Design and Methods of the Early Age-Related Hearing Loss Investigation Randomized Controlled Trial-Reference-Cited by-同舟云学术

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

Published:2024-06 Issue:5 Volume:45 Page:594-601
ISSN:1537-4505
Container-title:Otology & Neurotology
language:en
Short-container-title:Otol Neurotol

Author:

Denham Michael W.¹,Arnold Michelle L.²,Sanchez Victoria A.³,Lin Frank R.,Tucker Lauren H.¹,Gomez Michael C.¹,Fernandez Karla¹,Arpi Pamela¹,Neil Haley³,Boyle Suzannah³,Selevan Sally²,Sussman Tamara J.¹,Gmelin Theresa⁴,Fine Ione⁵,Glynn Nancy W.⁶,Teresi Jeanne⁷,Noble James M.⁸,Goldberg Terry⁹,Luchsinger Jose A.¹⁰,Golub Justin S.¹

Affiliation:

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

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Reference61 articles.

1. Prevalence of selected chronic conditions: United States, 1990–1992;Vital Health Stat 10,1997

2. The association between early age-related hearing loss and brain β-amyloid;Laryngoscope,2020

3. Association of subclinical hearing loss with cognitive performance;JAMA Otolaryngol Head Neck Surg,2019

4. Audiometric age-related hearing loss and cognition in the Hispanic community health study;J Gerontol A Biol Sci Med Sci,2020

5. Observed hearing loss and incident dementia in a multiethnic cohort;J Am Geriatr Soc,2017