Clinical trial NCT06341413: Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder
Official title: Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-04-02
Enrollment: 180
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

All participants must meet all of the following criteria:

* Aged 15-18 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 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
* MRI contraindication
* Claustrophobia or inability lie still in the scanner after practice MRI sessions.
* Any participant presenting current serious suicide risk, as determined through the KSADS, responses to C-SSRS, and/or clinical judgment of the investigator, will be excluded; however, history of suicide attempts is not an exclusion. Would present a serious risk to others as established through clinical interview and contact with treating physician.
* Neurodevelopmental disorders such as autism spectrum disorder
* Intellectual Disability (IQ less than 70, per self-report)
* Currently impaired by any medical condition that would prevent study participation
* Traumatic brain injury with ongoing symptoms, including headache, visual disturbances, and/or impairments in concentration.
* Neurological disorder(s) such as seizures, epilepsy, or brain tumors (Tourette's disorder, as diagnosed in the KSADS, is not exclusionary for TEC/PTSD youth)
* Current use of medications or other drugs (i.e., alcohol) in a manner that may interfere with sleep.
* Possible pregnancy

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.
* Current diagnosis of a sleep disorder (self-report).
* Any history of any traumatic experience as defined by the DSM-V, including IPV exposure, neglect, or emotional abuse etc.

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.

Primary outcomes:
measure: Change in Emotional Regulation - arousal
timeFrame: First overnight session to second overnight, up to 5 weeks
measure: Change in Emotional Regulation - recall
timeFrame: First overnight session to second overnight, up to 5 weeks
measure: Change in Slow-wave Activity (SWA)
timeFrame: First overnight session to second overnight, up to 5 weeks
Secondary outcomes:
measure: Change in Positive and Negative Affect Schedule (PANAS)
timeFrame: First week at-home recordings to second week, up to 6 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stephanie Jones, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: