Actively Recruiting

Phase Not Applicable
Age: 50Years - 90Years
All Genders
ID04240561

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

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

20

Participants Needed

2

Research Sites

N/A

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

Researchers are investigating how different hearing aid signal processing strategies affect older adults with Alzheimer's dementia and its common precursor, amnestic mild cognitive impairment. The study aims to understand how cognitive abilities, such as working memory, influence the benefit individuals receive from advanced hearing aid signal modifications. The goal is to optimize hearing aid settings based on each person's hearing and cognitive capacities. Participants will use commercially available hearing aids programmed with two different signal processing approaches: one with a high level of signal manipulation and another with a low level. Each participant will wear hearing aids with one type of signal modification for 3 to 5 weeks, then switch to the other type for another 3 to 5 weeks. The order of these treatments is randomized. During the study, participants' speech understanding and conversations will be evaluated both with and without hearing aids. Researchers will measure changes in speech intelligibility and analyze communication breakdowns and repair behaviors. Assessments occur at the start and end of each treatment phase. The study is double-masked and aims to identify which hearing aid processing best supports communication for people with cognitive impairment. Participation lasts for the duration of both treatment phases, approximately 6 to 10 weeks total.

CONDITIONS

Brief 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
  • Pure-tone average of ≥30 dB in each ear at 0.5, 1, 2, 3 kHz frequencies
  • Clinical Dementia Rating (CDR) of 0.5 or 1 indicating slight or mild cognitive impairment
  • Diagnosis of Alzheimer's dementia or amnestic mild cognitive impairment with 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 posing unacceptable risk
  • History of unresolved communication difficulties from neurological problems (e.g., stroke, brain tumor), neurodevelopmental disorders, or head/neck cancer
  • History of major psychiatric disorders like schizophrenia or untreated depression
  • Currently co-enrolled in other intervention studies targeting hearing, language, or communication
  • Conductive, congenital, or fluctuating hearing loss
  • Current active hearing aid wearer using aids at least 4 hours a day most days within the past year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 3 to 5 weeks per hearing aid setting

Participants are fitted with hearing aids programmed to a high or low level of signal manipulation and wear them for 3 to 5 weeks to assess hearing aid outcomes.

2 hearing aid fitting visits and follow-up visits after each fitting

Implementation

Duration - 3 to 5 weeks per hearing aid setting

Participants switch to the alternate hearing aid signal processing setting and wear the hearing aids for another 3 to 5 weeks to evaluate outcomes.

Follow-up visits after fitting

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.

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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