Investigating the impact of hearing aids on cognitive decline in older adults
Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess the Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementias
This study is testing if using hearing aids can help older adults with early hearing loss and mild memory problems think better and stay socially active compared to those who only get health education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06174038 on ClinicalTrials.gov |
What this trial studies
The Early Age-Related Hearing Loss Investigation (EARHLI) is a randomized controlled trial that aims to assess the effects of a hearing intervention, including hearing aids, compared to a health education program in late middle-aged adults with early-stage age-related hearing loss and mild cognitive impairment. Participants aged 55-75 will be enrolled and followed for one year, with assessments of cognition, social engagement, and brain connectivity conducted at the start, 6 months, and 12 months. The study will involve approximately 150 participants, with half receiving hearing aids at the beginning and the other half at the end of the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55-75 with mild to moderate age-related hearing loss and amnestic mild cognitive impairment.
Not a fit: Patients with congenital hearing loss or those whose hearing loss began before middle age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function and quality of life for older adults at risk for Alzheimer's Disease.
How similar studies have performed: Other studies have shown promising results in the relationship between hearing interventions and cognitive outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Justin S Golub, MD — Columbia University
- Study coordinator: Larry Tapia
- Email: earhli@cumc.columbia.edu
- Phone: 646-317-3252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.