The Efficacy of the Nanit-Insights App in Improving Infant Sleep: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change from baseline in parent-reported infant sleep quality at 3 and 6 months follow-up as assessed using the Extended Brief Infant Sleep Questionnaire
研究概览
简要总结
The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep.
详细描述
The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep. The intervention provides parents with daily sleep metrics as well as personalized sleep recommendations, based on their infant's developmental stage and weekly sleep data.
Participants will be parents of 5-7 month-old infants, randomized into one of two groups: (1) the intervention group, which will include users who have purchased the baby monitor without subscribing to Nanit Insights and are then offered a six month subscription to Nanit-Insights when their baby is 5-7 months of age; and (2) the control group, which will include users of the baby monitor, who have not subscribed to Nanit-Insights.
Each group will include approximately 150 families.
Sleep will be assessed at baseline and 3- and 6-months following the beginning of the intervention. Computer vision technology will be used to assess infant sleep, as well as parental adherence to the intervention, allowing us to determine whether adherence mediates sleep benefits.
The results of this study are expected to evaluate the effectiveness of a low-cost, app-based intervention for infant sleep problems. Furthermore, the results may broaden the understanding of the mediating role of parent adherence in such interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant aged 5-7 months
- •Presence of a moderate to severe sleep problem at baseline
- •Sleeping arrangement in which the infant sleeps in a crib at night
排除标准
- 未提供
研究组 & 干预措施
Nanit-monitor control group
Participants in the control group will be given the same monitoring device, that will serve in this group as a baby-monitor only, without providing sleep recommendations to parents.
Nanit-Insights intervention group
Nanit-Insights is an app-based intervention that provides parents with personalized sleep recommendations, based on their infant's developmental stage and weekly sleep data.
干预措施: Nanit-Insights (Behavioral)
结局指标
主要结局
Change from baseline in parent-reported infant sleep quality at 3 and 6 months follow-up as assessed using the Extended Brief Infant Sleep Questionnaire
时间窗: Infant sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in parent-reported sleep quality at 3 and 6 months follow-up using the Extended Brief Infant Sleep Questionnaire. Items in this questionnaire are either open-ended or reported on a 5-point scale, with 1=poor sleep quality and 5=very good sleep quality.
Change from baseline in infant sleep efficacy at 3 and 6 months follow-up: Videosomnography
时间窗: Infant sleep efficacy will be assessed at baseline, and at 3- and 6-month follow-ups.
Change from baseline in videosomnography metric of sleep efficacy at 3 and 6 months follow-up. infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm. Sleep efficacy will be provided using the algorithm.
次要结局
- Change from baseline in parent sleep quality as assessed using the Pittsburgh Sleep Quality Index at 3 and 6 month follow ups.(Parent sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.)
- Change from baseline in parent mood as assessed using the Clinically Useful Depression Outcome Scale at 3 and 6 month follow ups.(Parent mood will be assessed at baseline, and at 3- and 6-month follow-ups.)
- Change from baseline in infant sleep onset latency at 3 and 6 months follow-up: Videosomnography(Infant sleep onset latency will be assessed at baseline, and at 3- and 6-month follow-ups.)
- Change from baseline in infant sleep duration at 3 and 6 months follow-up: Videosomnography(Infant sleep duration will be assessed at baseline, and at 3- and 6-month follow-ups.)
- Change from baseline in infant number of night-wakings at 3 and 6 months follow-up: Videosomnography(Infant number of night-wakings will be assessed at baseline, and at 3- and 6-month follow-ups.)
- Change from baseline in infant time out of bed at 3 and 6 months follow-up: Videosomnography(Infant time out of bed will be assessed at baseline, and at 3- and 6-month follow-ups.)
- Change from baseline in parental "nightly visits" at 3 and 6 months follow-up: Videosomnography(Infant time out of bed will be assessed at baseline, and at 3- and 6-month follow-ups.)
研究者
Michal Kahn
Post-doctoral fellow, Children's Sleep Laboratory
Tel Aviv University