Recruiting
Phase 1

Biofeedback & Hydrogen Water

Sponsor:

Stony Brook University

Code:

NCT05397626

Conditions

Chronic Fatigue Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Heart Rhythm Biofeedback

Hydrogen Water

Combined treatment: Heart rhythm biofeedback plus hydrogen water

Study Details

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.

Conditions

Chronic Fatigue Syndrome

Study ID

NCT05397626

Start date

May 23, 2022

Status verified date

May, 2022

Completion date

May 23, 2023

Anticipated

Primary completion date

May 23, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

39 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Heart Rhythm Biofeedback

Heart rhythm biofeedback is a non-invasive physiological treatment that is administered via an app downloaded to personal smart phones. It involves participants attaching a wireless sensor to the ear that monitors heart rate that is displayed on the phone screen app. The participant is actively involved in modifying the heart biofeedback to achieve optimal levels of heart rate variability, an established indicator of health and well-being and a potential factor in chronic fatigue syndrome. The treatment lasts 8 weeks.

active comparator: Hydrogen Water

Hydrogen pills are mixed in a water glass that is ingested up to 3 times a day for 8 weeks. The hydrogen supplement is intended to reduce oxidative stress and inflammation both of which are implicated in the pathophysiology of chronic fatigue syndrome. This is an 8 week treatment.

active comparator: Combined treatment: Heart rhythm biofeedback plus hydrogen water

This condition combines heart rhythm biofeedback and hydrogen water, as described above, which is intended to assess any additive or synergistic effects of the two treatments. This is an 8 week treatment.

Interventions

Heart Rhythm Biofeedback

Heart rhythm biofeedback is a non-invasive intervention intended to improve heart rate variability and physical resilience that is often limited in chronic fatigue syndrome

Hydrogen Water

Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome

Combined treatment: Heart rhythm biofeedback plus hydrogen water

This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.

Primary outcome measure

  • Fatigue Severity Scale [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

FRED FRIEDBERG, PhD

6316381931fred.friedberg@stonybrookmedicine.edu

Daniel Gordon, BA

6316380056

Locations

Fred Friedberg

Recruiting

Stony Brook, New York, United States, 11794

Contacts

FRED FRIEDBERG, PhD

631-638-1931fred.friedberg@stonybrookmedicine.edu

Principal Investigator:

Fred Friedberg, PhD

More Information

Sponsor

Stony Brook University

Last update posted

May 31, 2022

Last verified

May, 2022

Keywords

  • Heart Rhythm Biofeedback; Hydrogen Water

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2022-05-31.