Design and Methods of the Early Age-Related Hearing Loss Investigation Randomized Controlled Trial
Michael W Denham1, Michelle L Arnold2, Victoria A Sanchez3
1Department of Otolaryngology-Head and Neck Surgery, Columbia University Vagelos College of Physicians and Surgeons, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY.
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.
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