Multi-Level Assessment of Physiologic Hyper-Arousal in Chronic Primary Insomnia: A Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Systolic Arterial Pressure Reactivity
研究概览
简要总结
The purpose of this study is to determine whether individuals with chronic insomnia disorder have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good sleepers. The primary goal is to perform a rigorous quantitative assessment of physiologic hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass index (BMI) and race/ethnicity.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Systolic Arterial Pressure Reactivity
时间窗: within 2 months after enrollment
Increase in blood pressure to stress
Sympathetic Baroreflex Sensitivity (BRS) Unit
时间窗: 2 months after enrollment
Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode.
次要结局
- Multiple Sleep Latency Test (MSLT)(2 months of enrollment)
- Heart Rate Variability During Wake and During Sleep(2 months after enrollment)
- Electroencephalography (EEG) During Wake and Sleep(2 months of enrollment)
- Noninvasive Beat-to-beat Blood Pressure Monitoring(2 months after enrollment)