NCT06419959 NightWare and Cardiovascular Health in Veterans With PTSD
| NCT ID | NCT06419959 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Post-traumatic Stress Disorder (PTSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2026-09-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 Criteria
Inclusion Criteria: 1. 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). 2. Self-report having repetitive nightmares contributing to disrupted sleep; 3. Age 22 years (rationale is because the device has only been used in adults in 22 years and older); 4. Resting blood pressure (BP, \<160/100 mmHg); 5. Fasted glucose \<126 mg/dL; 6. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher; 7. 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; 8. Wireless Internet and two power outlets in sleeping location; 9. Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare; Exclusion Crit
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.