PAP adherence and real-world driving safety in OSA

描述(由申请人提供)：该研究项目的广泛目标是量化患有阻塞性睡眠呼吸暂停(OSA)的汽车司机的真实驾驶行为，并确定在驾驶安全方面产生临床意义的改善所需的气道正压(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撞车的风险，而PAP治疗可能会逆转这种风险。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综合症的人没有意识到自己的损害，尽管发生撞车的风险增加，但他们不太可能限制自己开车。我们认为，这个问题的解决方案可以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来得出。这项翻译研究项目的具体目标是：1)量化75名OSA司机和75名正常对照司机的真实驾驶表现；2)确定PAP使用与驾驶员安全之间的剂量反应关系；3)确定在调整PAP使用水平后，预测OSA司机真实驾驶表现中剩余损害的因素。为了解决这些具体目标，UI的一个跨学科专家团队将使用标准化的神经心理测试来全面评估1)认知功能；2)基于实验室的多导睡眠图(PSG)的疾病严重程度的生理指数；3)对真实世界的PAP遵守情况、睡眠模式以及嗜睡和生活质量的自我评级进行扩展测量；以及4)通过司机自己车内的“黑匣子”记录器对现实世界的司机表现和行为进行扩展观察。研究团队在睡眠医学、认知科学、人类因素工程学、生物统计学和公共政策方面拥有专业知识。该项目得益于我们使用仪表化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。这项研究的统计能力得益于一项纵向设计，该设计将日常驾驶表现与3个月内连续多天每天使用PAP相关联。我们全面测量与疾病相关的临床因素(即治疗前的AHI和血氧饱和度、BMI、自我报告的困倦)、认知障碍和非疾病相关的临床因素(例如夜间睡眠时间)，这将使我们能够确定不同PAP使用水平的司机在现实世界驾驶表现中残留损害的来源。通过解决现实世界社区环境中的睡眠和行为研究，这项研究通过提供关于PAP有效性和使用的经验数据，解决了满足NIH优先执行翻译研究的关键步骤。在现实世界中观察到的OSA司机的表现和行为模式，然后可以用来帮助制定其他睡眠障碍的新假设和治疗策略，以及普通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.