No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Columbia University · Other
Who this trial is looking for
This trial is looking for adults aged 55-75 with mild to moderate hearing loss and signs of memory issues. If you join, you will receive either hearing aids or health education while being monitored for one year.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 55 and 75 years old.
I have mild to moderate hearing loss.
I have a word recognition score of 60% or higher in my better ear.
I have memory issues as defined by a cognitive assessment.
I have a study partner to help with assessments.
I live in the community.
I speak English or Spanish fluently.
I can be available for the study.
You may not be able to join if
I have congenital hearing loss or genetic hearing loss.
I was diagnosed with dementia.
I have a disability in two or more daily activities.
I currently use hearing aids regularly.
I am unwilling to wear hearing aids for at least 8 hours a day.
I have a medical condition that prevents me from using hearing aids.
I have serious vision impairment.
I have untreatable conductive hearing loss.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 Demen…
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).
Trial Locations
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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 e…
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
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