NCT07812896 · Udisense DBA Nanit
Smart Baby Monitor Effects on Infant Sleep and Parent Well-being
What this study is about
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.
View original scientific description
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
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.
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.
Primary outcome measures
Infant Bedtime Variability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 10, 2026 · Source of record for eligibility and locations