Over-the-counter hearing aid treatment with cognitive decline due to Alzheimer’s disease and related dementias

Overview

About this study

The purpose of this study is to measure communication benefit for OTC hearing aids in older adults with ADRD or MCI and their communication partners.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participant Inclusion Criteria:

  • Over 60 years of age
  • Mild[CF1]  dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers.
  • Bilateral hearing loss with pure-tone average ≤ 50 dB HL
  • No history of hearing aid use, defined as not an active/regular user in past year
  • 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 .

Communication Partner Inclusion Criteria:

  • Adults ages 18-90 years
  • No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration).
  • Able to have a conversation with the main participant in a quiet room (i.e. either has hearing aids or has hearing sufficient to hear the main participant). 
  • Pass a cognitive screener.

Exclusion Criteria of Participant/Communication partner:

  • Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) place the participant at unacceptable risk if they were to participate.
  • History of unresolved communication difficulties following another neurological problem (i.e., stroke, 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 intervention studies targeting hearing, language, or communication strategies.
  • History of or current fluctuating hearing loss
  • Speak a primary language other than English

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/23/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

La Crosse, Wis.

Mayo Clinic principal investigator

Courtney McAlister, Ph.D.

Open for enrollment

Contact information:

Janel Tunison CCRP

(608) 392-6880

Tunison.Janel@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20574790

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