Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

NCT05397626 | Unknown Phase 1 DMC

• 1 other identifier: AWD00002822
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Keywords

Heart Rhythm Biofeedback; Hydrogen Water

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Short Form-36 Physical Function Subscale

  8 weeks

• Depression, Anxiety and Stress Scale

  8 weeks

• Brief Resilience Scale

  8 weeks

Study Arms (3)

Heart Rhythm Biofeedback

ACTIVE COMPARATOR

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; Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen water

Hydrogen Water

ACTIVE COMPARATOR

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; Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen water

Combined treatment: Heart rhythm biofeedback plus hydrogen water

ACTIVE COMPARATOR

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; Dietary Supplement: Hydrogen Water

Interventions

Heart Rhythm Biofeedback BEHAVIORAL

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

Combined treatment: Heart rhythm biofeedback plus hydrogen water; Hydrogen Water

Hydrogen Water DIETARY_SUPPLEMENT

Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome

Combined treatment: Heart rhythm biofeedback plus hydrogen water; Heart Rhythm Biofeedback

Combined treatment: Heart rhythm biofeedback plus hydrogen water COMBINATION_PRODUCT

This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.

Heart Rhythm Biofeedback; Hydrogen Water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-65. - BMI\>30.

You may not qualify if:

• Other major medical condition or regular medication that produces fatigue. No home computer or internet access. No smart phone.

Sponsors & Collaborators

• Stony Brook University: lead
• Natural Wellness Now Health Products: collaborator

Study Sites (1)

Fred Friedberg

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Water

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• FRED FRIEDBERG, Phd

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FRED FRIEDBERG, PhD

CONTACT

6316381931; fred.friedberg@stonybrookmedicine.edu

Daniel Gordon, BA

CONTACT

6316380056

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: May 23, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

US (1)