Early Age-Related Hearing Loss Investigation (EARHLI)

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).

Conditions

• Alzheimer Disease
• Hearing Loss
• Cognitive Impairment

Interventions

DEVICE

Hearing 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.

BEHAVIORAL

Health 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.

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• University of South Florida

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Justin S Golub, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations