Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07009691

Heart Rate Variability as an Autonomic Marker of Improvement in ME/CFS in a Hydrogen Water Treatment Study

Led by Stony Brook University · Updated on 2025-06-08

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of hydrogen water, an over-the-counter magnesium-based supplement, to treat fatigue-related symptoms and improve function in adults with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This pilot study aims to identify heart rate variability (HRV) as a biological marker that can predict who will benefit from hydrogen water treatment. The study focuses on whether hydrogen water can reduce fatigue and enhance physical function in this population. Participants will follow a 10-day graduated dosing schedule of hydrogen water, followed by a standard daily dose over 16 weeks. The treatment involves consuming hydrogen water prepared from the supplement, which is known for its antioxidant properties. Researchers expect to observe two groups among participants: those who improve and those who do not, based on their HRV measurements. During the study, participants will be assessed for fatigue severity using the Fatigue Severity Scale at 12 months. Heart rate variability will be monitored as a key biological measure to track health and well-being. The study will evaluate changes in fatigue symptoms and physical functioning over the treatment period, with safety and health status observed throughout participation, which may last up to one year.

CONDITIONS

Brief Title

Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meets Institute of Medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome
Not Eligible

You will not qualify if you...

  • Medical illness that explains presenting fatigue
  • Any psychosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 16 weeks

Participants receive hydrogen water prepared from an over-the-counter supplement following a 10-day graduated dosing schedule, then continue with a standard daily dose over 16 weeks.

Daily dosing with visits not explicitly specified

Trial Site Locations

Total: 1 location

1

Stony Brook University

Stony Brook, New York, United States, 11794-8101

Actively Recruiting

Loading map...

Research Team

F

Fred Friedberg, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Similar Trials

A 3-day Course for Adults With Chronic Fatigue Syndrome/Myal...

Chronic Fatigue Syndrome

Actively Recruiting

1 location

Use of a Remote Voice Analysis Tool for Diagnosing and Monit...

Encephalomyelitis

Actively Recruiting

1 location

Mechanistic Assessment of N-Acetylcysteine as an Antioxidant...

Chronic Fatigue Syndrome

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here