Addressing Hearing Loss as a Common Unmet Contributor to Neuropsychiatric Symptoms

项目总结 随着65岁及以上成年人数量的持续增加，阿尔茨海默病和 其他相关痴呆症(ADRD)预计也会增加美国的神经精神症状(NPS) 如烦躁、冷漠、抑郁和睡眠障碍在ADRD患者中非常普遍， 高达97%的人在病程中至少遭受一次NPS。核动力源需要相当大的 护理伙伴的管理和时间，并与认知和功能的快速下降有关，情况更糟 生活质量，更大的护理伙伴负担，以及更早的养老院入院时间。虽然不是药理学的 建议对NPS进行干预，继续广泛使用精神药物，导致 不良事件。与ADRD相似，听力损失的患病率随着年龄的增长而增加。然而，听力护理作为 对已经出现认知障碍的老年人进行三级预防在很大程度上被忽视了。 多年来，MPI和当前提案的合作伙伴一直在合作，表明i) 在患有轻度认知障碍(MCI)和ADRD的个体中，听力损失的发生率很高。 二)听力损失的严重程度与NPS和NPS严重程度的增加有关，并且III)a 利用新兴的非处方(OTC)听力技术的以用户为中心的听力护理干预可以 改善NPS。目前的提议是基于NIA先前的1b阶段试验，该试验涉及一名初始飞行员 门诊患者使用OTC助听器进行听力护理干预的研究 布景。拟议的研究返回到阶段1a和1b，以完善和测试经修订的 听力护理干预策略，以NPS为目标，研究行动的潜在机制(S)。目标 1寻求通过涉及咨询专家的阶段1a研究来完善听力护理干预 和最终用户制定一项修订的干预方案，将最新的证据知情 核动力源的方法以及与理论框架的一致性，对实施的考虑 在最初的试点研究中遇到的挑战，以及在各种情况下提供干预的能力， 包括房子在内。然后，AIM 2将评估修订后的听力护理干预的初步疗效 通过更大的1b阶段随机对照试验，这将允许更严格地评估 干预比以前的工作要好。目标3将采用混合方法来表征响应 作用的异质性和潜在机制(S)。拟议的研究包括迭代和 NIA阶段模型的多向性，目标是开发有效的行为干预 达到最大的效力水平，并可能实现到最大数量的较老的 成年人。这项建议建立了关于听力护理作为一个整体的作用的关键基础知识 管理NPS的组件。这些发现将直接转化为更大的2/3阶段疗效试验。

PROJECT SUMMARY As the number of adults age 65 and older continue to increase, the prevalence of Alzheimer’s disease and other related dementias (ADRD) is also expected to increase in the U.S. Neuropsychiatric symptoms (NPS) such as agitation, apathy, depression, and sleep disturbance are highly prevalent in patients with ADRD, with up to 97% of the individuals suffering at least one NPS over the disease course. NPS requires considerable management and time by care partners, and are associated with rapid cognitive and functional decline, worse quality of life, greater care partner burden, and earlier nursing home admissions. Although nonpharmacological intervention for NPS is recommended, psychotropic medications continue to be widely prescribed, resulting in adverse events. Similar to ADRD, the prevalence of hearing loss increases with age. However, hearing care as tertiary prevention for older adults who have already developed cognitive impairment has largely been ignored. MPIs and the Co-Is of the current proposal have been working together for many years, demonstrating that i) there is a high prevalence of hearing loss among indiviudals with mild cognitive impairment (MCI) and ADRD, ii) increasing severity of hearing loss is associated with greater number of NPS and NPS severity, and that iii) a user-centered hearing care intervention that utilizes emerging over-the-counter (OTC) hearing technology may ameliorate NPS. The current proposal is based upon a prior NIA Stage 1b trial that involved an initial pilot study of a hearing care intervention that utilized OTC hearing devices and was delivered in an outpatient setting. The proposed study returns to Stage 1a and 1b to refine and test the preliminary efficacy of a revised hearing care intervention strategy that targets NPS and examines the underlying mechanism(s) of action. Aim 1 seeks to refine the hearing care intervention through a Stage 1a study that involves consultation with experts and end-users to develop a revised intervention protocol that integrates the latest evidence-informed approaches to NPS along with alignment with theoretical frameworks, consideration of implementation challenges encountered in the initial pilot study, and the ability to deliver the intervention in various settings, including the home. Aim 2 will then assess the preliminary efficacy of the revised hearing care intervention through a larger Stage 1b randomized controlled trial, which will allow for greater rigor in assessing the intervention than prior work. Aim 3 will employ a mixed methods approach to characterize response heterogeneity and underlying mechanism(s) of action. The proposed study embraces the iterative and multidirectional nature of the NIA Stage Model with the goal of developing impactful behavioral interventions that reach the maximum level of potency and potentially implementable to the maximum number of older adults. This proposal builds critical foundational knowledge regarding the role of hearing care as an integral component of managing NPS. These findings will directly translate to a larger Stage 2/3 efficacy trial.