RecruitingNot ApplicableNCT06174038

Early Age-Related Hearing Loss Investigation (EARHLI)

Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess the Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementias

Sponsor

Columbia University

Enrollment

150 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Cognitive Impairment Alzheimer Disease Hearing Loss

Summary

Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD).

Eligibility

Min Age: 55 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (called EARHLI) is investigating whether treating mild-to-moderate hearing loss in older adults who also have early memory problems (mild cognitive impairment) might slow down memory decline — essentially exploring a possible link between hearing and brain health. **You may be eligible if...** - You are between 55 and 75 years old - You have mild-to-moderate hearing loss in your better ear - You have been diagnosed with amnestic mild cognitive impairment (early memory problems, but not full dementia) - You have a study partner (family member or friend) who can attend some visits with you - You live in the community (not a nursing home) and are fluent in English or Spanish **You may NOT be eligible if...** - You were born with hearing loss or have hearing loss due to a known genetic condition - You already use hearing aids - You have a diagnosis of full dementia (Alzheimer's disease or similar) - You have significant depression or other untreated psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHearing Intervention

The hearing intervention includes an auditory needs assessment, hearing aid fitting, establishing Bluetooth connectivity from hearing aids to devices such as smartphones and computers, systematic orientation and instruction in device use, and provision and discussion of hearing "toolkit" materials for self-management and communication strategies. The hearing intervention is person-centered, focusing on identification of individual needs, setting of specific goals, engagement in shared-informed decision-making, and development of self-management abilities. Intervention-centric outcomes (e.g., hearing aid data logging, real ear measures) to verify the best-practices intervention will be gathered at all 5 intervention sessions as well as weeks 16 and 52. Additional visits to troubleshoot hearing aids or address concerns will be scheduled as needed.

BEHAVIORALHealth Education Intervention

The evidence-based interactive health education program is designed for older adults and addresses chronic disease and disability prevention. Session content will be individualized for each participant based on a "key," depending on his/her goals/interests. The curriculum includes didactics, activities, and goal setting led by staff trained/certified to deliver the intervention.