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

ObjectiveHearing 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 DesignRandomized, controlled, single-site, early phase II, superiority trial.SettingTertiary academic medical center.ParticipantsOne 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.InterventionsParticipants will be randomized 1:1 to a best practice hearing intervention or a health education control.Main Outcome MeasuresThe 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.ResultsTrial enrollment will begin in early 2024.ConclusionsAfter 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.