Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

Phase 1

• Conditions: Chronic Fatigue Syndrome

• Registration Number: NCT05397626
• Lead Sponsor: Stony Brook University

Brief Summary

The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.

Detailed Description

The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and over the counter (OTC) supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.

Participants will be randomized to one of the three study condition, HRV-BF alone, hydrogen water alone or combined HRV-BF and hydrogen water. All interventions are home-based with no in person visits. All communications with participants will be via virtual call, phone call, email and land mail.

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-23
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-25
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-05-31
• Primary Completion: 2023-05-23
• Study Completion: 2023-05-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-65. - BMI>30.

Exclusion Criteria

• Other major medical condition or regular medication that produces fatigue. No home computer or internet access. No smart phone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	8 weeks	self-report measure of fatigue impact on functioning.Minimum value=1; Maximum value=7; Range: 1.00-7.00. High scores indicate more sever fatigue and a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Depression, Anxiety and Stress Scale	8 weeks	Self-report measure if depression, anxiety and stress symptoms. This 21 item stress measure contains three 7-item subscales: anxiety, depression and stress. Domain scores are calculated by summing all items in a domain and multiplying by two.
Brief Resilience Scale	8 weeks	This 6 item self-report scale focuses on how quickly an individuals bounces back and physically and emotionally exhausting events. 5 answer choices range from strongly disagree to strongly agree. Higher scores indicate higher resilience.
Short Form-36 Physical Function Subscale	8 weeks	Self-report measure of physical functioning. The short-form 36 physical function subscale is composed of ten items encompassing a hierarchical range of difficulties. Each item is scores on the basis of the limitations perceived by surveyed individuals. Item scores (1, 2, or 3) are summed to obtain a total score, which can then be scaled relative to its range. Higher scores indicate higher physical function.

Trial Locations

Locations (1)

Fred Friedberg; 🇺🇸 Stony Brook, New York, United States