Planning a trial of hearing rehabilitative treatment to reduce cognitive decline

描述（由申请人提供）：考虑到人口老龄化以及老年人认知障碍对个人、社会经济和公共卫生的影响，需要减少老年人认知能力下降的新方法。目前的流行病学数据有力地表明，老年人与年龄相关的外周性听力损失与认知能力加速下降和痴呆发生率独立相关。这种观察到的关联背后的机制途径包括听力差和声音外围编码扭曲对认知负荷和/或社会参与减少的影响。这些途径可能适合综合听力康复治疗，包括使用听力辅助技术（助听器，其他综合听力辅助装置）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。我们建议开展这样一项临床试验，其具体目标如下：临床试验目标#1：确定最佳实践听力损失治疗对70-79岁功能良好和认知正常的听力损失老年人认知衰退率（主要结局指标）的影响。临床试验目的#2：确定最佳听力损失治疗方法对结构MRI上与健康相关的生活质量、社会/休闲活动、日常功能、活动能力和纵向脑萎缩的次要结局指标的影响。临床试验目的#3：探讨机制

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.