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Could a hearing aid be a shield against dementia?

NCT ID NCT06174038

Prevention Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study tests whether using hearing aids and related support can help slow memory decline in adults aged 55-75 who have mild to moderate hearing loss and early signs of memory problems. Participants are randomly assigned to receive either a hearing intervention or a health education program, and their cognitive and social functioning is tracked for a year. The goal is to understand if treating hearing loss could reduce the risk of Alzheimer's disease and related dementias.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hearing aids and related hearing intervention (device and behavioral support)
What this could lead to
If hearing aids help preserve memory and thinking, this could point toward a simple way to lower dementia risk in people with hearing loss.
What could go wrong
This is a small, early-stage trial, and results may not apply to everyone. Hearing aids may not affect cognition, and the study only follows participants for one year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction hearing loss disorder Memory Disorders presbycusis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Cognitive impairment Hearing loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.