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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether improving sleep quality can positively impact emotions in teens with post-traumatic stress disorder (PTSD). Researchers will use a device called SmartSleep to enhance sleep and compare its effects to a non-active version. Teens aged 15-18 who have experienced trauma, such as witnessing violence or a natural disaster, and are currently dealing with severe PTSD symptoms may be a good fit. Participants will attend study visits, including sleep studies and assessments.

As an unphased trial, this study offers teens the opportunity to contribute to important research that could improve PTSD treatment options.

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 prior data suggests that the SmartSleep device is safe for adolescents with PTSD?

Current research examines the safety of the SmartSleep device, which aims to enhance deep sleep and potentially improve sleep quality. Good sleep plays a crucial role in managing emotions, particularly for individuals with PTSD (post-traumatic stress disorder).

The device is designed for comfort and safety. Although specific side effects have not yet been identified, similar devices typically prove safe and cause only minor issues, if any. As this study is in its early stages, it primarily focuses on ensuring the device does not harm participants.

Prospective trial participants should know that the main goal is to ensure safety while exploring the device's potential benefits for sleep and emotional well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SmartSleep device is unique because it explores a new, non-invasive method to address adolescent PTSD. Unlike traditional treatments like therapy and medication, which can take time and have various side effects, the SmartSleep device uses targeted brain stimulation to potentially provide quicker relief. Researchers are excited about this device because it offers a novel approach that could be more accessible and easier for young people to incorporate into their daily routines. Additionally, the use of a sham mode helps ensure that any improvements are truly due to the device's active stimulation, providing robust data on its effectiveness.

What evidence suggests that the SmartSleep device is effective for adolescent PTSD?

Research has shown that better sleep can help alleviate post-traumatic stress disorder (PTSD) symptoms. In this trial, participants will use the SmartSleep device, which employs special technology to enhance deep sleep. The trial includes two arms: one with the SmartSleep device set to stimulation mode and another set to sham mode. Studies suggest that improving deep sleep can lead to better sleep quality and fewer sleep problems. Good sleep can help manage emotions and stress, which is crucial for people with PTSD. Early research supports the idea that focusing on sleep can significantly improve emotional health for teenagers with PTSD. ^{1 2 6 7 8}

Who Is on the Research Team?

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

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 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?

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+

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.

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]

Citations

1. withpower.com withpower.com/trial/phase-stress-disorders-traumatic-3-2024-a8f42

SmartSleep Device for Adolescent PTSD What data supports the effectiveness of the SmartSleep device treatment for adolescent PTSD? Research shows that sleep therapies, like cognitive behavioral ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06341413?term=AREA%5BBasicSearch%5D(PTSD%20OR%20post%20traumatic%20stress%20disorder%20OR%20post%20traumatic%20neuroses%20OR%20traumatic%20stress%20disorders%20OR%20combat%20disorders%20OR%20combat%20fatigue%20OR%20disaster%20survivor%20OR%20emotional%20trauma%20OR%20psychological%20shock)%20AND%20AREA%5BOverallStatus%5D(RECRUITING%20OR%20NOT_YET_RECRUITING%20OR%20AVAILABLE)%20AND%20AREA%5BFunderTypeSearch%5D(NIH)&rank=5

Sleep and Emotion Processing in Adolescent Post- ... Using SmartSleep's sleep enhancement algorithms, researchers will determine whether the deepest sleep, slow-wave activity (SWA) of non-rapid eye-movement (NREM) ...

3. researchgate.net researchgate.net/publication/376411928_SleepSmart_an_IoT-enabled_continual_learning_algorithm_for_intelligent_sleep_enhancement

SleepSmart: an IoT-enabled continual learning algorithm ... ... results show that SleepSmart can significantly improve sleep quality and reduce sleep disturbance. The proposed system has the potential to ...

4. mdpi.com mdpi.com/2077-0383/13/13/3926

Light Therapy in Post-Traumatic Stress Disorder LT was associated with a significant improvement in PTSD symptom severity in the single-arm study and two RCTs, as well as a greater retention of extinction ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2950193825000166

Sleep: An unplayed ace in research and treatment of youth ... Ruoff, et al. Cognitive behavioral therapy for insomnia reduces fear of sleep in individuals with posttraumatic stress disorder. Journal of Clinical Sleep ...

6. trialx.com trialx.com/clinical-trials/listings/315639/sleep-and-emotion-processing-in-adolescent-post-traumatic-stress-disorder/

Sleep and Emotion Processing in Adolescent Post ... The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7402856/

Sleep, a Governor of Morbidity in PTSD: A Systematic Review ... Research has identified two distinct SDs highly prevalent in PTSD; insomnia and nightmares. Those who report SDs prior to a traumatic event are at greater risk ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12006942/

Protocol MelatoSom-Kids-PTSD: sleep disturbances in ... Preliminary data suggest that (e) treatment of sleep disorders may yield significant improvement ... adolescents with posttraumatic stress ...