Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

Stony Brook University

Status and phase: Unknown; Phase 1

Conditions: Chronic Fatigue Syndrome

Treatments: Dietary Supplement: Hydrogen Water; Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen water; Behavioral: Heart Rhythm Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05397626

AWD00002822

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Heart Rhythm Biofeedback

Active Comparator group

Description:

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.

Treatment:

Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen water

Dietary Supplement: Hydrogen Water

Hydrogen Water

Active Comparator group

Description:

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.

Treatment:

Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen water

Behavioral: Heart Rhythm Biofeedback

Combined treatment: Heart rhythm biofeedback plus hydrogen water

Active Comparator group

Description:

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.

Treatment:

Behavioral: Heart Rhythm Biofeedback

Dietary Supplement: Hydrogen Water