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RECRUITING
NCT06112860
NA

OTC Hearing Aid and MCI

Sponsor: Northwestern University

View on ClinicalTrials.gov

Summary

The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids: 1. improve communication 2. Whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits. Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.

Official title: Over-the-counter Hearing Aids and Mild Cognitive Impairment

Key Details

Gender

All

Age Range

60 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-07-23

Completion Date

2026-12-31

Last Updated

2025-09-19

Healthy Volunteers

No

Interventions

DEVICE

Over the counter hearing aid

An over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist.

BEHAVIORAL

Communication Strategies Information/Counseling

Communication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist.

Locations (3)

Northwestern University HA Lab

Evanston, Illinois, United States

La Crosse Mayo Clinic

La Crosse, Wisconsin, United States

UW Madison

Madison, Wisconsin, United States