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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Larry Tapia
earhli@cumc.columbia.edu
646-317-3252
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 150
Treatments
Other: Hearing Intervention
Participants will receive 4 sessions across 8 weeks with a later booster session and hearing aid fitting. Each session will take \~75 minutes.
Other: Health Education Intervention
Participants will receive a modified health education program on healthy aging. It will match the number and length of sessions as the hearing intervention, including compliance/phone checks. Participants will be on a waitlist to obtain hearing aids without fee at the end of their 12-month participation.
Sponsors
Collaborators: University of Washington, University of South Florida, University of Pittsburgh, National Institute on Aging (NIA), Johns Hopkins University
Leads: Columbia University

This content was sourced from clinicaltrials.gov