RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Legs Syndrome in Patients with Alzheimer's Disease

RestEaze：一种新型可穿戴设备和移动应用程序，可改善阿尔茨海默病患者不宁腿综合症的诊断和管理

• 批准号: 10384159
• 负责人: Justin Brooks
• 金额: $ 50.07万
• 依托单位: TANZEN MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384159
• 关键词: Academy; Address; Age; Agitation; Algorithms; Alzheimer' s Disease; Alzheimer' s disease patient; American; Ankle; Biological Markers; Blood Pressure; Body Temperature; Care given by nurses; Caregivers; Clinical; Clinical Trials; Data; Data Store; Dementia; Devices; Diagnosis; Economic Burden; Elderly; Electrocardiogram; Emotional; Etiology; Family; Family Caregiver; Feasibility Studies; Feeling; Functional disorder; Future; General Population; Goals; Gold; Health; Home Care Services; Individual; Industrialization; Institutionalization; Iron deficiency anemia; Lead; Leg; Longitudinal Studies; Measurement; Measures; Medical; Medicine; Methods; Monitor; Movement; Output; Pain; Participant; Pathology; Patients; Periodicity; Pharmaceutical Preparations; Phase; Photoplethysmography; Physiological; Population; Prevention; Quality of life; Reporting; Restless Legs Syndrome; Risk Factors; Selective Serotonin Reuptake Inhibitor; Services; Signal Transduction; Sleep; Sleep Disorders; Sleep disturbances; Small Business Innovation Research Grant; Sum; Symptoms; Technology; Testing; Time; United States Food and Drug Administration; accurate diagnosis; algorithm development; clinical diagnosis; comorbidity; design; diagnostic value; ergonomics; experience; feasibility testing; functional status; improved; indexing; mobile application; novel; preservation; prevent; sensor; tool; treatment response; usability; wearable device

Project Abstract Millions of patients with Alzheimer’s disease (AD) suffer from sleep disturbances that significantly degrade their quality of life and amplifies the heavy emotional burden on caregivers. Restless Legs Syndrome (RLS) is likely a factor for the sleep disturbance in these patients, however, RLS is currently difficult to diagnose, particularly in patients with AD. The diagnosis is made clinically with subjective, patient reports and the symptoms themselves are variable across individuals. Thus, patients with AD who may already have difficulty with verbal expression are especially vulnerable to being misdiagnosed. Furthermore, recent studies suggest that nighttime agitations (a particularly troublesome symptom of AD that leads to early institutionalization) may be a manifestation of undiagnosed and therefore unmanaged RLS. RestEaze is an ankle-worn wearable technology and mobile application developed by Tanzen Medical Inc to measure leg movements during sleep that are highly related to RLS and can serve as an objective biomarker of the condition. The device is industrially designed to be comfortably worn by the patient and washable to permit extended, nightly use. The mobile application is easy to use by the patient (or caregiver) to interact with and store data from the device. The read-out provided to the clinician provides clear, actionable information that quantifies the patients’ leg movements during sleep in reference to American Academy of Sleep Medicine standards. In sum, RestEaze directly addresses a significant unmet medical need by providing a technology that can substantially improve the diagnosis and subsequent management of RLS in patients with AD. The use of this technology is expected to improve the quality of life for patients with AD and their caregivers by directly addressing their sleep disturbance and preventing the need for early institutionalization or other ancillary medical services.

项目摘要 数百万阿尔茨海默病（AD）患者患有睡眠障碍， 降低了他们的生活质量，加重了照顾者沉重的情感负担。不安 腿综合征（RLS）可能是这些患者睡眠障碍的一个因素，然而， 目前很难诊断，特别是在AD患者中。诊断是临床上作出的 由于主观性，患者报告和症状本身在个体之间是可变的。 因此，可能已经有语言表达困难的AD患者尤其需要 容易被误诊此外，最近的研究表明， （AD的一个特别麻烦的症状，导致早期机构化）可能是一个 表现为未诊断的，因此未管理的RLS。RestEaze是一款脚踝磨损的 Tanzen Medical Inc开发的可穿戴技术和移动的应用程序，用于测量腿部 睡眠期间的运动与RLS高度相关，可以作为客观的生物标志物 的症状。该装置在工业上被设计成由患者舒适地佩戴， 可水洗，允许延长，夜间使用。移动的应用程序易于患者使用（或 护理人员）与设备交互并存储来自设备的数据。提供给临床医生的读数 提供清晰、可操作的信息，量化患者在睡眠期间的腿部运动， 参考美国睡眠医学学会标准。总之，RestEaze直接 通过提供一种技术， 改善AD患者RLS的诊断和后续管理。使用这种 技术有望改善AD患者及其护理人员的生活质量， 直接解决他们的睡眠障碍，并防止需要早期机构化 或其他辅助医疗服务。