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

NCT ID: NCT04240561

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-08-31

Brief Summary

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.

Detailed Description

While the advanced signal-processing algorithms used in digital hearing aids have improved average hearing aid benefit and satisfaction, benefit is still highly variable between individual patients, with some individuals reporting much greater benefit than others. The standard approach to selecting signal processing does not consider individual auditory and cognitive differences and how these may be affected by different levels of advanced signal processing. Data provided by the parent grant, R01 DC0012289, indicate that adults with low working memory capacity (a cognitive skill describing ability to process and store information), more hearing loss and/or advanced age receive limited benefit from hearing aid signal processing that substantially modifies the original speech signal. The long term goal of the investigator's research is to optimize choice of signal processing based on individual auditory and cognitive abilities.

The investigators will measure patient outcomes in response to two hearing aid signal processing strategies that represent two clinically common but very different approaches, which differ in the extent of their signal modification. Commercially available hearing aids will be used for this study. The primary patient outcomes for this project are an individual's speech intelligibility and conversation analysis in aided and unaided conditions. Conversation Analysis quantifies conversation breakdowns and repair behaviors as a function of hearing aid signal manipulations and communication partner perceptions of conversation difficulty. Outcome measures will take place after 3-5 weeks of use of each signal modification strategy. The flexibility in timing is to accommodate the scheduling needs of individual participants.

Conditions

Hearing Loss, Sensorineural; Dementia of Alzheimer Type; Amnestic Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hearing Aid Fitting Order A

Participants wear hearing aids with a high level of signal manipulation, followed by a low level of signal manipulation

Group Type: EXPERIMENTAL

High level of signal manipulation

Intervention Type: DEVICE

Hearing aid will be programmed to a high level of signal manipulation.

Low level of signal manipulation

Intervention Type: DEVICE

Hearing aid will be programmed to a low level of signal manipulation.

Hearing Aid Fitting Order B

Participants wear hearing aids with a low level of signal manipulation, followed by a high level of signal manipulation

Group Type: EXPERIMENTAL

High level of signal manipulation

Intervention Type: DEVICE

Hearing aid will be programmed to a high level of signal manipulation.

Low level of signal manipulation

Intervention Type: DEVICE

Hearing aid will be programmed to a low level of signal manipulation.

Interventions

High level of signal manipulation

Hearing aid will be programmed to a high level of signal manipulation.

Intervention Type: DEVICE

Low level of signal manipulation

Hearing aid will be programmed to a low level of signal manipulation.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Pamela Souza

Professor and Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pam Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Northwestern University

Evanston, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kendra Marks, Au.D.

Role: CONTACT

kendra.marks@northwestern.edu

847-467-0897

Facility Contacts

Kendra Marks, AuD

Role: primary

kendra.marks@northwestern.edu

847-467-0897

Kendra Marks

Role: primary

kendra.marks@northwestern.edu

847-467-0897

Other Identifiers

3R01DC012289-08S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00211218

Identifier Type: -

Identifier Source: org_study_id