NightWare and Cardiovascular Health in Veterans With PTSD

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Post-traumatic Stress Disorder (PTSD), Cardiovascular Diseases, Autonomic Dysfunction, Vascular Stiffness, Nightmare, Endothelial Dysfunction, Veteran

In brief

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.

Key facts

Study ID: NCT06419959
Run by: VA Office of Research and Development
People needed: 125
Starts: 2025-09-10
Expected to finish: 2026-12-31
Last updated by the study team: 2025-09-12

Who can join

Age: 22 and older, up to 88. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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;

You may not qualify if…

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)

Where it is running

Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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