Pediatric Polysomnography at Home: Feasibility, Quality, and Satisfaction in Normal Children and Children With Neurodevelopmental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 563
- 试验地点
- 1
- 主要终点
- Acceptability of Home Unattended Polysomnography
研究概览
简要总结
Laboratory polysomnography is the gold standard for objective sleep measurement. With hospital waiting times becoming increasingly long, outpatient polysomnography seems a good solution. Children are at greater risk of developing sleep disorders and polysomnography in the hospital laboratory can be a stressful examination for these children and their parents. This can be even more the case in populations of children with neurodevelopmental disorders, such as Attention Deficit Disorder with or without Hyperactivity (ADHD), or dys- learning disorders. Several studies have already demonstrated the feasibility of ambulatory, in a home setting, polysomnography in children. The objective of this study is to demonstrate the acceptability and satisfaction of performing polysomnography at home on a large cohort of children, including children with neurodevelopmental disorders.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All consecutive children who underwent a H-PSH
- •Age beetween 2 and 17 years old
排除标准
- •No signed informed consent form for study participation
结局指标
主要结局
Acceptability of Home Unattended Polysomnography
时间窗: One day after the polysomnography
Parents and children completed 10 cm visual analog scales (VAS) to assess their satisfaction with the home recording (scored from 0 (not enjoyed) to 10 (very satisfied) and preference for home versus laboratory PSG (scored from 0 preference for H-PSG to 10 preference for L-PSG).
次要结局
- REM latency assessed by Polysomnography.(One night of polysomnography.)
- List of symptoms prompting polysomnographic examination(During the polysomnography analysis)
- Global signal quality across all channels of the polysomnographic recording.(One night of polysomnography.)
- SpO₂ signal quality of the polysomnographic recording.(One night of polysomnography.)
- Nasal cannula signal quality of the polysomnography recording.(One night of polysomnography.)
- RIP (Respiratory Inductance Plethysmography) quality of the polysomnography recording.(One night of polysomnography.)
- Sleep latency assessed by Polysomnography.(One night of polysomnography.)
- Sleep Efficiency assessed by Polysomnography.(One night of polysomnography.)
- Arousal Index assessed by Polysomnography.(One night of polysomnography.)
- Sleep Stage Distribution assessed by Polysomnography(One night of polysomnography.)
- Number of Periodic Limb Movements per Hour of Sleep (PLMS Index), measured by Polysomnography.(One night of polysomnography.)
- Respiratory events during sleep assessed by Polysomnography(One night of polysomnography.)