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

4 september 2026 bijgewerkt door: Udisense DBA Nanit

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Actieve vergelijker: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Infant Bedtime Variability
Tijdsspanne: 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
Month 4 and Month 6 postpartum
Infant Nighttime Sleep Duration
Tijdsspanne: 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
Month 4 and Month 6 postpartum
Infant Nighttime Awakenings
Tijdsspanne: 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
Month 4 and Month 6 postpartum
Parental Nighttime Interventions
Tijdsspanne: 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
Month 4 and Month 6 postpartum
Parental Sleep Quality
Tijdsspanne: 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
Baseline (third trimester), Month 4, and Month 6 postpartum
Postpartum Depression Symptoms
Tijdsspanne: 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
Baseline (third trimester), Month 4, and Month 6 postpartum
Postpartum Anxiety Symptoms
Tijdsspanne: 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
Baseline (third trimester), Month 4, and Month 6 postpartum

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parenting Confidence and Self-Efficacy
Tijdsspanne: 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.
Month 4 and Month 6 postpartum
Infant-Related Orthosomnia
Tijdsspanne: 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.
Month 4 and Month 6 postpartum
Household Chaos
Tijdsspanne: 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
Month 4 and Month 6 postpartum
Postpartum Social Support
Tijdsspanne: 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
Month 4 and Month 6 postpartum
Return-to-Work Productivity
Tijdsspanne: 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.
Month 4 and Month 6 postpartum
Torticollis and Plagiocephaly Knowledge and Incidence
Tijdsspanne: Baseline (third trimester) and Month 6 postpartum
Parent-reported knowledge of torticollis and plagiocephaly and any infant diagnosis, assessed via survey.
Baseline (third trimester) and Month 6 postpartum

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Udisense DBA Nanit

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 juli 2026

Primaire voltooiing (Geschat)

15 april 2027

Studie voltooiing (Geschat)

15 april 2027

Studieregistratiedata

Eerst ingediend

27 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 september 2026

Eerst geplaatst (Werkelijk)

10 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

4 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Pro00094891

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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