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).
Description
EARHLI will be a phase II 1:1 randomized controlled trial of a hearing intervention (including prescription hearing aids) versus a health education program. Participants must be 55-75 years old and have early-stage age-related hearing loss and amnestic mild cognitive impairment. The trial will last 1 year and occur at a single site (Columbia University Irving Medical Center). Outcome measurements will include cognition, social engagement, and change in brain organization/connectivity. Assessments will occur at study start, 6 months, and 12 months. A total of 150 participants will be enrolled (75 per intervention group). Participants will also have a hearing test and a blood test. Approximately half of participants will have two MRI scans. As part of participating, all participants will get prescription hearing aids, either at study start or end.
Eligibility
Inclusion 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
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