SmartSleep Device for Adolescent PTSD

Overseen By Sara Heyn, JD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Sleep medications, Alcohol

Disqualifiers: Neurodevelopmental disorders, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

180 Participants Needed

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

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

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

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

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+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid eye movement sleep disturbance in posttraumatic stress disorder. Ross, RJ., Ball, WA., Dinges, DF., et al.[2019]

The use of a removable mandibular neuroprosthesis (RMN) significantly reduced the frequency and intensity of nighttime headaches, nightmares, and sleep disturbances in 32 participants with PTSD or mild traumatic brain injury, with scores dropping from an average of 0.52 at baseline to 0.20 in the first experimental phase.

All participants reported improvements in their symptoms while using the RMN, and importantly, no one experienced worsening symptoms, indicating the device's safety and potential efficacy in managing PTSD-related sleep issues.

NCBI (Pubmed)

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. Moeller, DR., Duffey, JM., Goolsby, AM., et al.[2022]

The study developed a room sensor unit to monitor sleep quality in combat veterans with PTSD and mild TBI, aiming to correlate sensor data with clinical assessments.

Current results show that the sensitivity of the remote vital sign monitoring system is low, with only 20% sensitivity for respiration and 10% for heart rates, indicating a need for improvement in the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous remote vital sign/environment monitoring for returning soldier adjustment assessment. Genc, S., Cleary, DJ., Yardibi, T., et al.[2020]

Prolonged Exposure (PE) therapy is a highly effective treatment for PTSD, and this study introduces a new technology that allows therapists to guide patients through in vivo exposures (IVEs) in real-time, enhancing the treatment process.

The study involves a pilot randomized clinical trial with 40 veterans to assess the feasibility and preliminary efficacy of this innovative system, which collects physiological and self-report data to optimize exposure therapy and potentially improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Prolonged Exposure therapy for PTSD using physiological biomarker-driven technology. Back, SE., Acierno, R., Saraiya, TC., et al.[2023]

In a study of 42 survivors of the 2011 mass shooting in Norway, 52.4% reported sleep disturbances compared to only 13.6% of matched controls, highlighting a significant impact of trauma on sleep health.

Specific sleep issues such as insomnia (56.3% vs. 11.0%), excessive daytime sleepiness (34.4% vs. 13.6%), and frequent nightmares (37.5% vs. 2.3%) were notably higher in survivors, indicating the need for targeted assessment and treatment of sleep disorders in traumatized adolescents.

NCBI (Pubmed)

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. Grønli, J., Melinder, A., Ousdal, OT., et al.[2018]

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]