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Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

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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

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

Trial contacts and locations

1

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Central trial contact

Daniel Gordon, BA; FRED FRIEDBERG, PhD

Data sourced from clinicaltrials.gov

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