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

开发可广泛使用的可穿戴昼夜节律分析系统，以评估痴呆症患者及其家庭护理人员的 24 小时行为节律紊乱

• 批准号: 10321398
• 负责人: Stephen F Smagula
• 金额: $ 29.95万
• 依托单位: ACTIVITY RHYTHM SOLUTIONS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10321398
• 关键词: Accelerometer; Address; Adherence; Adverse effects; Affect; Alzheimer' s disease related dementia; Apple watch; Architecture; Area; Back; Behavior; Behavioral; Benign; Businesses; Caregivers; Cessation of life; Circadian Dysregulation; Clinical; Clinical Trials; Custom; Dancing; Data; Dementia; Development; Devices; Disease Progression; Elderly; Family; Family Caregiver; Feedback; Focus Groups; Goals; Gold; Health; Health Technology; Healthcare; High Prevalence; Hour; Intervention; Interview; Link; Malignant Neoplasms; Measures; Medical; Medicine; Mental Health; Monitor; Outcome; Patient Care; Patient Monitoring; Patient Self-Report; Patients; Pattern; Phase; Population; Pre-Post Tests; Problem behavior; Provider; Public Health; Quality of life; Research; Research Personnel; Rest; Risk; Shapes; Sleep; Small Business Technology Transfer Research; Suicide; System; Technology; Technology Transfer; Testing; Time; Validation; Work; base; care recipients; caregiving; chemotherapy; circadian; clinical practice; depressive symptoms; design; digital; digital health; efficacy evaluation; experience; fitbit; improved; mortality; personalized intervention; programs; prototype; randomized trial; real time monitoring; remote monitoring; success; systematic review; tool; user-friendly; ward; wearable device; wearable sensor technology

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.

项目摘要：阿尔茨海默病和相关痴呆症 (ADRD) 患者经常经历 昼夜节律活动节律 (CAR) 紊乱，其特点是失去强有力、稳定的 24 小时睡眠 - CAR 破坏与 ADRD 患者的生活质量较低有关，以及 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。 CAR，消费或医疗市场上没有产品可以衡量它们； 流行的消费类可穿戴设备所包含的干扰未被充分检测到，并且在实践中很少得到管理。 可以利用加速度计为目标 CAR 提供广泛使用的无源系统 但当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），以及 不提供其模式或 CAR 破坏的经过验证的测量（即节律稳定性、形状、 我们建议通过一个新的“数字”平台来填补这一空白。 跨现有可穿戴设备：昼夜节律活动分析系统 (CAPS) 为患者提供他们的信息。 我们的首要目标是让护理人员及其长辈能够进行实时 CAR 监控。 个性化和适应性定制干预措施，解决 CAR 中断问题，以减少相关健康 为此，我们提出了第一阶段小型企业技术转让项目。 验证该技术并评估 ADRD 患者及其护理人员的用户接受度（n=30 我们组建了一支在 CAR 健康影响、睡眠/昼夜节律方面具有专业知识的团队（Smagula 博士，PI）。 医学（Hall 博士，Pitt PI）、老年患者护理（Co-I Patira 博士和 Vahia 博士，顾问）和数字健康 技术（Dancy 先生和 Ward 先生）将巩固 Apple Watch 和 Apple Watch 上的原始数据提取例程。 扩展到 FitBit（目标 1a）；并根据黄金标准研究级加速度计验证 CAPS（目标） 1b) 目标 1 成功的标准是：成功同步至少 95% 的 epoch； (≥0.9) CAPS 与黄金标准的组内相关系数将收集客观用户。 接受数据、前后生活质量测量、与用户进行焦点小组讨论以及访谈人群。 对于目标 2，成功将通过关键领域证据的综合来定义：用户依从性的证据 与现有的医疗治疗相当（即 >70%）；有证据表明监测系统本身就具有影响 健康措施；以及临床医生利益相关者关于他们如何在实践中使用 CAPS 的意见。 我们预计第一阶段项目将产生指导制定第二阶段提案的证据 评估 CAPS 在改善重要健康结果方面的临床效用的随机试验 相反，如果我们发现 CAPS 对于 ADRD 用户来说是不可接受的，或者 在临床实践中，验证被动 CAR 监测解决方案仍可能对公共卫生/市场产生影响， 因为 CAR 破坏模式也可以标记/驱动自杀、癌症死亡和一般死亡的风险。