NightWare and Cardiovascular Health in Veterans With PTSD
VA Office of Research and Development · NCT06419959
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22–88 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 125
- US sites recruiting
- 1
- Study start
- September 10, 2025
- Record last updated
- October 8, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: NightWare
Conditions: Post-traumatic Stress Disorder (PTSD); Cardiovascular Diseases; Autonomic Dysfunction; Vascular Stiffness; Nightmare; Endothelial Dysfunction; Veteran
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Diagnosis of Post-traumatic stress disorder (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
- Resting blood pressure (BP, \<160/100 millimeters of mercury (mmHg)
- Fasted glucose \<126 milligrams per deciliter (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 Criteria
- Unstable medical condition (e.g., uncontrolled hypertension or active Cardiovascular disease (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 thyroid stimulating hormone (TSH)\<0.5 or >5.0 milliunits per liter (mU/L); volunteers with abnormal thyroid stimulating hormone (TSH) values will be re-considered for participation in the study after follow-up evaluation by the Primary Care Provider (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 NightWare (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)
Recruiting US locations
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, CO 80045-7211
Site contact: Claire Cox, BS · (303) 372-1396 · claire.cox@va.gov
Study contacts (from the official record)
- Kerrie L Moreau, PhD · (720) 885-1950 · Kerrie.Moreau@va.gov
- Claire Cox, BS · (303) 372-1396 · claire.cox@va.gov
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