跳至主要内容
临床试验/NCT04759482
NCT04759482Unknown不适用

Validation of an Innovative Algorithm for Screening Sleep Apnea Syndrome From an Electrocardiographic Recording During Sleep

Central Hospital, Nancy, France0 个研究点目标入组 150 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
主要终点
Concordance of the number of sleep hypopnea and apnea between an algorithm computerizing the electrocardiographic signal and the standard interpretation of the polysomnography by an expert in sleep scoring (gold standard)

研究概览

简要总结

Sleep apnea syndrome is a prevalent disease, recognized as an independant risk factor for cardiovascular diseases The gold standard for the diagnosis of sleep apnea is the polysomnography. But polysomnography is time-consuming and very expensive. We developed an algorithm for screening sleep apnea from electrocardiographic signal. This would lead to the simplification of screening sleep apnea by using a two-channels recording device and computerizing the scoring of respiratory events. The validation of the algorithm will consist in comparing the number of apnea and hypopnea per hour of sleep (AHI) detected by the algorithm from the electrocardiographic signal recorded during a standard polysomnography in the Center for Sleep Medicine and Research in Nancy, with the AHI resulted from the standard interpretation of the same polysomnography by experts in sleep scoring (gold standard).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • •all patients with a polysomnography recorded in the Center for Sleep Medecine and Research (CSMR) in Nancy from january 2019 and june 2020
  • •results of standard interpretation of polysomnography giving a number of hypopnea and apnea per hour of sleep (AHI) superior to 5

排除标准

  • •refusal to participate

结局指标

主要结局

Concordance of the number of sleep hypopnea and apnea between an algorithm computerizing the electrocardiographic signal and the standard interpretation of the polysomnography by an expert in sleep scoring (gold standard)

时间窗: 18 months

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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