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Recruiting Studies | chronic fatigue syndrome
Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
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| ClinicalTrials.gov Identifier: NCT05397626 |
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Recruitment Status :
Recruiting
First Posted : May 31, 2022
Last Update Posted : May 31, 2022
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Sponsor:
Stony Brook University
Collaborator:
Natural Wellness Now Health Products
Information provided by (Responsible Party):
Fred Friedberg, Stony Brook University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Fatigue Syndrome | Behavioral: Heart Rhythm Biofeedback Dietary Supplement: Hydrogen Water Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen water | Phase 1 |
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 (Clinical Trial) |
| Estimated Enrollment : | 39 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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: | Single (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. |
| Primary Purpose: | Treatment |
| Official Title: | Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome |
| Actual Study Start Date : | May 23, 2022 |
| Estimated Primary Completion Date : | May 23, 2023 |
| Estimated Study Completion Date : | May 23, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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 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. |
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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.
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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 |
Primary Outcome Measures :
- Fatigue Severity Scale [ Time Frame: 8 weeks ]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 [ Time Frame: 8 weeks ]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 [ Time Frame: 8 weeks ]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 [ Time Frame: 8 weeks ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05397626
Contacts
| Contact: FRED FRIEDBERG, PhD | 6316381931 | fred.friedberg@stonybrookmedicine.edu | |
| Contact: Daniel Gordon, BA | 6316380056 |
Locations
| United States, New York | |
| Fred Friedberg | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| Contact: FRED FRIEDBERG, PhD 631-638-1931 fred.friedberg@stonybrookmedicine.edu | |
| Principal Investigator: Fred Friedberg, PhD | |
Sponsors and Collaborators
Stony Brook University
Natural Wellness Now Health Products
Investigators
| Principal Investigator: | FRED FRIEDBERG, Phd | Stony Brook University |
| Responsible Party: | Fred Friedberg, Principal Investigator, Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT05397626 |
| Other Study ID Numbers: |
AWD00002822 |
| First Posted: | May 31, 2022 Key Record Dates |
| Last Update Posted: | May 31, 2022 |
| Last Verified: | May 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Fred Friedberg, Stony Brook University:
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Heart Rhythm Biofeedback; Hydrogen Water |
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic Syndrome Fatigue Disease Pathologic Processes Virus Diseases Infections |
Muscular Diseases Musculoskeletal Diseases Encephalomyelitis Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases |