Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children.
研究概览
简要总结
It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital.
Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, aged 2 to 6 years old, requiring a polysomnography or admitted for intense snoring or suspected sleep apnea
- •Parents must have signed the inform consent form and be covered by the National Health Insurance Program.
排除标准
- •Parents opposed to the study.
结局指标
主要结局
Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children.
时间窗: 1 night
* Standard polysomnography considered pathological if obstructive apnea-hypopnea index (AHI) \> 5 / hr. * Home polysomnography considered pathological if at least one of the following criteria is present : 1. Respiratory Disturbance Index (RDI) \> 10 / hr + /- Desaturation Index \> 4% for more than 2.5 / hr. 2. Brouillette index ; pulse wave \> 3 desaturation clusters and \> 3 desaturation \<90%.
次要结局
- To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography.(1 night)