University of Colorado, Denver
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.
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…
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…
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.
NightWare decive will not deliver an intervention (i.e., no vibration)
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