Assessment of Objective Sleep Disturbances in Orthostatic Intolerance Using Actigraphy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sleep Latency
研究概览
简要总结
We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.
详细描述
We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •Diagnosed with orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center
- •Control subjects will be free of orthostatic intolerance and other major medical problems, free of medications during the study
- •Age between 18-65 years
- •Male and female subjects are eligible.
- •Able and willing to provide informed consent
排除标准
- •Overt cause for postural tachycardia (such as acute dehydration)
- •Self-report of pregnancy
- •Inability to give, or withdrawal of, informed consent
- •Other factors which in the investigator's opinion would prevent the subject from completing the protocol
结局指标
主要结局
Sleep Latency
时间窗: 1 week
次要结局
- Wake After Sleep Onset(1 week)
- Sleep Efficiency(1 week)
研究者
Satish R. Raj
Assistant Professor of Medicine & Pharmacology
Vanderbilt University Medical Center