Early Age-Related Hearing Loss Investigation (EARHLI)

Columbia University

Status: Enrolling

Conditions: Alzheimer Disease; Cognitive Impairment; Hearing Loss

Treatments: Behavioral: Health Education Intervention; Device: Hearing Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06174038

R01AG075083 (U.S. NIH Grant/Contract)

AAAU1896

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Hearing Intervention

Other group

Description:

Participants will receive 4 sessions across 8 weeks with a later booster session and hearing aid fitting. Each session will take \~75 minutes.

Treatment:

Device: Hearing Intervention

Health Education Intervention

Other group

Description:

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.

Treatment:

Behavioral: Health Education Intervention