Can a sleep app save teen lives? new study aims to find out
NCT ID NCT07303959
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests whether a smartphone app called Sleepio, which teaches better sleep habits, can help teens ages 14-18 who were recently hospitalized for suicide risk and also have insomnia. Half the teens will use the app plus get their usual care, while the other half gets usual care alone. Researchers will track sleep quality and suicidal thoughts over several weeks to see if the app makes a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sleepio (digital cognitive behavioral therapy app)
- What this could lead to
- If it works, this could point toward a simple, scalable way to lower suicide risk in teens by improving sleep.
- What could go wrong
- This is a small pilot study (80 teens) testing feasibility, not a proven treatment. The app may not reduce suicidal thoughts more than usual care.
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
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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
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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14 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: 1. Age 14-18 years old. 2. Recent hospitalization due to suicide risk (i.e., suicide attempts, aborted/interrupted attempts, or suicide ideation with intent and/or a plan) using an abbreviated version of the semi-structured and well-validated Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011). Regarding recency, adolescents will need to complete the baseline within three months (Study 1) or 45 days (Study 2) of discharge in order to capture the high-risk post-discharge period, which is up to 3 months following discharge from acute psychiatric hospitalization (Chung et al., 2017). 3. Clinically significant insomnia symptoms: SCI scores ≤16 will be used to recruit a sample with clinically significant insomnia symptoms. The ISI will also be administered to gain additional information about the nature of adolescents' sleep problems in order to confirm primary insomnia. ISI scores may also be obtained via chart review when applicable 4. Access to or willingness to use a compatible Smart Device. SleepioTM works with any internet connection (cellular or Wifi) on any iOS device running iOS 10.3 or later or on any Android device running Android OS 8.0 or later. Metricwire is compatible with all devices that SleepioTM is compatible with. If an interested adolescent does not have access to their own smart device, the research team will offer them a loaner device for the duration of the treatment/follow-up phase. Adolescents will be excluded based on the following exclusion criteria: 1. Prior CBT-I treatment, which would indicate lack of response to a prior reasonable dose of this treatment. 2. Bipolar disorder given that certain components of CBT-I (e.g., sleep restriction) may be risky for this population. 3. Substance use disorder that is primary to insomnia which would require alternative treatment. 4. Presence of factors that may reduce participants' ability to consent or complete the study procedures (e.g., current psychosis, other-directed violence; severe cognitive impairment, non-English speaking). 5. Unwillingness to wear wrist actigraphy or complete the EMA surveys. 6. Not having a parent willing to provide permission (if participant is a minor) or to consent to their own participation (required for all adolescents). Eligibility will not be based on biological sex, gender identity, race, or ethnicity. These variables will be assessed during screening to compare those who are and are not eligible. 7. Having a sibling who has enrolled in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Children's Hospital of The King's Daughters
RECRUITINGNorfolk, Virginia, 23507, United States
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Rutgers University Behavioral Healthcare
RECRUITINGPiscataway, New Jersey, 08854, United States
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