OTC Hearing Aid and MCI

Description

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.

Conditions

Hearing Loss, Mild Cognitive Impairment, Alzheimer Disease and Related Dementias (ADRD)

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Study Overview

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Study Details

Study overview

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.

Over-the-counter Hearing Aids and Mild Cognitive Impairment

OTC Hearing Aid and MCI

Condition
Hearing Loss
Intervention / Treatment

-

Contacts and Locations

Evanston

Northwestern University HA Lab, Evanston, Illinois, United States, 60201

La Crosse

La Crosse Mayo Clinic, La Crosse, Wisconsin, United States, 54601

Madison

UW Madison, Madison, Wisconsin, United States, 53706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

60 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Pamela Souza, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

2025-12-31