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NOT YET RECRUITING
NCT07288463
NA

Hearing Loss and Genetic Risks for Alzheimer's Disease and Related Dementia

Sponsor: University of Southern California

View on ClinicalTrials.gov

Summary

Hearing loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may benefit most from earlier intervention. This pilot study aims to evaluate the feasibility and acceptability of OTC hearing aid use among older adults at increased risk for dementia. Participants aged ≥50 years will undergo standardized hearing screening to identify bilateral, mild-to-moderate hearing loss. Eligible participants will be randomized to one of two sequences: (1) immediate intervention: 4-mo using OTC hearing aids or (2) waitlist control: 2-mo without devices followed by an additional 4-mo using OTC hearing aids. Feasibility outcomes include study enrollment and retention, protocol adherence, and average daily device use determined by data-logging. Acceptability outcomes will be assessed using the International Outcome Inventory for Hearing Aids (IOI-HA), device satisfaction ratings, and participant intention to continue hearing-aid use. Hearing outcomes include validated questionnaires on hearing and listenign efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health in high-risk older adults.

Official title: Hearing Loss and Genetic Risks for Dementia

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2027-07-01

Completion Date

2031-06-30

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DEVICE

Over-The-Counter (OTC) hearing aid

Over-The-Counter (OTC) hearing aid

Locations (1)

University of Southern California

Los Angeles, California, United States