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Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

Phase 1

Waitlist Available

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

No Placebo-Only Group

Summary

This trial is testing two new home-based treatments for chronic fatigue syndrome: a breathing exercise technique called heart rate variability biofeedback (HRV-BF) and drinking water with extra hydrogen. HRV-BF helps people relax and manage stress, while hydrogen water might reduce harmful substances in the body and boost energy. The goal is to see if these methods can help people with chronic fatigue syndrome feel better.

Eligible Conditions

Chronic Fatigue Syndrome (CFS)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fatigue Severity Scale

Secondary study objectives

Brief Resilience Scale

Depression, Anxiety and Stress Scale

Short Form-36 Physical Function Subscale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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