Design and Methods of the Early Age-Related Hearing Loss Investigation Randomized Controlled Trial

Michael W Denham; Michelle L Arnold; Victoria A Sanchez; Frank R Lin; Lauren H Tucker; Michael C Gomez; Karla Fernandez; Pamela Arpi; Haley Neil; Suzannah Boyle; Sally Selevan; Tamara J Sussman; Theresa Gmelin; Ione Fine; Nancy W Glynn; Jeanne Teresi; James M Noble; Terry Goldberg; Jose A Luchsinger; Justin S Golub

doi:10.1097/MAO.0000000000004093

Design and Methods of the Early Age-Related Hearing Loss Investigation Randomized Controlled Trial

Otol Neurotol. 2024 Jun 1;45(5):594-601. doi: 10.1097/MAO.0000000000004093.

Authors

Michael W Denham¹, Michelle L Arnold², Victoria A Sanchez³, Frank R Lin, Lauren H Tucker¹, Michael C Gomez¹, Karla Fernandez¹, Pamela Arpi¹, Haley Neil³, Suzannah Boyle³, Sally Selevan², Tamara J Sussman¹, Theresa Gmelin⁴, Ione Fine⁵, Nancy W Glynn⁶, Jeanne Teresi⁷, James M Noble⁸, Terry Goldberg⁹, Jose A Luchsinger¹⁰, Justin S Golub¹

Affiliations

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 and Disorders, College of Behavioral and Community Sciences.
³ Department of Otolaryngology-Head and Neck Surgery, University of South Florida, Tampa, FL.
⁴ Department of Epidemiology, University of Pittsburgh School of Public Health, Pittsburgh, PA.
⁵ Department of Psychology/Center for Human Neuroscience University of Washington, Seattle, WA.
⁶ Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA.
⁷ Columbia University Stroud Center at New York State Psychiatric Institute and Department of Medicine.
⁸ Department of Neurology, GH Sergievsky Center, and Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Columbia University.
⁹ Department of Psychiatry, New York State Psychiatric Institute and Columbia University Irving Medical Center.
¹⁰ Department of Medicine, Columbia University Irving Medical Center, New York, NY.

PMID: 38728564
PMCID: PMC11093050 (available on 2025-06-01)
DOI: 10.1097/MAO.0000000000004093

Abstract

Objective: Hearing loss has been identified as a major modifiable risk factor for cognitive decline. The Early Age-Related Hearing Loss Investigation (EARHLI) study will assess the mechanisms linking early age-related hearing loss (ARHL) and cognitive impairment.

Study design: Randomized, controlled, single-site, early phase II, superiority trial.

Setting: Tertiary academic medical center.

Participants: One hundred fifty participants aged 55 to 75 years with early ARHL (severity defined as borderline to moderate) and amnestic mild cognitive impairment will be included.

Interventions: Participants will be randomized 1:1 to a best practice hearing intervention or a health education control.

Main outcome measures: The primary study outcome is cognition measured by the Alzheimer Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite. Secondary outcomes include additional measures of cognition, social engagement, and brain organization/connectivity.

Results: Trial enrollment will begin in early 2024.

Conclusions: After its completion in 2028, the EARHLI trial should offer evidence on the effect of hearing treatment versus a health education control on cognitive performance, social engagement, and brain organization/connectivity in 55- to 75-year-old community-dwelling adults with early ARHL and amnestic mild cognitive impairment.

Trial registration: ClinicalTrials.gov NCT06174038.

Publication types

Research Support, N.I.H., Extramural
Randomized Controlled Trial
Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Cognitive Dysfunction*
Female
Hearing Loss
Humans
Male
Middle Aged
Presbycusis

Associated data

ClinicalTrials.gov/NCT06174038

Abstract

Publication types

MeSH terms

Associated data

Grants and funding