Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

NCT06341413 | Recruiting DMC

• 5 other identifiers: 2023-1281A539500SMPH/SLEEP CENTER/SLEEP CTRProtocol Approved 8/6/20241R01MH132221
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in Positive and Negative Affect Schedule (PANAS)

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

Study Arms (2)

Stimulation mode first

EXPERIMENTAL

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

Device: SmartSleep device

Sham mode first

SHAM COMPARATOR

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

Device: SmartSleep device

Interventions

SmartSleep device DEVICE

Device worn during sleep

Sham mode first; Stimulation mode first

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Stephanie Jones, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Heyn, JD, PhD

CONTACT

303-296-2116; sheyn@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)