Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 18
Healthy Volunteers: t
View:

⁃ 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).

Locations
United States
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Sara Heyn, JD, PhD
sheyn@wisc.edu
303-296-2116
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 180
Treatments
Experimental: Stimulation mode first
During one week, the SmartSleep device will be set to stimulation mode.
Sham_comparator: Sham mode first
During one week, the SmartSleep device will be set to sham.
Related Therapeutic Areas
Sponsors
Leads: University of Wisconsin, Madison
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov