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

• 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
• 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

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.

项目概要/摘要 创伤后应激障碍 (PTSD) 与加速衰老有关，并且与以下风险增加有关： 男性和女性的早发性心血管疾病（CVD）。 PTSD 与早产有关 血管老化（即大弹性动脉硬化和血管内皮功能障碍）和自主神经 功能障碍（例如，心血管压力反射敏感性 [cBRS] 和心率变异性 [HRV] 降低），关键 CVD发展的前因。睡眠通过细胞和组织对心血管健康很重要 修复、自由基解毒、减少氧化应激和炎症。噩梦，一个核心特征 PTSD 是一种使人衰弱的疾病，可能导致睡眠不足或失眠、白天嗜睡和 其他后遗症，最终导致临床上显着的痛苦和社交、职业和损害 心血管功能。因此，解决噩梦相关的治疗策略和干预措施 PTSD 患者的睡眠障碍对于改善睡眠质量、心血管疾病具有临床重要意义。 健康状况和未来与年龄相关的 CVD 风险。 NightWare™数字治疗系统是一款新颖的智能手表 该申请最近被 FDA 授予突破性设备称号，用于治疗 患有创伤后应激障碍 (PTSD) 的成年人会做噩梦。它使用机器学习来检测、跟踪和唤醒个体 通过向智能手表发送振动触觉反馈，并将个人从噩梦中唤醒 不会唤醒和扰乱睡眠。在目前的 R21 中，我们提出了一项随机、双盲、 安慰剂（即假干预）对照平行试点研究将为该研究提供第一个临床证据 NightWare 数字治疗系统改善成人心血管健康结果的功效 与创伤后应激障碍（PTSD）相关的噩梦。 R21 的另一个目标是获得探索性机制 NightWare 改善心血管功能的见解，特别是与睡眠质量、一氧化氮相关的见解 生物利用度、自由基产生、氧化应激和炎症。我们假设 6 周 NightWare 干预将改善血管老化的结果（例如，大弹性动脉硬化、血管老化） 患有 PTSD 相关噩梦的成人的内皮功能障碍）和自主神经功能（cBRS、HRV）。这 这项试点调查的结果将为更大规模的随机临床试验提供基础 旨在确定 NightWare 作为一种安全有效的治疗策略的功效 噩梦，促进健康的血管老化、自主神经功能并降低晚年患 CVD 的风险 患有与 PTSD 相关的噩梦的成年人。