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

The NANIT Insights Study: Impact of Smart Baby Monitor Technology on Infant Sleep and Parental Well-being in First-Time Parents - A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Infant Sleep Problem
• Intervention / Treatment: Device: Smart Baby Monitor with Sleep Analytics and Behavioral Guidance; Device: Smart Baby Monitor with Live Video Only

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalie Barnett, PhD; Phone Number: +1 (866) 696-2648; Email: natalie.barnett@nanit.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Recruiting
      • Nanit
      • Contact: Shambhavi Thakur; Phone Number: 5512636389; Email: Shambhavithakur68@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group - Nanit Full Features (Milestone Insights); 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; 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.
Active Comparator: Control Group - Nanit Live Video Only; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	Baseline (third trimester), Month 4, and Month 6 postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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.	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.	Baseline (third trimester) and Month 6 postpartum

Collaborators and Investigators

• Sponsor: Udisense DBA Nanit

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: September 4, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Pro00094891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No