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RecruitingNCT06341413Updated Jul 15, 2026

Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

An interventional study of SmartSleep device in Post Traumatic Stress Disorder, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
All
01

Study summary

The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth.

Participants will attend 4 study visits:

  • A clinical and trauma assessment visit
  • A testing day that may include cognitive testing, surveys, and an MRI.
  • An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition
  • An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition
Read the detailed description

In this study, researchers aim to characterize sleep and explore its relationship to emotion processing and daily affect in 165 youth spilt into 3 groups. Researchers will use advanced sleep assessment methodologies including: (1) high-density EEG (256 channels) in the laboratory to explore the regional distribution of sleep before and after an emotional learning task and; (2) a sleep-wearable EEG recording headband, SmartSleep, to record sleep longitudinally at home. Using SmartSleep's sleep enhancement algorithms, researchers will determine whether the deepest sleep, slow-wave activity (SWA) of non-rapid eye-movement (NREM) sleep, can be reliably increased in all youth.

02

Conditions studied

  • Post Traumatic Stress Disorder
03

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's planned enrollment of 180 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Stimulation mode first

    During one week, the SmartSleep device will be set to stimulation mode.

    Device: SmartSleep device

  • Sham comparator
    Sham mode first

    During one week, the SmartSleep device will be set to sham.

    Device: SmartSleep device

Interventions

  • DeviceSmartSleep device

    Device worn during sleep

06

What researchers measure

Primary outcomes

  1. Change in Emotional Regulation - arousal

    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).

    Time frame: First overnight session to second overnight, up to 5 weeks

  2. Change in Emotional Regulation - recall

    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.

    Time frame: First overnight session to second overnight, up to 5 weeks

  3. Change in Slow-wave Activity (SWA)

    Measured by overnight high-density EEG

    Time frame: First overnight session to second overnight, up to 5 weeks

Secondary outcomes

  1. Change in Positive and Negative Affect Schedule (PANAS)

    PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50.

    Time frame: First week at-home recordings to second week, up to 6 weeks

07

Study locations

1 of 1 sites recruiting
  • University of Wisconsin
    Madison, Wisconsin 53705, United States
    • Sara Heyn, JD, PhD · Contact · sheyn@wisc.edu · 303-296-2116
    • Stephanie Jones, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06341413
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Apr 2, 2024
Start date
Jul 16, 2024
Primary completion
Oct 1, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jul 15, 2026

Study contacts

Sara Heyn, JD, PhD
Contact
sheyn@wisc.edu
303-296-2116
Stephanie Jones, MD, PhD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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