measures": [ { "type": "primary", "measure": "The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment", "description": "Based on the results of a multicenter RCT on CFS conducted earlier, it was found that the higher the baseline Chalder scale score, the greater the decrease in the score after treatment. Therefore, to reduce the differences in efficacy caused by the baseline, we used the nimodipine efficacy calculation method to evaluate the improvement in Chalder scale scores.\n\nCalculation method: Improvement = \\[(Baseline score - Post-treatment score) / Baseline score\\] \\* 100%", "time_frame": "Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)" }, { "type": "secondary", "measure": "Changes in Chalder scale scores and sub-scores", "description": "", "time_frame": "Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)" }, { "type": "secondary", "measure": "Changes in TCM syndrome scores and sub-scores", "description": "", "time_frame": "Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)" }, { "type": "secondary", "measure": "Changes in scores of EQ-5D-5L Quality of Life questionnaire", "description": "", "time_frame": "Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)" } ], "relevance_tags": [ "General", "Phase 4", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 235, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT06245642", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05791812", "title": "Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-09-19", "start_date": "2023-03-16", "completion_date": "2026-03-31", "primary_completion_date": "2025-11-30", "conditions_raw": [ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Home-Based Transcranial Direct Current Stimulation" ], "sponsor": "University of Regensburg", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "It is a one-arm open-label interventional study with transcranial direct current stimulation in an remote home-based setting with the aims to evaluate the feasibility (usability of the device, compliance of patients, usability of the teletherapy), the effectiveness (clinical ratings) and the compatability of this intervention in 20 patients with myalgic encephalomyelitis/chronic fatigue syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Usability for the patients", "description": "Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \\[1-7, 26 items, the higher the better\\]", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Usability for the handlers/clinicians", "description": "Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \\[1-7, 26 items, the higher the better\\]", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Number of days out of 30 the patients used the device", "description": "Number of days out of 30 the patients used the device", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Number of patients who completed the treatment regularly", "description": "Number of patients who completed the treatment regularly", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Number of responders according the the clinical global impression change score for patients in the per protocol analysis", "description": "Number of responders according the the clinical global impression change score for patients in the per protocol analysis (range: 1-7; the lower the better)", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score", "description": "Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score (fatigue scale; 0-100; the higher the better)", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale", "description": "Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale (fatigue scale; 0-33; the lower the better)", "time_frame": "6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Major Depression Inventory", "description": "Depression inventory (0-50, the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)", "description": "Quality of life scale inventory (4-20, the higher the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "Clinical Global Impression change", "description": "Clinical Global Impression (1-7, the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "Pittsburgh sleep quality index", "description": "sleep inventory (0-21, the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "numeric analogue scale pain", "description": "pain scale (0-10, the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "d2 test", "description": "concentration test (percentiles; the higher the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "digital span", "description": "memory test (percentiles; the higher the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "Chalder fatigue scale", "description": "fatigue scale (0-33; the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "Bell score", "description": "fatigue scale (0-100; the higher the better)", "time_frame": "18 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Usability for the patients", "description": "Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \\[1-7, 26 items, the higher the better\\]", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Usability for the handlers/clinicians", "description": "Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \\[1-7, 26 items, the higher the better\\]", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Number of days out of 30 the patients used the device", "description": "Number of days out of 30 the patients used the device", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Number of patients who completed the treatment regularly", "description": "Number of patients who completed the treatment regularly", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Number of responders according the the clinical global impression change score for patients in the per protocol analysis", "description": "Number of responders according the the clinical global impression change score for patients in the per protocol analysis (range: 1-7; the lower the better)", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score", "description": "Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score (fatigue scale; 0-100; the higher the better)", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale", "description": "Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale (fatigue scale; 0-33; the lower the better)", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Major Depression Inventory", "description": "Depression inventory (0-50, the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)", "description": "Quality of life scale inventory (4-20, the higher the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "Clinical Global Impression change", "description": "Clinical Global Impression (1-7, the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "Pittsburgh sleep quality index", "description": "sleep inventory (0-21, the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "numeric analogue scale pain", "description": "pain scale (0-10, the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "d2 test", "description": "concentration test (percentiles; the higher the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "digital span", "description": "memory test (percentiles; the higher the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "Chalder fatigue scale", "description": "fatigue scale (0-33; the lower the better)", "time_frame": "18 weeks" }, { "type": "secondary", "measure": "Bell score", "description": "fatigue scale (0-100; the higher the better)", "time_frame": "18 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05791812", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05956405", "title": "Retraining of the Amygdala and Insula for the Treatment of Persistent Covid", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-09-16", "start_date": "2023-09-01", "completion_date": "2024-03-31", "primary_completion_date": "2024-03-31", "conditions_raw": [ "Mental Health Wellness" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Air + Mindfulness", "Relaxation Condition" ], "sponsor": "Hospital Miguel Servet", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Prolonged COVID, also known as post-COVID or Sar-CoV-2 infection with post-acute sequelae, refers to a set of multi-organ symptoms that persist in patients who have suffered SARS-CoV-2 infection, even after of the acute phase of the disease. Approximately 10% of people experience this set of symptoms after their acute COVID has resolved. Such symptoms may include respiratory problems, myalgia, extreme fatigue, moodiness, cognitive impairment, and difficulty sleeping.\n\nPsychological therapies, such as mindfulness, have already demonstrated their effectiveness in pathologies of this type, improving mental health and physical function, as well as reinforcing acceptance and reducing symptoms. Specifically, amygdala-insula training was originally designed for patients with chronic fatigue syndrome as a method of reducing chronic over-sensitization and heightened fear response of the amygdala, which may be behind some of the symptoms related to both with this pathology as with fibromyalgia.\n\nA lot of research is currently being done on different types of treatments such as pharmaceutical, biological, dietary, homeopathic and rehabilitation for the treatment of persistent COVID; however, an effective treatment has not yet been found. Therefore, this study aims to evaluate the impact of a retraining intervention of the amygdala and insula for the improvement of the quality of life of patients with persistent COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Sociodemographic data Gender, age, marital status, education, occupation, economical level", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Sociodemographic data Gender, age, marital status, education, occupation, economical level", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the AIR + Mindfulness program group", "time_frame": "In the relaxation program group" } ], "outcome_measures": [ { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "primary", "measure": "Short Form de 36 items (SF-36)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Sociodemographic data Gender, age, marital status, education, occupation, economical level", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Sociodemographic data Gender, age, marital status, education, occupation, economical level", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Spanish Chronic Pain Grading Scale", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale (PCS)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Modified Fatigue Impact Scale (MFIS)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "General Anxiety Disorder-7 (GAD-7)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Patient Health Questionnaire (PHQ-9)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Memory failures of Everyday (MFE)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Five Facets of Mindfulness Questionnaire (FFMQ)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Emotional Regulation Questionnaire (ERQ)", "description": "In the relaxation program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the AIR + Mindfulness program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the relaxation program group", "time_frame": "Baseline" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the AIR + Mindfulness program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the relaxation program group", "time_frame": "Post-treatment 8 weeks from baseline" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the AIR + Mindfulness program group", "time_frame": "Three-months follow-up" }, { "type": "secondary", "measure": "Acceptance and Action Questionnaire-II (AAQ-II)", "description": "In the AIR + Mindfulness program group", "time_frame": "In the relaxation program group" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05956405", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01071044", "title": "Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2025-09-09", "start_date": "2009-11", "completion_date": "2011-03", "primary_completion_date": "2011-03", "conditions_raw": [ "Chronic Fatigue Syndrome", "Cognitive Impairments" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Lisdexamfetamine Dimesylate" ], "sponsor": "Rochester Center for Behavioral Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Over the past decade, the Rochester Center for Behavioral Medicine (RCBM) has evaluated many patients with attention deficit hyperactivity disorder (ADHD). A recurrent finding in these patients is a history of unexplained fatigue and musculoskeletal pain.\n\nTreatment of these patients in our clinic has revealed that when their underlying ADHD is treated with psychostimulant medication, many patients report significant improvements with regard to their fatigue and musculoskeletal pain. Patients report less subjective fatigue and pain and note overall functional improvement, although the initial and primary objective was the treatment of their attention or hyperactivity problems. We speculate that stimulants are efficacious by offering two distinct clinical properties. 1) anti-fatigue properties and 2) properties that allow patients to filter out extraneous stimuli (i.e. chronic muscle pain).", "primary_outcomes": [ { "type": "primary", "measure": "Change in BRIEF-A", "description": "The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale is designed to measure the impact of fatigue on the life of the subject. It is a nine-question likert scale survey with a raw score range of 0-63. Scores of 36 and above indicate significant fatigue. In this study, we compared the mean change in the Fatigue Severity Scale (FSS) from baseline to endpoint between LDX and placebo treated patients.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Hamiliton Anxiety Inventory", "description": "The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 6 between LDX and placebo-treated patients.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Short Form McGill Pain Questionnaire", "description": "The McGill Pain Questionniare (Short Form) consists of 15 pain descriptors (11 sensory; 4 affective) which are rated on an intensity scale. 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sum of the intensity scores of the words chosen for sensory, affective and total descriptors are added for a total score. The score range is 0-45. In this study, we compared the change in the Short Form McGill Pain Questionnaire (SF-MPQ) from baseline to week 6 between LDX and placebo treated patients.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Fibromyalgia Impact Questionnaire (FIQ)", "description": "The Fibromyalgia Impact Questionnaire (FIQ) is an assessment that quantifies the impact of fibromyalgia on an individual, including questions on pain level, fatigue, sleep disturbance, and psychological distress, among others. The score range is 0 to 100, with higher number indicating higher Fibromyalgia severity/impact.\n\nBelow, we compare the mean change in the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 6 between LDX and placebo treated patients.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)", "description": "The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared mean change in ADHD-RS total score from baseline to endpoint of the study.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Clinical Global Impression (Severity)", "description": "The Clinical Global Impression (Severity) is a one-item, 7-point clinician-rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). The clinician rates the subject based on perceived severity of psychopathology, with higher numbers indicating higher severity. In this study, we compared the mean change in severity from baseline to endpoint.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in BRIEF-A", "description": "The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Fatigue Severity Scale (FSS)", "description": "The Fatigue Severity Scale is designed to measure the impact of fatigue on the life of the subject. It is a nine-question likert scale survey with a raw score range of 0-63. Scores of 36 and above indicate significant fatigue. In this study, we compared the mean change in the Fatigue Severity Scale (FSS) from baseline to endpoint between LDX and placebo treated patients.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Hamiliton Anxiety Inventory", "description": "The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 6 between LDX and placebo-treated patients.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Short Form McGill Pain Questionnaire", "description": "The McGill Pain Questionniare (Short Form) consists of 15 pain descriptors (11 sensory; 4 affective) which are rated on an intensity scale. 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sum of the intensity scores of the words chosen for sensory, affective and total descriptors are added for a total score. The score range is 0-45. In this study, we compared the change in the Short Form McGill Pain Questionnaire (SF-MPQ) from baseline to week 6 between LDX and placebo treated patients.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Fibromyalgia Impact Questionnaire (FIQ)", "description": "The Fibromyalgia Impact Questionnaire (FIQ) is an assessment that quantifies the impact of fibromyalgia on an individual, including questions on pain level, fatigue, sleep disturbance, and psychological distress, among others. The score range is 0 to 100, with higher number indicating higher Fibromyalgia severity/impact.\n\nBelow, we compare the mean change in the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 6 between LDX and placebo treated patients.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)", "description": "The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared mean change in ADHD-RS total score from baseline to endpoint of the study.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" }, { "type": "secondary", "measure": "Change in Clinical Global Impression (Severity)", "description": "The Clinical Global Impression (Severity) is a one-item, 7-point clinician-rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). The clinician rates the subject based on perceived severity of psychopathology, with higher numbers indicating higher severity. In this study, we compared the mean change in severity from baseline to endpoint.", "time_frame": "Baseline and end of study (6 weeks), assessed every 2 weeks with last observation carried forward" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 4", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 26, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01071044", "extraction_date": "2026-10-07" }, { "nct_id": "NCT07009691", "title": "Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-06-08", "start_date": "2025-06-09", "completion_date": "2026-05-31", "primary_completion_date": "2026-05-31", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Hydrogen Water Which Is Prepared From An Otc Supplement." ], "sponsor": "Stony Brook University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this clinical trial is to learn if the OTC supplement, hydrogen water, works to treat the fatigue-related symptoms and functional limitations in adults with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). It will also examine if heart rate variability (HRV) can be used to predict who will benefit from the hydrogen water treatment. The main questions it aims to answer are:\n\nDoes the OTC supplement, hydrogen water, work to reduce the fatigue-related symptoms and improve functioning in participants who have ME/CFS?\n\nCan HRV be used to predict who will benefit from treatment with hydrogen water?", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "This is a validated self-report measure of the effect of fatigue on functioning.", "time_frame": "12 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "This is a validated self-report measure of the effect of fatigue on functioning.", "time_frame": "12 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT07009691", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00518869", "title": "Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue", "status": "TERMINATED", "phase": "PHASE2", "last_updated": "2025-06-04", "start_date": "2007-09", "completion_date": "2009-12", "primary_completion_date": "2008-06", "conditions_raw": [ "Quality of Life", "Fatigue", "Complementary" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Pg2" ], "sponsor": "PhytoHealth Corporation", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The objective of this study is to evaluate the efficacy and safety of PG2 as a complementary treatment to conventional chemotherapy among NSCLC patients. In reference to previous studies, \"Clinical Benefit Response\" and \"Incidence of Grade III plus VI Neutropenia\" will be used as the primary endpoints in this study. Clinical Benefit Response is a metric measurement including change in cancer or cancer treatment related \"fatigue\" which is related to chronic fatigue syndrome (CFS), change in karnofsky performance status and change in weight. The secondary endpoints include patient's global quality of life, and the blood c-reactive protein level which is related to weight change, tumor response, survival time, incidences of myelosuppression (including neutropenia, anemia and thrombocytopenia) and the related G-CSF and antibiotics consumption.", "primary_outcomes": [ { "type": "primary", "measure": "Clinical Benefit Response", "description": "", "time_frame": "within and between each chemo-cycle (21 days)" }, { "type": "primary", "measure": "Incidence of Grade III plus IV Neutropenia", "description": "", "time_frame": "within and between each chemo-cycle (21 days)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Quality of Life Assessments", "description": "", "time_frame": "within and between each chemo-cycle (21 days)" }, { "type": "secondary", "measure": "The blood c-reactive protein level which is related to weight change", "description": "", "time_frame": "within and between each chemo-cycle (21 days)" }, { "type": "secondary", "measure": "Tumor Response", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "Survival Time", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption", "description": "", "time_frame": "within and beween each chemo-cycle (21 days)" } ], "outcome_measures": [ { "type": "primary", "measure": "Clinical Benefit Response", "description": "", "time_frame": "within and between each chemo-cycle (21 days)" }, { "type": "primary", "measure": "Incidence of Grade III plus IV Neutropenia", "description": "", "time_frame": "within and between each chemo-cycle (21 days)" }, { "type": "secondary", "measure": "Quality of Life Assessments", "description": "", "time_frame": "within and between each chemo-cycle (21 days)" }, { "type": "secondary", "measure": "The blood c-reactive protein level which is related to weight change", "description": "", "time_frame": "within and between each chemo-cycle (21 days)" }, { "type": "secondary", "measure": "Tumor Response", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "Survival Time", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption", "description": "", "time_frame": "within and beween each chemo-cycle (21 days)" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 13, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00518869", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03773003", "title": "Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)", "status": "RECRUITING", "phase": "NA", "last_updated": "2025-05-29", "start_date": "2021-07-20", "completion_date": "2025-12-01", "primary_completion_date": "2025-07-01", "conditions_raw": [ "Cancer Related Fatigue", "Fatigue Syndrome, Chronic" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Probiotics" ], "sponsor": "Universität des Saarlandes", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by Lipidomics, Metabolomics, Intestinal and Peritoneal Microbiome Analysis and Exome Analysis and Investigation of a Possible Benefit of Probiotics.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement of fatigue symptoms", "description": "Improvement of fatigue as measured by validated psychometric questionnaires.", "time_frame": "3 months after end of chemotherapy" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Improvement of fatigue symptoms", "description": "Improvement of fatigue as measured by validated psychometric questionnaires.", "time_frame": "3 months after end of chemotherapy" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 150, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03773003", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02374112", "title": "Creatine Supplementation in Chronic Fatigue Syndrome", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2025-05-23", "start_date": "2016-01", "completion_date": "2025-12", "primary_completion_date": "2025-12", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Creatine" ], "sponsor": "Center for Health Sciences, Serbia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study evaluates the effectiveness of medium-term supplementation with creatine to improve clinical outcomes in well-defined adult CFS population. Half of the participants will receive creatine while the other half will receive placebo.", "primary_outcomes": [ { "type": "primary", "measure": "Multidimensional Fatigue Inventory (MFI) score", "description": "", "time_frame": "3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "health-related quality of life", "description": "", "time_frame": "3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Multidimensional Fatigue Inventory (MFI) score", "description": "", "time_frame": "3 months" }, { "type": "secondary", "measure": "health-related quality of life", "description": "", "time_frame": "3 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02374112", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06952413", "title": "Study of the Efficacy and Safety for Rituximab in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2025-04-30", "start_date": "2025-04-09", "completion_date": "2027-10-31", "primary_completion_date": "2026-09-30", "conditions_raw": [ "Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Rituximab" ], "sponsor": "National Center of Neurology and Psychiatry, Japan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The efficacy and safety of rituximab on ME/CFS symptoms after administration to patients with myalgic encephalomyelitis/chronic fatigue syndrome will be compared in an exploratory, placebo-controlled, double-blind fashion. In the subsequent secondary evaluation period, subjects who received rituximab in the primary evaluation period will receive placebo, and the timing and duration of rituximab's effect will be explored throughout the entire evaluation period. Subjects who received placebo during the primary evaluation period will receive rituximab during the secondary evaluation period to explore changes in endpoints before and after switching from placebo to rituximab in the same subjects.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement rate", "description": "Percentage of cases in which the severity score of ME/CFS based on PS by the MHLW research group improved by 1 or more compared to that before the start of study drug administration (week 0)", "time_frame": "From Baseline to the end of treatment at 24 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Percentage of patients whose MHLW-PS-based ME/CFS severity score improved by 1 or more at each evaluation point (improvement rate) compared to that before the start of treatment with the investigational drug (week 0).", "description": "", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "The amount of change in the severity score of ME/CFS based on PS by the MHLW Research Group at each assessment point from that before the start of treatment with the investigational drug (week 0)", "description": "", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Proportion of awake time spent in supine position (%),Proportion of awake time spent in sitting position (%)", "description": "Changes in proportions will be aggregated.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Duration of standing and activity (hours)", "description": "Changes in time will be aggregated.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Fatigue during rest and lying position", "description": "Patients will be asked to report the level of fatigue they feel even while lying down, and changes in their fatigue levels will be aggregated.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Records on exertion and Post-Exertional Malaise (PEM)", "description": "Patients will be asked to describe the specific activities they perform and the exhaustion they experience afterward, and a summary table will be created.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Assessment of fatigue during physical activity", "description": "Patients will be asked to report the level of fatigue they experience during physical activity in daily life, and changes in fatigue levels will be aggregated.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Evaluation based on Fatigue Score", "description": "Patients will be asked to complete the Fatigue Score questionnaire, and changes in the score will be aggregated.", "time_frame": "At 2-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "SF-36", "description": "Changes in scores obtained from the SF-36 questionnaire will be assessed to evaluate patients' quality of life.", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "COMPASS31", "description": "Changes in scores obtained from the COMPASS31 questionnaire will be assessed to evaluate patients' autonomic symptoms.", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "Changes in scores obtained from the PSQI questionnaire will be assessed to evaluate patients' sleep quality.", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Pain intensity", "description": "Pain intensity will be assessed using the Visual Analogue Scale (VAS)", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Grip strength", "description": "Patients' grip strength will be measured, and changes in the measurements will be aggregated.", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Analysis of the gut microbiota", "description": "samples collected from patients will be analyzed, and the composition of the gut microbiota will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Brain imaging evaluation (Magnetic Resonance Imaging (MRI) of the head, Single Photon Emission Computed Tomography (SPECT) of cerebral blood flow)", "description": "Findings from imaging will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Immune biomarker analysis (qPCR)", "description": "qPCR will be measured, and changes in their levels will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Immune biomarker analysis (anti-autonomic receptor antibody analysis)", "description": "Quantify the level of anti-autonomic receptor antibodies will be measured, and changes in their levels will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Immune biomarker analysis (immune cell subfractionation analysis)", "description": "The subsets of immune cells will be measured, and changes in the levels will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Metabolome analysis", "description": "A detailed characterization of the patients' metabolome at baseline will be conducted.", "time_frame": "At Baseline" }, { "type": "secondary", "measure": "Adverse events", "description": "The number of adverse events will be aggregated.", "time_frame": "From Baseline up to Week 48" }, { "type": "secondary", "measure": "Vital signs (body temperature)", "description": "Summary statistics of vital signs will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48" }, { "type": "secondary", "measure": "Vital signs (blood pressure)", "description": "Summary statistics of vital signs will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48" }, { "type": "secondary", "measure": "Vital signs (pulse rate)", "description": "Summary statistics of vital signs will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48" }, { "type": "secondary", "measure": "Serum immunoglobulins (IgG)", "description": "Summary statistics of serum immunoglobulins will be calculated to monitor changes over time.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Serum immunoglobulins (IgM)", "description": "Summary statistics of serum immunoglobulins will be calculated to monitor changes over time.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Serum immunoglobulins (IgA)", "description": "Summary statistics of serum immunoglobulins will be calculated to monitor changes over time.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Rituximab concentration of the blood plasma", "description": "Rituximab concentration of the blood plasma", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 12, 24, 25, 26, 27, 28, 36, and 48" }, { "type": "secondary", "measure": "Blood drug concentration Anti-Drug Antibody (ADA)", "description": "Summary statistics of ADA will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 4, 12, 24, 28, 36, and 48." }, { "type": "secondary", "measure": "B cells (CD19/CD20 positive cells) and T cells (CD3/CD4/CD8 positive cells)", "description": "Summary statistics of B cells and T cells will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 12, 24, 25, 36, and 48." } ], "outcome_measures": [ { "type": "primary", "measure": "Improvement rate", "description": "Percentage of cases in which the severity score of ME/CFS based on PS by the MHLW research group improved by 1 or more compared to that before the start of study drug administration (week 0)", "time_frame": "From Baseline to the end of treatment at 24 weeks" }, { "type": "secondary", "measure": "Percentage of patients whose MHLW-PS-based ME/CFS severity score improved by 1 or more at each evaluation point (improvement rate) compared to that before the start of treatment with the investigational drug (week 0).", "description": "", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "The amount of change in the severity score of ME/CFS based on PS by the MHLW Research Group at each assessment point from that before the start of treatment with the investigational drug (week 0)", "description": "", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Proportion of awake time spent in supine position (%),Proportion of awake time spent in sitting position (%)", "description": "Changes in proportions will be aggregated.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Duration of standing and activity (hours)", "description": "Changes in time will be aggregated.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Fatigue during rest and lying position", "description": "Patients will be asked to report the level of fatigue they feel even while lying down, and changes in their fatigue levels will be aggregated.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Records on exertion and Post-Exertional Malaise (PEM)", "description": "Patients will be asked to describe the specific activities they perform and the exhaustion they experience afterward, and a summary table will be created.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Assessment of fatigue during physical activity", "description": "Patients will be asked to report the level of fatigue they experience during physical activity in daily life, and changes in fatigue levels will be aggregated.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Evaluation based on Fatigue Score", "description": "Patients will be asked to complete the Fatigue Score questionnaire, and changes in the score will be aggregated.", "time_frame": "At 2-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "SF-36", "description": "Changes in scores obtained from the SF-36 questionnaire will be assessed to evaluate patients' quality of life.", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "COMPASS31", "description": "Changes in scores obtained from the COMPASS31 questionnaire will be assessed to evaluate patients' autonomic symptoms.", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index (PSQI)", "description": "Changes in scores obtained from the PSQI questionnaire will be assessed to evaluate patients' sleep quality.", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Pain intensity", "description": "Pain intensity will be assessed using the Visual Analogue Scale (VAS)", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Grip strength", "description": "Patients' grip strength will be measured, and changes in the measurements will be aggregated.", "time_frame": "At 12-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Analysis of the gut microbiota", "description": "samples collected from patients will be analyzed, and the composition of the gut microbiota will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Brain imaging evaluation (Magnetic Resonance Imaging (MRI) of the head, Single Photon Emission Computed Tomography (SPECT) of cerebral blood flow)", "description": "Findings from imaging will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Immune biomarker analysis (qPCR)", "description": "qPCR will be measured, and changes in their levels will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Immune biomarker analysis (anti-autonomic receptor antibody analysis)", "description": "Quantify the level of anti-autonomic receptor antibodies will be measured, and changes in their levels will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Immune biomarker analysis (immune cell subfractionation analysis)", "description": "The subsets of immune cells will be measured, and changes in the levels will be aggregated.", "time_frame": "At 24-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Metabolome analysis", "description": "A detailed characterization of the patients' metabolome at baseline will be conducted.", "time_frame": "At Baseline" }, { "type": "secondary", "measure": "Adverse events", "description": "The number of adverse events will be aggregated.", "time_frame": "From Baseline up to Week 48" }, { "type": "secondary", "measure": "Vital signs (body temperature)", "description": "Summary statistics of vital signs will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48" }, { "type": "secondary", "measure": "Vital signs (blood pressure)", "description": "Summary statistics of vital signs will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48" }, { "type": "secondary", "measure": "Vital signs (pulse rate)", "description": "Summary statistics of vital signs will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 8, 12, 24, 25, 26, 27, 28, 32, 36, and 48" }, { "type": "secondary", "measure": "Serum immunoglobulins (IgG)", "description": "Summary statistics of serum immunoglobulins will be calculated to monitor changes over time.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Serum immunoglobulins (IgM)", "description": "Summary statistics of serum immunoglobulins will be calculated to monitor changes over time.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Serum immunoglobulins (IgA)", "description": "Summary statistics of serum immunoglobulins will be calculated to monitor changes over time.", "time_frame": "At 4-week intervals from Baseline up to Week 48" }, { "type": "secondary", "measure": "Rituximab concentration of the blood plasma", "description": "Rituximab concentration of the blood plasma", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 2, 3, 4, 12, 24, 25, 26, 27, 28, 36, and 48" }, { "type": "secondary", "measure": "Blood drug concentration Anti-Drug Antibody (ADA)", "description": "Summary statistics of ADA will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 4, 12, 24, 28, 36, and 48." }, { "type": "secondary", "measure": "B cells (CD19/CD20 positive cells) and T cells (CD3/CD4/CD8 positive cells)", "description": "Summary statistics of B cells and T cells will be calculated to monitor changes over time.", "time_frame": "Assessments will be conducted at baseline and at Weeks 1, 12, 24, 25, 36, and 48." } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06952413", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04141696", "title": "A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2025-04-15", "start_date": "2021-07-26", "completion_date": "2024-03-21", "primary_completion_date": "2024-03-21", "conditions_raw": [ "Fatigue" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Ketamine", "Midazolam" ], "sponsor": "National Institute of Nursing Research (NINR)", "sponsor_type": "NIH", "primary_purpose": "N/A", "brief_summary": "Background:\n\nMany people experience fatigue as a side effect of their illnesses and treatments. There are no medicines to treat fatigue, but a drug called ketamine has reduced fatigue in depressed people. Researchers hope that ketamine, compared to a drug called midazolam, can reduce fatigue in people with illnesses.\n\nObjective:\n\nTo test whether ketamine reduces fatigue in cancer survivors and people with chronic illness.\n\nEligibility:\n\nAdults between the ages of 18 and 70 who have fatigue and are cancer survivors or have been diagnosed with a chronic illness such as chronic fatigue syndrome and lupus.\n\nDesign:\n\nParticipants will be screened with a physical exam, medical history, blood and urine tests, questions about their fatigue, and breathalyzer test.\n\nDuring phase 1, participants will complete rating their fatigue using questionnaires. They will be provided thinking, memory, and motivation tests. They will also take a handgrip test. For this study, the participant will have an IV, which a needle guides a thin plastic tube (intravenous or IV line) into an arm in their vein. An IV will be required for two of the visits. They will get a single dose of either ketamine or midazolam through an IV line over 40 minutes. Participants must be accompanied by a responsible friend/family/colleague to take them home after getting the study drug.\n\nParticipants will have follow-up visits where they repeat the above tests. They will also have follow-up phone calls.\n\nPhase 2 is the same as phase 1, but participants get the other study drug.\n\nThe study lasts 1 month. Each phase lasts 2 weeks. Participants will have 6-8 total NIH visits. For the whole study, they will wear a device on their wrists that records physical activity.\n\nDrug side effects can include vivid dreams, seeing colors, perceiving time as moving slower or faster than normal, dizziness, headache, restlessness, nausea, or vomiting, among others.", "primary_outcomes": [ { "type": "primary", "measure": "Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale", "description": "Percentage change in self-reported Fatigue Visual Analog Scale (VAS) after a single intravenous dose of the study drug. The Fatigue VAS is a 0-100 mm scale widely used to assess fatigue in patients with chronic illness. Higher score indicates worse fatigue. Change in fatigue VAS scores measured as comparison of fatigue VAS scores collected at the first visit (baseline) and three days post infusion of study drug during each treatment arm (Ketamine, active comparator). Analysis is measured as the difference between day three score minus the baseline score, divided by the baseline score.", "time_frame": "Baseline to three days post infusion for each study arm" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale - Day 7", "description": "Percentage change in self-reported Fatigue Visual Analog Scale (VAS) after a single intravenous dose of the study drug. The Fatigue VAS is a 0-100 mm scale widely used to assess fatigue in patients with chronic illness. Higher score indicates worse fatigue. Change in fatigue VAS scores measured as comparison of fatigue VAS scores collected at the first visit (baseline) and seven days post infusion for each treatment arm (Ketamine, active comparator). Analysis is measured as the percentage change in day seven score minus the baseline score, divided by the baseline score.", "time_frame": "Up to 7 days post infusion for each study drug" }, { "type": "secondary", "measure": "Areas Under the Curve (AUC) for Percentage Changes in Self-reported Fatigue VAS Score - Through Day 7", "description": "Percentage change in self-reported Fatigue Visual Analog Scale (VAS) after a single intravenous dose of the study drug. The Fatigue VAS is a 0-100 mm scale widely used to assess fatigue in patients with chronic illness. Higher score indicates worse fatigue. Change in fatigue VAS scores measured as comparison of fatigue VAS scores collected at the first visit (baseline), and then 40, 80, 120, 230 minutes, and 1, 3, and 7 days post infusion for each treatment arm (Ketamine, active comparator). Analysis is measured as the areas under the curve.", "time_frame": "Up to 7 days post infusion for each study drug" }, { "type": "secondary", "measure": "Mean Physical Activity Count Using Actigraphy", "description": "Mean physical activity count using actigraphy. Participants wore a portable device to monitor activity levels at day seven post infusion for each study drug. Analysis is measured as the mean of physical activity count on day seven post infusion for each treatment arm.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Fatigue Level Measured by Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale", "description": "The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale is a 13-item questionnaire that measures level of fatigue symptoms. Each item is rated on a scale of 0 (not al all) to 4 (very much) with total score ranging from 0 to 52. Lower score indicates greater fatigue. The Fatigue subscale was used to assess participant's level of fatigue at day seven post infusion for each study arm analyzed as the mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety Domain", "description": "The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The anxiety domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more anxiety. Participants completed the computerized adaptive test version of PROMIS anxiety subscale on day seven post infusion and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Patient Reported Outcome Measurement Information System (PROMIS) - Depression Domain", "description": "The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The depression domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher score indicates worsening depression. Participants completed the computerized adaptive test version of PROMIS depression subscale on day seven post infusion and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue Domain", "description": "The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The fatigue domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher score indicates worsening fatigue. Participants completed the computerized adaptive test version of PROMIS fatigue subscale on day seven post infusion and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Patient Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance Domain", "description": "The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The Sleep Disturbance domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate worsening sleep disturbance being measured. Participants completed the computerized adaptive test version of PROMIS sleep disturbance subscale on day seven post infusion and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Fatigue Level Measured by Fatigue Visual Analogue Scale", "description": "The fatigue visual analogue scale (VAS) provides a simple method to assess fatigue. The Fatigue VAS is a 0-100 mm scale with 0 (no fatigue at all) to 100 (extreme fatigue). Higher score indicates worsening fatigue. Fatigue VAS score collected from all participants on day seven post infusion for each treatment arm and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Measure of Depression Using the Hamilton Rating Scale for Depression (HAM-D)", "description": "Hamilton Depression (HAM-D) utilizes a 21-item, clinician-rated paper questionnaire that measures the severity of depressive symptoms of the participants in the past week prior to the interview though only the first 17 items are used in scoring. Depending on the item, it is scored between 0 (not present) and 4 (severe) points using either a three-point or a five-point scale and summed up to obtain the total score. The HAM-D comprises 17 items, of which 9 are evaluated on a five-point scale (0-4) and 8-on a three-point scale (0-2). The total score range from 0 to the maximum score 52 on a 17-item scale, with higher scores indicating more serious depression. Total scores of 0-7 are considered as normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. Data was collected from all participants on day seven post infusion for each treatment arm and analyzed as mean score.", "time_frame": "Day 7 post infusion" } ], "outcome_measures": [ { "type": "primary", "measure": "Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale", "description": "Percentage change in self-reported Fatigue Visual Analog Scale (VAS) after a single intravenous dose of the study drug. The Fatigue VAS is a 0-100 mm scale widely used to assess fatigue in patients with chronic illness. Higher score indicates worse fatigue. Change in fatigue VAS scores measured as comparison of fatigue VAS scores collected at the first visit (baseline) and three days post infusion of study drug during each treatment arm (Ketamine, active comparator). Analysis is measured as the difference between day three score minus the baseline score, divided by the baseline score.", "time_frame": "Baseline to three days post infusion for each study arm" }, { "type": "secondary", "measure": "Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale - Day 7", "description": "Percentage change in self-reported Fatigue Visual Analog Scale (VAS) after a single intravenous dose of the study drug. The Fatigue VAS is a 0-100 mm scale widely used to assess fatigue in patients with chronic illness. Higher score indicates worse fatigue. Change in fatigue VAS scores measured as comparison of fatigue VAS scores collected at the first visit (baseline) and seven days post infusion for each treatment arm (Ketamine, active comparator). Analysis is measured as the percentage change in day seven score minus the baseline score, divided by the baseline score.", "time_frame": "Up to 7 days post infusion for each study drug" }, { "type": "secondary", "measure": "Areas Under the Curve (AUC) for Percentage Changes in Self-reported Fatigue VAS Score - Through Day 7", "description": "Percentage change in self-reported Fatigue Visual Analog Scale (VAS) after a single intravenous dose of the study drug. The Fatigue VAS is a 0-100 mm scale widely used to assess fatigue in patients with chronic illness. Higher score indicates worse fatigue. Change in fatigue VAS scores measured as comparison of fatigue VAS scores collected at the first visit (baseline), and then 40, 80, 120, 230 minutes, and 1, 3, and 7 days post infusion for each treatment arm (Ketamine, active comparator). Analysis is measured as the areas under the curve.", "time_frame": "Up to 7 days post infusion for each study drug" }, { "type": "secondary", "measure": "Mean Physical Activity Count Using Actigraphy", "description": "Mean physical activity count using actigraphy. Participants wore a portable device to monitor activity levels at day seven post infusion for each study drug. Analysis is measured as the mean of physical activity count on day seven post infusion for each treatment arm.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Fatigue Level Measured by Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale", "description": "The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale is a 13-item questionnaire that measures level of fatigue symptoms. Each item is rated on a scale of 0 (not al all) to 4 (very much) with total score ranging from 0 to 52. Lower score indicates greater fatigue. The Fatigue subscale was used to assess participant's level of fatigue at day seven post infusion for each study arm analyzed as the mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety Domain", "description": "The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The anxiety domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more anxiety. Participants completed the computerized adaptive test version of PROMIS anxiety subscale on day seven post infusion and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Patient Reported Outcome Measurement Information System (PROMIS) - Depression Domain", "description": "The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The depression domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher score indicates worsening depression. Participants completed the computerized adaptive test version of PROMIS depression subscale on day seven post infusion and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue Domain", "description": "The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The fatigue domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher score indicates worsening fatigue. Participants completed the computerized adaptive test version of PROMIS fatigue subscale on day seven post infusion and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Patient Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance Domain", "description": "The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The Sleep Disturbance domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate worsening sleep disturbance being measured. Participants completed the computerized adaptive test version of PROMIS sleep disturbance subscale on day seven post infusion and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Fatigue Level Measured by Fatigue Visual Analogue Scale", "description": "The fatigue visual analogue scale (VAS) provides a simple method to assess fatigue. The Fatigue VAS is a 0-100 mm scale with 0 (no fatigue at all) to 100 (extreme fatigue). Higher score indicates worsening fatigue. Fatigue VAS score collected from all participants on day seven post infusion for each treatment arm and analyzed as mean score.", "time_frame": "Day 7 post infusion" }, { "type": "secondary", "measure": "Measure of Depression Using the Hamilton Rating Scale for Depression (HAM-D)", "description": "Hamilton Depression (HAM-D) utilizes a 21-item, clinician-rated paper questionnaire that measures the severity of depressive symptoms of the participants in the past week prior to the interview though only the first 17 items are used in scoring. Depending on the item, it is scored between 0 (not present) and 4 (severe) points using either a three-point or a five-point scale and summed up to obtain the total score. The HAM-D comprises 17 items, of which 9 are evaluated on a five-point scale (0-4) and 8-on a three-point scale (0-2). The total score range from 0 to the maximum score 52 on a 17-item scale, with higher scores indicating more serious depression. Total scores of 0-7 are considered as normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. Data was collected from all participants on day seven post infusion for each treatment arm and analyzed as mean score.", "time_frame": "Day 7 post infusion" } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Nih" ], "enrollment": 10, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04141696", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06575920", "title": "Breathing Therapy for Patients in General Practice", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-04-06", "start_date": "2023-10-11", "completion_date": "2024-02-14", "primary_completion_date": "2023-11-15", "conditions_raw": [ "Mind-Body Therapies" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Breathing Excercizes" ], "sponsor": "University of Agder", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Medically unexplained physical symptoms (MUPS) capture conditions characterized by symptoms without corresponding objective findings, such as asthenia, low back pain, fibromyalgia, irritable bowel syndrome, or chronic fatigue syndrome. In order to establish the grounds for a RCT. this pilot study aims to investigate the effectiveness and feasibility of a 5-week breathing retraining programme on patients who meet the criteria for MUPS.", "primary_outcomes": [ { "type": "primary", "measure": "Nijmegen Questionnaire", "description": "To detect dysfunctional breathing (DB). The NQ consists of 16 questions ranked on a five-point Likert scale where \"never\" counts as 0 and \"very often\" counts as 4, giving a total DB score between 0-64. Healthy, asymptomatic individuals generally have a DB score between 7-12. A score above 19 is suggestive of DB.", "time_frame": "Base line, end of intervention, and 3 months post-interventions" }, { "type": "primary", "measure": "Subjective Health Complaints Inventory", "description": "Measures 29 subjective health problems. The form lists 29 common somatic and psychological ailments, where the degree of complaints and duration must be stated for the last 30 days, graded on a four-point scale. The 29 individual health issues were grouped into five sub-issues \\[musculoskeletal pain (8 items), pseudoneurology (7 items), gastrointestinal disorders (7 items), allergic disorders (5 items), colds (2 items)\\], and a total score comprising all items. All scales were scored 0-100 (where 0 indicates no symptom pressure and 100 the highest possible symptom pressure).", "time_frame": "Base line, end of intervention, and 3 months post-interventions" }, { "type": "primary", "measure": "Measure Yourself Medical Outcome Profile", "description": "Participants are asked to rate four items (symptom 1, symptom 2, well-being, and impact of symptoms on their daily activity status) on a scale of 0-6 where 0 is \"As good as it could be\" and 6 is \"As bad as it could be\". Participants report one or two symptoms (physical or mental) which bother them the most, consider how bad each symptom was during the last week, and score them accordingly. They also report how much these symptoms affected a particular activity, their well-being during the last week, use of medication, and any possible adverse effects or worsening of symptoms. The symptom pressure and general well-being (scales 0-6) are presented.", "time_frame": "Base line, end of intervention, and 3 months post-interventions" }, { "type": "primary", "measure": "Carbon dioxide levels", "description": "End-tidal CO2 (EtCO2) (Microstream™) is an objective measure of hyperventilation and is easily detected through a nasal cannula with a capnograph together with respiratory rate (RR). The normal values of EtCO2 are 4.7 kPa - 6 kPa (45). Values below 4.6 are regarded as hypocapnia.", "time_frame": "Base line, end of intervention, and 3 months post-interventions" }, { "type": "primary", "measure": "Heart rate variability", "description": "The registrations of HRV were performed using HeartMath with the participants in a sitting position, relaxed, and breathing regularly. In the 1990s, HeartMath Institute researchers identified a physiological state called heart coherence. Physiologically, the coherence state is marked by the development of a smooth, sine-wave-like pattern in the heart rate variability trace. This characteristic pattern, called heart rhythm coherence, is the primary indicator of the psychophysiological coherence state. The emWave Coherence score is a measure of the degree of coherence in the heart rhythm pattern. A coherent heart rhythm is a stable, regular, repeating rhythm resembling a sine wave at a single frequency between 0.04 - 0.24 Hz (3 - 15 cycles per minute). The more stable and regular the heart rhythm frequency, the higher the coherence score. Scores range from 0 - 16.", "time_frame": "Base line, end of intervention, and 3 months post-interventions" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient adherence and attrition rates", "description": "Number of patients", "time_frame": "Base line, end of intervention, and 3 months post-interventions" } ], "outcome_measures": [ { "type": "primary", "measure": "Nijmegen Questionnaire", "description": "To detect dysfunctional breathing (DB). The NQ consists of 16 questions ranked on a five-point Likert scale where \"never\" counts as 0 and \"very often\" counts as 4, giving a total DB score between 0-64. Healthy, asymptomatic individuals generally have a DB score between 7-12. A score above 19 is suggestive of DB.", "time_frame": "Base line, end of intervention, and 3 months post-interventions" }, { "type": "primary", "measure": "Subjective Health Complaints Inventory", "description": "Measures 29 subjective health problems. The form lists 29 common somatic and psychological ailments, where the degree of complaints and duration must be stated for the last 30 days, graded on a four-point scale. The 29 individual health issues were grouped into five sub-issues \\[musculoskeletal pain (8 items), pseudoneurology (7 items), gastrointestinal disorders (7 items), allergic disorders (5 items), colds (2 items)\\], and a total score comprising all items. All scales were scored 0-100 (where 0 indicates no symptom pressure and 100 the highest possible symptom pressure).", "time_frame": "Base line, end of intervention, and 3 months post-interventions" }, { "type": "primary", "measure": "Measure Yourself Medical Outcome Profile", "description": "Participants are asked to rate four items (symptom 1, symptom 2, well-being, and impact of symptoms on their daily activity status) on a scale of 0-6 where 0 is \"As good as it could be\" and 6 is \"As bad as it could be\". Participants report one or two symptoms (physical or mental) which bother them the most, consider how bad each symptom was during the last week, and score them accordingly. They also report how much these symptoms affected a particular activity, their well-being during the last week, use of medication, and any possible adverse effects or worsening of symptoms. The symptom pressure and general well-being (scales 0-6) are presented.", "time_frame": "Base line, end of intervention, and 3 months post-interventions" }, { "type": "primary", "measure": "Carbon dioxide levels", "description": "End-tidal CO2 (EtCO2) (Microstream™) is an objective measure of hyperventilation and is easily detected through a nasal cannula with a capnograph together with respiratory rate (RR). The normal values of EtCO2 are 4.7 kPa - 6 kPa (45). Values below 4.6 are regarded as hypocapnia.", "time_frame": "Base line, end of intervention, and 3 months post-interventions" }, { "type": "primary", "measure": "Heart rate variability", "description": "The registrations of HRV were performed using HeartMath with the participants in a sitting position, relaxed, and breathing regularly. In the 1990s, HeartMath Institute researchers identified a physiological state called heart coherence. Physiologically, the coherence state is marked by the development of a smooth, sine-wave-like pattern in the heart rate variability trace. This characteristic pattern, called heart rhythm coherence, is the primary indicator of the psychophysiological coherence state. The emWave Coherence score is a measure of the degree of coherence in the heart rhythm pattern. A coherent heart rhythm is a stable, regular, repeating rhythm resembling a sine wave at a single frequency between 0.04 - 0.24 Hz (3 - 15 cycles per minute). The more stable and regular the heart rhythm frequency, the higher the coherence score. Scores range from 0 - 16.", "time_frame": "Base line, end of intervention, and 3 months post-interventions" }, { "type": "secondary", "measure": "Patient adherence and attrition rates", "description": "Number of patients", "time_frame": "Base line, end of intervention, and 3 months post-interventions" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 15, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06575920", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04622293", "title": "A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2025-04-06", "start_date": "2021-04-27", "completion_date": "2024-12-01", "primary_completion_date": "2024-09-01", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Solriamfetol Oral Tablet [Sunosi]" ], "sponsor": "Rochester Center for Behavioral Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is an 8-week single center, randomized, double-blind, placebo-controlled, flexible titration trial evaluating the efficacy of solriamfetol in the treatment of fatigue symptoms in adult patients with chronic fatigue syndrome. Subjects will be randomized to a solriamfetol group or placebo group. The investigators will utilize an intent to treat model and impute data. The overall goal of this study is to determine the efficacy and effectiveness of solriamfetol for treating chronic fatigue syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Symptom Inventory (FSI)", "description": "This measure has excellent internal reliability and good convergent validity and construct validity. The FSI has been demonstrated to effectively discriminate between patients with clinically significant fatigue and those that do not. Its psychometric properties have repeatedly been demonstrated to support its use in research for fatigue symptoms.", "time_frame": "Up to 8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "BRIEF-A", "description": "The BRIEF-A is a comprehensive measure of executive functioning, examining 8 cognitive tasks. It is non-diagnosis specific and applicable for use with a variety of cognition-impacting conditions", "time_frame": "Up to 8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Symptom Inventory (FSI)", "description": "This measure has excellent internal reliability and good convergent validity and construct validity. The FSI has been demonstrated to effectively discriminate between patients with clinically significant fatigue and those that do not. Its psychometric properties have repeatedly been demonstrated to support its use in research for fatigue symptoms.", "time_frame": "Up to 8 weeks" }, { "type": "secondary", "measure": "BRIEF-A", "description": "The BRIEF-A is a comprehensive measure of executive functioning, examining 8 cognitive tasks. It is non-diagnosis specific and applicable for use with a variety of cognition-impacting conditions", "time_frame": "Up to 8 weeks" } ], "relevance_tags": [ "General", "Phase 4", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 44, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04622293", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05863897", "title": "e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury", "status": "ENROLLING_BY_INVITATION", "phase": "NA", "last_updated": "2025-04-03", "start_date": "2023-09-01", "completion_date": "2026-09", "primary_completion_date": "2026-09", "conditions_raw": [ "Acquired Brain Injury", "Fatigue" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "E-Cograt" ], "sponsor": "Universiteit Leiden", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Fatigue is a common, persistent consequence of acquired brain injury (ABI). Research into treatments that may alleviate post-ABI fatigue is been limited. Pharmacological treatment (methylphenidate) has shown the greatest scientific effects, but is complicated because the risk of adverse side effects and its potential for abuse. COGRAT, an evidence-based treatment combining cognitive therapy (CO) with graded activity training (GRAT), is found to be effective in treating fatigue in patients with acquired brain injury. However, therapist guided internet-based CBT (I-CBT) could offer a more accessible and cheaper alternative to this highly frequent face to face treatment. Moreover, I-CBT is found to be effective in a population with patients with psychiatric and chronic somatic disorders, including chronic fatigue syndrome. Recent studies suggests that I-CBT is effective for people with ABI as well. To obtain optimal benefit from both group delivered face to face therapy and e-health and to combine the available evidence of COGRAT and I-CBT in patients with ABI, we developed a blended e-health cognitive behavioral (group)intervention; e-COGRAT.\n\nThe goal of this intervention study is to evaluate the efficacy and feasibility of e-COGRAT to treat fatigue in people with ABI. The main questions it aims to answer are:\n\n* Is a blended eHealth cognitive behavioral (group)intervention (e-COGRAT) effective as a treatment for fatigue in people with ABI?\n* Is e-COGRAT the blended care variant of COGRAT, a cognitive behavioral group treatment for fatigue afer ABI, comparable to COGRAT in terms of efficacy?\n* Will participants of e-COGRAT improve significant on overall fatigue, emotional well-being and participation?\n* Will it be feasible for at least 80% of the participants to complete the intervention completely?", "primary_outcomes": [ { "type": "primary", "measure": "Daily fatigue", "description": "Primary outcome is the change in severity of fatigue complaints on a daily visual analogue scale (VAS) (\"How would you rate your fatigue today?\") which will be registered by text messages. Participants can indicate the severity of the experienced fatigue by given themselves a grade between 0 - 4. 0: \"I'm not tired\"; 1: \"I'm a little bit tired\"; 2: \"tired\"; 3: \"pretty tired\"; \"; 4: \"seriously tired\". These grades will also be used in the intervention.", "time_frame": "1 year (daily in baseline and intervention phase and daily in the last week of follow-up)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue after ABI", "description": "Fatigue after ABI will be assessed with the Dutch Multifactor Fatigue Scale (DMFS). The DMFS measures 5 aspects of fatigue regarding the four weeks preceding the assessment: Impact of fatigue, Mental fatigue, Signs and Direct consequences of fatigue, Physical fatigue and Coping with fatigue. The DMFS contains 38 items. Questions are answered on a 5-point Likert scale. Subscales of the DMFS showed sufficient to good reliability (Cronbach's alpha = 0.70 to 0.91), good convergent validity with an existing fatigue scale, and good divergent validity with measures of mood and self-esteem.", "time_frame": "1 year (once in baseline, treatment and follow-up)" }, { "type": "secondary", "measure": "Fatigue in the general population", "description": "Fatigue in the general population will be assessed with the Checklist Individual Strength - subscale Fatigue (CIS-f). The CIS-f contains 8 questions on fatigue severity regarding the two weeks preceding the assessment. The CIS-f has good reliability and is sensitive to change. Questions are answered on a 7-point Likert scale (1-7, higher scores represent higher fatigue).", "time_frame": "1 year (once in baseline, treatment and follow-up)" }, { "type": "secondary", "measure": "Emotional distress", "description": "Depression and anxiety symptoms of the last week will be assessed with the Dutch version of the 14-item Hospital Anxiety and Depression Scale (HADS). The reliability of the HADS is good (Cronbach's Alpha = 0.71 to 0.90) as is the test-retest reliability (0.86-0.90) (Spinhoven et al., 1997). Questions are answered on a 4-point Likert scale (0-3): 7 items on the depression subscale (HADS-D) and 7 items of the anxiety subscale (HADS-A). Subscale sumscores are categorized as normal (0-7), mild (8-10), moderate (11-14) or severe (15-21).", "time_frame": "1 year (once in baseline, treatment and follow-up)" }, { "type": "secondary", "measure": "Level of participation", "description": "The Utrecht Scale for Evaluation of Rehabilitation - Participation (USER-P) is a questionnaire to rate objective and subjective participation after rehabilitation. Internal consistency is satisfactory (Cronbach's Alpha = 0.70-0.91).", "time_frame": "1 year (once in baseline, treatment and follow-up)" }, { "type": "secondary", "measure": "Feasibility of the overall online intervention", "description": "Feasibility will be assessed with structured interviews about overall usability, experienced benefits and difficulties and level of involvement. These interviews, for both participants and therapists, will take place posttreatment and after follow up.", "time_frame": "1 year (once in treatment and follow-up)" }, { "type": "secondary", "measure": "Feasibility of each specific online session", "description": "After each online session both patients and therapists fill in a questionnaire with questions about their experiences with the specific session concerning usability, content, lay out, potential technical difficulties and other assorted comments.", "time_frame": "1 year (weekly during treatment and after follow-up)" } ], "outcome_measures": [ { "type": "primary", "measure": "Daily fatigue", "description": "Primary outcome is the change in severity of fatigue complaints on a daily visual analogue scale (VAS) (\"How would you rate your fatigue today?\") which will be registered by text messages. Participants can indicate the severity of the experienced fatigue by given themselves a grade between 0 - 4. 0: \"I'm not tired\"; 1: \"I'm a little bit tired\"; 2: \"tired\"; 3: \"pretty tired\"; \"; 4: \"seriously tired\". These grades will also be used in the intervention.", "time_frame": "1 year (daily in baseline and intervention phase and daily in the last week of follow-up)" }, { "type": "secondary", "measure": "Fatigue after ABI", "description": "Fatigue after ABI will be assessed with the Dutch Multifactor Fatigue Scale (DMFS). The DMFS measures 5 aspects of fatigue regarding the four weeks preceding the assessment: Impact of fatigue, Mental fatigue, Signs and Direct consequences of fatigue, Physical fatigue and Coping with fatigue. The DMFS contains 38 items. Questions are answered on a 5-point Likert scale. Subscales of the DMFS showed sufficient to good reliability (Cronbach's alpha = 0.70 to 0.91), good convergent validity with an existing fatigue scale, and good divergent validity with measures of mood and self-esteem.", "time_frame": "1 year (once in baseline, treatment and follow-up)" }, { "type": "secondary", "measure": "Fatigue in the general population", "description": "Fatigue in the general population will be assessed with the Checklist Individual Strength - subscale Fatigue (CIS-f). The CIS-f contains 8 questions on fatigue severity regarding the two weeks preceding the assessment. The CIS-f has good reliability and is sensitive to change. Questions are answered on a 7-point Likert scale (1-7, higher scores represent higher fatigue).", "time_frame": "1 year (once in baseline, treatment and follow-up)" }, { "type": "secondary", "measure": "Emotional distress", "description": "Depression and anxiety symptoms of the last week will be assessed with the Dutch version of the 14-item Hospital Anxiety and Depression Scale (HADS). The reliability of the HADS is good (Cronbach's Alpha = 0.71 to 0.90) as is the test-retest reliability (0.86-0.90) (Spinhoven et al., 1997). Questions are answered on a 4-point Likert scale (0-3): 7 items on the depression subscale (HADS-D) and 7 items of the anxiety subscale (HADS-A). Subscale sumscores are categorized as normal (0-7), mild (8-10), moderate (11-14) or severe (15-21).", "time_frame": "1 year (once in baseline, treatment and follow-up)" }, { "type": "secondary", "measure": "Level of participation", "description": "The Utrecht Scale for Evaluation of Rehabilitation - Participation (USER-P) is a questionnaire to rate objective and subjective participation after rehabilitation. Internal consistency is satisfactory (Cronbach's Alpha = 0.70-0.91).", "time_frame": "1 year (once in baseline, treatment and follow-up)" }, { "type": "secondary", "measure": "Feasibility of the overall online intervention", "description": "Feasibility will be assessed with structured interviews about overall usability, experienced benefits and difficulties and level of involvement. These interviews, for both participants and therapists, will take place posttreatment and after follow up.", "time_frame": "1 year (once in treatment and follow-up)" }, { "type": "secondary", "measure": "Feasibility of each specific online session", "description": "After each online session both patients and therapists fill in a questionnaire with questions about their experiences with the specific session concerning usability, content, lay out, potential technical difficulties and other assorted comments.", "time_frame": "1 year (weekly during treatment and after follow-up)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 16, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05863897", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04363606", "title": "Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability", "status": "TERMINATED", "phase": "NA", "last_updated": "2025-03-25", "start_date": "2020-05-27", "completion_date": "2022-03-01", "primary_completion_date": "2021-08-26", "conditions_raw": [ "Chronic Fatigue Syndrome", "Intensive Care Unit", "Muscle" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Blood Test", "Maximal Effort Test", "Actigraphy", "Neuromuscular Evaluation", "Stool Analysis", "Food Diary" ], "sponsor": "Centre Hospitalier Universitaire de Saint Etienne", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life.\n\nThe aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.", "primary_outcomes": [ { "type": "primary", "measure": "voluntary maximum force reduction", "description": "", "time_frame": "6 weeks post-discharge" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Neuromuscular function : cortical activity", "description": "Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "Neuromuscular function : Peripheral function", "description": "Peripheral function by electrical nerve stimulation", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "Maximal oxygen uptake (VO2max)", "description": "measured by effort test", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "quality of sleep", "description": "measured by actigraphy", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "muscle volume", "description": "with Magnetic resonance imaging", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "metabolic fatigue", "description": "measured by a Phosphorus 31 Nuclear magnetic resonance test", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "microbiote intestinal", "description": "stool analysis (concerns only the patients of Saint Etienne)", "time_frame": "baseline and 6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "voluntary maximum force reduction", "description": "", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "Neuromuscular function : cortical activity", "description": "Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "Neuromuscular function : Peripheral function", "description": "Peripheral function by electrical nerve stimulation", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "Maximal oxygen uptake (VO2max)", "description": "measured by effort test", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "quality of sleep", "description": "measured by actigraphy", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "muscle volume", "description": "with Magnetic resonance imaging", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "metabolic fatigue", "description": "measured by a Phosphorus 31 Nuclear magnetic resonance test", "time_frame": "6 weeks post-discharge" }, { "type": "secondary", "measure": "microbiote intestinal", "description": "stool analysis (concerns only the patients of Saint Etienne)", "time_frame": "baseline and 6 months" } ], "relevance_tags": [ "Persistence / Antiviral", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 69, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04363606", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04313972", "title": "IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone", "status": "TERMINATED", "phase": "PHASE4", "last_updated": "2025-03-07", "start_date": "2021-09-07", "completion_date": "2023-02-23", "primary_completion_date": "2023-01-23", "conditions_raw": [ "Interstitial Cystitis", "Painful Bladder Syndrome", "Bladder Pain Syndrome", "Low Dose Naltrexone", "Low-dose Naltrexone", "Naltrexone" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Low-Dose Naltrexone (LDN)" ], "sponsor": "Endeavor Health", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition with symptoms of urinary urgency, frequency, nocturia (waking up at night to void), and pain, without evidence of urinary tract infection or other identifiable causes. IC/PBS often coexists with other chronic pain syndromes, such as irritable bowel syndrome, chronic fatigue syndrome, and fibromyalgia.\n\nSeveral treatments exist for IC/PBS; some are not effective, others are time consuming for patients to receive, some can take weeks to months before they become effective, and many have risks associated with them. Low-dose naltrexone (LDN) has demonstrated improvement of symptoms in conditions associated with IC/PBS. LDN is defined as less than 5mg of naltrexone. Some adverse effects have been reported with LDN, the most common are vivid dreams, nightmares, and insomnia.\n\nThe investigators hypothesis LDN will have greater than 30% reduction in symptoms as defined by the Interstitial Cystitis Symptom Index in patients diagnosed with IC/PBS from baseline when compared to placebo. The 30% reduction in pain is a standard outcome measure in the pain literature. This improvement has been seen in prior studies where LDN was used to treat pain syndromes.\n\nThis will be a randomized double-blinded placebo-controlled prospective trial. Patients meeting diagnostic criteria for IC/PBS by American Urologic Association (AUA) guidelines will be eligible, and then must then meet all applicable inclusion and exclusion criteria. Study participants will sign a consent, complete several questionnaires, give a blood sample to measure liver function tests, and once at home, complete a 24-hour bladder diary.\n\nParticipants will be randomized to receive either placebo or study medication. Participants will be instructed to take one capsule nightly for two weeks, then increase to two capsules nightly for four weeks. They will be given a log to record the date and time they take the medication. All study participants will also receive first-line behavioral therapy for IC/PBS of a bladder diet and bladder drills.\n\nAfter six weeks, participants will complete a second bladder diary. They will then complete the exit study questionnaires, have a second liver function test, return any unused medication, and meet with their doctor to discuss conventional treatment options for IC/PBS.", "primary_outcomes": [ { "type": "primary", "measure": "Interstitial Cystitis Symptom Index", "description": "The effect of LDN (low-dose naltrexone) in decreasing symptoms associated with IC/PBS (interstitial cystitis/painful bladder syndrome) when treating with low-dose naltrexone as scored by the Interstitial Cystitis Symptom Index as compared to placebo. Scores are from 0 to 20, with lower scores indicating less symptoms associated with IC/PBS.", "time_frame": "six weeks" }, { "type": "primary", "measure": "Visual Analog Scale", "description": "The effect of LDN in decreasing pain associated with IC/PBS when treating with low-dose naltrexone as scored by visual analog scale as compared with placebo. Scores are from 0 to 10, with lower scores indicating less pain.", "time_frame": "six weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in Interstitial Cystitis Problem Index", "description": "The changes in IC/PBS associated problems when treating interstitial cystitis/painful bladder syndrome with low-dose naltrexone as scored by the Interstitial Cystitis Problem Index, prior to initiating treatment and at the conclusion of 6 weeks of treatment. Scores are from 0-16, with lower scores indicating a better score, with fewer problems associated with IC/PBS. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Change in Urinary Frequency", "description": "The change in number of patient voids during the day when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment and at the conclusion of 6 weeks of treatment. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Change in Number of Nocturia", "description": "The change in number of patient voids during at night when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment and at the conclusion of 6 weeks of treatment. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Change in Pelvic Pain and Urgency/Frequency Symptoms", "description": "The change in pelvic pain and urgency/frequency symptoms as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale, prior to initiating treatment and at the conclusion of 6 weeks of treatment. Scores can range from 0-23, with higher scores indicating more severe symptoms associated with IC/PBS. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Change in Pelvic Pain and Urgency/Frequency Bother", "description": "The change in pelvic pain and urgency/frequency bother as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale, prior to initiating treatment and at the conclusion of 6 weeks of treatment. Scores can range from 0-12, with higher values corresponding to more bother from IC/PBS symptoms. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Patient Perceived Quality of Life: SF-36", "description": "Patient perceived quality of life as measured by the medical outcomes study short form 36 (SF-36). Higher scores indicate a more favorable health status. There are 8 subscales, which when averaged, include a score from 0-100.", "time_frame": "six weeks" }, { "type": "secondary", "measure": "Adverse Effects", "description": "The percentage of patients complaining of adverse effects from LDN including vivid dreams, nightmares, insomnia, GI disturbances such as stomach cramps or diarrhea, agitation, anxiety, flu-like symptoms and headaches.", "time_frame": "six weeks" }, { "type": "secondary", "measure": "Medication Tolerability", "description": "The percentage of patients who discontinue the study medication measured by the tolerability survey.", "time_frame": "six weeks" }, { "type": "secondary", "measure": "Number of Days With Pain Medications", "description": "The number of days with pain medication use while using LDN, as determined by a pain medication diary.", "time_frame": "six weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Interstitial Cystitis Symptom Index", "description": "The effect of LDN (low-dose naltrexone) in decreasing symptoms associated with IC/PBS (interstitial cystitis/painful bladder syndrome) when treating with low-dose naltrexone as scored by the Interstitial Cystitis Symptom Index as compared to placebo. Scores are from 0 to 20, with lower scores indicating less symptoms associated with IC/PBS.", "time_frame": "six weeks" }, { "type": "primary", "measure": "Visual Analog Scale", "description": "The effect of LDN in decreasing pain associated with IC/PBS when treating with low-dose naltrexone as scored by visual analog scale as compared with placebo. Scores are from 0 to 10, with lower scores indicating less pain.", "time_frame": "six weeks" }, { "type": "secondary", "measure": "Change in Interstitial Cystitis Problem Index", "description": "The changes in IC/PBS associated problems when treating interstitial cystitis/painful bladder syndrome with low-dose naltrexone as scored by the Interstitial Cystitis Problem Index, prior to initiating treatment and at the conclusion of 6 weeks of treatment. Scores are from 0-16, with lower scores indicating a better score, with fewer problems associated with IC/PBS. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Change in Urinary Frequency", "description": "The change in number of patient voids during the day when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment and at the conclusion of 6 weeks of treatment. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Change in Number of Nocturia", "description": "The change in number of patient voids during at night when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment and at the conclusion of 6 weeks of treatment. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Change in Pelvic Pain and Urgency/Frequency Symptoms", "description": "The change in pelvic pain and urgency/frequency symptoms as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale, prior to initiating treatment and at the conclusion of 6 weeks of treatment. Scores can range from 0-23, with higher scores indicating more severe symptoms associated with IC/PBS. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Change in Pelvic Pain and Urgency/Frequency Bother", "description": "The change in pelvic pain and urgency/frequency bother as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale, prior to initiating treatment and at the conclusion of 6 weeks of treatment. Scores can range from 0-12, with higher values corresponding to more bother from IC/PBS symptoms. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.", "time_frame": "prior to initiating treatment and at the conclusion of 6 weeks of treatment" }, { "type": "secondary", "measure": "Patient Perceived Quality of Life: SF-36", "description": "Patient perceived quality of life as measured by the medical outcomes study short form 36 (SF-36). Higher scores indicate a more favorable health status. There are 8 subscales, which when averaged, include a score from 0-100.", "time_frame": "six weeks" }, { "type": "secondary", "measure": "Adverse Effects", "description": "The percentage of patients complaining of adverse effects from LDN including vivid dreams, nightmares, insomnia, GI disturbances such as stomach cramps or diarrhea, agitation, anxiety, flu-like symptoms and headaches.", "time_frame": "six weeks" }, { "type": "secondary", "measure": "Medication Tolerability", "description": "The percentage of patients who discontinue the study medication measured by the tolerability survey.", "time_frame": "six weeks" }, { "type": "secondary", "measure": "Number of Days With Pain Medications", "description": "The number of days with pain medication use while using LDN, as determined by a pain medication diary.", "time_frame": "six weeks" } ], "relevance_tags": [ "Immunomodulatory", "Phase 4", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 3, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04313972", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06211062", "title": "The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2025-03-04", "start_date": "2022-12-20", "completion_date": "2026-02-24", "primary_completion_date": "2026-02-24", "conditions_raw": [ "ME/CFS", "IBS - Irritable Bowel Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Floradapt Intensive Gi" ], "sponsor": "Nova Southeastern University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are:\n\n* how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the GI and systemic/brain interface?\n* how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).", "primary_outcomes": [ { "type": "primary", "measure": "The Incidence of Intervention-Related Adverse Events [Safety]", "description": "Safety will be assessed by documenting the frequency and severity of adverse events using a standardized form at each visit.", "time_frame": "from baseline to the eight week visit" }, { "type": "primary", "measure": "The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy]", "description": "The inflammation biomarkers panel will be measured at baseline and during the eight-week visit.\n\nInflammation biomarkers analyses (such as zonulin, LPS (lipopolysaccharide) endotoxin, LBP (lipopolysaccharide-binding protein)", "time_frame": "from baseline to the eight week visit" }, { "type": "primary", "measure": "level of CRP (C-reactive protein)", "description": "CRP (C-reactive protein) will be measured at baseline and the eight-week visit (The Measurement of Biomarker Response)", "time_frame": "from baseline to the eight week visit" }, { "type": "primary", "measure": "The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α", "description": "The Measurement of Biomarker Response : cytokine panel.", "time_frame": "from baseline to the eight week visit" }, { "type": "primary", "measure": "The Symptom Severity Measurement [Efficacy]", "description": "The symptom severity will be measured as a change of scores on the DePaul Symptom Questionnaire (DSQ) from baseline to eight-week visit. The severity and frequency are calculated on the Likert scale, where for severity 0 refers to symptoms not present, and 4 is for very severe, and for the frequency: 0 is for none of the time, and 4 is for all of the time. The score range is from 0 to 216. A higher score means a worse outcome (symptoms are present more often with more severity).", "time_frame": "from baseline to the eight week visit" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The Impact on the Irritable Bowel Syndrome (IBS) Severity", "description": "The impact on the Irritable Bowel Syndrome (IBS) severity will be assessed by response to intervention based on the change in score on the IBS-SSS (Irritable Bowel Syndrome Symptom Severity Scale) questionnaire from a baseline visit to an eight-week visit. Scores response on a 100-point visual analogue scale range from 0 to 500. Subjects can be categorized as mild (75-175), moderate (175-300), or severe (\\>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.", "time_frame": "from baseline to the eight week" }, { "type": "secondary", "measure": "The IBS-related Quality of Life Measurement", "description": "The measurement will be provided using the IBS-QOL (the Irritable Bowel Syndrome Quality of Life Measurement) questionnaire every visit from baseline to week eight. Each item is related on the Likert scale, ranging from 1 to 5 (1 as \"not at all\", 5 as \"extremely\"). Total score ranges from 34 to 170; higher scores mean a lower life quality. A decrease of 10 points is a clinically meaningful improvement.", "time_frame": "from the eight week visit to the 12 week visit" } ], "outcome_measures": [ { "type": "primary", "measure": "The Incidence of Intervention-Related Adverse Events [Safety]", "description": "Safety will be assessed by documenting the frequency and severity of adverse events using a standardized form at each visit.", "time_frame": "from baseline to the eight week visit" }, { "type": "primary", "measure": "The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy]", "description": "The inflammation biomarkers panel will be measured at baseline and during the eight-week visit.\n\nInflammation biomarkers analyses (such as zonulin, LPS (lipopolysaccharide) endotoxin, LBP (lipopolysaccharide-binding protein)", "time_frame": "from baseline to the eight week visit" }, { "type": "primary", "measure": "level of CRP (C-reactive protein)", "description": "CRP (C-reactive protein) will be measured at baseline and the eight-week visit (The Measurement of Biomarker Response)", "time_frame": "from baseline to the eight week visit" }, { "type": "primary", "measure": "The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α", "description": "The Measurement of Biomarker Response : cytokine panel.", "time_frame": "from baseline to the eight week visit" }, { "type": "primary", "measure": "The Symptom Severity Measurement [Efficacy]", "description": "The symptom severity will be measured as a change of scores on the DePaul Symptom Questionnaire (DSQ) from baseline to eight-week visit. The severity and frequency are calculated on the Likert scale, where for severity 0 refers to symptoms not present, and 4 is for very severe, and for the frequency: 0 is for none of the time, and 4 is for all of the time. The score range is from 0 to 216. A higher score means a worse outcome (symptoms are present more often with more severity).", "time_frame": "from baseline to the eight week visit" }, { "type": "secondary", "measure": "The Impact on the Irritable Bowel Syndrome (IBS) Severity", "description": "The impact on the Irritable Bowel Syndrome (IBS) severity will be assessed by response to intervention based on the change in score on the IBS-SSS (Irritable Bowel Syndrome Symptom Severity Scale) questionnaire from a baseline visit to an eight-week visit. Scores response on a 100-point visual analogue scale range from 0 to 500. Subjects can be categorized as mild (75-175), moderate (175-300), or severe (\\>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.", "time_frame": "from baseline to the eight week" }, { "type": "secondary", "measure": "The IBS-related Quality of Life Measurement", "description": "The measurement will be provided using the IBS-QOL (the Irritable Bowel Syndrome Quality of Life Measurement) questionnaire every visit from baseline to week eight. Each item is related on the Likert scale, ranging from 1 to 5 (1 as \"not at all\", 5 as \"extremely\"). Total score ranges from 34 to 170; higher scores mean a lower life quality. A decrease of 10 points is a clinically meaningful improvement.", "time_frame": "from the eight week visit to the 12 week visit" } ], "relevance_tags": [ "Anti-inflammatory", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06211062", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06393790", "title": "Strength Training Protocol in Fibromyalgia Women", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-02-13", "start_date": "2024-04-01", "completion_date": "2025-01-01", "primary_completion_date": "2024-07-30", "conditions_raw": [ "Fibromyalgia", "Fatigue", "Fatigue; Muscle, Heart", "Strength Training", "Stress" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Fmg", "Hg" ], "sponsor": "Catholic University of Murcia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Physical exercise is an effective tool for the prevention of various chronic diseases. Fibromyalgia (FM) is a common chronic pain condition, in which patients may also experience a variety of other symptoms, including sleep disturbances, fatigue, stiffness, frequent episodes of pain and mental health problems, as well as possible gastrointestinal disorders. Furthermore, according to the American College of Rheumatology, such a generalised non-joint pain state occurs for at least three months in duration, predominantly in women over 50 years of age. In turn, chronic fatigue syndrome (CFS) presents as a disease characterised by persistent and debilitating fatigue lasting at least six months.\n\nThe origin of FM and CFS is unknown, although alterations in the central nervous system (CNS), as well as abnormalities in muscle physiology and immune/inflammatory response are suggested as the main causes.\n\nIn addition, most patients with FM are sedentary and in poor physical condition, exacerbated by pain, fatigue or depression, which can limit their daily activities and affect their quality of life and work opportunities. In this regard, physical exercise is considered the most important non-pharmacological strategy for the treatment of FM; however, many clinically relevant questions remain unanswered regarding the most effective approach to exercise therapy in FM patients.\n\nTherefore, the main objective of this project is to analyse the possible physical and mental benefits of a physical exercise programme in people diagnosed with fibromyalgia and/or chronic fatigue syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "PRE-TEST Time up and go test (TUG test)", "description": "The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE-TEST 5 Times Sit to stand test (5TSTS)", "description": "The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST 10 meters walk test", "description": "Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST 2 minutes walk", "description": "Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Upper body dinamometry", "description": "The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Lower body dinamometry", "description": "Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply \"as much force as possible, as fast as possible\" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Sleep assessment: Karolinska Sleepiness Diary", "description": "The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Beck Depression Inventory", "description": "Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST State-Trait Anxiety Inventory", "description": "State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \\& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Perceived stress scale", "description": "The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Pain and fatigue Inventory", "description": "-Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Pittsburgh Sleep Quality Questionnaire (PSQI)", "description": "Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST FIQ (Fibromyalgia Impact Questionnaire)", "description": "FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \\& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Ergospirometry", "description": "The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Heart Rate Variability (HRV)", "description": "HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST BLOOD EXTRACTION", "description": "To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Balance test", "description": "Determination of monopodal and bipodal equilibrium levels.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "POST-TEST Time up and go test (TUG test)", "description": "The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST-TEST 5 Times Sit to stand test (5TSTS)", "description": "The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST 10 meters walk test", "description": "Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST 2 minutes walk", "description": "Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Upper body dinamometry", "description": "The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Lower body dinamometry", "description": "Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply \"as much force as possible, as fast as possible\" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Sleep assessment: Karolinska Sleepiness Diary", "description": "The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Beck Depression Inventory", "description": "Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST State-Trait Anxiety Inventory", "description": "State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \\& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Perceived stress scale", "description": "The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Pain and fatigue Inventory", "description": "-Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Pittsburgh Sleep Quality Questionnaire (PSQI)", "description": "Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST FIQ (Fibromyalgia Impact Questionnaire)", "description": "FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \\& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Ergospirometry", "description": "The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Heart Rate Variability (HRV)", "description": "HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST BLOOD EXTRACTION", "description": "To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Balance test", "description": "Determination of monopodal and bipodal equilibrium levels.", "time_frame": "7 days after protocol ends" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "ACUTE PRE-TEST Time up and go test (TUG test)", "description": "The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST-TEST Time up and go test (TUG test)", "description": "The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE-TEST 5 Times Sit to stand test (5TSTS)", "description": "The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST-TEST 5 Times Sit to stand test (5TSTS)", "description": "The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE TEST 10 meters walk test", "description": "Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST TEST 10 meters walk test", "description": "Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE TEST Upper body dinamometry", "description": "The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST TEST Upper body dinamometry", "description": "The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE TEST Lower body dinamometry", "description": "Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply \"as much force as possible, as fast as possible\" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST TEST Lower body dinamometry", "description": "Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply \"as much force as possible, as fast as possible\" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE TEST Sleep assessment: Karolinska Sleepiness Diary", "description": "The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST TEST Sleep assessment: Karolinska Sleepiness Diary", "description": "The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.", "time_frame": "5 week since the start of the protocol" } ], "outcome_measures": [ { "type": "primary", "measure": "PRE-TEST Time up and go test (TUG test)", "description": "The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE-TEST 5 Times Sit to stand test (5TSTS)", "description": "The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST 10 meters walk test", "description": "Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST 2 minutes walk", "description": "Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Upper body dinamometry", "description": "The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Lower body dinamometry", "description": "Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply \"as much force as possible, as fast as possible\" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Sleep assessment: Karolinska Sleepiness Diary", "description": "The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Beck Depression Inventory", "description": "Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST State-Trait Anxiety Inventory", "description": "State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \\& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Perceived stress scale", "description": "The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Pain and fatigue Inventory", "description": "-Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Pittsburgh Sleep Quality Questionnaire (PSQI)", "description": "Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST FIQ (Fibromyalgia Impact Questionnaire)", "description": "FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \\& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Ergospirometry", "description": "The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Heart Rate Variability (HRV)", "description": "HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST BLOOD EXTRACTION", "description": "To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "PRE TEST Balance test", "description": "Determination of monopodal and bipodal equilibrium levels.", "time_frame": "7 days before protocol starts" }, { "type": "primary", "measure": "POST-TEST Time up and go test (TUG test)", "description": "The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST-TEST 5 Times Sit to stand test (5TSTS)", "description": "The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST 10 meters walk test", "description": "Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST 2 minutes walk", "description": "Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Upper body dinamometry", "description": "The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Lower body dinamometry", "description": "Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply \"as much force as possible, as fast as possible\" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Sleep assessment: Karolinska Sleepiness Diary", "description": "The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Beck Depression Inventory", "description": "Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST State-Trait Anxiety Inventory", "description": "State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \\& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Perceived stress scale", "description": "The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Pain and fatigue Inventory", "description": "-Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Pittsburgh Sleep Quality Questionnaire (PSQI)", "description": "Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST FIQ (Fibromyalgia Impact Questionnaire)", "description": "FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \\& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Ergospirometry", "description": "The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Heart Rate Variability (HRV)", "description": "HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST BLOOD EXTRACTION", "description": "To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.", "time_frame": "7 days after protocol ends" }, { "type": "primary", "measure": "POST TEST Balance test", "description": "Determination of monopodal and bipodal equilibrium levels.", "time_frame": "7 days after protocol ends" }, { "type": "secondary", "measure": "ACUTE PRE-TEST Time up and go test (TUG test)", "description": "The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST-TEST Time up and go test (TUG test)", "description": "The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE-TEST 5 Times Sit to stand test (5TSTS)", "description": "The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST-TEST 5 Times Sit to stand test (5TSTS)", "description": "The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE TEST 10 meters walk test", "description": "Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST TEST 10 meters walk test", "description": "Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE TEST Upper body dinamometry", "description": "The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST TEST Upper body dinamometry", "description": "The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE TEST Lower body dinamometry", "description": "Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply \"as much force as possible, as fast as possible\" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST TEST Lower body dinamometry", "description": "Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply \"as much force as possible, as fast as possible\" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE PRE TEST Sleep assessment: Karolinska Sleepiness Diary", "description": "The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.", "time_frame": "5 week since the start of the protocol" }, { "type": "secondary", "measure": "ACUTE POST TEST Sleep assessment: Karolinska Sleepiness Diary", "description": "The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.", "time_frame": "5 week since the start of the protocol" } ], "relevance_tags": [ "Immunomodulatory", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06393790", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05273372", "title": "RESTORE ME -- RCT of Oxaloacetate on Improving Fatigue in ME/CFS", "status": "COMPLETED", "phase": "NA", "last_updated": "2025-02-04", "start_date": "2022-03-15", "completion_date": "2024-11-15", "primary_completion_date": "2024-06-15", "conditions_raw": [ "Myalgic Encephalomyelitis", "Chronic Fatigue Syndrome", "Fatigue" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Medical Food - Anhydrous Enol-Oxaloacetate" ], "sponsor": "Terra Biological LLC", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "There is no approved treatment for fatigue in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a condition with as many as 2.5 million people in the US. Initial case studies have shown an improvement in fatigue in ME/CFS with anhydrous enol-oxaloacetate (AEO).\n\nThis randomized, double blinded, placebo controlled trial will seek to further evaluate the efficacy of AEO to reduce fatigue in ME/CFS, based on change in the Chalder Fatigue Score (Likert Scoring) of the AEO group against the placebo group at 90 days.\n\nAs secondary evaluations on other core ME/CFS symptoms, the investigators are measuring the health related quality of life as assessed by the SF-36, hours of upright activity, functional capacity (activity, steps, cognition, and heart rate variability), and general health status (global change, vitals)\n\nFinally, this test will gain preliminary insights on the safety, tolerability, and efficacy of AEO in ME/CFS patients.", "primary_outcomes": [ { "type": "primary", "measure": "Reduction of Fatigue", "description": "Reduction in fatigue, Likert Scoring, on the Chalder Fatigue Scale 0-33 Point Scale, with 0 being no fatigue, and 33 being maximum measurable fatigue", "time_frame": "90 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Number of participants with treatment-related adverse events as assessed by CTCAE v4.0", "description": "Comparison of adverse events in the treatment group as opposed to the placebo group", "time_frame": "90 days" }, { "type": "secondary", "measure": "Physical Functioning on the SF-36", "description": "Evaluation of the SF-36 for physical functioning, role physical, bodily pain, and others", "time_frame": "90 days" }, { "type": "secondary", "measure": "Patient Global Impression of Change Questionnaire, 7 point scale, -3 to +3, with the higher score indicating more improvement", "description": "Measurement of patlient's rating of overall improvement", "time_frame": "90 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Reduction of Fatigue", "description": "Reduction in fatigue, Likert Scoring, on the Chalder Fatigue Scale 0-33 Point Scale, with 0 being no fatigue, and 33 being maximum measurable fatigue", "time_frame": "90 days" }, { "type": "secondary", "measure": "Number of participants with treatment-related adverse events as assessed by CTCAE v4.0", "description": "Comparison of adverse events in the treatment group as opposed to the placebo group", "time_frame": "90 days" }, { "type": "secondary", "measure": "Physical Functioning on the SF-36", "description": "Evaluation of the SF-36 for physical functioning, role physical, bodily pain, and others", "time_frame": "90 days" }, { "type": "secondary", "measure": "Patient Global Impression of Change Questionnaire, 7 point scale, -3 to +3, with the higher score indicating more improvement", "description": "Measurement of patlient's rating of overall improvement", "time_frame": "90 days" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 82, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05273372", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05719493", "title": "Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)", "status": "ACTIVE_NOT_RECRUITING", "phase": "NA", "last_updated": "2024-12-18", "start_date": "2021-10-04", "completion_date": "2025-12", "primary_completion_date": "2024-05-31", "conditions_raw": [ "Fibromyalgia", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Multicomponent Treatment" ], "sponsor": "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic pain, fatigue and insomnia are classical symptoms of Fibromyalgia and Chronic Fatigue Syndrome, affecting seriously life quality. Non-pharmacological multicomponent approach is gaining relevance in Fibromyalgia treatment. However, nutrition and chronobiology are often not approached in-depth despite their potential. Furthermore, programs addressed to Chronic Fatigue Syndrome are still scare. This study aims to evaluate the effectiveness of a compact multidisciplinary group intervention based on nutrition, chronobiology and physical exercise in the improvement of lifestyle and life quality in Fibromyalgia and Chronic Fatigue syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "change in quality of life", "description": "to be evaluated with the EuroQol-5D questionnaire. It will be measured by a scale Likert: 0 (worst health) to 100 (better health) and a descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; with five levels of severity in each dimension: no problems, mild problems, moderate problems, severe problems, and extreme problems/impossibility.", "time_frame": "change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "change in fatigue indicator", "description": "to be evaluated with the \"Multidimensional Fatigue Inventory\" (MFI) questionnaire (Smet et al., 1995). It will measure 20-items. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue.", "time_frame": "change from fatigue indicator at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in sleep quality and insomnia indicator", "description": "Sleep quality and insomnia will be assessed with the Pittsburgh Sleep Quality Index (PSQI-19 items) (Buysse et al., 1989). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.", "time_frame": "change from sleep quality and insomnia indicator at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in pain indicator", "description": "To assess pain, the VAS questionnaire will be used (Marques et al., 2008). It will be measured by a scale Likert: 0 (absence of pain) to 10 (worst possible pain).", "time_frame": "change from pain indicator at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in adherence to the Mediterranean diet", "description": "adherence to the Mediterranean diet will be assessed with the erMEDAS-17-item questionnaire (PREDIMED Plus; Schröder et al., 2021). Adherence to dietary habits characteristic of a MedDiet is scored, in each item, with 1 point and the opposite, with 0 points. Total scoring scale goes from 0 to 17 points, where 0 means no adherence and 17, maximum adherence. The score can be also classified into approximate tertiles: low (≤ 7), medium (8-10), and high (11-17).", "time_frame": "change from adherence to the Mediterranean diet at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in physical exercise practice and sedentary lifestyle", "description": "physical exercise practice and sedentary lifestyle will be assessed with the REGICOR-Short questionnaire (Molina et al., 2017). The short questionnaire estimates energy expenditure in total physical activity and by intensity (light, moderate, vigorous) following REGICOR-Short algoritmes, and includes 2 questions about sedentary behavior and a question about occupational physical activity. We will evaluate change in amount of time dedicated to physical activity (minutes or hours) and physical activity intensity per week (energy expenditure or METs x min/week), and change in sedentarism (number of hours per week doing sedentary activities).", "time_frame": "change from physical exercise practice and sedentary lifestyle at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in circadian biological rhythm", "description": "the circadian biological rhythm will be assessed with the \"Biological Rhythms Interview of Assessment in Neuropsychiatry\" (BRIAN) questionnaire (Giglio et al., 2008). The BRIAN includes 18-items to investigate four main areas related to circadian rhythm disturbance: sleep, activities, social rhythms and eating patterns. Items are rated using a 4-point scale, (1)= no difficulty, (2)= mild difficulty, (3)= moderate difficulty, and (4) =severe difficulty. The BRIAN scores thus range from 1 to 72, where the higher scores suggest severe circadian rhythm disturbance.", "time_frame": "change from circadian biological rhythm at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in functional impact of fibromyalgia", "description": "to be evaluatedwith the Revised Questionnaire on the Impact of Fibromyalgia (FIQR). It will be measured by a scale Likert: 0 (best) to 100 (worst).", "time_frame": "change from functional impact of fibromyalgia at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in mood indicator (anxiety)", "description": "To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale llikert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety)", "time_frame": "change from mood indicator (anxiety) at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in food intake", "description": "Will be evaluate through R24h and FFQ (Rodríguez et al., 2008). The R24h will be evaluated qualitatively (number of intakes/day; intake composition, etc.) while the FFQ register weekly and monthly intake of different food (times per week; times per month), and will evaluated qualitatively.", "time_frame": "change from food intake at at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in body mass index (BMI)", "description": "Weight and height will be combined to report BMI in Kg/m2.", "time_frame": "change from BMI at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in body fat", "description": "Body fat (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.", "time_frame": "change from body fat at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in skeletal muscle", "description": "Skeletal muscle (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.", "time_frame": "change from skeletal muscle at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in endurance", "description": "Endurance will be evaluated with the ''6-min walk test' (Rikli and Jones, 1999). This test involves determining the maximum distance (m) that can be walked in 6 min .", "time_frame": "change from endurance at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in lower body muscular strength", "description": "The ''30-s chair stand test''(Rikli and Jones, 1999) involves counting the number of times within 30 s that an individual can rise to a full stand from a seated position with the back straight and the feet flat on the floor, without pushing off with the arms.", "time_frame": "change from lower body muscular strength at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in upper body muscular strength", "description": "The handgrip strength will be assessed using a \"hand dynamometer\". The subject continuously and gradually squeezes for at least 2 s. Each patient completes two attempts with each hand, with the arm fully extended, forming an angle of 30- with respect to the trunk. The maximum score in kilograms for each hand is recorded.", "time_frame": "change from upper body muscular strength at at 1, 3, 6 and 12 months after the beginning of the intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "change in quality of life", "description": "to be evaluated with the EuroQol-5D questionnaire. It will be measured by a scale Likert: 0 (worst health) to 100 (better health) and a descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; with five levels of severity in each dimension: no problems, mild problems, moderate problems, severe problems, and extreme problems/impossibility.", "time_frame": "change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in fatigue indicator", "description": "to be evaluated with the \"Multidimensional Fatigue Inventory\" (MFI) questionnaire (Smet et al., 1995). It will measure 20-items. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue.", "time_frame": "change from fatigue indicator at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in sleep quality and insomnia indicator", "description": "Sleep quality and insomnia will be assessed with the Pittsburgh Sleep Quality Index (PSQI-19 items) (Buysse et al., 1989). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.", "time_frame": "change from sleep quality and insomnia indicator at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in pain indicator", "description": "To assess pain, the VAS questionnaire will be used (Marques et al., 2008). It will be measured by a scale Likert: 0 (absence of pain) to 10 (worst possible pain).", "time_frame": "change from pain indicator at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in adherence to the Mediterranean diet", "description": "adherence to the Mediterranean diet will be assessed with the erMEDAS-17-item questionnaire (PREDIMED Plus; Schröder et al., 2021). Adherence to dietary habits characteristic of a MedDiet is scored, in each item, with 1 point and the opposite, with 0 points. Total scoring scale goes from 0 to 17 points, where 0 means no adherence and 17, maximum adherence. The score can be also classified into approximate tertiles: low (≤ 7), medium (8-10), and high (11-17).", "time_frame": "change from adherence to the Mediterranean diet at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in physical exercise practice and sedentary lifestyle", "description": "physical exercise practice and sedentary lifestyle will be assessed with the REGICOR-Short questionnaire (Molina et al., 2017). The short questionnaire estimates energy expenditure in total physical activity and by intensity (light, moderate, vigorous) following REGICOR-Short algoritmes, and includes 2 questions about sedentary behavior and a question about occupational physical activity. We will evaluate change in amount of time dedicated to physical activity (minutes or hours) and physical activity intensity per week (energy expenditure or METs x min/week), and change in sedentarism (number of hours per week doing sedentary activities).", "time_frame": "change from physical exercise practice and sedentary lifestyle at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in circadian biological rhythm", "description": "the circadian biological rhythm will be assessed with the \"Biological Rhythms Interview of Assessment in Neuropsychiatry\" (BRIAN) questionnaire (Giglio et al., 2008). The BRIAN includes 18-items to investigate four main areas related to circadian rhythm disturbance: sleep, activities, social rhythms and eating patterns. Items are rated using a 4-point scale, (1)= no difficulty, (2)= mild difficulty, (3)= moderate difficulty, and (4) =severe difficulty. The BRIAN scores thus range from 1 to 72, where the higher scores suggest severe circadian rhythm disturbance.", "time_frame": "change from circadian biological rhythm at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in functional impact of fibromyalgia", "description": "to be evaluatedwith the Revised Questionnaire on the Impact of Fibromyalgia (FIQR). It will be measured by a scale Likert: 0 (best) to 100 (worst).", "time_frame": "change from functional impact of fibromyalgia at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in mood indicator (anxiety)", "description": "To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale llikert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety)", "time_frame": "change from mood indicator (anxiety) at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in food intake", "description": "Will be evaluate through R24h and FFQ (Rodríguez et al., 2008). The R24h will be evaluated qualitatively (number of intakes/day; intake composition, etc.) while the FFQ register weekly and monthly intake of different food (times per week; times per month), and will evaluated qualitatively.", "time_frame": "change from food intake at at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in body mass index (BMI)", "description": "Weight and height will be combined to report BMI in Kg/m2.", "time_frame": "change from BMI at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in body fat", "description": "Body fat (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.", "time_frame": "change from body fat at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in skeletal muscle", "description": "Skeletal muscle (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.", "time_frame": "change from skeletal muscle at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in endurance", "description": "Endurance will be evaluated with the ''6-min walk test' (Rikli and Jones, 1999). This test involves determining the maximum distance (m) that can be walked in 6 min .", "time_frame": "change from endurance at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in lower body muscular strength", "description": "The ''30-s chair stand test''(Rikli and Jones, 1999) involves counting the number of times within 30 s that an individual can rise to a full stand from a seated position with the back straight and the feet flat on the floor, without pushing off with the arms.", "time_frame": "change from lower body muscular strength at 1, 3, 6 and 12 months after the beginning of the intervention" }, { "type": "secondary", "measure": "change in upper body muscular strength", "description": "The handgrip strength will be assessed using a \"hand dynamometer\". The subject continuously and gradually squeezes for at least 2 s. Each patient completes two attempts with each hand, with the arm fully extended, forming an angle of 30- with respect to the trunk. The maximum score in kilograms for each hand is recorded.", "time_frame": "change from upper body muscular strength at at 1, 3, 6 and 12 months after the beginning of the intervention" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 86, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05719493", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05168124", "title": "Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis", "status": "RECRUITING", "phase": "NA", "last_updated": "2024-12-16", "start_date": "2023-08-08", "completion_date": "2026-07", "primary_completion_date": "2025-12", "conditions_raw": [ "Fatigue Syndrome, Chronic" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Acceptance Commitment Therapy For Chronic Fatigue", "Micro Breaks In Everyday Life For Chronic Fatigue" ], "sponsor": "Sarah Schiebler", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a distinct disease entity with an estimated prevalence of 0.3-0.7% and more common in women (3:1 ratio). It can be diagnosed according to the Institute of Medicine (IOM) 2015 consensus definition using 3 major criteria and one of 2 minor criteria.\n\nDiagnosis requires that the patient have the following three symptoms:\n\n1. A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest,\n2. Post-exertional malaise,\\* and\n3. Unrefreshing sleep\\*\n\nAt least one of the two following manifestations is also required:\n\n1. Cognitive impairment\\* or\n2. Orthostatic intolerance\n\nNote\\* Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity.\n\nCurrently, individually tailored therapy with emphasis on cognitive behavioral therapy and graduated activity therapy is considered the therapy of first choice, although their effectiveness has been critically questioned in recent years. There are often frustrating treatment courses, a larger proportion of partial remissions, a significantly smaller proportion of full remissions and return to work.\n\nThe study aims to evaluate patients of the outpatient service for chronic fatigue at the Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Switzerland, in the context of a group therapy for the treatment of CFS/ME in respect to the response to different, non-drug based therapeutic procedures and to gain knowledge about the effects of the therapy.\n\nThe study is a clinical comparative study of therapeutic procedures/interventions without the use of drugs or a medical product. The interventions are Acceptance Commitment Therapy (ACT) and Micro Breaks in Everyday Life (MBEL) adapted to CFS/ME. The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale (FSS)", "description": "The FSS comprises 9 questions, by answering which the patient can assess his limitations due to fatigue of the past week on a 7-point scale. The FSS is considered a well-established assessment tool for surveying subjective fatigue, the resulting limitations in daily, social, as well as occupational life and physical activities. Total score 36-52 is indicative of moderate fatigue (\"mild/ no fatigue\" at FSS total ≤ 35, \"moderate fatigue\" at 36 ≤ FSS total ≤ 52), score greater than or equal to 53 is indicative of severe fatigue (\"severe fatigue\" at FSS total ≥ 53).", "time_frame": "The entire duration of the study is 3 years." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale (FSS)", "description": "The FSS comprises 9 questions, by answering which the patient can assess his limitations due to fatigue of the past week on a 7-point scale. The FSS is considered a well-established assessment tool for surveying subjective fatigue, the resulting limitations in daily, social, as well as occupational life and physical activities. Total score 36-52 is indicative of moderate fatigue (\"mild/ no fatigue\" at FSS total ≤ 35, \"moderate fatigue\" at 36 ≤ FSS total ≤ 52), score greater than or equal to 53 is indicative of severe fatigue (\"severe fatigue\" at FSS total ≥ 53).", "time_frame": "The entire duration of the study is 3 years." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 90, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05168124", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05803824", "title": "Qigong Exercise on Fatigue and Postural Imbalance in Lower Limb Burn Injury", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-11-19", "start_date": "2022-12-30", "completion_date": "2023-12-01", "primary_completion_date": "2023-08-30", "conditions_raw": [ "Lower Limb Burn Injury" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Exercise Therapy Program" ], "sponsor": "Cairo University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "90 patients who suffer from chronic fatigue syndrome and postural imbalance following Lower Limb Burn Injury. will be selected from outpatient clinic, faculty of physical therapy, Cairo university. Patients will be assigned randomly into 3 groups of equal numbers, group A: (Study group A) will receive Baduanjin Qigong exercise plus selected exercise program. group B:(Study group B) will receive Baduanjin Qigong exercise, Group C (control group C) will receive selected exercise program .", "primary_outcomes": [ { "type": "primary", "measure": "The Brief Fatigue Inventory (BFI)", "description": "The instrument is used to quickly assess the severity of fatigue experienced by cancer patients, as well as its impact on their ability to function over the previous 24 h.he BFI is a reliable and valid tool with a low respondent burden, suitable for measuring fatigue in burn patients during the first year of recovery.", "time_frame": "3months" }, { "type": "primary", "measure": "b. The dynamic balance score", "description": "c. The dynamic balance score that was measured by the Biodex Balance System (Biodex Medical System, Shirley, NY, USA). Biodex Balance System is a valid and reliable method to assess the dynamic balance. The system has a movable circular platform that permits about 20◦ tilt in 360◦ range so it is free to move about the anterior-posterior and mediallateral directions simultaneously", "time_frame": "3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "b. The timed up and go (TUG) test", "description": "e. The timed up and go (TUG) test is a basic mobility assessment tool that records the time taken (in seconds) to get up from a chair, walk 3-meter distance, come back and sit down again on the chair", "time_frame": "3 months" }, { "type": "secondary", "measure": "c. The Activities-specific Balance (ABC) scale", "description": "d. The Activities-specific Balance (ABC) scale is a popular and subjective questionnaire to assess balance confidence and the risk of fall in people with balance problems.34 The ABC scale consisted of 16 items with a total score between 0% (not confident) to 100% (completely confident), where higher scores equate to higher balance confidence and vice versa. The Arabic version of the ABC scale is reliable and valid in the assessment of balance confidence.", "time_frame": "3months" } ], "outcome_measures": [ { "type": "primary", "measure": "The Brief Fatigue Inventory (BFI)", "description": "The instrument is used to quickly assess the severity of fatigue experienced by cancer patients, as well as its impact on their ability to function over the previous 24 h.he BFI is a reliable and valid tool with a low respondent burden, suitable for measuring fatigue in burn patients during the first year of recovery.", "time_frame": "3months" }, { "type": "primary", "measure": "b. The dynamic balance score", "description": "c. The dynamic balance score that was measured by the Biodex Balance System (Biodex Medical System, Shirley, NY, USA). Biodex Balance System is a valid and reliable method to assess the dynamic balance. The system has a movable circular platform that permits about 20◦ tilt in 360◦ range so it is free to move about the anterior-posterior and mediallateral directions simultaneously", "time_frame": "3 months" }, { "type": "secondary", "measure": "b. The timed up and go (TUG) test", "description": "e. The timed up and go (TUG) test is a basic mobility assessment tool that records the time taken (in seconds) to get up from a chair, walk 3-meter distance, come back and sit down again on the chair", "time_frame": "3 months" }, { "type": "secondary", "measure": "c. The Activities-specific Balance (ABC) scale", "description": "d. The Activities-specific Balance (ABC) scale is a popular and subjective questionnaire to assess balance confidence and the risk of fall in people with balance problems.34 The ABC scale consisted of 16 items with a total score between 0% (not confident) to 100% (completely confident), where higher scores equate to higher balance confidence and vice versa. The Arabic version of the ABC scale is reliable and valid in the assessment of balance confidence.", "time_frame": "3months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 90, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05803824", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06635928", "title": "Bright Light Therapy in ME/CFS Patients", "status": "COMPLETED", "phase": "NA", "last_updated": "2024-10-10", "start_date": "2021-01-01", "completion_date": "2024-03-25", "primary_completion_date": "2024-03-25", "conditions_raw": [ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Bright Light Therapy" ], "sponsor": "Medical University of Vienna", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In this study patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) will receive bright light therapy through portable lamps for 2 weeks. They will either start with this treatment and then go through a wash-out period of two weeks followed by a wait period of two weeks or they will start with the wait period, followed by a wash-out period, followed by the treatment phase. Patients are asked to fill out questionnaires (rating their level of fatigue) and they go through a standardized computer test assessing their attention levels, both at multiple times throughout the study. The aim of this study is to find out if treatment with bright light will improve subjective fatigue levels and objective attention levels inME/CFS patients.", "primary_outcomes": [ { "type": "primary", "measure": "Chalder Fatigue Score", "description": "subjective Fatigue score", "time_frame": "As a baseline variable: day 1 of inclusion in the study, day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Test of Attentional Performance", "description": "three subtests of attention", "time_frame": "On day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list" } ], "outcome_measures": [ { "type": "primary", "measure": "Chalder Fatigue Score", "description": "subjective Fatigue score", "time_frame": "As a baseline variable: day 1 of inclusion in the study, day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list" }, { "type": "secondary", "measure": "Test of Attentional Performance", "description": "three subtests of attention", "time_frame": "On day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 36, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06635928", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06235177", "title": "Psychoneuromentalism Disorder: A Medical Condition That Affects People With Psychological Impairments From Health Issues", "status": "UNKNOWN", "phase": "EARLY_PHASE1", "last_updated": "2024-08-12", "start_date": "2024-10-10", "completion_date": "2025-09-19", "primary_completion_date": "2025-06-29", "conditions_raw": [ "Schizoaffective Disorder, Bipolar Type", "Bipolar Disorder", "ADHD - Combined Type", "Dissociative Disorder", "Stress Disorder", "Dementia", "Anxiety", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Decompartmentalization Framework", "Liquid Herbal Tinctures", "Mental Imagery", "Clinical Yoga", "Dietary Supplements", "Applied Relaxation", "Pain Relaxation Techniques", "Comprehensive Theocentric Psychological Assessment" ], "sponsor": "The Essence of Integrative Health and Medicine Practice", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Psychoneuromentalism Disorder is a disorder arising in the mind; that is related to the mental and emotional state of a person. It is the science of mental life. The body has a natural design to heal itself. This is a mental phenomena that cannot be explained, until now.\n\nPsychoneuromentalism Disorder is a new condition resulting from behavioral impairments, neurodiversity, and neurobehavioral dysfunctions that are related to the mental and emotional state of a participant.", "primary_outcomes": [ { "type": "primary", "measure": "Primary Outcomes for those diagnosed with Psychoneuromentalism Disorder", "description": "Memory will become more clear.", "time_frame": "4-6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Primary Outcomes for those diagnosed with Psychoneuromentalism Disorder", "description": "An improvement in mental health and psychological symptoms and functioning across various domains in life", "time_frame": "8-12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Primary Outcomes for those diagnosed with Psychoneuromentalism Disorder", "description": "Memory will become more clear.", "time_frame": "4-6 weeks" }, { "type": "secondary", "measure": "Primary Outcomes for those diagnosed with Psychoneuromentalism Disorder", "description": "An improvement in mental health and psychological symptoms and functioning across various domains in life", "time_frame": "8-12 weeks" } ], "relevance_tags": [ "General", "EARLY_Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06235177", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06145867", "title": "A Feasibility Study: Assessing Photobiomodulation in Myalgic Encephalomyelitis", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-04-29", "start_date": "2024-04-24", "completion_date": "2024-08-01", "primary_completion_date": "2024-08-01", "conditions_raw": [ "Myalgic Encephalomyelitis", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Photobiomodulation Therapy" ], "sponsor": "Quadram Institute Bioscience", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "There is no cure or approved treatments for ME. Several causes have been implicated in ME, including poor mitochondrial function. Mitochondria are the powerhouse of cells, producing energy. Therefore, loss of mitochondrial function and reduced energy production could be an explanation for the debilitating chronic fatigue that defines ME.\n\nThe primary site of red light absorption in cells is the mitochondria. Mitochondrial red light absorption can boost energy production. Light therapy is already FDA approved for the treatment of acne, muscle and joint pain, arthritis, blood circulation issues and hair loss. This is the first study to trial the use of red light therapy in ME and results will help us understand if the use of red light therapy is accepted by ME patients.\n\nIn past clinical trials the monitoring of symptom reduction/increase in ME patients was mainly done using symptom questionnaires. These questionnaires have not been specifically developed for ME symptoms and therefore the reliability of results is poor. This study will be assessing the use of a new symptom questionnaire developed specifically for ME and will also be trialling the use of other tools to measure symptom reduction/increase.\n\nIn addition, this study will also trial the use of Mantal, an online remote research management portal. This is to improve accessibility of ME patients to research participation.\n\nEach ME participants involvement in the study should take approximately 7 weeks. Involvement is split into four phases: 1) baseline, 2) intervention, 3) follow-up and 4) feedback.\n\nBaseline assessments:\n\n* Week one: complete a 27-item questionnaire on functional capacity (FUNCAP27) and online cognitive function tests\n* Week two: participants are posted an activity monitor which they are to wear for seven days. Participants will complete a sleep diary (consensus sleep diary version E) for seven days\n\nIntervention:\n\n\\- Participants are posted the red lamp to use in their own homes during weeks three and four. Participants use the red lamp for two minutes, daily, each morning for a total of 14 days.\n\nFollow-up:\n\n* Weeks five and six\n* Repeating the baseline assessments\n\nFeedback:\n\n\\- Participants are asked to complete an online questionnaire during week seven.", "primary_outcomes": [ { "type": "primary", "measure": "Compliance of PBM therapy in ME patients.", "description": "Compliance will be measured when participants log in daily into Mantal study portal to confirm the use of the lamp during the 14 days from week 3 to 4.", "time_frame": "Week 3 and 4" }, { "type": "primary", "measure": "Acceptance of PBM therapy in ME patients.", "description": "Acceptance will be measured at week 7 using the Feedback questionnaire which will ask about ease of setting up the red lamp (PBM), ease of use during the 14 day intervention and future use of lamp. The responses are binary (YES or NO). Greater number of YES responses compared to NO responses will indicate that PBM therapy was acceptable in ME patients.", "time_frame": "Week 7" }, { "type": "primary", "measure": "Safety of PBM therapy in ME patients.", "description": "Self-reported adverse reaction or event by participants to the red (PBM) lamp will be used to measure safety. Safety will be measured at week 3 (start of intervention) through week 4 (at the end of intervention) and at week 7 (feedback questionnaire). The severity of the adverse event will be reported using the University of East Anglia and Norfolk and Norwich University Hospitals SOP 205 guidelines. Safety will be reported as mild, moderate, or severe. PBM therapy in ME patients will be regarded safe when severity of self-reported adverse reaction is no greater than mild in severity.", "time_frame": "Week 3, 4, and 7" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Compliance of the GENEActiv accelerometers in ME patients", "description": "Compliance will be measured with daily completion of the consensus sleep diary version E during the 7-day intervention at week 2.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Acceptance of the GENEActiv accelerometers in ME patients", "description": "Acceptance will be measured at week 2 when participants initially sign into Mantal study portal at the start of intervention and at week 7 with the Feedback questionnaire which will ask about ease of wearing the accelerometer. The responses are binary (YES or NO). Greater number of YES responses compared to NO responses will indicate that the GENEActiv accelerometers was acceptable in ME patients.", "time_frame": "Week 2 and week 7" }, { "type": "secondary", "measure": "Safety of GENEActiv accelerometers in ME patients.", "description": "Self-reported adverse reaction or event by participants to the accelerometer. Safety will be measured at week 2 (during intervention), at week 6 (follow-up phase) and at week 7 (feedback questionnaire). The severity of the adverse event will be reported using the University of East Anglia and Norfolk and Norwich University Hospitals SOP 205 guidelines. Safety will be reported as mild, moderate, or severe. GENEActiv accelerometers in ME patients will be regarded safe when severity of self-reported adverse reaction is no greater than mild in severity.", "time_frame": "Week 2, 6, and 7" }, { "type": "secondary", "measure": "Changes in NeurOn (online cognitive function assessments) completion rates in ME patients.", "description": "Comparison of the completion rates in NeurOn will be assessed at baseline (week 1) and follow up visit (week 5).", "time_frame": "Week 1 and 5" }, { "type": "secondary", "measure": "Acceptability of NeurOn in ME patients.", "description": "Feedback questionnaire at week 7 regarding NeurON (online cognitive function assessments) will be used to measure the ease of using an online cognitive function test and the acceptability of the number of assessments that were administered during the study.", "time_frame": "Week 7" }, { "type": "secondary", "measure": "Acceptability of FUNCAP27 in ME patients.", "description": "Feedback questionnaire at week 7 regarding FUNCAP27 (quantitative assessment of functional capacity) will be use to measure the acceptability of the length of FUNCAP27 assessment and ability to understand the questions in FUNCAP27.", "time_frame": "Week 7" }, { "type": "secondary", "measure": "Compliance of the consensus sleep diary version E (CSD-E) in ME patients.", "description": "Number of completed daily sleeping diaries submitted during the 7 day intervention (week 2)", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Acceptability of the consensus sleep diary version E (CSD-E) in ME patients.", "description": "Feedback questionnaire at week 7 regarding consensus sleep diary version E will be used to measure the acceptability by assessing the ease of use and frequency of sleep diary documentation (day and evenings).", "time_frame": "Week 7." }, { "type": "secondary", "measure": "Acceptability of Mantal in ME patients.", "description": "Feedback questionnaire at week 7 regarding Mantal (online study and participant management tool) will be used to measure acceptability by assess the ease of using Mantal study portal and use of online informed consent procedure, and the notifications sent by Mantal.", "time_frame": "week 7" } ], "outcome_measures": [ { "type": "primary", "measure": "Compliance of PBM therapy in ME patients.", "description": "Compliance will be measured when participants log in daily into Mantal study portal to confirm the use of the lamp during the 14 days from week 3 to 4.", "time_frame": "Week 3 and 4" }, { "type": "primary", "measure": "Acceptance of PBM therapy in ME patients.", "description": "Acceptance will be measured at week 7 using the Feedback questionnaire which will ask about ease of setting up the red lamp (PBM), ease of use during the 14 day intervention and future use of lamp. The responses are binary (YES or NO). Greater number of YES responses compared to NO responses will indicate that PBM therapy was acceptable in ME patients.", "time_frame": "Week 7" }, { "type": "primary", "measure": "Safety of PBM therapy in ME patients.", "description": "Self-reported adverse reaction or event by participants to the red (PBM) lamp will be used to measure safety. Safety will be measured at week 3 (start of intervention) through week 4 (at the end of intervention) and at week 7 (feedback questionnaire). The severity of the adverse event will be reported using the University of East Anglia and Norfolk and Norwich University Hospitals SOP 205 guidelines. Safety will be reported as mild, moderate, or severe. PBM therapy in ME patients will be regarded safe when severity of self-reported adverse reaction is no greater than mild in severity.", "time_frame": "Week 3, 4, and 7" }, { "type": "secondary", "measure": "Compliance of the GENEActiv accelerometers in ME patients", "description": "Compliance will be measured with daily completion of the consensus sleep diary version E during the 7-day intervention at week 2.", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Acceptance of the GENEActiv accelerometers in ME patients", "description": "Acceptance will be measured at week 2 when participants initially sign into Mantal study portal at the start of intervention and at week 7 with the Feedback questionnaire which will ask about ease of wearing the accelerometer. The responses are binary (YES or NO). Greater number of YES responses compared to NO responses will indicate that the GENEActiv accelerometers was acceptable in ME patients.", "time_frame": "Week 2 and week 7" }, { "type": "secondary", "measure": "Safety of GENEActiv accelerometers in ME patients.", "description": "Self-reported adverse reaction or event by participants to the accelerometer. Safety will be measured at week 2 (during intervention), at week 6 (follow-up phase) and at week 7 (feedback questionnaire). The severity of the adverse event will be reported using the University of East Anglia and Norfolk and Norwich University Hospitals SOP 205 guidelines. Safety will be reported as mild, moderate, or severe. GENEActiv accelerometers in ME patients will be regarded safe when severity of self-reported adverse reaction is no greater than mild in severity.", "time_frame": "Week 2, 6, and 7" }, { "type": "secondary", "measure": "Changes in NeurOn (online cognitive function assessments) completion rates in ME patients.", "description": "Comparison of the completion rates in NeurOn will be assessed at baseline (week 1) and follow up visit (week 5).", "time_frame": "Week 1 and 5" }, { "type": "secondary", "measure": "Acceptability of NeurOn in ME patients.", "description": "Feedback questionnaire at week 7 regarding NeurON (online cognitive function assessments) will be used to measure the ease of using an online cognitive function test and the acceptability of the number of assessments that were administered during the study.", "time_frame": "Week 7" }, { "type": "secondary", "measure": "Acceptability of FUNCAP27 in ME patients.", "description": "Feedback questionnaire at week 7 regarding FUNCAP27 (quantitative assessment of functional capacity) will be use to measure the acceptability of the length of FUNCAP27 assessment and ability to understand the questions in FUNCAP27.", "time_frame": "Week 7" }, { "type": "secondary", "measure": "Compliance of the consensus sleep diary version E (CSD-E) in ME patients.", "description": "Number of completed daily sleeping diaries submitted during the 7 day intervention (week 2)", "time_frame": "Week 2" }, { "type": "secondary", "measure": "Acceptability of the consensus sleep diary version E (CSD-E) in ME patients.", "description": "Feedback questionnaire at week 7 regarding consensus sleep diary version E will be used to measure the acceptability by assessing the ease of use and frequency of sleep diary documentation (day and evenings).", "time_frame": "Week 7." }, { "type": "secondary", "measure": "Acceptability of Mantal in ME patients.", "description": "Feedback questionnaire at week 7 regarding Mantal (online study and participant management tool) will be used to measure acceptability by assess the ease of using Mantal study portal and use of online informed consent procedure, and the notifications sent by Mantal.", "time_frame": "week 7" } ], "relevance_tags": [ "Metabolic", "Mitochondrial", "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 10, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT06145867", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05130099", "title": "A Complex Intervention for Chronically Fatigued Lymphoma Survivors", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-04-08", "start_date": "2021-11-20", "completion_date": "2025-06-30", "primary_completion_date": "2023-06-30", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Interdisciplinary Complex Intervention" ], "sponsor": "Oslo University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The present study is a randomized controlled trial (RCT) with an overall objective to examine the effect of an interdisciplinary complex intervention on the level of fatigue in lymphoma survivors with chronic fatigue. Secondary aims are to examine the effects of the intervention on daily functioning, work status/ability, physical fitness and QoL among the survivors, on QoL of their relatives and on the societal costs.The intervention will last for 12+12 weeks and include four components; patient education, supervised physical exercise, cognitive behavioral program and nutritional counselling. Outcomes will be assessed at baseline,post-intervention (12 weeks after baseline) and at 3-month, 6-month, 12-month and 24-month follow-up after completed intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3. This provides a physical fatigue score from 0 to 21, mental fatigue score from 0 to 12, and total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From baseline (T0) to 12 weeks (T1)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From post-intervention (T1) to 12-month follow-up (T4)" }, { "type": "secondary", "measure": "Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From post-intervention (T1) to 24-month follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From post-intervention (T1) to 12-month follow-up (T4)" }, { "type": "secondary", "measure": "Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From post-intervention (T1) to 24-month follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From post-intervention (T1) to 12-month follow-up (T4)" }, { "type": "secondary", "measure": "Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From post-intervention (T1) to 24-month follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in work status between groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in work status between groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in work status between groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in work status in both groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in work status in both groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)", "description": "Peak oxygen uptake (VO2peak) is measured", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)", "description": "Peak oxygen uptake (VO2peak) is measured", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)", "description": "Peak oxygen uptake (VO2peak) is measured", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test", "description": "In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test", "description": "In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test", "description": "In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in lower body muscle strength between groups assessed by leg press", "description": "The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in lower body muscle strength between groups assessed by leg press", "description": "The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in lower body muscle strength between groups assessed by leg press", "description": "The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in lower body muscle strength between groups assessed by push-ups", "description": "The maximum number of push-ups that can be performed in one set", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in upper body muscle strength between groups assessed by push-ups", "description": "The maximum number of push-ups that can be performed in one set", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in upper body muscle strength between groups assessed by push-ups", "description": "The maximum number of push-ups that can be performed in one set", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From post-intervention (T1) to 12-month follow-up (T4)" }, { "type": "secondary", "measure": "Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From post-intervention (T1) to 24-month follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each item is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 12 months follow-up weeks (T4)" }, { "type": "secondary", "measure": "Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 24 months follow-up weeks (T5)" }, { "type": "secondary", "measure": "Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in adherence to the Norwegian food-based dietary guidelines between groups assessed by DIGIKOST-FFQ", "description": "DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ", "description": "DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ", "description": "DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)", "description": "EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain \\& discomfort, anxiety \\& depression), each of which has five severity levels that are described by statements appropriate to that dimension.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)", "description": "EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain \\& discomfort, anxiety \\& depression), each of which has five severity levels that are described by statements appropriate to that dimension.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)", "description": "EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain \\& discomfort, anxiety \\& depression), each of which has five severity levels that are described by statements appropriate to that dimension.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)", "description": "RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)", "description": "RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)", "description": "RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 36 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Cost-effectiveness of the intervention, calculated based on measurements of health-related QoL and resource use (costs related to the intervention).", "description": "Combining information about health-related QoL will give quality-adjusted life-years, while valuation of resource use using standard principles of health economic evaluation will provide estimates of costs", "time_frame": "From baseline (0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Perceived benefits of the intervention components assessed by questions used in and modified from the PasOpp study from the Directorate of Health in Norway", "description": "Questions assessing benefits of the intervention", "time_frame": "At 12- and 24-month follow-up" }, { "type": "secondary", "measure": "Use of information, experiences, strategies and advices learned in the intervention program assessed by self-made questions", "description": "Questions assessing daily use of information, strategies and advices learned in the intervention program", "time_frame": "At 12- and 24-month follow-up" } ], "outcome_measures": [ { "type": "primary", "measure": "Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3. This provides a physical fatigue score from 0 to 21, mental fatigue score from 0 to 12, and total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From post-intervention (T1) to 12-month follow-up (T4)" }, { "type": "secondary", "measure": "Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire", "description": "The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.", "time_frame": "From post-intervention (T1) to 24-month follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From post-intervention (T1) to 12-month follow-up (T4)" }, { "type": "secondary", "measure": "Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.\n\nA high score for a functional scale represents a high / healthy level of functioning.", "time_frame": "From post-intervention (T1) to 24-month follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From post-intervention (T1) to 12-month follow-up (T4)" }, { "type": "secondary", "measure": "Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From post-intervention (T1) to 24-month follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in work status between groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in work status between groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in work status between groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in work status in both groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in work status in both groups assessed by questions from the HUNT4-study", "description": "Participants are asked to report their current work status", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index scale", "description": "Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job", "description": "Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job", "description": "Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)", "description": "Peak oxygen uptake (VO2peak) is measured", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)", "description": "Peak oxygen uptake (VO2peak) is measured", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)", "description": "Peak oxygen uptake (VO2peak) is measured", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test", "description": "In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test", "description": "In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test", "description": "In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in lower body muscle strength between groups assessed by leg press", "description": "The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in lower body muscle strength between groups assessed by leg press", "description": "The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in lower body muscle strength between groups assessed by leg press", "description": "The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in lower body muscle strength between groups assessed by push-ups", "description": "The maximum number of push-ups that can be performed in one set", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in upper body muscle strength between groups assessed by push-ups", "description": "The maximum number of push-ups that can be performed in one set", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in upper body muscle strength between groups assessed by push-ups", "description": "The maximum number of push-ups that can be performed in one set", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From post-intervention (T1) to 12-month follow-up (T4)" }, { "type": "secondary", "measure": "Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9", "description": "Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.", "time_frame": "From post-intervention (T1) to 24-month follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each item is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 12 months follow-up weeks (T4)" }, { "type": "secondary", "measure": "Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).", "description": "Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.", "time_frame": "From baseline (T0) to 24 months follow-up weeks (T5)" }, { "type": "secondary", "measure": "Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From post-intervention (T1) to 12 months follow-up (T4)" }, { "type": "secondary", "measure": "Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.", "description": "The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.", "time_frame": "From post-intervention (T1) to 24 months follow-up (T5)" }, { "type": "secondary", "measure": "Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale", "description": "The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in adherence to the Norwegian food-based dietary guidelines between groups assessed by DIGIKOST-FFQ", "description": "DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ", "description": "DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ", "description": "DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)", "description": "EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain \\& discomfort, anxiety \\& depression), each of which has five severity levels that are described by statements appropriate to that dimension.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)", "description": "EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain \\& discomfort, anxiety \\& depression), each of which has five severity levels that are described by statements appropriate to that dimension.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)", "description": "EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain \\& discomfort, anxiety \\& depression), each of which has five severity levels that are described by statements appropriate to that dimension.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)", "description": "RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)", "description": "RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)", "description": "RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 12 weeks (T1)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 24 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 36 weeks (T2)" }, { "type": "secondary", "measure": "Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).", "description": "The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.", "time_frame": "From baseline (T0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Cost-effectiveness of the intervention, calculated based on measurements of health-related QoL and resource use (costs related to the intervention).", "description": "Combining information about health-related QoL will give quality-adjusted life-years, while valuation of resource use using standard principles of health economic evaluation will provide estimates of costs", "time_frame": "From baseline (0) to 36 weeks (T3)" }, { "type": "secondary", "measure": "Perceived benefits of the intervention components assessed by questions used in and modified from the PasOpp study from the Directorate of Health in Norway", "description": "Questions assessing benefits of the intervention", "time_frame": "At 12- and 24-month follow-up" }, { "type": "secondary", "measure": "Use of information, experiences, strategies and advices learned in the intervention program assessed by self-made questions", "description": "Questions assessing daily use of information, strategies and advices learned in the intervention program", "time_frame": "At 12- and 24-month follow-up" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 150, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05130099", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04151693", "title": "Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)", "status": "RECRUITING", "phase": "NA", "last_updated": "2024-04-03", "start_date": "2019-11-30", "completion_date": "2028-05-31", "primary_completion_date": "2028-05-31", "conditions_raw": [ "Psychological Adaptation", "Cognitive Change", "Adaptive Behavior", "Functioning" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Health Psychological Group Rehabilitation For Patients With Chronic Fatigue Syndrome" ], "sponsor": "Joint Authority for Päijät-Häme Social and Health Care", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome (ME/CFS) is a severe medical condition. It is characterized by long term fatique and other persisted symptoms, such as a cognitive disabilities and orthostatic intolerance. Symptoms limit a persons ability to carry out ordinary daily activities. In ICD- 10, disease is known as G93.3, postviral fatigue syndrome.\n\nThe purpose of this research (doctoral study) is to produce a health psychological group intervention for patients with ME/CFS.\n\nResearch protocol: 70-80 patients with diagnosis G 93.3. Psychological and psychiatric evaluation for patients (SCID I and parts from SCID II). Depression diagnosis is allowed (on remission). Medication for depression is also allowed. Measurements for ortostatic intolerance (Somnotouch nimbTM) and laboratory measurements: complete blood count, CRP, alkaline phosphatase, GT, ALAT, CK, bilirubin, kidney and thyroid (TSH, T4V) function tests, serum ferritin, glucose, electrolytes and daily urine sodium excretion.\n\nAutonomic nervous system ganglio antibodies: Anti-AT1R- Antibodies, Anti- ETAR- Antibodies, anti alpha-1 adrenergic Receptor Antibodies, anti alpha 2 adrenergic Receptor Antibodies, anti beta-1 adrenergic Receptor Antibodies, anti beta-2-adrenergic Receptor Antibodies, anti- Muscarinic Cholinergic Receptor 1 (M1)- Antibodies, anti- Muscarinic Cholinergic Receptor 2 (M2)- Antibodies, anti- Muscarinic Cholinergic Receptor 3 (M3)- Antibodies, anti- Muscarinic Cholinergic Receptor 4 (M4)- Antibodies, anti- Muscarinic Cholinergic Receptor 5 (M5)- Antibodies.", "primary_outcomes": [ { "type": "primary", "measure": "WHODAS 22.0 (World Health Organization Disability Assessment Schedule) 2.0.", "description": "36 questions, scale 0-5 (not difficult at all-very difficult) Subscales: 1)communication with other people 2) Mobility/ movement in everyday activities 3)Daily functions and taking care of oneself 4) Relationships 5) Daily routines 6) Disabilities in last 30 days 7)Participating on community", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" }, { "type": "primary", "measure": "COMPASS31", "description": "Autonomic nervous system/ neurological symptoms, inventory,31 questions. Subscales: different neurological symptoms, scales from 0-1 to 0-7. Score is reported on subscales.", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "HADS (Hospital Anxiety and Depression Scale)", "description": "Depression and anxiety, inventory,14 questions, scale 0-3. Total score is reported (0-7:normal- 8-10:borderline-11-21:abnormal)", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" }, { "type": "secondary", "measure": "SOC-14 (Sense Of Coherence)", "description": "Sense of coherence, inventory, 14 questions, scale 0-7. Total score is reported/ scores are reported on subscales: (comprehensibility, manageability, meaningfulness)", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" }, { "type": "secondary", "measure": "FSS (Fatigue severity scale)", "description": "Fatigue severity scale,9 questions, scale 0-7 (I strongly disagree- I strongly agree) total score is reported.", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" }, { "type": "secondary", "measure": "PHQ-4 (patient health questionnaire)", "description": "Depression and anxiety, inventory, 4 guestions. Subscales: anxiety and depression. Total score is reported ( 0-1 none,3-5 mild, 6-8 moderate, 10-12 severe)", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" } ], "outcome_measures": [ { "type": "primary", "measure": "WHODAS 22.0 (World Health Organization Disability Assessment Schedule) 2.0.", "description": "36 questions, scale 0-5 (not difficult at all-very difficult) Subscales: 1)communication with other people 2) Mobility/ movement in everyday activities 3)Daily functions and taking care of oneself 4) Relationships 5) Daily routines 6) Disabilities in last 30 days 7)Participating on community", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" }, { "type": "primary", "measure": "COMPASS31", "description": "Autonomic nervous system/ neurological symptoms, inventory,31 questions. Subscales: different neurological symptoms, scales from 0-1 to 0-7. Score is reported on subscales.", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" }, { "type": "secondary", "measure": "HADS (Hospital Anxiety and Depression Scale)", "description": "Depression and anxiety, inventory,14 questions, scale 0-3. Total score is reported (0-7:normal- 8-10:borderline-11-21:abnormal)", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" }, { "type": "secondary", "measure": "SOC-14 (Sense Of Coherence)", "description": "Sense of coherence, inventory, 14 questions, scale 0-7. Total score is reported/ scores are reported on subscales: (comprehensibility, manageability, meaningfulness)", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" }, { "type": "secondary", "measure": "FSS (Fatigue severity scale)", "description": "Fatigue severity scale,9 questions, scale 0-7 (I strongly disagree- I strongly agree) total score is reported.", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" }, { "type": "secondary", "measure": "PHQ-4 (patient health questionnaire)", "description": "Depression and anxiety, inventory, 4 guestions. Subscales: anxiety and depression. Total score is reported ( 0-1 none,3-5 mild, 6-8 moderate, 10-12 severe)", "time_frame": "Before intervention and change immediately after the intervention and 3 months follow up" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04151693", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01156922", "title": "B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome", "status": "TERMINATED", "phase": "PHASE2", "last_updated": "2024-03-04", "start_date": "2010-06", "completion_date": "2016-04", "primary_completion_date": "2016-04", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Rituximab" ], "sponsor": "Haukeland University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that severely affected chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.\n\nThe hypothesis is that at least a subset of chronic fatigue syndrome (CFS) patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.\n\nAn approved amendment (April 15th 2011): the study will be extended with up to 5 patients. For up to 5 patients in the study, standard plasma exchange may be performed 2-3 weeks prior to start of B-lymphocyte depletion using Rituximab (as in the protocol).\n\nApproved amendment (December 2011): for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.", "primary_outcomes": [ { "type": "primary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes", "description": "The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.", "time_frame": "Major response of at least six weeks duration, independent on when occuring, during the follow-up period" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The secondary outcome measures are effect on the CFS symptoms, by evaluation at 3, 6, 10, 15, 20, 24, 30, and 36 months after first intervention (i.e. first Rituximab infusion)", "time_frame": "At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes", "description": "The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.", "time_frame": "Major response of at least six weeks duration, independent on when occuring, during the follow-up period" }, { "type": "secondary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The secondary outcome measures are effect on the CFS symptoms, by evaluation at 3, 6, 10, 15, 20, 24, 30, and 36 months after first intervention (i.e. first Rituximab infusion)", "time_frame": "At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention" } ], "relevance_tags": [ "Immunomodulatory", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 8, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01156922", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03691987", "title": "The Comeback Study", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2024-02-23", "start_date": "2019-02-15", "completion_date": "2023-12-31", "primary_completion_date": "2023-03-01", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Preprocessed Thawed Donor Fmt", "Preprocessed Thawed Autologous Fmt" ], "sponsor": "University Hospital of North Norway", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a single-center stratified (on gender and donor), block randomized, placebo-controlled, parallel group trial with 12-months follow-up of 80 chronic fatigue syndrome/encephalomyelitis (CFS/ME) participants. Participants will be randomized to treatment by preprocessed thawed donor fecal microbiota transplant or preprocessed thawed autologous fecal microbiota transplant. Primary endpoint is the efficacy of FMT at three months by the Fatigue Severity Scale. The investigators will use patient reported outcomes for primary and secondary outcome measures.\n\nPrevious studies suggest that a dysbiosis of the gut microbiota may be a key feature in CFS/ME. We hypothesize that\n\nA: CFS/ME is caused by a dysbiosis in the gut flora causing barrier leakage of bacterial products, a low grade systemic immune activation and disturbances in the host energy metabolism.\n\nB: Recovery of a normal gut flora by fecal microbiota transplantation (FMT) alleviates symptoms and may even induce remission of CFS/ME.\n\nThis project aims to determine if there is a true cause and effect relationship between a dysbiotic gut flora and CFS/ME by testing if treatment of the observed dysbiosis by FMT also can resolve CFS/ME symptoms. In this process, collection of blood, fecal, and urine samples before and after FMT will open the possibility to explore the relationship between the gut flora, immune response, host energy metabolism and CFS/ME using technologies of microbiomics, metabolomics and immunological characterizations for a better understanding of the pathobiology of CFS/ME.", "primary_outcomes": [ { "type": "primary", "measure": "Proportion with treatment success in FSS score in donor versus placebo FMT group. Treatment success is defined as an improvement of more than 1.2 points on the Fatigue Severity Scale (FSS)", "description": "Fatigue Severity Scale (FSS) is a self-reported, 9-item fatigue scale. Participants rate all 9 items on a 7-point Likert scale (1-2-3-4-5-6-7) depending on how appropriate they felt the statement applied to them over the preceding week. The total score is calculated by adding up the answer from each item and divide by 9. Lower scores indicate better outcomes. Maximum score is 7.\n\nIn an intention to treat analysis we will categorize participants as responders/non-responders, defining responders as decrease of more than 1,2 to the total baseline score in the FSS at 3 months post FMT by Chi Square. Baseline score will be the average of the two scores from the screening period. Missing values will be regarded as non responders", "time_frame": "Three months after treatment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in donor versus placebo FMT group in fatigue by the Fatigue Severity Scale score", "description": "", "time_frame": "Change in Fatigue severity scale by repeated measures from baseline and until 1, 3, 6, 9 and 12 months after treatment" }, { "type": "secondary", "measure": "Change in donor versus placebo FMT group in quality of life by the SF36 score", "description": "The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "Change in SF36 score by repeated measures from baseline and until 3 and 12 months after treamtent" }, { "type": "secondary", "measure": "Change in donor versus placebo FMT group in neurocognitive function by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score from baseline and until 3 months after treatment.", "description": "RBANS is a neuropsychological assessment that consists of ten subtests which give scores to five domains: Immediate memory, visuospatial/constructional ability, language, attention and delayed memory.", "time_frame": "Change from baseline and until three months after treatment" }, { "type": "secondary", "measure": "Change in donor versus placebo FMT group in anxiety and depression by the Hospital Anxiety Depression Scale (HADS) score", "description": "HADS is an instrument with 14-items for detection of depression and anxiety in hospitalized patients. Scores range from 1-21 interpreted as: normal (0-7), mild (8-10), moderate (11-14), severe (15-21). Subscales for anxiety (HADS-A) and depression (HADS-D) is also defined. We will explore the FMT effects on HADS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in global score. We will apply last value forward for missing values.", "time_frame": "Change in HADS score by repeated measures from baseline and until 3 and 12 months after treatment" }, { "type": "secondary", "measure": "Change in donor versus placebo FMT group in gastrointestinal related complaints by the sum score of selected items in the DePaul Questionnaire (DPQ) (29, 30, 46 and 47)", "description": "The DPQ assesses key symptoms of ME/CFS such as fatigue, gastrointestinal complaints, post-exertional malaise, sleep, pain, neurological/cognitive impairments and autonomic, neuroendocrine and immune symptoms. At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. We wil use the sum score from the questions that assess gastrointestinal complaints in the DPQ in this endpoint. This endpoint was implemented after 19 out of 80 participants had completed the three months follow up", "time_frame": "Change in DPQ score by repeated measures from baseline and until 6 and 12 months after treatment" }, { "type": "secondary", "measure": "Number of Participants with Adverse Events as a Measure of Safety and Tolerability", "description": "Participants will be screened for adverse events from the time of informed consent through the end of the trial. In case of an identified adverse event, this will be recorded and described in the CRF", "time_frame": "Baseline to end of follow up at 12 months after FMT" }, { "type": "secondary", "measure": "Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in continuous ECG recordings. The primary vagal function outcome will be differences in changes from pre-post treatment between groups in High Frequency HRV (HF-HRV; in ms2", "description": "Firstbeat Bodyguard will record R-R interval and the Firstbeat life style assessment software will analyze the R-R interval recording and provide the outcome measure", "time_frame": "3 months after treatment" }, { "type": "secondary", "measure": "Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in the resting continuous ECG recordings. The secondary vagal function outcome will be differences in changes from pre-post treatment between groups in RMSSD (RMSSD; in ms2)", "description": "", "time_frame": "3 months after treatment" }, { "type": "secondary", "measure": "Difference in mean baseline HRV (HF-HRV and RMSSD) between responders vs non-responders to donor FMT.", "description": "As defined by the primary endpoint in the clinical study, a responder will be defined as an improvement of more than 1.2 points on the Fatigue Severity Scale (FSS) from baseline and until 3 months after treatment. To determine HRV in each group we will use High Frequency Power analysis denominating HRV in ms2.", "time_frame": "3 months after treatment" } ], "outcome_measures": [ { "type": "primary", "measure": "Proportion with treatment success in FSS score in donor versus placebo FMT group. Treatment success is defined as an improvement of more than 1.2 points on the Fatigue Severity Scale (FSS)", "description": "Fatigue Severity Scale (FSS) is a self-reported, 9-item fatigue scale. Participants rate all 9 items on a 7-point Likert scale (1-2-3-4-5-6-7) depending on how appropriate they felt the statement applied to them over the preceding week. The total score is calculated by adding up the answer from each item and divide by 9. Lower scores indicate better outcomes. Maximum score is 7.\n\nIn an intention to treat analysis we will categorize participants as responders/non-responders, defining responders as decrease of more than 1,2 to the total baseline score in the FSS at 3 months post FMT by Chi Square. Baseline score will be the average of the two scores from the screening period. Missing values will be regarded as non responders", "time_frame": "Three months after treatment" }, { "type": "secondary", "measure": "Change in donor versus placebo FMT group in fatigue by the Fatigue Severity Scale score", "description": "", "time_frame": "Change in Fatigue severity scale by repeated measures from baseline and until 1, 3, 6, 9 and 12 months after treatment" }, { "type": "secondary", "measure": "Change in donor versus placebo FMT group in quality of life by the SF36 score", "description": "The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.", "time_frame": "Change in SF36 score by repeated measures from baseline and until 3 and 12 months after treamtent" }, { "type": "secondary", "measure": "Change in donor versus placebo FMT group in neurocognitive function by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score from baseline and until 3 months after treatment.", "description": "RBANS is a neuropsychological assessment that consists of ten subtests which give scores to five domains: Immediate memory, visuospatial/constructional ability, language, attention and delayed memory.", "time_frame": "Change from baseline and until three months after treatment" }, { "type": "secondary", "measure": "Change in donor versus placebo FMT group in anxiety and depression by the Hospital Anxiety Depression Scale (HADS) score", "description": "HADS is an instrument with 14-items for detection of depression and anxiety in hospitalized patients. Scores range from 1-21 interpreted as: normal (0-7), mild (8-10), moderate (11-14), severe (15-21). Subscales for anxiety (HADS-A) and depression (HADS-D) is also defined. We will explore the FMT effects on HADS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in global score. We will apply last value forward for missing values.", "time_frame": "Change in HADS score by repeated measures from baseline and until 3 and 12 months after treatment" }, { "type": "secondary", "measure": "Change in donor versus placebo FMT group in gastrointestinal related complaints by the sum score of selected items in the DePaul Questionnaire (DPQ) (29, 30, 46 and 47)", "description": "The DPQ assesses key symptoms of ME/CFS such as fatigue, gastrointestinal complaints, post-exertional malaise, sleep, pain, neurological/cognitive impairments and autonomic, neuroendocrine and immune symptoms. At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. We wil use the sum score from the questions that assess gastrointestinal complaints in the DPQ in this endpoint. This endpoint was implemented after 19 out of 80 participants had completed the three months follow up", "time_frame": "Change in DPQ score by repeated measures from baseline and until 6 and 12 months after treatment" }, { "type": "secondary", "measure": "Number of Participants with Adverse Events as a Measure of Safety and Tolerability", "description": "Participants will be screened for adverse events from the time of informed consent through the end of the trial. In case of an identified adverse event, this will be recorded and described in the CRF", "time_frame": "Baseline to end of follow up at 12 months after FMT" }, { "type": "secondary", "measure": "Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in continuous ECG recordings. The primary vagal function outcome will be differences in changes from pre-post treatment between groups in High Frequency HRV (HF-HRV; in ms2", "description": "Firstbeat Bodyguard will record R-R interval and the Firstbeat life style assessment software will analyze the R-R interval recording and provide the outcome measure", "time_frame": "3 months after treatment" }, { "type": "secondary", "measure": "Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in the resting continuous ECG recordings. The secondary vagal function outcome will be differences in changes from pre-post treatment between groups in RMSSD (RMSSD; in ms2)", "description": "", "time_frame": "3 months after treatment" }, { "type": "secondary", "measure": "Difference in mean baseline HRV (HF-HRV and RMSSD) between responders vs non-responders to donor FMT.", "description": "As defined by the primary endpoint in the clinical study, a responder will be defined as an improvement of more than 1.2 points on the Fatigue Severity Scale (FSS) from baseline and until 3 months after treatment. To determine HRV in each group we will use High Frequency Power analysis denominating HRV in ms2.", "time_frame": "3 months after treatment" } ], "relevance_tags": [ "Metabolic", "Immunomodulatory", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03691987", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06227273", "title": "Hydrogen Water Dosing Study for ME/CFS", "status": "UNKNOWN", "phase": "NA", "last_updated": "2024-01-26", "start_date": "2023-12-01", "completion_date": "2024-11-30", "primary_completion_date": "2024-11-01", "conditions_raw": [ "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Hydrogen Water" ], "sponsor": "Stony Brook University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of this 16-week pilot randomized trial is to explore the potential benefit of the OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Methods: This 16-week home-based trial will compare two groups: (1) low dose hydrogen water (2-3 glasses/day) for all 16 weeks; and (2) low dose followed by high dose hydrogen water (up to 5 glasses/day). Condition (2) involves an initial 8 weeks of low dose H2 followed by 8 weeks of high dose H2 in order to test the premise that the higher dosage will be more effective with fewer adverse effects if preceded by several weeks of low dose H2. Outcomes measures will include online assessments of fatigue, physical function and stress. A salivary biomarker for oxidative stress, Uric Acid, will also be assessed.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "Self-report measure of effect of fatigue on functioning.", "time_frame": "16 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "SF-36 PF", "description": "Self-report physical function measure", "time_frame": "16 weeks" }, { "type": "secondary", "measure": "Depression, Anxiety and Stress Scale", "description": "Self-report measure of depression, anxiety and stress symptoms", "time_frame": "16 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "Self-report measure of effect of fatigue on functioning.", "time_frame": "16 weeks" }, { "type": "secondary", "measure": "SF-36 PF", "description": "Self-report physical function measure", "time_frame": "16 weeks" }, { "type": "secondary", "measure": "Depression, Anxiety and Stress Scale", "description": "Self-report measure of depression, anxiety and stress symptoms", "time_frame": "16 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06227273", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05630378", "title": "Evaluation of an Integrative Medicine Outpatient Clinical Setting for Post-COVID-19 Patients", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-12-04", "start_date": "2022-05-11", "completion_date": "2023-06-30", "primary_completion_date": "2023-02-01", "conditions_raw": [ "COVID-19", "Fatigue" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Outpatient Clinic With Multimodal Integrative Medicine And Naturopathy For Post-Covid-19 Patients", "Waiting Group" ], "sponsor": "Universität Duisburg-Essen", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The study aims to identify whether a multimodal integrative naturopathy outpatient clinical concept can improve the symptoms of patients suffering from post-COVID-Syndrome. Main outcome is fatigue. The outpatient clinical programme consists of 11 weeks wherein patients visit the clinic one day per week. The pillars of classical naturopathy are combined with extended naturopathy and complementary procedures. Previous naturopathical studies on patients with chronic fatigue syndrome could find numerous indications that different types of naturopathy can help patients with fatigue.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue - Change from week 0 to week 11", "description": "measured with MFI-20 questionnaire and Chalder fatigue scale MFI-20: 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Higher total scores correspond with more acute levels of fatigue.\n\nChalder fatigue scale: a questionnaire to measure the severity of tiredness in fatiguing illnesses. The 11-item chalder fatigue scale is often divided into two components: one that measures physical fatigue (questions 1-7) and one that measures mental fatigue (questions 8-11).", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Quality of life 1", "description": "SF-12: Short Form of the Health Survey Questionnaire is a 12-item, patient-reported survey of patient health. It is a reduced size version of the SF-36, and is widely used.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression", "description": "HADS: Hospital Anxiety and Depression Scale, 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. High scores indicate depressivness and anxiety.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Perceived Stress", "description": "PSS-10: Perceived Stress Scale, Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "perceived Pain", "description": "BPI: Brief Pain Inventory, An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. Higher scores indicate higher average pain/pain impairment.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Quality of life 2", "description": "EQ-5D: Quality of life EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Sleep Quality", "description": "PSQI: Der Pittsburgh Sleep Quality Index It contains seven subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. All items refer to the last four weeks and are assessed either in four frequency levels or in an open-end format. A total sum score from 0 - 21 can be derived from the subscales with higher scores indicating higher sleep disturbance.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Resilience", "description": "BRS: Brief Resilience Scale Questionnaire A 6-item questionnaire to assess the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience).", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue - Change from week 0 to week 11", "description": "measured with MFI-20 questionnaire and Chalder fatigue scale MFI-20: 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Higher total scores correspond with more acute levels of fatigue.\n\nChalder fatigue scale: a questionnaire to measure the severity of tiredness in fatiguing illnesses. The 11-item chalder fatigue scale is often divided into two components: one that measures physical fatigue (questions 1-7) and one that measures mental fatigue (questions 8-11).", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Quality of life 1", "description": "SF-12: Short Form of the Health Survey Questionnaire is a 12-item, patient-reported survey of patient health. It is a reduced size version of the SF-36, and is widely used.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression", "description": "HADS: Hospital Anxiety and Depression Scale, 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. High scores indicate depressivness and anxiety.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Perceived Stress", "description": "PSS-10: Perceived Stress Scale, Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "perceived Pain", "description": "BPI: Brief Pain Inventory, An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. Higher scores indicate higher average pain/pain impairment.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Quality of life 2", "description": "EQ-5D: Quality of life EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Sleep Quality", "description": "PSQI: Der Pittsburgh Sleep Quality Index It contains seven subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. All items refer to the last four weeks and are assessed either in four frequency levels or in an open-end format. A total sum score from 0 - 21 can be derived from the subscales with higher scores indicating higher sleep disturbance.", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" }, { "type": "secondary", "measure": "Resilience", "description": "BRS: Brief Resilience Scale Questionnaire A 6-item questionnaire to assess the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience).", "time_frame": "before start of intervention (week 0) and afterwards (week 11)" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 42, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05630378", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04378634", "title": "Epigenetics of Post-exertional Malaise in Patients With ME/CFS", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-11-07", "start_date": "2021-04-01", "completion_date": "2023-04-30", "primary_completion_date": "2023-04-30", "conditions_raw": [ "Fatigue Syndrome, Chronic" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Exercise", "Mental Stress Test" ], "sponsor": "Vrije Universiteit Brussel", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Exploring epigenetic mechanisms of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) is crucial to understand the mechanisms underlying its pathophysiology. Three potential candidates have been selected (BDNF, COMT, and HDAC genes). DNA methylation in the promoter regions of those genes will be explored.\n\nThe investigators designed a randomised controlled trial and will enrol 70 patients with ME/CFS and 35 age-, sex-, and BMI-matched healthy controls. Both groups will be randomised in 2 groups and receive either one session of aerobic exercise or a validated test designed to trigger mental stress and mental fatigue. The primary aim is to assess genetic and epigenetic mechanisms of BDNF, COMT and HDAC genes in response to exercise and the stress task.", "primary_outcomes": [ { "type": "primary", "measure": "DNA methylation", "description": "DNA methylation measured at several CpGs of the genes' promoter regions using pyrosequencing technology", "time_frame": "Baseline through 1 week post intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Clinical Symptoms", "description": "Symptoms reported by the patients using the DePaul Symptoms Questionniare", "time_frame": "Baseline through 1 week post intervention" }, { "type": "secondary", "measure": "Pain sensitivity", "description": "Sensitivity to mechanical stimuli using a digital algometer (FPXTM, Fisher, Wagner Instruments, Greenwich) as well as heat and cold stimuli using the TSA-II device (Medoc, CA, USA). The devices will be placed, in random order to prevent test order effects, at three different body sites: the skin web between thumb and index finger, trapezius muscle, and proximal third of tibialis anterior muscle, in order to test pain thresholds on non-specific locations both on the extremities and the trunk.", "time_frame": "Baseline through 1 week post intervention" }, { "type": "secondary", "measure": "Serum BDNF", "description": "BDNF protein expression in serum using Enzyme-Linked Immunosorbent Assay (ELISA) kit for human BDNF", "time_frame": "Baseline through 1 week post intervention" }, { "type": "secondary", "measure": "Cortisol response", "description": "Cortisol will be measured in saliva and used as a measure of stress responses using LC/MS-MS method.", "time_frame": "Baseline through 1 week post intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "DNA methylation", "description": "DNA methylation measured at several CpGs of the genes' promoter regions using pyrosequencing technology", "time_frame": "Baseline through 1 week post intervention" }, { "type": "secondary", "measure": "Clinical Symptoms", "description": "Symptoms reported by the patients using the DePaul Symptoms Questionniare", "time_frame": "Baseline through 1 week post intervention" }, { "type": "secondary", "measure": "Pain sensitivity", "description": "Sensitivity to mechanical stimuli using a digital algometer (FPXTM, Fisher, Wagner Instruments, Greenwich) as well as heat and cold stimuli using the TSA-II device (Medoc, CA, USA). The devices will be placed, in random order to prevent test order effects, at three different body sites: the skin web between thumb and index finger, trapezius muscle, and proximal third of tibialis anterior muscle, in order to test pain thresholds on non-specific locations both on the extremities and the trunk.", "time_frame": "Baseline through 1 week post intervention" }, { "type": "secondary", "measure": "Serum BDNF", "description": "BDNF protein expression in serum using Enzyme-Linked Immunosorbent Assay (ELISA) kit for human BDNF", "time_frame": "Baseline through 1 week post intervention" }, { "type": "secondary", "measure": "Cortisol response", "description": "Cortisol will be measured in saliva and used as a measure of stress responses using LC/MS-MS method.", "time_frame": "Baseline through 1 week post intervention" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 105, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04378634", "extraction_date": "2026-10-07" }, { "nct_id": "NCT06012552", "title": "Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of Tianeptine in the Treatment of Covid Fog Symptoms in Patients After COVID-19.", "status": "RECRUITING", "phase": "PHASE2", "last_updated": "2023-08-25", "start_date": "2023-02-17", "completion_date": "2027-10-31", "primary_completion_date": "2027-04-30", "conditions_raw": [ "Nervous System Diseases" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Tianeptine" ], "sponsor": "Military Institute od Medicine National Research Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "COVID-19 is associated with a high risk of complications from the central nervous system. Syndrome of cognitive disorders- in terms of memory, attention or executive functions among COVID-19 convalescents is often called brain fog (covid fog - CF). CF leads to psychomotor retardation and chronic fatigue syndrome, resulting in poor functioning and low quality of life. CF may affect up to 81% of patients after COVID-19.\n\nPrevalence of CF may be even greater among patients with severe forms of COVID-19. In the preliminary assessment authors found that 83% of COVID-19 inpatients had at least mild cognitive impairment. Moreover, SARS-CoV-2 infection is associated with higher incidence of depression and anxiety disorders. CF pathogenesis is not fully understood. There exist no strict diagnostic criteria for it, as well as no therapeutic recommendations. Health care systems of many countries, including Poland, lack therapeutic programs addressed at patients with CF. Tianeptine may be a drug with potentially beneficial effects in CF. Neuroprotective, antidepressive, sleep-improving and anxiolytic properties of tianeptine allow it to choose as a candidate for CF amelioration. There is also data supporting the thesis that patients with CF may benefit from short-term group therapy. It has been proven to improve quality of life, reduce stress, and improve cognitive function in non-MC cognitive disorders.\n\nExpected research results: A database will be created from the collected clinical, laboratory and additional data. Statistical models will be created to predict: the duration of disorders, response to therapy, the final result of treatment. Among the markers of CNS damage, those which correlates with the patient's condition will be selected.\n\nThe study will allow to estimate the prevalence of CF in the population. PET-CT and auditory evoked potentials also will be used to expand knowledge in the field of CF.\n\nBased on the existing data, an improvement is expected in all investigated participants as a result of rehabilitation and psychotherapy.\n\nAdditional improvement is expected in the tianeptine group. Improvement will be defined as: reduction in the severity of anxiety and depression disorders, reduction in the severity of cognitive disorders, improvement in the quality of life. The results will be used to develop a new diagnostic and therapeutic pathway and a comprehensive intervention program in CF.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement in covid fog symptoms", "description": "Improvement in covid fog symptoms at week 16 after randomization defined as a 2 point improvement in MoCA score.", "time_frame": "16 week after randomization" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "improving cognitive function", "description": "Complete resolution of covid fog symptoms at week 16 after randomization defined as normalization of MoCA scale score (MoCA = 26\n\n\\- 30 points).", "time_frame": "16 week after randomization" }, { "type": "secondary", "measure": "Change in brain metabolic activity", "description": "Change in brain metabolic activity as assessed by PET-CT at week 16 after randomization.", "time_frame": "16 week after randomization" } ], "outcome_measures": [ { "type": "primary", "measure": "Improvement in covid fog symptoms", "description": "Improvement in covid fog symptoms at week 16 after randomization defined as a 2 point improvement in MoCA score.", "time_frame": "16 week after randomization" }, { "type": "secondary", "measure": "improving cognitive function", "description": "Complete resolution of covid fog symptoms at week 16 after randomization defined as normalization of MoCA scale score (MoCA = 26\n\n\\- 30 points).", "time_frame": "16 week after randomization" }, { "type": "secondary", "measure": "Change in brain metabolic activity", "description": "Change in brain metabolic activity as assessed by PET-CT at week 16 after randomization.", "time_frame": "16 week after randomization" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 140, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT06012552", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04026425", "title": "Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-07-07", "start_date": "2018-08-01", "completion_date": "2023-03-31", "primary_completion_date": "2022-03-15", "conditions_raw": [ "Myalgic Encephalomyelitis", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Two-Day Cardiopulmonary Exercise Test" ], "sponsor": "Ithaca College", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study aims to collect and identify key outcome measures or disease parameters in ME/CFS that are altered during elevated symptoms relative to baseline by gathering information before and after symptom provocation using a two-day cardiopulmonary exercise test.", "primary_outcomes": [ { "type": "primary", "measure": "Volume of oxygen consumed at peak effort", "description": "Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Volume of oxygen consumed at ventilatory/anaerobic threshold (VAT)", "description": "VAT is a non-invasive surrogate measure for anaerobic threshold, which is indicated during incremental exercise by a non-linear increase in rate of carbon dioxide production relative to rate of oxygen consumption.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Rate of work performed at peak effort", "description": "Rate of work performed at peak effort during CPET 1 and during CPET 2. Rate of work is measured in Watts.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Rate of work performed at VAT", "description": "Rate of work performed at VAT during CPET 1 and during CPET 2. Rate of work is measured in Watts.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Heart rate at peak effort", "description": "Heart rate at peak effort during CPET 1 and during CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Heart rate at VAT", "description": "Heart rate at VAT during CPET 1 and during CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Systolic blood pressure at seated rest", "description": "Systolic blood pressure at seated rest 1-minute before the start of CPET 1 and 1-minute before the start of CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Systolic blood pressure at peak effort", "description": "Systolic blood pressure at peak effort during CPET 1 and during CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Respiratory Exchange Ratio (RER) at peak effort", "description": "RER at peak effort during CPET 1 and during CPET 2. RER is calculated as the rate of carbon dioxide production divided by the rate of oxygen consumption, and during exercise is an indicator of participant effort.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Volume of oxygen consumed at peak effort", "description": "Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Volume of oxygen consumed at ventilatory/anaerobic threshold (VAT)", "description": "VAT is a non-invasive surrogate measure for anaerobic threshold, which is indicated during incremental exercise by a non-linear increase in rate of carbon dioxide production relative to rate of oxygen consumption.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Rate of work performed at peak effort", "description": "Rate of work performed at peak effort during CPET 1 and during CPET 2. Rate of work is measured in Watts.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Rate of work performed at VAT", "description": "Rate of work performed at VAT during CPET 1 and during CPET 2. Rate of work is measured in Watts.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Heart rate at peak effort", "description": "Heart rate at peak effort during CPET 1 and during CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Heart rate at VAT", "description": "Heart rate at VAT during CPET 1 and during CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Systolic blood pressure at seated rest", "description": "Systolic blood pressure at seated rest 1-minute before the start of CPET 1 and 1-minute before the start of CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Systolic blood pressure at peak effort", "description": "Systolic blood pressure at peak effort during CPET 1 and during CPET 2.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." }, { "type": "primary", "measure": "Respiratory Exchange Ratio (RER) at peak effort", "description": "RER at peak effort during CPET 1 and during CPET 2. RER is calculated as the rate of carbon dioxide production divided by the rate of oxygen consumption, and during exercise is an indicator of participant effort.", "time_frame": "During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date." } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 173, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04026425", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03849326", "title": "Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2023-04-26", "start_date": "2023-12", "completion_date": "2025-04", "primary_completion_date": "2025-03", "conditions_raw": [ "Chronic Fatigue Syndrome", "Intensive Care Unit", "Muscle" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Blood Test", "Maximal Effort Test", "Actigraphy", "Neuromuscular Evaluation" ], "sponsor": "Centre Hospitalier Universitaire de Saint Etienne", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life.\n\nThe aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve life quality.", "primary_outcomes": [ { "type": "primary", "measure": "voluntary maximum force reduction", "description": "", "time_frame": "at 2 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Neuromuscular function : cortical activity", "description": "Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation", "time_frame": "at 2 weeks" }, { "type": "secondary", "measure": "Neuromuscular function : Peripheral function", "description": "Peripheral function by electrical nerve stimulation", "time_frame": "at visit 2" }, { "type": "secondary", "measure": "Maximal oxygen uptake (VO2max)", "description": "measured by effort test", "time_frame": "at 2 weeks" }, { "type": "secondary", "measure": "quality of sleep", "description": "measured by actigraphy", "time_frame": "at baseline" }, { "type": "secondary", "measure": "Quadriceps muscle volume (optional)", "description": "with Magnetic resonance imaging", "time_frame": "at 3 weeks" }, { "type": "secondary", "measure": "muscle dysfunction (optional)", "description": "measured by a Phosphorus 31 Nuclear magnetic resonance test", "time_frame": "at 3 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "voluntary maximum force reduction", "description": "", "time_frame": "at 2 weeks" }, { "type": "secondary", "measure": "Neuromuscular function : cortical activity", "description": "Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation", "time_frame": "at 2 weeks" }, { "type": "secondary", "measure": "Neuromuscular function : Peripheral function", "description": "Peripheral function by electrical nerve stimulation", "time_frame": "at visit 2" }, { "type": "secondary", "measure": "Maximal oxygen uptake (VO2max)", "description": "measured by effort test", "time_frame": "at 2 weeks" }, { "type": "secondary", "measure": "quality of sleep", "description": "measured by actigraphy", "time_frame": "at baseline" }, { "type": "secondary", "measure": "Quadriceps muscle volume (optional)", "description": "with Magnetic resonance imaging", "time_frame": "at 3 weeks" }, { "type": "secondary", "measure": "muscle dysfunction (optional)", "description": "measured by a Phosphorus 31 Nuclear magnetic resonance test", "time_frame": "at 3 weeks" } ], "relevance_tags": [ "Persistence / Antiviral", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT03849326", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04301609", "title": "Clinical Trial to Assess the Improvement of Fatigue, Sleep Problems, Anxiety / Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome Patients", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-03-15", "start_date": "2021-11-10", "completion_date": "2023-01-31", "primary_completion_date": "2022-12-30", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Active" ], "sponsor": "Vitae Health Innovation", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Chronic Fatigue Syndrome, also known as Myalgic Encephalomyelitis (CFS / MS) is a medical entity characterized mainly by debilitating and prolonged fatigue lasting more than 6 months, post-exertion fatigue (physical and / or mental), non-sleep restorative, cognitive impairment and orthostatic intolerance with prolonged recovery that is not relieved by rest. Currently, the etiopathogenic mechanisms of the disease are not known, although mitochondrial dysfunction with bioenergetic immuno-metabolism alterations, oxidative stress, and immuno-inflammatory response stands out. At present, there is no diagnostic test, nor effective treatment in the disease. ImmunoVita, is a food supplement composed of the latest yeast beta-glucans, in addition to vitamin D3, vitamin B6 and zinc, which could contribute to the normal functioning of the immune system and the inflammatory response.", "primary_outcomes": [ { "type": "primary", "measure": "Perception of fatigue (FIS-40).", "description": "The Fatigue Impact Scale (FIS-40) is a 40-item questionnaire designed to assess fatigue symptoms as part of an underlying chronic condition. It includes three domains reflecting the perceived feeling of fatigue: physical (10 items), cognitive (10 items) and psychosocial functions (20 items). Each item is scored from 0 (no fatigue) to 4 (severe fatigue). The overall score is calculated by adding together the responses to the 40 questions (ranging from 0 to 160). Higher scores indicate more functional limitations due to fatigue.", "time_frame": "9 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Sleep dysfunction (Pittsburg questionnaire)", "description": "The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-administrated questionnaire commonly used to assess sleep disturbances over a 1-month interval. Scores are acquired on each of seven domains of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each domain is scored from 0 to 3 (0 = no problems and 3 = severe problems). The overall PSQI score ranges from 0 to 21 points, with scores of \\> 5 indicating poorer sleep quality.", "time_frame": "9 months" }, { "type": "secondary", "measure": "Hospital anxiety-depression scale (HAD)", "description": "To assess anxiety and depression symptoms the Hospital Anxiety and Depression Scale (HADS) was used; a validated 14 item self-reported measure (seven items associated with anxiety symptoms and seven with depression) over the last week. Each item is scored on a 4-point Likert scale (e.g., 0 = as much as I always do; 1 = not quite so much; 2 = definitely not so much; and 3 = not at all) giving maximum subscale scores of 21 for depression and anxiety, respectively. Scores of 0-7 are interpreted as normal; scores of 8-10 reflect mild symptoms, 11-14 moderate, and 15-21 severe for either anxiety or depression. The global HADS score ranges from 0 (no anxiety/depression) to 42 (severe anxiety/depression).", "time_frame": "9 months" }, { "type": "secondary", "measure": "Quality of life (SF-36)", "description": "The SF-36 questionnaire was used to assess health-related quality of life. This is a 36-item broadly-based self-report survey of physical and mental functioning status related to health. The SF-36 assesses functioning on eight subscales including domains of physical functioning, physical role functioning, bodily pain, general health perception, vitality, social role functioning, emotional role functioning, and mental health. Lower scores indicate a more negative impact of an individual's health on functioning.", "time_frame": "9 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Perception of fatigue (FIS-40).", "description": "The Fatigue Impact Scale (FIS-40) is a 40-item questionnaire designed to assess fatigue symptoms as part of an underlying chronic condition. It includes three domains reflecting the perceived feeling of fatigue: physical (10 items), cognitive (10 items) and psychosocial functions (20 items). Each item is scored from 0 (no fatigue) to 4 (severe fatigue). The overall score is calculated by adding together the responses to the 40 questions (ranging from 0 to 160). Higher scores indicate more functional limitations due to fatigue.", "time_frame": "9 months" }, { "type": "secondary", "measure": "Sleep dysfunction (Pittsburg questionnaire)", "description": "The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-administrated questionnaire commonly used to assess sleep disturbances over a 1-month interval. Scores are acquired on each of seven domains of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each domain is scored from 0 to 3 (0 = no problems and 3 = severe problems). The overall PSQI score ranges from 0 to 21 points, with scores of \\> 5 indicating poorer sleep quality.", "time_frame": "9 months" }, { "type": "secondary", "measure": "Hospital anxiety-depression scale (HAD)", "description": "To assess anxiety and depression symptoms the Hospital Anxiety and Depression Scale (HADS) was used; a validated 14 item self-reported measure (seven items associated with anxiety symptoms and seven with depression) over the last week. Each item is scored on a 4-point Likert scale (e.g., 0 = as much as I always do; 1 = not quite so much; 2 = definitely not so much; and 3 = not at all) giving maximum subscale scores of 21 for depression and anxiety, respectively. Scores of 0-7 are interpreted as normal; scores of 8-10 reflect mild symptoms, 11-14 moderate, and 15-21 severe for either anxiety or depression. The global HADS score ranges from 0 (no anxiety/depression) to 42 (severe anxiety/depression).", "time_frame": "9 months" }, { "type": "secondary", "measure": "Quality of life (SF-36)", "description": "The SF-36 questionnaire was used to assess health-related quality of life. This is a 36-item broadly-based self-report survey of physical and mental functioning status related to health. The SF-36 assesses functioning on eight subscales including domains of physical functioning, physical role functioning, bodily pain, general health perception, vitality, social role functioning, emotional role functioning, and mental health. Lower scores indicate a more negative impact of an individual's health on functioning.", "time_frame": "9 months" } ], "relevance_tags": [ "Metabolic", "Immunomodulatory", "Mitochondrial", "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 67, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04301609", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05194059", "title": "'Activity Pacing' in PLWH With Fatigue Symptoms.", "status": "COMPLETED", "phase": "NA", "last_updated": "2023-01-18", "start_date": "2021-12-03", "completion_date": "2022-10-28", "primary_completion_date": "2022-10-28", "conditions_raw": [ "Hiv" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Home-Based Physical Activity" ], "sponsor": "Scientific Institute San Raffaele", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Physical activity helps to improve health and prevent chronic diseases. However, the fatigue usually hampers the training and execution of physical exercises, especially in people with chronic fatigue syndromes (CFCs), such as persons living with HIV (PLWH). We hypothesize that the \"activity pacing\", i.e. the strategy to optimize daily physical activity into manageable exercises in a way that should not exacerbate fatigue symptoms, may help a progressive improvement in physical activity of a group of PLWH with fatigue symptoms. Motivation and adherence to exercise will be monitored through the use of digital supports.", "primary_outcomes": [ { "type": "primary", "measure": "Activity pacing improvement", "description": "To compare the improvement in the physical fitness between the Experimental Group and Control Group", "time_frame": "16 week" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Activity pacing improvement", "description": "To compare the improvement in the physical fitness between the Experimental Group and Control Group", "time_frame": "16 week" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 24, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05194059", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04532827", "title": "Web-based Rehabilitation for Persistent Physical Symptoms.", "status": "UNKNOWN", "phase": "NA", "last_updated": "2023-01-04", "start_date": "2020-08-18", "completion_date": "2023-09-30", "primary_completion_date": "2023-07-01", "conditions_raw": [ "Persistent Physical Symptoms", "Indoor Environment Associated Symptoms", "Indoor Air Associated Symptoms", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Case Formulation With Web-Program" ], "sponsor": "Finnish Institute of Occupational Health", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Persistent physical symptoms (PPS) might diminish studying or workability and daily functioning without a clear medical or environment-related explanation. Psychosocial, patient-involving treatments that support individuals' abilities managing with the PPS and health behaviours have shown promising effects in treating PPS but the acceptability of these treatments among symptomatic individuals is low.\n\nThis study aims to assess the effectiveness of an eHealth intervention based on relational frame theory and acceptance and commitment therapy on PPS with two focus groups, among participants with indoor air associated disabling symptoms or persistent, chronic fatigue.\n\nThis study will compare web program enhanced with video-based individual case formulation with treatment as usual. The web program includes 10 one weeks (pilot included 6 two weeks) modules. In addition to patient-reported outcomes, ecological momentary assessments are conducted to provide real-time data on functioning and national registers are used to obtain information on health-care use and social benefits.\n\nData collection begins in August 2020 and will continue until 2023.", "primary_outcomes": [ { "type": "primary", "measure": "The 15D questionnaire (health related quality of life)", "description": "The 15D is a utility-based generic, standardized measure, comprising the following 15 dimensions that describe physical, mental, and social well-being: mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is graded by the respondent on a scale ranging between 1 and 5, where 1 indicates an experience of no problems at all with the dimension and 5 indicates severe problems. Thus, the 15D can be used to measure a vast number of health states. We will use the 15D data both to derive 15D overall scores with values from 1 (full health) to 0 (being dead), and to obtain dimensional symptom profiles.", "time_frame": "Chance from baseline (i.e. at self-referral) to after randomisation (i.e. after clinical assessment), and to 6 and 14 weeks and to 6 and to 12 months after randomisation" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Demographic questions: age (years)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: gender (male, female, prefer not to say)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: marital status (Unmarried, married or cohabiting, divorced or separation, widow)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: education (basic, secondary, higher)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: daily exercise", "description": "One item of the frequency of the exercise on a six point likert scale (No weekly exercise - 4 times/week or more)", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: Diet", "description": "Two items of the diet on a six point likert scale (have daily regular eating habits - have no regular eating habits; Caffeine consumption never - 7 or more proportion per day)", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Social support and loneliness", "description": "Five questions of frequency of perceived loneliness and and social support in challenging situations (likert scale).", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Smoking, Alcohol Use Disorders Identification Test (Audit-C)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: Self-reported health", "description": "Five point likert scale (very poor - very good)", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: Self-reported diseases (diagnosed by medical doctor)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: medication", "description": "Self-reported medication during past four weeks (name, dose, purpose of use)", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: Health care unit", "description": "An open question of the participant´s health care provider.", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: Information seeking", "description": "Questions about health information seeking from different sources (on a six point likert scale)", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: height in meters", "description": "height in meters to calculate BMI kg/m\\^2", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Questions about health: weight in kilograms", "description": "weight in kilograms to calculate BMI kg/m\\^2", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Work characteristics", "description": "Questions about participant work characteristics (working hours, field of industry etc)", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Symptoms related to environmental factors", "description": "Questions whether environmental factors such as mold or water damage in buildings, electromagnetic fields, chemicals or indoor air have associated with symptoms and have they associated with avoidance behavior (yes - no).", "time_frame": "At baseline (i.e. at self-referral), and 6 and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Health worries and health worries related to environmental factors", "description": "Questions about health worries in general and related to environmental factors (scale 0 not worried at all - 10 extremely worried)", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Environmental factors: influence on everyday life", "description": "Questions about the influence of environmental factors on everyday life (scale 0 no consequences - 10 severe consequences)", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Resiliency (SOC-3)", "description": "", "time_frame": "Time Frame: At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Personality Inventory (PK5)", "description": "", "time_frame": "Time Frame: At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Questions about sleep quality, sleeping patterns", "description": "Length of sleep (weekdays and weekends, hours)", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about sleep quality, sleeping patterns", "description": "Nap (frequency per week and length, hours)", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about sleep quality, sleeping patterns", "description": "Self-reported i) sleep quality, ii) night awakening iii) sleep disorders and iv) frequency of sleeping medicine usage at five point likert scale.", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about sleep quality, sleeping patterns", "description": "Self-reported quality of rest and rhythmicity at four point likert scale.", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Fatigue", "description": "Questionnaire about perceived fatigue and its´consequences on daily functioning during past six months.", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder 7 (GAD-7)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Patient Health Questionnaire-15 (PHQ-15)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "The Patient Health Questionnaire (PHQ-9)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "AIDO Healthcare app: daily mood and fatigue", "description": "", "time_frame": "1.5, 3.5 and 12 months after randomisation" }, { "type": "secondary", "measure": "The Acceptance and Action Questionnaire -II AAQ-7", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Comprehensive assessment of Acceptance and Commitment Therapy CompACT", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Cognitive Fusion Questionnaire (CFQ-7)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Whiteley index -7 questionnaire", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "White Bear Suppression Inventory (WBSI)", "description": "", "time_frame": "At baseline (i.e. at self-referral), after randomization and 14 weeks and, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Five Facet Mindfulness Questionnaire (FFMQ)", "description": "", "time_frame": "At baseline (i.e. at self-referral), after randomization and 12 months after randomisation" }, { "type": "secondary", "measure": "Toronto alexithymia scale (TAS-20)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Illness Perception Questionnaire", "description": "", "time_frame": "At baseline (i.e. at self-referral) and 6 and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Self-assessed current ability to study or work", "description": "One question about current ability to study or work on a scale 1-10.", "time_frame": "At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Own prognosis of ability to study or work two years from now", "description": "One question about of work ability two years from now (scale Unlikely; Not certain; Relatively certain)", "time_frame": "At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Self-assessed stress and recovery", "description": "One question about stress and recovery on a scale 1-10.", "time_frame": "At baseline (i.e. at self-referral) and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Daily functioning in three sub-domains.", "description": "Three questions about daily functioning (work, social life, home) on a scale 1-10 each", "time_frame": "At baseline (i.e. at self-referral and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Working Alliance Inventory (WAI) - patient version for eHealth intervention", "description": "", "time_frame": "after randomization and 6 and 14 weeks after randomisation" }, { "type": "secondary", "measure": "Treatment satisfaction", "description": "Six items of treatment satisfaction based on Seligman´s report (1995). The effectiveness of psychotherapy: The Consumer Reports study. American psychologist, 50(12), 965.", "time_frame": "after randomization and 6 and 14 weeks after randomisation" } ], "outcome_measures": [ { "type": "primary", "measure": "The 15D questionnaire (health related quality of life)", "description": "The 15D is a utility-based generic, standardized measure, comprising the following 15 dimensions that describe physical, mental, and social well-being: mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is graded by the respondent on a scale ranging between 1 and 5, where 1 indicates an experience of no problems at all with the dimension and 5 indicates severe problems. Thus, the 15D can be used to measure a vast number of health states. We will use the 15D data both to derive 15D overall scores with values from 1 (full health) to 0 (being dead), and to obtain dimensional symptom profiles.", "time_frame": "Chance from baseline (i.e. at self-referral) to after randomisation (i.e. after clinical assessment), and to 6 and 14 weeks and to 6 and to 12 months after randomisation" }, { "type": "secondary", "measure": "Demographic questions: age (years)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: gender (male, female, prefer not to say)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: marital status (Unmarried, married or cohabiting, divorced or separation, widow)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: education (basic, secondary, higher)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: daily exercise", "description": "One item of the frequency of the exercise on a six point likert scale (No weekly exercise - 4 times/week or more)", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Demographic questions: Diet", "description": "Two items of the diet on a six point likert scale (have daily regular eating habits - have no regular eating habits; Caffeine consumption never - 7 or more proportion per day)", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Social support and loneliness", "description": "Five questions of frequency of perceived loneliness and and social support in challenging situations (likert scale).", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Smoking, Alcohol Use Disorders Identification Test (Audit-C)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: Self-reported health", "description": "Five point likert scale (very poor - very good)", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: Self-reported diseases (diagnosed by medical doctor)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: medication", "description": "Self-reported medication during past four weeks (name, dose, purpose of use)", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: Health care unit", "description": "An open question of the participant´s health care provider.", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: Information seeking", "description": "Questions about health information seeking from different sources (on a six point likert scale)", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about health: height in meters", "description": "height in meters to calculate BMI kg/m\\^2", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Questions about health: weight in kilograms", "description": "weight in kilograms to calculate BMI kg/m\\^2", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Work characteristics", "description": "Questions about participant work characteristics (working hours, field of industry etc)", "time_frame": "At baseline (i.e. at self-referral), and 12 months after randomisation" }, { "type": "secondary", "measure": "Symptoms related to environmental factors", "description": "Questions whether environmental factors such as mold or water damage in buildings, electromagnetic fields, chemicals or indoor air have associated with symptoms and have they associated with avoidance behavior (yes - no).", "time_frame": "At baseline (i.e. at self-referral), and 6 and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Health worries and health worries related to environmental factors", "description": "Questions about health worries in general and related to environmental factors (scale 0 not worried at all - 10 extremely worried)", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Environmental factors: influence on everyday life", "description": "Questions about the influence of environmental factors on everyday life (scale 0 no consequences - 10 severe consequences)", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Resiliency (SOC-3)", "description": "", "time_frame": "Time Frame: At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Personality Inventory (PK5)", "description": "", "time_frame": "Time Frame: At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Questions about sleep quality, sleeping patterns", "description": "Length of sleep (weekdays and weekends, hours)", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about sleep quality, sleeping patterns", "description": "Nap (frequency per week and length, hours)", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about sleep quality, sleeping patterns", "description": "Self-reported i) sleep quality, ii) night awakening iii) sleep disorders and iv) frequency of sleeping medicine usage at five point likert scale.", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Questions about sleep quality, sleeping patterns", "description": "Self-reported quality of rest and rhythmicity at four point likert scale.", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Fatigue", "description": "Questionnaire about perceived fatigue and its´consequences on daily functioning during past six months.", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Generalized Anxiety Disorder 7 (GAD-7)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Insomnia Severity Index (ISI)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Patient Health Questionnaire-15 (PHQ-15)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "The Patient Health Questionnaire (PHQ-9)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "AIDO Healthcare app: daily mood and fatigue", "description": "", "time_frame": "1.5, 3.5 and 12 months after randomisation" }, { "type": "secondary", "measure": "The Acceptance and Action Questionnaire -II AAQ-7", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Comprehensive assessment of Acceptance and Commitment Therapy CompACT", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Cognitive Fusion Questionnaire (CFQ-7)", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 6 and 14 weeks and, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Whiteley index -7 questionnaire", "description": "", "time_frame": "At baseline (i.e. at self-referral), and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "White Bear Suppression Inventory (WBSI)", "description": "", "time_frame": "At baseline (i.e. at self-referral), after randomization and 14 weeks and, 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Five Facet Mindfulness Questionnaire (FFMQ)", "description": "", "time_frame": "At baseline (i.e. at self-referral), after randomization and 12 months after randomisation" }, { "type": "secondary", "measure": "Toronto alexithymia scale (TAS-20)", "description": "", "time_frame": "At baseline (i.e. at self-referral)" }, { "type": "secondary", "measure": "Illness Perception Questionnaire", "description": "", "time_frame": "At baseline (i.e. at self-referral) and 6 and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Self-assessed current ability to study or work", "description": "One question about current ability to study or work on a scale 1-10.", "time_frame": "At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Own prognosis of ability to study or work two years from now", "description": "One question about of work ability two years from now (scale Unlikely; Not certain; Relatively certain)", "time_frame": "At baseline (i.e. at self-referral) and 14 weeks 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Self-assessed stress and recovery", "description": "One question about stress and recovery on a scale 1-10.", "time_frame": "At baseline (i.e. at self-referral) and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Daily functioning in three sub-domains.", "description": "Three questions about daily functioning (work, social life, home) on a scale 1-10 each", "time_frame": "At baseline (i.e. at self-referral and 14 weeks and 6 and 12 months after randomisation" }, { "type": "secondary", "measure": "Working Alliance Inventory (WAI) - patient version for eHealth intervention", "description": "", "time_frame": "after randomization and 6 and 14 weeks after randomisation" }, { "type": "secondary", "measure": "Treatment satisfaction", "description": "Six items of treatment satisfaction based on Seligman´s report (1995). The effectiveness of psychotherapy: The Consumer Reports study. American psychologist, 50(12), 965.", "time_frame": "after randomization and 6 and 14 weeks after randomisation" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 105, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04532827", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01584934", "title": "Sodium Oxybate in Patients With Chronic Fatigue Syndrome.", "status": "WITHDRAWN", "phase": "PHASE4", "last_updated": "2022-12-15", "start_date": "2013-06", "completion_date": "2015-12", "primary_completion_date": "2015-06", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Sodium Oxybate" ], "sponsor": "University Hospital, Ghent", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome (CFS) is a disabling, unexplained disorder characterized by physical and mental exhaustion. Complaints of disturbed and unrefreshing sleep are very common in CFS patients, however, the relationship between (disturbed) sleep quality and fatigue is still not fully elucidated. To evaluate the effect of sodium oxybate on fatigue and to explore the interdependence of sleep quality and fatigue in CFS, a double blind, randomized, placebo controlled cross-over trial with sodium oxybate is carried out in CFS patients.\n\nThe aim of this study is to address the issue of the effect of sodium oxybate on fatigue as a presenting symptom in chronic fatigue (CF) and CFS patients, in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the effect of sodium oxybate on sleepiness and general health in the same target population.\n\nZero-hypothesis: there is no effect.", "primary_outcomes": [ { "type": "primary", "measure": "Measurement of the effect of sodium oxybate on fatigue with questionnaires.", "description": "Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).", "time_frame": "before treatment (baseline evaluation)" }, { "type": "primary", "measure": "Measurement of the effect of sodium oxybate on fatigue with questionnaires.", "description": "Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).", "time_frame": "after 42 days of first treatment" }, { "type": "primary", "measure": "Measurement of the effect of sodium oxybate on fatigue with questionnaires.", "description": "Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).", "time_frame": "after 42 days of second treatment (113 days after baseline)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Effect of sodium oxybate on sleepiness.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "before treatment (baseline evaluation)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleepiness", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "after 42 days of first treatment" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleepiness.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "after 42 days of second treatment (113 days after baseline)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleep quality.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "before treatment (baseline evaluation)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleep quality.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after first treatment" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleep quality.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after second treatment (113 days after baseline)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on general health.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "before treatment (baseline evaluation)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on general health.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after first treatment" }, { "type": "secondary", "measure": "Effect of sodium oxybate on general health.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after second treatment (113 days after baseline)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on pain.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "before treatment (baseline evaluation)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on pain.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after first treatment" }, { "type": "secondary", "measure": "Effect of sodium oxybate on pain.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after second treatment (113 days after baseline)" } ], "outcome_measures": [ { "type": "primary", "measure": "Measurement of the effect of sodium oxybate on fatigue with questionnaires.", "description": "Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).", "time_frame": "before treatment (baseline evaluation)" }, { "type": "primary", "measure": "Measurement of the effect of sodium oxybate on fatigue with questionnaires.", "description": "Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).", "time_frame": "after 42 days of first treatment" }, { "type": "primary", "measure": "Measurement of the effect of sodium oxybate on fatigue with questionnaires.", "description": "Questionnaires: Visual Analog Scale (VAS), fatigue severity scale (FSS) and checklist individual strength (CIS).", "time_frame": "after 42 days of second treatment (113 days after baseline)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleepiness.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "before treatment (baseline evaluation)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleepiness", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "after 42 days of first treatment" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleepiness.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "after 42 days of second treatment (113 days after baseline)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleep quality.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "before treatment (baseline evaluation)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleep quality.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after first treatment" }, { "type": "secondary", "measure": "Effect of sodium oxybate on sleep quality.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after second treatment (113 days after baseline)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on general health.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "before treatment (baseline evaluation)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on general health.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after first treatment" }, { "type": "secondary", "measure": "Effect of sodium oxybate on general health.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after second treatment (113 days after baseline)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on pain.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "before treatment (baseline evaluation)" }, { "type": "secondary", "measure": "Effect of sodium oxybate on pain.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after first treatment" }, { "type": "secondary", "measure": "Effect of sodium oxybate on pain.", "description": "Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study 36-item Short Form health survey (MOS SF-36), Visual Analogue Scale for Pain (VAS-P), Multidimensional Pain Inventory (MPI), Polysomnography, multiple sleep latency test.", "time_frame": "42 days after second treatment (113 days after baseline)" } ], "relevance_tags": [ "General", "Phase 4", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT01584934", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05543408", "title": "Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention \"CON-VIDA Clinical Trial\"", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-09-22", "start_date": "2022-05-03", "completion_date": "2022-10-31", "primary_completion_date": "2022-08-02", "conditions_raw": [ "COVID-19", "Long COVID", "Post-COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Exercise" ], "sponsor": "Universidad San Jorge", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms \\>12 weeks once the acute phase of the disease is over).", "primary_outcomes": [ { "type": "primary", "measure": "Change in Lower Limb Strength: 30 s Sit-to-Stand test", "description": "The test starts with the participant seated on a chair (43.2 cm), arms crossed at the wrists and held against the chest. From this position, participants will conduct as much as sit-to-stand repetitions, as fast as possible, during 30 s", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in Lower Limb Strength: 5 times Sit-to-Stand Test", "description": "Participants will have to sit and stand 5 times (as quickly as possible) from a chair (43.2 cm), arms crossed at the wrists and held against the chest. Time will be register.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in Handgrip Strength", "description": "Start by holding the instrument in the testing hand. Squeeze the dynamometer handle as hard as possible to obtain peak force values.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Chance in upper limbs strength: Arm Curl Biceps", "description": "The subject sits on chair, holding the weight in the hand using suitcase grip, with the arm in a vertically downward position beside the chair. Curl the arm up through a full range of motion, gradually returns to the starting position. The arm must be fully bent and then fully straightened at the elbow. The aim of this test is to do as many arm curl as possible in 30 seconds.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in Balance: Flamingo Balance Test", "description": "Number of seconds keeping balance with one foot on the floor and the other resting on the opposite ankle (maximum 60 s)", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in walking speed: Brisk Walking Test", "description": "Number of seconds required to walk 30 m.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in cardiovascular fitness: 6-Minute Walk Test", "description": "Number of meters that can be walked in 6 min around 30 m track.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in pulmonary function: Inspiratory and Expiratory Pressures", "description": "The maximal inspiratory pressure (MIP) and Maximum Expiratory Pressure (MEP) reflects the respiratory muscles ability to generate force during a short quasi-static contraction.\n\nMIP and MEP measurements are conducted with a manometer that measures mouth pressure and these depend on the motivation and co-ordination of the patient.\n\nProcedures:\n\n* MIP: from tidal breathing the patient slowly exhales as deeply as possible. During expiration the measurement is started manually. The shutter will be set as soon as the patient starts to breathe in. Now the patient is asked to inspire as fast and as powerful as possible against the shutter. The maximal inspiratory pressure will be reached after about 0.5-1 s.\n* MEP: from tidal breathing the patient slowly breathes in as deeply as possible. The shutter will be closed with expiration onset. Now the patient is asked to expire as fast and as powerful as possible against the shutter.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in pulmonary function: Peak flow Test", "description": "Peak expiratory flow measurement (peak flow) is a simple measure of the maximal flow rate that can be achieved during forceful expiration following full inspiration.\n\nFirst, the patient should reset the meter by sliding the marker all the way to zero on the scale. While sitting or standing up straight, the patient should take in a full, deep breath. The mouthpiece is then placed in the patient's mouth followed by a single, fast, forceful expiration. The marker will slide outward on the numbered scale, indicating the peak expiratory flow rate for that attempt.", "time_frame": "Baseline to 8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Body Composition", "description": "Bio-Electrical Impedance Analysis (BIA) with 200 kg maximum capacity and 50 g error margin (TANITA BC-418MA, Tanita Corp., Tokyo, Japan).The meassurement includes: body weight (kg) body fat mass, the percentage of body fat (BF%) and the fat-free mass (FFM). Body mass index (BMI) will be calculated dividing weight (kg) by squared height (m2).", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in Quality of Life-SF-36", "description": "The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in The International Physical Activity Questionnaire (IPAQ)", "description": "The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires.\n\nLong (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in Modified Medical Research Council dyspnea scale (mMRC)", "description": "The mMRC Dyspnea Scale is used to assess the degree of baseline functional disability due to dyspnea in patients with respiratory problems. The mMRC breathlessness scale ranges from grade 0 to 4 (low to high).", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in Modified Fatigue Impact Scale (MFIS)", "description": "The MFIS measures the impact fatigue takes on a patient's daily life. It consists of 21 items divided into 3 subdivision containing 9 physical items , 10 cognitive items and 2 psychosocial. All the items are rated from 0-4 .\n\nThe sum of all the questions are calculated where 84 is the highest score. Highest the score means higher the impact of fatigue in daily living.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in Hospital Anxiety and Depression Scale (HADS)", "description": "HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \\>8 denotes anxiety or depression.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in the short form of the DePaul Symptom Questionnaire (DSQ-SF)", "description": "The short for of the DSQ-SF is a self-report measure of demographic characteristics, myalgic encephalomyelitis and chronic fatigue syndrome symptomatology, and medical, occupational, and social history.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in the Insommia Severity Index (ISI)", "description": "The ISI is composed of seven items that evaluate the severity of sleep disturbance during the past 2 week\n\n\\* The first three items assess the severity of difficulties with falling sleep, maintaining sleep, and early morning awakening.\n\nThe last four items capture satisfaction with the current sleep patte, interference with daily functioning, noticeability of impairment, and degree of distress caused by the sleep problem.\n\nThe scores of each of the seven items range from 0 to 4 (0 = none; 4 = very severe), and a total score can be calculated by summing the seven items, giving a range from 0 to 28, with higher scores indicating greater insomnia severity. Total scores are interpreted as 0-7, absence of insomnia; 8-14, sub-threshold insomnia; 15-21, moderate insomnia; 22-28, severe insomnia.", "time_frame": "Baseline to 8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Lower Limb Strength: 30 s Sit-to-Stand test", "description": "The test starts with the participant seated on a chair (43.2 cm), arms crossed at the wrists and held against the chest. From this position, participants will conduct as much as sit-to-stand repetitions, as fast as possible, during 30 s", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in Lower Limb Strength: 5 times Sit-to-Stand Test", "description": "Participants will have to sit and stand 5 times (as quickly as possible) from a chair (43.2 cm), arms crossed at the wrists and held against the chest. Time will be register.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in Handgrip Strength", "description": "Start by holding the instrument in the testing hand. Squeeze the dynamometer handle as hard as possible to obtain peak force values.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Chance in upper limbs strength: Arm Curl Biceps", "description": "The subject sits on chair, holding the weight in the hand using suitcase grip, with the arm in a vertically downward position beside the chair. Curl the arm up through a full range of motion, gradually returns to the starting position. The arm must be fully bent and then fully straightened at the elbow. The aim of this test is to do as many arm curl as possible in 30 seconds.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in Balance: Flamingo Balance Test", "description": "Number of seconds keeping balance with one foot on the floor and the other resting on the opposite ankle (maximum 60 s)", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in walking speed: Brisk Walking Test", "description": "Number of seconds required to walk 30 m.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in cardiovascular fitness: 6-Minute Walk Test", "description": "Number of meters that can be walked in 6 min around 30 m track.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in pulmonary function: Inspiratory and Expiratory Pressures", "description": "The maximal inspiratory pressure (MIP) and Maximum Expiratory Pressure (MEP) reflects the respiratory muscles ability to generate force during a short quasi-static contraction.\n\nMIP and MEP measurements are conducted with a manometer that measures mouth pressure and these depend on the motivation and co-ordination of the patient.\n\nProcedures:\n\n* MIP: from tidal breathing the patient slowly exhales as deeply as possible. During expiration the measurement is started manually. The shutter will be set as soon as the patient starts to breathe in. Now the patient is asked to inspire as fast and as powerful as possible against the shutter. The maximal inspiratory pressure will be reached after about 0.5-1 s.\n* MEP: from tidal breathing the patient slowly breathes in as deeply as possible. The shutter will be closed with expiration onset. Now the patient is asked to expire as fast and as powerful as possible against the shutter.", "time_frame": "Baseline to 8 weeks" }, { "type": "primary", "measure": "Change in pulmonary function: Peak flow Test", "description": "Peak expiratory flow measurement (peak flow) is a simple measure of the maximal flow rate that can be achieved during forceful expiration following full inspiration.\n\nFirst, the patient should reset the meter by sliding the marker all the way to zero on the scale. While sitting or standing up straight, the patient should take in a full, deep breath. The mouthpiece is then placed in the patient's mouth followed by a single, fast, forceful expiration. The marker will slide outward on the numbered scale, indicating the peak expiratory flow rate for that attempt.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Body Composition", "description": "Bio-Electrical Impedance Analysis (BIA) with 200 kg maximum capacity and 50 g error margin (TANITA BC-418MA, Tanita Corp., Tokyo, Japan).The meassurement includes: body weight (kg) body fat mass, the percentage of body fat (BF%) and the fat-free mass (FFM). Body mass index (BMI) will be calculated dividing weight (kg) by squared height (m2).", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in Quality of Life-SF-36", "description": "The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in The International Physical Activity Questionnaire (IPAQ)", "description": "The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires.\n\nLong (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in Modified Medical Research Council dyspnea scale (mMRC)", "description": "The mMRC Dyspnea Scale is used to assess the degree of baseline functional disability due to dyspnea in patients with respiratory problems. The mMRC breathlessness scale ranges from grade 0 to 4 (low to high).", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in Modified Fatigue Impact Scale (MFIS)", "description": "The MFIS measures the impact fatigue takes on a patient's daily life. It consists of 21 items divided into 3 subdivision containing 9 physical items , 10 cognitive items and 2 psychosocial. All the items are rated from 0-4 .\n\nThe sum of all the questions are calculated where 84 is the highest score. Highest the score means higher the impact of fatigue in daily living.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in Hospital Anxiety and Depression Scale (HADS)", "description": "HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \\>8 denotes anxiety or depression.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in the short form of the DePaul Symptom Questionnaire (DSQ-SF)", "description": "The short for of the DSQ-SF is a self-report measure of demographic characteristics, myalgic encephalomyelitis and chronic fatigue syndrome symptomatology, and medical, occupational, and social history.", "time_frame": "Baseline to 8 weeks" }, { "type": "secondary", "measure": "Change in the Insommia Severity Index (ISI)", "description": "The ISI is composed of seven items that evaluate the severity of sleep disturbance during the past 2 week\n\n\\* The first three items assess the severity of difficulties with falling sleep, maintaining sleep, and early morning awakening.\n\nThe last four items capture satisfaction with the current sleep patte, interference with daily functioning, noticeability of impairment, and degree of distress caused by the sleep problem.\n\nThe scores of each of the seven items range from 0 to 4 (0 = none; 4 = very severe), and a total score can be calculated by summing the seven items, giving a range from 0 to 28, with higher scores indicating greater insomnia severity. Total scores are interpreted as 0-7, absence of insomnia; 8-14, sub-threshold insomnia; 15-21, moderate insomnia; 22-28, severe insomnia.", "time_frame": "Baseline to 8 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05543408", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05534997", "title": "Rehabilitation Therapy for Post COVID 19 Chronic Fatigue Syndrome", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-09-10", "start_date": "2022-10-01", "completion_date": "2023-10-01", "primary_completion_date": "2023-09-01", "conditions_raw": [ "Post-COVID-19 Syndrome" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Intensive Combined Rehabilitation Therapy" ], "sponsor": "Cairo University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of this study is to investigate the effect of intensive combined rehabilitation therapy in form of Graded Exercise Therapy (GET) , Cognitive Behavioral Therapy (CBT) to treat patients with post COVID19 chronic fatigue syndrome .", "primary_outcomes": [ { "type": "primary", "measure": "The fatigue severity level", "description": "The fatigue severity level will be measured via the Arabic version of the Fatigue Severity Scale (FSS)", "time_frame": "12 weeks" }, { "type": "primary", "measure": "aerobic capacity and endurance", "description": "Aerobic capacity and endurance will be measured via The 6 Minute Walk Test. The test will be performed at Modern University for the technology and information rehabilitation center corridor.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Maximal hand grip strength and fatigue resistance", "description": "Maximal hand grip strength and fatigue resistance will be measured using the Handgrip dynamometer", "time_frame": "12 weeks" }, { "type": "primary", "measure": "the Fall risk", "description": "Fall risk will measure via the Biodex Balance System (BBS) (Biodex Medical Systems Inc, Shirley, NY).", "time_frame": "12 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "The fatigue severity level", "description": "The fatigue severity level will be measured via the Arabic version of the Fatigue Severity Scale (FSS)", "time_frame": "12 weeks" }, { "type": "primary", "measure": "aerobic capacity and endurance", "description": "Aerobic capacity and endurance will be measured via The 6 Minute Walk Test. The test will be performed at Modern University for the technology and information rehabilitation center corridor.", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Maximal hand grip strength and fatigue resistance", "description": "Maximal hand grip strength and fatigue resistance will be measured using the Handgrip dynamometer", "time_frame": "12 weeks" }, { "type": "primary", "measure": "the Fall risk", "description": "Fall risk will measure via the Biodex Balance System (BBS) (Biodex Medical Systems Inc, Shirley, NY).", "time_frame": "12 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT05534997", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02965768", "title": "Immune Effects of Low-dose Naltrexone in ME/CFS", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2022-09-02", "start_date": "2016-01", "completion_date": "2022-08-25", "primary_completion_date": "2022-08-25", "conditions_raw": [ "Fatigue Syndrome, Chronic" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Naltrexone Hcl" ], "sponsor": "University of Alabama at Birmingham", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior work in which we showed that chronic fatigue symptoms are associated with immune activity, and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is thought to share some pathophysiological and clinical characteristics with CFS.", "primary_outcomes": [ { "type": "primary", "measure": "Reduction in plasma inflammatory biomarkers", "description": "Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest.", "time_frame": "Four-week baseline; 12 weeks drug" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Durability of reduction in plasma inflammatory biomarkers", "description": "Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest. 24 weeks vs 12 weeks drug.", "time_frame": "Baseline; 12 weeks drug; 24 weeks drug" }, { "type": "secondary", "measure": "Reduction in self-reported fatigue", "description": "Fatigue will be reported daily on a hand-held computer device.", "time_frame": "12 weeks drug" }, { "type": "secondary", "measure": "Increase in physical function", "description": "Physical function will be reported weekly on a Patient-Specific Functional Scale.", "time_frame": "12 weeks drug" }, { "type": "secondary", "measure": "Reduction in self-reported symptoms of (i) depression, (ii) anxiety", "description": "Symptoms of depression and anxiety will be reported weekly on a Hospital Anxiety and Depression Scale.", "time_frame": "12 weeks drug" } ], "outcome_measures": [ { "type": "primary", "measure": "Reduction in plasma inflammatory biomarkers", "description": "Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest.", "time_frame": "Four-week baseline; 12 weeks drug" }, { "type": "secondary", "measure": "Durability of reduction in plasma inflammatory biomarkers", "description": "Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest. 24 weeks vs 12 weeks drug.", "time_frame": "Baseline; 12 weeks drug; 24 weeks drug" }, { "type": "secondary", "measure": "Reduction in self-reported fatigue", "description": "Fatigue will be reported daily on a hand-held computer device.", "time_frame": "12 weeks drug" }, { "type": "secondary", "measure": "Increase in physical function", "description": "Physical function will be reported weekly on a Patient-Specific Functional Scale.", "time_frame": "12 weeks drug" }, { "type": "secondary", "measure": "Reduction in self-reported symptoms of (i) depression, (ii) anxiety", "description": "Symptoms of depression and anxiety will be reported weekly on a Hospital Anxiety and Depression Scale.", "time_frame": "12 weeks drug" } ], "relevance_tags": [ "Immunomodulatory", "Anti-inflammatory", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT02965768", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05397626", "title": "Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome", "status": "UNKNOWN", "phase": "PHASE1", "last_updated": "2022-05-31", "start_date": "2022-05-23", "completion_date": "2023-05-23", "primary_completion_date": "2023-05-23", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Heart Rhythm Biofeedback", "Hydrogen Water", "Combined Treatment: Heart Rhythm Biofeedback Plus Hydrogen Water" ], "sponsor": "Stony Brook University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "self-report measure of fatigue impact on functioning.Minimum value=1; Maximum value=7; Range: 1.00-7.00. High scores indicate more sever fatigue and a worse outcome.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Short Form-36 Physical Function Subscale", "description": "Self-report measure of physical functioning. The short-form 36 physical function subscale is composed of ten items encompassing a hierarchical range of difficulties. Each item is scores on the basis of the limitations perceived by surveyed individuals. Item scores (1, 2, or 3) are summed to obtain a total score, which can then be scaled relative to its range. Higher scores indicate higher physical function.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Depression, Anxiety and Stress Scale", "description": "Self-report measure if depression, anxiety and stress symptoms. This 21 item stress measure contains three 7-item subscales: anxiety, depression and stress. Domain scores are calculated by summing all items in a domain and multiplying by two.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Brief Resilience Scale", "description": "This 6 item self-report scale focuses on how quickly an individuals bounces back and physically and emotionally exhausting events. 5 answer choices range from strongly disagree to strongly agree. Higher scores indicate higher resilience.", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "self-report measure of fatigue impact on functioning.Minimum value=1; Maximum value=7; Range: 1.00-7.00. High scores indicate more sever fatigue and a worse outcome.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Short Form-36 Physical Function Subscale", "description": "Self-report measure of physical functioning. The short-form 36 physical function subscale is composed of ten items encompassing a hierarchical range of difficulties. Each item is scores on the basis of the limitations perceived by surveyed individuals. Item scores (1, 2, or 3) are summed to obtain a total score, which can then be scaled relative to its range. Higher scores indicate higher physical function.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Depression, Anxiety and Stress Scale", "description": "Self-report measure if depression, anxiety and stress symptoms. This 21 item stress measure contains three 7-item subscales: anxiety, depression and stress. Domain scores are calculated by summing all items in a domain and multiplying by two.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Brief Resilience Scale", "description": "This 6 item self-report scale focuses on how quickly an individuals bounces back and physically and emotionally exhausting events. 5 answer choices range from strongly disagree to strongly agree. Higher scores indicate higher resilience.", "time_frame": "8 weeks" } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 39, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05397626", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00478465", "title": "Valganciclovir (Valcyte) for Chronic Fatigue Syndrome Patients Who Have Elevated Antibody Titers Against Human Herpes Virus 6 (HHV-6)and Epstein-Barr Virus (EBV)", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2022-05-27", "start_date": "2007-05", "completion_date": "2007-08", "primary_completion_date": "2007-08", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Valganciclovir" ], "sponsor": "Stanford University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study determine whether the drug valganciclovir has a significant and real benefit on the central core of symptoms experienced by patients who have high titers to EBV and HHV-6 and are experiencing long-standing fatigue and cognitive impairment (CFS).\n\nIn addition, to characterize a quantifiable biological marker in these patients that will facilitate the identification of those likely to respond to valganciclovir and will make it possible to assess response to treatment.", "primary_outcomes": [], "secondary_outcomes": [], "outcome_measures": [], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00478465", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04947488", "title": "Evaluation of the Effects of Treatment With Bioarginin C in Adult Subjects Belonging to the Post-Covid Day Hospital", "status": "UNKNOWN", "phase": "NA", "last_updated": "2022-05-17", "start_date": "2021-06-18", "completion_date": "2022-11-18", "primary_completion_date": "2022-09-18", "conditions_raw": [ "Fatigue Syndrome, Chronic", "Inflammation" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Bioarginina C" ], "sponsor": "University of Milan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Long Covid could be much more frequent than it is thought to be. Few dwell on the great problem represented by the post covid syndrome. The virus often leaves important marks on our body, and those who recover face problems of various kinds: chronic fatigue, shortness of breath, dry cough, headache, cognitive difficulties.\n\nOn the duration and resolution of this syndrome, now recognized as a highly debilitating condition, there are still no great answers: for this reason it is always important to emphasize that contracting Covid, even in a not serious form, still means exposing oneself to long-term risks that are still not well codified by the scientific community. Guidelines and more tools are expected to best assist these patients.", "primary_outcomes": [ { "type": "primary", "measure": "6 minute walking test to evaluate Fatigue", "description": "Effect of Bioarginina C on the prolonged fatigue", "time_frame": "30 days" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "6 minute walking test to evaluate Fatigue", "description": "Effect of Bioarginina C on the prolonged fatigue", "time_frame": "30 days" } ], "relevance_tags": [ "Neurological / Autonomic", "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04947488", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04158427", "title": "Intestinal Microbiota and Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-04-28", "start_date": "2020-01-01", "completion_date": "2022-03-31", "primary_completion_date": "2021-12-31", "conditions_raw": [ "Fatigue Syndrome, Chronic", "Microbial Colonization" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Faecal Transplantation" ], "sponsor": "Tampere University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Gut microbiota of 1) patients with chronic fatigue syndrome and 2) their healthy family members are analyzed.\n\nUp to 40 patients with chronic fatigue syndrome are randomized to receive either 1) a faecal transplant from a healthty donor or 2) their own feces via colonoscopy. Patient's health related quality and ability to work are assessed (baseline, 1 and 6 months after the procedure)", "primary_outcomes": [ { "type": "primary", "measure": "Health related quality of life assessed by EQ-5D-5L questionnaire", "description": "Health related quality of life, Euro-QoL 5 Dimension (EQ-5D-5L scores) (5 levels of perceived problems, scale from 1 (no problems/the best) to 5 (extreme problems/unable to)", "time_frame": "Change from Baseline EQ-5D-5L scores at 6 months after the procedure" }, { "type": "primary", "measure": "Health related quality of life assessed by 15D questionnaire", "description": "Health related quality of life, 15D scores (15 separate dimensions, scale from 1 to 5; 1=the highest/best level), 5=the lowest/worst level)", "time_frame": "Change from Baseline 15D scores at 6 months after the procedure" }, { "type": "primary", "measure": "Health related quality of life assessed by Modified Fatigue Impact Scale", "description": "Health related quality of life, Modified Fatigue Impact Scale scores (Total Score, range 0 to 84; Physical subscale, range 0 to 36; Cognitive Subscale, range 0 to 40; Psychosocial Subscale, range from 0 to 8 (0 = no fatigue, highest points = extreme fatigue)", "time_frame": "Change from Baseline Modified Fatigue Impact Scale scores at 6 months after the procedure" }, { "type": "primary", "measure": "Ability to work or study", "description": "Whether ability to work or study has been restored (value is 1) or not (value is 0)", "time_frame": "Change from Baseline at 6 months after the procedure" }, { "type": "primary", "measure": "Visual Analog Fatigue Scale", "description": "A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)", "time_frame": "Change from Baseline Visual Analog Fatigue Scale point at 6 months after the procedure" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Health related quality of life assessed by EQ-5D-5L questionnaire", "description": "Health related quality of life, Euro-QoL 5 Dimension (EQ-5D-5L scores) (5 levels of perceived problems, scale from 1 (no problems/the best) to 5 (extreme problems/unable to)", "time_frame": "Change from Baseline EQ-5D-5L scores at 1 months after the procedure" }, { "type": "secondary", "measure": "Health related quality of life assessed by 15D questionnaire", "description": "Health related quality of life, 15D scores (15 separate dimensions, scale from 1 to 5; 1=the highest/best level), 5=the lowest/worst level)", "time_frame": "Change from Baseline 15D at 1 months after the procedure" }, { "type": "secondary", "measure": "Health related quality of life assessed by Modified Fatigue Impact Scale", "description": "Health related quality of life, Modified Fatigue Impact Scale scores (Total Score, range 0 to 84; Physical subscale, range 0 to 36; Cognitive Subscale, range 0 to 40; Psychosocial Subscale, range from 0 to 8 (0 = no fatigue, highest points = extreme fatigue)", "time_frame": "Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure" }, { "type": "secondary", "measure": "Ability to work or study", "description": "Whether ability to work or study has been restored (value is 1) or not (value is 0)", "time_frame": "Change from Baseline at 1 months after the procedure" }, { "type": "secondary", "measure": "Visual Analog Fatigue Scale", "description": "A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)", "time_frame": "Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure" } ], "outcome_measures": [ { "type": "primary", "measure": "Health related quality of life assessed by EQ-5D-5L questionnaire", "description": "Health related quality of life, Euro-QoL 5 Dimension (EQ-5D-5L scores) (5 levels of perceived problems, scale from 1 (no problems/the best) to 5 (extreme problems/unable to)", "time_frame": "Change from Baseline EQ-5D-5L scores at 6 months after the procedure" }, { "type": "primary", "measure": "Health related quality of life assessed by 15D questionnaire", "description": "Health related quality of life, 15D scores (15 separate dimensions, scale from 1 to 5; 1=the highest/best level), 5=the lowest/worst level)", "time_frame": "Change from Baseline 15D scores at 6 months after the procedure" }, { "type": "primary", "measure": "Health related quality of life assessed by Modified Fatigue Impact Scale", "description": "Health related quality of life, Modified Fatigue Impact Scale scores (Total Score, range 0 to 84; Physical subscale, range 0 to 36; Cognitive Subscale, range 0 to 40; Psychosocial Subscale, range from 0 to 8 (0 = no fatigue, highest points = extreme fatigue)", "time_frame": "Change from Baseline Modified Fatigue Impact Scale scores at 6 months after the procedure" }, { "type": "primary", "measure": "Ability to work or study", "description": "Whether ability to work or study has been restored (value is 1) or not (value is 0)", "time_frame": "Change from Baseline at 6 months after the procedure" }, { "type": "primary", "measure": "Visual Analog Fatigue Scale", "description": "A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)", "time_frame": "Change from Baseline Visual Analog Fatigue Scale point at 6 months after the procedure" }, { "type": "secondary", "measure": "Health related quality of life assessed by EQ-5D-5L questionnaire", "description": "Health related quality of life, Euro-QoL 5 Dimension (EQ-5D-5L scores) (5 levels of perceived problems, scale from 1 (no problems/the best) to 5 (extreme problems/unable to)", "time_frame": "Change from Baseline EQ-5D-5L scores at 1 months after the procedure" }, { "type": "secondary", "measure": "Health related quality of life assessed by 15D questionnaire", "description": "Health related quality of life, 15D scores (15 separate dimensions, scale from 1 to 5; 1=the highest/best level), 5=the lowest/worst level)", "time_frame": "Change from Baseline 15D at 1 months after the procedure" }, { "type": "secondary", "measure": "Health related quality of life assessed by Modified Fatigue Impact Scale", "description": "Health related quality of life, Modified Fatigue Impact Scale scores (Total Score, range 0 to 84; Physical subscale, range 0 to 36; Cognitive Subscale, range 0 to 40; Psychosocial Subscale, range from 0 to 8 (0 = no fatigue, highest points = extreme fatigue)", "time_frame": "Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure" }, { "type": "secondary", "measure": "Ability to work or study", "description": "Whether ability to work or study has been restored (value is 1) or not (value is 0)", "time_frame": "Change from Baseline at 1 months after the procedure" }, { "type": "secondary", "measure": "Visual Analog Fatigue Scale", "description": "A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)", "time_frame": "Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 13, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04158427", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04958161", "title": "Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms", "status": "WITHDRAWN", "phase": "NA", "last_updated": "2022-02-24", "start_date": "2022-01", "completion_date": "2023-05", "primary_completion_date": "2022-12", "conditions_raw": [ "Covid19" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Exercise Therapy" ], "sponsor": "Wake Forest University Health Sciences", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Individuals who had COVID-19 and are thought to have recovered from the disease often experience long-term symptoms such as fatigue, extreme tiredness and shortness of breath, a condition referred to as Long COVID. Previous studies have shown that regular exercise is beneficial for individuals suffering similar symptoms as a result of other diseases such as Chronic Fatigue Syndrome. The goal of this study is determine if participation in a three-month structured exercise program will improve physical function in individuals suffering from Long COVID.", "primary_outcomes": [ { "type": "primary", "measure": "Performance Based Physical Function", "description": "Six minute walk distance will be used to measure performance based physical function. Subjects will walk at their chosen pace for six minutes on a pre-determined course. Total distance walked will be recorded.", "time_frame": "Baseline" }, { "type": "primary", "measure": "Performance Based Physical Function", "description": "Six minute walk distance will be used to measure performance based physical function. Subjects will walk at their chosen pace for six minutes on a pre-determined course. Total distance walked will be recorded.", "time_frame": "Week 12" }, { "type": "primary", "measure": "Self-reported Physical Function", "description": "The Physical Functioning scale of the Medical Outcomes 36 Item Short Form (SF-36) will be used to measure self-reported physical function. Patient responses are rated on a on a 3-point scale (1- yes, limited a lot; 2 - yes, limited a little; or 3- no, not limited at all) and will then be normalized with a mean of 50 and standard deviation of 10.", "time_frame": "Baseline" }, { "type": "primary", "measure": "Self-reported Physical Function", "description": "The Physical Functioning scale of the Medical Outcomes 36 Item Short Form (SF-36) will be used to measure self-reported physical function. Patient responses are rated on a on a 3-point scale (1- yes, limited a lot; 2 - yes, limited a little; or 3- no, not limited at all) and will then be normalized with a mean of 50 and standard deviation of 10.", "time_frame": "Week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Physical Function", "description": "Physical functioning will also be assessed using the Short Physical Performance Battery (SPPB). The SPPB score is based on timed measures of standing balance, walking speed, and ability to rise from a chair. Scores on each measure range from 0 - 4 and will be summed for a final score. Scores for the SPPB range from 0 to 12 with higher scores indicative of greater physical function.", "time_frame": "Baseline and Week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Performance Based Physical Function", "description": "Six minute walk distance will be used to measure performance based physical function. Subjects will walk at their chosen pace for six minutes on a pre-determined course. Total distance walked will be recorded.", "time_frame": "Baseline" }, { "type": "primary", "measure": "Performance Based Physical Function", "description": "Six minute walk distance will be used to measure performance based physical function. Subjects will walk at their chosen pace for six minutes on a pre-determined course. Total distance walked will be recorded.", "time_frame": "Week 12" }, { "type": "primary", "measure": "Self-reported Physical Function", "description": "The Physical Functioning scale of the Medical Outcomes 36 Item Short Form (SF-36) will be used to measure self-reported physical function. Patient responses are rated on a on a 3-point scale (1- yes, limited a lot; 2 - yes, limited a little; or 3- no, not limited at all) and will then be normalized with a mean of 50 and standard deviation of 10.", "time_frame": "Baseline" }, { "type": "primary", "measure": "Self-reported Physical Function", "description": "The Physical Functioning scale of the Medical Outcomes 36 Item Short Form (SF-36) will be used to measure self-reported physical function. Patient responses are rated on a on a 3-point scale (1- yes, limited a lot; 2 - yes, limited a little; or 3- no, not limited at all) and will then be normalized with a mean of 50 and standard deviation of 10.", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Physical Function", "description": "Physical functioning will also be assessed using the Short Physical Performance Battery (SPPB). The SPPB score is based on timed measures of standing balance, walking speed, and ability to rise from a chair. Scores on each measure range from 0 - 4 and will be summed for a final score. Scores for the SPPB range from 0 to 12 with higher scores indicative of greater physical function.", "time_frame": "Baseline and Week 12" } ], "relevance_tags": [ "General", "NA", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT04958161", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02499302", "title": "Mental Training for CFS Following EBV Infection in Adolescents", "status": "COMPLETED", "phase": "NA", "last_updated": "2022-02-16", "start_date": "2015-10", "completion_date": "2018-10", "primary_completion_date": "2017-10", "conditions_raw": [ "Fatigue Syndrome, Chronic", "Epstein-Barr Virus Infection" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Mental Training" ], "sponsor": "University Hospital, Akershus", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The general aim of this study is to investigate the effect of an individually tailored mental training program in adolescents developing chronic fatigue syndrome (CFS) after an acute Epstein Barr-virus (EBV) infection. Endpoints include physical activity (primary endpoint), symptoms (fatigue, pain, insomnia), cognitive function (executive functions) and markers of disease mechanisms (autonomic, endocrine, and immune responses).", "primary_outcomes": [ { "type": "primary", "measure": "Physical activity", "description": "Mean steps/day during 7 consecutive days measured by accelerometer", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Plasma catecholamines", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Plasma catecholamines", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Urine cortisol:creatinin ratio", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Urine cortisol:creatinin ratio", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Degree centrality index of cytokine network", "description": "An index of node centrality, based upon network analyses", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Degree centrality index of cytokine network", "description": "An index of node centrality, based upon network analyses", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Number of NK-cells", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Number of NK-cells", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Supine heart rate", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Supine heart rate", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Heart rate variability indices", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Heart rate variability indices", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Heart rate, blood pressure and total peripheral resistence responses to upright posture", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Heart rate, blood pressure and total peripheral resistence responses to upright posture", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Working memory", "description": "Digit span forward and backward test", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Working memory", "description": "Digit span forward and backward test", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Cognitive inhibition", "description": "Color-word interference test from the D-KEFS instrument", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Cognitive inhibition", "description": "Color-word interference test from the D-KEFS instrument", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Correlation matrix indices of regions of interests (ROIs) in the brain salience network", "description": "Functional connectivity analyses from resting state brain fMRI", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Correlation matrix indices of regions of interests (ROIs) in the brain salience network", "description": "Functional connectivity analyses from resting state brain fMRI", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Fatigue score (Chalder fatigue questionnaire)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Fatigue score (Chalder fatigue questionnaire)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Pain scores (Brief pain Inventory)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Pain scores (Brief pain Inventory)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Quality of Life score (PedsQL)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Quality of Life score (PedsQL)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Anxiety and depression score (HADS)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Anxiety and depression score (HADS)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Alexithymia score (TAS-20)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Alexithymia score (TAS-20)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Insomnia score (KSQ)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Insomnia score (KSQ)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Pain threshold (algometry)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Pain threshold (algometry)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Disability score (FDI)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Disability score (FDI)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Side effect and unexpected events questionnaire", "description": "", "time_frame": "3 weeks" }, { "type": "secondary", "measure": "Side effect and unexpected events questionnaire", "description": "", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Side effect and unexpected events questionnaire", "description": "", "time_frame": "9 weeks" }, { "type": "secondary", "measure": "Side effect and unexpected events questionnaire", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Physical activity", "description": "Mean steps/day during 7 consecutive days measured by accelerometer", "time_frame": "64 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Physical activity", "description": "Mean steps/day during 7 consecutive days measured by accelerometer", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Plasma catecholamines", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Plasma catecholamines", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Urine cortisol:creatinin ratio", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Urine cortisol:creatinin ratio", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Degree centrality index of cytokine network", "description": "An index of node centrality, based upon network analyses", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Degree centrality index of cytokine network", "description": "An index of node centrality, based upon network analyses", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Number of NK-cells", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Number of NK-cells", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Supine heart rate", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Supine heart rate", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Heart rate variability indices", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Heart rate variability indices", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Heart rate, blood pressure and total peripheral resistence responses to upright posture", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Heart rate, blood pressure and total peripheral resistence responses to upright posture", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Working memory", "description": "Digit span forward and backward test", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Working memory", "description": "Digit span forward and backward test", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Cognitive inhibition", "description": "Color-word interference test from the D-KEFS instrument", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Cognitive inhibition", "description": "Color-word interference test from the D-KEFS instrument", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Correlation matrix indices of regions of interests (ROIs) in the brain salience network", "description": "Functional connectivity analyses from resting state brain fMRI", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Correlation matrix indices of regions of interests (ROIs) in the brain salience network", "description": "Functional connectivity analyses from resting state brain fMRI", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Fatigue score (Chalder fatigue questionnaire)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Fatigue score (Chalder fatigue questionnaire)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Pain scores (Brief pain Inventory)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Pain scores (Brief pain Inventory)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Quality of Life score (PedsQL)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Quality of Life score (PedsQL)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Anxiety and depression score (HADS)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Anxiety and depression score (HADS)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Alexithymia score (TAS-20)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Alexithymia score (TAS-20)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Insomnia score (KSQ)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Insomnia score (KSQ)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Pain threshold (algometry)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Pain threshold (algometry)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Disability score (FDI)", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Disability score (FDI)", "description": "", "time_frame": "64 weeks" }, { "type": "secondary", "measure": "Side effect and unexpected events questionnaire", "description": "", "time_frame": "3 weeks" }, { "type": "secondary", "measure": "Side effect and unexpected events questionnaire", "description": "", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Side effect and unexpected events questionnaire", "description": "", "time_frame": "9 weeks" }, { "type": "secondary", "measure": "Side effect and unexpected events questionnaire", "description": "", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Physical activity", "description": "Mean steps/day during 7 consecutive days measured by accelerometer", "time_frame": "64 weeks" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02499302", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04593225", "title": "Effectiveness of VIRTUAL SFCAMINA STUDY", "status": "UNKNOWN", "phase": "NA", "last_updated": "2021-12-30", "start_date": "2020-04-21", "completion_date": "2022-01-21", "primary_completion_date": "2021-12-21", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Tau + Multicomponent Treatment Virtual Sfcamina", "Treatment As Usual" ], "sponsor": "Hospital Universitari Vall d'Hebron Research Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The main objective of this study is to analyse the effectiveness of the VIRTUAL SFCAMINA multicomponent treatment program as coadjuvant of treatmentas- usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of VIRTUAL SFCAMINA treatment in the short- and long term.", "primary_outcomes": [ { "type": "primary", "measure": "Multidimensional Fatigue Inventory (MFI)", "description": "Multidimensional Fatigue Inventory (MFI), a 20-item instrument consisting of several subscales including general fatigue and reduced activity. Severe fatigue it is defined as a score of greater than or equal to 13 on the MFI general fatigue subscale or greater than or equal to 10 on the MFI reduced activity subscale. The mean MFI general fatigue scores ranged from 18.3 to 18.8", "time_frame": "Through study completion, an average of 3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Tampa Scale for Kinesiophobia (TSK-11)", "description": "TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.", "time_frame": "Through study completion, an average of 3 months" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms.", "time_frame": "Through study completion, an average of 3 months" }, { "type": "secondary", "measure": "Physical Function of the 36-Item Short Form Survey (SF-36)", "description": "Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function.This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function.", "time_frame": "Through study completion, an average of 3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Multidimensional Fatigue Inventory (MFI)", "description": "Multidimensional Fatigue Inventory (MFI), a 20-item instrument consisting of several subscales including general fatigue and reduced activity. Severe fatigue it is defined as a score of greater than or equal to 13 on the MFI general fatigue subscale or greater than or equal to 10 on the MFI reduced activity subscale. The mean MFI general fatigue scores ranged from 18.3 to 18.8", "time_frame": "Through study completion, an average of 3 months" }, { "type": "secondary", "measure": "Tampa Scale for Kinesiophobia (TSK-11)", "description": "TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.", "time_frame": "Through study completion, an average of 3 months" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms.", "time_frame": "Through study completion, an average of 3 months" }, { "type": "secondary", "measure": "Physical Function of the 36-Item Short Form Survey (SF-36)", "description": "Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function.This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function.", "time_frame": "Through study completion, an average of 3 months" } ], "relevance_tags": [ "General", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 480, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT04593225", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05128292", "title": "Effect of CoQ10 Plus Selenium Supplementation on Clinical Outcomes and Biochemical Markers in ME/CFS (CoSeME Study)", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-11-19", "start_date": "2018-01-01", "completion_date": "2018-11-30", "primary_completion_date": "2018-09-01", "conditions_raw": [ "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Coenzyme Q10 (CoQ10)" ], "sponsor": "Hospital Universitari Vall d'Hebron Research Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In recent years, it has been suggested that nutritional deficiencies may be of causal relevance in individuals with ME/CFS. These include deficiencies of vitamins and trace elements. It is likely that the observed nutritional deficiencies contribute to the core symptoms of the disease. Coenzyme Q10 (CoQ10) has been studied as an alternative and complementary therapy in ME/CFS for fatigue, pain, tiredness, neurocognitive impairment, and sleep problems. This demonstrates how alterations in energy metabolism, mitochondrial dysfunction, oxidative stress, imbalance of the immune-inflammatory response, and activation of the NLRP3 inflammasome are likely consequences of low levels of CoQ10 and selenium, which are related to the main symptoms in ME/CFS. Hypothesis: CoQ10 and selenium levels are decreased in ME/CFS patients. A natural therapeutic alternative in the treatment of common symptoms in ME/CFS could be the oral CoQ10 (Ubiquinone) plus selenium supplementation to module redox status and inflammation response in ME/CFS. Aims: To evaluate the efficacy of oral Ubiquinone + selenium supplementation on clinical outcome and circulating biomarkers in ME/CFS. We enrolled 42 ME/CFS patients diagnosed according to the 1994 CDC/Fukuda criteria who have received oral treatment of 400 mg Ubiquinone + 200 microgram selenium daily for 8 weeks. Demographic, clinical characteristics and laboratory variables, and validated outcome measures to perceived fatigue, sleep disturbances, and quality of life will be also evaluated. In addition, plasma biomarkers related to oxidative stress status (total antioxidant capacity and lipoperoxide levels), inflammatory response (pro-and anti-inflammatory cytokines), and cardiovascular dysfunction (FGF-21 and NT-proBNP) will be assayed.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue perception assessed through FIS-40 questionnaire", "description": "FIS-40 self-reported questionnaire: Change of fatigue perception from baseline will be assessed.", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Sleep disturbances evaluated through PSQI", "description": "Change of sleep problems from baseline will be assessed.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Health-related quality of life assessed by SF-36", "description": "Change of quality of life (SF-36) from baseline will be assessed.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Measurement of biomarkers of redox status.", "description": "Change of the circulating biomarker levels of oxidative stress (malondialdehydes and total antioxidant capacity) from baseline will be measured.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Measurement of biomarkers of inflammatory immune response.", "description": "Change of the circulating biomarker levels of inflammatory cytokines (IL-1 beta, IL-6, IL-8, IL-10, TNF-alpha, and C-reactive protein) from baseline will be measured.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Measurement of biomarkers of cardiovascular risk.", "description": "Change of the circulating biomarker levels of cardiovascular function (FGF-21 and NT-proBNP) from baseline will be measured.", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue perception assessed through FIS-40 questionnaire", "description": "FIS-40 self-reported questionnaire: Change of fatigue perception from baseline will be assessed.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Sleep disturbances evaluated through PSQI", "description": "Change of sleep problems from baseline will be assessed.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Health-related quality of life assessed by SF-36", "description": "Change of quality of life (SF-36) from baseline will be assessed.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Measurement of biomarkers of redox status.", "description": "Change of the circulating biomarker levels of oxidative stress (malondialdehydes and total antioxidant capacity) from baseline will be measured.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Measurement of biomarkers of inflammatory immune response.", "description": "Change of the circulating biomarker levels of inflammatory cytokines (IL-1 beta, IL-6, IL-8, IL-10, TNF-alpha, and C-reactive protein) from baseline will be measured.", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Measurement of biomarkers of cardiovascular risk.", "description": "Change of the circulating biomarker levels of cardiovascular function (FGF-21 and NT-proBNP) from baseline will be measured.", "time_frame": "8 weeks" } ], "relevance_tags": [ "Metabolic", "Immunomodulatory", "Mitochondrial", "Neurological / Autonomic", "Anti-inflammatory", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 42, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05128292", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04741841", "title": "Effect of Probiotics in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-10-14", "start_date": "2020-03-30", "completion_date": "2021-06-30", "primary_completion_date": "2021-03-30", "conditions_raw": [ "Myalgic Encephalomyelitis", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Gutmagnific™ H.", "Gutmagnific™ L." ], "sponsor": "ImmuneBiotech Medical Sweden AB", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a neurological disease. Currently there is no effective treatment for ME/CFS due to unclear etiology of the disease. The aim of this randomized double-blind placebo-control clinical trial is to study the efficacy of the probiotic food supplement \"GutMagnific™\" in ME/CFS and comorbid gastrointestinal complications. The outcome of the study will be assessed based on the data from different self-reporting questionnaires and intestinal microbial flora analysis.", "primary_outcomes": [ { "type": "primary", "measure": "Changes in ME/CFS symptoms", "description": "ME/CFS symptom rating scale filled up weekly by participants, graded 0-4 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria. Higher score indicating worse outcome.", "time_frame": "At the baseline and weekly for 4 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes in Irritable Bowel Syndrome (IBS) symptoms", "description": "Questionnaire for IBS filled up by participants, graded 1-10 to evaluate degree of different bowel symptoms. Higher score indicating better condition.", "time_frame": "At the baseline and weekly for 4 months" }, { "type": "secondary", "measure": "Changes in the gastrointestinal symptoms based on Rome III criteria", "description": "Rome III questionnaire for IBS filled up by participants", "time_frame": "At the baseline and after 3 & 4 months" }, { "type": "secondary", "measure": "Changes in health related quality of life (RAND 36-Item Health Survey)", "description": "RAND-36 questionnaire for health-related quality of life filled up by participants. The questionnaire evaluating eight health concepts: physical functioning, role limitations caused by physical health problem, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Possible score is 0 (lowest) to 100 (highest) for each item.", "time_frame": "At the baseline and monthly for 4 months" }, { "type": "secondary", "measure": "Changes in Hospital Anxiety and Depression Scale (HADS)", "description": "HADS questionnaire for anxiety and depression filled up by participants.The questionnaire comprises questions for anxiety and depression. Each item on the questionnaire is scored from 0-3 and means that a person can score between 0 and 21 for either anxiety or depression. Higher score representing worse outcome.", "time_frame": "At the baseline and after 3 & 4 months" }, { "type": "secondary", "measure": "Changes in gut microbiota composition", "description": "Fecal samples will be analysed using sequencing-based methods to monitor possible changes related to probiotic treatment. Samples taken prior to and after probiotic treatment in the same participant will be compared.", "time_frame": "At the baseline and after 3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Changes in ME/CFS symptoms", "description": "ME/CFS symptom rating scale filled up weekly by participants, graded 0-4 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria. Higher score indicating worse outcome.", "time_frame": "At the baseline and weekly for 4 months" }, { "type": "secondary", "measure": "Changes in Irritable Bowel Syndrome (IBS) symptoms", "description": "Questionnaire for IBS filled up by participants, graded 1-10 to evaluate degree of different bowel symptoms. Higher score indicating better condition.", "time_frame": "At the baseline and weekly for 4 months" }, { "type": "secondary", "measure": "Changes in the gastrointestinal symptoms based on Rome III criteria", "description": "Rome III questionnaire for IBS filled up by participants", "time_frame": "At the baseline and after 3 & 4 months" }, { "type": "secondary", "measure": "Changes in health related quality of life (RAND 36-Item Health Survey)", "description": "RAND-36 questionnaire for health-related quality of life filled up by participants. The questionnaire evaluating eight health concepts: physical functioning, role limitations caused by physical health problem, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Possible score is 0 (lowest) to 100 (highest) for each item.", "time_frame": "At the baseline and monthly for 4 months" }, { "type": "secondary", "measure": "Changes in Hospital Anxiety and Depression Scale (HADS)", "description": "HADS questionnaire for anxiety and depression filled up by participants.The questionnaire comprises questions for anxiety and depression. Each item on the questionnaire is scored from 0-3 and means that a person can score between 0 and 21 for either anxiety or depression. Higher score representing worse outcome.", "time_frame": "At the baseline and after 3 & 4 months" }, { "type": "secondary", "measure": "Changes in gut microbiota composition", "description": "Fecal samples will be analysed using sequencing-based methods to monitor possible changes related to probiotic treatment. Samples taken prior to and after probiotic treatment in the same participant will be compared.", "time_frame": "At the baseline and after 3 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 74, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04741841", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04381780", "title": "Treatment of Fibromyalgia With Recovery Factors", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-10-11", "start_date": "2020-05-06", "completion_date": "2021-01-15", "primary_completion_date": "2020-12-01", "conditions_raw": [ "Fibromyalgia", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Recovery Factors" ], "sponsor": "Practitioners Alliance Network", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Treatment of Fibromyalgia and CFS with Recovery Factors", "primary_outcomes": [ { "type": "primary", "measure": "Composite VAS", "description": "Composite of VAS for Fatigue, sleep, cognition, pain and overall well being", "time_frame": "6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "FIQ-R", "description": "Fibromyalgia Impact Questionnaire", "time_frame": "1 month" } ], "outcome_measures": [ { "type": "primary", "measure": "Composite VAS", "description": "Composite of VAS for Fatigue, sleep, cognition, pain and overall well being", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "FIQ-R", "description": "Fibromyalgia Impact Questionnaire", "time_frame": "1 month" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 100, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04381780", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04810065", "title": "SingStrong: Strong Lungs Through Song - Long COVID-19 Study", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-09-28", "start_date": "2021-03-29", "completion_date": "2021-09-01", "primary_completion_date": "2021-07-29", "conditions_raw": [ "Long Covid" ], "mapped_conditions": [ "Long COVID / PASC" ], "agents": [ "Singstrong: Strong Lungs Through Song" ], "sponsor": "University of Limerick", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Evidence is emerging that many individuals who recover from Covid-19 are experiencing a range of residual problems. These include fatigue, pain, reduced exercise tolerance and breathing issues. This study includes participants who are experiencing problems with their lungs such as breathing difficulties, shortness of breath, and/or reduced exercise tolerance. The intervention is a twice weekly singing and breathing retraining intervention conducted over ten weeks. A range of self-report questionnaire measures will evaluate the efficacy of the intervention in addressing these problems. Focus groups and individual interviews will also be used to gather information on the impact and acceptability of the programme.", "primary_outcomes": [ { "type": "primary", "measure": "Covid-19 Yorkshire Rehab Screen (C19YRS)", "description": "The C19YRS was developed as a screening tool to monitor long-term symptoms due to Covid-19. The screening tool covers 19 items which combines yes/no answers and an 11 point ordinal scale (0-10) where a higher score denotes increased symptom severity.", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "DePaul Symptom Questionnaire - Short Form DSQ - SF", "description": "The DPSQ -SF assesses key symptoms of ME/Chronic Fatigue Syndrome such as fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments and autonomic, neuroendocrine and immune symptoms. At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. A higher score denotes increased symptom severity.", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Covid-19 Yorkshire Rehab Screen (C19YRS)", "description": "The C19YRS was developed as a screening tool to monitor long-term symptoms due to Covid-19. The screening tool covers 19 items which combines yes/no answers and an 11 point ordinal scale (0-10) where a higher score denotes increased symptom severity.", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "DePaul Symptom Questionnaire - Short Form DSQ - SF", "description": "The DPSQ -SF assesses key symptoms of ME/Chronic Fatigue Syndrome such as fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments and autonomic, neuroendocrine and immune symptoms. At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. A higher score denotes increased symptom severity.", "time_frame": "12 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04810065", "extraction_date": "2026-10-07" }, { "nct_id": "NCT05013606", "title": "Hydrogen Water Treatment for Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-08-19", "start_date": "2019-04-01", "completion_date": "2021-06-01", "primary_completion_date": "2021-04-01", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Hydrogen Water" ], "sponsor": "Stony Brook University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The proposed placebo-controlled pilot study will examine hydrogen water as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). 25 subjects who meet strict criteria for ME/CFS will be recruited. The 30 day trial will involve subjects ingesting 1-5 8 oz. glasses of hydrogen-dissolved water per day. The placebo condition will involve the same daily ingestion schedule but with an inert placebo pill instead of the active hydrogen treatment pill. The proposed study is intended to establish feasibility of the clinical protocol and examine potential treatment effects of hydrogen water which may include symptom reduction and possibly improved functioning. If feasibility and apparent treatment effects are confirmed, a large clinical trial will be proposed for submission to NIH. In addition to potential therapeutic properties, H2 water is portable, easily administered and safe to ingest.\n\nSelf-report assessments for ME/CFS symptoms, fatigue, autonomic symptoms, physical function, anxiety, and depression will be done in the week before and the week after the 30 day trial. In addition, 7-day home-based objective assessments of heart rate variability (a measure of parasympathetic function) and accelerometry (a physical activity assessment) will be scheduled before and after the intervention period.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "Fatigue Severity Scale; Minimum value=1; Maximum value=7; Range: 1.00-7.00. Higher scores indicate a worse outcome.", "time_frame": "4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index", "description": "Self-report measure of sleep quality; A patient's seven subscores, each of which can range from 0 to 3 are tallied, yielding a \"global\" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Short Form-36 Physical Function Subscale", "description": "Self-report measure of physical functioning. The Short Form 36 physical function subscale is composed of ten items encompassing a hierarchical range of difficulties. Each item is scored on the basis of the limitations perceived by surveyed individuals. Item scores (1, 2, or 3) are summed to obtain a total score, which can then be scaled relative to its range. Higher scores indicate higher physical function.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Depression, Anxiety, and Stress Scale", "description": "Self-report measure of depression, anxiety and stress symptoms; This 21-item stress measure contains three seven-item subscales: anxiety, depression and stress. Domain scores are calculated by summing all items in a domain and multiplying by two.\n\nScores range from 0-37+ on each subscale with higher scores indicated greater symptom severity.", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "Fatigue Severity Scale; Minimum value=1; Maximum value=7; Range: 1.00-7.00. Higher scores indicate a worse outcome.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index", "description": "Self-report measure of sleep quality; A patient's seven subscores, each of which can range from 0 to 3 are tallied, yielding a \"global\" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Short Form-36 Physical Function Subscale", "description": "Self-report measure of physical functioning. The Short Form 36 physical function subscale is composed of ten items encompassing a hierarchical range of difficulties. Each item is scored on the basis of the limitations perceived by surveyed individuals. Item scores (1, 2, or 3) are summed to obtain a total score, which can then be scaled relative to its range. Higher scores indicate higher physical function.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "Depression, Anxiety, and Stress Scale", "description": "Self-report measure of depression, anxiety and stress symptoms; This 21-item stress measure contains three seven-item subscales: anxiety, depression and stress. Domain scores are calculated by summing all items in a domain and multiplying by two.\n\nScores range from 0-37+ on each subscale with higher scores indicated greater symptom severity.", "time_frame": "4 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 23, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT05013606", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04435002", "title": "The Effect of Acupressure on Fatigue in Individuals With Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2021-08-11", "start_date": "2020-05-09", "completion_date": "2021-02-01", "primary_completion_date": "2020-12-09", "conditions_raw": [ "Acupressure", "Fatigue Syndrome, Chronic", "Complementary Therapies", "Quality of Life", "Depression" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Acupressure" ], "sponsor": "Istanbul Medipol University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome is a common problem in society. The treatment of this problem is limited. Acupressure is a treatment method that has become widespread and promising in recent years. For this purpose, the effect of acupressure treatment on chronic fatigue syndrome was investigated.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "Min Score:9 Max:63 Greater score shows greater fatigue", "time_frame": "5 min" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Beck Depression Inventory", "description": "", "time_frame": "15 min" }, { "type": "secondary", "measure": "Short Form-36 questionnaire", "description": "", "time_frame": "15 min" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "Min Score:9 Max:63 Greater score shows greater fatigue", "time_frame": "5 min" }, { "type": "secondary", "measure": "Beck Depression Inventory", "description": "", "time_frame": "15 min" }, { "type": "secondary", "measure": "Short Form-36 questionnaire", "description": "", "time_frame": "15 min" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 39, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04435002", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02444091", "title": "Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS)", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2021-05-11", "start_date": "2015-03", "completion_date": "2019-12-06", "primary_completion_date": "2019-12-06", "conditions_raw": [ "Chronic Fatigue Syndrome (CFS)", "Myalgic Encephalomyelitis (ME)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Cyclophosphamide" ], "sponsor": "Haukeland University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Significant clinical improvements of ME/CFS symptoms were observed in two patients with long-standing ME/CFS who received adjuvant chemotherapy including cyclophosphamide for breast cancer, also in one ME/CFS patient who received chemotherapy including iphosphamide for Hodgkin lymphoma.\n\nThree pilot ME/CFS patients were thereafter treated with six intravenous infusions four weeks apart, in two of these with a significant clinical response.\n\nThe hypothesis is that a subset of ME/CFS patients have an activated immune system, and that ME/CFS symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total.\n\nThe purpose of the present study is to treat ME/CFS patients with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total. The effects on ME/CFS symptoms and tolerability/side effects during 12 months follow-up will be registered, and additional tests will be performed to objectively register changes in physical ability during follow-up. Studies to investigate possible large vessel endothelial dysfunction and skin microvascular dysfunction will be performed before start of intervention and during follow-up.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue score, selfreported", "description": "Selfreported Fatigue score is registered every second week, always compared to baseline, as the mean of the four symptoms: \"Post-exertional malaise\", \"Fatigue\", \"Need for rest\", Daily functioning\" (scale 0-6, in which 3 is unchanged from baseline). Mean Fatigue scores for the time intervals 0-3, 3-6, 6-9 and 9-12 months are recorded for each patient. Changes in selfreported Fatigue scores from baseline to the mean values in each of the time intervals 0-3, 3-6, 6-9 and 9-12 months follow up, will constitute the primary endpoint.\n\nResponses for the primary endpoint will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Within 12 months follow-up" }, { "type": "primary", "measure": "Overall response", "description": "Overall response is recorded as the effect on ME/CFS symptoms during 12 months follow-up. The overall response is not predefined to a specific time interval during follow-up, but is defined as mean Fatigue score at least 4.5 for at least 6 consecutive weeks for moderate response, and mean Fatigue score at least 5.0 for at least 6 consecutive weeks for major response. Single response periods and the sum of response periods during 12 months follow-up will be recorded.\n\nOverall response will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Within 12 months follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Short Form-36 (SF-36)", "description": "SF-36 (ver 1.2) is completed by patients at baseline, and at 3, 6, 9, 12 months follow-up. Changes in Physical health summary score, Physical function, and \"Mean of five subdimensions\" (Physical function, Bodily pain, Vitality, Social function, General health) from baseline to each of the time points 3, 6, 9 and 12 months follow-up are recorded and constitute secondary endpoints. Secondary endpoints will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Recorded at baseline, and at 3, 6, 9 and 12 months follow-up." }, { "type": "secondary", "measure": "Physical activity (Sensewear armband)", "description": "The patients' physical activity level, in a home setting for 7 consecutive days, is recorded using Sensewear armbands, with registration at baseline and repeated in the time interval 7-9 months follow-up, and in the interval 11-12 months. Changes from baseline to analysis during the time intervals 7-9 months and 11-12 months, for mean number of steps per 24h, maximum number of steps per 24h, mean duration per 24h with activity level at least 3.5 METs, max duration per 24h with activity level at least 3.5 METs, are recorded. Changes in Physical activity will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Recorded at baseline, at 7-9 months, and at 11-12 months" }, { "type": "secondary", "measure": "Cardiopulmonary exercise tests for two following days", "description": "For patients who can tolerate exercise, cardiopulmonary exercise tests will be performed for two consecutive days, at baseline, and repeated in the time intervals 7-9 months, and 11-12 months. A programmed ramp-protocol is used. Oxygen-uptake and work load (Watt) day 2, at maximum effort and at anaerobic threshold, will be recorded and used for comparison to oxygen-uptake and work load with repeated tests after 7-9 and 11-12 months. Changes from baseline to repeated exercise tests after 7-9 and 11-12 months will be analyzed.", "time_frame": "At baseline, and repeated at 7-9 months, and 11-12 months" }, { "type": "secondary", "measure": "Self-recorded Function level", "description": "Self-recorded \"Function level\" (scale 0-100, compared to healthy state, according to a set of examples) are registered every second week. Mean \"Function level\" for the time intervals 0-3, 3-6, 6-9, 9-12 months are calculated. The changes in selfreported \"Function level\", from baseline to the mean value during each of the the time intervals 0-3, 3-6, 6-9, 9-12 months constitute secondary endpoints.\n\nChanges in Self-reported Function level will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "At baseline, and at 3, 6, 9 and 12 months follow-up" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "Fatigue Severity Scale (FSS) is completed by patients at baseline and at 3, 6, 9, 12 months. The changes in FSS from baseline to 3, 6, 9 and 12 months constitute secondary endpoints.\n\nChanges in Fatigue severity scale will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Baseline, 3, 6, 9 and 12 months" }, { "type": "secondary", "measure": "Longest continuous response duration", "description": "The longest duration of continuous self-reported Fatigue score ≥ 4,5 (for at least 6 consecutive weeks) within 12 months follow-up.\n\nThe longest response duration will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Within 12 months follow-up" }, { "type": "secondary", "measure": "Sustained clinical response at 12 months", "description": "The fraction of patients with sustained clinical response (defined as Fatigue score of at least 4.5) at 12 months, constitute a secondary endpoint.\n\nSustained clinical response at 12 months will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response, and for the group with previous rituximab intervention with clinical response but later relapse, and for all included patients together.", "time_frame": "Assessment at end of follow-up (12 months)" }, { "type": "secondary", "measure": "Safety and tolerability", "description": "Safety will be assessed by interim history, physical examination, and laboratory assessments every four weeks the first six months, thereafter at 6, 9 and 12 months follow-up. Adverse events will be graded according to the Common Toxicity Criteria for Adverse Effects (NCI-CTCAE, version 4.0). Number of patients with any grade, or severe (≥ grade 3 NCI-CTCAE version 4.0) toxicity will be reported, as a measure of tolerability and safety.\n\nAdverse Events may include include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis, disturbed ovarian function. The investigators will also collect information on possible toxicity after the formal 12 months study period.", "time_frame": "Continuously within the study period of 12 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue score, selfreported", "description": "Selfreported Fatigue score is registered every second week, always compared to baseline, as the mean of the four symptoms: \"Post-exertional malaise\", \"Fatigue\", \"Need for rest\", Daily functioning\" (scale 0-6, in which 3 is unchanged from baseline). Mean Fatigue scores for the time intervals 0-3, 3-6, 6-9 and 9-12 months are recorded for each patient. Changes in selfreported Fatigue scores from baseline to the mean values in each of the time intervals 0-3, 3-6, 6-9 and 9-12 months follow up, will constitute the primary endpoint.\n\nResponses for the primary endpoint will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Within 12 months follow-up" }, { "type": "primary", "measure": "Overall response", "description": "Overall response is recorded as the effect on ME/CFS symptoms during 12 months follow-up. The overall response is not predefined to a specific time interval during follow-up, but is defined as mean Fatigue score at least 4.5 for at least 6 consecutive weeks for moderate response, and mean Fatigue score at least 5.0 for at least 6 consecutive weeks for major response. Single response periods and the sum of response periods during 12 months follow-up will be recorded.\n\nOverall response will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Within 12 months follow-up" }, { "type": "secondary", "measure": "Short Form-36 (SF-36)", "description": "SF-36 (ver 1.2) is completed by patients at baseline, and at 3, 6, 9, 12 months follow-up. Changes in Physical health summary score, Physical function, and \"Mean of five subdimensions\" (Physical function, Bodily pain, Vitality, Social function, General health) from baseline to each of the time points 3, 6, 9 and 12 months follow-up are recorded and constitute secondary endpoints. Secondary endpoints will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Recorded at baseline, and at 3, 6, 9 and 12 months follow-up." }, { "type": "secondary", "measure": "Physical activity (Sensewear armband)", "description": "The patients' physical activity level, in a home setting for 7 consecutive days, is recorded using Sensewear armbands, with registration at baseline and repeated in the time interval 7-9 months follow-up, and in the interval 11-12 months. Changes from baseline to analysis during the time intervals 7-9 months and 11-12 months, for mean number of steps per 24h, maximum number of steps per 24h, mean duration per 24h with activity level at least 3.5 METs, max duration per 24h with activity level at least 3.5 METs, are recorded. Changes in Physical activity will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Recorded at baseline, at 7-9 months, and at 11-12 months" }, { "type": "secondary", "measure": "Cardiopulmonary exercise tests for two following days", "description": "For patients who can tolerate exercise, cardiopulmonary exercise tests will be performed for two consecutive days, at baseline, and repeated in the time intervals 7-9 months, and 11-12 months. A programmed ramp-protocol is used. Oxygen-uptake and work load (Watt) day 2, at maximum effort and at anaerobic threshold, will be recorded and used for comparison to oxygen-uptake and work load with repeated tests after 7-9 and 11-12 months. Changes from baseline to repeated exercise tests after 7-9 and 11-12 months will be analyzed.", "time_frame": "At baseline, and repeated at 7-9 months, and 11-12 months" }, { "type": "secondary", "measure": "Self-recorded Function level", "description": "Self-recorded \"Function level\" (scale 0-100, compared to healthy state, according to a set of examples) are registered every second week. Mean \"Function level\" for the time intervals 0-3, 3-6, 6-9, 9-12 months are calculated. The changes in selfreported \"Function level\", from baseline to the mean value during each of the the time intervals 0-3, 3-6, 6-9, 9-12 months constitute secondary endpoints.\n\nChanges in Self-reported Function level will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "At baseline, and at 3, 6, 9 and 12 months follow-up" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "Fatigue Severity Scale (FSS) is completed by patients at baseline and at 3, 6, 9, 12 months. The changes in FSS from baseline to 3, 6, 9 and 12 months constitute secondary endpoints.\n\nChanges in Fatigue severity scale will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Baseline, 3, 6, 9 and 12 months" }, { "type": "secondary", "measure": "Longest continuous response duration", "description": "The longest duration of continuous self-reported Fatigue score ≥ 4,5 (for at least 6 consecutive weeks) within 12 months follow-up.\n\nThe longest response duration will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response and for the group with previous rituximab intervention with clinical response but later relapse, and also for all 40 included patients together.", "time_frame": "Within 12 months follow-up" }, { "type": "secondary", "measure": "Sustained clinical response at 12 months", "description": "The fraction of patients with sustained clinical response (defined as Fatigue score of at least 4.5) at 12 months, constitute a secondary endpoint.\n\nSustained clinical response at 12 months will be recorded separately for the group of (at least) 25 ME/CFS patients not given rituximab previously, for the group with previous rituximab intervention for ME/CFS with no clinical response, and for the group with previous rituximab intervention with clinical response but later relapse, and for all included patients together.", "time_frame": "Assessment at end of follow-up (12 months)" }, { "type": "secondary", "measure": "Safety and tolerability", "description": "Safety will be assessed by interim history, physical examination, and laboratory assessments every four weeks the first six months, thereafter at 6, 9 and 12 months follow-up. Adverse events will be graded according to the Common Toxicity Criteria for Adverse Effects (NCI-CTCAE, version 4.0). Number of patients with any grade, or severe (≥ grade 3 NCI-CTCAE version 4.0) toxicity will be reported, as a measure of tolerability and safety.\n\nAdverse Events may include include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis, disturbed ovarian function. The investigators will also collect information on possible toxicity after the formal 12 months study period.", "time_frame": "Continuously within the study period of 12 months" } ], "relevance_tags": [ "Immunomodulatory", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02444091", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02229942", "title": "B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study.", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2021-05-11", "start_date": "2014-09", "completion_date": "2017-11", "primary_completion_date": "2017-09", "conditions_raw": [ "Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Rituximab" ], "sponsor": "Haukeland University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from B-lymphocyte treatment using the monoclonal anti-CD20 antibody rituximab with induction and maintenance treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue score, selfreported.", "description": "Selfreported Fatigue score is registered every second week, as the mean score for the four symptoms: \"Post-exertional malaise\", \"Fatigue\", \"Need for rest\", \"Daily functioning\" (scale 0-6). Mean Fatigue scores for the time intervals 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 months are recorded for each patient. These data are used for statistical analysis. The difference in course of Fatigue score during 24 months follow-up, between the rituximab and placebo groups, will constitute the primary endpoint.\n\nOverall response is recorded as the effect on CFS/ME symptoms during 24 months follow-up. The overall response is not predefined to a specific time interval, but is defined as mean Fatigue score at least 4.5 for at least 8 consecutive weeks for moderate response, and mean Fatigue score at least 5.0 for at least 8 consecutive weeks for major response. Single response periods and the sum of response periods during 24 months follow-up will be recorded.", "time_frame": "Course of Fatigue score during 24 months follow-up." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Short Form-36 (SF-36)", "description": "SF-36 (ver 1.2) are selfreported by patients at baseline, and at 3, 6, 9, 12, 15, 18, 21 and 24 months follow-up. Changes in Physical health summary score, Physical function, and \"Mean of five subdimensions\" (Physical function, Bodily pain, Vitality, Social function, General health) are recorded. The difference in course during 24 months follow-up, between the rituximab and placebo groups, will constitute secondary endpoints.\n\nAlso, the difference between rituximab and placebo groups, in changes from baseline to recording at 18 months, for Physical health summary score, Physical function, and \"mean of five SF-36 subdimensions\", constitute secondary endpoints.", "time_frame": "Changes in SF-36 scores during 24 months follow-up" }, { "type": "secondary", "measure": "Physical activity (Sensewear armband)", "description": "The patients' physical activity level, in a home setting for 7 consecutive days, is recorded using Sensewear armbands, with registration at baseline and repeated in the time interval 17-21 months follow-up. Changes from baseline to analysis during the time interval 17-21 months, for mean number of steps per 24h, maximum number of steps per 24h, mean duration per 24h with activity level at least 3.5 METs, max duration per 24h with activity level at least 3.5 METs, are recorded. The difference between rituximab and placebo groups will constitute secondary endpoints.", "time_frame": "Analyzed at baseline and at interval 17-21 months" }, { "type": "secondary", "measure": "Self-recorded \"Function level\"", "description": "Self-recorded \"Function level\" (scale 0-100, compared to healthy state, according to a set of examples) are registered every second week. Mean \"Function level\" for the time intervals 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 months are calculated. The difference in course of \"Function level\", between the rituximab and placebo groups, constitute a secondary endpoint.\n\nAlso, the differences between the rituximab and placebo groups, for changes in selfreported \"Fatigue score\" and in selfreported \"Function level\", calculated from baseline to the mean value during the time interval 16-20 months, constitute secondary endpoints.", "time_frame": "Course during 24 months follow-up" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "Fatigue Severity Scale (FSS) is self-recorded at baseline and at 6, 12, 18, 24 months. The difference between the rituximab and placebo groups, in changes in FSS from baseline to 18 months follow-up, constitutes a secondary endpoint.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Clinical response duration", "description": "Clinical response periods, defined as consecutive self-recorded Fatigue score at least 4.5 (scale 0-6) for a minimum of 8 weeks, during 24 months follow-up, are recorded.\n\nThe difference in the longest consecutive clinical response period, between rituximab and placebo groups, constitutes a secondary endpoint.", "time_frame": "During 24 months follow-up" }, { "type": "secondary", "measure": "Sustained clinical response at 24 months", "description": "The difference between rituximab and placebo groups, in fraction of patients with sustained clinical response (defined as Fatigue score of at least 4.5) at 24 months, constitute a secondary endpoint.", "time_frame": "Assessment at 24 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue score, selfreported.", "description": "Selfreported Fatigue score is registered every second week, as the mean score for the four symptoms: \"Post-exertional malaise\", \"Fatigue\", \"Need for rest\", \"Daily functioning\" (scale 0-6). Mean Fatigue scores for the time intervals 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 months are recorded for each patient. These data are used for statistical analysis. The difference in course of Fatigue score during 24 months follow-up, between the rituximab and placebo groups, will constitute the primary endpoint.\n\nOverall response is recorded as the effect on CFS/ME symptoms during 24 months follow-up. The overall response is not predefined to a specific time interval, but is defined as mean Fatigue score at least 4.5 for at least 8 consecutive weeks for moderate response, and mean Fatigue score at least 5.0 for at least 8 consecutive weeks for major response. Single response periods and the sum of response periods during 24 months follow-up will be recorded.", "time_frame": "Course of Fatigue score during 24 months follow-up." }, { "type": "secondary", "measure": "Short Form-36 (SF-36)", "description": "SF-36 (ver 1.2) are selfreported by patients at baseline, and at 3, 6, 9, 12, 15, 18, 21 and 24 months follow-up. Changes in Physical health summary score, Physical function, and \"Mean of five subdimensions\" (Physical function, Bodily pain, Vitality, Social function, General health) are recorded. The difference in course during 24 months follow-up, between the rituximab and placebo groups, will constitute secondary endpoints.\n\nAlso, the difference between rituximab and placebo groups, in changes from baseline to recording at 18 months, for Physical health summary score, Physical function, and \"mean of five SF-36 subdimensions\", constitute secondary endpoints.", "time_frame": "Changes in SF-36 scores during 24 months follow-up" }, { "type": "secondary", "measure": "Physical activity (Sensewear armband)", "description": "The patients' physical activity level, in a home setting for 7 consecutive days, is recorded using Sensewear armbands, with registration at baseline and repeated in the time interval 17-21 months follow-up. Changes from baseline to analysis during the time interval 17-21 months, for mean number of steps per 24h, maximum number of steps per 24h, mean duration per 24h with activity level at least 3.5 METs, max duration per 24h with activity level at least 3.5 METs, are recorded. The difference between rituximab and placebo groups will constitute secondary endpoints.", "time_frame": "Analyzed at baseline and at interval 17-21 months" }, { "type": "secondary", "measure": "Self-recorded \"Function level\"", "description": "Self-recorded \"Function level\" (scale 0-100, compared to healthy state, according to a set of examples) are registered every second week. Mean \"Function level\" for the time intervals 0-4, 4-8, 8-12, 12-16, 16-20, 20-24 months are calculated. The difference in course of \"Function level\", between the rituximab and placebo groups, constitute a secondary endpoint.\n\nAlso, the differences between the rituximab and placebo groups, for changes in selfreported \"Fatigue score\" and in selfreported \"Function level\", calculated from baseline to the mean value during the time interval 16-20 months, constitute secondary endpoints.", "time_frame": "Course during 24 months follow-up" }, { "type": "secondary", "measure": "Fatigue Severity Scale", "description": "Fatigue Severity Scale (FSS) is self-recorded at baseline and at 6, 12, 18, 24 months. The difference between the rituximab and placebo groups, in changes in FSS from baseline to 18 months follow-up, constitutes a secondary endpoint.", "time_frame": "24 months" }, { "type": "secondary", "measure": "Clinical response duration", "description": "Clinical response periods, defined as consecutive self-recorded Fatigue score at least 4.5 (scale 0-6) for a minimum of 8 weeks, during 24 months follow-up, are recorded.\n\nThe difference in the longest consecutive clinical response period, between rituximab and placebo groups, constitutes a secondary endpoint.", "time_frame": "During 24 months follow-up" }, { "type": "secondary", "measure": "Sustained clinical response at 24 months", "description": "The difference between rituximab and placebo groups, in fraction of patients with sustained clinical response (defined as Fatigue score of at least 4.5) at 24 months, constitute a secondary endpoint.", "time_frame": "Assessment at 24 months" } ], "relevance_tags": [ "Immunomodulatory", "Phase 3", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 151, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02229942", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00848692", "title": "Drug Intervention in Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2021-05-11", "start_date": "2008-06", "completion_date": "2010-06", "primary_completion_date": "2010-06", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Rituximab" ], "sponsor": "Haukeland University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy.\n\nThe hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "", "time_frame": "3 months after intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes", "description": "", "time_frame": "2, 4, 6, 8, 10, 12 months after intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "", "time_frame": "3 months after intervention" }, { "type": "secondary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes", "description": "", "time_frame": "2, 4, 6, 8, 10, 12 months after intervention" } ], "relevance_tags": [ "Immunomodulatory", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 30, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00848692", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03496961", "title": "Yan Nian Jiu Zhuan Fa Improve Chronic Fatigue Syndromes", "status": "UNKNOWN", "phase": "NA", "last_updated": "2021-03-17", "start_date": "2018-12-01", "completion_date": "2021-12-01", "primary_completion_date": "2021-06-01", "conditions_raw": [ "Chronic Fatigue Syndromes" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Yan Nian Jiu Zhuan Fa" ], "sponsor": "Shanghai University of Traditional Chinese Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study is to disclose the mechanism of characteristic Tao yin exercises regulate Chronic Fatigue Syndromes based on Brain-Gut Axis.Explore the clinical manifestation of Chronic Fatigue Syndromes, changes of neurotransmitter and central brain function. Then provide some new methods of treating Chronic Fatigue Syndromes.", "primary_outcomes": [ { "type": "primary", "measure": "Multidimensional Fatigue Inventory (MFI-20)", "description": "A self-report instrument consisting of 20-item devised to measure fatigue, covering the dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This instrument takes about 5 to 10 minutes to complete. The instrument's psychometric properties were tested and determined to have good internal consistency and construct validity in samples with Chronic Fatigue Syndrome (CFS).", "time_frame": "6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Short Form 36-item Health Survey (SF-36)", "description": "The SF-36 is an internationally well-validated measure of Health-related quality of life that has a broad scope of questions validated across different chronic diseases and comorbidities.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Brain functional connectivity", "description": "Functional connectivity density (FCD) is a newly developed data-driven method to measure the number of functional connections of each voxel, possibly providing new insight into the neural correlates of fluid reasoning.Functional magnetic resonance imaging (fMRI) is a novel method for studying the changes of brain functional connectivity.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Bristol Stool Scale", "description": "The Bristol stool scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. It is used in both clinical and experimental fields. The seven types of stool are:\n\nScale 1: Separate hard lumps, like nuts (hard to pass), also known as goat feces or sausage-shaped, but lumpy.\n\nScale 2: Like a sausage but with cracks on its surface or like a sausage or snake, smooth and soft.\n\nScale 3: Soft blobs with clear cut edges (passed easily). Scale 4: Fluffy pieces with ragged edges, a mushy stool even watery, no solid pieces, entirely liquid.\n\nScale 1 indicate constipation, Scale 2 being the ideal stools as they are easy to defecate while not containing excess liquid, Scale 3 tending towards diarrhea, and Scale 4 indicate diarrhea.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index", "description": "A self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Neuropeptide Y", "description": "Neuropeptide Y (NPY) is a 36 amino-acid neuropeptide that is involved in various physiological and homeostatic processes in both the central and peripheral nervous systems. NPY has been identified as the most abundant peptide present in the mammalian central nervous system, which consists of the brain and spinal cord. It is secreted alongside other neurotransmitters such as glutamate.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Substance P", "description": "Substance P is a bioactive 11-amino acid peptide (Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met-amide) first isolated in 1931 from brain and intestine. The peptide is involved in many physiological processes including pain modulation, smooth muscle contraction, blood pressure control, kidney function and water homeostasis.Substance P is widely distributed in numerous tissues and body fluids including the central and peripheral nervous system, gastrointestinal tract, respiratory tract, visual system and circulatory system.", "time_frame": "6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Multidimensional Fatigue Inventory (MFI-20)", "description": "A self-report instrument consisting of 20-item devised to measure fatigue, covering the dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This instrument takes about 5 to 10 minutes to complete. The instrument's psychometric properties were tested and determined to have good internal consistency and construct validity in samples with Chronic Fatigue Syndrome (CFS).", "time_frame": "6 months" }, { "type": "secondary", "measure": "Short Form 36-item Health Survey (SF-36)", "description": "The SF-36 is an internationally well-validated measure of Health-related quality of life that has a broad scope of questions validated across different chronic diseases and comorbidities.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Brain functional connectivity", "description": "Functional connectivity density (FCD) is a newly developed data-driven method to measure the number of functional connections of each voxel, possibly providing new insight into the neural correlates of fluid reasoning.Functional magnetic resonance imaging (fMRI) is a novel method for studying the changes of brain functional connectivity.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Bristol Stool Scale", "description": "The Bristol stool scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. It is used in both clinical and experimental fields. The seven types of stool are:\n\nScale 1: Separate hard lumps, like nuts (hard to pass), also known as goat feces or sausage-shaped, but lumpy.\n\nScale 2: Like a sausage but with cracks on its surface or like a sausage or snake, smooth and soft.\n\nScale 3: Soft blobs with clear cut edges (passed easily). Scale 4: Fluffy pieces with ragged edges, a mushy stool even watery, no solid pieces, entirely liquid.\n\nScale 1 indicate constipation, Scale 2 being the ideal stools as they are easy to defecate while not containing excess liquid, Scale 3 tending towards diarrhea, and Scale 4 indicate diarrhea.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Pittsburgh Sleep Quality Index", "description": "A self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Neuropeptide Y", "description": "Neuropeptide Y (NPY) is a 36 amino-acid neuropeptide that is involved in various physiological and homeostatic processes in both the central and peripheral nervous systems. NPY has been identified as the most abundant peptide present in the mammalian central nervous system, which consists of the brain and spinal cord. It is secreted alongside other neurotransmitters such as glutamate.", "time_frame": "6 months" }, { "type": "secondary", "measure": "Substance P", "description": "Substance P is a bioactive 11-amino acid peptide (Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met-amide) first isolated in 1931 from brain and intestine. The peptide is involved in many physiological processes including pain modulation, smooth muscle contraction, blood pressure control, kidney function and water homeostasis.Substance P is widely distributed in numerous tissues and body fluids including the central and peripheral nervous system, gastrointestinal tract, respiratory tract, visual system and circulatory system.", "time_frame": "6 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 135, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03496961", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02055898", "title": "SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2020-11-18", "start_date": "2014-04", "completion_date": "2015-08", "primary_completion_date": "2015-08", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Sodium Oxybate" ], "sponsor": "Imperial College London", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators wish to investigate whether enhancement of SWS, which is seen after a drug called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function, specifically sleepiness and mental performance. This is a safe and well-tolerated drug that is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.\n\nThe investigators will study 12 patients diagnosed with CFS using international diagnostic guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement on the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be taken nightly, and the investigators will measure next-day sleepiness, mental performance and fatigue, and compare drug and placebo nights.", "primary_outcomes": [ { "type": "primary", "measure": "EEG Slow Wave Activity During Sleep", "description": "Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\\^2/Hz)", "time_frame": "night 1" }, { "type": "primary", "measure": "EEG Slow Wave Activity During Sleep", "description": "Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\\^2/Hz)", "time_frame": "night 4" }, { "type": "primary", "measure": "Daytime Sleepiness", "description": "time to fall asleep in minutes", "time_frame": "Day 2" }, { "type": "primary", "measure": "Daytime Sleepiness", "description": "time to fall asleep in minutes", "time_frame": "Day 5" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "EEG Slow Wave Activity During Sleep", "description": "Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\\^2/Hz)", "time_frame": "night 1" }, { "type": "primary", "measure": "EEG Slow Wave Activity During Sleep", "description": "Total power in 0.5-4Hz band in microvolts squared per Hertz (uV\\^2/Hz)", "time_frame": "night 4" }, { "type": "primary", "measure": "Daytime Sleepiness", "description": "time to fall asleep in minutes", "time_frame": "Day 2" }, { "type": "primary", "measure": "Daytime Sleepiness", "description": "time to fall asleep in minutes", "time_frame": "Day 5" } ], "relevance_tags": [ "General", "Phase 4", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 13, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02055898", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04599348", "title": "Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng", "status": "UNKNOWN", "phase": "EARLY_PHASE1", "last_updated": "2020-10-22", "start_date": "2020-10-14", "completion_date": "2021-04-30", "primary_completion_date": "2021-04-30", "conditions_raw": [ "Fibromyalgia", "CFS" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Hrg 80 Red Ginseng" ], "sponsor": "Practitioners Alliance Network", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Will a unique form of ginseng be clinically helpful in those with chronic fatigue syndrome and fibromyalgia?", "primary_outcomes": [ { "type": "primary", "measure": "Composite Visual analog scale of symptoms", "description": "Composite Score visual analog scale (0 - 30 Visual analog scale units , with 30 VAS units representing optimal function) of energy, cognition, and overall well-being. Each on a 0-10 scale with 10 being healthy. The units are the same for all 3 allowing them to be combined into a single composite total score. This total score (0-30 with 30 being the best outcome ) is the primary outcome measure", "time_frame": "6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "VAS of pain and sleep", "description": "VAS of pain and sleep", "time_frame": "6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Composite Visual analog scale of symptoms", "description": "Composite Score visual analog scale (0 - 30 Visual analog scale units , with 30 VAS units representing optimal function) of energy, cognition, and overall well-being. Each on a 0-10 scale with 10 being healthy. The units are the same for all 3 allowing them to be combined into a single composite total score. This total score (0-30 with 30 being the best outcome ) is the primary outcome measure", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "VAS of pain and sleep", "description": "VAS of pain and sleep", "time_frame": "6 weeks" } ], "relevance_tags": [ "General", "EARLY_Phase 1", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 70, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT04599348", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04381793", "title": "Treatment of CFS & Fibromyalgia With Recovery Factors", "status": "COMPLETED", "phase": "NA", "last_updated": "2020-10-19", "start_date": "2019-05-20", "completion_date": "2020-07-04", "primary_completion_date": "2020-07-04", "conditions_raw": [ "Fibromyalgia", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Recovery Factors" ], "sponsor": "Practitioners Alliance Network", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome", "primary_outcomes": [ { "type": "primary", "measure": "VAS", "description": "Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being", "time_frame": "6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "antibody titres", "description": "Total IgG and IgG 1-4 subsets", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "FIQ-R", "description": "Fibromyalgia severity scale", "time_frame": "6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "VAS", "description": "Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "antibody titres", "description": "Total IgG and IgG 1-4 subsets", "time_frame": "10 weeks" }, { "type": "secondary", "measure": "FIQ-R", "description": "Fibromyalgia severity scale", "time_frame": "6 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 43, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04381793", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04174300", "title": "Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)", "status": "COMPLETED", "phase": "NA", "last_updated": "2020-08-27", "start_date": "2019-03-20", "completion_date": "2020-03-10", "primary_completion_date": "2020-03-10", "conditions_raw": [ "Fibromyalgia (FM)", "Chronic Fatigue Syndrome (CFS)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Manual Therapy" ], "sponsor": "Fundación Universidad Católica de Valencia San Vicente Mártir", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Fibromyalgia (FM)and Chronic Fatigue Syndrome (CFS) are complex diseases often presenting overlapping symptomatology. Manual therapy (MT) protocols report benefits for pain treatment of FM, but the underlying mechanisms for patient improvement remain unknown.\n\nThe main goal of this study is to assess the molecular changes associating to mechanical and additional MT triggers, possibly involved in patient symptom improvement.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue score", "description": "MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Pain index", "description": "FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, \\<39 mild, 39-58 moderate, ≥59 severe", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Differential gene expression", "description": "RNAseq", "time_frame": "8 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Quality of life score", "description": "SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "ANS (autonomic nervous system) dysfunction", "description": "Plantar pressure maps", "time_frame": "8 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue score", "description": "MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Pain index", "description": "FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, \\<39 mild, 39-58 moderate, ≥59 severe", "time_frame": "8 weeks" }, { "type": "primary", "measure": "Differential gene expression", "description": "RNAseq", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "Quality of life score", "description": "SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health", "time_frame": "8 weeks" }, { "type": "secondary", "measure": "ANS (autonomic nervous system) dysfunction", "description": "Plantar pressure maps", "time_frame": "8 weeks" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04174300", "extraction_date": "2026-10-07" }, { "nct_id": "NCT04177459", "title": "Rehabilitation of Adolescents Living With Chronic Fatigue", "status": "TERMINATED", "phase": "NA", "last_updated": "2020-06-25", "start_date": "2019-12-06", "completion_date": "2020-04-30", "primary_completion_date": "2020-04-30", "conditions_raw": [ "Fatigue Syndrome, Chronic" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Health Promoting Dialogue", "Standard Treatment / Treatment As Usual" ], "sponsor": "St. Olavs Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Previous studies have shown that health-related quality of life (HRQoL) in adolescents living with chronic fatigue syndrome (CFS/ME) is low if compared with healthy adolescents and adolescents living with other chronic diseases. Effective strategies to improve HRQoL in this group are still lacking. Recently we have observed HRQoL in a group of Norwegian adolescents with CFS/ME (not yet published), which is the background for a new study where we have planned an intervention with health promoting dialogues between patient and nurse, as a strategy to improve HRQoL. In this study we have also opened to include adolescents with other chronic fatigue diagnosis with similar challenges in follow-up as in CFS/ME.", "primary_outcomes": [ { "type": "primary", "measure": "Health-related quality of life (HRQoL)", "description": "assessed by PedsQL Generic Core scale 4.0", "time_frame": "1 year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue Questionnaire", "description": "PedsQL Multidimensional Fatigue Questionnaire", "time_frame": "1 year" }, { "type": "secondary", "measure": "Mood and Feelings Questionnaire", "description": "Short Mood and Feelings Questionnaire", "time_frame": "1 year" }, { "type": "secondary", "measure": "Self-reported follow-up, School functioning and participation in Leisure activities", "description": "Self-report form with yes/no answers regarding follow-up from health care personnel, follow-up from school, school attendance and participation in leisure activities.", "time_frame": "1 year" }, { "type": "secondary", "measure": "EQ-5D-5L", "description": "EQ-5D-5L is a 5 dimension and 5 level Questionnaire from the Euro Qol Group (supported by the Euro QolGroup Association and Euro Qol Research Foundation). Health states which is defined by EQ-5D-5L-answers, is assigned a score between 0 and 1 by applying preference weights. In Norway it has been common to use preference weights obtained from a sample of the general population in the UK. Norwegian preference weights will be available in near future. EQ-5D is the name of the instrument and is not an acronym. EQ-5D is the correct term to use in print or verbally.", "time_frame": "1 year" } ], "outcome_measures": [ { "type": "primary", "measure": "Health-related quality of life (HRQoL)", "description": "assessed by PedsQL Generic Core scale 4.0", "time_frame": "1 year" }, { "type": "secondary", "measure": "Fatigue Questionnaire", "description": "PedsQL Multidimensional Fatigue Questionnaire", "time_frame": "1 year" }, { "type": "secondary", "measure": "Mood and Feelings Questionnaire", "description": "Short Mood and Feelings Questionnaire", "time_frame": "1 year" }, { "type": "secondary", "measure": "Self-reported follow-up, School functioning and participation in Leisure activities", "description": "Self-report form with yes/no answers regarding follow-up from health care personnel, follow-up from school, school attendance and participation in leisure activities.", "time_frame": "1 year" }, { "type": "secondary", "measure": "EQ-5D-5L", "description": "EQ-5D-5L is a 5 dimension and 5 level Questionnaire from the Euro Qol Group (supported by the Euro QolGroup Association and Euro Qol Research Foundation). Health states which is defined by EQ-5D-5L-answers, is assigned a score between 0 and 1 by applying preference weights. In Norway it has been common to use preference weights obtained from a sample of the general population in the UK. Norwegian preference weights will be available in near future. EQ-5D is the name of the instrument and is not an acronym. EQ-5D is the correct term to use in print or verbally.", "time_frame": "1 year" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 3, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT04177459", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00920777", "title": "Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis", "status": "COMPLETED", "phase": "NA", "last_updated": "2020-06-09", "start_date": "2009-05", "completion_date": "2015-05", "primary_completion_date": "2014-07", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis", "Fatigue", "Pain" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Cbt" ], "sponsor": "Norwegian University of Science and Technology", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to analyze income variables in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, and to analyze the effect of short vs. long Cognitive Behaviour Therapy.", "primary_outcomes": [ { "type": "primary", "measure": "Mental and physical function", "description": "Mental and physical function, measured by \"SF 36\". Success criteria are measured by \\>10 point improvement of mental and/ or physical function.", "time_frame": "1 year" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Mental and physical function", "description": "Mental and physical function, measured by \"SF 36\". Success criteria are measured by \\>10 point improvement of mental and/ or physical function.", "time_frame": "1 year" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 234, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT00920777", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03613129", "title": "Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2020-05-12", "start_date": "2018-07-23", "completion_date": "2019-04-30", "primary_completion_date": "2019-04-30", "conditions_raw": [ "Myalgic Encephalomyelitis", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Ct38" ], "sponsor": "LUCINDA BATEMAN, MD", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study seeks to investigate the safety, tolerability and efficacy of CT38, an experimental peptide administered by subcutaneous infusion, in the treatment of ME/CFS patients.", "primary_outcomes": [ { "type": "primary", "measure": "Total Daily Symptom Score (TDSS)", "description": "Pre-/post-treatment difference in TDSS (0-65 scale, 0=no symptoms; 65=maximum of 5 for each of 13 specific patient-reported symptoms). The TDSS sums the patient-reported daily symptom score for each of 13 specific symptoms (including fatigue, muscle/joint pain, sleep problems, cognitive problems, orthostatic intolerance, body temperature perceptions, flu-like symptoms, headaches or sensitivities, shortness of breath, gastrointestinal problems, urogenital problems, anxiety and depression), each assessed on a 0-5 scale (0=no symptom, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=severe)", "time_frame": "28 days preceding Visit 3 (pre-treatment) and 28 days preceding Visit 6 (post-treatment)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "SF-36, PCS", "description": "Pre-/post-treatment difference in the physical component score (PCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)", "time_frame": "Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)" }, { "type": "secondary", "measure": "SF-36, MCS", "description": "Pre-/post-treatment difference in the mental component score (MCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)", "time_frame": "Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)" } ], "outcome_measures": [ { "type": "primary", "measure": "Total Daily Symptom Score (TDSS)", "description": "Pre-/post-treatment difference in TDSS (0-65 scale, 0=no symptoms; 65=maximum of 5 for each of 13 specific patient-reported symptoms). The TDSS sums the patient-reported daily symptom score for each of 13 specific symptoms (including fatigue, muscle/joint pain, sleep problems, cognitive problems, orthostatic intolerance, body temperature perceptions, flu-like symptoms, headaches or sensitivities, shortness of breath, gastrointestinal problems, urogenital problems, anxiety and depression), each assessed on a 0-5 scale (0=no symptom, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=severe)", "time_frame": "28 days preceding Visit 3 (pre-treatment) and 28 days preceding Visit 6 (post-treatment)" }, { "type": "secondary", "measure": "SF-36, PCS", "description": "Pre-/post-treatment difference in the physical component score (PCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)", "time_frame": "Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)" }, { "type": "secondary", "measure": "SF-36, MCS", "description": "Pre-/post-treatment difference in the mental component score (MCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)", "time_frame": "Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)" } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 17, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03613129", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03191201", "title": "A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.", "status": "TERMINATED", "phase": "PHASE4", "last_updated": "2020-03-26", "start_date": "2017-06-21", "completion_date": "2020-03-09", "primary_completion_date": "2020-03-09", "conditions_raw": [ "Iron-deficiency", "Iron Toxicity", "Glucose Metabolism Disorders (Including Diabetes Mellitus)", "Metabolic Side Effects of Drugs", "Metabolic Disorder, Glucose", "Safety Issues" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Ferric Carboxymaltose" ], "sponsor": "Prof Gérard WAEBER", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In this study the investigators aim at addressing potential relationships between iron stores and glucose homeostasis. Iron (i.e. Ferric Carboxymaltose) will be perfused to pre-menopausal, iron-deficient non-anaemic women suffering from a chronic fatigue syndrome and parameters related to glucose homeostasis, parameters related to metabolic syndrome and inflammation will be measured before and after the intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation.", "description": "two-step hyperglycaemic clamp investigation", "time_frame": "at 28 days of the injection of the Investigation Product" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 14 days", "description": "plasma hs-CRP levels", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 28 days", "description": "plasma hs-CRP levels", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in interleukin-6 (IL-6) levels at 14 days", "description": "plasam IL-6 levels", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in interleukin-6 (IL-6) levels at 28 days", "description": "plasam IL-6 levels", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in adiponectin levels at 14 days", "description": "adiponectin", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in adiponectin levels at 28 days", "description": "adiponectin", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in interleukin-1beta levels at 14 days", "description": "IL-1b", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in interleukin-1beta levels at 28 days", "description": "IL-1b", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in blood pressure levels at 14 days", "description": "systolic and diastolic blood pressure", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in blood pressure levels at 28 days", "description": "systolic and diastolic blood pressure", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in the plasma lipid profile level at 14 days", "description": "plasma total- and HDL-cholesterol and plasam triglycerides", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in the plasma lipid profile level at 28 days", "description": "plasma total- and HDL-cholesterol and plasam triglycerides", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 14 days", "description": "Calculated Homeostasis Model Assessment (HOMA-2) index", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 28 days", "description": "Calculated Homeostasis Model Assessment (HOMA-2) index", "time_frame": "at 28 days of the injection of the Investigation Product" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from baseline in glucose homeostasis status, assessed by a dynamic two-step hyperglycaemic clamp investigation.", "description": "two-step hyperglycaemic clamp investigation", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 14 days", "description": "plasma hs-CRP levels", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in ultrasensitive C-reactive protein (hs-CRP) levels at 28 days", "description": "plasma hs-CRP levels", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in interleukin-6 (IL-6) levels at 14 days", "description": "plasam IL-6 levels", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in interleukin-6 (IL-6) levels at 28 days", "description": "plasam IL-6 levels", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in adiponectin levels at 14 days", "description": "adiponectin", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in adiponectin levels at 28 days", "description": "adiponectin", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in interleukin-1beta levels at 14 days", "description": "IL-1b", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in interleukin-1beta levels at 28 days", "description": "IL-1b", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in blood pressure levels at 14 days", "description": "systolic and diastolic blood pressure", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in blood pressure levels at 28 days", "description": "systolic and diastolic blood pressure", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in the plasma lipid profile level at 14 days", "description": "plasma total- and HDL-cholesterol and plasam triglycerides", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in the plasma lipid profile level at 28 days", "description": "plasma total- and HDL-cholesterol and plasam triglycerides", "time_frame": "at 28 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 14 days", "description": "Calculated Homeostasis Model Assessment (HOMA-2) index", "time_frame": "at 14 days of the injection of the Investigation Product" }, { "type": "secondary", "measure": "Change from baseline in the Homeostasis Model Assessment (HOMA-2) index at 28 days", "description": "Calculated Homeostasis Model Assessment (HOMA-2) index", "time_frame": "at 28 days of the injection of the Investigation Product" } ], "relevance_tags": [ "Metabolic", "Anti-inflammatory", "Phase 4", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 32, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03191201", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01534130", "title": "Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2020-02-17", "start_date": "2011-04", "completion_date": "2012-08", "primary_completion_date": "2012-08", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Acupuncture" ], "sponsor": "Chengdu University of Traditional Chinese Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators will conduct acupuncture for participants with chronic fatigue syndrome(CFS). Firstly the investigators aim to figure out the characteristic of sleep structure of CFS and the changes caused by acupuncture. Secondly the investigators seek to investigate the characteristic of sleep-wake rhythm, slow wave sleep(SWS)-rapid eye movement(REM)sleep rhythm, and REM sleep rhythm of CFS and the readjusting of acupuncture for it. Thirdly the investigators want to know the efficacy of acupuncture for relieving the fatigue, reducing accompanying symptoms and for improving the life quality of CFS.", "primary_outcomes": [ { "type": "primary", "measure": "The sleep perception", "description": "The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG.", "time_frame": "Change from baseline in sleep perception at 4 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "The Pittsburgh Sleep Quality Index(PSQI)", "description": "", "time_frame": "Change from baseline in PSQI at 4 weeks" }, { "type": "secondary", "measure": "The Fatigue Severity Scale(FSS)", "description": "", "time_frame": "Change from baseline in FSS at 4 weeks" }, { "type": "secondary", "measure": "The Somatic and Psychological Health Report(SPHR)", "description": "", "time_frame": "Change from baseline in SPHR at 4 weeks" }, { "type": "secondary", "measure": "The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36)", "description": "", "time_frame": "Change from baseline in SF-36 at 4 weeks" }, { "type": "secondary", "measure": "Sleep-wake rhythm", "description": "", "time_frame": "Change from baseline in sleep-wake rhythm at 4 weeks" }, { "type": "secondary", "measure": "DSWS-REM sleep rhythm", "description": "", "time_frame": "Change from baseline in DSWS-REM sleep rhythm at 4 weeks" }, { "type": "secondary", "measure": "REM sleep rhythm", "description": "", "time_frame": "Change from baseline in REM sleep rhythm at 4 weeks" }, { "type": "secondary", "measure": "Sleep latency", "description": "", "time_frame": "Change from baseline in sleep latency at 4 weeks" }, { "type": "secondary", "measure": "Total sleep time", "description": "", "time_frame": "Change from baseline in total sleep time at 4 weeks" }, { "type": "secondary", "measure": "Sleep efficiency", "description": "", "time_frame": "Change from baseline in sleep efficiency at 4 weeks" }, { "type": "secondary", "measure": "Percentage of every sleep stage", "description": "", "time_frame": "Change from baseline in percentage of every sleep stage at 4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "The sleep perception", "description": "The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG.", "time_frame": "Change from baseline in sleep perception at 4 weeks" }, { "type": "secondary", "measure": "The Pittsburgh Sleep Quality Index(PSQI)", "description": "", "time_frame": "Change from baseline in PSQI at 4 weeks" }, { "type": "secondary", "measure": "The Fatigue Severity Scale(FSS)", "description": "", "time_frame": "Change from baseline in FSS at 4 weeks" }, { "type": "secondary", "measure": "The Somatic and Psychological Health Report(SPHR)", "description": "", "time_frame": "Change from baseline in SPHR at 4 weeks" }, { "type": "secondary", "measure": "The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36)", "description": "", "time_frame": "Change from baseline in SF-36 at 4 weeks" }, { "type": "secondary", "measure": "Sleep-wake rhythm", "description": "", "time_frame": "Change from baseline in sleep-wake rhythm at 4 weeks" }, { "type": "secondary", "measure": "DSWS-REM sleep rhythm", "description": "", "time_frame": "Change from baseline in DSWS-REM sleep rhythm at 4 weeks" }, { "type": "secondary", "measure": "REM sleep rhythm", "description": "", "time_frame": "Change from baseline in REM sleep rhythm at 4 weeks" }, { "type": "secondary", "measure": "Sleep latency", "description": "", "time_frame": "Change from baseline in sleep latency at 4 weeks" }, { "type": "secondary", "measure": "Total sleep time", "description": "", "time_frame": "Change from baseline in total sleep time at 4 weeks" }, { "type": "secondary", "measure": "Sleep efficiency", "description": "", "time_frame": "Change from baseline in sleep efficiency at 4 weeks" }, { "type": "secondary", "measure": "Percentage of every sleep stage", "description": "", "time_frame": "Change from baseline in percentage of every sleep stage at 4 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 72, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01534130", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01689467", "title": "Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise", "status": "COMPLETED", "phase": "NA", "last_updated": "2019-08-26", "start_date": "2013-04-25", "completion_date": "2014-06-26", "primary_completion_date": "2014-06-26", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Fermented Velvet Antler Extract" ], "sponsor": "Chonbuk National University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue recovery after exercise. The investigators measured fatigue recovery parameters , including lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood pressure.", "primary_outcomes": [ { "type": "primary", "measure": "Changes in lactate", "description": "Lactate was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Changes in ammonia", "description": "Ammonia was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Changes in inorganic phosphorus", "description": "Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Changes in creatine kinase", "description": "Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Changes in Lactage dehydrogenase(LDH)", "description": "Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes in Multidimensional Fatigue Scale(MFS)", "description": "Multidimensional Fatigue Scale(MFS) was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Changes in 36-Item Short-Form Health Survey(SF-36)", "description": "36-Item Short-Form Health Survey(SF-36) was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Changes in lactate", "description": "Lactate was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Changes in ammonia", "description": "Ammonia was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Changes in inorganic phosphorus", "description": "Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Changes in creatine kinase", "description": "Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "primary", "measure": "Changes in Lactage dehydrogenase(LDH)", "description": "Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Changes in Multidimensional Fatigue Scale(MFS)", "description": "Multidimensional Fatigue Scale(MFS) was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" }, { "type": "secondary", "measure": "Changes in 36-Item Short-Form Health Survey(SF-36)", "description": "36-Item Short-Form Health Survey(SF-36) was measured in study visit 1(0 week) and visit 3(12 week).", "time_frame": "12 weeks" } ], "relevance_tags": [ "Metabolic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01689467", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03567811", "title": "Exertional Exhaustion in Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2019-06-20", "start_date": "2013-08-01", "completion_date": "2018-07-31", "primary_completion_date": "2018-07-31", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Submaximal Bicycle Exercise Stress Test On Days 1 And 2" ], "sponsor": "Georgetown University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Post-exertional malaise was modeled by having Chronic Fatigue Syndrome (CFS) and sedentary control subjects perform submaximal exercise on 2 consecutive days with objective changes in brain function measured by magnetic resonance imaging (MRI) during cognitive tests before and after the 2 exercise sessions.", "primary_outcomes": [ { "type": "primary", "measure": "Change in blood oxygenation level dependent (BOLD) patterns of brain blood flow during cognitive testing", "description": "MRI with cognitive tasks were performed before Day 1 exercise and compared to after the Day 2 exercise.", "time_frame": "Day 1 (pre-exercise) and Day 2 (after 2nd exercise)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Postural change in heart rate and heart rate variability after exercise", "description": "Heart rates were recorded while subjects resting supine for 5 minutes, and during 5 minutes of standing. The change in heart rate (deltaHR) was calculated.", "time_frame": "Before exercise. 1, 3, 8, 24 and 36 hours after exercise" }, { "type": "secondary", "measure": "Pressure-induced pain (systemic hyperalgesia) by dolorimetry", "description": "A strain gauge (algometer, dolorimeter) was pressed over 18 traditional fibromyalgia tender point locations at a slow rate \\< kg/sec with the subject instructed to tell the operator to stop pushing as soon as they felt pain.", "time_frame": "10 am each day for 4 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in blood oxygenation level dependent (BOLD) patterns of brain blood flow during cognitive testing", "description": "MRI with cognitive tasks were performed before Day 1 exercise and compared to after the Day 2 exercise.", "time_frame": "Day 1 (pre-exercise) and Day 2 (after 2nd exercise)" }, { "type": "secondary", "measure": "Postural change in heart rate and heart rate variability after exercise", "description": "Heart rates were recorded while subjects resting supine for 5 minutes, and during 5 minutes of standing. The change in heart rate (deltaHR) was calculated.", "time_frame": "Before exercise. 1, 3, 8, 24 and 36 hours after exercise" }, { "type": "secondary", "measure": "Pressure-induced pain (systemic hyperalgesia) by dolorimetry", "description": "A strain gauge (algometer, dolorimeter) was pressed over 18 traditional fibromyalgia tender point locations at a slow rate \\< kg/sec with the subject instructed to tell the operator to stop pushing as soon as they felt pain.", "time_frame": "10 am each day for 4 days" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 72, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03567811", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01650636", "title": "Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process", "status": "COMPLETED", "phase": "NA", "last_updated": "2018-12-10", "start_date": "2010-10", "completion_date": "2017-05", "primary_completion_date": "2017-05", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Patient-Partner Videotelephone-Delivered Health Information", "Patient-Partner Videotelephone-Delivered Cognitive Behavioral Stress Management Intervention" ], "sponsor": "University of Miami", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to test the effects of a videotelephone-delivered patient-partner dual-focused cognitive behavioral stress management intervention on chronic fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM) intervention improves patient CFS symptoms relative to a videophone-delivered patient-partner Health Information (PP-T- HI) condition.", "primary_outcomes": [ { "type": "primary", "measure": "Changes in Frequency and Severity of CDC-based CFS Symptoms", "description": "Changes in the average frequency and average severity ratings of CFS symptoms as assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The outcome measure was calculated as a set of two composite scores: 1) Average Symptom Frequency, reflecting an aggregated average of frequency across all symptoms, and 2) Average Symptom Severity, reflecting an aggregated average of severity across all symptoms. Change scores are expressed and calculated as Follow-Up minus Baseline scores for average symptom frequency and average symptom severity.", "time_frame": "baseline and 5 and 9 month post-intervention follow-up" }, { "type": "primary", "measure": "Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms", "description": "Changes in the composite product of average frequency and severity scores of CDC-based CFS symptoms assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The composite outcome measure was calculated as the product of Average Symptom Frequency and Average Symptom Severity. Change scores are expressed and calculated as Follow-Up minus Baseline scores for the composite product score.", "time_frame": "baseline and 5 and 9 months post-intervention follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.", "description": "Changes in salivary cortisol diurnal pattern is measured to determine changes in neuroimmune function. Salivary cortisol diurnal pattern is computed as the natural log of the average within-day slope of change over the 2-day collection period. This measurement is made at baseline, 5 month follow-up and 9 month follow-up. Outcomes are expressed as change in Cortisol Diurnal Pattern (natural log of average 2-day slope values) and expressed and calculated as Follow-Up minus Baseline values (using the natural log of average 2-day slope values).", "time_frame": "baseline and 5 and 9 month post-intervention follow-up" }, { "type": "secondary", "measure": "Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines", "description": "Serum samples were collected to measure the pro-inflammatory cytokines Interleukin (IL)-1a, IL-6 and Tumor Necrosis Factor (TNF)-a for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).", "time_frame": "Baseline, 5 months, 9 months" }, { "type": "secondary", "measure": "Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines", "description": "Serum samples were collected to measure the anti-inflammatory cytokines Interleukin (IL)-4, IL-5 and IL-10 for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).", "time_frame": "Baseline, 5 months, 9 months" }, { "type": "secondary", "measure": "Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines", "description": "Serum samples were collected to measure the pro-inflammatory:anti-inflammatory cytokine ratio (\\[IL-1β + IL-6 + TNF-α\\]:\\[IL-13 + IL-10\\]) for neuroimmune function. These values are expressed as ratios. Change values are expressed and calculated as Follow-Up minus Baseline values (using ratio values).", "time_frame": "baseline and 5 and 9 months post-intervention follow-up" }, { "type": "secondary", "measure": "Changes in Psychosocial Functioning", "description": "Changes in psychosocial functioning measured with the Perceived Stress Scale (PSS), Center for Epidemiologic Studies-Depression (CES-D) scale, and the subscales of the Sickness Impact Profile (SIP) for Recreation and Pastimes, and Social Interaction. Greater scores on the PSS indicate greater perceived stress (range: 0-56) and greater scores on the CES-D indicate greater depressive symptoms (range: 0-60). The SIP is divided into 'Social Interaction' and 'Recreation and Pastimes' subscales (ranges: 0-11 and 0-5, respectively), with greater scores indicating greater impact of sickness in the respective domain. Change scores are expressed and calculated as Follow-Up minus Baseline scores.", "time_frame": "baseline and 5 and 9 month post-intervention follow-up" } ], "outcome_measures": [ { "type": "primary", "measure": "Changes in Frequency and Severity of CDC-based CFS Symptoms", "description": "Changes in the average frequency and average severity ratings of CFS symptoms as assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The outcome measure was calculated as a set of two composite scores: 1) Average Symptom Frequency, reflecting an aggregated average of frequency across all symptoms, and 2) Average Symptom Severity, reflecting an aggregated average of severity across all symptoms. Change scores are expressed and calculated as Follow-Up minus Baseline scores for average symptom frequency and average symptom severity.", "time_frame": "baseline and 5 and 9 month post-intervention follow-up" }, { "type": "primary", "measure": "Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms", "description": "Changes in the composite product of average frequency and severity scores of CDC-based CFS symptoms assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The composite outcome measure was calculated as the product of Average Symptom Frequency and Average Symptom Severity. Change scores are expressed and calculated as Follow-Up minus Baseline scores for the composite product score.", "time_frame": "baseline and 5 and 9 months post-intervention follow-up" }, { "type": "secondary", "measure": "Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.", "description": "Changes in salivary cortisol diurnal pattern is measured to determine changes in neuroimmune function. Salivary cortisol diurnal pattern is computed as the natural log of the average within-day slope of change over the 2-day collection period. This measurement is made at baseline, 5 month follow-up and 9 month follow-up. Outcomes are expressed as change in Cortisol Diurnal Pattern (natural log of average 2-day slope values) and expressed and calculated as Follow-Up minus Baseline values (using the natural log of average 2-day slope values).", "time_frame": "baseline and 5 and 9 month post-intervention follow-up" }, { "type": "secondary", "measure": "Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines", "description": "Serum samples were collected to measure the pro-inflammatory cytokines Interleukin (IL)-1a, IL-6 and Tumor Necrosis Factor (TNF)-a for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).", "time_frame": "Baseline, 5 months, 9 months" }, { "type": "secondary", "measure": "Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines", "description": "Serum samples were collected to measure the anti-inflammatory cytokines Interleukin (IL)-4, IL-5 and IL-10 for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).", "time_frame": "Baseline, 5 months, 9 months" }, { "type": "secondary", "measure": "Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines", "description": "Serum samples were collected to measure the pro-inflammatory:anti-inflammatory cytokine ratio (\\[IL-1β + IL-6 + TNF-α\\]:\\[IL-13 + IL-10\\]) for neuroimmune function. These values are expressed as ratios. Change values are expressed and calculated as Follow-Up minus Baseline values (using ratio values).", "time_frame": "baseline and 5 and 9 months post-intervention follow-up" }, { "type": "secondary", "measure": "Changes in Psychosocial Functioning", "description": "Changes in psychosocial functioning measured with the Perceived Stress Scale (PSS), Center for Epidemiologic Studies-Depression (CES-D) scale, and the subscales of the Sickness Impact Profile (SIP) for Recreation and Pastimes, and Social Interaction. Greater scores on the PSS indicate greater perceived stress (range: 0-56) and greater scores on the CES-D indicate greater depressive symptoms (range: 0-60). The SIP is divided into 'Social Interaction' and 'Recreation and Pastimes' subscales (ranges: 0-11 and 0-5, respectively), with greater scores indicating greater impact of sickness in the respective domain. Change scores are expressed and calculated as Follow-Up minus Baseline scores.", "time_frame": "baseline and 5 and 9 month post-intervention follow-up" } ], "relevance_tags": [ "Immunomodulatory", "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 300, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT01650636", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02082730", "title": "The Feasibility, Acceptability and Clinical Utility of a New Remote-mobile Technology Intervention (ASARM) for CFS/ME in a Paediatric Population", "status": "COMPLETED", "phase": "NA", "last_updated": "2018-12-04", "start_date": "2013-01", "completion_date": "2014-08-01", "primary_completion_date": "2014-08-01", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Asarm" ], "sponsor": "Manchester University NHS Foundation Trust", "sponsor_type": "OTHER_GOV", "primary_purpose": "N/A", "brief_summary": "This study aims to improve on the delivery of treatment for people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). People with CFS/ME have low energy. This interferes with doing everyday activities and has a major impact on quality of life. Energy management is a key aspect of treatment and involves patients building up their energy levels gradually. Their health professional finds out how much energy the patient uses daily so they can prescribe how much activity and rest is right for the patient. The prescription is adjusted throughout treatment. Over time, the patient learns the best way to \"spend\" and \"preserve\" energy. To begin treatment, patients record their activity levels on paper over a few weeks. Records need to be accurate, but this is often difficult because of problems with memory, concentration or low energy and pain.\n\nWe have recently developed a new technology called ASARM (\"Advanced Sleep Rest Activity and Rest Management\") that records activity levels electronically and checks whether they match the activity prescription. The ASARM device is worn on the patient's wrist. It measures sleep, activity and rest, and has an electronic diary (a smartphone app) for recording daily activities. The health professional has remote access to the information and uses the app to change the prescription. This study will investigate if ASARM is (i) acceptable to patients; (ii) a good way to deliver Cognitive Behavioural therapy CBT treatment; (iii) able to improve their symptoms. Patients and clinicians will gain experience of ASARM for a short time, and we will analyse their data. Our findings will help us develop ASARM so that it can be used in routine care of CFS/ME patients.", "primary_outcomes": [ { "type": "primary", "measure": "Change from Baseline Pediatric Quality of Life Inventory (PedsQL) score at post intervention.", "description": "measure of fatigue and quality of life, separately rated by child and parent (Varni, J.W., \\& Limbers,C.A. (2009). An increase in score would indicate improvement in Quality of life and fatigue.", "time_frame": "Baseline and post intervention" }, { "type": "primary", "measure": "Change from Baseline in Revised Child Anxiety and Depression Scale (RCADS) at post intervention.", "description": "Measure of anxiety and depression. A reduction in score indicates an improvement.", "time_frame": "Baseline and Post intervention" }, { "type": "primary", "measure": "Change from Baseline Activity level at post intervention.", "description": "The average and standard variation in number of hours of clinically defined sleep, rest and activity per day for each patient will be measured through the ASARM system.", "time_frame": "Baseline, post intervention," } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change from Baseline Pain score at post intervention.", "description": "A pain visual analogue pain scale. A reduction in pain score indicates improvement", "time_frame": "Baseline and post intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Change from Baseline Pediatric Quality of Life Inventory (PedsQL) score at post intervention.", "description": "measure of fatigue and quality of life, separately rated by child and parent (Varni, J.W., \\& Limbers,C.A. (2009). An increase in score would indicate improvement in Quality of life and fatigue.", "time_frame": "Baseline and post intervention" }, { "type": "primary", "measure": "Change from Baseline in Revised Child Anxiety and Depression Scale (RCADS) at post intervention.", "description": "Measure of anxiety and depression. A reduction in score indicates an improvement.", "time_frame": "Baseline and Post intervention" }, { "type": "primary", "measure": "Change from Baseline Activity level at post intervention.", "description": "The average and standard variation in number of hours of clinically defined sleep, rest and activity per day for each patient will be measured through the ASARM system.", "time_frame": "Baseline, post intervention," }, { "type": "secondary", "measure": "Change from Baseline Pain score at post intervention.", "description": "A pain visual analogue pain scale. A reduction in pain score indicates improvement", "time_frame": "Baseline and post intervention" } ], "relevance_tags": [ "Metabolic", "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other Gov" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02082730", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03000777", "title": "Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)", "status": "COMPLETED", "phase": "NA", "last_updated": "2018-08-09", "start_date": "2016-02", "completion_date": "2017-09", "primary_completion_date": "2017-07", "conditions_raw": [ "Fatigue Syndrome, Chronic", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Melatonin Plus Zinc" ], "sponsor": "Laboratorios Viñas, S.A.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME", "primary_outcomes": [ { "type": "primary", "measure": "To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Side effects during treatment.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" }, { "type": "secondary", "measure": "Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" }, { "type": "secondary", "measure": "Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" }, { "type": "secondary", "measure": "Self-reported dysautonomia using the Composite Autonomic Symptom Score 31-items (COMPASS 31) questionnaire.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" }, { "type": "secondary", "measure": "Self-reported QoL through the Short Form Health Survey 36-items (SF-36) questionnaire.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" } ], "outcome_measures": [ { "type": "primary", "measure": "To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" }, { "type": "secondary", "measure": "Side effects during treatment.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" }, { "type": "secondary", "measure": "Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" }, { "type": "secondary", "measure": "Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" }, { "type": "secondary", "measure": "Self-reported dysautonomia using the Composite Autonomic Symptom Score 31-items (COMPASS 31) questionnaire.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" }, { "type": "secondary", "measure": "Self-reported QoL through the Short Form Health Survey 36-items (SF-36) questionnaire.", "description": "", "time_frame": "within the first 16 weeks (plus 4 weeks with no treatment)" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03000777", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02955420", "title": "A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BC 007 in Healthy Subjects", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2018-07-18", "start_date": "2016-08", "completion_date": "2018-05", "primary_completion_date": "2018-04", "conditions_raw": [ "Healthy Volunteers" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "BC 007 (Aptamer)", "N-Acetylcysteine (NAC)" ], "sponsor": "Berlin Cures GmbH", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Berlin Cures develops BC 007 to treat patients suffering from diseases (chronic heart failure, pulmonary hypertension, chronic fatigue syndrome etc.) which are associated with functional autoantibodies (AAB) directed against G-protein coupled receptors (GPCR).\n\nThe first part of the study (part A) is designed to evaluate the safety and tolerability of ascending doses of BC 007. The study part is blinded and placebo controlled in order to better discriminate possible safety signals. The assessment of safety and tolerability in an elderly cohort is a bridge to dosing elderly GPCR AAB positive subjects in part B. The subjects in part A are confirmed to be GPCR AAB negative.\n\nThe objective of the second part of the study (part B) is to evaluate the efficacy of BC 007 in neutralizing AAB against GPCR shortly after dosing compared to baseline and to find the optimal dose for the neutralization of the AAB in all individuals. This dose shall be taken to progress into a Phase II/III trial with beta1-adrenergic receptor-AAB positive patients suffering from chronic heart failure.", "primary_outcomes": [ { "type": "primary", "measure": "Part A: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment", "description": "", "time_frame": "24 hours post dose" }, { "type": "primary", "measure": "Part B: Conversion rate from positive GPCR AAB to negative immune status", "description": "", "time_frame": "24 hours post dose" }, { "type": "primary", "measure": "Part C: Conversion rate from positive GPCR AAB to negative immune status", "description": "", "time_frame": "24 hours and 8-12 days post dose" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Part A, B and C: Area under the plasma concentration time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Area under the plasma concentration time curve (AUC) from time zero extrapolated to infinity (AUC0-inf) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: AUC from time zero to 24 hour post-dose (AUC0-24) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Maximum observed plasma concentration (Cmax) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Apparent terminal half-life (t1/2) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Nominal time of Cmax (tmax) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Plasma clearance (CL) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Volume of distribution during terminal phase (Vz) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Terminal elimination rate constant (λz) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "A, B and C: Cumulative amount of unchanged drug excreted into urine (Ae)", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "A, B and C: Fraction of intravenous administered drug that is excreted unchanged in urine (fe)", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Renal clearance (CLR) of BC 007", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment", "description": "", "time_frame": "24 hours post dose" } ], "outcome_measures": [ { "type": "primary", "measure": "Part A: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment", "description": "", "time_frame": "24 hours post dose" }, { "type": "primary", "measure": "Part B: Conversion rate from positive GPCR AAB to negative immune status", "description": "", "time_frame": "24 hours post dose" }, { "type": "primary", "measure": "Part C: Conversion rate from positive GPCR AAB to negative immune status", "description": "", "time_frame": "24 hours and 8-12 days post dose" }, { "type": "secondary", "measure": "Part A, B and C: Area under the plasma concentration time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Area under the plasma concentration time curve (AUC) from time zero extrapolated to infinity (AUC0-inf) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: AUC from time zero to 24 hour post-dose (AUC0-24) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Maximum observed plasma concentration (Cmax) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Apparent terminal half-life (t1/2) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Nominal time of Cmax (tmax) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Plasma clearance (CL) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Volume of distribution during terminal phase (Vz) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Terminal elimination rate constant (λz) derived from BC 007 plasma concentrations", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "A, B and C: Cumulative amount of unchanged drug excreted into urine (Ae)", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "A, B and C: Fraction of intravenous administered drug that is excreted unchanged in urine (fe)", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Renal clearance (CLR) of BC 007", "description": "", "time_frame": "24 hours post dose" }, { "type": "secondary", "measure": "Part A, B and C: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment", "description": "", "time_frame": "24 hours post dose" } ], "relevance_tags": [ "General", "Phase 1", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 74, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02955420", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03562325", "title": "ACT for ME/CFS - an Open Case Trial", "status": "COMPLETED", "phase": "NA", "last_updated": "2018-06-19", "start_date": "2012-11-10", "completion_date": "2017-10-31", "primary_completion_date": "2017-10-31", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Acceptance And Commitment Therapy" ], "sponsor": "Rikard Wicksell", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The goal of this research project is to evaluate if our well-researched behavior medicine treatment model for chronic pain, based on Acceptance and Commitment Therapy, is safe and effective in increasing quality of life and functioning also in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). To date there are no effective treatments for ME/CFS as the ethology and pathophysiology are unknown, while levels of functioning and quality of life as well as secondary effects such as depressive and anxiety symptoms indicate a highly affected patient population. As such, there is a need for behavior medicine approaches that aim to alleviate suffering and promote increases in quality of life for these patients. The aim of the present study is to do a preliminary evaluation of the safety, acceptability and efficacy of an ACT-based treatment protocol for ME/CFS. An additional aim is to explore potential mediators of change for the effect of treatment on disability.", "primary_outcomes": [ { "type": "primary", "measure": "ME/CFS Disability Index (changes between assessments)", "description": "Self-reported ME/CFS-related disability in 7 life domains (domestic; recreational activities; social activities; occupational; sexual life; daily activities; life-sustaining activities). Each item is scored 0-10 (0= no disability, 10=total disability).", "time_frame": "Baseline to 6-month follow-up" }, { "type": "primary", "measure": "Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments)", "description": "Self-rated psychological inflexibility related to fatigue", "time_frame": "Baseline to 6-month follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "ME/CFS Symptoms (changes between assessments)", "description": "Self-reported prevalence and intensity (0-4) of ME/CFS symptoms based on the 2003 clinical case definition (0=symptom absence, 4=unbearable).", "time_frame": "Baseline to 6-month follow-up" } ], "outcome_measures": [ { "type": "primary", "measure": "ME/CFS Disability Index (changes between assessments)", "description": "Self-reported ME/CFS-related disability in 7 life domains (domestic; recreational activities; social activities; occupational; sexual life; daily activities; life-sustaining activities). Each item is scored 0-10 (0= no disability, 10=total disability).", "time_frame": "Baseline to 6-month follow-up" }, { "type": "primary", "measure": "Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments)", "description": "Self-rated psychological inflexibility related to fatigue", "time_frame": "Baseline to 6-month follow-up" }, { "type": "secondary", "measure": "ME/CFS Symptoms (changes between assessments)", "description": "Self-reported prevalence and intensity (0-4) of ME/CFS symptoms based on the 2003 clinical case definition (0=symptom absence, 4=unbearable).", "time_frame": "Baseline to 6-month follow-up" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT03562325", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03029377", "title": "Noradrenergic and Stress-Related Etiologies of Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2018-04-26", "start_date": "2017-01", "completion_date": "2018-02-23", "primary_completion_date": "2018-02-23", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Posture Study, Autonomic Function Tests, And A Stress Test" ], "sponsor": "Vanderbilt University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The objective of this study is to measure sympathetic nervous system function and stress responses in patients with clinically documented and self-reported chronic fatigue that is worsened by stress, compared to healthy controls. Baseline norepinephrine (NE) levels and stress-induced NE levels in patients who fulfill criteria for Chronic Fatigue Syndrome (CFS) and who self-identify with stress induced worsening fatigue, will be compared to data from normal individuals pre and post-stress.", "primary_outcomes": [ { "type": "primary", "measure": "dihydroxyphenylglycol (DHPG)/norepinephrine (NE) Ratio (post stress)", "description": "Change in DHPG/NE Ratio from Baseline to post stress compared across arms", "time_frame": "Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "DHPG/NE Ratio (post Autonomic Function test)", "description": "Change in DHPG/NE Ratio from Baseline to post Autonomic Function test compared across arms", "time_frame": "Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "DHPG/NE Ratio (post Standing position)", "description": "Change in DHPG/NE Ratio from Baseline to post Standing position compared across arms", "time_frame": "Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "DHPG/NE Ratio (post Sitting position)", "description": "Change in DHPG/NE Ratio from Baseline to post Sitting position compared across arms", "time_frame": "Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Absolute DHPG and NE Levels (post stress)", "description": "Change in absolute DHPG and NE Levels from Baseline to post stress compared across arms", "time_frame": "Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Absolute DHPG and NE Levels (post Autonomic Function test)", "description": "Change in DHPG and NE levels from Baseline to post Autonomic Function test compared", "time_frame": "Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Absolute DHPG and NE Levels (post Standing position)", "description": "Change in absolute DHPG and NE Levels from Baseline to post Standing position compared across arms", "time_frame": "Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Absolute DHPG and NE Levels (post Sitting position)", "description": "Change in DHPG and NE levels from Baseline to post Sitting position compared across arms", "time_frame": "Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Fatigue as assessed by Multidimensional Assessment of Fatigue Scale (MAF)", "description": "Mean values +/- standard deviation (SD) compared across arms", "time_frame": "End of Study Visit (approximately 140 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Mood as assessed by Hospital Anxiety and Depression Scale (HADS)", "description": "Mean values +/- SD compared across arms", "time_frame": "End of Study Visit (approximately 140 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Quality of Life as assessed by 36-Item Short Form Survey Instrument (SF-36)", "description": "Mean values +/- SD compared across arms", "time_frame": "End of Study Visit (approximately 140 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Stress as assessed by Stress Overload Scale", "description": "Mean values +/- SD compared across arms", "time_frame": "Beginning of Study Visit (Approximately 15 minutes pre-baseline blood collection)" }, { "type": "secondary", "measure": "Cytokines", "description": "Compared across arms", "time_frame": "At baseline (approximately 30 minutes after supine position start)" } ], "outcome_measures": [ { "type": "primary", "measure": "dihydroxyphenylglycol (DHPG)/norepinephrine (NE) Ratio (post stress)", "description": "Change in DHPG/NE Ratio from Baseline to post stress compared across arms", "time_frame": "Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "DHPG/NE Ratio (post Autonomic Function test)", "description": "Change in DHPG/NE Ratio from Baseline to post Autonomic Function test compared across arms", "time_frame": "Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "DHPG/NE Ratio (post Standing position)", "description": "Change in DHPG/NE Ratio from Baseline to post Standing position compared across arms", "time_frame": "Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "DHPG/NE Ratio (post Sitting position)", "description": "Change in DHPG/NE Ratio from Baseline to post Sitting position compared across arms", "time_frame": "Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Absolute DHPG and NE Levels (post stress)", "description": "Change in absolute DHPG and NE Levels from Baseline to post stress compared across arms", "time_frame": "Change from Baseline to post stress test (approximately 100 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Absolute DHPG and NE Levels (post Autonomic Function test)", "description": "Change in DHPG and NE levels from Baseline to post Autonomic Function test compared", "time_frame": "Change from Baseline to post Autonomic Function test (approximately 30 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Absolute DHPG and NE Levels (post Standing position)", "description": "Change in absolute DHPG and NE Levels from Baseline to post Standing position compared across arms", "time_frame": "Change from Baseline to post Standing position (approximately 40 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Absolute DHPG and NE Levels (post Sitting position)", "description": "Change in DHPG and NE levels from Baseline to post Sitting position compared across arms", "time_frame": "Change from Baseline to post Sitting position (approximately 70 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Fatigue as assessed by Multidimensional Assessment of Fatigue Scale (MAF)", "description": "Mean values +/- standard deviation (SD) compared across arms", "time_frame": "End of Study Visit (approximately 140 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Mood as assessed by Hospital Anxiety and Depression Scale (HADS)", "description": "Mean values +/- SD compared across arms", "time_frame": "End of Study Visit (approximately 140 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Quality of Life as assessed by 36-Item Short Form Survey Instrument (SF-36)", "description": "Mean values +/- SD compared across arms", "time_frame": "End of Study Visit (approximately 140 minutes post-baseline blood collection)" }, { "type": "secondary", "measure": "Stress as assessed by Stress Overload Scale", "description": "Mean values +/- SD compared across arms", "time_frame": "Beginning of Study Visit (Approximately 15 minutes pre-baseline blood collection)" }, { "type": "secondary", "measure": "Cytokines", "description": "Compared across arms", "time_frame": "At baseline (approximately 30 minutes after supine position start)" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 55, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT03029377", "extraction_date": "2026-10-07" }, { "nct_id": "NCT03502044", "title": "New MRT Imaging Biomarkers and Treatment With Kinetic Oscillatory Stimulation (KOS) in Nasal Cavity for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)", "status": "UNKNOWN", "phase": "NA", "last_updated": "2018-04-19", "start_date": "2018-04-17", "completion_date": "2020-06-15", "primary_completion_date": "2019-12-31", "conditions_raw": [ "Myalgic Encephalomyelitis", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "N-Acetylcysteine (NAC)", "Active Kinetic Oscillation Stimulation" ], "sponsor": "Karolinska University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Placebo controlled trial study of efficacy of Kinetic Oscillation Stimulation (KOS) in nasal cavity will be conducted in patients with myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The outcome of the treatment will be assessed with clinical evaluation of patients, cognitive tests, structural and functional MRI of the brain.", "primary_outcomes": [ { "type": "primary", "measure": "Change in Fatigue severity scale", "description": "A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. Maximum score possible is 63.", "time_frame": "Baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Diagnostic MRI of the brain", "description": "Functional MRI of the brain at 3T", "time_frame": "At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)" }, { "type": "secondary", "measure": "Signature of systemic inflammation and severity", "description": "Analysis of high dimensional immune signature from peripheral venous blood samples using mass cytometry.", "time_frame": "At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)" }, { "type": "secondary", "measure": "SF-36 PHYSICAL FUNCTIONING SUBSCALE (PF-10) SF-36 Physical Functioning Subscale (PF-10)", "description": "The PF-10 is a generic outcome measure designed to examine a person's perceived limitation with physical functioning and is a subscale within the Medical Outcomes Study 36-item Short Form Health Survey (SF-36). There are 10 items, each item is rated on a 3-point scale.", "time_frame": "At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment." }, { "type": "secondary", "measure": "ME/CFS symptom rating scale", "description": "Series of questions regarding ME/CFS symptoms graded 0-5 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria.", "time_frame": "At baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment." }, { "type": "secondary", "measure": "Hospital anxiety depression scale (HADS)", "description": "The questionnaire comprises 7 questions for anxiety and 7 questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.", "time_frame": "At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment." } ], "outcome_measures": [ { "type": "primary", "measure": "Change in Fatigue severity scale", "description": "A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. Maximum score possible is 63.", "time_frame": "Baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment." }, { "type": "secondary", "measure": "Diagnostic MRI of the brain", "description": "Functional MRI of the brain at 3T", "time_frame": "At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)" }, { "type": "secondary", "measure": "Signature of systemic inflammation and severity", "description": "Analysis of high dimensional immune signature from peripheral venous blood samples using mass cytometry.", "time_frame": "At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)" }, { "type": "secondary", "measure": "SF-36 PHYSICAL FUNCTIONING SUBSCALE (PF-10) SF-36 Physical Functioning Subscale (PF-10)", "description": "The PF-10 is a generic outcome measure designed to examine a person's perceived limitation with physical functioning and is a subscale within the Medical Outcomes Study 36-item Short Form Health Survey (SF-36). There are 10 items, each item is rated on a 3-point scale.", "time_frame": "At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment." }, { "type": "secondary", "measure": "ME/CFS symptom rating scale", "description": "Series of questions regarding ME/CFS symptoms graded 0-5 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria.", "time_frame": "At baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment." }, { "type": "secondary", "measure": "Hospital anxiety depression scale (HADS)", "description": "The questionnaire comprises 7 questions for anxiety and 7 questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.", "time_frame": "At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment." } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 200, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT03502044", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02075489", "title": "Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans", "status": "COMPLETED", "phase": "NA", "last_updated": "2017-10-10", "start_date": "2012-09", "completion_date": "2017-10", "primary_completion_date": "2017-10", "conditions_raw": [ "Persian Gulf Syndrome", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Acupressure Treatment.", "Reiki" ], "sponsor": "The Cleveland Clinic", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will provide symptomatic veterans with acupressure treatment and determine its effectiveness in fatigue relief and pain management for Gulf War Illness (GWI). Investigators plan to recruit patients reporting symptoms of GWI through the Department of Veterans Affairs (VA), and randomize them into acupressure group (to receive acupressure treatment) and control group (to receive Reiki treatment). The acupressure treatment, twice per week for 6 weeks, will be offered by a licensed acupressure practitioner. Evaluations will be made before and after treatment (at 6 weeks). Clinical outcomes will be compared between groups (acupressure group vs. control group) and between different timepoints (before treatment vs. after treatment) within the same group.\n\nThe results of this study may provide useful information to develop more effective treatment for veterans with GWI disease. Since acupressure treatment is of Asian origin and has shown excellent promise within its Eastern traditions, if successful, this study has the potential to produce a paradigm shift in clinical practice to more effectively relieve the symptoms of veterans with GWI disease. Meanwhile, as a non-invasive therapeutic massage, acupressure may lend to better patient acceptance and ultimately, greater clinical accessibility.\n\nHypotheses\n\n1. Acupressure besides routine clinical care will produce a more complete fatigue relief and pain alleviation in veterans with GWI versus routine clinical care plus reiki treatment.\n2. EEG measures will exhibit a positive change when fatigue is relieved and pain is alleviated for symptomatic veterans after effective treatment.", "primary_outcomes": [ { "type": "primary", "measure": "Piper Fatigue Scale", "description": "Piper et al., The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum 1998 25(4):677-84. This scale is used to assess fatigue levels in patients.", "time_frame": "Change from baseline score will be assessed at 6 weeks." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Changes in corticomuscular coherence", "description": "Changes in the relation between brain (EEG) and muscle (EMG) surface signals will be analyzed. This is a non-invasive procedure.", "time_frame": "Change from baseline score will be assessed at 6 weeks." } ], "outcome_measures": [ { "type": "primary", "measure": "Piper Fatigue Scale", "description": "Piper et al., The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum 1998 25(4):677-84. This scale is used to assess fatigue levels in patients.", "time_frame": "Change from baseline score will be assessed at 6 weeks." }, { "type": "secondary", "measure": "Changes in corticomuscular coherence", "description": "Changes in the relation between brain (EEG) and muscle (EMG) surface signals will be analyzed. This is a non-invasive procedure.", "time_frame": "Change from baseline score will be assessed at 6 weeks." } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 7, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02075489", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02454244", "title": "Efficacy of Amygdala Retraining With Mindfulness (ART+MF) vs Compassion Therapy (CT) for the Treatment of Patients With Fibromyalgia", "status": "COMPLETED", "phase": "NA", "last_updated": "2017-08-10", "start_date": "2015-06", "completion_date": "2016-09", "primary_completion_date": "2015-12", "conditions_raw": [ "Fibromyalgia" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Art With Mindfulness", "Mindfulness Compassion", "Relaxation" ], "sponsor": "Hospital Miguel Servet", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Amygdala Retraining Treatment (ART) is a new and promising therapy for patients with Chronic Fatigue Syndrome (CFS) and Fibromyalgia (FM), however, randomized controlled trials (RCT) are scarce. The investigators have added mindfulness to this therapy, based on preliminary reports of its efficacy on patients, obtaining Amygdala Retraining Treatment with Mindfulness (ART+MF).\n\nOther therapy that has been assessed in many psychiatric and medical disorders during the last years has been Compassion Therapy (CT). There are no studies on its efficacy in FM.\n\nAims: The aim of this trial is to assess the efficacy of both ART+MF and CT on the general function of the patients with FM. A secondary objective is to assess the effect of these therapies on psychological (pain, depression, anxiety, etc.) and biological variables (some biomarkers related with inflammation).\n\nMethods:\n\n* Design: Randomized, controlled trial with three arms: a) ART+MF, b) CT and c) Relaxation as control intervention.\n* Sample: A sample (N=60 patients, about N=20 for each arm) will be recruited from primary care settings at the city of Zaragoza, Spain.", "primary_outcomes": [ { "type": "primary", "measure": "Fibromyalgia Impact Questionnaire (FIQ)", "description": "", "time_frame": "baseline" }, { "type": "primary", "measure": "Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "primary", "measure": "Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ)", "description": "", "time_frame": "follow-up (6 months)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Sociodemographic Data", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS)", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS)", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Fibrofatigue Scale (FFS)", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Fibrofatigue Scale (FFS)", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Fibrofatigue Scale (FFS)", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Euroqol Quality of Life Questionnaire", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Euroqol Quality of Life Questionnaire", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Euroqol Quality of Life Questionnaire", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Pain Catastrophizing Scale", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Pain Catastrophizing Scale", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Acceptance Questionaire AAQ-II", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Acceptance Questionaire AAQ-II", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Acceptance Questionaire AAQ-II", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Five Facets Mindfulness Questionaire FFMQ", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Self-compassion Scale", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Self-compassion Scale", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Self-compassion Scale", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Serum Levels of Interleukins IL-6, IL-10", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Serum levels of Brain Derived Neurotrophic Factor BDNF", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "High-sensitivity C-reactive Protein", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) High-sensitivity C-reactive Protein", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Serum levels of Tumor Necrosis Factor TNF alpha", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha", "description": "", "time_frame": "post-intervention (3 months)" } ], "outcome_measures": [ { "type": "primary", "measure": "Fibromyalgia Impact Questionnaire (FIQ)", "description": "", "time_frame": "baseline" }, { "type": "primary", "measure": "Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "primary", "measure": "Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ)", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Sociodemographic Data", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Hospital Anxiety and Depression Scale (HADS)", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS)", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS)", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Fibrofatigue Scale (FFS)", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Fibrofatigue Scale (FFS)", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Fibrofatigue Scale (FFS)", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Euroqol Quality of Life Questionnaire", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Euroqol Quality of Life Questionnaire", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Euroqol Quality of Life Questionnaire", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Pain Catastrophizing Scale", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Pain Catastrophizing Scale", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Pain Catastrophizing Scale", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Acceptance Questionaire AAQ-II", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Acceptance Questionaire AAQ-II", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Acceptance Questionaire AAQ-II", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Five Facets Mindfulness Questionaire FFMQ", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Self-compassion Scale", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Self-compassion Scale", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Change follow-up (6 months) Self-compassion Scale", "description": "", "time_frame": "follow-up (6 months)" }, { "type": "secondary", "measure": "Serum Levels of Interleukins IL-6, IL-10", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Serum levels of Brain Derived Neurotrophic Factor BDNF", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "High-sensitivity C-reactive Protein", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) High-sensitivity C-reactive Protein", "description": "", "time_frame": "post-intervention (3 months)" }, { "type": "secondary", "measure": "Serum levels of Tumor Necrosis Factor TNF alpha", "description": "", "time_frame": "baseline" }, { "type": "secondary", "measure": "Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha", "description": "", "time_frame": "post-intervention (3 months)" } ], "relevance_tags": [ "Anti-inflammatory", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02454244", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00598585", "title": "Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2017-06-27", "start_date": "2002-07", "completion_date": "2010-12", "primary_completion_date": "2010-12", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Sildenafil" ], "sponsor": "Charles Drew University of Medicine and Science", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)", "primary_outcomes": [ { "type": "primary", "measure": "Change in Fatigue Impact Scale at 6 Weeks", "description": "change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated", "time_frame": "6 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Change in Fatigue Impact Scale at 6 Weeks", "description": "change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated", "time_frame": "6 weeks" } ], "relevance_tags": [ "General", "Phase 4", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 12, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00598585", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02816060", "title": "Neural Tensioner Exercise on Conditioned Pain Modulation", "status": "COMPLETED", "phase": "NA", "last_updated": "2017-03-09", "start_date": "2016-05", "completion_date": "2016-11", "primary_completion_date": "2016-11", "conditions_raw": [ "Neck Pain", "Diffuse Noxious Inhibitory Control" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Manual Therapy" ], "sponsor": "Universidad Rey Juan Carlos", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain there is no activation of CPM.\n\nObjectives: The purpose of this study is to measure the CPM response and determine whether neural tensioner exercise in patients with chronic neck pain is effective in the improvement of neck pain intensity, neck disability and cervical range of motion.\n\nDesign: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the sham technique (ST) group.\n\nIndividuals will be included in the study if they meet the following inclusion criteria: aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head. Neck pain intensity with a visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion will be measured pre and port intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Physiological parameter", "description": "Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test", "time_frame": "5 minutes" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Visual analogue scale", "description": "Neck pain intensity measured by visual analogue scale (VAS)", "time_frame": "5 minutes" }, { "type": "secondary", "measure": "physiological movement", "description": "Cervical range of motion measured with cervical range of motion device", "time_frame": "5 minutes" } ], "outcome_measures": [ { "type": "primary", "measure": "Physiological parameter", "description": "Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test", "time_frame": "5 minutes" }, { "type": "secondary", "measure": "Visual analogue scale", "description": "Neck pain intensity measured by visual analogue scale (VAS)", "time_frame": "5 minutes" }, { "type": "secondary", "measure": "physiological movement", "description": "Cervical range of motion measured with cervical range of motion device", "time_frame": "5 minutes" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 54, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02816060", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00860236", "title": "Giardia Induced Fatigue and Functional Gastrointestinal Diseases", "status": "COMPLETED", "phase": "PHASE4", "last_updated": "2017-03-03", "start_date": "2009-03", "completion_date": "2010-06", "primary_completion_date": "2010-06", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Cognitive Behavioural Therapy" ], "sponsor": "University of Bergen", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "A giardiasis outbreak in Bergen has given us the opportunity to approach two basic research questions of national and global importance:\n\n* Studying the pathoimmunology of giardiasis in a natural setting, and following the genetic and immunological responses leading to recovery or persistent disease and sequelae.\n* Studying the two disease entities FGID and CFS when induced by acute giardiasi and their risk factors.\n* Interventional cognitive behavioural therapy is the only intervention documented to have significant effect on CFS outcome, and conventional cognitive behavioural therapy will be compared to a psycho-educational programme in the format of a randomised controlled trial.", "primary_outcomes": [ { "type": "primary", "measure": "Improvement minimum 6 points in Chalder Fatigue scale score", "description": "", "time_frame": "6 months" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Improvement minimum 6 points in Chalder Fatigue scale score", "description": "", "time_frame": "6 months" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 4", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00860236", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02213679", "title": "Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2017-02-01", "start_date": "2014-08", "completion_date": "2015-07", "primary_completion_date": "2015-06", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Guanidinoacetic Acid" ], "sponsor": "Center for Health Sciences, Serbia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome (CFS) is a debilitating condition of unknown etiology. Recent studies have shown that CFS is associated with impaired cellular energetics and low levels of phosphocreatine. Since guanidinoacetic acid (GAA) acts as a highly bioavailable precursor of creatine it may provide an ideal dietary supplement to facilitate treatment and perhaps prevention of CFS. The overall hypothesis to be evaluated is that medium-term supplementation with GAA will improve clinical outcomes in well-defined adult CFS patients via augmented provision of creatine. Specific aims: (1) To determine the effects of GAA on CFS symptomatology using a fatigue severity inventory, soreness of locomotive apparatus scales, and a health-related quality of life survey; (2) To determine the effect of GAA on creatine metabolism using laboratory studies and magnetic resonance spectroscopy; (3) To characterize the physiological effects of GAA on work capacity via actigraphy and exercise performance tests; and (4); To determine the prevalence of subjectively reported side-effects and biochemical adverse events associated with GAA intervention.", "primary_outcomes": [ { "type": "primary", "measure": "Change in the Multidimensional Fatigue Inventory (MFI) score", "description": "", "time_frame": "Baseline and afetr 3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Pain in the locomotive apparatus", "description": "", "time_frame": "Baseline and after 3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in the Multidimensional Fatigue Inventory (MFI) score", "description": "", "time_frame": "Baseline and afetr 3 months" }, { "type": "secondary", "measure": "Pain in the locomotive apparatus", "description": "", "time_frame": "Baseline and after 3 months" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 20, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02213679", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00580619", "title": "Autonomic Nervous System and Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2017-01-18", "start_date": "2007-04", "completion_date": "2017-01", "primary_completion_date": "2017-01", "conditions_raw": [ "Chronic Fatigue Syndrome", "Orthostatic Intolerance", "Postural Tachycardia Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Autonomic Function Testing", "Saline Infusions", "L-Nmma Trimethaphan", "Methyldopa" ], "sponsor": "Vanderbilt University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The investigators propose to test the hypothesis that the sympathetic nervous system contributes to the cardiovascular and inflammatory abnormalities present in the chronic fatigue syndrome (CFS) and, in particular in the subset of patients characterized by postural tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise normal young women, and are the cause of significant disability. A substantial proportion of patients referred for evaluation of POTS met diagnostic criteria for CFS and, conversely, a subset of patients referred for treatment for CFS have POTS. The investigators hypothesize that sympathetic activation underlies the pathophysiology of patients in whom CFS and POTS overlap (CFS-P).", "primary_outcomes": [ { "type": "primary", "measure": "Heart rate", "description": "", "time_frame": "Duration of the intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Blood Pressure", "description": "", "time_frame": "Duration of the intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Heart rate", "description": "", "time_frame": "Duration of the intervention" }, { "type": "secondary", "measure": "Blood Pressure", "description": "", "time_frame": "Duration of the intervention" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 1", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 170, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT00580619", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02964533", "title": "Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial", "status": "UNKNOWN", "phase": "NA", "last_updated": "2016-11-16", "start_date": "2016-11", "completion_date": "Unknown", "primary_completion_date": "2017-02", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Thunder-Fire Moxibustion Therapy", "Common Moxa-Stick Moxibustion" ], "sponsor": "Guangzhou University of Chinese Medicine", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome is a group of syndrome and is prevalent in adult. Thunder-fire moxibustion is a commentary therapy belonged to acupuncture therapy. To evaluate the effect and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a randomized controlled trial by recruiting chronic fatigue syndrome patient as subject, applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick moxibustion, taking fatigue rating scale score, the content of CD3+、CD4+、CD8+、CD4+/CD8+ as evaluation indexes. The treatment time is 20-30 minutes per session, 3-4 times a week, there are totally 15 sessions.", "primary_outcomes": [ { "type": "primary", "measure": "fatigue rating scale score", "description": "", "time_frame": "5 minutes" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "content of peripheral t-lymphocyte subsets", "description": "", "time_frame": "3 minutes" } ], "outcome_measures": [ { "type": "primary", "measure": "fatigue rating scale score", "description": "", "time_frame": "5 minutes" }, { "type": "secondary", "measure": "content of peripheral t-lymphocyte subsets", "description": "", "time_frame": "3 minutes" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 70, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02964533", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02924831", "title": "High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2016-10-05", "start_date": "2016-11", "completion_date": "2018-07", "primary_completion_date": "2018-05", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Acupuncture", "Moxibustion" ], "sponsor": "Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "1. To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV).\n2. To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).", "primary_outcomes": [ { "type": "primary", "measure": "Chalder's Fatigue Scale Score(CFSS)", "description": "In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.", "time_frame": "Two years" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Numeric Rating Scale(NRS)", "description": "NRC is a 10cm scale to assess the fatigue degree ranging from 0 to 10, the score of 0 stands for 'no fatigue' and 10 for 'serious'.", "time_frame": "Two years" }, { "type": "secondary", "measure": "36-item Short-Form Health Survey (SF-36)", "description": "SF-36 consists of 36 items categorized as 8 dimensions: social functioning (2 items), role limitation-emotion (3 items), mental health (5 items), physical functioning (10 items), role limitation-physical (4 items), bodily pain (2 items), vitality (4 items), general health (5 items) and 1 question of health change in recent one year.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Deficiency of Qi Scale Score (DQSS)", "description": "In DQSS, symptoms are assessed by scores ranging from 1 to 3, which stand for 'mild' to 'serious'.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Total Power(TP)", "description": "Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Low frequency(LF)", "description": "Low frequency band (ms²/Hz, %), detected by portable HRV device.", "time_frame": "Two years" }, { "type": "secondary", "measure": "High frequency (HF)", "description": "High frequency band (ms²/Hz, %), detected by portable HRV device.", "time_frame": "Two years" }, { "type": "secondary", "measure": "LF/HF", "description": "Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Ultra-low frequency(ULF)", "description": "Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Very low frequency", "description": "Very low frequency band (ms²/Hz, %),,detected by portable HRV device.", "time_frame": "Two years" } ], "outcome_measures": [ { "type": "primary", "measure": "Chalder's Fatigue Scale Score(CFSS)", "description": "In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Numeric Rating Scale(NRS)", "description": "NRC is a 10cm scale to assess the fatigue degree ranging from 0 to 10, the score of 0 stands for 'no fatigue' and 10 for 'serious'.", "time_frame": "Two years" }, { "type": "secondary", "measure": "36-item Short-Form Health Survey (SF-36)", "description": "SF-36 consists of 36 items categorized as 8 dimensions: social functioning (2 items), role limitation-emotion (3 items), mental health (5 items), physical functioning (10 items), role limitation-physical (4 items), bodily pain (2 items), vitality (4 items), general health (5 items) and 1 question of health change in recent one year.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Deficiency of Qi Scale Score (DQSS)", "description": "In DQSS, symptoms are assessed by scores ranging from 1 to 3, which stand for 'mild' to 'serious'.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Total Power(TP)", "description": "Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Low frequency(LF)", "description": "Low frequency band (ms²/Hz, %), detected by portable HRV device.", "time_frame": "Two years" }, { "type": "secondary", "measure": "High frequency (HF)", "description": "High frequency band (ms²/Hz, %), detected by portable HRV device.", "time_frame": "Two years" }, { "type": "secondary", "measure": "LF/HF", "description": "Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Ultra-low frequency(ULF)", "description": "Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device.", "time_frame": "Two years" }, { "type": "secondary", "measure": "Very low frequency", "description": "Very low frequency band (ms²/Hz, %),,detected by portable HRV device.", "time_frame": "Two years" } ], "relevance_tags": [ "General", "Phase 2", "Large (200-999 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 210, "enrollment_type": "ESTIMATED", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT02924831", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02847845", "title": "A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng", "status": "UNKNOWN", "phase": "NA", "last_updated": "2016-07-28", "start_date": "2016-06", "completion_date": "2017-06", "primary_completion_date": "2017-06", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Red Ginseng Powder Capsule" ], "sponsor": "Eun Jung Kim", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.", "primary_outcomes": [ { "type": "primary", "measure": "100mm visual analogue scale(VAS) about fatigue change", "description": "The patient is asked to indicate their perceived fatigue intensity along a 100 mm horizontal line, where '0' represents 'no fatigue' and '100', 'unbearable fatigue'", "time_frame": "at 1(screening),2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "fatigue severity scale change", "description": "The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "Chalder fatigue severity questionnaire change", "description": "The Chalder fatigue severity questionnaire is composed of 11 questions about fatigue. Grading of each item ranges from 0 to 9, where 0 indicate non-fatigue and 9 strong fatigue", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "a short form of stress response inventory,SRI-short form change", "description": "SRI-short form is composed of 22 items about stress response. 22 items are classified into three categories(Somatization,anger and depression).", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "beck depression inventory, BDI change", "description": "When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity.", "time_frame": "at 2(baseline),5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "insomnia severity index, ISI change", "description": "The ISI is composed of seven items assessing recent problems with sleep onset, sleep maintenance and early morning awakening, interference of sleep problems with daily functioning and perceived prominence of impairment attributed to the sleep problem, concern about sleep problems and satisfaction with sleep patterns. Perceived severity of each item is rated on a 0-4 scale and a total score, which ranges from 0 to 28 obtains from summing the items ratings", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "EuroQol - 5 Dimensions - 5 Levels, EQ-5D-5L change", "description": "The EuroQOL - 5 Dimensions (EQ-5D) was employed for measuring health-related quality of life. It consisted of a weighted sum of five dimensions: Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression, which provided a simple descriptive profile and a single index value for health status . We used a recently developed version, the EQ-5D-5L, which includes five-level response options: no problems, slight problems, moderate problems, severe problems, and extreme problems", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "derivatives of Reactive Oxygen Metabolites (d-ROMs) change", "description": "measure antioxidant levels in blood", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "Biological Antioxidant Potential (BAP) change", "description": "measure antioxidant levels in blood", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "Thiobarbituric Reactive Acid Substances(TBARs) change", "description": "measure antioxidant levels in blood", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "Superoxide Dismutase(SOD) change", "description": "measure antioxidant levels in blood", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "Stress hormone test", "description": "measure cortisol level in saliva\n\nFirst saliva sample : 07:00-09:00 (within 30 minutes after waking up)\n\nSecond saliva sample :\n\n11:00-13:00\n\nThird saliva sample :\n\n16:00-18:00\n\nfourth saliva sample : 22:00-00:00", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "ginseng subjective symptoms questionnaire change", "description": "ginseng subjective symptoms questionnaire is composed of 13 items about subjective symptoms after taking red ginseng", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "check abnormal responses", "description": "", "time_frame": "at 1(screening),2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" } ], "outcome_measures": [ { "type": "primary", "measure": "100mm visual analogue scale(VAS) about fatigue change", "description": "The patient is asked to indicate their perceived fatigue intensity along a 100 mm horizontal line, where '0' represents 'no fatigue' and '100', 'unbearable fatigue'", "time_frame": "at 1(screening),2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "fatigue severity scale change", "description": "The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "Chalder fatigue severity questionnaire change", "description": "The Chalder fatigue severity questionnaire is composed of 11 questions about fatigue. Grading of each item ranges from 0 to 9, where 0 indicate non-fatigue and 9 strong fatigue", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "a short form of stress response inventory,SRI-short form change", "description": "SRI-short form is composed of 22 items about stress response. 22 items are classified into three categories(Somatization,anger and depression).", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "beck depression inventory, BDI change", "description": "When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity.", "time_frame": "at 2(baseline),5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "insomnia severity index, ISI change", "description": "The ISI is composed of seven items assessing recent problems with sleep onset, sleep maintenance and early morning awakening, interference of sleep problems with daily functioning and perceived prominence of impairment attributed to the sleep problem, concern about sleep problems and satisfaction with sleep patterns. Perceived severity of each item is rated on a 0-4 scale and a total score, which ranges from 0 to 28 obtains from summing the items ratings", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "EuroQol - 5 Dimensions - 5 Levels, EQ-5D-5L change", "description": "The EuroQOL - 5 Dimensions (EQ-5D) was employed for measuring health-related quality of life. It consisted of a weighted sum of five dimensions: Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression, which provided a simple descriptive profile and a single index value for health status . We used a recently developed version, the EQ-5D-5L, which includes five-level response options: no problems, slight problems, moderate problems, severe problems, and extreme problems", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" }, { "type": "secondary", "measure": "derivatives of Reactive Oxygen Metabolites (d-ROMs) change", "description": "measure antioxidant levels in blood", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "Biological Antioxidant Potential (BAP) change", "description": "measure antioxidant levels in blood", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "Thiobarbituric Reactive Acid Substances(TBARs) change", "description": "measure antioxidant levels in blood", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "Superoxide Dismutase(SOD) change", "description": "measure antioxidant levels in blood", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "Stress hormone test", "description": "measure cortisol level in saliva\n\nFirst saliva sample : 07:00-09:00 (within 30 minutes after waking up)\n\nSecond saliva sample :\n\n11:00-13:00\n\nThird saliva sample :\n\n16:00-18:00\n\nfourth saliva sample : 22:00-00:00", "time_frame": "at 2(baseline) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "ginseng subjective symptoms questionnaire change", "description": "ginseng subjective symptoms questionnaire is composed of 13 items about subjective symptoms after taking red ginseng", "time_frame": "at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration) and 5(after 6 weeks of administration) visit" }, { "type": "secondary", "measure": "check abnormal responses", "description": "", "time_frame": "at 1(screening),2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02847845", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02807649", "title": "Effect of Ginko and Cistanche Against Fatigue Symptoms", "status": "COMPLETED", "phase": "NA", "last_updated": "2016-06-21", "start_date": "2015-05", "completion_date": "2015-12", "primary_completion_date": "2015-10", "conditions_raw": [ "Mental Fatigue", "Fatigue", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Experimental: Nutrilite® Low Dose", "Experimental: Nutrilite® High Dose" ], "sponsor": "Access Business Group", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "To evaluate the efficacy of Nutrilite® ginkgo biloba cistanche tablets in relieving the symptoms of chronic fatigue syndrome(CFS), the investigators randomly recruit189 subjects with CFS, aged 35-60 yrs. The relief of fatigue and improvement of sexual function are evaluated by World Health Organization Quality Of Life Brief (WHOQoL-Bref), Sexual Life Quality Questionnaire (SLQQ), chronic fatigue syndrome, symptoms of self-assessment at the baseline and the end of intervention. Subjects also underwent a blood test measuring the concentration of biochemical indicators. Cistanche is mainly used to strengthen the renal function, nourish essence and blood in the treatment of lumbar debility, impotence, infertility and muscles weakness, constipation. etc. The study is to test the hypothesis that consecutive 60-day intake of the study tablets can relieve the symptoms of CFS; according to the change of blood biology indicators, the investigators will also evaluate the association between the change of plasma outcome measures and chronic fatigue syndrome.", "primary_outcomes": [ { "type": "primary", "measure": "Net change in the score of World Health Organization Quality of Life survey before and after intervention", "description": "", "time_frame": "60 days" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Net change in the score of Chalder fatigue scale survey before and after intervention", "description": "", "time_frame": "60 days" }, { "type": "secondary", "measure": "Net change in the score of Chalder fatigue self assessment survey before and after intervention", "description": "", "time_frame": "60 days" } ], "outcome_measures": [ { "type": "primary", "measure": "Net change in the score of World Health Organization Quality of Life survey before and after intervention", "description": "", "time_frame": "60 days" }, { "type": "secondary", "measure": "Net change in the score of Chalder fatigue scale survey before and after intervention", "description": "", "time_frame": "60 days" }, { "type": "secondary", "measure": "Net change in the score of Chalder fatigue self assessment survey before and after intervention", "description": "", "time_frame": "60 days" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 159, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02807649", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02108210", "title": "Cytokine Inhibition in Chronic Fatigue Syndrome Patients", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2016-05-25", "start_date": "2014-06", "completion_date": "2016-05", "primary_completion_date": "2015-12", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Anakinra" ], "sponsor": "Radboud University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Rationale: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine network has been suspected to play a role in the pathophysiology of CFS. Although derangements of the cytokine network in CFS are controversial, a major problem is that many studies did not use adequate controls. In addition, all studies have been performed on peripheral venous blood of the patients. As cytokines mainly act in the tissues, e.g., the brain, the information that can be derived from peripheral blood cells is limited. The only information regarding the possible role of cytokines in the pathophysiology of CFS could come from intervention studies in which pathogenetically important cytokines are inhibited. A potentially relevant cytokine which can be blocked in humans without severe side effects is IL-1. Although it is plausible that these cytokines play a role in CFS, there is limited evidence for this.\n\nObjective: To investigate the effect on symptomatology of interference with IL-1 in CFS patients.\n\nStudy design: A randomized placebo controlled study will be performed to determine whether interference with IL-1 is able to reduce fatigue and disabilities in CFS patients.\n\nStudy population: Female CFS patients without psychiatric co-morbidity will be included in this study. Patients of the outpatient clinic of the Department of General internal medicine and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study. Patients will be asked to bring a healthy neighbourhood control to their first study visit.\n\nIntervention: After inclusion patients will be randomized to receive one of the following treatments:\n\n* interleukin-1 inhibitor Anakinra (IL-1Ra) for 4 weeks (N=25);\n* placebo for 4 weeks (N=25).\n\nMain study parameters/endpoints: The primary outcome measure will be fatigue severity measured with the Checklist Individual Strength (CIS) at 4 weeks, measurement will be repeated up to 26 weeks.\n\nSecondary outcome measures will be:\n\n* level of functional impairment measured with the Sickness Impact Profile (SIP8) total score;\n* physical and social functioning assessed with the subscale physical functioning and social functioning of the SF-36;\n* level of psychological distress assessed with the total score on the Symptom Checklist-90 (SCL-90);\n* pain severity assessed with a Visual Analog Scale (VAS);\n* cytokine measurement in blood (plasma and blood in Pax-gene tubes) and saliva (at protein and mRNA level);\n* cortisol measurement in saliva and hair;\n* microbiome determination in faeces;\n* body temperature and pulse rate.", "primary_outcomes": [ { "type": "primary", "measure": "CIS (checklist individual strength, compared to baseline)", "description": "To investigate the role of the cytokine IL-1 in the pathogenesis of CFS and to find leads for future treatment of CFS, a disorder for which there is no proven effective drug treatment. The primary outcome measure will be fatigue severity at 4 weeks measured with the Checklist Individual Strength (CIS).", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "SIP8 (sickness impact profile, change from baseline)", "description": "level of functional impairment", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" }, { "type": "secondary", "measure": "SF-36 (subscale physical functioning and social functioning, compared to baseline)", "description": "physical and social functioning assessed with the subscale physical functioning and social functioning of the SF-36", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" }, { "type": "secondary", "measure": "SCL-90 (symptom checklist-90, compared to baseline)", "description": "level of psychological distress assessed with the total score on the Symptom Checklist-90", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" }, { "type": "secondary", "measure": "VAS pain (visual analog scale, compared to baseline)", "description": "pain severity assessed with a Visual Analog Scale", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" }, { "type": "secondary", "measure": "Cortisol in saliva and hair (concentration compared to baseline)", "description": "Because of the possible role of the hypothalamus-pituitary-adrenal axis we will also measure the cortisol concentration in saliva and hair. For the baseline assessment, comparison will be made with matched neighbourhood controls.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "microbiome determination faeces", "description": "A new field of great interest in pathophysiology is the role of the microbial flora of the host (microbiome). The availability of well defined patients with CFS and matched controls is a great opportunity in an unexplored area of CFS research, to assess whether the microbiome of CFS patients is peculiar.", "time_frame": "at baseline" }, { "type": "secondary", "measure": "cytokine concentrations in blood and saliva (compared to baseline)", "description": "In addition to the cytokine intervention, we will assess cytokines (at the transcriptional level and as proteins) in serum and saliva at baseline and after 4 weeks of intervention. For the baseline assessment, comparison will be made with matched neighbourhood controls.", "time_frame": "4 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "CIS (checklist individual strength, compared to baseline)", "description": "To investigate the role of the cytokine IL-1 in the pathogenesis of CFS and to find leads for future treatment of CFS, a disorder for which there is no proven effective drug treatment. The primary outcome measure will be fatigue severity at 4 weeks measured with the Checklist Individual Strength (CIS).", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" }, { "type": "secondary", "measure": "SIP8 (sickness impact profile, change from baseline)", "description": "level of functional impairment", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" }, { "type": "secondary", "measure": "SF-36 (subscale physical functioning and social functioning, compared to baseline)", "description": "physical and social functioning assessed with the subscale physical functioning and social functioning of the SF-36", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" }, { "type": "secondary", "measure": "SCL-90 (symptom checklist-90, compared to baseline)", "description": "level of psychological distress assessed with the total score on the Symptom Checklist-90", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" }, { "type": "secondary", "measure": "VAS pain (visual analog scale, compared to baseline)", "description": "pain severity assessed with a Visual Analog Scale", "time_frame": "4 weeks, measurement will be repeated up to 26 weeks" }, { "type": "secondary", "measure": "Cortisol in saliva and hair (concentration compared to baseline)", "description": "Because of the possible role of the hypothalamus-pituitary-adrenal axis we will also measure the cortisol concentration in saliva and hair. For the baseline assessment, comparison will be made with matched neighbourhood controls.", "time_frame": "4 weeks" }, { "type": "secondary", "measure": "microbiome determination faeces", "description": "A new field of great interest in pathophysiology is the role of the microbial flora of the host (microbiome). The availability of well defined patients with CFS and matched controls is a great opportunity in an unexplored area of CFS research, to assess whether the microbiome of CFS patients is peculiar.", "time_frame": "at baseline" }, { "type": "secondary", "measure": "cytokine concentrations in blood and saliva (compared to baseline)", "description": "In addition to the cytokine intervention, we will assess cytokines (at the transcriptional level and as proteins) in serum and saliva at baseline and after 4 weeks of intervention. For the baseline assessment, comparison will be made with matched neighbourhood controls.", "time_frame": "4 weeks" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 50, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02108210", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00498485", "title": "Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome", "status": "TERMINATED", "phase": "PHASE4", "last_updated": "2016-05-19", "start_date": "2007-05", "completion_date": "2008-12", "primary_completion_date": "2008-12", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Sodium Oxybate" ], "sponsor": "University of Medicine and Dentistry of New Jersey", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce the sleep disturbances of CFS leading to better sleep with less fatigue. Its ability to produce the rapid onset of deep sleep is a reason it became a street drug, but its availability is currently limited via distribution through a single centralized pharmacy. Xyrem has been successfully used based on results from a study on patients with fibromyalgia (FM), an ailment closely resembling CFS. However, in that study, the researchers provided no information as to whether patients had FM alone or FM plus CFS. Thus, it is not clear from this study just which patient may be helped. I have prescribed Xyrem for patients who have both FM and CFS with good results. In this study, funded by the company that makes Xyrem, I propose testing the drug's efficacy on patients with CFS alone - that is, they do not have fibromyalgia.\n\nVolunteers for this study will complete paper and pencil questionnaires about their symptoms as well as a computerized test to assess their degree of brain fog. They will then be randomly assigned to one of two groups, placebo or drug. Volunteers will not know what group they are in until the end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks identical to the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will be told to skip taking the second dose. We will call patients weekly to see how they are doing on the \"drug.\" If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect of treatment, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.", "primary_outcomes": [ { "type": "primary", "measure": "Global Assessment of Change", "description": "A count was made of subject responses on a Patient Assessment of Change questionnaire where scores went from +2 \\[much better\\] thru 0 \\[no change\\] to -2 \\[much worse\\]", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Self Reported Assessment of Sleep", "description": "Subjects were asked to provide their input as to the quality of their sleep over the past week", "time_frame": "Assessed at week 6" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Global Assessment of Change", "description": "A count was made of subject responses on a Patient Assessment of Change questionnaire where scores went from +2 \\[much better\\] thru 0 \\[no change\\] to -2 \\[much worse\\]", "time_frame": "6 weeks" }, { "type": "primary", "measure": "Self Reported Assessment of Sleep", "description": "Subjects were asked to provide their input as to the quality of their sleep over the past week", "time_frame": "Assessed at week 6" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 4", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 17, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00498485", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02336126", "title": "Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study", "status": "COMPLETED", "phase": "NA", "last_updated": "2016-04-18", "start_date": "2014-10", "completion_date": "2015-01", "primary_completion_date": "2015-01", "conditions_raw": [ "Adolescent Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Biopsychological Intervention" ], "sponsor": "Oslo University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This is a pilot study of a biopsychological intervention program for adolescent chronic fatigue syndrome. The program is related to cognitive behavioral therapy, which has been proven beneficial in this disorders, but includes other mental techniques, such as emotional control and metacognitive elaboration.\n\nThe aim of this pilot study is to explore a) patients' experiences and b) possible positive effects on symptoms. We hypothesise that the intervention will be regarded feasible by the patients, and that fatigue score will improve during the intervention period.", "primary_outcomes": [ { "type": "primary", "measure": "Chalder fatigue score", "description": "", "time_frame": "Up to 3 months after inclusion" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patients' experiences (semistructured interview)", "description": "Qualitative data, further analysed by thematic structural analysis", "time_frame": "Up to 3 months after inclusion" }, { "type": "secondary", "measure": "Quality of Life (PedsQL)", "description": "", "time_frame": "Up to 3 months after inclusion" } ], "outcome_measures": [ { "type": "primary", "measure": "Chalder fatigue score", "description": "", "time_frame": "Up to 3 months after inclusion" }, { "type": "secondary", "measure": "Patients' experiences (semistructured interview)", "description": "Qualitative data, further analysed by thematic structural analysis", "time_frame": "Up to 3 months after inclusion" }, { "type": "secondary", "measure": "Quality of Life (PedsQL)", "description": "", "time_frame": "Up to 3 months after inclusion" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 8, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT02336126", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01512342", "title": "Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2015-12-17", "start_date": "2011-08", "completion_date": "2014-08", "primary_completion_date": "2014-06", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Pacing", "Relaxation Therapy" ], "sponsor": "Vrije Universiteit Brussel", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with CFS.", "primary_outcomes": [ { "type": "primary", "measure": "the change in score on the Canadian Occupational Performance Measure (COPM)", "description": "well-validated, reliable and frequently used outcome measure semi-structered interview", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)", "description": "The SF-36 assesses functional status and well-being or quality of life. The SF-36 has been documented to have reliability and validity in a wide variety of patient populations and it is the most frequently used measure in CFS research.", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" }, { "type": "secondary", "measure": "the change in Ckecklist Individual Strength (CIS)", "description": "The CIS aims at assessing the subjective fatigue experience, concentration difficulties, motivation and physical activity. Higher scores on the CIS correspond to severe fatigue, many concentration difficulties, problems with motivation and a low level of physical activity. Its psychometric properties are well established.", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" }, { "type": "secondary", "measure": "the change in CFS Symptom List", "description": "The CFS Symptom List is a self-reported measure for assessing symptom severity in CFS patients. In order to assess the severity of the symptoms included in the CFS Symptom List, visual analogue scales (100 mm) are used. Psychometric work supporting the use of the CFS Symptom List has been published.", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" }, { "type": "secondary", "measure": "the change in autonomic activity at rest and following 3 activities of daily living", "description": "The 3 activities of daily living entail writing a standardized test on a laptop computer, ironing, and climbing 26 flights of stairs. For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during a 2 minutes period, with the patient sitting on a chair (back supported and hands resting on legs). Electrodes will be placed on the left hand in all patients.", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" } ], "outcome_measures": [ { "type": "primary", "measure": "the change in score on the Canadian Occupational Performance Measure (COPM)", "description": "well-validated, reliable and frequently used outcome measure semi-structered interview", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" }, { "type": "secondary", "measure": "the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)", "description": "The SF-36 assesses functional status and well-being or quality of life. The SF-36 has been documented to have reliability and validity in a wide variety of patient populations and it is the most frequently used measure in CFS research.", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" }, { "type": "secondary", "measure": "the change in Ckecklist Individual Strength (CIS)", "description": "The CIS aims at assessing the subjective fatigue experience, concentration difficulties, motivation and physical activity. Higher scores on the CIS correspond to severe fatigue, many concentration difficulties, problems with motivation and a low level of physical activity. Its psychometric properties are well established.", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" }, { "type": "secondary", "measure": "the change in CFS Symptom List", "description": "The CFS Symptom List is a self-reported measure for assessing symptom severity in CFS patients. In order to assess the severity of the symptoms included in the CFS Symptom List, visual analogue scales (100 mm) are used. Psychometric work supporting the use of the CFS Symptom List has been published.", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" }, { "type": "secondary", "measure": "the change in autonomic activity at rest and following 3 activities of daily living", "description": "The 3 activities of daily living entail writing a standardized test on a laptop computer, ironing, and climbing 26 flights of stairs. For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during a 2 minutes period, with the patient sitting on a chair (back supported and hands resting on legs). Electrodes will be placed on the left hand in all patients.", "time_frame": "measured at baseline (week 1) and post-treatment (week 5)" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 33, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01512342", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01730495", "title": "Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome", "status": "TERMINATED", "phase": "PHASE2", "last_updated": "2015-12-02", "start_date": "2012-10", "completion_date": "2014-08", "primary_completion_date": "2014-08", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Etanercept" ], "sponsor": "Haukeland University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis factor-alpha inhibition using Etanercept as weekly subcutaneous injections.", "primary_outcomes": [ { "type": "primary", "measure": "Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.", "time_frame": "Response of at least six weeks duration, independent on when occuring, during 12 months follow-up." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.", "time_frame": "At 3, 6, 9, 12 months after start of intervention." } ], "outcome_measures": [ { "type": "primary", "measure": "Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.", "time_frame": "Response of at least six weeks duration, independent on when occuring, during 12 months follow-up." }, { "type": "secondary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.", "time_frame": "At 3, 6, 9, 12 months after start of intervention." } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 4, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01730495", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01806246", "title": "A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2015-10-23", "start_date": "2013-02", "completion_date": "2015-09", "primary_completion_date": "2015-09", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Integrative Rehabilitation Program" ], "sponsor": "St. Olavs Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation reflecting the current knowledge about the disease, Heart Rate Variability Coherence Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy. The study is designed as a Single-Case study including 10- 15 participants.", "primary_outcomes": [ { "type": "primary", "measure": "fatigue change", "description": "assessed by Fatigue Severity Scale", "time_frame": "baseline and 52 weeks" }, { "type": "primary", "measure": "quality of life change", "description": "assessed by Inventory of Life Quality for Children and Adolescents", "time_frame": "baseline and 52 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "mood change", "description": "assessed by Mood and Feelings Questionnaire", "time_frame": "baseline and 52 weeks" }, { "type": "secondary", "measure": "change in heart rate variability", "description": "", "time_frame": "baseline and 52 weeks" }, { "type": "secondary", "measure": "school attendance change", "description": "", "time_frame": "baseline and 52 weeks" }, { "type": "secondary", "measure": "general health change", "description": "General Health Questionnaire (GHQ-12)", "time_frame": "baseline and 52 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "fatigue change", "description": "assessed by Fatigue Severity Scale", "time_frame": "baseline and 52 weeks" }, { "type": "primary", "measure": "quality of life change", "description": "assessed by Inventory of Life Quality for Children and Adolescents", "time_frame": "baseline and 52 weeks" }, { "type": "secondary", "measure": "mood change", "description": "assessed by Mood and Feelings Questionnaire", "time_frame": "baseline and 52 weeks" }, { "type": "secondary", "measure": "change in heart rate variability", "description": "", "time_frame": "baseline and 52 weeks" }, { "type": "secondary", "measure": "school attendance change", "description": "", "time_frame": "baseline and 52 weeks" }, { "type": "secondary", "measure": "general health change", "description": "General Health Questionnaire (GHQ-12)", "time_frame": "baseline and 52 weeks" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 13, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01806246", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00375973", "title": "Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2015-08-21", "start_date": "2006-09", "completion_date": "2014-03", "primary_completion_date": "2012-06", "conditions_raw": [ "Fatigue Syndrome, Chronic" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Duloxetine" ], "sponsor": "University of Cincinnati", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to determine the safety and efficacy of duloxetine compared with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).", "primary_outcomes": [ { "type": "primary", "measure": "Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score", "description": "The MFI is a self-reported instrument that contains 20 statements covering different aspects of fatigue. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced concentration. Each subscale includes 4 items with 5-point Likert scales. Scores on each subscale range from 4-20 with higher scores indicating greater fatigue. A decrease in the score indicates improvement.\n\nThe general fatigue subscale (primary measure) includes general statements about tiredness, feeling rested, and overall feelings of being fit.", "time_frame": "Baseline to endpoint at 12 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score", "description": "The BPI is a self-administered scale that measures the severity of pain. Pain severity is rated on a 0 \\[no pain\\] to 10 \\[pain as bad a you can imagine\\] scale. Average pain is rated over the previous 24 hours. Higher scores indicate greater pain severity. A decrease in the score indicates improvement (i.e. decrease in pain severity).", "time_frame": "Baseline to endpoint at 12 weeks" }, { "type": "secondary", "measure": "Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale", "description": "The HADS is a self-reported instrument designed as a brief assessment tool of anxiety and depression in nonpsychiatric populations. It is a 14-item questionnaire that consistes of 2 subscales of 7 items designed to measure levels of both anxiety and depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater levels of anxiety or depression. A decrease in the score indicates improvement.", "time_frame": "baseline to endpoint at 12 weeks" }, { "type": "secondary", "measure": "Change From Baseline in the Clinical Global Impression of Severity (CGI-S)", "description": "Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.", "time_frame": "baseline to endpoint at 12 weeks" }, { "type": "secondary", "measure": "Patient Global Impression of Improvement (PGI-I)", "description": "Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.", "time_frame": "baseline to endpoint at 12 weeks." }, { "type": "secondary", "measure": "Number of Participants Who Discontinued the Study for Any Reason", "description": "Description of discontinuation rates of participants; all participants who dropped out of the study after randomization were included. The reasons for drop outs included lack of efficacy, adverse event, lost to follow-up, personal conflict or other patient decision, withdrawal of informed consent, and non-compliance.", "time_frame": "Any time after randomization up to 12 weeks." }, { "type": "secondary", "measure": "Number of Participants Who Discontinued Use of Treatment Due to Adverse Events", "description": "Paticipants who dropped out of the study because of intolerable adverse events.", "time_frame": "Any time after randomization up to 12 weeks." } ], "outcome_measures": [ { "type": "primary", "measure": "Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score", "description": "The MFI is a self-reported instrument that contains 20 statements covering different aspects of fatigue. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced concentration. Each subscale includes 4 items with 5-point Likert scales. Scores on each subscale range from 4-20 with higher scores indicating greater fatigue. A decrease in the score indicates improvement.\n\nThe general fatigue subscale (primary measure) includes general statements about tiredness, feeling rested, and overall feelings of being fit.", "time_frame": "Baseline to endpoint at 12 weeks" }, { "type": "secondary", "measure": "Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score", "description": "The BPI is a self-administered scale that measures the severity of pain. Pain severity is rated on a 0 \\[no pain\\] to 10 \\[pain as bad a you can imagine\\] scale. Average pain is rated over the previous 24 hours. Higher scores indicate greater pain severity. A decrease in the score indicates improvement (i.e. decrease in pain severity).", "time_frame": "Baseline to endpoint at 12 weeks" }, { "type": "secondary", "measure": "Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale", "description": "The HADS is a self-reported instrument designed as a brief assessment tool of anxiety and depression in nonpsychiatric populations. It is a 14-item questionnaire that consistes of 2 subscales of 7 items designed to measure levels of both anxiety and depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater levels of anxiety or depression. A decrease in the score indicates improvement.", "time_frame": "baseline to endpoint at 12 weeks" }, { "type": "secondary", "measure": "Change From Baseline in the Clinical Global Impression of Severity (CGI-S)", "description": "Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.", "time_frame": "baseline to endpoint at 12 weeks" }, { "type": "secondary", "measure": "Patient Global Impression of Improvement (PGI-I)", "description": "Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.", "time_frame": "baseline to endpoint at 12 weeks." }, { "type": "secondary", "measure": "Number of Participants Who Discontinued the Study for Any Reason", "description": "Description of discontinuation rates of participants; all participants who dropped out of the study after randomization were included. The reasons for drop outs included lack of efficacy, adverse event, lost to follow-up, personal conflict or other patient decision, withdrawal of informed consent, and non-compliance.", "time_frame": "Any time after randomization up to 12 weeks." }, { "type": "secondary", "measure": "Number of Participants Who Discontinued Use of Treatment Due to Adverse Events", "description": "Paticipants who dropped out of the study because of intolerable adverse events.", "time_frame": "Any time after randomization up to 12 weeks." } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT00375973", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00007748", "title": "Exercise and Behavioral Therapy Trial (EBT).", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2015-06-26", "start_date": "1999-03", "completion_date": "2001-08", "primary_completion_date": "Unknown", "conditions_raw": [ "Persian Gulf Syndrome" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Aerobic Exercise", "Cognitive Behavioral Therapy" ], "sponsor": "US Department of Veterans Affairs", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "This trial is a study of Gulf War era veterans who have unexplained chronic medical symptoms such as pain, fatigue, and/or cognitive difficulties. The treatments to be studied, cognitive behavior therapy (CBT) and aerobic exercise, have been shown to be effective in alleviating symptoms in individuals with other similar types of illnesses, such as chronic fatigue syndrome and fibromyalgia. This is a Phase 3, 2X2 factorial designed study. All study participants are assigned to one of four treatment groups - CBT and aerobic exercise, aerobic exercise alone, CBT alone or usual and customary care. This study durations is 28 months; 1092 participants were enrolled and will be followed in clinic at 3, 6 and 12 months after enrollment.", "primary_outcomes": [], "secondary_outcomes": [], "outcome_measures": [], "relevance_tags": [ "Neurological / Autonomic", "Phase 3", "Very Large (1000+ participants)", "Sponsor Type: Fed" ], "enrollment": 1064, "enrollment_type": "N/A", "size_category": "Very Large (1000+ participants)", "link": "https://clinicaltrials.gov/study/NCT00007748", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01471652", "title": "Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder", "status": "WITHDRAWN", "phase": "PHASE2", "last_updated": "2015-04-13", "start_date": "2012-03", "completion_date": "2013-02", "primary_completion_date": "2013-02", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Nutraceutical Supplements" ], "sponsor": "Columbia University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The pathogenesis of chronic fatigue syndrome (CFS) is poorly understood and no effective therapy has been developed. Recent studies suggest that a preceding viral infection causes mitochondrial dysfunction of the brain and skeletal muscle of genetically susceptible individuals. There is no specific laboratory test to identify patients with CFS. However, certain clinical manifestations are similar to those seen in mitochondrial disorders. Both patients with mitochondrial disorders and CFS manifest elevated serum lactate levels after exercise, and demonstrate elevated brain cerebrospinal fluid levels and decreased brain glutathione levels on nuclear magnetic resonance (NMR) spectroscopy.\n\nTherapy consisting of daily conditioning exercise, dietary recommendations, and nutraceutical supplements (ENT) has been show to be beneficial in treating patients with mitochondrial disorders. Similar therapy has been instituted in individual patients with CFS and has been shown to also improve their clinical conditions.\n\nA placebo-controlled trial will be undertaken in 24 CFS patients aged 25-55. Patients fulfilling the CDC criteria for CFS will participate in this 6 month study. Other medical causes for fatigue will be excluded. Half the patients will receive treatment consisting of daily conditioning exercise plus nutraceutical supplements (ENT), that has been shown to be beneficial for patients with mitochondrial dysfunction, while the other half will receive daily conditioning exercise and placebo tablets. Response to ENT will be evaluated by maximum oxygen consumption (VO2max) and circulating lactate levels during \\& after treadmill exercise, a 6-minute walk test, and a fatigue questionnaire. In addition, whether ENT corrects the elevated brain cerebrospinal fluid levels and decreased brain glutathione levels will be measured. To ensure compliance to therapy patients will be monitored frequently. The objective of this study is to assess the safety and efficacy of ENT and whether ENT leads to sustained improvement of CFS patients compared to their baseline status, and compared to an exercised group of patients not receiving supplements.", "primary_outcomes": [ { "type": "primary", "measure": "Change in rate of fatigue status and other CFS symptoms", "description": "Rate of decrease in fatigue and other CFS symptoms, as measured by SF-36 and The Fatigue Assessment Instrument.", "time_frame": "0, 3, and 6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change in brain lactate and glutathione levels", "description": "Patients will undergo nuclear magnetic resonance spectroscopy of the brain prior to starting therapy (baseline) and repeat it after 6 months of therapy.", "time_frame": "0 and 6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in rate of fatigue status and other CFS symptoms", "description": "Rate of decrease in fatigue and other CFS symptoms, as measured by SF-36 and The Fatigue Assessment Instrument.", "time_frame": "0, 3, and 6 months" }, { "type": "secondary", "measure": "Change in brain lactate and glutathione levels", "description": "Patients will undergo nuclear magnetic resonance spectroscopy of the brain prior to starting therapy (baseline) and repeat it after 6 months of therapy.", "time_frame": "0 and 6 months" } ], "relevance_tags": [ "Metabolic", "Mitochondrial", "Phase 2", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 0, "enrollment_type": "ACTUAL", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT01471652", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02063126", "title": "Clinical Trial to Measure the Maximun HR After ReConnect ® Supplementation vs. Placebo in CFS.", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2015-02-19", "start_date": "2013-01", "completion_date": "2013-12", "primary_completion_date": "2013-01", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Coenzyme Q10 (CoQ10)" ], "sponsor": "Hospital Universitari Vall d'Hebron Research Institute", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The main objective is evaluate to safety and efficacy of oral Reconnect ® (food supplementation composed by Coenzyme Q10, NADH, phosphoserine y vitamin C) on the maximum HR during an exercise test in CFS", "primary_outcomes": [ { "type": "primary", "measure": "Maximum HR changes after ReConnect supplementation during an incremental exercise test in CFS patients", "description": "Researchers hypothesize that the low maximun HR in CFS is tied to the brain via the autonomic nervous system, which regulates the body's automatic functions. Dysregulation of the autonomic nervous system is called dysautonomia and is believed to be a feature of CFS patients.", "time_frame": "within the first 30 days (plus or minus 15 days) after treatment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Perception of fatigue, pain and sleep disruption after ReConnect supplementation during an incremental exercise test in CFS patients", "description": "Researchers hypothesize that perception of fatigue, pain and sleep disturbances in CFS is tied to the brain via the autonomic nervous system, which regulates the body's automatic functions. Dysregulation of the autonomic nervous system is called dysautonomia and is believed to be a feature of CFS patients.", "time_frame": "within the first 30 days (plus or minus 15 days)" } ], "outcome_measures": [ { "type": "primary", "measure": "Maximum HR changes after ReConnect supplementation during an incremental exercise test in CFS patients", "description": "Researchers hypothesize that the low maximun HR in CFS is tied to the brain via the autonomic nervous system, which regulates the body's automatic functions. Dysregulation of the autonomic nervous system is called dysautonomia and is believed to be a feature of CFS patients.", "time_frame": "within the first 30 days (plus or minus 15 days) after treatment" }, { "type": "secondary", "measure": "Perception of fatigue, pain and sleep disruption after ReConnect supplementation during an incremental exercise test in CFS patients", "description": "Researchers hypothesize that perception of fatigue, pain and sleep disturbances in CFS is tied to the brain via the autonomic nervous system, which regulates the body's automatic functions. Dysregulation of the autonomic nervous system is called dysautonomia and is believed to be a feature of CFS patients.", "time_frame": "within the first 30 days (plus or minus 15 days)" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02063126", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00468013", "title": "A Computer-Based Intervention for Medically Unexplained Physical Symptoms", "status": "COMPLETED", "phase": "NA", "last_updated": "2015-02-09", "start_date": "2007-03", "completion_date": "2010-03", "primary_completion_date": "2010-03", "conditions_raw": [ "Fibromyalgia", "Irritable Bowel Syndrome", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Resilience Building Exercises", "Journaling" ], "sponsor": "University of Medicine and Dentistry of New Jersey", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "In this study 60 people with medically unexplained physical symptoms (MUPS) will receive either a 6-session resilience skill building intervention provided fully online or a weekly computerized journaling assignment. Both programs can be completed from home. Participants will complete questionnaires both before and after the intervention and changes in symptoms, mood and satisfaction with life will be assessed.", "primary_outcomes": [ { "type": "primary", "measure": "Quick Inventory of Depressive Symptoms", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "primary", "measure": "Positive and Negative Affect Scale", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "primary", "measure": "Satisfaction with Life Scale", "description": "", "time_frame": "Baseline and 6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Patient Health Questionnaire", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Health Assessment Questionnaire", "description": "", "time_frame": "Baseline and 6 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Quick Inventory of Depressive Symptoms", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "primary", "measure": "Positive and Negative Affect Scale", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "primary", "measure": "Satisfaction with Life Scale", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Patient Health Questionnaire", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Health Assessment Questionnaire", "description": "", "time_frame": "Baseline and 6 weeks" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT00468013", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00252629", "title": "Sleep Disordered Breathing in Gulf War Illness and the Effect of Nasal CPAP Treatment", "status": "COMPLETED", "phase": "NA", "last_updated": "2014-12-11", "start_date": "2005-11", "completion_date": "2010-11", "primary_completion_date": "2008-10", "conditions_raw": [ "Apnea, Sleep", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Nasal Cpap Treatment During Sleep" ], "sponsor": "US Department of Veterans Affairs", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to determine any sleep disordered breathing in veterans with Gulf War Syndrome (GWS) and compare it to healthy normal asymptomatic Gulf War veterans. This study will also determine the effect of treatment with continuous positive airway pressure on veterans with Gulf War Syndrome.\n\n1. The investigators hypothesize that sleep complaints (insomnia, un-refreshing sleep and daytime fatigue) among GWS patients are related to increased sleep fragmentation secondary to the presence of sleep disordered breathing in GWS patients.\n2. The investigators hypothesize that increased collapsibility of the upper airway during sleep with the development of inspiratory flow limitation (IFL) and sleep disordered breathing causes the increased sleep fragmentation in GWS patients.\n3. The investigators hypothesize that correction of IFL and sleep disordered breathing in GWS patients will result in an improvement of their sleep quality resulting in an improvement of their sleep complaints and other functional symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Change of Fatigue Symptom", "description": "Fatigue- increasing impact was rated 1-7 using the fatigue severity scale on days 1 and 7 averaged, where 1= no fatigue and 7= severe fatigue.", "time_frame": "3 weeks treatment with either therapeutic or sham CPAP" }, { "type": "primary", "measure": "The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.", "description": "IFL was determined by plotting inspiratory flow against supra-glottic pressure for each breath sampled during continuous stage 2 sleep on a full night polysomnogram on both veterans with GWS and asymptomatic gulf war veterans.\n\nWe expressed the prevalence of inspiratory flow limitations during sleep as the percentage of flow limited breath in the sample of both GWS and asymptomatic gulf was veterans.", "time_frame": "On a full night polysomnogram" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change of Pain Complaint", "description": "Pain- increased level were rated 0-10 by visual analogue scale, where 0= no pain and 10= severe pain.\n\nWe compared the change of pain symptom before and after treatment of either 3 weeks on therapeutic nasal CPAP or sham nasal CPAP", "time_frame": "3 weeks of treatment on either therapeutic or sham nasal CPAP" }, { "type": "secondary", "measure": "Change of Cognitive Dysfunction", "description": "Cognition dysfunction- increasing difficulty with memory, ability to think, and ability to concentrate was rated 0-10 daily by visual analogue scale, where 0 no problem and 10=severe problems.", "time_frame": "3 weeks treatment with either therapeutic or sham CPAP" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of Fatigue Symptom", "description": "Fatigue- increasing impact was rated 1-7 using the fatigue severity scale on days 1 and 7 averaged, where 1= no fatigue and 7= severe fatigue.", "time_frame": "3 weeks treatment with either therapeutic or sham CPAP" }, { "type": "primary", "measure": "The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.", "description": "IFL was determined by plotting inspiratory flow against supra-glottic pressure for each breath sampled during continuous stage 2 sleep on a full night polysomnogram on both veterans with GWS and asymptomatic gulf war veterans.\n\nWe expressed the prevalence of inspiratory flow limitations during sleep as the percentage of flow limited breath in the sample of both GWS and asymptomatic gulf was veterans.", "time_frame": "On a full night polysomnogram" }, { "type": "secondary", "measure": "Change of Pain Complaint", "description": "Pain- increased level were rated 0-10 by visual analogue scale, where 0= no pain and 10= severe pain.\n\nWe compared the change of pain symptom before and after treatment of either 3 weeks on therapeutic nasal CPAP or sham nasal CPAP", "time_frame": "3 weeks of treatment on either therapeutic or sham nasal CPAP" }, { "type": "secondary", "measure": "Change of Cognitive Dysfunction", "description": "Cognition dysfunction- increasing difficulty with memory, ability to think, and ability to concentrate was rated 0-10 daily by visual analogue scale, where 0 no problem and 10=severe problems.", "time_frame": "3 weeks treatment with either therapeutic or sham CPAP" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Fed" ], "enrollment": 29, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00252629", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01873482", "title": "Traditional African Healing Ceremony in a U.S. Population", "status": "COMPLETED", "phase": "NA", "last_updated": "2014-11-03", "start_date": "2014-05", "completion_date": "Unknown", "primary_completion_date": "2014-05", "conditions_raw": [ "Chronic Fatigue Syndrome", "Anxiety", "Depression", "Cancer" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Movement To Rhythm" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Pre-agricultural societies almost universally used healing ceremonies that involved reverence, rhythm and dance in the presence of a healer. It is believed that we are \"wired\" for such experiences and they foster an integrative mode of consciousness similar to that of mindfulness based stress reduction, which has been shown to have therapeutic effects in a variety of conditions. Collaborator Ava Lavonne Vinesett of the Duke Dance Program has developed a healing ceremony based in sub-Saharan African traditions. The investigators plan is to have 25 subjects with a variety of clinical conditions participate in this ceremony. Subjects will then be asked to write a commentary about their experience and to participate in a focus group discussion. It is anticipated that the study will give us some idea of how promising this approach would be and what kinds of patients might benefit. Safety issues are minimal and include the possibility of injury (though the dancing is not strenuous) and psychological distress.", "primary_outcomes": [ { "type": "primary", "measure": "Report from each participant as to whether they found the experience positive, neutral or negative.", "description": "", "time_frame": "During the first hour after the intervention" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "written narrative of experience", "description": "", "time_frame": "During the first hour after the intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Report from each participant as to whether they found the experience positive, neutral or negative.", "description": "", "time_frame": "During the first hour after the intervention" }, { "type": "secondary", "measure": "written narrative of experience", "description": "", "time_frame": "During the first hour after the intervention" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 17, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01873482", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01966276", "title": "The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2014-09-25", "start_date": "2013-11", "completion_date": "2014-12", "primary_completion_date": "2014-12", "conditions_raw": [ "Chronic Fatigue Syndrome (CFS)", "Myalgic Encephalomyelitis (ME)" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Methyl-P Plus Nutrient Formula" ], "sponsor": "K-PAX Pharmaceuticals, Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "The Synergy Trial will evaluate the safety and efficacy of a currently available medication (methylphenidate hydrochloride) combined with a CFS-specific dietary supplement (CFS Nutrient Formula) to treat Chronic Fatigue Syndrome (CFS).", "primary_outcomes": [ { "type": "primary", "measure": "Change in patient reported Checklist Individual Strength (CIS) Total Score", "description": "", "time_frame": "Week 12" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Percentage of patients with 20% or greater improvement in the CIS total score", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Concentration Disturbances Subscore on the CIS", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Concentration Disturbances Score by Visual Analog Scale (VAS)", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Fatigue Score by Visual Analog Scale (VAS)", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Pain Symptoms by Brief Pain Inventory Form", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep)", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Number of Participants with Adverse Events to Assess Safety and Tolerability", "description": "", "time_frame": "Week 12" } ], "outcome_measures": [ { "type": "primary", "measure": "Change in patient reported Checklist Individual Strength (CIS) Total Score", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Percentage of patients with 20% or greater improvement in the CIS total score", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Concentration Disturbances Subscore on the CIS", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Concentration Disturbances Score by Visual Analog Scale (VAS)", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Fatigue Score by Visual Analog Scale (VAS)", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Pain Symptoms by Brief Pain Inventory Form", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep)", "description": "", "time_frame": "Week 12" }, { "type": "secondary", "measure": "Number of Participants with Adverse Events to Assess Safety and Tolerability", "description": "", "time_frame": "Week 12" } ], "relevance_tags": [ "General", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 134, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01966276", "extraction_date": "2026-10-07" }, { "nct_id": "NCT02246088", "title": "Neuroscience Education on Osteoarthritis", "status": "UNKNOWN", "phase": "NA", "last_updated": "2014-09-22", "start_date": "2013-12", "completion_date": "2015-12", "primary_completion_date": "2015-12", "conditions_raw": [ "Osteoarthritis" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Mt + Ne", "Mt + E" ], "sponsor": "University of Valencia", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great disability and significant healthcare costs. Substantial scientific evidence indicates a role for central sensitization in OA pain. Reconceptualization of pain through Neuroscience Education (NE) is an intervention that has already been used successfully in some chronic musculoskeletal pain conditions characterized by alteration on CNS pain processing or central sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and chronic whiplash associate disorders).There is compelling evidence that NE have a positive effect on pain, disability, catastrophization and physical performance for chronic musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are essentially lacking.\n\nThe primary aim of this study is to assess the effect of NE on pain, disability and physical performance in subjects with chronic OA knee pain waiting for replacement surgery. This will be the first time NE will be addressed specifically to OA pain. To investigate the benefits of NE on pain related to knee OA, the effect of a manual therapy intervention combined with NE (MT+NE) will be compared with this same manual intervention plus an educational program based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary aims will be addressed as well:\n\n* Examining the effects of the two interventions on the mechanism of central sensitization in patients with knee OA;\n* Examining the effects of the two interventions on pain catastrophizing, illness perceptions and kinesiophobia in patients with knee OA;\n* Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.", "primary_outcomes": [ { "type": "primary", "measure": "Endogenous analgesia through the experimental protocol of conditioned pain modulation", "description": "For assessing endogenous analgesia, the method examining the influence of the Diffuse Noxious Inhibitory Control system (or spatial summation) on temporal summation will be applied. Recently, the term conditioned pain modulation has been recommended to describe the psychophysical paradigm of Diffuse Noxious Inhibitory Control system in humans", "time_frame": "Up to 3 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Pain at rest and in the last 24 hours", "description": "Participants will be asked to rate their pain at rest and in the last 24 hours on a horizontal 100-mm visual analogue scale (VAS). The horizontal line anchors will be \"no pain\" and \"worst imaginable pain\". The VAS is a valid and reliable instrument compared with other pain rating scales and has been well established in clinical practice and research for measuring pain levels in arthritis populations.", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Pressure Pain Thresholds", "description": "Local and distant sites will be chosen for pressure pain threshold measurement. Regarding local sites, two points will be measured from the knee, 3 cm medial and lateral to the midpoint of the medial and lateral edge of patella, respectively. Regarding control site, a distant site will be used to assess systematic analgesic effect of NE at 5 cm distal to lateral epicondyle.", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Western Ontario and McMaster osteoarthritis index (WOMAC scale)", "description": "WOMAC assesses pain, stiffness and physical function and can be completed in less than 5 minutes. It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Health-related quality of life using the self-reported Spanish version SF-36 questionnaire", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Tampa Scale of Kinesiophobia (TSK) (Spanish version)", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Pain Catastrophization Scale (PCS) (Spanish version)", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Chronic Pain Coping Inventory-42 (Spanish version)", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Chronic Pain Acceptance Questionnaire (Spanish version)", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Goniometric assessment of knee flexion and extension range of motion", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Strength of the hamstrings and quadriceps muscles", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Timed \"Up & Go\" (TUG) Test", "description": "Participants will be required to rise from a standard arm chair, walk at a safe and comfortable pace to a mark 3 m away and then return to a sitting position in the chair. The outcome of the test will be the time to complete the task. Time will be measured on a stopwatch to the nearest one-hundredth of a second.", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Central Sensitization Inventory", "description": "Signs and symptoms suggesting central sensitization will be monitorized using the Central Sensitization Inventory", "time_frame": "Up to 3 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Endogenous analgesia through the experimental protocol of conditioned pain modulation", "description": "For assessing endogenous analgesia, the method examining the influence of the Diffuse Noxious Inhibitory Control system (or spatial summation) on temporal summation will be applied. Recently, the term conditioned pain modulation has been recommended to describe the psychophysical paradigm of Diffuse Noxious Inhibitory Control system in humans", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Pain at rest and in the last 24 hours", "description": "Participants will be asked to rate their pain at rest and in the last 24 hours on a horizontal 100-mm visual analogue scale (VAS). The horizontal line anchors will be \"no pain\" and \"worst imaginable pain\". The VAS is a valid and reliable instrument compared with other pain rating scales and has been well established in clinical practice and research for measuring pain levels in arthritis populations.", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Pressure Pain Thresholds", "description": "Local and distant sites will be chosen for pressure pain threshold measurement. Regarding local sites, two points will be measured from the knee, 3 cm medial and lateral to the midpoint of the medial and lateral edge of patella, respectively. Regarding control site, a distant site will be used to assess systematic analgesic effect of NE at 5 cm distal to lateral epicondyle.", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Western Ontario and McMaster osteoarthritis index (WOMAC scale)", "description": "WOMAC assesses pain, stiffness and physical function and can be completed in less than 5 minutes. It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Health-related quality of life using the self-reported Spanish version SF-36 questionnaire", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Tampa Scale of Kinesiophobia (TSK) (Spanish version)", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Pain Catastrophization Scale (PCS) (Spanish version)", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Chronic Pain Coping Inventory-42 (Spanish version)", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Chronic Pain Acceptance Questionnaire (Spanish version)", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Goniometric assessment of knee flexion and extension range of motion", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Strength of the hamstrings and quadriceps muscles", "description": "", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Timed \"Up & Go\" (TUG) Test", "description": "Participants will be required to rise from a standard arm chair, walk at a safe and comfortable pace to a mark 3 m away and then return to a sitting position in the chair. The outcome of the test will be the time to complete the task. Time will be measured on a stopwatch to the nearest one-hundredth of a second.", "time_frame": "Up to 3 months" }, { "type": "secondary", "measure": "Central Sensitization Inventory", "description": "Signs and symptoms suggesting central sensitization will be monitorized using the Central Sensitization Inventory", "time_frame": "Up to 3 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 53, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT02246088", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01156909", "title": "B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2014-09-01", "start_date": "2010-10", "completion_date": "2014-02", "primary_completion_date": "2014-02", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Rituximab" ], "sponsor": "Haukeland University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.\n\nThe hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.", "primary_outcomes": [ { "type": "primary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.", "time_frame": "Major response of at least six weeks duration, independent on when occuring, during the follow-up period." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The secondary outcome measures are effect on the CFS symptoms, by evaluation at 3, 6, 10, 15, 20, 24, 30, and 36 months after first intervention (i.e. first Rituximab infusion)", "time_frame": "At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention" } ], "outcome_measures": [ { "type": "primary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.", "time_frame": "Major response of at least six weeks duration, independent on when occuring, during the follow-up period." }, { "type": "secondary", "measure": "Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.", "description": "The secondary outcome measures are effect on the CFS symptoms, by evaluation at 3, 6, 10, 15, 20, 24, 30, and 36 months after first intervention (i.e. first Rituximab infusion)", "time_frame": "At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention" } ], "relevance_tags": [ "Immunomodulatory", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 29, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01156909", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00977171", "title": "Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome", "status": "TERMINATED", "phase": "PHASE2", "last_updated": "2014-06-09", "start_date": "2010-07", "completion_date": "2011-10", "primary_completion_date": "2011-10", "conditions_raw": [ "Chronic Fatigue Syndrome", "Orthostatic Hypotension", "Neurally Mediated Hypotension", "Neurogenic Orthostatic Hypotension" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Droxidopa" ], "sponsor": "Chelsea Therapeutics", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "A subset of patients suffering from chronic fatigue syndrome exhibit symptoms of neurally mediated hypotension. While the underlying pathophysiology of chronic fatigue syndrome is not precisely understood, a dysfunction of the autonomic nervous system is thought to play a role in this subset of patients. In several small studies, subjects within this subset have noted improvement in their chronic fatigue symptoms when treated for their neurally mediated hypotension. As droxidopa acts on the autonomic nervous system and has been shown to ameliorate symptoms of neurally mediated hypotension, it is hypothesized that droxidopa could aid in the treatment of chronic fatigue symptoms.\n\nNeurally mediated hypotension has been associated with patients suffering from chronic fatigue syndrome. Droxidopa meanwhile has been approved in Japan for the treatment of the symptoms of neurogenic orthostatic hypotension. As such, it is hypothesized that regulating the autonomic nervous system in patients with Chronic fatigue syndrome may prove to be clinically beneficial.", "primary_outcomes": [ { "type": "primary", "measure": "Patient Global Impression of Improvement", "description": "The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.", "time_frame": "Baseline to end of 12 week treatment period" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Patient Global Impression of Improvement", "description": "The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.", "time_frame": "Baseline to end of 12 week treatment period" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Industry" ], "enrollment": 3, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00977171", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01742013", "title": "Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate in the Chronic Fatigue Patients", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2013-09-26", "start_date": "2013-01", "completion_date": "2013-09", "primary_completion_date": "2013-08", "conditions_raw": [ "Chronic Fatigue Syndrome", "Idiopathic Chronic Fatigue" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Gcjbp Laennec Inj." ], "sponsor": "Ho Cheol Shin, M.D., Ph.D.", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "GCJBP Laennec Injection contains a variety of cytokines derived from human placenta, amino acids, peptides, nucleobases, and carbohydrates. This product is approved for improving liver function. Also, it has been prescribed for lots of diseases such as menopausal disorders, atopic dermatitis, skin cares as well as fatigue for long time. Although its action mechanism and clinical effectiveness are not still clear, there are reports which say a strong probability of its clinical effectiveness in the chronic fatigue patients.\n\nThis study aims to investigate the safety and efficacy of GCJBP Laennec Inj. (Human placenta hydrolysate) in the chronic fatigue patients through a randomized controlled tial.", "primary_outcomes": [ { "type": "primary", "measure": "Change of Fatigue Severity Scale (FSS)", "description": "", "time_frame": "Baseline and 6 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Change per item of Fatigue Severity Scale (FSS)", "description": "", "time_frame": "Baseline, 3, 6 and 9 weeks" }, { "type": "secondary", "measure": "Rate of patients whose FSS decreased from 4 and more to less than 4", "description": "", "time_frame": "Baseline, 3, 6 and 9 weeks" }, { "type": "secondary", "measure": "Change of Visual Analogue Scale (VAS)", "description": "", "time_frame": "Baseline, 3 and 6 weeks" }, { "type": "secondary", "measure": "Change of Multidimensional Fatigue Inventory (MFI)", "description": "", "time_frame": "Baseline, 3 and 6 weeks" }, { "type": "secondary", "measure": "Global Improvement Scale (GIS)", "description": "GIS assessment after 6-week study treatment by investigator", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Change in the concentration of salivary cortisol", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Change in the concentration of interleukin-6 and interleukin 1b", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Heart Rate Variability (HRV) parameters at resting", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Drug compliance", "description": "Compliance rate of used study drugs to prescribed study drugs after 6-week treatment", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Adverse Events", "description": "All adverse events reported for study duration of 9 weeks", "time_frame": "9 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "Change of Fatigue Severity Scale (FSS)", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Change per item of Fatigue Severity Scale (FSS)", "description": "", "time_frame": "Baseline, 3, 6 and 9 weeks" }, { "type": "secondary", "measure": "Rate of patients whose FSS decreased from 4 and more to less than 4", "description": "", "time_frame": "Baseline, 3, 6 and 9 weeks" }, { "type": "secondary", "measure": "Change of Visual Analogue Scale (VAS)", "description": "", "time_frame": "Baseline, 3 and 6 weeks" }, { "type": "secondary", "measure": "Change of Multidimensional Fatigue Inventory (MFI)", "description": "", "time_frame": "Baseline, 3 and 6 weeks" }, { "type": "secondary", "measure": "Global Improvement Scale (GIS)", "description": "GIS assessment after 6-week study treatment by investigator", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Change in the concentration of salivary cortisol", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Change in the concentration of interleukin-6 and interleukin 1b", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Heart Rate Variability (HRV) parameters at resting", "description": "", "time_frame": "Baseline and 6 weeks" }, { "type": "secondary", "measure": "Drug compliance", "description": "Compliance rate of used study drugs to prescribed study drugs after 6-week treatment", "time_frame": "6 weeks" }, { "type": "secondary", "measure": "Adverse Events", "description": "All adverse events reported for study duration of 9 weeks", "time_frame": "9 weeks" } ], "relevance_tags": [ "General", "Phase 3", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 78, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01742013", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01907711", "title": "Clinical Trial to Evaluate the Effectiveness of Acupuncture as a Treatment in Patients Diagnosed With CFS.", "status": "UNKNOWN", "phase": "PHASE2", "last_updated": "2013-08-29", "start_date": "2013-02", "completion_date": "2014-10", "primary_completion_date": "2014-01", "conditions_raw": [ "Chronic Fatigue Syndrome.", "Muscular Diseases.", "Cognitive Impairment", "Sleep Disturbances", "Pain." ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Acupuncture." ], "sponsor": "Hospital Vall d'Hebron", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "background: The Chronic Fatigue Syndrome (CFS) presents many disturbances multidimensional affect holistically to people who have the disease and current management of fatigue, pain, anxiety, depression and sleep disturbances present in this clinical entity is unsatisfactory.\n\nHypothesis:\n\nThe hypothesis of this essay is to contrast that acupuncture is more useful than placebo.\n\nThe investigators suggest the use of a clinical study protocol (PEC), randomized, placebo-controlled, acupuncture technique, aimed at increasing the patient's sense of well-being, relief of pain and stiffness, acupuncture is effective to reduce fatigue, anxiety, depression and sleep disorders in patients diagnosed with CFS.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue, asses the scale fatigue FÍS. • Fatigue: Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques", "description": "first visit,13 visit, 6 months and 1 year", "time_frame": "one year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "• Pain scale (McGill) (MPQ)", "description": "first visit, 13th visit, 6 months and one year", "time_frame": "one year" }, { "type": "secondary", "measure": "Sleep quality (Pittsburgh) scale (PSQI)", "description": "first visit, 13th visit, 6 months and one year", "time_frame": "one year" }, { "type": "secondary", "measure": "Quality of life scale (ST-36)", "description": "first visit, 13th visit, 6 months and one year", "time_frame": "one year" }, { "type": "secondary", "measure": "Anxiety and depression scale HAD.", "description": "first visit, 13th visit, 6 months and one year", "time_frame": "one year" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue, asses the scale fatigue FÍS. • Fatigue: Scores on the fatigue impact scale (FIS) after treatment with two acupuncture techniques", "description": "first visit,13 visit, 6 months and 1 year", "time_frame": "one year" }, { "type": "secondary", "measure": "• Pain scale (McGill) (MPQ)", "description": "first visit, 13th visit, 6 months and one year", "time_frame": "one year" }, { "type": "secondary", "measure": "Sleep quality (Pittsburgh) scale (PSQI)", "description": "first visit, 13th visit, 6 months and one year", "time_frame": "one year" }, { "type": "secondary", "measure": "Quality of life scale (ST-36)", "description": "first visit, 13th visit, 6 months and one year", "time_frame": "one year" }, { "type": "secondary", "measure": "Anxiety and depression scale HAD.", "description": "first visit, 13th visit, 6 months and one year", "time_frame": "one year" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 60, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01907711", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00893438", "title": "Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2013-05-22", "start_date": "2008-01", "completion_date": "2011-11", "primary_completion_date": "2011-11", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Fitnet Treatment" ], "sponsor": "UMC Utrecht", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of this study is to determine the efficacy of FITNET (web-based cognitive behavioural treatment) for adolescents with Chronic Fatigue Syndrome (CFS) in The Netherlands. The second goal of the study is to establish predictors of outcome. It is very important to know the characteristics of patients who will benefit from Cognitive Behavioural Treatment (CBT) and who will not. Possible predictors of outcome are: age, depression, anxiety, fatigue of the mother, parental bonding, self-efficacy, body consciousness of child and mother, physical activity (Actometer).", "primary_outcomes": [ { "type": "primary", "measure": "School presence", "description": "", "time_frame": "one year" }, { "type": "primary", "measure": "Severity of fatigue", "description": "", "time_frame": "one year" }, { "type": "primary", "measure": "Physical functioning as measured by the subscale physical functioning", "description": "", "time_frame": "one year" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Self-rated improvement", "description": "", "time_frame": "one year" } ], "outcome_measures": [ { "type": "primary", "measure": "School presence", "description": "", "time_frame": "one year" }, { "type": "primary", "measure": "Severity of fatigue", "description": "", "time_frame": "one year" }, { "type": "primary", "measure": "Physical functioning as measured by the subscale physical functioning", "description": "", "time_frame": "one year" }, { "type": "secondary", "measure": "Self-rated improvement", "description": "", "time_frame": "one year" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 135, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT00893438", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00215800", "title": "The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE3", "last_updated": "2013-04-17", "start_date": "1998-12", "completion_date": "2004-02", "primary_completion_date": "2004-02", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Ampligen" ], "sponsor": "AIM ImmunoTech Inc.", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.", "primary_outcomes": [], "secondary_outcomes": [], "outcome_measures": [], "relevance_tags": [ "General", "Phase 3", "Large (200-999 participants)", "Sponsor Type: Industry" ], "enrollment": 234, "enrollment_type": "N/A", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT00215800", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00540254", "title": "Behavioral Insomnia Therapy With Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "PHASE1", "last_updated": "2013-03-01", "start_date": "2007-09", "completion_date": "2010-07", "primary_completion_date": "2010-07", "conditions_raw": [ "Chronic Fatigue Syndrome", "Behavioral Therapy Targeted to Sleep Problems" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Cognitive Behavioral Therapy" ], "sponsor": "Duke University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study is to determine how best to manage the sleep problems of people with Chronic Fatigue Syndrome. This study is being conducted to determine how improvements in sleep affect other Chronic Fatigue symptoms including pain, fatigue, and mood as well as a person's sense of general well-being.", "primary_outcomes": [ { "type": "primary", "measure": "total wake time", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "primary", "measure": "total sleep time", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "primary", "measure": "sleep efficiency", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "primary", "measure": "beliefs about sleep", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "primary", "measure": "sleep habits", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "actigraphy (measurement of activity)", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "secondary", "measure": "scores on measures of fatigue, mood, anxiety, quality of life, chronic fatigue syndrome symptoms, fibromyalgia symptoms, medication usage", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" } ], "outcome_measures": [ { "type": "primary", "measure": "total wake time", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "primary", "measure": "total sleep time", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "primary", "measure": "sleep efficiency", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "primary", "measure": "beliefs about sleep", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "primary", "measure": "sleep habits", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "secondary", "measure": "actigraphy (measurement of activity)", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" }, { "type": "secondary", "measure": "scores on measures of fatigue, mood, anxiety, quality of life, chronic fatigue syndrome symptoms, fibromyalgia symptoms, medication usage", "description": "", "time_frame": "Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up" } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 24, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00540254", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01793415", "title": "Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)", "status": "UNKNOWN", "phase": "PHASE1", "last_updated": "2013-02-15", "start_date": "2013-02", "completion_date": "2013-12", "primary_completion_date": "2013-12", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Iodocarb" ], "sponsor": "PharmaLundensis AB", "sponsor_type": "INDUSTRY", "primary_purpose": "N/A", "brief_summary": "Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest. Interestingly, many of the symptoms experienced by people with CFS are identical to symptoms caused by long-term low-level exposure to mercury, which is called micromercurialism.\n\nThis study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.", "primary_outcomes": [ { "type": "primary", "measure": "Quality of life questionnaire score", "description": "The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period. Results from patients receiving active substance will be compared to patients who received placebo.", "time_frame": "The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period." } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Use of psychotropic drugs", "description": "The intake of psychotropic drugs (sedatives, anxiolytics or hypnotic drugs) during the last (fourth) treatment week is compared to the intake of psychotropic drugs during the control week just prior to the treatment period. Results from the IodoCarb group will be compared to results from the Placebo group.", "time_frame": "The intake of psychotropic drugs during the last (fourth) treatment week is compared to the intake during the control week just prior to the treatment period." }, { "type": "secondary", "measure": "Physical activity measured by a pedometer", "description": "The physical activity of patients during the last (fourth) treatment week is compared to the physical activity during the control week just prior to the treatment period using a pedometer. Results from the IodoCarb group will be compared to results from the Placebo group.", "time_frame": "The physical activity of patients during the last (fourth) treatment week is compared to the physical activity during the control week just prior to the treatment period." } ], "outcome_measures": [ { "type": "primary", "measure": "Quality of life questionnaire score", "description": "The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period. Results from patients receiving active substance will be compared to patients who received placebo.", "time_frame": "The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period." }, { "type": "secondary", "measure": "Use of psychotropic drugs", "description": "The intake of psychotropic drugs (sedatives, anxiolytics or hypnotic drugs) during the last (fourth) treatment week is compared to the intake of psychotropic drugs during the control week just prior to the treatment period. Results from the IodoCarb group will be compared to results from the Placebo group.", "time_frame": "The intake of psychotropic drugs during the last (fourth) treatment week is compared to the intake during the control week just prior to the treatment period." }, { "type": "secondary", "measure": "Physical activity measured by a pedometer", "description": "The physical activity of patients during the last (fourth) treatment week is compared to the physical activity during the control week just prior to the treatment period using a pedometer. Results from the IodoCarb group will be compared to results from the Placebo group.", "time_frame": "The physical activity of patients during the last (fourth) treatment week is compared to the physical activity during the control week just prior to the treatment period." } ], "relevance_tags": [ "General", "Phase 1", "Small (<50 participants)", "Enrollment: Estimated", "Sponsor Type: Industry" ], "enrollment": 40, "enrollment_type": "ESTIMATED", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01793415", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01040429", "title": "The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2012-11-20", "start_date": "2010-02", "completion_date": "2012-11", "primary_completion_date": "2012-06", "conditions_raw": [ "Chronic Fatigue Syndrome", "Myalgic Encephalomyelitis" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Clonidine", "Lactose Capsula" ], "sponsor": "Oslo University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this study IS to\n\n* explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents, particularly focusing on genetics, infections/immunology, endocrinology, autonomic control and cognitions\n* to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity) in adolescent CFS.", "primary_outcomes": [ { "type": "primary", "measure": "Mean steps/day count during one week", "description": "", "time_frame": "8 weeks after inclusion" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Fatigue scores", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Pain scores", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Algometer testing response", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Autonomic symptom scores", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Quality of life-score", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Disability scores", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "School attendance", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Mean steps/day count during one week", "description": "", "time_frame": "30 weeks after inclusion" }, { "type": "secondary", "measure": "Scores on cognitive function tests", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "The change in mean arterial pressure (MAP) during head-up tilt-test", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "The change in heart rate during head-up tilt-test", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Hormonal levels (inluding tryptophan metabolites)", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Microbiological analyses", "description": "", "time_frame": "8 and 30 weeks after inclusion" } ], "outcome_measures": [ { "type": "primary", "measure": "Mean steps/day count during one week", "description": "", "time_frame": "8 weeks after inclusion" }, { "type": "secondary", "measure": "Fatigue scores", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Pain scores", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Algometer testing response", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Autonomic symptom scores", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Quality of life-score", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Disability scores", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "School attendance", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Mean steps/day count during one week", "description": "", "time_frame": "30 weeks after inclusion" }, { "type": "secondary", "measure": "Scores on cognitive function tests", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "The change in mean arterial pressure (MAP) during head-up tilt-test", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "The change in heart rate during head-up tilt-test", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Hormonal levels (inluding tryptophan metabolites)", "description": "", "time_frame": "8 and 30 weeks after inclusion" }, { "type": "secondary", "measure": "Microbiological analyses", "description": "", "time_frame": "8 and 30 weeks after inclusion" } ], "relevance_tags": [ "Neurological / Autonomic", "Phase 2", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 120, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01040429", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01417923", "title": "The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain", "status": "UNKNOWN", "phase": "PHASE4", "last_updated": "2012-11-06", "start_date": "2011-09", "completion_date": "2012-12", "primary_completion_date": "2012-12", "conditions_raw": [ "Vitamin D Deficiency", "Chronic Pain Syndrome", "Inflammatory Response" ], "mapped_conditions": [ "Unspecified / Overlap" ], "agents": [ "Vitamin D" ], "sponsor": "Meir Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Vitamin D3 is produced in the skin following exposure to UVB light from the sun or artificial sources, and occurs naturally in a small range of foods.More recently, several reports underlined the impact of vitamin D on the prevalence and consequences of inadequate vitamin D intake and the research supporting its benefits for alleviating chronic musculoskeletal pain and fatigue syndromes in outpatients. Experts have recommended that vitamin D inadequacy should be addressed in all patients with bone or joint pain, myalgia, fibromyalgia, or chronic fatigue syndrome. It appears that soothing the daily musculoskeletal pain by supplementation of vitamin D may be a simple, well tolerated, and cost-effective modality.\n\nAim of study:\n\nTo study the potential therapeutic effects of vitamin D supplementation on patients with persistent musculo-skeletal pain. Clinicalparameters, visual analog score,short form McGill Pain Questionnaire,patient global perceived effect, quality of life assessed by SF-36 Questionnaire and laboratory parameters, the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF and prostaglandin E will be assessed.", "primary_outcomes": [ { "type": "primary", "measure": "serologic inflamatory responses with prolong vitamin D therapy", "description": "On the day of recruitment blood will be drawn in order to determine the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF and prostaglandin E2. Vitamin D or placebo will be taken for 6 weeks on top of the individual's daily medications. A second blood analysis will be conducted following the 6 week duration", "time_frame": "6 weeks" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "serologic inflamatory responses with prolong vitamin D therapy", "description": "On the day of recruitment blood will be drawn in order to determine the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF and prostaglandin E2. Vitamin D or placebo will be taken for 6 weeks on top of the individual's daily medications. A second blood analysis will be conducted following the 6 week duration", "time_frame": "6 weeks" } ], "relevance_tags": [ "Immunomodulatory", "Phase 4", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 80, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01417923", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00997451", "title": "Fatigue Self-Management in Primary Care", "status": "COMPLETED", "phase": "NA", "last_updated": "2012-10-01", "start_date": "2009-02", "completion_date": "2011-12", "primary_completion_date": "2011-12", "conditions_raw": [ "Medically Unexplained Chronic Fatigue", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Cognitive-Behavioral Self-Management", "Symptom Monitoring" ], "sponsor": "Stony Brook University", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.", "primary_outcomes": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "", "time_frame": "3 months, 6 months, 15 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Beck Anxiety Inventory", "description": "", "time_frame": "3 months, 6 months, 15 months" }, { "type": "secondary", "measure": "Beck Depression Inventory", "description": "", "time_frame": "3 months, 6 months, 15 months" }, { "type": "secondary", "measure": "SF-36 physical function subscale", "description": "", "time_frame": "3 months, 6 months, 15 months" }, { "type": "secondary", "measure": "Global Impression of Change Rating", "description": "", "time_frame": "3 months, 6 months, 15 months" } ], "outcome_measures": [ { "type": "primary", "measure": "Fatigue Severity Scale", "description": "", "time_frame": "3 months, 6 months, 15 months" }, { "type": "secondary", "measure": "Beck Anxiety Inventory", "description": "", "time_frame": "3 months, 6 months, 15 months" }, { "type": "secondary", "measure": "Beck Depression Inventory", "description": "", "time_frame": "3 months, 6 months, 15 months" }, { "type": "secondary", "measure": "SF-36 physical function subscale", "description": "", "time_frame": "3 months, 6 months, 15 months" }, { "type": "secondary", "measure": "Global Impression of Change Rating", "description": "", "time_frame": "3 months, 6 months, 15 months" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 107, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT00997451", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01651754", "title": "Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome", "status": "COMPLETED", "phase": "NA", "last_updated": "2012-07-27", "start_date": "2010-09", "completion_date": "2012-06", "primary_completion_date": "2011-08", "conditions_raw": [ "Postcancer Fatigue", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Seasonal Influenza Vaccination" ], "sponsor": "Radboud University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postcancer fatigue (PCF) is a frequently occurring, severe and invalidating problem, impairing quality of life. Patients with chronic fatigue syndrome (CFS) also suffer from severe fatigue symptoms. Although it is possible to effectively treat CFS, the nature of the underlying physiology remains unclear. The presence of an underlying immunological problem has been suggested as an explanation for PCF and CFS. The aim of this study is to compare the humoral and cellular immune responses upon influenza vaccination in PCF patients, CFS patients, non-fatigued cancer survivors, and healthy controls.\n\nPCF (n=20) and CFS patients (n=20) will be vaccinated against influenza. Age and gender matched non-fatigued cancer survivors (n=20) and healthy controls (n=20) will be included for comparison. Antibody responses will be measured at baseline and at day 21 by a hemagglutination inhibition test. T cell responses will be measured at baseline and at day 7 by lymphocyte proliferation, activation, and cytokine secretion.", "primary_outcomes": [ { "type": "primary", "measure": "Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome.", "description": "Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome. The humoral immune responses will be measured by the hemagglutination-inhibition antibody test. The cellular immune responses will be measured by T lymphocyte proliferation and cytokine secretion of peripheral blood mononuclear cells. A full blood cell count will be performed and hemoglobin, glucose, and cholesterol levels, iron status, electrolyte balance, erythrocyte sedimentation rate, and thyroid, kidney, and liver function will be checked.", "time_frame": "before vaccination, 1 and 3 weeks after vaccination (change in immune response from pre- to post-vaccination)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome.", "description": "Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome. The humoral immune responses will be measured by the hemagglutination-inhibition antibody test. The cellular immune responses will be measured by T lymphocyte proliferation and cytokine secretion of peripheral blood mononuclear cells. A full blood cell count will be performed and hemoglobin, glucose, and cholesterol levels, iron status, electrolyte balance, erythrocyte sedimentation rate, and thyroid, kidney, and liver function will be checked.", "time_frame": "before vaccination, 1 and 3 weeks after vaccination (change in immune response from pre- to post-vaccination)" } ], "relevance_tags": [ "Immunomodulatory", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 72, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01651754", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00959998", "title": "Acupressure for Post-Treatment Cancer Fatigue", "status": "COMPLETED", "phase": "PHASE2", "last_updated": "2012-06-26", "start_date": "2007-09", "completion_date": "2009-07", "primary_completion_date": "2009-07", "conditions_raw": [ "Fatigue" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Self-Administered Acupressure" ], "sponsor": "University of Michigan", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Persistent cancer related fatigue (PCRF) is a common symptom experienced by many cancer survivors, which may last for as long as 10 years following treatment. PCRF is currently under diagnosed, with between 20% to \\>60% of survivors experiencing this symptom. Currently there are few effective treatment options for these patients. Acupressure offers a potential low-toxicity self-administered treatment option to treat PCRF.\n\nThe investigators performed a pilot randomized single-blinded controlled trial of acupressure in cancer survivors experiencing moderate to severe PCRF. Potential participants were excluded if they had other causes of fatigue such as anemia, malnutrition, or chronic fatigue syndrome. Participants were randomized to one of three treatment groups: 1. relaxation acupressure (RA), 2. high intensity stimulatory acupressure (HIS), and 3. low intensity stimulatory acupressure (LIS). Participants performed acupressure for 12 weeks between 3 to 14 times per week depending on group. Fatigue was measured with the Brief Fatigue Inventory (BFI). Secondary outcomes included beliefs and expectations, assessment of blinding, compliance to treatment, demographics, and clinical parameters. The effect of group on BFI was assessed with ANOVA and linear regression. Correlations were also made between compliance and change in BFI.", "primary_outcomes": [ { "type": "primary", "measure": "To examine the effect of two intensities of self-administered stimulating acupressure compared to self-administered relaxation acupressure on severity of chronic fatigue in people diagnosed with cancer who had completed all cancer therapies", "description": "", "time_frame": "Once per week for 13 weeks" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Secondary objects were to evaluate the safety, tolerability, adherence, blinding and beliefs/expectation of participants of the three acupressure treatments", "description": "", "time_frame": "" } ], "outcome_measures": [ { "type": "primary", "measure": "To examine the effect of two intensities of self-administered stimulating acupressure compared to self-administered relaxation acupressure on severity of chronic fatigue in people diagnosed with cancer who had completed all cancer therapies", "description": "", "time_frame": "Once per week for 13 weeks" }, { "type": "secondary", "measure": "Secondary objects were to evaluate the safety, tolerability, adherence, blinding and beliefs/expectation of participants of the three acupressure treatments", "description": "", "time_frame": "" } ], "relevance_tags": [ "General", "Phase 2", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 43, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT00959998", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01096641", "title": "An Explorative Study on Physiological and Neurophysiological Determinants of Fatigue in Cancer Survivors", "status": "UNKNOWN", "phase": "NA", "last_updated": "2012-06-22", "start_date": "2010-04", "completion_date": "2012-10", "primary_completion_date": "2012-09", "conditions_raw": [ "Postcancer Fatigue" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Immediate Cbt", "Delayed Cbt" ], "sponsor": "Radboud University Medical Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Postcancer fatigue is a severe and invalidating problem, impairing quality of life. About 20 to 40% of the patients remain fatigued, at least one year after successful cancer treatment. Fortunately, there is an effective treatment for postcancer fatigue; cognitive behavior therapy. However, no cause for postcancer fatigue has been identified yet. The aim of the study is to identify factors that (partly) cause postcancer fatigue to improve the theoretical understanding of fatigue and to improve the diagnostics of fatigue, predict therapy outcome, and facilitate other treatment options.\n\nIn this study, disease-free fatigued cancer patients, who finished treatment for cancer at least one year and maximally ten years ago, will be approached for this study. They will be compared to non-fatigued patients.\n\nFirst, a baseline assessment will take place. Magnetic resonance imaging of the brains will be performed to assess brain volume and magnetic resonance spectroscopy will be performed to measure the concentrations of specific substances in the brains. Changes in the volume of parts of the brains have been observed in (non-cancer) patients with the chronic fatigue syndrome (CFS), in comparison with healthy controls. In addition, abnormal concentrations of specific substances have been observed in patients with CFS compared to healthy controls. To assess muscle fatigue, a two-minute endurance test of the upper arm will be administered at maximal voluntary contraction. Next to differences in the brains, CFS patients showed (central) muscle fatigue. A maximal exercise test on a bicycle will be performed to assess physical fitness. Physical activity in fatigued cancer survivors is decreased, compared to healthy controls. It is not known whether physical deconditioning originated during the cancer treatment is the reason why these patients are still less active. In addition, patients and controls will wear an actometer for two weeks to register baseline daily physical activity and for an additional 5 days after the maximal exercise test, to assess the effect of exercise on the daily physical activity. Finally, patients and controls will complete standardized questionnaires and will perform neurological/psychological tests, like a reaction time test and a short time memory task, at baseline.\n\nThe results of the non-fatigued and the fatigued patients will be compared at baseline. For the non-fatigued participants, the study will be finished after the baseline measurements. The fatigued participants will start with cognitive behavior therapy immediately after the baseline measurements or after 6 months, depending on the randomization.\n\nAt the end of the therapy, after six months, or after 6 months of waiting for cognitive behavior therapy, a second assessment will take place, comparable to the baseline measurements. These results will be compared with the baseline situation to analyze the effect of cognitive behavior therapy on the (possible) causes of postcancer fatigue.", "primary_outcomes": [ { "type": "primary", "measure": "Possible (neuro)physiological determinants of postcancer fatigue", "description": "MRI to assess brain morphology; MRS to assess brain metabolite concentrations; sEMG and force registration to assess central and peripheral muscle fatigue; maximal exercise test to assess physical condition; actometer measurements and self-observation list to assess daily activity and symptoms; standardized questionnaires to assess fatigue severity and general health; neurological tests to assess information processing and motor speed; screening of blood and urine to find possible explanations for postcancer fatigue.", "time_frame": "The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition)" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Possible (neuro)physiological determinants of postcancer fatigue", "description": "MRI to assess brain morphology; MRS to assess brain metabolite concentrations; sEMG and force registration to assess central and peripheral muscle fatigue; maximal exercise test to assess physical condition; actometer measurements and self-observation list to assess daily activity and symptoms; standardized questionnaires to assess fatigue severity and general health; neurological tests to assess information processing and motor speed; screening of blood and urine to find possible explanations for postcancer fatigue.", "time_frame": "The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition)" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 57, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01096641", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01046370", "title": "A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia", "status": "COMPLETED", "phase": "NA", "last_updated": "2012-05-03", "start_date": "2009-10", "completion_date": "2011-05", "primary_completion_date": "2011-05", "conditions_raw": [ "Chronic Fatigue Syndrome", "Chronic Fatigue", "Fibromyalgia" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Amygdala Retraining Program" ], "sponsor": "Mayo Clinic", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The purpose of this pilot study is to gather preliminary data on the efficacy and feasibility of the Amygdala Retraining Program (ARP), a mind-body practice versus a control (C) on fatigue, quality of life and sleep in patients with Chronic Fatigue Syndrome (CFS), Chronic Fatigue (CF) and Fibromyalgia (FM).\n\nCFS, CF and FM are incapacitating disorders characterized by profound fatigue, muscle pain, impaired memory, insomnia, and post-exertional malaise (Fukuda 1994). Current literature points to a centrally sensitized state in CFS, CF and FM (Meeus 2007). The ARP attempts to retrain this neuronal network through mind-body practices such as cognitive restructuring via neurolinguistic programming, yoga based breathing and simple mindfulness based meditation. A case series of 33 patients with CFS and ARP reported improvement in 92% of patients with two-thirds of patients reaching 80-100% of pre-illness levels of health (Gupta 2009). However ARP has never been formally studied in CFS.\n\nWe propose to gather preliminary data on the efficacy and feasibility of ARP versus C on fatigue, quality of life and sleep in 30 patients with CFS, CF and FM. All participants will undergo standard clinical treatment which consist of a 2 day self-management program in the Chronic Fatigue Clinic. Following this, participants will be randomized into the ARP or C group. The ARP group will receive an additional 2.5 hour training surrounding core concepts of the ARP program. They will then be given the ARP DVD program and booklet, to reinforce and continue the practice. They will then receive scheduled bi-monthly phone calls for 3 months from a study investigator for support. The C group will receive only standard care. However they will receive a complementary copy of the ARP program at the end of the study (6 month time point) as a gift for participation in the study.\n\nPreliminary data on efficacy will be assessed at baseline, 1, 3 and 6 months using the following validated questionnaires: Multidimensional Fatigue Inventory (MDFI), Short form-36 (SF36) Fibromyalgia Impact Questionnaire (FIQ), Epworth Sleep Scale (ESS) and Measure Your Medical Outcome Profile (MYMOP-2). Feasibility will be assessed by evaluation of a daily practice log where patients record the total time spent daily in the practice of ARP and any specific difficulties they encountered in the practice of the program.", "primary_outcomes": [ { "type": "primary", "measure": "chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity", "description": "", "time_frame": "6 months" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "fatigue as assessed by Multidimensional Fatigue Inventory (MDFI) and Epworth Sleep Scale (ESS)", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "pain as assessed by the Fibromyalgia Impact Questionnaire (FIQ) and Measure Your Medical Outcome Profile (MYMOP-2)", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "quality of life as assessed by the Short Form-36 (SF-36)", "description": "", "time_frame": "6 months" } ], "outcome_measures": [ { "type": "primary", "measure": "chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "fatigue as assessed by Multidimensional Fatigue Inventory (MDFI) and Epworth Sleep Scale (ESS)", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "pain as assessed by the Fibromyalgia Impact Questionnaire (FIQ) and Measure Your Medical Outcome Profile (MYMOP-2)", "description": "", "time_frame": "6 months" }, { "type": "secondary", "measure": "quality of life as assessed by the Short Form-36 (SF-36)", "description": "", "time_frame": "6 months" } ], "relevance_tags": [ "Neurological / Autonomic", "NA", "Medium (50-199 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 57, "enrollment_type": "ACTUAL", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01046370", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01507701", "title": "Pilot Study for the NorCAPITAL Trial", "status": "COMPLETED", "phase": "NA", "last_updated": "2012-01-13", "start_date": "2010-01", "completion_date": "Unknown", "primary_completion_date": "2010-03", "conditions_raw": [ "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Clonidine" ], "sponsor": "Oslo University Hospital", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the investigators wanted to assess appropriate dosage in relation to a) plasma concentration levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure responses when rising up), and c) reports of possible adverse effects.\n\nA possible beneficial effect of clonidine in adolescent CFS will be investigated in NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.", "primary_outcomes": [ { "type": "primary", "measure": "Plasma concentration level (Cmax and Co) of clonidine", "description": "", "time_frame": "After 14 days of treatment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Orthostatic cardiovascular responses (head-up tilt test)", "description": "", "time_frame": "After 14 days of treatment" }, { "type": "secondary", "measure": "Reports of adverse effects", "description": "", "time_frame": "Participants will be followed for the duration of treatment period, an expected average of 14 days" }, { "type": "secondary", "measure": "Plasma concentration (Cmax) of clonidine", "description": "", "time_frame": "First day of treatment, approximately 5 hours after the first dose" } ], "outcome_measures": [ { "type": "primary", "measure": "Plasma concentration level (Cmax and Co) of clonidine", "description": "", "time_frame": "After 14 days of treatment" }, { "type": "secondary", "measure": "Orthostatic cardiovascular responses (head-up tilt test)", "description": "", "time_frame": "After 14 days of treatment" }, { "type": "secondary", "measure": "Reports of adverse effects", "description": "", "time_frame": "Participants will be followed for the duration of treatment period, an expected average of 14 days" }, { "type": "secondary", "measure": "Plasma concentration (Cmax) of clonidine", "description": "", "time_frame": "First day of treatment, approximately 5 hours after the first dose" } ], "relevance_tags": [ "General", "NA", "Small (<50 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 5, "enrollment_type": "ACTUAL", "size_category": "Small (<50 participants)", "link": "https://clinicaltrials.gov/study/NCT01507701", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01154647", "title": "Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes", "status": "UNKNOWN", "phase": "NA", "last_updated": "2010-07-01", "start_date": "2010-09", "completion_date": "Unknown", "primary_completion_date": "2012-09", "conditions_raw": [ "Fatigue Syndrome, Chronic", "Fibromyalgia", "Arthritis, Rheumatoid" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Citalopram", "N-Acetylcysteine (NAC)" ], "sponsor": "Vrije Universiteit Brussel", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "Both patients with peripheral structural pathologies, like rheumatoid arthritis (RA)-patients, or patients with central sensitivity syndromes (CSS) suffer chronic pain. CSS are characterized by an increased responsiveness of central pain neurons. An impaired endogenous pain inhibition is already demonstrated in CSS. In the present study the investigators want to evaluate the efficacy of pain inhibition in response to physical stressors and whether the efficacy is opioid-mediated in two chronic pain populations (RA \\& CCS) compared to controls.\n\nTherefore a triple-blinded randomized controlled trial (RCT) with cross-over design will be performed. The efficacy of wind-up of pain and spatial summation of pain is evaluated before and after a submaximal exercise, while the experimental group receives a selective serotonin reuptake inhibitor. Participants are 20 RA-patients and 20 CSS-patients, more specific patients with fibromyalgia and chronic fatigue syndrome, and 30 healthy controls. This way, the investigators analyze how pain inhibition reacts on different types of physical stressors in different pain patients and if pain inhibition is opioid-mediated.", "primary_outcomes": [ { "type": "primary", "measure": "Pain rates according to a visual analogue scale upon repeated pulses at pressure pain detection threshold intensity", "description": "Temporal summation is elicited with 10 pulses of the algometer at pressure pain detection threshold intensity on the dorsal surface of the right hand middle finger midway between the first and the second digital joints, and at the trapezius. Subjects are instructed to rate the pain level of the 1st, 5th and 10th pulse according to a visual analogue scale (VAS).\n\nTo assess spatial summation an occlusion cuff inflated to a painful intensity and maintained at that level while repeated algometer pulses are administered and pain ratings are recorded again.", "time_frame": "5 minutes before and after exercise" } ], "secondary_outcomes": [], "outcome_measures": [ { "type": "primary", "measure": "Pain rates according to a visual analogue scale upon repeated pulses at pressure pain detection threshold intensity", "description": "Temporal summation is elicited with 10 pulses of the algometer at pressure pain detection threshold intensity on the dorsal surface of the right hand middle finger midway between the first and the second digital joints, and at the trapezius. Subjects are instructed to rate the pain level of the 1st, 5th and 10th pulse according to a visual analogue scale (VAS).\n\nTo assess spatial summation an occlusion cuff inflated to a painful intensity and maintained at that level while repeated algometer pulses are administered and pain ratings are recorded again.", "time_frame": "5 minutes before and after exercise" } ], "relevance_tags": [ "General", "NA", "Medium (50-199 participants)", "Enrollment: Estimated", "Sponsor Type: Other" ], "enrollment": 70, "enrollment_type": "ESTIMATED", "size_category": "Medium (50-199 participants)", "link": "https://clinicaltrials.gov/study/NCT01154647", "extraction_date": "2026-10-07" }, { "nct_id": "NCT01108549", "title": "Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose- a Multicenter Study", "status": "COMPLETED", "phase": "NA", "last_updated": "2010-04-22", "start_date": "2009-04", "completion_date": "2009-09", "primary_completion_date": "2009-09", "conditions_raw": [ "Fibromyalgia", "Chronic Fatigue Syndrome" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Ribose" ], "sponsor": "Kona Research Center", "sponsor_type": "OTHER", "primary_purpose": "N/A", "brief_summary": "To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS).", "primary_outcomes": [ { "type": "primary", "measure": "total score of hedonic scale of 5 symptoms", "description": "The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale", "time_frame": "Change in total score of 5 symptoms after 3 weeks of treatment" } ], "secondary_outcomes": [ { "type": "secondary", "measure": "Total of change in hedonic scale", "description": "The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale", "time_frame": "at 1 week of treatment" }, { "type": "secondary", "measure": "total change in hedonic scale", "description": "The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale", "time_frame": "after 2 weeks of treatment" }, { "type": "secondary", "measure": "Side effects", "description": "subjects and health practitioners were asked to report any side effects", "time_frame": "3 weeks" } ], "outcome_measures": [ { "type": "primary", "measure": "total score of hedonic scale of 5 symptoms", "description": "The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale", "time_frame": "Change in total score of 5 symptoms after 3 weeks of treatment" }, { "type": "secondary", "measure": "Total of change in hedonic scale", "description": "The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale", "time_frame": "at 1 week of treatment" }, { "type": "secondary", "measure": "total change in hedonic scale", "description": "The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale", "time_frame": "after 2 weeks of treatment" }, { "type": "secondary", "measure": "Side effects", "description": "subjects and health practitioners were asked to report any side effects", "time_frame": "3 weeks" } ], "relevance_tags": [ "Metabolic", "Neurological / Autonomic", "NA", "Large (200-999 participants)", "Enrollment: Actual", "Sponsor Type: Other" ], "enrollment": 257, "enrollment_type": "ACTUAL", "size_category": "Large (200-999 participants)", "link": "https://clinicaltrials.gov/study/NCT01108549", "extraction_date": "2026-10-07" }, { "nct_id": "NCT00100412", "title": "Hyporeactivity and Gulf War Illness", "status": "COMPLETED", "phase": "NA", "last_updated": "2009-01-21", "start_date": "1999-10", "completion_date": "2002-09", "primary_completion_date": "Unknown", "conditions_raw": [ "Gulf War Syndrome", "Chronic Fatigue Syndrome", "Post-Traumatic Stress Disorder" ], "mapped_conditions": [ "ME/CFS" ], "agents": [ "Graded Dobutamine Infusions", "Graded Phenylephrine Injections", "Psychosocial Challenge Involving Socioevaluative Public Speaking" ], "sponsor": "US Department of Veterans Affairs", "sponsor_type": "FED", "primary_purpose": "N/A", "brief_summary": "This research project is a follow-up to the prior VA-funded study that found that chronic fatigue reported by many Gulf War veterans may be a symptom of dysfunctional cardiovascular stress response regulation. Specifically, ill veterans had diminished autonomic responses during demanding psychosocial tasks involving high level cognitive processing and emotional stress. There was a close relationship between clinical status of ill veterans and their inability to mount an appropriate physiological response under stress. The main objective of the present investigation is to determine the specific mechanism through which this abnormality may contribute to Gulf War-related chronic fatigue. We also observed that Gulf veterans with posttraumatic stress disorder (PTSD) had the most dampened autonomic activation to stressors involving higher brain activities. The second major focus of this study is to explore the role of a psychiatric disorder, specifically PTSD, as a factor in abnormalities in stress response regulation. This aspect of the study may also provide pertinent information as to the role of stress of military deployment as a contributing factor in post-Gulf War illnesses.", "primary_outcomes": [], "secondary_outcomes": [], "outcome_measures": [], "relevance_tags": [ "Neurological / Autonomic", "NA", "Sponsor Type: Fed" ], "enrollment": null, "enrollment_type": "N/A", "size_category": null, "link": "https://clinicaltrials.gov/study/NCT00100412", "extraction_date": "2026-10-07" } ] }