Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study at Home - Differences Between Monosymptomatic Nocturnal Enuresis Patients and Healthy Controls
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sleep efficiency
研究概览
简要总结
Full ambulatory polysomnography at home performed two nights in 30 healthy children and one night in 30 children with mono-symptomatic nocturnal enuresis (15 with polyuria and 15 without polyuria). The children will be aged 7-14 years of age.
The sleep will be evaluated on sleep quality, number of periodic limb movements per hour, blood pressure and pulse, beat to beat variation by electrocardiography during sleep, respiration during sleep, nocturnal urine production, and enuresis episodes.
详细描述
Purpose and perspectives:
The purpose of the study is to investigate the quality of sleep, the sleep architecture and the intra-individual variation from night to night in healthy children and children with mono-symptomatic nocturnal enuresis (MNE) using full polysomnography at home.
Hypotheses:
- There is large intra-individual night to night variation in sleep quality and architecture.
- Children with MNE have different sleep architecture than healthy children when looking at sleep quality and arousals.
- Periodic limp movements at sleep is more frequent in children with MNE than in healthy children.
Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •7-14 years of age
- •Normal objective evaluation including blood pressure
- •For healthy controls achieved continence both day and night before the age of
- •For children with nocturnal enuresis at least 3 wet nights per week.
- •For children with enuresis clinical characteristics and at least one week of home recordings of nocturnal urine production and two days of full recording of fluid intake and urine production.
排除标准
- •Obstipation (according to ROM IV criteria)
- •Day incontinence or severe urgency
- •Insomnia or known sleep disorders such as sleep walking, heavy snoring, night terrors or abnormal circadian rhythm.
- •Present or former deceases in the urinary tract, liver or in the endocrinological system.
- •Hypertension
- •Treatment with medication at the time of the study
- •ADHD, autism or other psychiatric disorders.
结局指标
主要结局
Sleep efficiency
时间窗: One night of polysomnography.
Sleep efficiency will be calculated as the ratio of the total time spent asleep to the total time spent in bed
次要结局
- Periodic limb movements during sleep(One night of polysomnography.)
- Enuresis episodes(One night of polysomnography)
- Intra-individual differences in periodic limb movements during sleep from night to night in healthy controls.(Two nights of polysomnography. Each evaluated after completing the two nights.)
- Intra-individual differences in nocturnal urine production from night to night in healthy controls.(Two nights of polysomnography. Each evaluated after completing the two nights.)
- Nocturnal urine production(One night of polysomnography.)
- Respiratory events during sleep(One night of polysomnography)
- Incidence of sleep disturbances(One night of polysomnography)
- Intra-individual differences in sleep efficiency from night to night in healthy controls.(Two nights of polysomnography. Each evaluated after completing the two nights.)
- Intra-individual differences in respiratory events from night to night in healthy controls.(Two nights of polysomnography. Each evaluated after completing the two nights.)