Investigating the impact of hearing aids on cognitive decline in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hearing care to reduce neuropsychiatric symptoms in people with Alzheimer's and related dementias

  This trial will try a tailored, community-delivered hearing care program using HEARS devices to see if it improves communication, reduces neuropsychiatric symptoms, and eases caregiver distress in English-speaking older adults with Alzheimer's disease or related dementias who have untreated hearing loss.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT06930560

• Blood tests using plasma biomarkers to diagnose and track Alzheimer’s disease

  A large, year-long study in Milan is testing whether blood markers can help diagnose Alzheimer’s and predict how it will progress in people with memory concerns.

  Recruiting IRCCS San Raffaele · Milan, Milano · NCT07717567

• Lifestyle for Brain Health — Time-Restricted Eating and Mindfulness

  This 9-month program tests whether combining yoga-based mindfulness with time-restricted eating improves cognition, physical fitness, metabolism, and plasma tau levels in adults 60–80 with subjective or mild cognitive impairment and positive pTau217.

  Recruiting St. Anne's University Hospital Brno, Czech Republic · Brno · NCT07042087

• Nutrition and exercise program for brain health in older adults

  This study tests whether a 9-month program of exercise and nutrition can help improve brain health and physical function in older adults at risk for Alzheimer's disease.

  Recruiting Slovak Academy of Sciences · Bratislava, Bratislava Region · NCT06986096

• Collecting data on neurodegenerative diseases progression markers

  This study is trying to find new signs that can help doctors understand how neurodegenerative diseases like Parkinson's progress, so they can improve early treatment options for patients.

  Recruiting IRCCS San Raffaele Roma · Cassino, Frosinone · NCT06596746

• Evaluating acupuncture for Alzheimer's treatment in different genetic groups

  This study is testing if acupuncture can help people with mild-to-moderate Alzheimer's disease feel better, especially looking at how it works for those with and without a specific gene.

  Recruiting Shanghai University of Traditional Chinese Medicine · Shanghai · NCT06417086

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.