🔎 Trials Near Me

Home › Post-Traumatic Stress Disorder › NCT06419959

NightWare and Cardiovascular Health in Veterans With PTSD

RecruitingHealthy volunteers welcome

Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare

Who can join

Ages 22 to 88 · All sexes · Healthy volunteers welcome

Full 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)

About the 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.

What is being tested

Sponsor: VA Office of Research and Development · Participants: 125 · Started: Sep 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06419959

Locations in the U.S.

ColoradoRocky Mountain Regional VA Medical Center, Aurora, CO, Aurora

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.