Effects of Bladder Voiding on Sleep Architecture in Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Occurrence of arousals / awakenings in a timely relation with bladder voiding.
研究概览
简要总结
Sleep changes rapidly during the first year of life. Brain maturation is accompanied by sleep consolidation in several episode during day and night (daytime naps and night sleep) and progressive organization during the 24h period (more wake during day et more sleep during night). In the first months of life, sleep episodes are frequently interrupted by wake, possibly induced by multiple external and internal stimuli. One of this stimulus could be bladder voiding that is particularly frequent in babies. Only one team worked on the link between sleep and bladder voiding and reported that bladder voiding was associated with cortical arousal during a daytime nap in a little group of babies.
In this study, investigators propose to study the relationship between sleep and bladder voiding in a bigger group of infant and during daytime but also nighttime sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants of both sex
- •Age ≥1 month and ≤ 12 months
- •Referred to the sleep unit for sleep trouble screening following ALTE (Apparent Life Threatening Event).
- •Patients should benefit from appropriate insurance system
- •Parents who have expressed a willingness to participate in the study, who have signed and dated the informed consent.
排除标准
- •Neurological, endocrinal or syndromic diseases :
- •Head and neck congenital malformations
- •Pierre Robin Syndrome
- •Achondroplasia
- •Prader Willy syndrome
- •Ondine syndrome
- •Cardiac diseases and malformations
- •Weight <2.5 kg
- •Preterm babies (under 37 weeks of gestational age)
研究组 & 干预措施
Babies hospitalized in the pediatric sleep unit
干预措施: Study of the effect of bladder voiding on sleep fragmentation during day and night sleep (Other)
结局指标
主要结局
Occurrence of arousals / awakenings in a timely relation with bladder voiding.
时间窗: 24 hours
The occurrence of arousals and awakenings will be determined form polysomnography signals including electroencephalogram (EEG), electrooculogram (EOG) and a electromyogram (EMG). Arousals and awakenings will be scored as defined by the international rules for visual scoring of EEG (AASM manual 2007). Investigators will calculate the percentage of bladder voiding episode leading to arousal / awakening events
次要结局
- Activity record with actigraphy in babies(24 hours)
- Sleep stage following bladder voiding events(24 hours)
- Heart rate following bladder voiding episode(24 hours)
- EEG frequencies following bladder voiding episodes(24 hours)