Planning a trial of hearing rehabilitative treatment to reduce cognitive decline

描述(由申请人提供)：考虑到人口老龄化和老年人认知障碍对个人、社会经济和公共健康的影响，需要新的方法来减少老年人的认知衰退。现在的流行病学数据有力地表明，老年人中与年龄相关的外周听力损失独立地与认知能力减退和痴呆症的发生有关。可能支持这种观察到的联系的机械途径包括听力差和声音的外围编码扭曲对认知负荷的影响和/或社交参与度的降低。这些途径可以接受全面的听力康复治疗，包括使用听力辅助技术(助听器、其他综合助听器)和康复训练。然而，到目前为止，还没有一项随机试验调查听力损失治疗是否可以减少老年人的认知和其他功能下降。我们建议开发这样一项临床试验，具有以下具体目标：临床试验目标1：确定最佳实践听力损失治疗对70-79岁功能正常和认知正常的老年听力损失患者认知减退率的影响(主要结果衡量标准)。第二项临床试验目的是确定最佳实践听力损失治疗对结构性MRI上与健康相关的生活质量、社交/休闲活动、日常功能、活动度和纵向脑萎缩的次要结果测量的影响。临床试验目标3：研究其作用机制 听力损失治疗通过研究与认知轨迹有关的近端/中介结果测量的纵向变化来影响认知功能的途径。为了设计和计划这项临床试验，我们组建了一支多元化的多学科专家团队，他们涵盖认知衰老/老年学和耳鼻喉科/听力学领域。我们将建立在社区动脉粥样硬化风险神经认知研究(ARIC-NCS)的大量现有资源的基础上，包括研究基础设施(已建立的现场站点、研究人员和数据协调中心)和一个特征良好的队列&gt；6000名ARIC-NCS参与者，他们已经被跟踪了25年，我们将从他们中招募试验参与者。此外，我们还将借鉴NIA支持的独立和有活力的老年人高级认知培训(积极)试验的现有试验经验和方案。在为期两年的临床试验规划资助阶段，主要活动包括最终确定和试点测试招募和保留战略、实施和试点测试听力康复干预措施、开发和试点测试最终结果单元、编写程序手册、开发数据管理系统，以及准备临床试验的最终拨款申请。

DESCRIPTION (provided by applicant): Novel approaches for reducing cognitive decline in older adults are needed given the aging of the population and the personal, socioeconomic, and public health implications of cognitive impairment in older adults. Epidemiologic data now strongly suggest that age-related peripheral hearing loss in older adults is independently associated with accelerated cognitive decline and incident dementia. Mechanistic pathways that could underlie this observed association include the effects of poor audition and distorted peripheral encoding of sound on cognitive load and/or reduced social engagement. These pathways may be amenable to comprehensive hearing rehabilitative treatment consisting of the use of hearing assistive technologies (hearing aids, other integrated hearing assistive devices) and rehabilitative training. To date, however, there has never been a randomized trial that has investigated whether hearing loss treatment could reduce cognitive and other functional declines in older adults. We propose to develop such a clinical trial that will have the following specific aims: Clinical Trial Aim #1: To determine the effects of best-practices hearing loss treatment on rates of cognitive decline (primary outcome measure) in 70-79 year-old well-functioning and cognitively-normal older adults with hearing loss. Clinical Trial Aim #2 To determine the effects of best-practices hearing loss treatment on secondary outcome measures of health-related quality of life, social/leisure activities, daily functioning, mobility, and longitudinal brain atrophy on structural MRI. Clinical Trial Aim #3: To investigate the mechanistic pathways through which hearing loss treatment affects cognitive functioning by studying longitudinal changes in proximal/mediating outcome measures in relation to cognitive trajectories. In order to design and plan this clinical trial, we have assembled a diverse, multidisciplinary team of experts who span the fields of cognitive aging/gerontology and otolaryngology/audiology. We will build upon the substantial existing resources of the Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS) that include research infrastructure (established field sites, study personnel, and data coordination center) and a well-characterized cohort of >6000 ARIC-NCS participants who have been followed for >25 years and from which we would recruit trial participants. In addition, we will also draw upon existing trial experience and protocols from the NIA- supported Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) trial. Major activities during the two-year clinical trial planning grant phase include finalizing and pilot testing recruitment and retention strategies, operationalizing and pilot testing the hearing rehabilitative intervention, developing and pilot testing the final outcome battery, writing the manual of procedures, developing the data management system, and preparing the final grant application for the clinical trial.