NCT04249011已完成不适用
Assessment of Sleep-related Respiratory Disorders at High Altitude With the WatchPAT200TMU Compared to PSG.
Itamar-Medical, Israel1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年5月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG.
研究概览
简要总结
Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'.
详细描述
The efficacy of the WP200U will be evaluated by comparing it to the PSG manual scoring of sleep disordered breathing (SDB) parameter using the PSG manual scoring as a "gold standard"
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and females ≥ age 17yrs
- •Subject is able to read understand and sign the informed consent form.
- •Willing to sleep with the WP200U and PSG simultaneously in the sleep lab.
排除标准
- •Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).
- •Any condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient ability to complete the study.
结局指标
主要结局
Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG.
时间窗: 8 months.
次要结局
未报告次要终点
研究者
研究点 (1)
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