NightWare for reducing nightmares and supporting heart health in Veterans with PTSD
Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare
This trial will test whether a prescription wrist-wearable app called NightWare can reduce PTSD-related nightmares and improve sleep and cardiovascular health in Veterans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 22 Years to 88 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06419959 on ClinicalTrials.gov |
What this trial studies
Veterans with DSM-5 PTSD who report repetitive nightmares and poor sleep will use the prescription NightWare wrist-wearable during sleep while researchers monitor outcomes. Sleep measures will include nightmare frequency and validated questionnaires, and cardiovascular assessments will include vascular stiffness, autonomic function, blood pressure, and relevant biomarkers. The study enrolls adults 22 and older with controlled blood pressure and glucose who can run the device at home with wireless internet and power. Safety, adherence, and device-collected heart-rate patterns will also be tracked over the intervention period.
Who should consider this trial
Good fit: Ideal candidates are Veterans aged 22 or older with DSM-5 PTSD who have repetitive nightmares, poor sleep (PSQI ≥6), controlled BP and glucose, and reliable home internet and power for the device.
Not a fit: Patients without PTSD-related nightmares, those with uncontrolled hypertension or diabetes, people who drive when drowsy, or those unable to use a compatible smartwatch or home internet likely will not benefit.
Why it matters
Potential benefit: If successful, NightWare could lessen nightmares and sleep disruption and may improve vascular and autonomic measures, lowering cardiovascular risk for affected Veterans.
How similar studies have performed: NightWare has received FDA Breakthrough Device designation and prior clinical work showed reductions in nightmares in adults with PTSD, but effects on cardiovascular health are largely untested.
Eligibility criteria
Show full inclusion / exclusion 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 Criteria:
1. Unstable medical condition (e.g., uncontrolled hypertension or active 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 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;
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);
9. Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy;
10. Nocturia that causes awakening from sleep;
11. Known sleep walking or acting out dreams (contraindication to NW use);
12. Diagnosis or suspicion of dementia;
13. Seizure disorder
14. Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)
Where this trial is running
Aurora, Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Kerrie L Moreau, PhD — Rocky Mountain Regional VA Medical Center, Aurora, CO
- Study coordinator: Kerrie L Moreau, PhD
- Email: Kerrie.Moreau@va.gov
- Phone: (720) 885-1950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.