Clinical trial NCT03640533: The Efficacy of the Nanit-Insights App in Improving Infant Sleep
Official title: The Efficacy of the Nanit-Insights App in Improving Infant Sleep: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infant Sleep Problems
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Flinders University
name: UdiSense Inc.
First posted: 2018-08-21
Enrollment: 37
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: 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
timeFrame: Infant sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.
measure: Change from baseline in infant sleep efficacy at 3 and 6 months follow-up: Videosomnography
timeFrame: Infant sleep efficacy will be assessed at baseline, and at 3- and 6-month follow-ups.
Secondary outcomes:
measure: Change from baseline in parent sleep quality as assessed using the Pittsburgh Sleep Quality Index at 3 and 6 month follow ups.
timeFrame: Parent sleep quality will be assessed at baseline, and at 3- and 6-month follow-ups.
measure: Change from baseline in parent mood as assessed using the Clinically Useful Depression Outcome Scale at 3 and 6 month follow ups.
timeFrame: Parent mood will be assessed at baseline, and at 3- and 6-month follow-ups.
measure: Change from baseline in infant sleep onset latency at 3 and 6 months follow-up: Videosomnography
timeFrame: Infant sleep onset latency will be assessed at baseline, and at 3- and 6-month follow-ups.
measure: Change from baseline in infant sleep duration at 3 and 6 months follow-up: Videosomnography
timeFrame: Infant sleep duration will be assessed at baseline, and at 3- and 6-month follow-ups.
measure: Change from baseline in infant number of night-wakings at 3 and 6 months follow-up: Videosomnography
timeFrame: Infant number of night-wakings will be assessed at baseline, and at 3- and 6-month follow-ups.
measure: Change from baseline in infant time out of bed at 3 and 6 months follow-up: Videosomnography
timeFrame: Infant time out of bed will be assessed at baseline, and at 3- and 6-month follow-ups.
measure: Change from baseline in parental "nightly visits" at 3 and 6 months follow-up: Videosomnography
timeFrame: Infant time out of bed will be assessed at baseline, and at 3- and 6-month follow-ups.
Other outcomes:
Locations:
city: New York
country: United States
facility: Nanit
state: New York
Study officials:
affiliation: Tel Aviv University
name: Michal Kahn, PhD
role: STUDY_DIRECTOR
affiliation: Flinders University
name: Michael Gradisar, PhD
role: PRINCIPAL_INVESTIGATOR
References: