Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder

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

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Device: SmartSleep device

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
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Heyn, JD, PhD; Phone Number: 303-296-2116; Email: sheyn@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin
      • Contact: Sara Heyn, JD, PhD; Phone Number: 303-296-2116; Email: sheyn@wisc.edu
      • Principal Investigator: Stephanie Jones, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulation mode first; During one week, the SmartSleep device will be set to stimulation mode.	Device: SmartSleep device; Device worn during sleep
Sham Comparator: Sham mode first; During one week, the SmartSleep device will be set to sham.	Device: SmartSleep device; Device worn during sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	First overnight session to second overnight, up to 5 weeks
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.	First overnight session to second overnight, up to 5 weeks
Change in Slow-wave Activity (SWA)	Measured by overnight high-density EEG	First overnight session to second overnight, up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First week at-home recordings to second week, up to 6 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Stephanie Jones, MD, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2023-1281; A539500 (Other Identifier: UW- Madison); SMPH/SLEEP CENTER/SLEEP CTR (Other Identifier: UW- Madison); 1R01MH132221 (U.S. NIH Grant/Contract); Protocol Approved 8/6/2024 (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No