SmartSleep Device for Adolescent PTSD

Recruiting in Palo Alto (17 mi)

Overseen by Stephanie Jones, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Wisconsin, Madison

Must not be taking: Sleep medications, Alcohol

Disqualifiers: Neurodevelopmental disorders, Psychotic disorder, others

No Placebo Group

Trial Summary

What is the purpose of 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

Will I have to stop taking my current medications?

The trial requires that participants do not use medications or other drugs in a way that might interfere with sleep. If your current medications affect your sleep, you may need to stop or adjust them.

What data supports the effectiveness of the SmartSleep device treatment for adolescent PTSD?

Research shows that sleep therapies, like cognitive behavioral therapy for insomnia, have been effective in treating sleep issues related to PTSD. Additionally, treatments for sleep disorders often lead to improvements in PTSD symptoms, suggesting that addressing sleep disturbances can be beneficial for managing PTSD. ^{1 2 3 4 5}

How does the SmartSleep Device treatment for adolescent PTSD differ from other treatments?

The SmartSleep Device is unique because it focuses on improving sleep disturbances, which are common in PTSD, by using a specialized device to potentially reduce symptoms like nightmares and sleep disruptions. Unlike traditional therapies that may not specifically target sleep issues, this device offers a novel approach by addressing a critical aspect of PTSD that can worsen other symptoms. ^{1 4 5 6 7}

Research Team

Stephanie Jones, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for adolescents who have PTSD. They must be able to attend four study visits, including assessments, cognitive tests, surveys, an MRI scan, and two overnight sleep studies after a week of at-home sleep recordings.

Inclusion Criteria

I am between 15 and 18 years old.

Fluent in or predominantly speaking and reading in English

Must not be pregnant

Exclusion Criteria

I have an intellectual disability (IQ below 70).

Currently impaired by any medical condition that would prevent study participation

Claustrophobia or inability to lie still in the scanner after practice MRI sessions

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinical and Trauma Assessment

Participants undergo a clinical and trauma assessment

1 day

1 visit (in-person)

Testing

Participants complete cognitive testing, surveys, and an MRI

1 day

1 visit (in-person)

Sham Condition Sleep Study

Participants complete an overnight sleep study following one week of at-home sleep recordings with the device in the sham condition

1 week

1 overnight visit (in-person)

Sleep Enhancement Condition Sleep Study

Participants complete an overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition

1 week

1 overnight visit (in-person)

Follow-up

Participants are monitored for changes in emotional regulation and sleep activity

4 weeks

Treatment Details

Interventions

• SmartSleep device (Behavioural Intervention)

Trial Overview The trial is testing the SmartSleep device's ability to enhance slow wave activity during sleep. The aim is to see if better sleep quality can improve how these youths feel the next day.

Participant Groups

Group I: Stimulation mode first Experimental Treatment 1 Intervention

During one week, the SmartSleep device will be set to stimulation mode.

Group II: Sham mode first Placebo Group 1 Intervention

During one week, the SmartSleep device will be set to sham.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

References

1. France pubmed.ncbi.nlm.nih.gov

Evaluation of sleep and therapeutic education needs of military with PTSD. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sleep disturbance in pediatric PTSD: current findings and future directions. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Rapid eye movement sleep disturbance in posttraumatic stress disorder. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Use of a Removable Mandibular Neuroprosthesis for the Reduction of Posttraumatic Stress Disorder (PTSD) and Mild Traumatic Brain Injury/PTSD/Associated Nightmares, Headaches, and Sleep Disturbances. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Continuous remote vital sign/environment monitoring for returning soldier adjustment assessment. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Enhancing Prolonged Exposure therapy for PTSD using physiological biomarker-driven technology. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Life Threat and Sleep Disturbances in Adolescents: A Two-Year Follow-Up of Survivors From the 2011 Utøya, Norway, Terror Attack. [2018]