An interventional study of NightWare in Post-traumatic Stress Disorder (PTSD), Cardiovascular Diseases and Autonomic Dysfunction, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 22 Years to 88 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.
Posttraumatic stress disorder (PTSD) is associated with profound health consequences in Veterans, including cardiovascular disease (CVD), the leading cause of death in adults in the United States. Trauma-related nightmares, a hallmark of PTSD, are a debilitating symptom that can lead to poor sleep quality and other health issues that ultimately cause clinically significant impairments in daily functioning. Recently, nightmares were reported to be an independent predictor of CVD in Veterans, for reasons that are unclear. Poor sleep is associated with increased CVD risk, possibly by impairing vascular health and nervous system function. Nightmare-related sleep disturbances are often resistant to first-line treatment (e.g., psychotherapy, medications) and even with improvements, residual nightmares and sleep disturbances often persist that still meet clinical significance. Moreover, significant barriers often exist including access to care and lack of trained providers, that prevent reaching and engagement of individuals to treatments, and there is poor adherence to interventions overall. As such, there is a need to implement interventions and/or complementary approaches that may appeal to Veterans experiencing PTSD-related nightmares who are looking for alternatives. In this regard, NightWare (NW) digital therapeutic is a novel smart watch application that was recently granted Breakthrough Device designation by the FDA for the treatment of nightmares in adults with PTSD. It uses the wearer's biometric data (i.e., heart rate, body movement and position) to distinguish normal and distressed sleep and interrupt nightmares. Preliminary evidence demonstrated an improvement in subjective sleep quality in Veterans after 30-days of NW compared with a sham condition. However, it is unknown whether NW improves sleep quality in Veterans with PTSD with co-morbid medical conditions such as obstructive sleep apnea (OSA) or in those using medications (e.g., prazosin) to treat nightmares related to PTSD. It is also unknown if the effects of NW on sleep are similar in male and female Veterans, or whether improvements in sleep with NW result in improvements in objective sleep (i.e., sleep physiology) or cardiovascular health. In this context, this study will determine if 8 weeks of NW improves subjective sleep in Veterans with PTSD-related nightmares, including those with OSA and/or taking medications to treat PTSD related nightmares (e.g., prazosin). The change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 8 weeks will be measured. Additional goals will evaluate changes in cardiovascular health outcomes with NW use and if there are potential sex differences in the response to NW. The proposed research is a high priority topic of the Veterans Affairs, as PTSD affects 11-23% of Veterans in a given year. The research is highly innovative and if successful will lead to significant advances in the healthcare of Veterans, particularly as it relates to the treatment of PTSD-related nightmares.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 125 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention with NightWare Therapeutic System
Device: NightWare
NightWare app disabled; device will not deliver an intervention
Device: NightWare
Nightware intervention app (enabled) will attempt to detect when an individual is having a nightmare based on a Nightware proprietary algorithm and attempt to disrupt the nightmare without awakening. In the sham comparator group the NightWare app will be disabled and not deliver an intervention.
Change in Pittsburgh Sleep Quality Index
Sleep questionnaire with a scale of 0 to 21 with a higher score indicating a significant sleep disturbance
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in physiological sleep - total sleep time
Total sleep duration (minutes) calculated through ambulatory electroencephalography.
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in endothelial function
Brachial artery flow mediated dilation (FMD) using ultrasound
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in Autonomic function - spontaneous baroreflex sensitivity (BRS)
Cardiovagal baroreflex sensitivity (cBRS) measured using beat-to-beat time series of systolic blood pressures (finger photo-plethysmography) and R-R interval (three-lead electrocardiogram) will be recorded simultaneously at 1,000 Hz.
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in large elastic artery stiffness
Carotid-femoral pulse wave velocity (PWV)
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in large elastic artery stiffness
Augmentation index and aortic blood pressure via pulse wave analysis
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in autonomic function - heart rate variability (HRV)
Heart rate variability
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in physiological sleep - wake after sleep onset
Wake after sleep (minutes) calculated through ambulatory electroencephalography.
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in physiological sleep - sleep efficiency
Sleep efficiency (percentage) calculated through ambulatory electroencephalography.
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in physiological sleep - REM sleep
REM sleep (minutes) calculated through ambulatory electroencephalography.
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in physiological sleep - Deep sleep
Deep sleep (minutes) calculated through ambulatory electroencephalography.
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Change in physiological sleep - Light sleep
Light sleep (minutes) calculated through ambulatory electroencephalography.
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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