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