Early Age-Related Hearing Loss Investigation (EARHLI)

Description

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).

Conditions

Alzheimer Disease, Hearing Loss, Cognitive Impairment

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Study Overview

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Study Details

Study overview

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).

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

Early Age-Related Hearing Loss Investigation (EARHLI)

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

55 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Justin S Golub, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2028-02-01