Chronic Fatigue SyndromePhase 1NCT05397626
Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
A Phase 1 study testing Heart Rhythm Biofeedback, Hydrogen Water and Combined treatment: Heart rhythm biofeedback plus hydrogen water in people with Chronic Fatigue Syndrome, run by Stony Brook University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Heart Rhythm Biofeedback, Hydrogen Water and Combined treatment: Heart rhythm biofeedback plus hydrogen water
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2022to 23 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-65. - BMI>30.
Who cannot join
- Other major medical condition or regular medication that produces fatigue. No home computer or internet access. No smart phone.
Trial locations and contacts
1 site in 1 country.
Daniel Gordon, BA contact
United States1 site, 1 recruiting
- Recruiting
Fred Friedberg
Stony Brook, New York, 11794
FRED FRIEDBERG, PhD, 631-638-1931, fred.friedberg@stonybrookmedicine.edu
Fred Friedberg, PhD
About this study
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.
Read the 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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Heart Rhythm Biofeedback, Hydrogen Water, Combined treatment: Heart rhythm biofeedback plus hydrogen water
- Keywords
- Heart Rhythm Biofeedback; Hydrogen Water
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rhythm BiofeedbackBehavioural
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 WaterDietary 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 waterCombination product
This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Heart Rhythm Biofeedback; Dietary Supplement: Hydrogen Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start23 May 2022
- Primary completion23 May 2023 (estimated)
- Study completion23 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Wellness Now Health Products
- Responsible party
- Principal investigator, Fred Friedberg, Stony Brook University
- Investigators
- FRED FRIEDBERG, Phd, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397626
- Sponsor's protocol ID
- AWD00002822
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT05397626
- Acronym / sponsor ID
- AWD00002822
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Heart Rhythm Biofeedback; Hydrogen Water
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Natural Wellness Now Health Products
- Study start
- 23 May 2022 (actual)
- Primary completion
- 23 May 2023 (estimated)
- Study completion
- 23 May 2023 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Heart Rhythm Biofeedback | Active comparator | Dietary Supplement: Hydrogen Water, Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen waterHeart 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 | Active comparator | Behavioral: Heart Rhythm Biofeedback, Combination Product: Combined treatment: Heart rhythm biofeedback plus hydrogen waterHydrogen 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. |
| Combined treatment: Heart rhythm biofeedback plus hydrogen water | Active comparator | Behavioral: Heart Rhythm Biofeedback, Dietary Supplement: Hydrogen WaterThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-65. - BMI>30.
Key exclusion criteria (1 listed)
- Other major medical condition or regular medication that produces fatigue. No home computer or internet access. No smart phone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rhythm BiofeedbackHeart rhythm biofeedback is a non-invasive intervention intended to improve heart rate variability and physical resilience that is often limited in chronic fatigue syndrome | Behavioural | Combined treatment: Heart rhythm biofeedback plus hydrogen water, Hydrogen Water |
| Hydrogen WaterHydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome | Dietary supplement | Combined treatment: Heart rhythm biofeedback plus hydrogen water, Heart Rhythm Biofeedback |
| Combined treatment: Heart rhythm biofeedback plus hydrogen waterThis treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water. | Combination product | Heart Rhythm Biofeedback, Hydrogen Water |
Primary outcome
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.
3 secondary outcomes
Short Form-36 Physical Function Subscale
Time frame: 8 weeks
Depression, Anxiety and Stress Scale
Time frame: 8 weeks
Brief Resilience Scale
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Gordon, BA contact
FRED FRIEDBERG, Phd principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Heart Rhythm Biofeedback, Hydrogen Water and Combined treatment: Heart rhythm biofeedback plus hydrogen water in people with Chronic Fatigue Syndrome, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FRED FRIEDBERG, PhD (6316381931, fred.friedberg@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.