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

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.

PMID: 30364572
PMCID: PMC6197326
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

Jennifer A Deal et al. Alzheimers Dement (N Y). 2018.

. 2018 Oct 5:4:499-507.

doi: 10.1016/j.trci.2018.08.007. eCollection 2018.

Authors

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.

PMID: 30364572
PMCID: PMC6197326
DOI: 10.1016/j.trci.2018.08.007

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.

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Figures

**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.

See this image and copyright information in PMC

References

1. Loughrey D.G., Kelly M.E., Kelley G.A., Brennan S., Lawlor B.A. Association of age-related hearing loss with cognitive function, cognitive impairment, and dementia: a systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. 2017;144:115–126. - PMC - PubMed
1. Livingston G., Sommerlad A., Orgeta V., Costafreda S.G., Huntley J., Ames D. Dementia prevention, intervention, and care. Lancet. 2017;390:2673–2734. - PubMed
1. Lin F.R., Albert M. Hearing loss and dementia—who is listening? Aging Ment Health. 2014;18:671–673. - PMC - PubMed
1. Lin F.R., Niparko J.K., Ferrucci L. Hearing loss prevalence in the United States. Arch Intern Med. 2011;171:1851–1852. - PMC - PubMed
1. Goman A.M., Lin F.R. Prevalence of hearing loss by severity in the United States. Am J Public Health. 2016;106:1820–1822. - PMC - PubMed

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

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

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