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临床试验/NCT04326127
NCT04326127已完成不适用

Performance Evaluation of the Compumedics "Somfit" Sleep Monitoring Device

Compumedics Limited1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11月6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
30
试验地点
1
主要终点
Comparison between raw EEG signals

研究概览

简要总结

To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.

详细描述

Sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). Poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. Given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. However, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (PSG) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. This will cause discomfort for the patients in a long run. To solve this problem, Compumedics has recently developed a miniaturized, portable and affordable sleep monitoring system with code name of "Somfit" which can be used in the comfort of patients' home. The aim of this study is to validate Somfit for home based sleep studies.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals age between 18 to 75
  • Be able to give informed consent
  • Individuals with diagnosed Obstructive Sleep Apnoea (OSA)

排除标准

  • Less than 18 years of age
  • Greater than 75 years of age
  • Unable or not willing to provide informed consent
  • Need for nursing care
  • Currently working nightshift

结局指标

主要结局

Comparison between raw EEG signals

时间窗: single night recording for each subject

Direct comparison of Raw EEG data between Somfit and Grael system on an epoch by epoch basis (with each epoch being equivalent to 30 secs) to test and validate Somfit for data acquisition, display and record of Raw EEG data.

次要结局

  • Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram(single night recording for each subject)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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Evaluation of Compumedics "Somfit" Device | 临床试验