Author(s)
Michael W. Denham, MPhil
Michelle L. Arnold, AuD, PhD
Victoria A. Sanchez, AuD, PhD
Frank R. Lin, MD, PhD
Jose A. Luchsinger, MD, MPH
Justin S. Golub, MD, MS
Affiliation(s)
1 Department of Otolaryngology-Head and Neck Surgery, Columbia University Vagelos College of Physicians and Surgeons,?NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY
2 Department of Communication Sciences & Disorders, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL
3 Department of Otolaryngology—Head and Neck Surgery, University of South Florida, Tampa, FL
4 Johns Hopkins Cochlear Center for Hearing and Public Health, Baltimore, MD
5 Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
6 Department of Otolaryngology, Johns Hopkins School of Medicine, Baltimore, MD
7 Department of Medicine, Columbia University Irving Medical Center, New York, NY
Abstract:
Objective: To describe the design and methods of the upcoming NIH-funded Early Age-Related Hearing Loss Investigation
(EARHLI) randomized controlled trial, which will assess whether a hearing intervention versus a health education
comparator affects cognition, social engagement, and brain connectivity
Study Design: Randomized controlled trial (RCT)
Setting: Single academic medical center
Subjects: 150 community-dwelling adults aged 55-75 years with borderline-to-moderate hearing loss (20-55 dB puretone
average) and amnestic mild cognitive impairment
Interventions: Subjects will be randomized to a best-practices hearing rehabilitation program including hearing aids
versus a standardized health education program comparator.
Main Outcome Measures: Subjects will be followed for one year to evaluate pre- vs. post- intervention change on: (1) Global
and domain-specific cognitive performance on the Alzheimer Disease Cooperative Study Preclinical Alzheimer Cognitive
Composite (ADCS-PACC) standardized assessment, Trail Making Test Part B, and the ADCS-Activities of Daily Living-
Prevention Instrument; (2) Social engagement (social activity frequency, Community Integration Measure, Cohen’s
Social Network Index, and the UCLA Loneliness Scale); and (3) Brain cross-modal organization and functional/structural
connectivity on fMRI.
Conclusions: When completed in 2027, the EARHLI trial will provide substantive evidence on the effects of hearing
intervention on cognitive performance, social engagement, and brain organization/connectivity in middle-aged to older
community-dwelling adults with hearing loss. In this presentation, we describe the design and methods of this first-in-kind
trial that will help clarify whether there is a causal relationship between hearing loss and cognitive decline.
Professional Practice Gap & Educational Need: While many studies have demonstrated an association between
hearing loss and cognitive decline, there remains a lack of evidence supporting a hypothesized causal relationship between
the two.
Learning Objective: Attendees will understand the design and methods of an upcoming NIH-funded RCT that will help
elucidate whether there is a causal relationship between hearing loss and cognitive decline.
Desired
Results: Attendees will leave with an understanding of an ongoing RCT with implications to change clinical
management of patients at risk of or experiencing cognitive decline.
Level of Evidence – Level I
IRB: Pending, Columbia University