An interventional study of Smart Baby Monitor with Sleep Analytics and Behavioral Guidance and Smart Baby Monitor with Live Video Only in Infant Sleep Problem, sponsored by Udisense DBA Nanit. Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Udisense DBA Nanit · Not applicable, Interventional, and Other
The goal of this clinical trial is to learn whether a smart baby monitor with full sleep analytics and behavioral guidance improves infant sleep and parent well-being in first-time parents during the first six months after birth.
The main questions it aims to answer are:
Researchers will compare families using the Nanit camera with full Milestone Insights features (sleep analytics, behavioral guidance, and developmental tracking) to families using the Nanit camera with live video only, to see whether the full suite of features leads to better sleep and well-being outcomes.
Exclusion Criteria:
Participants in this arm receive a Nanit baby monitor camera with full access to the Nanit Milestone Insights subscription, including sleep analytics, behavioral guidance, developmental tracking, and all in-app features. Participants use this as their primary baby monitor from enrollment through 6 months postpartum.
Device: Smart Baby Monitor with Sleep Analytics and Behavioral Guidance
Participants in this arm receive a Nanit baby monitor camera with access to live video streaming only. Sleep analytics, behavioral guidance, and developmental tracking features are disabled. Participants use this as their primary baby monitor from enrollment through 6 months postpartum.
Device: Smart Baby Monitor with Live Video Only
A smart baby monitor camera providing live video streaming combined with full access to sleep analytics, behavioral guidance notifications, developmental milestone tracking, and in-app parenting tips via the Nanit mobile application. Participants use the device as their primary infant monitor from birth through 6 months postpartum.
A smart baby monitor camera providing live video streaming only. Sleep analytics, behavioral guidance, developmental tracking, and in-app guidance features are disabled for the duration of the study. Participants use the device as their primary infant monitor from birth through 6 months postpartum.
Infant Bedtime Variability
Night-to-night consistency of infant bedtime measured objectively by the Nanit camera. The bedtime variability is in minutes and higher variability shows worse outcome
Time frame: Month 4 and Month 6 postpartum
Infant Nighttime Sleep Duration
Total nighttime sleep duration measured objectively via the Nanit camera and parent-reported via the Brief Infant Sleep Questionnaire-Revised (BISQ-R). Both are measured in minutes and higher score means better outcome
Time frame: Month 4 and Month 6 postpartum
Infant Nighttime Awakenings
Number of infant nighttime awakenings measured objectively by the Nanit camera and parent-reported via the Brief Infant Sleep Questionnaire-Revised (BISQ-R). Measured in whole number, higher night awakenings show worse outcome
Time frame: Month 4 and Month 6 postpartum
Parental Nighttime Interventions
Number of times a parent intervenes in the infant's sleep during the night, measured objectively by the Nanit camera. Measured in whole number, minimum 0 and higher interventions show worse outcome
Time frame: Month 4 and Month 6 postpartum
Parental Sleep Quality
Self-reported sleep quality for primary and secondary caregivers measured by the Pittsburgh Sleep Quality Index (PSQI). The scale is from 0-21, higher score shows worse outcome
Time frame: Baseline (third trimester), Month 4, and Month 6 postpartum
Postpartum Depression Symptoms
Self-reported postpartum depression symptoms for primary and secondary caregivers measured by the Edinburgh Postnatal Depression Scale (EPDS). The range is 0 to 30. Higher scores show worse outcome
Time frame: Baseline (third trimester), Month 4, and Month 6 postpartum
Postpartum Anxiety Symptoms
Self-reported postpartum anxiety symptoms for primary and secondary caregivers measured by the Edinburgh Postnatal Depression Scale (EPDS). Measured on scale of 0-9. Higher score shows worse outcome
Time frame: Baseline (third trimester), Month 4, and Month 6 postpartum
Parenting Confidence and Self-Efficacy
Self-reported parenting confidence and shared parental responsibility measured by the Parenting Confidence Scale (0 to 45), higher scores indicate greater parenting confidence and parental self-efficacy. Shared Parental Responsibility Scale (14 to 70), The scale measures the relative division of labor between maternal and paternal roles rather than "good" or "bad" parenting.
Time frame: Month 4 and Month 6 postpartum
Infant-Related Orthosomnia
Parental preoccupation with infant sleep tracking data and its association with parental anxiety, measured by the infant-related orthosomnia survey.
Time frame: Month 4 and Month 6 postpartum
Household Chaos
Self-reported household disorganization and instability measured by the CHAOS scale on 0 to 15 score. Higher score shows worse outcome
Time frame: Month 4 and Month 6 postpartum
Postpartum Social Support
Self-reported perceived social support measured by the Postpartum Social Support Questionnaire (PSSQ) on 50 to 350 score. A higher score indicates a better outocme
Time frame: Month 4 and Month 6 postpartum
Return-to-Work Productivity
Self-reported workplace productivity and absenteeism following parental leave, measured by the workplace productivity and return-to-work survey.
Time frame: Month 4 and Month 6 postpartum
Torticollis and Plagiocephaly Knowledge and Incidence
Parent-reported knowledge of torticollis and plagiocephaly and any infant diagnosis, assessed via survey.
Time frame: Baseline (third trimester) and Month 6 postpartum
Plan to share: No
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Udisense DBA Nanit