RecruitingNot ApplicableNCT06112860

OTC Hearing Aid and MCI

Over-the-counter Hearing Aids and Mild Cognitive Impairment

Sponsor

Northwestern University

Enrollment

50 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Mild Cognitive Impairment Hearing Loss Alzheimer Disease and Related Dementias (ADRD)

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

Min Age: 60 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether providing over-the-counter (OTC) hearing aids — which are now available without a prescription — to older adults with mild cognitive impairment (MCI) or mild dementia who also have untreated hearing loss helps slow cognitive decline or improve daily functioning. **You may be eligible if...** - You are over 60 years old - You have been diagnosed with mild cognitive impairment or mild dementia at a participating memory center - You have mild to moderate hearing loss in both ears and are not currently using hearing aids - You have a communication partner (family member or caregiver) willing to participate with you - You are able to provide your own informed consent **You may NOT be eligible if...** - You have clinically significant unstable or progressive medical conditions - You have had communication difficulties following a stroke, brain tumor, or neurodevelopmental disorder - You have a major untreated psychiatric disorder (like schizophrenia) - You are enrolled in another study targeting hearing, language, or communication - You have a history of fluctuating hearing loss Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOver the counter hearing aid

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.

BEHAVIORALCommunication Strategies Information/Counseling

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.