Early Age-Related Hearing Loss Investigation (EARHLI)

Launched by COLUMBIA UNIVERSITY · Dec 8, 2023

Keywords

ClinConnect Summary

The Early Age-Related Hearing Loss Investigation (EARHLI) is a clinical trial that aims to study how hearing interventions, like hearing aids, can help reduce cognitive decline in older adults who may be at risk for Alzheimer’s Disease. The trial is specifically looking at late middle-aged adults, aged 55 to 75, who have mild to moderate hearing loss and some early signs of memory issues, known as mild cognitive impairment. Participants will be randomly assigned to either receive hearing aids and support or health education for one year.

To be eligible for the study, individuals must have a certain level of hearing loss that can be improved with hearing aids, along with a specific score on a memory test. They should also have a study partner who can help with the assessments. It's important to note that individuals who have had hearing problems since childhood, have been diagnosed with dementia, or have used hearing aids in the last six months are not eligible. Participants can expect regular check-ins and assessments over the year to see how the hearing intervention affects their cognitive health. This study is currently recruiting participants and is open to anyone who speaks English or Spanish.

Gender

ALL

Eligibility criteria

• 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