Infant Sleep ProblemNCT07812896
Smart Baby Monitor Effects on Infant Sleep and Parent Well-being
A study testing Smart Baby Monitor with Sleep Analytics and Behavioral Guidance and Smart Baby Monitor with Live Video Only in people with Infant Sleep Problem, run by Udisense DBA Nanit at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infant Sleep Problem
- What is being tested?
- Smart Baby Monitor with Sleep Analytics and Behavioral Guidance and Smart Baby Monitor with Live Video Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nanit
New York, New York, 10001
Shambhavi Thakur, 5512636389, Shambhavithakur68@gmail.com
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Infant Sleep Problem
- Being tested
- Smart Baby Monitor with Sleep Analytics and Behavioral Guidance, Smart Baby Monitor with Live Video Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Baby Monitor with Sleep Analytics and Behavioral GuidanceDevice
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.
Smart Baby Monitor with Live Video OnlyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Nanit Full Features (Milestone Insights) | Experimental | 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. Receives: Device: Smart Baby Monitor with Sleep Analytics and Behavioral Guidance |
| Control Group - Nanit Live Video Only | Active comparator | 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. Receives: Device: Smart Baby Monitor with Live Video Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Bedtime Variability
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
Measured: Month 4 and Month 6 postpartum
Infant Nighttime Sleep Duration
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
Measured: Month 4 and Month 6 postpartum
Infant Nighttime Awakenings
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
Measured: Month 4 and Month 6 postpartum
Parental Nighttime Interventions
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
Measured: Month 4 and Month 6 postpartum
Parental Sleep Quality
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
Measured: Baseline (third trimester), Month 4, and Month 6 postpartum
Postpartum Depression Symptoms
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
Measured: Baseline (third trimester), Month 4, and Month 6 postpartum
Postpartum Anxiety Symptoms
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
Measured: Baseline (third trimester), Month 4, and Month 6 postpartum
Secondary outcomes (6)
Parenting Confidence and Self-Efficacy
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.
Measured: Month 4 and Month 6 postpartum
Infant-Related Orthosomnia
Parental preoccupation with infant sleep tracking data and its association with parental anxiety, measured by the infant-related orthosomnia survey.
Measured: Month 4 and Month 6 postpartum
Household Chaos
Self-reported household disorganization and instability measured by the CHAOS scale on 0 to 15 score. Higher score shows worse outcome
Measured: Month 4 and Month 6 postpartum
Postpartum Social Support
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
Measured: Month 4 and Month 6 postpartum
Return-to-Work Productivity
Self-reported workplace productivity and absenteeism following parental leave, measured by the workplace productivity and return-to-work survey.
Measured: Month 4 and Month 6 postpartum
Torticollis and Plagiocephaly Knowledge and Incidence
Parent-reported knowledge of torticollis and plagiocephaly and any infant diagnosis, assessed via survey.
Measured: Baseline (third trimester) and Month 6 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Jul 2026
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Sleep ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udisense DBA Nanit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812896
- Sponsor's protocol ID
- Pro00094891
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07812896
- Acronym / sponsor ID
- Pro00094891
- Conditions
- Infant Sleep Problem
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Udisense DBA NanitIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Nanit Full Features (Milestone Insights) | Experimental | Device: Smart Baby Monitor with Sleep Analytics and Behavioral GuidanceParticipants 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. |
| Control Group - Nanit Live Video Only | Active comparator | Device: Smart Baby Monitor with Live Video OnlyParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Baby Monitor with Sleep Analytics and Behavioral GuidanceA 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 | Intervention Group - Nanit Full Features (Milestone Insights) |
| Smart Baby Monitor with Live Video OnlyA 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. | Device | Control Group - Nanit Live Video Only |
Primary outcome
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
6 secondary outcomes
Parenting Confidence and Self-Efficacy
Time frame: Month 4 and Month 6 postpartum
Infant-Related Orthosomnia
Time frame: Month 4 and Month 6 postpartum
Household Chaos
Time frame: Month 4 and Month 6 postpartum
Postpartum Social Support
Time frame: Month 4 and Month 6 postpartum
Return-to-Work Productivity
Time frame: Month 4 and Month 6 postpartum
Torticollis and Plagiocephaly Knowledge and Incidence
Time frame: Baseline (third trimester) and Month 6 postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Baby Monitor with Sleep Analytics and Behavioral Guidance and Smart Baby Monitor with Live Video Only in people with Infant Sleep Problem, run by Udisense DBA Nanit at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Barnett, PhD (+1 (866) 696-2648, natalie.barnett@nanit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Bedtime Variability (time frame: Month 4 and Month 6 postpartum). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.