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Hydrogen Water for Chronic Fatigue Syndrome

Phase 1
Recruiting
Led By FRED FRIEDBERG, Phd
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will study the potential benefits of two non-invasive interventions, heart rate variability biofeedback and OTC supplement hydrogen water, for chronic fatigue syndrome symptoms.

Eligible Conditions
  • Chronic Fatigue Syndrome (CFS)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigue Severity Scale
Secondary outcome measures
Brief Resilience Scale
Depression, Anxiety and Stress Scale
Short Form-36 Physical Function Subscale

Trial Design

3Treatment groups
Active Control
Group I: Hydrogen WaterActive Control2 Interventions
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.
Group II: Combined treatment: Heart rhythm biofeedback plus hydrogen waterActive Control2 Interventions
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.
Group III: Heart Rhythm BiofeedbackActive Control2 Interventions
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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Who is running the clinical trial?

Natural Wellness Now Health ProductsUNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
Stony Brook UniversityLead Sponsor
213 Previous Clinical Trials
39,488 Total Patients Enrolled
FRED FRIEDBERG, PhdPrincipal InvestigatorStony Brook University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to geriatric individuals for this clinical trial?

"The age requirements are clearly outlined in the eligibility criteria, with a minimum of 18 years and an upper limit of 65."

Answered by AI

Can I join this clinical trial?

"This medical trial will admit 39 individuals afflicted with a chronic fatigue-related syndrome, aged 18 to 65. Prospective patients must have been diagnosed with either chronic fatigue or a similar disorder and possess a BMI greater than 30."

Answered by AI

Has the FDA certified Hydrogen Water for general consumption?

"Since this is an initial assessment of Hydrogen Water, and data pertaining to safety and efficacy are scarce, the safety rating was set at 1 out of 3."

Answered by AI

How many participants are included in the analysis of this research?

"Affirmative. Clinicaltrials.gov shows that, since its first posting on May 23rd 2022, this research project is recruiting 39 individuals from 1 centre. The data was last refreshed on 5/25/2022."

Answered by AI

Is enrollment still taking place for this research endeavor?

"Affirmative. As per the information available on clinicaltrials.gov, enrollment for this trial is ongoing since its initial posting on May 23rd 2022 and most recently updated on May 25th 2022. 39 patients are being sought out from a single medical institution."

Answered by AI

Who else is applying?

What state do they live in?
Delaware
What site did they apply to?
Fred Friedberg
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
Fred Friedberg 2022. "Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05397626.
All > Me Cfs > Chronic Fatigue Syndrome
~13 spots leftby Apr 2025
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