Can simpler hearing aids help Alzheimer's patients hear better?

NCT ID NCT04240561

Knowledge-focused Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at whether simpler hearing aid settings work better for older adults with Alzheimer's dementia or mild memory problems. Researchers will test two different hearing aid programs in 20 participants to see which one helps them understand speech in noisy settings and communicate more easily during meals. The goal is to learn how to best adjust hearing aids for people with memory and thinking challenges.

What this could mean

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

Active substance: hearing aid with different signal manipulation settings
What this could lead to: If successful, this could help tailor hearing aid programming for people with Alzheimer's or memory problems, improving their communication and quality of life.
What could go wrong: This is a very small early-stage study with only 20 participants, so results may not apply to everyone. It is observational in nature and does not test a new treatment or cure.

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 20 people

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

Started

Jul 2021

Expected to finish

Aug 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

50 to 90 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: 1. Speak English as their primary language 2. Normal or corrected to normal vision (20/40 binocular vision or unaided using a Snellen chart) 3. Sensorineural hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 500 and 3000 Hz and a 4 frequency (.5, 1, 2, 3 kHz) pure-tone average of greater than or equal to 30 dB in each ear 4. Clinical Dementia Rating (CDR) of 0.5 or 1 (indicating slight or mild cognitive impairment in the areas of memory, orientation, judgment/problem solving, community affairs, behavior at home/hobbies, and personal care) 5. Diagnosis of dementia Alzheimer's type or amnestic mild cognitive impairment (minimum MoCA score of 18). 6. Living at home 7. Minimum Grade 10 education 8. Able to provide own consent as evaluated by the Consent Assessment. Exclusion Criteria: 1. Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study 2. History of unresolved communication difficulties following another neurological problem (e.g. stroke or brain tumor), neurodevelopmental disorder (e.g. Down's syndrome), or head/neck cancer 3. Positive history of major psychiatric disorder (e.g. schizophrenia, significant untreated depression) 4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies 5. Conductive hearing loss pathology, congenital hearing loss, or fluctuating hearing loss 6. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction Hearing Loss, Sensorineural sensorineural hearing loss disorder

As listed by the trial registrant

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

Amnestic mild cognitive impairment Dementia of Alzheimer type Hearing loss, sensorineural

How to take part

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

The places running it

2 sites. The list below names each one and where it is.
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 ↗
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.

Can simpler hearing aids help Alzheimer's patients hear better?

What the study statuses mean