Development of Memesto, a wearable repetitive message and music therapy device that senses and reduces agitation in persons with AD/ADRD.

项目摘要 阿尔茨海默病及相关痴呆（AD/ADRD）是一种与年龄相关的神经退行性疾病 其特征为记忆丧失、定向障碍、决策能力和自我照顾能力降低。70%的 720多万患有AD/ADRD的美国人经历了包括攻击性在内的问题性激动， 好斗、叫喊、寻求出口和抑制解除。迫切需要采取干预措施， 这些人的健康状况。利用研究结果，熟悉的声音为基础的大脑通路， 令人想起的音乐被保存，直到非常晚的阶段ADRD，埃奇沃特安全系统开发了一个智能 可穿戴媒体播放器（Memesto），家庭和其他护理人员可以使用网络应用程序来记录， 通过该设备为ADRD患者安排和提供语音和音乐。护理人员能够记录 问候，提醒服药，喝水或吃午饭，这些消息可以播放给 在设定的日期和时间通过器械对患者进行检查。在对使用Memesto的护理人员的后续调查中， 在护理机构的患者中，11人中有11人将其评为4.5分（满分5分），用于“缓解躁动的有用性”。Edgewater 建议开发一种更具创新性的可穿戴设备，可以感知患者体内不断上升的躁动， 自动播放治疗信息和音乐，显示有最大的成功减少或 消除了佩戴者先前发作时的焦虑。通过下一代Memesto，Edgewater旨在 改善不同ADRD人群的生活质量;减少潜在有害药物的使用 作为一种干预;并帮助减轻照顾者的压力和倦怠。新的Memesto将有四个关键 创新要素：1）可穿戴设备中的重复，可编程语音和音乐治疗，这是第一个 AD/ADRD护理; 2）基于网络的应用程序，使家人和朋友能够传递个人信息和音乐 3）从非侵入式身体佩戴传感器读取生物特征数据的搅拌感测系统， 自动部署媒体治疗;以及4）在播放媒体的开始和结束时获取的传感器数据， 确定该介质在减少搅动方面的有效性，并持续地对最有效的介质进行优先级排序。 在第一阶段的研究中，Edgewater将与拉什阿尔茨海默病中心合作：1）进行为期10周的 对20名ADRD患者进行临床试验，以收集原始音频播放器有效性的定量证据， 减少躁动; 2）证明ADRD躁动检测和自动干预的可行性。 第二阶段将专注于完全实现完全自动化，小型化，可穿戴的Memesto设备 以及广泛的现场试验，测试新的搅动感测和自动干预系统的功效。的 阿尔茨海默病诊断和治疗市场在2018年达到75亿美元，预计 到2024年111亿美元。有一个500万美国ADRD患者谁经验激动谁会 受益于拟议的搅拌管理系统。

PROJECT SUMMARY Alzheimer’s Disease and Related Dementias (AD/ADRD) are age-associated neuro-degenerative diseases characterized by memory loss, disorientation, and reduced decision-making capacity and self-care. 70% of the 7.2+ million Americans with AD/ADRD experience problematic agitation that includes aggression, combativeness, shouting, exit-seeking and disinhibition. An urgent need exists for interventions that improve health outcomes for these individuals. Utilizing findings that familiar-voice-based brain pathways and reminiscent music are preserved until very late stage ADRD, Edgewater Safety Systems developed a smart wearable media player (Memesto) that family and other caregivers could use with a web app to record, schedule and deliver voice and music to an ADRD patient through this device. Caregivers were able to record greetings, reminders to take medication, drink water or eat lunch, and these messages could be played for the patient via the device at set dates and times. In a follow-up survey with caregivers who used the Memesto with patients at care facilities, 11 of 11 rated it 4.5 out of 5 for “usefulness in mitigating agitation.” Edgewater proposes to develop a more innovative wearable device that senses rising agitation in the patient and automatically plays therapeutic messages and music shown to have had the greatest success reducing or eliminating agitation in the wearer’s previous episodes. With this next generation Memesto, Edgewater aims to improve quality of life for a diverse population of ADRD persons; diminish the use of potentially harmful drugs as an intervention; and help reduce stress and burnout in caregivers. The new Memesto will have four key elements of innovation: 1) repetitive, programmable voice and music therapy in a wearable device, a first for AD/ADRD care; 2) web-based app that enables family and friends to deliver personal messages and music anytime; 3) agitation-sensing system that reads biometric data from non-invasive body-worn sensors to automatically deploy media therapy; and 4) sensor data taken at start and end of the played media to determine effectiveness of that media in reducing agitation and continually prioritize the most effective media. In the Phase I study, Edgewater will partner with Rush Alzheimer’s Disease Center to: 1) carry out a 10-week clinical trial on 20 ADRD persons to gather quantitative evidence of the original audio player’s effectiveness at reducing agitation; and 2) demonstrate feasibility of ADRD agitation detection and automated intervention. Phase II will focus on complete implementation of a fully automated, miniaturized, wearable Memesto device and a broad field trial testing efficacy of the new agitation sensing and automated intervention system. The Alzheimer's Disease Diagnostics and Therapeutics market reached $7.5 billion in 2018, with a projection of $11.1 billion by 2024. There is a pool of 5 million U.S. ADRD sufferers who experience agitation who would benefit from the proposed agitation management system.