PAP adherence and real-world driving safety in OSA

描述（由申请人提供）：本研究项目的主要目标是量化患有阻塞性睡眠呼吸暂停（OSA）的汽车驾驶员的实际驾驶行为，并确定临床上有意义的驾驶员安全改善所需的气道正压通气（PAP）使用量。阻塞性睡眠呼吸暂停会导致认知障碍，增加驾驶员失误导致车祸的风险，这可能会通过PAP治疗逆转。然而，对许多患者来说，坚持PAP治疗是一个问题。此外，一些患有阻塞性睡眠呼吸暂停的人并没有意识到他们的损伤，尽管撞车的风险增加了，但他们不太可能限制自己开车。我们建议，通过使用现代传感器技术，在现实世界中对患者进行系统的行为和生理测量，可以得出解决这一问题的方法。本转化研究项目的具体目标是：1)量化75名OSA患者和75名正常对照驾驶员的真实驾驶表现；2)确定PAP使用与驾驶员安全的剂量反应关系；3)在调整PAP使用水平后，确定预测OSA驾驶员实际驾驶性能残留损伤的因素。为了解决这些具体目标，UI的跨学科专家团队将全面评估1)使用标准化神经心理学测试的认知功能；2)基于实验室多导睡眠图（PSG）的疾病严重程度生理指标；3)扩展了现实世界PAP依从性、睡眠模式、困倦和生活质量自评的测量；4)通过驾驶员自己车内的“黑匣子”记录仪对驾驶员在现实世界中的表现和行为进行扩展观察。研究团队在睡眠医学、认知科学、人因工程、生物统计学、公共政策等领域拥有专业知识。该项目得益于我们使用仪表车辆进行成功研究的悠久历史，以及对驾驶员行为进行分类和量化的分类法。该研究的统计能力得益于纵向设计，该设计将日常驾驶表现与连续3个月内每天使用PAP的天数联系起来。我们综合测量疾病相关临床因素（如治疗前AHI和氧饱和度、BMI、自述嗜睡）、认知障碍和非疾病相关临床因素（如夜间睡眠时间）的方法，将使我们能够确定不同PAP使用水平的驾驶员在实际驾驶表现中残留损伤的来源。通过在现实世界的社区环境中进行睡眠和行为研究，本研究通过提供有关PAP有效性和使用的经验数据，解决了满足NIH优先进行转化研究的重要步骤。在现实世界中观察到的OSA驱动者的表现和行为模式可以用来帮助制定新的假设和治疗其他睡眠障碍的策略，以及解决一般人群中睡眠不足的更广泛问题。

DESCRIPTION (provided by applicant): The broad goals of this research project are to quantify real-world driving behavior in automobile drivers with obstructive sleep apnea (OSA) and to determine the amount of positive airway pressure (PAP) use needed to produce clinically meaningful improvements in driver safety. OSA causes cognitive impairments that increase the risk of driver errors that lead to a crash, which may be reversed with PAP treatment. However adherence to PAP therapy is a problem for many patients. Moreover, some individuals with OSA are not aware of their impairments, and are less likely to restrict themselves from driving despite being at increased risk for a crash. We propose that solutions to this problem can be derived through systematic behavioral and physiological measurements of patients in real world settings, using modern sensor technology. The specific aims of this translational research project are to 1) Quantify real-world driving performance in 75 drivers with OSA and 75 normal comparison drivers; 2) Determine the dose response relationship between PAP use and driver safety; and 3) Determine the factors that predict residual impairments in real-world driving performance in drivers with OSA after adjusting for levels of PAP use. To address these specific aims an interdisciplinary team of experts at UI will comprehensively assess 1) cognitive functions using standardized neuropsychological tests; 2) physiologic indices of disease severity from laboratory based polysomnography (PSG); 3) extended measurements of real-world PAP adherence, sleep patterns, and self-ratings of sleepiness and quality of life; and 4) extended observations of real-world driver performance and behavior from "black box" recorders in the drivers' own cars. The research team has expertise in sleep medicine, cognitive science, human factors engineering, biostatistics, and public policy. The project benefits from our long history of successful research using instrumented vehicles and a taxonomy for classifying and quantifying driver behavior. The statistical power of the study benefits from a longitudinal design, which correlates daily driving performance with PAP use each day for multiple consecutive days over 3 months. Our comprehensive approach to measuring disease-related clinical factors (i.e., pre-treatment AHI and oxygen saturation, BMI, self-reported sleepiness), cognitive impairment, and non-disease-related clinical factors (e.g., duration of nightly sleep) will enable us to determine the source of residual impairment in real-world driving performance in drivers with differing levels of PAP use. By tackling sleep and behavior research in real-world community settings, this study addresses an essential step in meeting the NIH priority of performing translational research by providing empirical data regarding PAP effectiveness and use. The patterns of performance and behavior observed in real-world OSA drivers can then be used to help formulate new hypotheses and treatment strategies for other sleep disorders, as well as for the broader issue of insufficient sleep in the general population. PUBLIC HEALTH RELEVANCE: The broad goal of this research project is to quantify real-world driving behavior in obstructive sleep apnea (OSA) and to determine the amount of positive airway pressure (PAP) usage needed to produce meaningful improvements in real world driver safety. To address our specific aims a multidisciplinary team with expertise in sleep disorders, cognitive neuroscience, driver performance assessment, human factors engineering, biostatistics and public policy will comprehensively assess 1) cognitive functions using standardized neuropsychological tests (of attention, perception, memory, and executive functions); 2) physiologic indices of sleep (from laboratory based sleep studies); 3) extended measurements of real-world PAP therapy adherence, sleep patterns, and self-ratings of sleepiness and quality of life in the driver's own homes; and 4) extended observations of real-world driver strategies and tactics from a "black box recorders in the drivers' own cars. By tackling sleep and behavior research in real-world community settings, this study addresses an essential step in meeting the NIH priority of performing translational research. The patterns of performance and behavior observed in real world OSA drivers can then be used to help formulate new experimental hypotheses and treatment strategies for other sleep disorders, as well as the broader issue of insufficient sleep in the general population.