Status:
RECRUITING
OTC Hearing Aid and MCI
Lead Sponsor:
Northwestern University
Conditions:
Hearing Loss
Mild Cognitive Impairment
Eligibility:
All Genders
60-90 years
Phase:
NA
Brief 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...
Detailed Description
This is a single blind cross-over study comparing OTC Hearing Aids to communication strategies information/counseling and their impact on communication between a person who has hearing loss and MCI an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06112860
Start Date
July 23 2024
End Date
December 31 2026
Last Update
September 19 2025
Active Locations (3)
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1
Northwestern University HA Lab
Evanston, Illinois, United States, 60201
2
La Crosse Mayo Clinic
La Crosse, Wisconsin, United States, 54601
3
UW Madison
Madison, Wisconsin, United States, 53706