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.

项目总结/摘要 创伤后应激障碍（PTSD）与加速衰老有关，并与增加的风险有关。 早发性心血管疾病（CVD）在男性和女性。创伤后应激障碍与早产儿 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，降低心迷走神经压力反射敏感性[cBRS]和心率变异性[HRV]），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，自由基解毒和减少氧化应激和炎症。夜间活动，一个中心特征 创伤后应激障碍，是一种使人衰弱的疾病，可导致睡眠剥夺或失眠，白天嗜睡， 其他后遗症，最终导致临床上显著的痛苦和社会，职业和 心血管功能因此，治疗策略和干预措施，解决噩梦相关的 PTSD患者的睡眠障碍在临床上对改善睡眠质量、心血管疾病、 健康和未来年龄相关CVD的风险。NightWare™数字治疗系统是一款新颖的智能手表 最近被FDA授予突破性器械称号的应用，用于治疗 患有创伤后应激障碍的成年人的噩梦它使用机器学习来检测、跟踪和唤醒一个人， 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， 而不会惊醒并扰乱睡眠在目前的R21中，我们提出了一个随机，双盲， 安慰剂（即，假干预）对照平行试点研究，将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局的有效性 与创伤后应激障碍有关的噩梦该R21的另一个目标是获得探索性机制 NightWare改善心血管功能的洞察力，特别是与睡眠质量，一氧化氮 生物利用度、自由基产生、氧化应激和炎症。我们假设6周的 NightWare干预将改善血管老化的结局（例如，大弹性动脉硬化，血管 内皮功能障碍）和自主神经功能（cBRS，HRV）在成人PTSD相关的噩梦。的 这项初步研究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疗效， 噩梦，促进健康的血管老化，自主神经功能，并降低以后生活中CVD的风险， 患有创伤后应激障碍相关噩梦的成年人