Recruiting

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

Sponsor:

Stony Brook University

Code:

NCT07009691

Conditions

Chronic Fatigue Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Hydrogen water which is prepared from an OTC supplement.

Study Details

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:

Does the OTC supplement, hydrogen water, work to reduce the fatigue-related symptoms and improve functioning in participants who have ME/CFS?

Can HRV be used to predict who will benefit from treatment with hydrogen water?

Conditions

Chronic Fatigue Syndrome

Study ID

NCT07009691

Start date

Jun 9, 2025

Status verified date

Jun, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria: Meets Institute of Medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome -

Exclusion Criteria: Medical illness that explains presenting fatigue; Any psychosis.

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Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydrogen water standard dosage

The intervention is hydrogen water which is prepared from an OTC supplement. Hydrogen water is a strong anti-oxidant.

Interventions

Hydrogen water which is prepared from an OTC supplement.

The intervention is hydrogen water which is prepared from an OTC supplement. It involves measurement of heart rate variability.

Primary outcome measure

Fatigue Severity Scale [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Fred Friedberg, PhD

15167024213 fred.friedberg@stonybrookmedicine.edu

Locations

Stony Brook University

Recruiting

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

Contacts

Fred Friedberg, PhD

fred.friedberg@stonybrookmedicine.edu

Principal Investigator:

Fred Friedberg, PhD

More Information

Sponsor

Stony Brook University

Last update posted

Jun 8, 2025

Last verified

Jun, 2025

Keywords

Chronic fatigue syndrome; heart rate variability; treatment; hydrogen water.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Stony Brook University on 2025-06-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.