Actively Recruiting

Phase Not Applicable
Age: 50Years - 90Years
All Genders
NCT04240561

Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia

Led by Northwestern University · Updated on 2026-04-30

20

Participants Needed

2

Research Sites

321 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

N

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This current translational project, funded by NIH, aims to better understand the impact of various signal modification strategies for older adults with Alzheimer's dementia and its potential precursor, known as amnestic mild cognitive impairment. The investigators hypothesize that adults with Alzheimer's dementia represent an extreme case of restricted cognitive ability, such that very low working memory capacity and overall reduced cognitive capacity will limit benefit from advanced signal processing. Thus, the investigators hypothesize that adults with Alzheimer's dementia will receive greater benefit from acoustically simple, high-fidelity hearing aid processing that minimally alters the acoustic signal.

CONDITIONS

Official Title

Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia

Who Can Participate

Age: 50Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Speak English as their primary language
  • Normal or corrected to normal vision (20/40 binocular vision or unaided using a Snellen chart)
  • 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 ≥30 dB in each ear
  • Clinical Dementia Rating of 0.5 or 1 indicating slight or mild cognitive impairment
  • Diagnosis of Alzheimer's dementia or amnestic mild cognitive impairment with a minimum MoCA score of 18
  • Living at home
  • Minimum Grade 10 education
  • Able to provide own consent as evaluated by the Consent Assessment
Not Eligible

You will not qualify if you...

  • Clinically significant unstable or progressive medical conditions or other risks as judged by investigators
  • History of unresolved communication difficulties from neurological problems (e.g., stroke, brain tumor), neurodevelopmental disorders (e.g., Down's syndrome), or head/neck cancer
  • History of major psychiatric disorders such as schizophrenia or untreated depression
  • Currently enrolled in other studies targeting hearing, language, or communication
  • Conductive hearing loss pathology, congenital hearing loss, or fluctuating hearing loss
  • Current active hearing aid wearer, defined as using hearing aids at least 4 hours a day on most days within the past year

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

2

Northwestern University

Evanston, Illinois, United States, 60208

Actively Recruiting

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Research Team

K

Kendra Marks, Au.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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