Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
- Conditions
- Chronic Fatigue Syndrome
- Interventions
- Behavioral: Heart Rhythm BiofeedbackDietary Supplement: Hydrogen Water
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 39
Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-65. - BMI>30.
- 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
- Arm && Interventions
Group Intervention Description Combined treatment: Heart rhythm biofeedback plus hydrogen water Heart Rhythm Biofeedback 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. Heart Rhythm Biofeedback Hydrogen Water 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. Hydrogen Water Heart Rhythm Biofeedback 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. Combined treatment: Heart rhythm biofeedback plus hydrogen water 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.
- 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