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

NCT07009691 | Recruiting DMC

• 1 other identifier: IRB2025-00017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fatigue Severity Scale

  This is a validated self-report measure of the effect of fatigue on functioning.

  12 months

Study Arms (1)

Hydrogen water standard dosage

EXPERIMENTAL

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

Dietary Supplement: Hydrogen water which is prepared from an OTC supplement.

Interventions

Hydrogen water which is prepared from an OTC supplement. DIETARY_SUPPLEMENT

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

Hydrogen water standard dosage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

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

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fred Friedberg, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fred Friedberg, PhD

CONTACT

15167024213; fred.friedberg@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a study of hydrogen water as an intervention for ME/CFS that includes heart rate variability as a potential outcome marker of improvement/non-improvement.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 8, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

US (1)