Early Age-Related Hearing Loss Investigation (EARHLI)
Recruiting now · Not applicable
Conditions studied: Alzheimer Disease, Hearing Loss, Cognitive Impairment
In brief
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).
Key facts
- Study ID
- NCT06174038
- Run by
- Columbia University
- People needed
- 150
- Starts
- 2024-08-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-08-05
Who can join
Age: 55 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Columbia University Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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