NightWare Smartwatch for Insomnia
(INSIGHT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a smartwatch to determine its effectiveness in helping military members with insomnia, particularly those with traumatic brain injuries or PTSD. The NightWare smartwatch uses gentle vibrations to interrupt stress-related sleep disruptions. Participants include current or former military members with sleep issues who have not recently used sleep aids or certain medications. The goal is to improve sleep quality and daytime functioning by reducing sleep disturbances. As an unphased trial, this study provides a unique opportunity for participants to explore innovative solutions for better sleep and improved daily life.
Do I need to stop taking my current medications to join the trial?
Yes, you may need to stop taking certain medications. The trial excludes participants who have used alpha or beta-receptor active medications, prescribed sleep aids, or started using SNRIs or SSRIs in the last 3 months. Additionally, if you've started any medication for improving sleep in the last 90 days, you may not be eligible.
What prior data suggests that the NightWare smartwatch is safe for treating insomnia?
Studies have shown that the FDA has approved the NightWare smartwatch for treating nightmares, indicating its general safety. In a previous study, participants used the NightWare device for 30 days in a controlled environment. The study found the smartwatch easy to use and free of major side effects. However, researchers continue to study the long-term safety of NightWare, so staying updated is important. Overall, the smartwatch provides a non-invasive method (not involving surgery or entering the body) to improve sleep by reducing the impact of nightmares.12345
Why are researchers excited about this trial?
The NightWare smartwatch is unique because it uses gentle haptic vibrations to interrupt stress signals during sleep without waking the user, aiming to improve sleep quality and alleviate insomnia symptoms. Unlike traditional insomnia treatments like medications or cognitive behavioral therapy, which can take time and require significant commitment, this smartwatch offers a non-invasive and immediate intervention by actively monitoring physiological signs of stress. Researchers are excited about this treatment because it represents a novel, tech-driven approach that could provide a more personalized and efficient way to manage insomnia.
What evidence suggests that the NightWare smartwatch is effective for insomnia?
Research has shown that the NightWare smartwatch can improve sleep for those with insomnia caused by nightmares. In this trial, participants in the intervention arm will receive a functioning NightWare smartwatch. The device senses spikes in heart rate and movement during sleep, indicating stress, and gently vibrates to interrupt these signals without waking the person. This process helps reduce nighttime stress and can enhance continuous sleep. Studies found that about 68.4% of users reported a good or excellent response to the treatment. The FDA has already approved NightWare for treating nightmares, supporting its potential effectiveness for insomnia related to stress and other conditions.23678
Are You a Good Fit for This Trial?
The INSIGHT trial is for warfighters with sleep issues, PTSD, or traumatic brain injury. It aims to improve their sleep and reduce symptoms like nightmares and insomnia by using a NightWare smartwatch that detects and interrupts excessive sympathetic activation during sleep.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo cognitive testing and detailed baseline assessments before completing a 2-week at-home data collection period with wearable devices.
In-lab Assessment
Participants complete an overnight in-lab polysomnogram combined with fNIRS to measure sleep stages, autonomic dynamics, cerebral hemodynamics, and glymphatic signatures.
Treatment
Participants enter a 30-day randomized trial testing the NightWare smartwatch, with daily wearable monitoring and ecological momentary assessments.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of sleep quality and autonomic stability.
What Are the Treatments Tested in This Trial?
Interventions
- NightWare smartwatch
Trial Overview
Participants will wear the NightWare smartwatch which vibrates in response to signs of stress during REM sleep. The study compares this intervention against no treatment (sham) over a period of time to see if it improves sleep quality, cognitive function, and reduces sympathetic hyperactivity.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants assigned to the active intervention receive a functioning NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns. When these stress signals exceed a preset threshold, the device delivers brief, gentle haptic vibrations designed to interrupt escalating autonomic arousal without fully awakening the user. The goal is to reduce nighttime sympathetic hyperactivity, improve sleep continuity, and alleviate insomnia symptoms. Participants wear the device nightly for 30 days and complete daily surveys and physiological monitoring to assess treatment effects.
Participants assigned to the sham intervention receive an outwardly identical NightWare smartwatch that does not deliver haptic interventions in response to stress physiology. The sham device collects the same passive physiological data but does not actively attempt to modify sleep or autonomic activity. This arm controls for placebo effects, device expectations, and nightly wear. Participants follow the same 30-day procedures, including daily surveys and physiological sensor wear, ensuring all aspects of participation are identical except for the therapeutic haptic function.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Uniformed Services University of the Health Sciences
Lead Sponsor
Walter Reed National Military Medical Center
Collaborator
Applied Physics Laboratory
Collaborator
University of Minnesota
Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborator
The Geneva Foundation
Collaborator
National Intrepid Center of Excellence
Collaborator
Citations
NIGHTWARE CLINICAL INFORMATION
NightWare is a digital therapeutic system that temporarily reduces sleep disturbance related to nightmares. NightWare provides customized medical treatment for ...
A randomized sham-controlled clinical trial of a novel ...
Overall, these results provide preliminary evidence that a wearable device may improve self-reported sleep quality for veterans reporting frequent trauma- ...
Retrospective Assessment of Smart Watch Haptic ...
Results: In this retrospective study, we found that 68.4% of patients reported a good or excellent response to treatment, and 92.9% of patients.
DEN200033 Decision Summary - accessdata.fda.gov
The NightWare digital therapeutic is indicated to provide vibrotactile feedback on an. Apple Watch based on an analysis of heart rate and motion during sleep, ...
Traumatic Nightmares Treated by NightWare (To Arouse ...
The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related ...
Important Safety Information
The long term safety and effectiveness of the NightWare device has not been established. The long term effects of the NightWare device use on the sleep ...
DATA SECURITY
NightWare is the first and only FDA cleared digital therapeutic to interrupt nightmares and help improve sleep quality. • NightWare's platform uses patented ...
Please refer to page 4 for safety and indication information. ...
NightWare uses cumulative data to calculate the Stress Index. NightWare improves sleep by interrupting nightmares when they happen. It is a non-invasive ...
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