Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT03640533
Status:
TERMINATED
Last Update Posted:
2021-04-01
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of the Nanit-Insights App in Improving Infant Sleep
Sponsor:
Tel Aviv University
Organization:
Study Overview
Official Title:
The Efficacy of the Nanit-Insights App in Improving Infant Sleep: A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Technical probelms led to inadequate randomization, and thus the project was terminated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: