RecruitingNot Applicable

Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

United States180 participantsStarted 2024-07-16

Plain-language 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

Who can participate

Age range

14 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 opi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Emotional Regulation - arousal

Timeframe: First overnight session to second overnight, up to 5 weeks

Change in Emotional Regulation - recall

Timeframe: First overnight session to second overnight, up to 5 weeks

Change in Slow-wave Activity (SWA)

Timeframe: First overnight session to second overnight, up to 5 weeks

Trial details

NCT IDNCT06341413

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10-01

Contact for this trial

Sara Heyn, JD, PhD

303-296-2116 sheyn@wisc.edu

View on ClinicalTrials.gov More Post Traumatic Stress Disorder trials

Plain-language summary

Who can participate

Age range

14 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Emotional Regulation - arousal

Timeframe: First overnight session to second overnight, up to 5 weeks

Change in Emotional Regulation - recall

Timeframe: First overnight session to second overnight, up to 5 weeks

Change in Slow-wave Activity (SWA)

Timeframe: First overnight session to second overnight, up to 5 weeks