OTC Hearing Aid and MCI

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT06112860

Run by

Northwestern University

People needed

50

Starts

2024-07-23

Expected to finish

2026-12-31

Last updated by the study team

2025-09-19

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwestern University HA Lab — Evanston, Illinois, United States (enrolling)
• UW Madison — Madison, Wisconsin, United States (enrolling)
• La Crosse Mayo Clinic — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.