Status:
RECRUITING
Early Age-Related Hearing Loss Investigation (EARHLI)
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Johns Hopkins University
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Hearing Loss
Eligibility:
All Genders
55-75 years
Phase:
NA
Brief Summary
Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education ...
Detailed Description
EARHLI will be a phase II 1:1 randomized controlled trial of a hearing intervention (including prescription hearing aids) versus a health education program. Participants must be 55-75 years old and ha...
Eligibility Criteria
Inclusion
- Age 55-75 years of age
- Adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 kHz pure tone average 20 dB to 55 dB HL in better hearing ear)
- Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear
- Amnestic mild cognitive impairment (MCI) defined by Mini-Mental State Exam (MMSE2) score \>23, Clinical Dementia Rating (CDR) global score equivalent = 0.5, and ADNI3 criteria of Logical Memory II score of ≤6 if 0-7 years of education, ≤9 if 8-15 years, and ≤11 if ≥16 years
- Availability of a study partner (informant) for the administration of the cognitive screen and the ADCS-Activities of Daily Living-Prevention Instrument (ADCS-ADL-PI)
- Community-dwelling
- Fluent in English or Spanish
- Availability of participant in area for study duration
Exclusion
- Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (\<45 years old)
- Prior dementia diagnosis
- Reported disability in ≥ 2 activities of daily living (ADLs)
- Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)
- Unwillingness to wear hearing aids regularly (≥8 hours/day)
- Medical contraindications to the use of hearing aids (e.g., actively draining ear)
- Corrected vision impairment (worse than 20/63 on MNRead Acuity Chart in worse eye)
- Untreatable conductive hearing loss with air-bone gap \> 15 dB in two or more contiguous octave frequencies in both ears
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06174038
Start Date
August 1 2024
End Date
December 31 2027
Last Update
August 5 2025
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032