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

4 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La 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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Comparateur actif: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Infant Bedtime Variability
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Parenting Confidence and Self-Efficacy
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Udisense DBA Nanit

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 juillet 2026

Achèvement primaire (Estimé)

15 avril 2027

Achèvement de l'étude (Estimé)

15 avril 2027

Dates d'inscription aux études

Première soumission

27 août 2026

Première soumission répondant aux critères de contrôle qualité

4 septembre 2026

Première publication (Réel)

10 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Pro00094891

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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