An interventional study of SmartSleep device in Post Traumatic Stress Disorder, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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:
In this study, researchers aim to characterize sleep and explore its relationship to emotion processing and daily affect in 165 youth spilt into 3 groups. Researchers will use advanced sleep assessment methodologies including: (1) high-density EEG (256 channels) in the laboratory to explore the regional distribution of sleep before and after an emotional learning task and; (2) a sleep-wearable EEG recording headband, SmartSleep, to record sleep longitudinally at home. Using SmartSleep's sleep enhancement algorithms, researchers will determine whether the deepest sleep, slow-wave activity (SWA) of non-rapid eye-movement (NREM) sleep, can be reliably increased in all youth.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's planned enrollment of 180 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
All participants must meet all of the following criteria:
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:
Exclusions for Typically developing youth:
No history of or current psychopathology, as defined in the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), with exception of past specific phobia and past, resolved episodes of depressive or anxiety disorders. Provided that:
PTSD Youth:
- Current diagnosis of or history of psychotic disorder, bipolar disorder, or autism spectrum disorder diagnosed by the KSADS interview. No other co-morbid disorders are exclusionary.
TEC Youth:
- A current diagnosis of PTSD or a current diagnosis of or history of psychotic disorder, bipolar disorder, or autism spectrum disorder diagnosed by the KSADS interview.
During one week, the SmartSleep device will be set to stimulation mode.
Device: SmartSleep device
During one week, the SmartSleep device will be set to sham.
Device: SmartSleep device
Device worn during sleep
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).
Time frame: 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.
Time frame: First overnight session to second overnight, up to 5 weeks
Change in Slow-wave Activity (SWA)
Measured by overnight high-density EEG
Time frame: First overnight session to second overnight, up to 5 weeks
Change in Positive and Negative Affect Schedule (PANAS)
PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50.
Time frame: First week at-home recordings to second week, up to 6 weeks
Plan to share: No
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Stress Disorders, Post-Traumatic→
University of Wisconsin, Madison