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临床试验/NCT07345312
NCT07345312招募中不适用

The Use of the BodySleep Algorithm (ResMed) for the Diagnosis of Obstructive Sleep Apnea Syndrome in Children

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Obstructive apnea-hypopnea index by BodySleep in comparison with OAHI by PSG

研究概览

简要总结

Diagnosing obstructive sleep apnea-hypopnea syndrome in children (OSA) requires the performance of polysomnography (PSG) in the hospital which is sometimes challenging to perform in children, and time-consuming for installation and analysis. Simplified recording and analysis methods are preferable in children but require validation in this population.

The BodySleep automatic algorithm of the polysomnograph used in our lab (A1-Nox, ResMed) associated only with respiratory signals could be used to identify respiratory events. Thus the child would have fewer sensors installed on him.

详细描述

The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSA) requires the performance of polysomnography (PSG) in the hospital with video surveillance and monitoring by a nurse to put the sensors back on the child if necessary. During the night. The PSG gives the index of obstructive apnea-hypopnea (IAHO) necessary for the diagnosis of OSAS and to determine its severity. But the PSG is a rather cumbersome examination, sometimes challenging to perform in children, with several sensors and electrodes to install (electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), necessary to determine the periods of wakefulness -sleep and intra-sleep micro-arousals, nasal cannula, thoracoabdominal straps, pulse oximetry, actimetry to score respiratory events), time-consuming for installation and analysis. Simplified recording and analysis methods are preferable in children but require validation in this population.

The BodySleep automatic algorithm of the polysomnograph used in our service (A1-Nox, ResMed) combines actigraphy data (body position during sleep) and induction plethysmography signal resulting from the thoracoabdominal belts to identify sleep-wake stages could be used instead of EEG, EOG and EMG electrodes. The BodySleep algorithm associated only with respiratory signals (nasal cannula, thoracoabdominal straps, pulse oximetry, actimetry) could be used to identify respiratory events. Thus the child would have fewer sensors installed on him.

The hypothesis of this study is that the BodySleep algorithm associated with respiratory signals can identify OSA in children.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Children suspected of OSA who are addressed for a PSG by the ear nose throat physician, pediatric pulmonologist, neurologist, psychiatrist, sleep specialist, genetics, and nutritionist physician.
  • Age between 2 and 18 years

排除标准

  • Age under 2 years and over 18 years

结局指标

主要结局

Obstructive apnea-hypopnea index by BodySleep in comparison with OAHI by PSG

时间窗: One night

To determine if the obstructive apnea-hypopnea index (OAHI) obtained by the BodySleep algorithm is underestimated in comparison with the OAHI obtained by the PSG

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

研究点 (1)

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