Actively Recruiting
Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare
Led by VA Office of Research and Development · Updated on 2025-09-12
125
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the impact of NightWare, a prescription wrist-wearable device, on improving sleep quality and cardiovascular health in Veterans suffering from posttraumatic stress disorder (PTSD) with trauma-related nightmares. PTSD is linked to serious health issues including cardiovascular disease, which is the leading cause of death in U.S. adults. Nightmares significantly disrupt sleep and daily functioning, and are also linked to cardiovascular risks. Existing treatments often leave residual symptoms, and access to care can be limited, highlighting the need for alternative therapies like NightWare. The study involves two groups: one using the active NightWare device, which detects nightmare distress through biometric data and attempts to interrupt the nightmare without waking the user, and a sham group where the device’s app is disabled. Participants will use the device for 8 weeks. The research also explores whether the device’s effects differ between male and female Veterans and whether it benefits those with other conditions like obstructive sleep apnea or those taking medications such as prazosin. Participants will be evaluated before and after the 8-week period using the Pittsburgh Sleep Quality Index to measure changes in subjective sleep quality. Additional assessments include various physiological sleep measures, cardiovascular function tests, and autonomic nervous system evaluations. The study will monitor safety and adherence throughout, aiming to better understand NightWare’s effects on sleep and cardiovascular health in this population. Total participation duration includes the 8 weeks of device use plus assessments.
CONDITIONS
Brief Title
NightWare and Cardiovascular Health in Veterans With PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of PTSD by DSM-5 criteria
- Self-reported repetitive nightmares causing disrupted sleep
- Age between 22 and 88 years
- Resting blood pressure below 160/100 mmHg
- Fasting glucose less than 126 mg/dL
- Poor sleep quality with Pittsburgh Sleep Quality Index score of 6 or higher
- Epworth Sleepiness Scale question #8 answered "No" to driving when drowsy
- Access to wireless internet and two power outlets in sleeping area
- Willingness not to use other heart rate monitoring apps on phone or watch used for NightWare
You will not qualify if you...
- Unstable medical conditions such as uncontrolled hypertension, active cardiovascular disease, or cancer
- Active infections
- Thyroid dysfunction with ultrasensitive TSH below 0.5 or above 5.0 mU/L without proper management
- Use of insulin or sulfonylureas
- Pregnancy or breastfeeding
- Substance or alcohol abuse in past 3 months (excluding marijuana)
- Elevated acute risk for suicidal self-directed violence requiring immediate hospitalization
- Shift work causing circadian rhythm disruption
- Diagnosed sleep disorders like disorder of arousal, REM sleep behavior disorder, or narcolepsy
- Nocturia causing awakening from sleep
- Known sleepwalking or acting out dreams
- Diagnosis or suspicion of dementia
- Seizure disorder
- Severe cognitive impairment or psychiatric symptoms preventing participation (e.g., active psychosis, imminent suicide risk)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants use the NightWare device for 8 weeks to treat trauma-related nightmares associated with PTSD.
Baseline visit and 1 follow-up visit after 8 weeks
Trial Site Locations
Total: 1 location
1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211
Actively Recruiting
Research Team
K
Kerrie L Moreau, PhD
C
Claire Cox, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here