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NCT06112860NARecruiting

OTC Hearing Aid and MCI

Northwestern University

Start Date

7/23/2024

Completion Date

12/31/2026

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.

Detailed Description

This is a single blind cross-over study comparing OTC Hearing Aids to communication strategies information/counseling and their impact on communication between a person who has hearing loss and MCI and a communication partner. Due to the nature of the study, it will not be possible to blind the participants to which arm they are in, but the scorers will be blinded.

Eligibility Criteria

Age Range: 60 years to 90 years

Inclusion Criteria: * Over 60 years of age * Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment). * Mild to moderate bilateral hearing loss and no current hearing aid use. * A communication partner who is able and willing to participate in the study. * No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration) * Able to provide own consent as evaluated by the Consent Assessment Exclusion Criteria: 1. Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study. 2. History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer 3. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression) 4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies. 5. History or current fluctuating hearing loss

Interventions

DEVICE

Over the counter hearing aid

BEHAVIORAL

Communication Strategies Information/Counseling

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Conditions

Hearing LossMild Cognitive ImpairmentAlzheimer Disease and Related Dementias (ADRD)

Locations

Northwestern University HA Lab

Evanston, Illinois 60201

United States

La Crosse Mayo Clinic

La Crosse, Wisconsin 54601

United States

UW Madison

Madison, Wisconsin 53706

United States