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听力治疗对减少认知衰退的作用:老年人衰老与认知健康评估随机对照试验的设计与方法

Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial.

作者信息

Deal Jennifer A, Goman Adele M, Albert Marilyn S, Arnold Michelle L, Burgard Sheila, Chisolm Theresa, Couper David, Glynn Nancy W, Gmelin Theresa, Hayden Kathleen M, Mosley Thomas, Pankow James S, Reed Nicholas, Sanchez Victoria A, Richey Sharrett A, Thomas Sonia D, Coresh Josef, Lin Frank R

机构信息

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA.

出版信息

Alzheimers Dement (N Y). 2018 Oct 5;4:499-507. doi: 10.1016/j.trci.2018.08.007. eCollection 2018.

Abstract

INTRODUCTION

Hearing impairment is highly prevalent and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders study is a multicenter randomized controlled trial to determine efficacy of hearing treatment in reducing cognitive decline in older adults. Clinicaltrials.gov Identifier: NCT03243422.

METHODS

Eight hundred fifty participants without dementia aged 70 to 84 years with mild-to-moderate hearing impairment recruited from four United States field sites and randomized 1:1 to a best-practices hearing intervention or health education control. Primary study outcome is 3-year change in global cognitive function. Secondary outcomes include domain-specific cognitive decline, incident dementia, brain structural changes on magnetic resonance imaging, health-related quality of life, physical and social function, and physical activity.

RESULTS

Trial enrollment began January 4, 2018 and is ongoing.

DISCUSSION

When completed in 2022, Aging and Cognitive Health Evaluation in Elders study should provide definitive evidence of the effect of hearing treatment versus education control on cognitive decline in community-dwelling older adults with mild-to-moderate hearing impairment.

摘要

引言

听力障碍极为普遍,且与认知能力下降独立相关。老年人衰老与认知健康评估研究是一项多中心随机对照试验,旨在确定听力治疗对降低老年人认知能力下降的疗效。Clinicaltrials.gov标识符:NCT03243422。

方法

从美国四个实地研究点招募了850名年龄在70至84岁之间、无痴呆症且有轻度至中度听力障碍的参与者,并将他们按1:1随机分配至最佳实践听力干预组或健康教育对照组。主要研究结果是全球认知功能的3年变化。次要结果包括特定领域的认知能力下降、新发痴呆症、磁共振成像上的脑结构变化、健康相关生活质量、身体和社会功能以及身体活动。

结果

试验于2018年1月4日开始招募,目前仍在进行中。

讨论

老年人衰老与认知健康评估研究预计在2022年完成,届时应能提供确凿证据,证明听力治疗与教育对照对社区中患有轻度至中度听力障碍的老年人认知能力下降的影响。

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