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:
- 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?
- 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.
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Natalie Barnett, PhD
- 電話番号：+1 (866) 696-2648
- メール：natalie.barnett@nanit.com
研究場所
-
-
New York
-
New York、New York、アメリカ、10001
- 募集
- Nanit
-
コンタクト：
- Shambhavi Thakur
- 電話番号：5512636389
- メール：Shambhavithakur68@gmail.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Infant Bedtime Variability
時間枠：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
|
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Infant Nighttime Sleep Duration
時間枠：Month 4 and Month 6 postpartum
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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
|
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Infant Nighttime Awakenings
時間枠：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
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Parental Nighttime Interventions
時間枠：Month 4 and Month 6 postpartum
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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
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Parental Sleep Quality
時間枠：Baseline (third trimester), Month 4, and Month 6 postpartum
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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
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Postpartum Depression Symptoms
時間枠：Baseline (third trimester), Month 4, and Month 6 postpartum
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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
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Postpartum Anxiety Symptoms
時間枠：Baseline (third trimester), Month 4, and Month 6 postpartum
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parenting Confidence and Self-Efficacy
時間枠：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.
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Month 4 and Month 6 postpartum
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Infant-Related Orthosomnia
時間枠：Month 4 and Month 6 postpartum
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Parental preoccupation with infant sleep tracking data and its association with parental anxiety, measured by the infant-related orthosomnia survey.
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Month 4 and Month 6 postpartum
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Household Chaos
時間枠：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
|
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Postpartum Social Support
時間枠：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
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Return-to-Work Productivity
時間枠：Month 4 and Month 6 postpartum
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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
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Torticollis and Plagiocephaly Knowledge and Incidence
時間枠：Baseline (third trimester) and Month 6 postpartum
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Parent-reported knowledge of torticollis and plagiocephaly and any infant diagnosis, assessed via survey.
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Baseline (third trimester) and Month 6 postpartum
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月15日
一次修了 (推定)
2027年4月15日
研究の完了 (推定)
2027年4月15日
試験登録日
最初に提出
2026年8月27日
QC基準を満たした最初の提出物
2026年9月4日
最初の投稿 (実際)
2026年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月4日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- Pro00094891
個々の参加者データ (IPD) の計画
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いいえ
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いいえ
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