Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

Official title:

Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397626
• Other study ID #: AWD00002822
• Status: Recruiting
• Phase: Phase 1
• Start date: May 23, 2022
• Est. completion date: May 23, 2023

Study information

• Verified date: May 2022
• Source: Stony Brook University
• Contact: FRED FRIEDBERG, PhD
• Phone: 6316381931
• Email: fred.friedberg[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

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

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.

Locations

Country	Name	City	State
United States	Fred Friedberg	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Natural Wellness Now Health Products

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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