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临床试验/NCT01925430
NCT01925430
已完成
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The Evaluation of a New Sleep/Wake State Algorithm

ResMed1 个研究点 分布在 1 个国家目标入组 36 人2013年11月
适应症Healthy

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Healthy
发起方
ResMed
入组人数
36
试验地点
1
主要终点
Total sleep time
状态
已完成
最后更新
12年前

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.

注册库
clinicaltrials.gov
开始日期
2013年11月
结束日期
2014年2月
最后更新
12年前
研究类型
Observational
性别
All

研究者

发起方
ResMed
责任方
Sponsor

入排标准

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)

研究点 (1)

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