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NCT06341413 | RECRUITING | Post Traumatic Stress Disorder

Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder
Sponsor:

University of Wisconsin, Madison

Brief 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

Condition or disease

Post Traumatic Stress Disorder

Intervention/treatment

SmartSleep device

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder
Actual Study Start Date : 2024-07-16
Estimated Primary Completion Date : 2028-10-01
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 15 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • All participants must meet all of the following criteria
    • * Aged 15-18 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.
          • * 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.
Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

Location Details

NCT06341413

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Locations

RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53705