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NCT Number: NCT06112860

OTC Hearing Aid and MCI

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.
  • 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
  • Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
  • Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
  • History or current fluctuating hearing loss

Treatment and study plan

Over the counter hearing aid

Device

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.

Other names: OTC hearing aid

Communication Strategies Information/Counseling

Behavioral

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.

Other names: Communication Strategies

Primary outcomes

  1. Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)

    Time frame: Baseline at enrollment, then after 4 weeks of using each intervention

    A questionnaire completed by the communication partner of the individual with MCI and hearing loss. On this scale, higher scores reflect more frequent and more problematic conversation difficulties; item possible scores range from 0 (not problematic) to 7 (.very problematic)

Secondary outcomes

  1. Hearing Handicap Inventory for the Elderly (HHIE)

    Time frame: Baseline at enrollment, then after 4 weeks of using each intervention

    Questionnaire has 25 items with subscales for social and emotional impacts and is scored from 0-100, with 100 representing least handicap.

Other outcomes

  1. Conversation Analysis

    Time frame: 4 weeks after first intervention

    The Diapix conversation task where participant and communication partner find the differences in two very similar pictures by discussing them.

  2. Adherence

    Time frame: 4 weeks after each intervention

    Reported Use (hours per day)

  3. Usability

    Time frame: 4 weeks after OTC intervention

    We will use a modification of the Systematic Usability Scale to query the patient's experience with the OTC aids.

Study contacts

Contact information is provided by the study sponsor or research team.

Kendra Marks

CONTACT

[email protected]

8474670897

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Over-the-counter Hearing Aids and Mild Cognitive Impairment

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 2, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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