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临床试验/NCT06696196
NCT06696196已完成不适用

Validation of Sleep Monitoring Algorithm Based on Smart Watches

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年12月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
sleep stages derived from smartwatch

研究概览

简要总结

In recent years, wearable devices are booming to enable not only the health monitoring but also the sleep efficiency assessment. To validate the algorithm of sleep staging and efficiency, this study will use a dedicated prototype to acquire photoplethysmogram (PPG), body movements, skin temperature, and galvanic skin response by recruiting 35 subjects. PSG will be used as gold standard for statistical analysi.

详细描述

Sleep efficiency has a great impact on the performance of work and learning during the day. If persons lack of sleep for a long time, they might be prone to memory loss and emotional instability. Traditionally, polysomnography (PSG) has been proved as golden results to assess the sleep efficiency. However, to accomplish the assessment, subjects are asked to sleep in a certified sleep laboratory or a sleep centers for nights. Under the supervision of nurses, subjects are put many adhesive electrodes on the body and connect wires to PSG, which causes discomfort. In recent years, wearable devices are booming to enable not only the health monitoring but also the sleep efficiency assessment. To validate the algorithm of sleep staging and efficiency, this study will use a dedicated prototype to acquire photoplethysmogram (PPG), body movements, skin temperature, and galvanic skin response by recruiting 35 subjects. PSG will be used as gold standard for statistical analysi.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Forty male or female subjects are recruited from those visiting Department of Medicine for health check up
  • •Subjects aged 20 to 65

排除标准

  • •Refuse to participate
  • •Active infection
  • •Active neurologic event
  • •Shift worker
  • •Substance abuse
  • •Fitted with implantable medical electronics, such as cardiac pacemakers and defibrillators

研究组 & 干预措施

smart watch

Experimental

This study will use a prototype (MediaTek Sleep Watch) to acquire PPG, body movements, skin temperature, and skin conductance to validate the algorithm of sleep staging and sleep efficiency assessment. PSG will be used as gold standard for statistical analysis.

干预措施: smart watches(wearable devices) (Device)

结局指标

主要结局

sleep stages derived from smartwatch

时间窗: 12 months

Comparing sleep stages detected by a smartwatch(hh:mm) with the sleep stages of an overnight PSG(N1 (%), N2 (%), N3 (%), REM(%), Arousal index (/h) to validate the effectiveness of the smartwatch.

次要结局

  • sleep efficiency derived from smartwatch(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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