NightWare and Cardiovascular Health in Veterans With PTSD
Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare
VA Office of Research and Development
125 participants
Sep 10, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Self-report having repetitive nightmares contributing to disrupted sleep;
- Age 22 years (rationale is because the device has only been used in adults in 22 years and older);
- Resting blood pressure (BP, \<160/100 mmHg);
- Fasted glucose \<126 mg/dL;
- Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;
- Epworth Sleepiness Scale (ESS): Question #8 score above "0" will prompt an additional question: Do you drive ("get behind the wheel") when you are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns;
- Wireless Internet and two power outlets in sleeping location;
- Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare;
Exclusion Criteria14
- Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer);
- Active infection (note, anyone with an active infection would become eligible once the infection has ended);
- Thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study;
- Use of insulin or sulfonylureas
- Pregnancy or currently breast feeding;
- Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate;
- Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]).
- Shift workers (due to circadian rhythm disruption);
- Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy;
- Nocturia that causes awakening from sleep;
- Known sleep walking or acting out dreams (contraindication to NW use);
- Diagnosis or suspicion of dementia;
- Seizure disorder
- Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06419959