OTC Hearing Aid and MCI

Launched by NORTHWESTERN UNIVERSITY · Oct 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how Over-the-Counter (OTC) hearing aids can help people with mild to moderate hearing loss who also have mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD). The main goals are to see if these hearing aids improve communication and if the benefits depend on how much cognitive difficulty a person has. The study will also explore whether using specific communication strategies could provide similar improvements.

To participate, you need to be over 60 years old, have mild dementia or cognitive impairment, and have mild to moderate hearing loss without currently using a hearing aid. You will need a communication partner, like a family member or friend, who is willing to join the study. Participants will be randomly assigned to either start with the OTC hearing aids or with communication strategies designed for those with cognitive challenges. If you join, you can expect to receive personalized information and support to improve communication and quality of life.

Gender

ALL

Eligibility criteria

• 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