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Can a smart monitor help babies sleep and parents cope?

NCT ID NCT07812896

Symptom relief Sponsor: Udisense DBA Nanit Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether a smart baby monitor with sleep analytics and behavioral guidance improves infant sleep and parent well-being in first-time parents. The trial enrolls 200 first-time parents from late pregnancy through six months postpartum. Families are randomly assigned to use the monitor with full features or with live video only, and researchers compare infant sleep patterns and parent-reported sleep quality, depression, and anxiety symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A smart baby monitor with sleep analytics and behavioral guidance
What this could lead to
If the full-featured monitor helps, it could give first-time parents a practical tool to improve infant sleep and reduce postpartum depression and anxiety symptoms.
What could go wrong
This is a behavioral device study, not a drug trial, and results may not generalize beyond first-time parents who volunteer. The monitor's alerts could also increase parental anxiety or night wakings rather than reduce them.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infant sleep problem

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nanit

    RECRUITING

    New York, New York, 10001, United States