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: 10741903
• 负责人: Justin Brooks
• 金额: $ 5.5万
• 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/10741903
• 关键词: Academy; Address; Agitation; Alzheimer' s Disease; Alzheimer' s disease patient; American; Ankle; Biological Markers; Caregiver Burden; Caregivers; Clinical; Data; Devices; Diagnosis; Emotional; Individual; Industrialization; Institutionalization; Leg; Measures; Medical; Medicine; Movement; Patients; Quality of life; Reporting; Restless Legs Syndrome; Services; Sleep; Sleep Disorders; Sleep disturbances; Symptoms; Technology; accurate diagnosis; design; improved; mobile application; novel; prevent; verbal; 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 数以百万计的阿尔茨海默氏病（AD）患有睡眠障碍的患者 降低其生活质量和放大器对护理人员的剧烈燃烧。不安 腿综合症（RLS）可能是这些患者睡眠灾难的因素，但是RLS 目前难以诊断，特别是在AD患者中。诊断是在临床上进行的 有了主观，患者报告和符号本身是各个个体的变化。 那尤其是言语表达困难的广告患者尤其是 容易被误诊。此外，最近的研究表明夜间搅动 （广告的特别麻烦症状，导致早期制度化）可能是 未经诊断的RLS的表现。 reteaze是脚踝差的 由Tanzen Medical Inc开发的可穿戴技术和移动应用程序测量腿 睡眠期间与RLS高度相关的运动，可以作为客观生物标志物 条件。该设备在工业上设计为舒适的患者佩戴， 可洗以允许延长，每晚使用。患者易于使用移动应用程序（或 护理人员）与设备中的数据进行交互并存储数据。提供给临床的读数 提供清晰，可操作的信息，可在睡眠中量化患者的腿部运动 参考美国睡眠医学学院标准。总之，直接重新安排 通过提供一项可以实质性的技术来解决重大的未满足医疗需求 改善AD患者RLS的诊断和后续管理。使用此 预计技术将改善AD患者及其护理人员的生活质量 直接解决其睡眠障碍并防止需要早期制度化 或其他辅助医疗服务。