About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SmartSleep device
Treatment groups
Sponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator