Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
试验速览
- 阶段
- 1 期
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-
排除标准
- •Other major medical condition or regular medication that produces fatigue. No home computer or internet access. No smart phone.
结局指标
主要结局
Fatigue Severity Scale
时间窗: 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.
次要结局
- Depression, Anxiety and Stress Scale(8 weeks)
- Brief Resilience Scale(8 weeks)
- Short Form-36 Physical Function Subscale(8 weeks)
研究者
Fred Friedberg
Principal Investigator
Stony Brook University