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Digital sleep coach for teens could boost mental health

NCT ID NCT05378373

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tests two digital sleep interventions designed to help teenagers aged 12-14 improve their sleep regularity and mental health. Participants wear a Garmin device and use a smartphone app that provides personalized feedback on their sleep patterns. The goal is to see if these tools are practical and effective in promoting healthier sleep habits during adolescence.

What this could mean

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

Active substance
Digital sleep intervention (wearable sensors and smartphone app)
What this could lead to
If effective, this could provide a simple, scalable way to improve sleep and mental health in teenagers.
What could go wrong
This is a small feasibility study, so results may not be generalizable. The interventions are behavioral, so effects may be modest.

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

83 people

The number who actually took part.

Started

Oct 2022

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

12 to 14 years

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: * ages 12-14 years * parent concern on the routines/consistency subscale of the Pediatric Sleep Practices Questionnaire, indicating poor sleep practices (score of 2) in at least one of the following: bedtime consistency, wake time consistency, and bedtime routines; * ability to speak, read and write in English * access to internet and smartphone device with capacity to download intervention App (iOS and Android) * valid email address * ability to follow written and verbal instructions * ability and willingness to comply with study procedures. Exclusion Criteria: * diagnosed sleep disorder * psychiatric disorder under treatment (medication and/or therapy) or intellectual disability * chronic pain condition interfering with sleep * substance use disorder * use of medication for sleep (prescription or over-the-counter) * has a sibling also enrolled/participating in the same study

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Conditions

The condition(s) this trial relates to.

psychiatric disorder sleep disorder

As listed by the trial registrant

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

Psychiatric health Sleep

Contacts and locations

Locations

  • Duke Children's Primary Care North Durham

    Durham, North Carolina, 27704, United States

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