180 Participants Needed

SmartSleep Device for Adolescent PTSD

SH
Overseen BySara Heyn, JD, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.23467

Who Is on the Research Team?

SJ

Stephanie Jones, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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

Fluent in or predominantly speaking and reading in English
Must not be pregnant
Must agree not to participate in any other interventional clinical trials during the duration of the study
See 7 more

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
See 16 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • SmartSleep device
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stimulation mode firstExperimental Treatment1 Intervention
During one week, the SmartSleep device will be set to stimulation mode.
Group II: Sham mode firstPlacebo Group1 Intervention
During one week, the SmartSleep device will be set to sham.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

Patients with PTSD experience severe sleep disorders, with 87% reporting difficulty falling asleep and 88% suffering from nightmares, which significantly affect their daily lives.
There is a strong demand for targeted support for sleep disorders among PTSD patients, with 91% expressing interest in a therapeutic patient education program focused on improving sleep hygiene and managing nocturnal awakenings.
Evaluation of sleep and therapeutic education needs of military with PTSD.Remadi, M., Dinis, S., Bernard, L., et al.[2023]
Sleep disturbances are significantly more common in children and adolescents with PTSD compared to those without trauma exposure, indicating a potential link between trauma and sleep issues.
Current research on sleep disorders in pediatric PTSD is limited, highlighting the need for more comprehensive studies using both subjective and objective measures to better understand and treat these conditions.
Sleep disturbance in pediatric PTSD: current findings and future directions.Kovachy, B., O'Hara, R., Hawkins, N., et al.[2021]
Combat veterans with PTSD showed increased tonic and phasic REM sleep activity compared to a normal control group, indicating a potential dysfunction in REM sleep mechanisms.
The study suggests that dysregulation of REM sleep, particularly in phasic activity, may contribute to the development of PTSD symptoms, highlighting the need for targeted treatments that address these specific sleep disturbances.
Rapid eye movement sleep disturbance in posttraumatic stress disorder.Ross, RJ., Ball, WA., Dinges, DF., et al.[2019]

Citations

Evaluation of sleep and therapeutic education needs of military with PTSD. [2023]
Sleep disturbance in pediatric PTSD: current findings and future directions. [2021]
Rapid eye movement sleep disturbance in posttraumatic stress disorder. [2019]
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]
Continuous remote vital sign/environment monitoring for returning soldier adjustment assessment. [2020]
Enhancing Prolonged Exposure therapy for PTSD using physiological biomarker-driven technology. [2023]
Life Threat and Sleep Disturbances in Adolescents: A Two-Year Follow-Up of Survivors From the 2011 Utøya, Norway, Terror Attack. [2018]
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