Environmental Risk Factors for Pediatric Sleep Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
In this research study, investigators want to learn more about the factors that influence children's breathing during sleep and their sleep quality. Specifically, investigators are interested in factors that are related to risk of snoring, sleep apnea (a condition where breathing stops during sleep), and poor sleep quality.
详细描述
Investigators are doing a research study to gather information to help better understand why snoring and sleep problems are so common in the community, and how the home and neighborhood environment impacts sleep in children. Investigators want to know if factors such as the quality of air, household dust, environmental noise, and family routines impact sleep and other health and behavioral factors associated with sleep.
Investigators want to test how sleep is influenced by factors such as: the quality of air inside and outside the child's home (including measuring pollution, second hand smoke, and dust); temperature and humidity; family routines and interactions; and characteristics of the home. Investigators will ask participants to come in for a one time visit for undergoing procedures as well as answering questions regarding general health, asthma and sleep. 10% of the participating children will have a second home assessment and sleep monitoring procedures performed 6 months after the initial home assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-12 years
- •Children living (50% of the time or more) at their current residence for at least 1 month
排除标准
- •Children with severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
- •Children with severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
- •Children living in the current residence for < 1 month will be not be eligible.
- •Families who do not speak English or Spanish well enough to complete the neuropsychological measures, as validated versions in other languages are not available for all of the measures.
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: 7days
Estimated Apnea and Hypopnea Indices, % recording time snoring using the EMFIT QS under mattress sensor.
次要结局
- sleep duration and sleep efficiency(7 days)
- Sleepiness Quality of Life(7 days)
- Quality of Life score(7 days)
研究者
Wanda Phipatanakul
Professor of Pediatrics
Harvard Medical School (HMS and HSDM)