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

doi:10.1016/j.trci.2018.08.007

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

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

Authors

Jennifer A Deal^{1

2

3}, Adele M Goman^{2

3}, Marilyn S Albert⁴, Michelle L Arnold⁵, Sheila Burgard⁶, Theresa Chisolm⁷, David Couper⁶, Nancy W Glynn⁸, Theresa Gmelin⁹, Kathleen M Hayden¹⁰, Thomas Mosley¹¹, James S Pankow¹², Nicholas Reed^{2

3}, Victoria A Sanchez¹³, A Richey Sharrett¹, Sonia D Thomas¹⁴, Josef Coresh^{1

15

16}, Frank R Lin^{1

2

3}

Affiliations

¹ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
² Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA.
³ Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
⁴ Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
⁵ College of Science and Mathematics, University of South Florida Sarasota - Manatee, Sarasota, FL, USA.
⁶ Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
⁷ Department of Communication Sciences and Disorders, University of South Florida, Tampa, FL, USA.
⁸ Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.
⁹ Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
¹⁰ Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA.
¹¹ The MIND Center, University of Mississippi Medical Center, Jackson, MS, USA.
¹² Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.
¹³ Department of Otolaryngology-Head and Neck Surgery, University of South Florida, Tampa, FL, USA.
¹⁴ RTI International, Research Triangle Park, NC, USA.
¹⁵ George W. Comstock Center for Public Health Research and Prevention, Johns Hopkins Bloomberg School of Public Health, Hagerstown, MD, USA.
¹⁶ Department of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.

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.

Associated data

ClinicalTrials.gov/NCT03243422

Abstract

Associated data

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