The Efficacy of the Nanit-Insights App in Improving Infant Sleep

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy of the Nanit-Insights App in Improving Infant Sleep: A Randomized Controlled Trial

Conditions
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Infant Sleep Problems

Intervention / Treatment
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* Behavioral: Nanit-Insights


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nanit-Insights intervention group<br>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. | Behavioral: Nanit-Insights<br>* Nanit-Insights is an app-based intervention that provides personalized sleep tips to parents.<br>|
| No Intervention: Nanit-monitor control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Infant sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups. | 
| Change from baseline in infant sleep efficacy at 3 and 6 months follow-up: Videosomnography | 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. | Infant sleep efficacy will be assessed at baseline, and at 3- and 6-month follow-ups. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in parent sleep quality as assessed using the Pittsburgh Sleep Quality Index at 3 and 6 month follow ups. | Change from baseline in parent-reported sleep quality using the Pittsburgh Sleep Quality Index (PSQI) at 3 and 6 month follow ups. The PSQI is comprised of 10 questions, from which the following subscales are generated: sleep latency, sleep duration, sleep disturbances, and daytime-dysfunction. Items are open-ended or rated on a 4-point scale, and higher scores represent poorer sleep. | 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. | Change from baseline in parent-reported mood using the Clinically Useful Depression Outcome Scale (CUDOS) at 3 and 6 month follow ups. Each of the 18 items in the CUDOS is rated on a 5-point scale, with higher ratings indicating poorer mood. Ratings on all items are summed to create a total score. | 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 | Change from baseline in videosomnography metric of sleep onset latency at 3 and 6 months follow-up. Infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm. | 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 | Change from baseline in videosomnography metric of sleep duration at 3 and 6 months follow-up. Infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm. | 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 | Change from baseline in videosomnography metric of number of night-wakings at 3 and 6 months follow-up. Infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm. | 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 | Change from baseline in videosomnography metric of number of time out of bed at 3 and 6 months follow-up. Infant sleep will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm. | 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 | Change from baseline in videosomnography metric of parental nightly visits to the crib at 3 and 6 months follow-up. Parental visits to the infant in the crib will be assessed for 10 consecutive nights using the Nanit videosomnography camera and algorithm. | Infant time out of bed will be assessed at baseline, and at 3- and 6-month follow-ups. |