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

2026年9月4日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：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.
有源比较器：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.
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Infant Bedtime Variability
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Parenting Confidence and Self-Efficacy
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Udisense DBA Nanit

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月15日

初级完成 (估计的)

2027年4月15日

研究完成 (估计的)

2027年4月15日

研究注册日期

首次提交

2026年8月27日

首先提交符合 QC 标准的

2026年9月4日

首次发布 (实际的)

2026年9月10日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pro00094891

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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