Using OTC hearing aids to improve communication in older adults with mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Over-the-Counter (OTC) hearing aids in enhancing communication for individuals over 60 years old who have mild to moderate hearing loss and are experiencing mild cognitive impairment (MCI) or Alzheimer's disease. Participants will be randomized into two groups: one receiving OTC hearing aids and the other receiving communication strategies information. The study will assess whether the benefits of using hearing aids vary based on the level of cognitive impairment and if alternative communication strategies provide similar improvements. The study employs a single-blind cross-over design to ensure objective assessment of outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Northwestern University HA Lab
  Evanston, Illinois, United States Recruiting
• La Crosse Mayo Clinic
  La Crosse, Wisconsin, United States Completed
• UW Madison
  Madison, Wisconsin, United States Completed

Study contacts

• Principal investigator: Pamela Souza, PhD — Northwestern University
• Study coordinator: Kendra Marks
• Email: kendra.marks@northwestern.edu
• Phone: 8474670897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.