RecruitingRecruiting
OTC Hearing Aid and MCI
NCT06112860 · Northwestern University
In plain English
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Official title
Over-the-counter Hearing Aids and Mild Cognitive Impairment
About this study
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 and a communication partner. Due to the nature of the study, it will not be possible to blind the participants to which arm they are in, but the scorers will be blinded.
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
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-07-23
Estimated completion: 2027-03-30
Last updated: 2026-09-04
Interventions
Device: Over the counter hearing aidBehavioral: Communication Strategies Information/Counseling
Primary outcomes
- • Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT) (Baseline at enrollment, then after 4 weeks of using each intervention)
Sponsor
Northwestern University · other
Contacts & investigators
ContactKendra Marks · contact · kendra.marks@northwestern.edu · 8474670897
InvestigatorPamela Souza, PhD · principal_investigator, Northwestern University
All locations (3)
Northwestern University HA LabRecruiting
Evanston, Illinois, United States
La Crosse Mayo ClinicCompleted
La Crosse, Wisconsin, United States
UW MadisonCompleted
Madison, Wisconsin, United States