Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

Study Overview
=================
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.

Official Title
-----------------
Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

Conditions
-----------------
Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Behavioral: Heart Rhythm Biofeedback
* Dietary Supplement: Hydrogen Water
* Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen water


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This clinical study involves three active intervention groups: group 1 receiving heart rhythm biofeedback alone, group receiving hydrogen water alone, and group 3 receiving both heart rhythm biofeedback and hydrogen water.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heart Rhythm Biofeedback<br>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. | Dietary Supplement: Hydrogen Water<br>* Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome<br>Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen water<br>* This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.<br>|
| Active Comparator: Hydrogen Water<br>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. | Behavioral: Heart Rhythm Biofeedback<br>* 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<br>Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen water<br>* This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.<br>|
| Active Comparator: Combined treatment: Heart rhythm biofeedback plus hydrogen water<br>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. | Behavioral: Heart Rhythm Biofeedback<br>* 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<br>Dietary Supplement: Hydrogen Water<br>* Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form-36 Physical Function Subscale | 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. | 8 weeks | 
| Depression, Anxiety and Stress Scale | 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. | 8 weeks | 
| Brief Resilience Scale | 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. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Rhythm Biofeedback; Hydrogen Water