OTC Hearing Aid and MCI

Last updated: March 18, 2025
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Dementia

Hearing Impairment

Treatment

Communication Strategies Information/Counseling

Over the counter hearing aid

Clinical Study ID

NCT06112860
STU00219514
  • Ages 60-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Over 60 years of age

  • Mild dementia or mild cognitive impairment. Diagnosis will be made at participatingmemory 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

Exclusion Criteria:

  1. Clinically significant unstable or progressive medical conditions, or conditionswhich, in the opinion of the investigator(s) places the participant at unacceptablerisk if he or she were to participate in the study.

  2. History of unresolved communication difficulties following another neurologicalproblem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down'ssyndrome), or head/neck cancer

  3. Positive history of major psychiatric disorder (i.e., schizophrenia, significantuntreated depression)

  4. Co-enrolled in other intervention studies targeting hearing, language, orcommunication strategies.

  5. History or current fluctuating hearing loss

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Communication Strategies Information/Counseling
Phase:
Study Start date:
July 23, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Northwestern University HA Lab

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • La Crosse Mayo Clinic

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

  • UW Madison

    Madison, Wisconsin 53706
    United States

    Active - Recruiting

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