Heart Rate Variability as an Autonomic Marker of Improvement in ME/CFS in a Hydrogen Water Treatment Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
The goal of this clinical trial is to learn if the OTC supplement, hydrogen water, works to treat the fatigue-related symptoms and functional limitations in adults with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). It will also examine if heart rate variability (HRV) can be used to predict who will benefit from the hydrogen water treatment. The main questions it aims to answer are:
Does the OTC supplement, hydrogen water, work to reduce the fatigue-related symptoms and improve functioning in participants who have ME/CFS?
Can HRV be used to predict who will benefit from treatment with hydrogen water?
详细描述
The purpose of this pilot study is to identify a biomarker for improvement in chronic fatigue syndrome. Treatment of ME/CFS starting on 10-day graduated dosing schedule followed by a standard daily dose of hydrogen water (a magnesium-based OTC supplement) over 16 weeks is expected to yield two subgroups, improvers and non-improvers. These subgroups will be delineated by heart rate variability (HRV), a biological measure of health and well-being. Higher HRV will predict improvement and lower HRV will predict non-improvement (no change or worsening). This would be the first biomarker of improvement found in ME/CFS. If treatment is successful, subjects will experience a reduction in fatigue and an increase in physical function. Thus, the study may advance potentially an effective intervention for individuals with ME/CFS and further the understanding of the biology of favorable treatment outcomes, i.e., improved HRV status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Meets Institute of Medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome -
排除标准
- •Medical illness that explains presenting fatigue; Any psychosis.
研究组 & 干预措施
Hydrogen water standard dosage
The intervention is hydrogen water which is prepared from an OTC supplement. Hydrogen water is a strong anti-oxidant.
干预措施: Hydrogen water which is prepared from an OTC supplement. (Dietary Supplement)
结局指标
主要结局
Fatigue Severity Scale
时间窗: 12 months
This is a validated self-report measure of the effect of fatigue on functioning.
次要结局
未报告次要终点
研究者
Fred Friedberg
Principal Investigator
Stony Brook University