NCT07021014

NightWare and Cardiovascular Health in Women With PTSD

Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 22 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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 endocrine balance and crucial for cardiovascular health. Sleep disturbances due to nightmares are a hallmark symptom of PTSD that cause significant distress and may independently contribute to elevated CVD risk in individuals with PTSD. As such, interventions aimed at treating trauma-related nightmares are a promising therapeutic approach in ameliorating the cardiovascular consequences of PTSD. NightWare™, a smart-watch based application that uses biometric data and vibrotactile feedback to disrupt nightmares, is an FDA approved digital therapeutic system for the treatment of nightmares in adults (≥22 years) with PTSD. While a preliminary study demonstrated that 30 days of NightWare treatment improved subjective sleep quality in Veterans, the influence of NightWare treatment on vascular and renal function in young women with PTSD-related nightmares is unknown. These investigations are critical among women who, despite having 2x greater prevalence of PTSD compared to men, and a differential progression of PTSD, CVD, and chronic kidney disease (CKD), are underrepresented in the literature. Accordingly, the investigators will examine if the NightWare digital therapeutic system improves vascular and renal function in premenopausal women with PTSD-related nightmares, and whether these improvements restore them to levels observed in age-matched women without PTSD. We will employ 1) cross-sectional comparisons between two groups of women: those with PTSD and nightmares (PTSD group) and those without PTSD and nightmares (age-matched control group); and 2) a short-term (8-week) NightWare or sham intervention in women with nightmares related to PTSD.

Conditions

• Post Traumatic Stress Disorder
• Cardiovascular Diseases
• Autonomic Dysfunction
• Vascular Stiffness
• Nightmare
• Endothelial Dysfunction
• Kidney Diseases
• Renal Dysfunction
• Trauma and Stressor Related Disorders

Interventions

Type	Name	Description
DEVICE	NightWare	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.
DEVICE	Sham NightWare	NightWare decive will not deliver an intervention (i.e., no vibration)

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study