University of Wisconsin
Madison, Wisconsin, 53705, United States
Location status: Recruiting
Location contact
Sara Heyn, JD, PhD
CONTACT
Stephanie Jones, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06341413
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
Interested in participating?
Request Info14 year–18 year
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
Location status: Recruiting
Sara Heyn, JD, PhD
CONTACT
Stephanie Jones, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants must meet all of the following criteria:
In addition, PTSD and TEC youth must satisfy the following criteria:
Additional criteria for PTSD youth:
Exclusion criteria
Exclusions for Typically developing youth:
PTSD Youth:
TEC Youth:
Device worn during sleep
Time frame: First overnight session to second overnight, up to 5 weeks
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
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
Measured by overnight high-density EEG
Time frame: First week at-home recordings to second week, up to 6 weeks
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.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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