RecruitingPost-traumatic Stress Disorder (PTSD)Cardiovascular DiseasesAutonomic Dysfunction
NightWare and Cardiovascular Health in Veterans With PTSD
Eligible age
22–88 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: VA Office of Research and Development
You may qualify if…
- ✓ 1. 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)
- ✓ 2. Self-report having repetitive nightmares contributing to disrupted sleep
- ✓ 3. Resting blood pressure (BP, \<160/100 millimeters of mercury (mmHg)
- ✓ 4. Fasted glucose \<126 milligrams per deciliter (mg/dL)
- ✓ 5. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher
- ✓ 6. 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
- ✓ 7. Wireless Internet and two power outlets in sleeping location
- ✓ 8. 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…
- ✕ 1. Unstable medical condition (e.g., uncontrolled hypertension or active Cardiovascular disease (CVD)or cancer)
- ✕ 2. Active infection (note, anyone with an active infection would become eligible once the infection has ended)
- ✕ 3. 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
- ✕ 4. Use of insulin or sulfonylureas
- ✕ 5. Pregnancy or currently breast feeding
- ✕ 6. 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
- ✕ 7. 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 \[C-SSRS\])
- ✕ 8. Shift workers (due to circadian rhythm disruption)
Where it's recruiting
Colorado
Aurora
Source: ClinicalTrials.gov · NCT06419959 · last updated 2026-09-22