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Can better sleep soothe PTSD in teens? new study investigates

NCT ID NCT06341413

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study looks at how sleep and emotion processing are linked in teenagers with post-traumatic stress disorder (PTSD). Researchers will use a special sleep device to try to improve sleep quality and see if it helps with next-day mood. 180 teens aged 15-18 will take part, completing sleep studies, surveys, and an MRI. The goal is to understand the role of sleep in PTSD, not to test a cure.

What this could mean

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

Active substance
SmartSleep device (worn during sleep to enhance slow-wave activity)
What this could lead to
If successful, this could point toward a non-drug way to improve daily mood and emotional health in teens with PTSD by enhancing sleep.
What could go wrong
This is an early-stage study focused on understanding, not treatment. It's small and may not lead to a proven therapy. The device's effect on PTSD symptoms is uncertain.

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 180 people

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

Started

Jul 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

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

14 to 18 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: All participants must meet all of the following criteria: * Aged 14-18 years old, inclusive * Must agree to inform the investigators within 48 hours of any emergent medical conditions and procedures * Able to lie still on their back for up to 1 hour * Must not be pregnant * Must agree not to participate in any other interventional clinical trials during the duration of the study * Must be willing to comply with all study procedures * Agree to have study visits video and/or audio recorded, including consent visit, clinical assessments (for staff training) and in-laboratory sleep visits (recording deleted within one month of study visit). * A primary parent or guardian is willing participate in the study and to provide informed consent * Are fluent in or predominantly speaking and reading in English In addition, PTSD and TEC youth must satisfy the following criteria: \- Must have a history of at least one traumatic event of any type, as defined by the DSM-V. This may include exposure to physical or sexual abuse, witnessing violence against loved ones or friends, traumatic accidents, natural disasters, death of a close family member etc. Additional criteria for PTSD youth: \- At baseline, meet threshold for DSM-5 criteria for current severe PTSD, as determined by the semi-structured clinical interview (KSADS). Exclusion Criteria: * Caregiver or adolescent is unwilling or unable to give adequate informed consent. * Are likely, in the investigator's opinion and via observation during the screening and clinical assessment period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation during study participation. * Any finding(s), based on the screening process, that the PI feels would make the study unsuitable for the participant. * Participation in the last 30 days in a clinical study involving an investigational drug * MRI contraindication * Claustrophobia or inability lie still in the scanner after practice MRI sessions. * Any participant presenting current serious suicide risk, as determined through the KSADS, responses to C-SSRS, and/or clinical judgment of the investigator, will be excluded; however, history of suicide attempts is not an exclusion. Would present a serious risk to others as established through clinical interview and contact with treating physician. * Neurodevelopmental disorders such as autism spectrum disorder * Intellectual Disability (IQ less than 70, per self-report) * Currently impaired by any medical condition that would prevent study participation * Traumatic brain injury with ongoing symptoms, including headache, visual disturbances, and/or impairments in concentration. * Neurological disorder(s) such as seizures, epilepsy, or brain tumors (Tourette's disorder, as diagnosed in the KSADS, is not exclusionary for TEC/PTSD youth) * Current use of medications or other drugs (i.e., alcohol) in a manner that may interfere with sleep. * Possible pregnancy Exclusions for Typically developing youth: * No history of or current psychopathology, as defined in the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), with exception of past specific phobia and past, resolved episodes of depressive or anxiety disorders. Provided that: * The episode is not current (i.e. does not meet current criteria as assessed by the KSADS), * The participant is not currently receiving psychiatric treatment (medication or psychotherapy) for mood/anxiety, and * There is no current serious suicide risk (per KSADS/C-SSRS). * Current diagnosis of a sleep disorder (self-report). * Any history of any traumatic experience as defined by the DSM-V, including IPV exposure, neglect, or emotional abuse etc. PTSD Youth: \- Current diagnosis of or history of psychotic disorder, bipolar disorder, or autism spectrum disorder diagnosed by the KSADS interview. No other co-morbid disorders are exclusionary. TEC Youth: \- A current diagnosis of PTSD or a current diagnosis of or history of psychotic disorder, bipolar disorder, or autism spectrum disorder diagnosed by the KSADS interview.

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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.

  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

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53705, United States

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Other studies related to the condition(s) this trial covers.