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 数百万阿尔茨海默氏病 (AD) 患者遭受睡眠障碍的困扰 降低了他们的生活质量并加重了护理人员的沉重情感负担。不安 腿部综合症 (RLS) 可能是这些患者睡眠障碍的一个因素，但是，RLS 目前很难诊断，尤其是 AD 患者。诊断是通过临床进行的 由于主观，患者的报告和症状本身因人而异。 因此，可能已经有言语表达困难的 AD 患者尤其需要 容易被误诊。此外，最近的研究表明夜间躁动 （AD 的一个特别麻烦的症状，导致早期住院）可能是 未确诊、因此未管理的不宁腿综合征的表现。 RestEaze 是一款脚踝磨损型 Tanzen Medical Inc 开发的可穿戴技术和移动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 的条件。该设备经过工业设计，患者佩戴舒适， 可水洗，可在夜间长时间使用。该移动应用程序易于患者（或 护理人员）与设备交互并存储来自设备的数据。向临床医生提供的读数 提供清晰、可操作的信息，量化患者睡眠期间的腿部运动 参考美国睡眠医学会标准。综上所述，RestEaze直接 通过提供一种可以显着改善医疗需求的技术来解决重大的未满足的医疗需求 改善 AD 患者 RLS 的诊断和后续管理。使用这个 预计该技术将通过以下方式改善 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避免早期入院的需要 或其他辅助医疗服务。