Exploring the link between sleep and emotions in teens with PTSD

Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder

This study is testing if improving sleep quality can help teens with PTSD feel better emotionally and improve their mood during the day.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 15 Years to 18 Years
• Sex: All
• Sponsor: University of Wisconsin, Madison (Academic / other)
• Locations: 1 site (Madison, Wisconsin)
• Trial ID: NCT06341413 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates how sleep quality affects emotion processing and daily mood in adolescents suffering from post-traumatic stress disorder (PTSD). Participants will undergo a series of assessments, including clinical evaluations, cognitive testing, and MRI scans, followed by two overnight sleep studies using a wearable EEG device. The study aims to enhance slow-wave sleep through advanced sleep technology and assess its impact on emotional well-being the following day. A total of 165 youth will be involved, divided into three groups to evaluate the effectiveness of the sleep enhancement intervention.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 15-18 who have experienced at least one traumatic event and are fluent in English.

Not a fit: Patients who are not within the specified age range or do not have a history of trauma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved emotional regulation and overall mental health in adolescents with PTSD.

How similar studies have performed: While the specific approach of enhancing sleep quality in PTSD youth is novel, related studies have shown promising results in the impact of sleep on emotional processing.

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.

Where this trial is running

Madison, Wisconsin

• University of Wisconsin — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Stephanie Jones, MD, PhD — University of Wisconsin, Madison
• Study coordinator: Sara Heyn, JD, PhD

Conditions Post Traumatic Stress Disorder