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

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

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.

Keywords: Clinical trials; Cognition; Dementia; Epidemiology; Hearing; Longitudinal study; Memory; Presbycusis.

Figures

Fig. 1
Fig. 1
Participant screening and randomization: the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized trial. ∗Strata defined by severity of hearing impairment, participant status (ARIC participant or recruited de novo), and field site.

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Source: PubMed

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