Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare
University of Colorado, Denver
Summary
The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.
Description
Women are disproportionally affected by posttraumatic stress disorder (PTSD), a debilitating mental health disorder that profoundly increases cardiovascular disease (CVD) risk. Biological processes including vascular dysfunction (i.e., impaired endothelial function, arterial stiffening), increased renin-angiotensin-aldosterone system (RAAS) activity, and altered renal vascular control and function may contribute to the pathophysiological link between PTSD and CVD. Sleep is a key regulator of cellular and tissue repair, free radical detoxification, oxidative stress, inflammation, autonomic and…
Eligibility
- Age range
- 22–40 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy, as determined by medical history * Group Specific Eligibility * PTSD Group * Lifetime PTSD: screened using Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and confirmed via Clinician Administered PTSD Scale for DSM-5 (CAPS-5) * Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ) * Self-report having repetitive nightmares contributing to disrupted sleep * Poor overall sleep quality: PSQI score 6 or higher * Control Group * No lifetime PTSD: screened using PC-PTSD-5 * No prior trauma exposure: screened using BTQ * Do not self-report having repeti…
Interventions
- DeviceNightWare
A wearable digital therapeutic platform consisting of an Apple Watch and iPhone pre-provisioned with Nightware intervention app that will deliver a mild vibration to the watch after detecting individual having a nightmare based on Nightware proprietary algorithm, arousing the individual and disrupting nightmare without awakening.
- DeviceSham NightWare
NightWare decive will not deliver an intervention (i.e., no vibration)
Locations (2)
- University of Colorado Anschutz Medical CampusAurora, Colorado
- University of Colorado CCTSI CTRCDenver, Colorado