Actively Recruiting
OTC Hearing Aid and MCI
Led by Northwestern University · Updated on 2025-09-19
50
Participants Needed
3
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OTC Hearing Aid and MCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 60 years of age
- Mild dementia or mild cognitive impairment diagnosed at participating memory evaluation centers
- Mild to moderate bilateral hearing loss with 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 completing study tasks (e.g., legally blind, severe cataracts, or macular degeneration)
- Able to provide own consent as evaluated by the Consent Assessment
You will not qualify if you...
- Clinically significant unstable or progressive medical conditions that pose unacceptable risk to participation
- History of unresolved communication difficulties due to neurological problems (e.g., stroke, brain tumor), neurodevelopmental disorders (e.g., Down's syndrome), or head/neck cancer
- History of major psychiatric disorders such as schizophrenia or significant untreated depression
- Currently co-enrolled in other intervention studies targeting hearing, language, or communication strategies
- History or current fluctuating hearing loss
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Northwestern University HA Lab
Evanston, Illinois, United States, 60201
Actively Recruiting
2
La Crosse Mayo Clinic
La Crosse, Wisconsin, United States, 54601
Enrolling by Invitation
3
UW Madison
Madison, Wisconsin, United States, 53706
Actively Recruiting
Research Team
K
Kendra Marks
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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