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

开发 Memesto，一种可穿戴式重复信息和音乐治疗设备，可感知并减少 AD/ADRD 患者的躁动。

• 批准号: 10322846
• 负责人: Jeffery Banker
• 金额: $ 50万
• 依托单位: EDGEWATER SAFETY SYSTEMS LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10322846
• 关键词: Address; Aftercare; Age; Aggressive behavior; Agitation; Alzheimer' s Disease; Alzheimer' s disease diagnostic; Alzheimer' s disease related dementia; American; Antipsychotic Agents; Anxiety; Assisted Living Facilities; Base of the Brain; Behavior; Behavioral; Biological Markers; Biometry; Caregivers; Cellular Phone; Clinical Trials; Collaborations; Data; Dementia; Detection; Development; Devices; Diagnostic; Disinhibition; Disorientation; Eating; Effectiveness; Elements; Equipment and supply inventories; Family; Family psychotherapy; Feedback; Friends; Goals; Health; Health care facility; Home; Impaired cognition; Individual; Intervention; Knowledge; Legal patent; Lewy Body Dementia; Medical Device; Memory Loss; Music; Music Therapy; Nerve Degeneration; Neurodegenerative Disorders; Notification; Nursing Homes; Online Systems; Outcome; Participant; Patient Monitoring; Patients; Persons; Pharmaceutical Preparations; Phase; Physical Function; Play; Population Heterogeneity; Problem behavior; Pulse Rates; Quality of life; Reporting; Safety; Sales; Schedule; Self Care; Site; Small Business Innovation Research Grant; Stress; Surveys; System; Techniques; Technology; Testing; Therapeutic; Time; Voice; Water; base; brain pathway; burnout; caregiver interventions; cognitive function; commercial application; decision-making capacity; dementia care; design; detection platform; direct patient care; effectiveness evaluation; efficacy testing; experience; follow-up; improved; innovation; miniaturize; neuropsychiatry; next generation; open label; operation; phase 1 study; preservation; programs; prototype; residential care facility; sensor; success; voice therapy; wearable device; wearable sensor technology; web app

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.

项目概要 阿尔茨海默病和相关痴呆症 (AD/ADRD) 是与年龄相关的神经退行性疾病 70% 的人表现为记忆丧失、定向力障碍、决策能力和自理能力下降。 超过 720 万患有 AD/ADRD 的美国人经历过有问题的躁动，包括攻击性、 好斗、喊叫、寻求退出和去抑制等现象迫切需要采取干预措施来改善。 利用基于熟悉声音的大脑通路的研究结果和这些人的健康结果。 缺席的音乐将被保留到 ADRD 的最后阶段，Edgewater 安全系统开发了一种智能 可穿戴媒体播放器 (Memesto)，家人和其他护理人员可以使用网络应用程序来记录、 护理人员可以通过该设备为 ADRD 患者安排和传送语音和音乐。 问候、提醒吃药、喝水或吃午餐，这些信息可以播放给 在对使用 Memesto 的护理人员进行的后续调查中，患者在设定的日期和时间通过该设备进行了调查。 在护理机构的患者中，11 名患者中的 11 名对其“缓解躁动有用”给予 4.5 分（满分 5 分）。 提议开发一种更具创新性的可穿戴设备，可以感知患者不断加剧的躁动，并 自动播放已证明已取得最大成功的治疗信息和音乐，以减少或 Edgewater 的目标是通过下一代 Memesto 消除佩戴者之前的烦躁情绪。 改善 ADRD 人群的生活质量；减少潜在有害药物的使用； 作为一种干预措施，并帮助减轻护理人员的压力和倦怠，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，这是首创 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消息和音乐 3) 激动感应系统，可从非侵入式身体佩戴传感器读取生物识别数据 自动部署媒体治疗；4) 在播放媒体开始和结束时采集的传感器数据 确定该媒体在减少骚乱方面的有效性，并不断优先考虑最有效的媒体。 在第一阶段研究中，Edgewater 将与 Rush 阿尔茨海默病中心合作：1) 进行为期 10 周的研究 对 20 名 ADRD 患者进行的临床试验，旨在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。 第二阶段将重点关注完全自动化、小型化、可穿戴 Memesto 设备的完整实施 以及广泛的现场试验测试新的躁动感应和自动干预系统的功效。 2018 年阿尔茨海默病诊断和治疗市场规模达到 75 亿美元，预计 到 2024 年将达到 111 亿美元。美国有 500 万 ADRD 患者经历了烦躁不安，他们将 受益于拟议的搅动管理系统。