A groundbreaking clinical trial has been announced to evaluate a medical device designed to address insomnia, nightmares, and sympathetic hyperactivity in vulnerable populations, including individuals with PTSD and TBI. The trial, sponsored by a coalition of esteemed institutions, will assess the performance of the NightWare smartwatch intervention.
What is this clinical trial about?
The announced study, titled INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention, explores the use of technology to tackle persistent sleep disorders and nighttime trauma-related symptoms. The trial specifically targets nightmare disorder, insomnia, PTSD, and traumatic brain injuries (TBI). It remains in the ‘not yet recruiting’ stage, but sponsors aim to begin participant enrollment soon.
This investigative study is being led by a distinguished group, including the Uniformed Services University of the Health Sciences, the University of Minnesota, Walter Reed National Military Medical Center, and several others. The primary aim is to collect safety and efficacy data to support its regulatory and clinical objectives.
How does the NightWare device work?
NightWare is a smartwatch-based innovation designed to identify physiological markers of sympathetic activation during sleep. The device monitors heart rate and movement to detect patterns associated with nightmares or distress. When it identifies abnormalities, it intervenes with subtle vibrations intended to disrupt nightmares without fully waking the individual.
Participants will be randomly assigned to active treatment with the NightWare system or to a sham device that offers no active intervention. This allows researchers to generate valid comparative data regarding the device’s effectiveness.
Who can benefit from and participate in this trial?
This trial is expected to be particularly beneficial to military personnel and veterans, as the associated conditions—such as PTSD and TBI—disproportionately impact these groups. However, civilians meeting the eligibility criteria may also be recruited.
While the trial’s specific inclusion and exclusion criteria have not been disclosed in detail yet, potential participants will likely include individuals who have been diagnosed with chronic sleep disturbances or trauma-related symptoms significantly affecting quality of life.
Further information about participant recruitment timelines and site locations will be available closer to the study activation.
Frequently Asked Questions
1. What conditions does this trial focus on?
This study focuses on nightmares, insomnia, PTSD, TBI, sleep disorders, and REM behavior disorder.
2. Is the NightWare device already approved for use?
No, the NightWare device is currently under investigation, and its safety and efficacy are being evaluated as part of this trial.
3. How can I learn more about study participation?
Interested participants can check updates on recruitment and further details on the official ClinicalTrials.gov page.
Conclusion
The INSIGHT clinical trial represents a promising step forward in addressing severe sleep disturbances through technology. With its focus on underserved populations, the study has the potential to improve quality of life for those struggling with pervasive sleep-related conditions. If successful, the NightWare device could revolutionize how these issues are managed in clinical and personal settings.
Disclaimer
The information provided here is for professional and informational purposes only. It does not constitute legal or regulatory advice.
Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07288593?term=medical+device