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
What safety data exists for the SmartSleep device for adolescent PTSD?The provided research does not contain specific safety data for the SmartSleep device or its variants. The studies focus on sleep disturbances in PTSD and the use of technology for sleep improvement, but do not evaluate the safety of the SmartSleep device.267810
Is the SmartSleep Device a promising treatment for adolescent PTSD?The SmartSleep Device could be a promising treatment for adolescent PTSD because it aims to improve sleep, which is often disturbed in PTSD patients. Better sleep can help reduce PTSD symptoms and improve overall quality of life.356910
What data supports the idea that SmartSleep Device for Adolescent PTSD is an effective treatment?The available research shows that sleep disturbances are a significant issue in PTSD, with many patients experiencing nightmares and difficulty falling asleep. While specific data on the SmartSleep Device for Adolescent PTSD is not provided, studies on sleep treatments in general suggest that addressing sleep issues can lead to improvements in PTSD symptoms. For example, treatments that improve sleep have been shown to help with PTSD symptoms in adults. This implies that a device like SmartSleep, which targets sleep problems, could potentially be effective for adolescents with PTSD as well.134510
Do I have to stop taking my current medications for the trial?The trial requires that participants do not use medications or other drugs in a manner that may interfere with sleep. If your current medications affect sleep, you may need to stop taking them.
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.Treatment Details
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.
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
Research locations nearbySelect from list below to view details:
University of WisconsinMadison, WI
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Rapid eye movement sleep disturbance in posttraumatic stress disorder. [2019]The subjective sleep disturbance in posttraumatic stress disorder (PTSD), including the repetitive, stereotypical anxiety dream, suggests dysfunctional rapid eye movement (REM) sleep mechanisms. The polysomnograms of a group of physically healthy combat veterans with current PTSD were compared with those of an age-appropriate normal control group. Tonic and phasic REM sleep measures in the PTSD subjects were elevated on the second night of recorded sleep. Increased phasic REM sleep activity persisted in the PTSD group on the subsequent night. During the study, an anxiety dream occurred in a PTSD subject in REM sleep. The results are consistent with the view that a dysregulation of the REM sleep control system, particularly phasic event generation, may be involved in the pathogenesis of PTSD. The finding of a specific disturbance of sleep unique to PTSD may have significant implications for the design of effective treatments for PTSD.
Sleep in posttraumatic stress disorder. [2019]Posttraumatic stress disorder (PTSD) is often associated with sleep disturbances. In this review, we focus on the published literature on subjective and objective findings of sleep in patients with PTSD. Insomnia and nightmares are most commonly reported subjective sleep disturbances. Polysomnographic investigations have frequently reported rapid eye movement (REM) sleep abnormalities in PTSD. However, studies have not been consistent about the type of REM sleep dysfunction in PTSD patients. Antidepressants such as nefazodone, trazodone, fluvoxamine, and imagery rehearsal therapy are found to be beneficial in the treatment of PTSD associated sleep disturbances as well as core symptoms of this anxiety disorder. We propose use of such modalities of treatment in PTSD patients with predominant sleep disturbances. Further studies are required to clarify polysomnographic sleep changes especially role of REM sleep dysregulation and treatment of sleep disturbances in PTSD.
Continuous remote vital sign/environment monitoring for returning soldier adjustment assessment. [2020]A three-stage study to develop and test an unobtrusive room sensor unit and subject data management system to discover correlation between sensor-based time-series measurements of sleep quality and clinical assessments of combat veterans suffering from Post-traumatic Stress Disorder (PTSD) and mild Traumatic Brain Injury (TBI), is described. Experiments and results for testing sensitivity and robustness of the sensor unit and data management protocol are provided. The current sensitivity of remote vital sign monitoring system is below 20% and 10% for respiration and heart rates, respectively.
Sleep disturbance in pediatric PTSD: current findings and future directions. [2021]Many studies have provided strong evidence of a fundamental and complex role for sleep disturbances in adult posttraumatic stress disorder (PTSD). Investigations of adult PTSD using subjective and objective measures document sleep architecture abnormalities and high prevalence of sleep disordered breathing, periodic limb movement disorder, nightmares, and insomnia. PTSD treatment methods do appear to significantly improve sleep disturbance, and also studies suggest that treatments for sleep disorders often result in improvements in PTSD symptoms. Further, the most recent evidence suggests sleep abnormalities may precede the development of PTSD. Given the importance of sleep disorders to the onset, course, and treatment of adult PTSD, examination of sleep disturbances far earlier in the life course is imperative. Here we review the literature on what we know about sleep disturbances and disorders in pediatric PTSD. Our review indicates that the extant, empirical data examining sleep disturbance and disorders in pediatric PTSD is limited. Yet, this literature suggests there are significantly higher reports of sleep disturbances and nightmares in children and adolescents exposed to trauma and/or diagnosed with PTSD than in non-trauma-exposed samples. Sleep questionnaires are predominantly employed to assess sleep disorders in pediatric PTSD, with few studies utilizing objective measures. Given the important, complex relationship being uncovered between adult PTSD and sleep, this review calls for further research of sleep in children with PTSD using more specific subjective measures and also objective measures, such as polysomnography and eventually treatment trial studies.
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]Posttraumatic stress disorder (PTSD) has been associated with nighttime headaches (HAs), nightmares (NMs), and difficulty falling or staying asleep (sleep disturbances [SD]). The authors of the current study evaluated the correlative elements of using a removable mandibular neuroprosthesis (RMN) and the reduction of these symptoms in participants diagnosed with PTSD or mild traumatic brain injury (mTBI)/PTSD. The RMN device is a form of specialized dental splint that has a potential to reduce the painful stimuli of bruxing and potential upregulation of threat response systems that may occur during sleep.
Life Threat and Sleep Disturbances in Adolescents: A Two-Year Follow-Up of Survivors From the 2011 Utøya, Norway, Terror Attack. [2018]A significant number of adolescents have been exposed to traumatic life events. However, knowledge about the specific sleep disturbance that occurs in individuals after trauma exposure is predominantly based on studies of adults. This study reports specific sleep disturbance in 42 survivors of the 2011 mass shooting at a youth summer camp on the Norwegian island Utøya, mean age = 20.91 years, SD = 2.32, 62.5% females. When compared with matched controls, significantly more survivors reported having sleep disturbances, 52.4% versus 13.6%, d = 0.93, of which onset began at the time of the shooting, χ2 = 14.9, p < .001. The prevalence of insomnia, 56.3% versus 11.0%, d = 0.73; excessive daytime sleepiness, 34.4% versus 13.6%, d = 0.61; symptoms of obstructive sleep apnea, 18.8% versus 0%, d = 0.70; and frequent nightmares, 37.5% versus 2.3%, d = 0.90, were all higher in the survivors than in the controls. In a subgroup of survivors (n = 20) with psychiatric diagnoses, sleep disturbances were more prevalent than in survivors without psychiatric diagnosis. Actigraphy data revealed delayed bedtime, sleep onset, and rise time in survivors compared with controls, ts > 1.7, ps = .044 to .028. These results corroborate the effects of a life threat on the range and extent of sleep disturbances, and emphasize the need to better assess and treat sleep disorders in adolescents exposed to trauma.
Pilot evaluation of the Sleep Ninja: a smartphone application for adolescent insomnia symptoms. [2020]The aim of this study was to test the feasibility, acceptability and preliminary effects of a recently developed smartphone application, Sleep Ninja, for adolescent sleep difficulties.
Using wearable and mobile technology to measure and promote healthy sleep behaviors in adolescents: a scoping review protocol. [2022]The objective of this scoping review is to map the evidence related to how consumer-targeted wearable and mobile technology is being used to measure and/or promote sleep among adolescents.
Enhancing Prolonged Exposure therapy for PTSD using physiological biomarker-driven technology. [2023]Prolonged Exposure (PE) therapy is one of the most efficacious, evidence-based treatments for posttraumatic stress disorder (PTSD). A key component of PE involves in vivo exposures (IVEs) during which patients approach situations or activities in "real life" that are safe but avoided because they elicit a fear response. Despite their critical role in treatment, little research has focused on IVEs. This gap in knowledge is primarily due to the fact that IVEs are typically conducted by patients in between therapy sessions, leaving clinicians reliant upon patient self-report. This approach has numerous shortcomings, which the current study addresses by leveraging technology to develop an innovative device that allows for physiological, biomarker-driven, therapist-guided IVEs. The new system enables clinicians to virtually accompany patients during IVEs and provides real-time physiological (heart rate, skin conductance) and self-report (subjective units of distress) data that clinicians can use to modify the exposure and optimize therapeutic value. This Small Business Innovation Research (SBIR) Phase I project aims to: (1) integrate physiological sensors and live audio/visual streaming into a system for clinicians to guide patients during IVEs; (2) determine feasibility and acceptability of the system; and (3) conduct a pilot randomized clinical trial among veterans with PTSD (N = 40) to evaluate the preliminary efficacy of the system in reducing PTSD symptoms during PE. This paper describes the rationale, design, and methodology of the Phase I project. The findings from this study have the potential to innovate clinical practice, advance the science of exposure therapy, and improve clinical outcomes.
Evaluation of sleep and therapeutic education needs of military with PTSD. [2023]Sleep disorders in post-traumatic stress disorder (PTSD) are both diagnostic (nocturnal reliving) and prognostic. Poor sleep worsens the daytime symptomatology of PTSD and makes it resistant to treatment. However, no specific treatment is codified in France to treat these sleep disorders although sleep therapies (cognitive behavioural therapy for insomnia, psychoeducation and relaxation) have proven for years to be effective in treating insomnia. Therapeutic sessions can be part of a therapeutic patient education program, which is a model for the management of chronic pathologies. It allows for an improvement in a patient's quality of life and enhanced medication compliance. We therefore carried out an inventory of sleep disorders of patients with PTSD. First, we collected data by means of sleep diaries concerning the population's sleep disorders at home. Then we assessed the population's expectations and needs regarding its management of sleep, thanks to a semi-qualitative interview. The data from sleep diaries, which was consistent with the literature, showed that our patients suffered from severe sleep disorders that strongly impact their daily lives, with 87% of patients having an increased sleep onset latency, and 88% having nightmares. We observed a strong demand from patients for specific support for these symptoms, 91% expressing an interest in a TPE program targeting sleep disorders. Thanks to the data collected, the emerging themes for a future therapeutic patient education program targeting sleep disorders of soldiers with PTSD are: sleep hygiene; management of nocturnal awakenings, including nightmares; and psychotropic drugs.