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临床试验/NCT05153161
NCT05153161已完成1 期

Development of Memesto Wearable Repetitive Message/Music Therapy Device That Senses and Reduces Agitation in Alzheimer's Disease and Alzheimer's Disease Related Dementia (AD/ADRD) Individuals

Edgewater Safety Systems, Inc.2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2022年8月31日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
9
试验地点
2
主要终点
Change from Baseline to Week 10 in average Neuropsychiatric Inventory (NPI) agitation domain score

研究概览

简要总结

An estimated 70% of the 7.2+ million people in the U.S. with Alzheimer's Disease and Alzheimer's Disease-Related Dementias experience agitation, characterized by poorly organized and purposeless psychomotor activity that diminishes their quality of life. The goal of this Small Business Innovation Research (SBIR) project is to develop a wearable therapy device that automatically senses rising agitation, and alerts caregivers while deploying calming voice and music therapy to help them avoid crisis level behavior. This device will improve health outcomes for AD/ADRD sufferers and reduce the substantial stress suffered by their caregivers.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligible participants will be adults with a dementia diagnosis who have clinically significant agitation, defined as a state of poorly organized and purposeless psychomotor activity characterized by at least one of the following: aggressive verbal (screaming, cursing), aggressive physical (destroying objects, grabbing, fighting), or non-aggressive physical (restlessness, pacing) behaviors.13 The behavioral symptoms must be severe enough to warrant pharmacological treatment. A family caregiver must be willing to participate along with a professional caregiver from the residential living facility.

排除标准

  • Persons could screen fail if the device cannot be utilized by the person living with AD/ADRD, family caregiver, or professional caregiver.

结局指标

主要结局

Change from Baseline to Week 10 in average Neuropsychiatric Inventory (NPI) agitation domain score

时间窗: 10 weeks

The NPI agitation domain score is a composite score (symptom frequency x severity) ranging from 1 to 12; a higher score represents greater distress.

次要结局

  • Change from Baseline to Week 10 in average Clinical Global Impression - Severity (CGI-S) score(10 weeks)

研究者

发起方
Edgewater Safety Systems, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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