Assessing SleeP IN Infants With Early-onset Atopic Dermatitis by Longitudinal Evaluation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Altered macrostructure of sleep from 6 to 12 months measured with parental sleep diaries
研究概览
简要总结
The SPINDLE study will examine sleep in infants with atopic dermatitis by serial assessment over the first year of life, in comparison to infants without atopic dermatitis. Sleep will be assessed using electroencephalography, actigraphy, and sleep questionnaires.
详细描述
Infants will be recruited at 6 to 8 months and followed up until 18 months of age. Sleep electroencephalography will be performed at 6 to 8 months. Sleep actigraphy will be performed at 6 to 8 months and 12 months. Infant sleep questionnaires will be completed on a monthly basis, and parental sleep questionnaires will be completed at 6 to 8 months, 9 to 10 months, and 12 months. A neurodevelopmental assessment will be performed at 18 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate to severe atopic dermatitis
排除标准
- •Premature birth (under 37 weeks gestation)
- •Severe medical condition (such as epidermolysis bullosa or ichthyosis) at time of enrolment that would complicate assessment for AD or preclude the use of investigational tools, or other major health problems (especially genetic or metabolic) that would have implications for neurodevelopment
- •Any medical condition requiring the using of sedating medications (eg antihistamines)
结局指标
主要结局
Altered macrostructure of sleep from 6 to 12 months measured with parental sleep diaries
时间窗: 6 months to 12 months
Measured as decreased sleep efficiency and increased night time awakenings
Altered macrostructure of sleep at 6 and 12 months measured by nocturnal actigraphy
时间窗: 6 months, 12 months
Measured as sensor-detected movement
次要结局
- Altered microstructure of sleep at six-eight months using electroencephalography to measure sleep spindle power in rapid eye movement and non-rapid eye movement stages(6-8 months)
- Parental sleep quality and quality of life measured using the Pittsburgh Sleep Quality Index (PSQI)(6 months to 12 months)