NCT04508595Unknown不适用
The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance
Tanzen Medical Inc1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年8月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Algorithm
研究概览
简要总结
This observational study will test and evaluate the RestEaze ambulatory sleep monitor for the detection and classification of leg movements during sleep (LMS) and other sleep measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 5 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages between 5 -75
- •General good health and ambulatory
- •Sleep complaint or other diagnosis that affects sleep (e.g. ADHD) with likely concomitant abnormal LMS requiring either HST or PSG
- •Reports no significant problems sleeping in a new bed and bedroom away from home
- •(If applicable) Parent or guardian available to spend the night with the child during the sleep study
排除标准
- •Amputation that would preclude use of wrist actigraph or the RestEaze device
结局指标
主要结局
Algorithm
时间窗: 1 year
Development of analysis tools to validate RestEaze as a biomarker of leg movements of sleep
次要结局
未报告次要终点
研究者
研究点 (1)
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