Actively Recruiting
NightWare and Cardiovascular Health in Veterans With PTSD
Led by VA Office of Research and Development · Updated on 2025-09-12
125
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NightWare and Cardiovascular Health in Veterans With PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of PTSD according to DSM-5 criteria
- Self-reported repetitive nightmares that disrupt sleep
- Age 22 years or older
- Resting blood pressure below 160/100 mmHg
- Fasting glucose less than 126 mg/dL
- Poor overall sleep quality with Pittsburgh Sleep Quality Index score of 6 or higher
- Epworth Sleepiness Scale question #8 score above 0 with a response of "No" to driving while drowsy
- Access to wireless internet and two power outlets in sleeping location
- Willingness to avoid other applications collecting heart rate data 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 infection at the time of screening
- Thyroid dysfunction with TSH less than 0.5 or greater than 5.0 mU/L without follow-up evaluation
- Use of insulin or sulfonylureas
- Pregnancy or currently breastfeeding
- Recent (past 3 months) substance or alcohol abuse except marijuana
- Elevated acute risk for suicidal self-directed violence requiring immediate hospitalization
- Shift work causing circadian rhythm disruption
- Active sleep disorders such as arousal disorder, 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 that prevent participation, including active psychosis or imminent suicidality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
C
Claire Cox, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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