An observational study in Chronic Fatigue Syndrome, sponsored by Stony Brook University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Stony Brook University · Observational
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Among 86 studies in Fatigue Syndrome, Chronic with a site in United States — 21 open to participants now, 24 under way, none of them phase 3. Fatigue Syndrome, Chronic · United States.
Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, this one is the 20th largest by planned enrollment of the 26 observational ones that give a count, is one of 3 that started in 2017, is one of 26 observational ones, and was the 39th registered.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
Browse Fatigue Syndrome, Chronic studies →21 of the 86 studies in Fatigue Syndrome, Chronic with a site in United States are open now. Recruiting first, the newest first:
Fred Friedberg · Sites in United States
Ages 18–65
University of Alabama at Birmingham · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+ · Healthy volunteers
IMMUNOe Research Centers · Sites in United States
Ages 18–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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86 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 17 · Phase 3 1 · Phase 4 5
First in 1994; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 150 across 77 observational studies indexed under Fatigue Syndrome, Chronic.
Median enrollment 50 across the 58 interventional studies, 152 across the 26 observational. Of the 47 that completed or were terminated, 15 (32%) have results posted.
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10 of 86 have an industry lead sponsor. The 10 most frequent:
Stony Brook University is the lead sponsor of 197 studies on the registry; 35 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
Stony Brook University has 7 studies filed under Fatigue Syndrome, Chronic — fewer than ten, so there is no comparison to draw.
10 of the studies in Fatigue Syndrome, Chronic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06511050Icahn School of Medicine at Mount SinaiLumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | 2026-12 |
| NCT06585254Icahn School of Medicine at Mount SinaitVNS in Long COVID-19 | 2026-12-31 |
| NCT04049331Seattle Institute for Biomedical and Clinical ResearchTestosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone | 2027-01-30 |
| NCT04542161Weill Medical College of Cornell UniversityAssessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | 2027-04-30 |
| NCT07600320Icahn School of Medicine at Mount SinaiFareon Open Label Device Clinical Trial | 2027-04-30 |
Add all 10 to your calendar (.ics) → With an account.
Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, from their registry updates:
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This pilot study is intended to identify sex differences in myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) during recovery from brief but high effort exercise tests. It is expected that women with ME/CFS as compared to males with ME/CFS will show slower recovery from exercise with respect to heart rate and blood pressure, physical functioning, and symptom severity. Also females with ME/CFS as compared to males with ME/CFS will show greater negative impacts on heart rate, blood pressure, physical functioning and symptom severity after the two exercise tests. The findings will have implications for sex differences in the pathophysiology of post-exertional malaise and activity/exercise self-management recommendations, given the expected detrimental effects of the brief intense exercise tests on patients with ME/CFS.
This supplement to the parent study, Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS): Activity patterns and autonomic function, is intended to enhance the larger home-based study with a face-to-face laboratory arm. Specifically, the investigators propose a pilot study to assess biobehavioral sex differences in ME/CFS during recovery after a brief high exertion exercise task, i.e., a six-minute walk test repeated on two consecutive days. The investigators expect adverse symptomatic, functional, and autonomic effects following this repeat exercise test. This "post-exertional malaise (PEM)" and its impact on global outcomes is a unique feature of ME/CFS that is being studied in the parent observational study conducted by participants entirely in their homes. In the proposed supplement, PEM and its impacts will be captured in real time under controlled conditions in the research team's laboratory. Of particular interest, autonomic effects of PEM on heart function and blood pressure using non-invasive research grade monitors. The specific aims are as follows:
Specific Aim 1: After two high-effort six minute walk tests conducted on consecutive days, female subjects with ME/CFS as compared to male ME/CFS subjects will show slower recovery with respect to cardiovascular autonomic functioning, physical functioning, and symptom resolution. Specific Aim 2: Female subjects with ME/CFS as compared to males with ME/CFS will show greater adverse impact on autonomic and physical functioning and symptom severity after the day 2 exercise test.
To more accurately characterize exercise recovery abnormalities differentiated by sex, the investigators propose to longitudinally monitor symptoms, activity levels, and autonomic status during the week before (baseline) as compared to the week after (follow-up) the two exercise tests. This pilot study will also provide potential cross-validation of the parent project which hypothesizes specific relationships between autonomic function symptom severity and activity limitations. A parallel analysis of sex differences will also be carried out on the data collected in the parent project.
The pilot study will remain within the scope of the original aims of the parent study to identify biobehavioral factors related to PEM, symptom-worsening activity patterns, and non-improvement in ME/CFS. This supplement will expand the parent project's home-based data collection to a controlled setting with direct observation and verification of exercise tests carried out by participants in the principal investigator's laboratory.
The study sample will be drawn from the population of patients with CFS who (a) respond to local recruitment ads placed online in University announcements and local newspapers; and (b) CFS subjects who have completed the parent study. Ads will emphasize that the study will help to advance our understanding of the biology of CFS (e.g., autonomic functioning).
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Exclusion Criteria:
Two brief high effort exercise tests on consecutive days in our laboratory in order to provoke abnormalities in ME/CFS patients with respect to autonomic function, symptom exacerbation, and activity limitations.
Behavioral: Exercise test
Two brief high effort exercise tests on consecutive days in our laboratory in order to provoke abnormalities in ME/CFS patients with respect to autonomic function, symptom exacerbation, and activity limitations.
Behavioral: Exercise test
30 sec of knee squats followed by a six minute walk test repeated on consecutive days.
Heart rate variability
The time and frequency variation in heart rate recorded on a portable heart monitor
Time frame: 15 days
Six minute walk distance (m)
Distance walked on the six minute walk test
Time frame: 24 hours
Blood pressure
Blood pressure taken before and after six minute walk tests
Time frame: 24 hours
Physical activity
The daily physical activity levels measured with an accelerometer
Time frame: 15 days
Online web diary
Symptom intensities recorded on online web diary
Time frame: 15 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Nov 2017; primary completion for Oct 2018, 11 months later.
Of 39 non-industry observational studies under Fatigue Syndrome, Chronic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's planned 11 months is below that.
Counting every sponsor, half of 41 studies reached it within 44 months; a quarter within 25 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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