Hydrogen water to reduce fatigue and improve function in ME/CFS
Heart Rate Variability as an Autonomic Marker of Improvement in ME/CFS in a Hydrogen Water Treatment Study
NA · Stony Brook University · NCT07009691
This project will try hydrogen water in adults with ME/CFS to see if it reduces fatigue and improves function and whether heart rate variability can predict who benefits.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stony Brook University (other) |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT07009691 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study enrolls adults with ME/CFS and gives hydrogen water made from an over-the-counter magnesium-based supplement using a 10-day graduated dosing schedule followed by a standard daily dose for 16 weeks. Participants will be monitored for changes in fatigue-related symptoms and physical functioning, and heart rate variability (HRV) will be measured as a candidate biomarker. Investigators plan to identify two outcome subgroups—improvers and non-improvers—and test whether higher baseline HRV predicts clinical improvement. The single-site study at Stony Brook University is intended to generate preliminary data to guide larger trials.
Who should consider this trial
Good fit: Adults who meet the Institute of Medicine criteria for ME/CFS, whose fatigue is not explained by another medical illness, and who do not have psychosis are ideal candidates.
Not a fit: People whose fatigue is due to another diagnosed medical condition or who have active psychosis are unlikely to benefit and would be excluded.
Why it matters
Potential benefit: If successful, hydrogen water could reduce fatigue and increase physical function for some people with ME/CFS.
How similar studies have performed: Prior clinical evidence for hydrogen water in ME/CFS is limited, and using HRV as a predictive biomarker in this condition is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Meets Institute of Medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome - Exclusion Criteria: Medical illness that explains presenting fatigue; Any psychosis. \-
Where this trial is running
Stony Brook, New York
- Stony Brook University — Stony Brook, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Fred Friedberg, PhD — Stony Brook University
- Study coordinator: Fred Friedberg, PhD
- Email: fred.friedberg@stonybrookmedicine.edu
- Phone: 15167024213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Fatigue Syndrome, Chronic fatigue syndrome, heart rate variability, treatment, hydrogen water.