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

项目总结 阿尔茨海默病和相关痴呆(AD/ADRD)是与年龄相关的神经退行性疾病 失忆的以失忆、迷失方向、决策能力和自理能力降低为特征的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焦虑， 好斗、大喊大叫、寻求退路和解除抑制。迫切需要采取干预措施来改善 这些人的健康结果。利用这些发现，基于熟悉声音的大脑通路和 令人回味的音乐一直保存到很晚的阶段ADRD，Edgewater Safe Systems开发了一款智能 家庭和其他照顾者可以通过网络应用程序使用的可穿戴媒体播放器(Memesto)， 通过此设备计划并向ADRD患者提供语音和音乐。护理者能够记录 问候，提醒吃药，喝水或吃午饭，这些信息可以播放给 患者在设定的日期和时间通过该设备进行治疗。在对使用Memesto的照顾者进行的后续调查中 在护理机构的患者中，11人中有11人给它打了4.5分(满分5分)的“对缓解焦虑的有用性”。Edgewater 建议开发一种更具创新性的可穿戴设备，它可以感知患者不断上升的焦虑情绪，并 自动播放治疗信息和音乐，显示出最成功的减少或 消除穿戴者之前插曲中的骚动。有了这个下一代Memesto，Edgewater的目标是 提高多样化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职业倦怠。新的Memesto将有四把钥匙 创新元素：1)在可穿戴设备中进行重复的、可编程的语音和音乐治疗，这是 AD/ADRD CARE；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 随时随地；3)搅动传感系统，从非侵入性身体佩戴传感器读取生物特征数据，以 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以 确定该媒体在减少骚动方面的有效性，并持续优先选择最有效的媒体。 在第一阶段的研究中，Edgewater将与拉什阿尔茨海默氏症中心合作：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 减少搅动；以及2)论证ADRD搅动检测和自动化干预的可行性。 第二阶段将集中于完全自动化、小型化、可穿戴的Memesto设备的实施 并进行了广泛的现场试验，测试了新型搅拌传感和自动干预系统的有效性。这个 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年达到111亿美元。有500万美国ADRD患者经历了焦虑症，他们会 从拟议的搅动管理系统中受益。

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.