Recruiting

Nanit with Insights

Sponsor:

Udisense DBA Nanit

Code:

NCT07812896

Conditions

Infant Sleep Problem

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Smart Baby Monitor with Sleep Analytics and Behavioral Guidance

Smart Baby Monitor with Live Video Only

Study Details

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.

Conditions

Infant Sleep Problem

Study ID

NCT07812896

Start date

Jul 15, 2026

Status verified date

Aug, 2026

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Infant Bedtime Variability [ Time Frame: Month 4 and Month 6 postpartum ]
  • Infant Nighttime Sleep Duration [ Time Frame: Month 4 and Month 6 postpartum ]
  • Infant Nighttime Awakenings [ Time Frame: Month 4 and Month 6 postpartum ]
  • Parental Nighttime Interventions [ Time Frame: Month 4 and Month 6 postpartum ]
  • Parental Sleep Quality [ Time Frame: Baseline (third trimester), Month 4, and Month 6 postpartum ]
  • Postpartum Depression Symptoms [ Time Frame: Baseline (third trimester), Month 4, and Month 6 postpartum ]
  • Postpartum Anxiety Symptoms [ Time Frame: Baseline (third trimester), Month 4, and Month 6 postpartum ]

Central Contacts and Locations

Central contacts

Natalie Barnett, PhD

+1 (866) 696-2648natalie.barnett@nanit.com

Locations

Nanit

Recruiting

New York, New York, United States, 10001

Contacts

Shambhavi Thakur

5512636389Shambhavithakur68@gmail.com

More Information

Sponsor

Udisense DBA Nanit

Last update posted

Sep 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Udisense DBA Nanit on 2026-09-10.