Sleep and Emotion Processing in Adolescent PTSD

This study is looking at how sleep, emotions, and daily feelings are connected in teenagers (ages 14-18) who have Post-Traumatic Stress Disorder (PTSD). Researchers want to see if improving sleep quality with a device called SmartSleep can help with emotions the next day. The SmartSleep device is worn during sleep to enhance "slow-wave activity," which is the deepest kind of sleep. The study will measure changes in how well participants regulate their emotions and their slow-wave activity over about 5 weeks. The goal is to enroll 180 participants. The current status of the study is unclear.

Study design
This interventional study plans to enroll 180 participants, split into three groups. It uses advanced sleep assessment methods, including a high-density EEG in the lab and a wearable SmartSleep headband at home.
What's involved
You would attend four study visits: a clinical and trauma assessment, a testing day (which may include cognitive tests, surveys, and an MRI), and two overnight sleep studies. You would also wear the SmartSleep device at home for one week before each overnight study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, such as changes in emotional regulation and slow-wave activity, are measured from the first overnight session to the second, up to 5 weeks.

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NCT06341413

Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

Recruiting
NAAges 14–18InterventionalTreatment
University of Wisconsin, Madison
~180 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:SmartSleep device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Emotional Regulation - arousal
Measured over First overnight session to second overnight, up to 5 weeks
+2 more outcomes measured
Post Traumatic Stress Disorder
1 sites across 1 states
Wisconsin1
  • Stephanie Jones, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

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Eligibility criteria

Inclusion

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

Exclusion

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
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.
  • Change in Emotional Regulation - arousalFirst overnight session to second overnight, up to 5 weeks

    Participants will view 140 target stimuli - 70 negative and 70 neutral- in pseudorandom order. The Self-Assessment Manikin Scale for Arousal 142 (SAM) appears after the target image and participants are asked to rate degree of emotional arousal experienced while processing the picture by pressing one of nine response buttons (ranging from 1 = very low to 9 = very high).

  • Change in Emotional Regulation - recallFirst overnight session to second overnight, up to 5 weeks

    Participants complete a recognition phase. In this phase, 200 neutral and negative images are viewed. This set includes the 140 previously viewed images intermixed with 70 novel images (50% negative and 50% neutral). Participants are asked to assess arousal using the SAM (degree of emotional arousal experienced while processing the picture by pressing one of nine response buttons (ranging from 1 = very low to 9 = very high)), and to indicate whether or not they recognize pictures from the previous encoding session (''old'') or not (''new'') by pressing one of two response buttons.

  • Change in Slow-wave Activity (SWA)First overnight session to second overnight, up to 5 weeks

    Measured by overnight high-density EEG