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.
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)
Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or systemic illness that would interfere with interpretation of the study outcomes
Body Mass Index ≥ 40 kg/m2
Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1/GIP RAs)
Active infection (note, anyone with an active infection would become eligible once the infection has ended)
Parallel
NightWare
DeviceA 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.
Sham NightWare
DeviceNightWare decive will not deliver an intervention (i.e., no vibration)
Brachial artery flow-mediated dilation (FMD)
FMD of the brachial artery, calculated as a percentage, is an index of vascular function. A higher number is a general indicator of better vascular function.
Large artery elastic stiffness
Carotid-femoral pulse wave velocity (PWV). A higher number is a general indicator of worse vascular function.
Large artery elastic stiffness-carotid artery
Carotid artery compliance using carotid artery ultrasound; a higher carotid artery compliance is a general indicator of better vascular function.
Autonomic function-baroreflex sensitivity
Cardiovagal baroreflex sensitivity (cBRS) measured using beat-to-beat time series of systolic blood pressures (finger photo-plethysmography) and R-R interval (three-lead electrocardiogram) will be recorded simultaneously at 1,000 Hz.
Autonomic function- heart rate variability
Heart rate variability
Blood pressure
Seated blood pressure measured in mmHg
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University of Colorado, Denver
Lead sponsor
Ludeman Family Center for Women's Health Research
Collaborator
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