Sleep Behaviors in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach
研究概览
简要总结
The researchers would like to know how long pregnant women spend in different positions during the night - and how often women change positions - across pregnancy. The researchers also want to see if the sleep monitor is able to improve sleep behaviors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 28 weeks pregnant
- •Receiving pre-natal care at Michigan Medicine
- •Have either and Android or iPhone smartphone
排除标准
- •Less then 28 weeks pregnant
- •Receiving pre-natal care external to Michigan Medicine
- •Does not poses a smartphone
研究组 & 干预措施
Active device
Wear active device for remainder of pregnancy (including 3 day run-in period)
干预措施: Active Pregnancy Coach (Device)
Deactivated device
Wear deactivated pregnancy coach device for the remainder of pregnancy.
干预措施: Deactivated Pregnancy Coach (Device)
结局指标
主要结局
Proportion of sleep time spent in the supine position as measured by the Pregnancy Coach
时间窗: Until delivery, approximately 12 weeks
Will be conducted using the naturalistic arm (deactivated device). Simple descriptive statistics to report the average number of minutes and the average proportion of supine sleep per week.
次要结局
- Proportion of participants where their 'going to sleep' position was the same as their dominant sleep position(Until delivery, approximately 12 weeks)
- Proportion of sleep time spent with objective snoring as indicated by the Pregnancy Coach(Until delivery, approximately 12 weeks)
- Percentage of sleep position changes following alert from Pregnancy Coach(Until delivery, approximately 12 weeks)
研究者
Louise O'Brien
Research Associate Professor, Neurology, Research Associate Professor, Obstetrics and Gynecology, Medical School and Associate Research Scientist, Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry
University of Michigan