Long-term effects of hearing intervention on brain health in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study

减少认知衰退、阿尔茨海默病和相关痴呆风险的新方法(ADRD) 鉴于人口老龄化，老年人迫切需要更多的老年人。在过去的十年里，观察性的 研究表明，外周听力损失是患耳聋的最大潜在可修改风险因素之一 痴呆症可能占所有痴呆症病例的8%-9%。观察到的这一现象背后的假设路径 关联可以与包括使用听力技术的听力损失治疗一起修改(例如， 助听器)和康复训练。老年人老龄化和认知健康评估(ACACHE)研究是 正在进行的、由NIA赞助的第三阶段RCT(R01AG055426，MPIS：LIN/Coresh)调查听力是否 失落治疗与老龄化教育控制干预相比，在三年的随访中减少了认知能力的下降 上行期。从2018-19年，我们招募了977名年龄在70-84岁之间的未经治疗的轻度至中度听力损失的成年人，他们 在基线(0年)时随机进行1：1的听力干预(HI；最佳实践听力服务和 技术)与成功的老龄化(SA)教育控制干预(即，与 健康教育者，介绍对健康老龄化重要的主题)。参与者目前正在被跟踪 每半年在ACESS外地站点进行一次考察，计划在2021-22年进行第三年的最后一次考察访问。在他们第三年之后 访问期间，随机分为SA教育对照组的所有参与者也将接受听力干预。 这项原始试验的最终3年结果将表明听力干预(与成功衰老相比 对照干预)在随机化后的3年时间间隔内减少认知能力下降。我们现在建议 继续跟踪实现队列另外3年(即直到第6年)，以确定长期- 听力干预的长期效应(即，参与者在第0年被随机分配到HI)与成功 老龄化/延迟HI控制(即，参与者在第0年随机进入SA，并在第3年后提供HI 访问)对认知和大脑结果的影响。鉴于认知障碍通常反映出反应迟缓 随着病理改变的积累，HI在减缓这种下降方面的好处可能不会在 只有3年。因此，这一为期6年的队列跟踪调查将使我们能够充分评估更长时间的、累积的 HI对老年人的影响。这些调查结果将补充2023年的主要试验结果，并直接告知 围绕可能使用听力干预以降低ADRD风险的临床和政策决定。这 拟议的研究有以下目标：目标1确定HI与SA/延迟HI的长期影响 控制以下共同主要结局的比率：(A)认知下降和(B)事件轻度认知损害 (MCI)/痴呆。目的2确定HI与SA/延迟HI控制的长期效果。 脑核磁共振测量：(A)局部脑容量和(B)白质束完整性。次要目标：1) 调查影响HI治疗效果异质性的潜在因素；2)调查医疗保健 通过分析Medicare索赔数据，比较HI与SA/Delay HI控制组之间的支出和使用情况。

Novel approaches to reduce the risk of cognitive decline and Alzheimer's disease and related dementias (ADRD) in older adults are urgently needed given the aging of the population. Over the past decade, observational research has implicated peripheral hearing loss as being one of the largest potentially modifiable risk factors for dementia that may account for 8-9% of all dementia cases. Hypothesized pathways underlying this observed association may be modifiable with hearing loss treatment consisting of the use of hearing technologies (e.g., hearing aids) and rehabilitative training. The Aging & Cognitive Health Evaluation in Elders (ACHIEVE) study is an ongoing, NIA-sponsored Phase III RCT (R01AG055426, MPIs: Lin/Coresh) investigating whether hearing loss treatment versus an aging education control intervention reduces cognitive decline over a three-year follow- up period. From 2018-19, we recruited 977 adults ages 70-84 with untreated mild-to-moderate hearing loss who were randomized 1:1 at baseline (Year 0) to receive hearing intervention (HI; best-practice hearing services and technologies) versus a successful aging (SA) education control intervention (i.e., one-on-one sessions with a health educator covering topics important for healthy aging). Participants are currently being followed semiannually at the ACHIEVE field sites with final Year 3 study visits scheduled from 2021-22. After their Year 3 visit, all participants randomized to the SA education control group will also be offered the hearing intervention. Final Year 3 results from this original trial will indicate whether hearing intervention (versus a successful aging control intervention) reduces cognitive decline over a 3-year interval after randomization. We now propose to continue following the ACHIEVE cohort for an additional 3 years (i.e., up to Year 6) to determine the long- term effects of hearing intervention (i.e., participants randomized to HI at Year 0) versus successful aging/delayed HI control (i.e., participants randomized to SA at Year 0 and offered HI after their Year 3 visit) on cognitive and brain outcomes. Given that cognitive impairment typically reflects the slow accumulation of pathologic changes, the benefits of HI in slowing this decline may not be fully appreciable within just 3 years. Therefore, this 6-year follow-up of the cohort will allow us to fully evaluate the longer, cumulative impact of HI on older adults. Such findings will complement the main trial results in 2023 and directly inform clinical and policy decisions around the potential use of hearing interventions to reduce the risk of ADRD. This proposed study has the following aims: Aim 1 To determine the long-term effect of HI versus SA/Delayed HI control on rates of the co-primary outcomes of: (a) cognitive decline and (b) incident mild cognitive impairment (MCI)/dementia. Aim 2 To determine the long-term effect of HI versus SA/Delayed HI control on changes in brain MRI measures of: (a) regional brain volumes and (b) white matter tract integrity. Secondary Aims: 1) To investigate potential factors contributing to HI treatment effect heterogeneity; 2) To investigate health care expenditures and utilization between the HI vs SA/Delayed HI control groups by analyzing Medicare claims data.