Developing a widely-useable wearable Circadian Profiling System to assess 24-hour behavioral rhythm disruption in people with dementia and their family caregivers

项目概述：阿尔茨海默病和相关痴呆症（ADRD）患者经常会经历 昼夜活动节律（CAR）中断，其特征是失去强，稳定的24小时睡眠， 唤醒行为模式CAR破坏与ADRD患者的生活质量降低相关， 另一种CAR模式与家庭照顾者的抑郁症状有关。尽管与健康相关， 消费者或医疗市场上没有产品可以测量它们;因此， 在实践中，对干扰的发现不足，也很少加以管理。流行的消费者可穿戴设备包含 加速度计，可用于为目标CAR提供广泛可用的无源系统 监测.但目前的平台使用活动数据来推断睡眠和活动的绝对水平（分别）， 没有提供其模式或CAR破坏的经验证的测量方法（即，节奏稳定性，形状， 碎片化和定时）。我们建议用一个新的“数字医疗”平台来填补这一空白， 在现有的可穿戴设备：昼夜活动分析系统（CAPS）。CAPS为患者提供， 护理人员及其临床医生进行实时CAR监测。我们的首要目标是使 个性化和适应性定制干预措施，解决CAR中断，以减少相关健康 后果为此，我们提出了第一阶段小企业技术转让项目， 在ADRD患者及其护理人员中验证该技术并评价用户接受度（n=30 二分体）。我们组建了一个团队，该团队具有汽车对健康影响的专业知识（Smagula博士，PI），睡眠/昼夜节律 医学（Hall博士，Pitt PI），老年患者护理（Patira博士，Co-I和Vahia博士，顾问）和数字健康 技术（丹西先生和沃德先生）。Aim 1将巩固Apple Watch上的原始数据提取例程， 扩展到FitBit（Aim 1a）;并针对黄金标准研究级加速度计（Aim）验证CAPS 1 b）。目标1中的成功标准是：成功同步至少95%的epoch;并实现出色的 CAPS与金标准的组内相关系数≥0.9。目标2将聚集目标用户 验收数据，前/后生活质量的措施，进行重点小组与用户，并采访临床医生。 对于目标2，成功将通过关键领域的综合证据来定义：用户依从性证据 与现有的医学治疗（即，>70%）;有证据表明，监测系统本身对 健康措施;以及临床医生利益相关者关于他们如何预见在实践中使用CAPS的投入。 我们预计，第一阶段项目将产生证据，指导第二阶段提案的制定， 评价CAPS在改善重要健康结局方面的临床效用的随机试验 与受痴呆症影响的家庭有关。相反，如果我们发现ADRD用户无法接受CAPS，或者 在临床实践中，验证被动CAR监测解决方案仍然可能对公共卫生/市场产生影响， 因为CAR破坏的模式也可以标记/驱动自杀、癌症死亡和一般死亡的风险。

PROJECT SUMMARY: People with Alzheimer’s Disease and Related Dementias (ADRDs) often experience Circadian Activity Rhythm (CAR) disruption, which is characterized by a loss of strong, stable, 24-hour sleep- wake behavioral patterns. CAR disruption correlates with lower quality of life in people with ADRDs, and another CAR pattern is linked with depression symptoms in family caregivers. Despite the health relevance of CARs, there are no products on the consumer or medical markets to measure them; as a result, CAR disruption is under-detected and seldom managed in practice. Popular consumer wearable devices contain accelerometers that could be leveraged to provide a widely-usable, passive system for objective CAR monitoring. But current platforms use activity data to infer absolute levels of sleep and activity (separately), and do not provide validated measures of their patterning or CAR disruption (i.e., rhythm stability, shape, fragmentation, and timing). We propose to fill this gap with a new “digiceutical” platform designed to work across existing wearables: the Circadian Activity Profiling System (CAPS). The CAPS provides patients, their caregivers, and their clinicians with real-time CAR monitoring. Our overarching goal is to enable the personalization and adaptive tailoring of interventions that address CAR disruption to reduce related health consequences. Towards this end, we propose a Phase I Small Business Technology Transfer project to validate this technology and evaluate user-acceptance in people with ADRDs and their caregivers (n=30 dyads). We assembled a team with expertise in health effects of CARs (Dr. Smagula, PI), sleep/circadian medicine (Dr. Hall, Pitt PI), geriatric patient care (Dr. Patira, Co-I and Dr. Vahia, consultant), and digital health technology (Mr. Dancy and Mr. Ward). Aim 1 will solidify raw-data extraction routines on the Apple Watch and expand to FitBit (Aim 1a); and validate the CAPS against gold-standard research-grade accelerometers (Aim 1b). Criteria for success in Aim 1 are: successfully syncing at least 95% of epochs; and achieving excellent (≥0.9) intraclass correlation coefficient of the CAPS against the gold-standard. Aim 2 will gather objective user acceptance data, pre-/post- quality of life measures, conduct focus groups with users, and interview clinicians. For Aim 2, success will be defined via a synthesis of evidence across key areas: evidence of user-adherence on par with existing medical treatments (i.e., >70%); evidence that the monitoring system alone has effects on health measures; and input from clinician-stakeholders regarding how they foresee using the CAPS in practice. We expect that this Phase I project will generate evidence guiding the development of a Phase II proposal for a randomized trial evaluating the clinical utility of the CAPS in terms of improving important health outcomes relevant to families affected by dementia. If, instead, we find that the CAPS is unacceptable to ADRD users or in clinical practice, validating a passive CAR monitoring solution could still have a public health/market impact, since patterns of CAR disruption also can mark/drive risk for suicidality, cancer death, and mortality in general.