Smart Baby Monitor Effects on Infant Sleep and Parent Well-being

Condition(s) studied

Investigational drug(s) / intervention(s)

Smart 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.

Smart 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More Udisense DBA Nanit trials in the USA