Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) Randomized Trial

降低与年龄相关的认知能力下降、阿尔茨海默病（AD）和其他疾病风险的新方法 鉴于人口老龄化，迫切需要老年痴呆症。流行病学研究 表明老年人的外周听力损失与以下因素密切相关， 加速认知能力下降和痴呆症这背后的假设机制途径 观察到的相关性包括听力差和周围声音编码失真对听力的影响。 认知负荷、大脑结构/功能和/或社交参与减少。重要的是，这些途径可能 通过使用听力技术进行全面的听力损失治疗， （助听器、其他综合助听器）和康复训练。然而，迄今为止， 从来没有一个随机试验研究过这种疗法是否可以减少认知能力的下降 以及老年人患阿尔茨海默病和其他痴呆症的风险。在过去的两年里，我们 老年人老化、认知和听力评估（ACHIEVE）随机试验。ACHIEVE一次性使用心内 试验将招募750名70-84岁认知正常的老年听力损失患者，按1：1的比例随机分配 听力干预（听力需求评估、助听器安装、教育/咨询）或 控制干预（与健康教育者进行个性化的成功老龄化教育课程， 健康老龄化主题）。试验将具有检测最小0.30标准差（SD）的把握度 听力干预和成功老化之间认知能力下降年速率的差异 干预武器超过3年的随访期。ACHIEVE研究汇集了多学科小组， 研究人员，并利用现有的研究基础设施，科学专业知识， 社区神经认知研究（ARIC-NCS）中动脉粥样硬化风险的参与者队列。的 ACHIEVE试验有以下目的：目的1确定听力康复干预的效果 与成功的衰老控制干预相比，在70名受试者中， 84岁认知正常的老年人听力损失。目的2确定听证的效果 康复干预与成功的衰老控制干预对次要结局指标的影响， 判定的痴呆事件，身体和社会功能，健康相关的生活质量，以及身体 活动次要目的：1）探讨听力康复干预是否能改变已建立的 从ARIC-NCS招募的参与者的认知下降轨迹。2)为了调查听力的影响 对有阿尔茨海默病危险因素的人的认知能力下降率进行康复干预， 生物标志物。鉴于近三分之二的70岁及以上的成年人有临床意义的听力， 进行ACHIEVE研究，以确定现有的听力康复干预措施是否可以减少听力损失， 老年人认知能力下降的速度具有重大的公共卫生意义。

Novel approaches to reduce the risk of age-related cognitive decline, Alzheimer’s disease (AD), and other dementias in older adults are urgently needed given the aging of the population. Epidemiologic studies demonstrate that peripheral hearing loss in older adults is strongly and independently associated with accelerated cognitive decline and incident dementia. Hypothesized mechanistic pathways underlying this observed association include the effects of poor hearing and distorted peripheral encoding of sound on cognitive load, brain structure/function, and/or reduced social engagement. Importantly, these pathways may be modifiable with comprehensive hearing loss treatment consisting of the use of hearing 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 such therapies could reduce cognitive decline and the risk of Alzheimer’s disease and other dementias in older adults. Over the past two years, we have developed the Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) randomized trial. The ACHIEVE trial will recruit 750 70-84 year-old cognitively-normal older adults with hearing loss who will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or control intervention (individualized successful aging education sessions with a health educator covering healthy aging topics). The trial will be powered to detect a minimum of a 0.30 standard deviation (SD) difference in the annual rate of cognitive decline between the hearing intervention and the successful aging intervention arms over a 3-year follow-up period. The ACHIEVE study brings together a multidisciplinary group of investigators and leverages the existing research infrastructure, scientific expertise, and well-characterized participant cohort of the Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS). The ACHIEVE trial has the following aims: Aim 1 To determine the effect of hearing rehabilitative intervention versus a successful aging control intervention on rates of cognitive decline (primary outcome measure) in 70‐ 84 year‐old cognitively-normal older adults with hearing loss. Aim 2 To determine the effect of hearing rehabilitative intervention versus a successful aging control intervention on secondary outcome measures of adjudicated incident dementia, physical and social functioning, health-related quality of life, and physical activity. Secondary Aims: 1) To investigate whether hearing rehabilitative intervention alters established trajectories of cognitive decline in participants recruited from ARIC-NCS. 2) To investigate the effect of hearing rehabilitative intervention on rates of cognitive decline in persons with Alzheimer’s disease risk factors and biomarkers. Given that nearly two-thirds of all adults 70 years and older have a clinically-significant hearing loss, conducting the ACHIEVE study to determine if existing hearing rehabilitative interventions can reduce the rate of cognitive decline in older adults is of substantial public health importance.