Home › Alzheimer's Disease › NCT06174038
Early Age-Related Hearing Loss Investigation (EARHLI)
Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess the Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementias
Who can join
Ages 55 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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 intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD).
What is being tested
- Hearing Intervention (device)
- Health Education Intervention (behavioral)
Sponsor: Columbia University · Participants: 150 · Started: Aug 1, 2024
Contact the study team
- Larry Tapia · Phone: 646-317-3252
Official record on ClinicalTrials.gov — NCT06174038
Locations in the U.S.
| New York | Columbia University Medical Center, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.