Who is eligible for clinical trial NCT06174038?

Participants must meet protocol criteria for Alzheimer Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06174038 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-10

Early Age-Related Hearing Loss Investigation (EARHLI) (NCT06174038)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Columbia University

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (9 items).

Location: Columbia University Medical Center — New York, New York

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Columbia University Medical Center — New York, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗