Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Fatigue Syndrome
• Intervention / Treatment: Dietary supplement: Hydrogen Water; Combination product: Combined treatment: Heart rhythm biofeedback plus hydrogen water; Behavioral: Heart Rhythm Biofeedback

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.

• Study Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: FRED FRIEDBERG, PhD; Phone Number: 6316381931; Email: fred.friedberg@stonybrookmedicine.edu
• Study Contact Backup: Name: Daniel Gordon, BA; Phone Number: 6316380056

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Fred Friedberg
      • Contact: FRED FRIEDBERG, PhD; Phone Number: 631-638-1931; Email: fred.friedberg@stonybrookmedicine.edu
      • Principal Investigator: Fred Friedberg, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Hydrogen Water; Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome; Combination product: 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.
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.	Combination product: 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.; Behavioral: 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
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.	Dietary supplement: Hydrogen Water; Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome; Behavioral: 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

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

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: Natural Wellness Now Health Products
• Investigators: Principal Investigator: Fred Friedberg, PhD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Anticipated): May 23, 2023
• Study Completion (Anticipated): May 23, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Heart Rhythm Biofeedback; Hydrogen Water
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: AWD00002822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No