Infant Sleep Problem
Conditions
Brief summary
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: 1. Does access to Nanit's full monitoring features improve infant nighttime sleep - including total sleep time, bedtime consistency, nighttime awakenings, and how often parents need to intervene at night? 2. Does it improve sleep quality and mental health outcomes for parents, including reduced postpartum depression and anxiety symptoms? 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.
Interventions
DEVICESmart Baby Monitor with Sleep Analytics and Behavioral Guidance
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.
DEVICESmart Baby Monitor with Live Video Only
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.
Sponsors
Udisense DBA Nanit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Primary caregiver is biological parent * Expecting first child (nulliparous) * Currently between 34 weeks of gestation and end of gestation * Primary caregiver aged 21 or older * Access to a smartphone or tablet compatible with the Nanit application * Able to complete study surveys in English * Any family structure (single parent, coupled, same-sex couples, etc.)
Exclusion criteria
* Infant born prior to 35 weeks gestational age (preterm birth) * Infant born with a severe medical condition requiring intensive neonatal care at time of study measures * Multiple gestation (twins, triplets, or higher-order multiples) * Prior children living in the household (not first-time parents) * Primary caregiver works shift work or irregular schedules * Primary caregiver diagnosed with a sleep disorder (OSA, RLS, PLMD, RBD, or other)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Bedtime Variability | Month 4 and Month 6 postpartum | 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 |
| Infant Nighttime Sleep Duration | Month 4 and Month 6 postpartum | 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 |
| Infant Nighttime Awakenings | Month 4 and Month 6 postpartum | 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 |
| Parental Nighttime Interventions | Month 4 and Month 6 postpartum | 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 |
| Parental Sleep Quality | Baseline (third trimester), Month 4, and Month 6 postpartum | 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 |
| Postpartum Depression Symptoms | Baseline (third trimester), Month 4, and Month 6 postpartum | 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 |
| Postpartum Anxiety Symptoms | Baseline (third trimester), Month 4, and Month 6 postpartum | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parenting Confidence and Self-Efficacy | Month 4 and Month 6 postpartum | 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. |
| Infant-Related Orthosomnia | Month 4 and Month 6 postpartum | Parental preoccupation with infant sleep tracking data and its association with parental anxiety, measured by the infant-related orthosomnia survey. |
| Household Chaos | Month 4 and Month 6 postpartum | Self-reported household disorganization and instability measured by the CHAOS scale on 0 to 15 score. Higher score shows worse outcome |
| Postpartum Social Support | Month 4 and Month 6 postpartum | 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 |
| Return-to-Work Productivity | Month 4 and Month 6 postpartum | Self-reported workplace productivity and absenteeism following parental leave, measured by the workplace productivity and return-to-work survey. |
| Torticollis and Plagiocephaly Knowledge and Incidence | Baseline (third trimester) and Month 6 postpartum | Parent-reported knowledge of torticollis and plagiocephaly and any infant diagnosis, assessed via survey. |
Countries
United States
Contacts
CONTACTNatalie Barnett, PhD
Outcome results
None listed