Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
NCT ID: NCT05397626
Last Updated: 2022-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
39 participants
INTERVENTIONAL
2022-05-23
2023-05-23
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Hydrogen Water
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
This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.
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.
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
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.
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.
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
Hydrogen Water
Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome
Interventions
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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
Hydrogen Water
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
This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Natural Wellness Now Health Products
UNKNOWN
Stony Brook University
OTHER
Responsible Party
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Fred Friedberg
Principal Investigator
Principal Investigators
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FRED FRIEDBERG, Phd
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University
Locations
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Fred Friedberg
Stony Brook, New York, United States
Countries
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Central Contacts
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Daniel Gordon, BA
Role: CONTACT
Phone: 6316380056
Facility Contacts
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FRED FRIEDBERG, PhD
Role: primary
Other Identifiers
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AWD00002822
Identifier Type: -
Identifier Source: org_study_id