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Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

Primary Purpose

Chronic Fatigue Syndrome

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Heart Rhythm Biofeedback
Hydrogen Water
Combined treatment: Heart rhythm biofeedback plus hydrogen water
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Heart Rhythm Biofeedback; Hydrogen Water

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fred FriedbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Heart Rhythm Biofeedback

Hydrogen Water

Combined treatment: Heart rhythm biofeedback plus hydrogen water

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 25, 2022
Last Updated
May 25, 2022
Sponsor
Stony Brook University
Collaborators
Natural Wellness Now Health Products
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1. Study Identification

Unique Protocol Identification Number
NCT05397626
Brief Title
Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
Official Title
Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
May 23, 2023 (Anticipated)
Study Completion Date
May 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
Natural Wellness Now Health Products

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
Heart Rhythm Biofeedback; Hydrogen Water

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Each participant fill out online outcome forms that involve no interaction with the principal investigator or study staff, thus avoiding any staff-specific influence on online outcome forms.
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart Rhythm Biofeedback
Arm Type
Active Comparator
Arm 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.
Arm Title
Hydrogen Water
Arm Type
Active Comparator
Arm 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.
Arm Title
Combined treatment: Heart rhythm biofeedback plus hydrogen water
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Heart Rhythm Biofeedback
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrogen Water
Intervention Description
Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome
Intervention Type
Combination Product
Intervention Name(s)
Combined treatment: Heart rhythm biofeedback plus hydrogen water
Intervention Description
This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.
Primary Outcome Measure Information:
Title
Fatigue Severity Scale
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Short Form-36 Physical Function Subscale
Description
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.
Time Frame
8 weeks
Title
Depression, Anxiety and Stress Scale
Description
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.
Time Frame
8 weeks
Title
Brief Resilience Scale
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FRED FRIEDBERG, PhD
Phone
6316381931
Email
fred.friedberg@stonybrookmedicine.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Gordon, BA
Phone
6316380056
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRED FRIEDBERG, Phd
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Friedberg
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRED FRIEDBERG, PhD
Phone
631-638-1931
Email
fred.friedberg@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Fred Friedberg, PhD

12. IPD Sharing Statement

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Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

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