NCT01925430已完成不适用
The Evaluation of a New Sleep/Wake State Algorithm
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Total sleep time
研究概览
简要总结
A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. This prototype will be compared against a commercially available device which monitors sleep/wake patterns. Volunteers will be asked to wear the prototype and comparative devices for 1-2 nights. The data from both devices will be downloaded after the completion of the study and analysis wil be performed to compare the two recordings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •=> 18yrs old
- •can read and write English
- •Provide informed written consent
排除标准
- •Unable to participate for the full duration of the study
- •An individual who is deemed unsuitable to participate in the opinion of the investigator
结局指标
主要结局
Total sleep time
时间窗: 12 hrs
To measure the total sleep time recorded and analysed on the device using the new algorithm
次要结局
- Frequency of arousals during sleep(12 hrs)
- Duration of arousals during sleep(12 hrs)
- Occurrence of arousals during sleep(12 hrs)
研究者
研究点 (1)
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