跳至主要内容
临床试验/NCT04071860
NCT04071860已完成不适用

Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study.

Papworth Hospital NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 445 人开始时间: 2019年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
445
试验地点
1
主要终点
Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography

研究概览

简要总结

Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. In children it may lead to hyperactivity in the day and poor school performance. There are a number of techniques for diagnosing the disorder but they can affect the quality of sleep which sometimes makes them inaccurate. Most are unsuitable for small children who cannot understand the value of the tests and tend to remove the monitoring wires and devices in the night. This study aims to validate a new non contact device "Safescan", based on low power radar technology, which can be put under a bed and record breathing patterns with no measuring device in contact with the sleeper. In this initial study the device will be validated in adults, against the gold standard of polysomnography (PSG) in the sleep laboratory at Royal Papworth Hospital.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older
  • Able to give informed consent

排除标准

  • Patient with known sleep disordered breathing using a treatment device (e.g. continuous positive airway pressure) on the night of the study.
  • Polysomnography study records less than 4 hours of respiratory data

结局指标

主要结局

Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography

时间窗: overnight (8-10 hours)

Agreement in AHI +/- 10% between Safescan device and PSG. A comparison will be made between the 2 AHI's for each participant. The proportion in whom there is an agreement within +/- 10% will be reported.

次要结局

  • Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG(overnight (8-10 hours))
  • Agreement in recorded body position between Safescan device and PSG(overnight (8-10 hours))

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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