Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06341413
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • SmartSleep device — DEVICE
    Device worn during sleep

Study Details

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

Key Dates

Start date
Jul 16, 2024
Status verified
Jan 2026
Primary completion
Oct 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Emotional Regulation - arousal [ Time Frame: First overnight session to second overnight, up to 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Sara Heyn, JD, PhD
[email protected]
303-296-2116
Stephanie Jones, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Madison, WI

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Wisconsin· Madison, WI

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