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Hearing aid trial aims to calm agitation in Alzheimer's patients

NCT ID NCT06930560

Symptom relief Sponsor: Johns Hopkins 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a personal sound amplifier, along with hearing training, can reduce troubling symptoms like agitation and distress in older adults with Alzheimer's or related dementias who also have hearing loss. Researchers will enroll 300 people aged 60-100 and their care partners. The goal is to see if addressing hearing loss can improve communication and ease neuropsychiatric symptoms.

What this could mean

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

Active substance
personal sound amplifier with aural rehabilitation
What this could lead to
If it works, this could offer a simple, drug-free way to reduce agitation and distress in people with dementia and hearing loss.
What could go wrong
This is an early-stage study with no phase, so results are uncertain. The device may not improve symptoms, and benefits may vary by individual.

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 300 people

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

Started

Oct 2025

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

60 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 60 - 100 years old * English-speaking * Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines * Speech frequency pure tone average (0.5- 4 kHz) \>25 db in the better-hearing ear; adult onset hearing loss * Availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision * Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms Exclusion Criteria: * Current self-reported use of hearing aid or amplification device * Medical contraindication to use hearing aids ( e.g. draining ears) * Inability to participate in the 1-month follow up

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia hearing loss disorder

As listed by the trial registrant

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

Alzheimer disease Cognitive impairment Dementia 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

  • Johns Hopkins Memory and Alzheimer's Treatment Center

    RECRUITING

    Baltimore, Maryland, 21224, United States

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