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 | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 125 participants in total. It began in 2025-09-10 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Exclusion Criteria: 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) 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 NightWare (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)
Contact & Investigator
Kerrie L Moreau, PhD
PRINCIPAL INVESTIGATOR
Rocky Mountain Regional VA Medical Center, Aurora, CO
Frequently Asked Questions
Who can join the NCT06419959 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 88 Years, studying Post-traumatic Stress Disorder (PTSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06419959 currently recruiting?
Yes, NCT06419959 is actively recruiting participants. Contact the research team at Kerrie.Moreau@va.gov for enrollment information.
Where is the NCT06419959 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06419959 clinical trial?
NCT06419959 is sponsored by VA Office of Research and Development. The principal investigator is Kerrie L Moreau, PhD at Rocky Mountain Regional VA Medical Center, Aurora, CO. The trial plans to enroll 125 participants.
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