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临床试验/NCT04755504
NCT04755504已完成不适用

The Development of an Algorithm to Detect Sleep Structure With a Wearable EEG Monitor in an Elderly Population

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月21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
100
试验地点
1
主要终点
Sleep algorithm

研究概览

简要总结

To evaluate whether it is able to perform sleep staging with EEG data recorded from 2 electrodes behind each ear.

详细描述

The Sensor Dot wearable device measures electroencephalography (EEG). It records from 2 electrodes behind each ear. The device was designed as a wearable for seizure detection in epilepsy patients. The purpose of this study is to test its ability to capture the information necessary for sleep monitoring in elderly patients. Trained electrophysiologists are unable to stage sleep on data from novel wearable devices, since AASM sleep scoring rules are only defined for standardized recording positions on the head. Therefore, we need an automated algorithm to perform sleep staging with data from the Sensor Dot device. We will train this algorithm using manual annotations made with the polysomnography simultaneously acquired with the wearable EEG.

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

入选标准

  • •Subjects planned to undergo a diagnostic polysomnography
  • •> 60y old

排除标准

  • •Patients unable to provide informed consent

研究组 & 干预措施

EEG evaluation

Experimental

All patients will be evaluated during 1 night by standard polysomnography and additionally EEG will be evaluated by 2 electrodes behind each ear connected to a recording device (Sensor Dot)

干预措施: EEG behind the ear (Diagnostic Test)

结局指标

主要结局

Sleep algorithm

时间窗: 1 night

To develop an algorithm to characterize sleep architecture based on EEG measurement by 2 electrodes behind each ear. To classify the sleep stages, a deep learning algorithm will be used. The algorithm will learn a complex function, transforming an input to an output, based on several examples. In this specific case, the input are 30s EEG epochs and the output are sleep stages. To classify the measured signal in the correct sleep stage, the deep learning algorithm will learn to extract useful features from the data.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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