Sleep and Physical Activity Recording Technical Analysis (SPARTA)System

描述（由申请人提供）：该SBIR I期申请旨在开发一种集成的、多用途的睡眠和身体活动记录和技术分析（SPARTA）系统，该系统可用于独立评估睡眠（持续时间、质量和时间）和身体活动（持续时间、频率、强度和时间）。作为研究睡眠、身体活动和/或它们之间相互关系的客观监测，SPARTA系统具有很大的潜力。睡眠呼吸紊乱和睡眠时间短与各种疾病的风险增加有关，如高血压、肥胖、心血管疾病和糖尿病。睡眠不足和睡眠质量差（即支离破碎）也与白天过度嗜睡有关，这对行为、认知和心理生理都有影响。尽管它很重要，但在大型临床研究中，对睡眠持续时间和质量进行准确客观的评估尚不现实。此外，体育活动是一种已知的生活方式和行为因素，在许多慢性疾病（如癌症和冠心病）的病因学和预防中发挥作用。准确测量儿童和成人的体力活动能量消耗和强度水平是一个具有挑战性的问题，这对流行病学家、运动科学家、临床医生和行为研究人员来说非常重要。虽然有许多间接和直接的方法来评估身体活动和能量消耗，但所有现有的方法都有充分证明的缺点。拟议的第一阶段SBIR工作将侧重于开发原型SPARTA监视器并在睡眠研究中进行测试；Barron Associates已经证明了SPARTA监测器的身体活动监测组件的概念可行性，并在此记录。与多导睡眠描记仪（标准测量）和手腕活动描记仪（一种常用的、低成本的多导睡眠描记仪替代品）相比，将严格评估SPARTA监测器的性能，根据其睡眠/清醒区分算法和睡眠质量测量的准确性进行评估。第一阶段的工作将包括在儿童和成人受试者中进行一晚睡眠研究，其中将包括相对健康的个体和患有睡眠相关呼吸障碍的个体，以便评估算法的敏感性和特异性。SPARTA集成ECG和三轴加速度计监测器将提供符合人体工程学的动态测量能力，适合于对自由生活个体的睡眠和身体活动进行准确和客观的评估。作为一个24/7“穿后即忘”的监视器，它将为佩戴者和临床医生/研究人员提供易用性和便利性。SPARTA监测器将介于高成本、高精度、专用临床/研究仪器和解决方案之间，用于评估睡眠和身体活动，以及低成本、低精度的活动和睡眠监测器（如活动记录仪）。它的体积小（宽12厘米，宽2.5厘米，宽1厘米），重量轻（10克），坚固，不受束缚的设计将使其比传统的（系留）心电图监测系统更不容易受到运动干扰。公共卫生相关性：SPARTA系统具有巨大的潜力，作为一种相对低成本的人体工程学监测仪，用于客观评估自由生活个体的身体活动和/或睡眠时间/质量。该系统将能够在临床和研究中收集准确和客观的数据，而这些测量是不可行的。SPARTA系统将提高从佩戴者和临床医生/研究人员的角度获取此类数据的便利性。

DESCRIPTION (provided by applicant): This SBIR Phase I application addresses the development of an integrated, multi-purpose Sleep and Physical Activity Recording and Technical Analysis (SPARTA) system that can be used to independently assess both sleep (duration, quality, and timing) and physical activity (duration, frequency, intensity, and timing). As an objective monitor for the study of sleep, physical activity, and/or their interrelationship, the SPARTA system has great potential. Sleep disordered breathing and short sleep duration are linked to greater risk of various diseases, such as high blood pressure, obesity, cardiovascular disease, and diabetes. Insufficient and poor quality (i.e., fragmented) sleep are also associated with excessive daytime sleepiness, which has behavioral, cognitive, and psychophysiological consequences. Despite its importance, accurate and objective assessment of sleep duration and quality has not been practical in large clinical research studies. Additionally, physical activity is a known lifestyle and behavioral factor that plays a role in the etiology and prevention of many chronic diseases, such as cancer and coronary heart disease. Accurate measurement of physical activity energy expenditure and intensity levels in children and adults is a challenging problem that is important to epidemiologists, exercise scientists, clinicians, and behavioral researchers. Although there are a number of indirect and direct methods for assessing physical activity and energy expenditure, all current methods have well-documented shortcomings. The proposed Phase I SBIR effort will focus on developing the prototype SPARTA monitor and testing it in sleep studies; concept feasibility for the physical activity monitoring component of the SPARTA monitor has already been demonstrated by Barron Associates and is documented herein. The performance of the SPARTA monitor will be rigorously assessed in terms of the accuracy of its sleep/awake discrimination algorithms and sleep quality measures in comparison with both polysomnography (the criterion measure) and wrist actigraphy (a commonly-used, low-cost alternative to polysomnography). The Phase I effort will involve one-night sleep studies conducted in both child and adult subjects that will include a mix of both relatively healthy individuals and individuals with sleep-related breathing disorders so that algorithm sensitivity and specificity can be assessed. The SPARTA integrated ECG and triaxial accelerometry monitor will provide an ergonomic ambulatory measurement capability suitable for the accurate and objective assessment of sleep and physical activity in free-living individuals. As a 24/7 "wear-and-forget" monitor, it will offer ease of use and convenience to both the wearer and the clinician/researcher. The SPARTA monitor will occupy the middle ground between high- cost, high-accuracy, dedicated clinical/research instruments and solutions for assessing both sleep and physical activity, and low-cost, low-accuracy activity and sleep monitors (e.g., actigraphs). Its small (12 cm W 2.5 cm W 1 cm), lightweight (10 g), consolidated, untethered design will make it less vulnerable to movement artifact than conventional (tethered) ECG monitoring systems. PUBLIC HEALTH RELEVANCE: The SPARTA system has huge potential as a relatively low-cost ergonomic monitor for the objective assessment of physical activity and/or sleep duration/quality in free-living individuals. The system will enable accurate and objective data to be collected in both clinical and research studies where such measurements have not been practicable. The SPARTA system will improve the convenience of obtaining such data from the perspectives of both the wearer and the clinician/researcher.