NCT06174038Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 8 Dec 2023
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Columbia University
- Diseases
- Alzheimer disease
- NCT number
- NCT06174038
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Aug 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior dementia diagnosis
- Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)
Other illness
- Corrected vision impairment (worse than 20/63 on MNRead Acuity Chart in worse eye)
Age
- Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (\<45 years old)
Other
- Reported disability in ≥ 2 activities of daily living (ADLs)
- Unwillingness to wear hearing aids regularly (≥8 hours/day)
- Medical contraindications to the use of hearing aids (e.g., actively draining ear)
- Untreatable conductive hearing loss with air-bone gap \> 15 dB in two or more contiguous octave frequencies in both ears
Who the study is looking for
- 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
Age in the registry: 55 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.