Early Age-Related Hearing Loss Investigation (EARHLI)
Purpose
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).
Conditions
- Alzheimer Disease
- Hearing Loss
- Cognitive Impairment
Eligibility
- Eligible Ages
- Between 55 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
New York, New York 10032
More Details
- NCT ID
- NCT06174038
- Status
- Recruiting
- Sponsor
- Columbia University
Detailed 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.