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NightWare Therapeutic Platform for improving Cardiovascular Health inAdults With Nightmares Associated with PTSD

NightWare 治疗平台可改善患有 PTSD 相关噩梦的成年人的心血管健康

基本信息

批准号：
10559634
负责人：
Kerrie Moreau
金额：
$ 19.44万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-02-01 至 2025-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10559634
关键词：
3-nitrotyrosine Acceleration Address Adherence Adult Age Aging Amendment Apple watch Autonomic Dysfunction Baroreflex Biological Availability Biological Markers Biometry Blood Vessels Breakthrough device Cardiovascular Diseases Cardiovascular Physiology Carotid Arteries Characteristics Clinical Clinical Trials Complex Data Development Disabled Persons Distress Double-Blind Method Drowsiness Drug Metabolic Detoxication Elasticity Endothelial Cells Endothelium Fatigue Feedback Femur Free Radicals Future Goals Grant Heart Rate Imagery Impaired cognition Impairment Individual Inflammation Interruption Intervention Investigation Knowledge Learning Life Link Machine Learning Measures Mediating Methods Modeling Movement Nightmare Nitric Oxide Nuclear Occupational Outcome Oxidative Stress Persons Pharmacologic Substance Physiologic pulse Physiological Pilot Projects Pittsburgh Sleep Quality Index Placebos Post-Traumatic Stress Disorders Prazosin Problem behavior Production Psychotherapy Randomized Risk Risk Reduction Sleep Sleep Deprivation Sleep disturbances Sleeplessness Stress Superoxides Symptoms System Therapeutic Therapeutic Intervention Time Vascular Diseases Venous Woman Wrist actigraphy affective disturbance arterial stiffness brachial artery cardiovascular disorder risk cardiovascular health cardiovascular risk factor clinically significant digital medicine digital platform digital treatment disabling symptom early onset effectiveness evaluation endothelial dysfunction heart rate variability implementation barriers improved improved outcome improvement on sleep indexing insight men novel peripheral blood pharmacologic post-traumatic symptoms premature randomized, clinical trials rehearsal response sleep onset sleep pattern sleep quality smart watch social stress related disorder suicidal risk therapeutically effective tissue repair ultrasound vascular endothelial dysfunction vibration

项目摘要

PROJECT SUMMARY/ABSTRACT Post traumatic stress disorder (PTSD) is linked to accelerated aging and is associated with increased risk of early-onset cardiovascular disease (CVD) in both men and women. PTSD is associated with premature vascular aging (i.e., large elastic arterial stiffening and vascular endothelial dysfunction) and autonomic dysfunction (e.g., reduced cardiovagal baroreflex sensitivity [cBRS] and heart rate variability [HRV]), key antecedents in the development of CVD. Sleep is important for cardiovascular health via cellular and tissue repair, free radical detoxification and reducing oxidative stress and inflammation. Nightmares, a central feature of PTSD, are a debilitating condition that can lead to sleep deprivation or insomnia, daytime sleepiness and other sequala, that ultimately causes clinically significant distress and impairment in social, occupational and cardiovascular function. As such, therapeutic strategies and interventions that address nightmare-associated sleep disturbances in individuals with PTSD is clinically important for improving sleep quality, cardiovascular health and risk for future age-associated CVD. NightWare™ digital therapeutic system is a novel smart watch application that was recently granted Breakthrough Device designation by the FDA for the treatment of nightmares in adults with PTSD. It uses machine learning to detect, track and arouse an individual out of a nightmare by sending vibrotactile feedback to a smart watch, and arousing the individual out of the nightmare without awakening and disrupting sleep. In the present R21 we are proposing a randomized, double-blind, placebo (i.e., sham intervention) controlled parallel pilot study that will provide the first clinical evidence for the efficacy of the NightWare digital therapeutic system to improve cardiovascular health outcomes in adults with nightmares associated with PTSD. An additional goal of this R21 will be to obtain exploratory mechanistic insight by which NightWare improves cardiovascular function, specifically, related to sleep quality, nitric oxide bioavailability, free radical production, oxidative stress and inflammation. We hypothesize that 6 weeks of the NightWare intervention will improve outcomes of vascular aging (e.g., large elastic arterial stiffening, vascular endothelial dysfunction) and autonomic function (cBRS, HRV) in adults with PTSD-related nightmares. The results from this pilot investigation will provide the basis for a larger randomized clinical trial that would be conducted to establish the efficacy of NightWare as a safe and effective therapeutic strategy for treating nightmares, promoting healthy vascular aging, autonomic function and reducing the risk for CVD later in life in adults with nightmares associated with PTSD.

项目总结/文摘