Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
2 other identifiers
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
April 30, 2026
April 1, 2026
6.2 years
January 10, 2020
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change In Speech Intelligibility (%Correct)
Participants will listen to and repeat recorded low-context sentences presented at conversational level at varying levels of background noise. Scoring is determined by percentage of key words in each sentence a participant is able to hear and correctly repeat back to the tester. Scores may range from 0 to 100% and a higher score indicates better understanding (i.e. a better outcome).
Change from Baseline to final appointment ineach hearing aid condition will be assessed. Participants will take an unaided baseline at the start of the trial. Measure will be repeated at the end of each intervention (3-5 weeks after each fitting).
Change in Conversation Analysis of Communication Breakdown
Data will be extracted from conversation samples recorded between person with cognitive impairment and caregiver participants during a mealtime. Conversations will be audio recorded, transcribed ortho graphically and annotated for conversation breakdowns and repairs using Trouble-Source-Repair conventions grounded in Conversation Analysis approaches. Units of measure are: 1)Proportion of problematic talk 2) Proportion of trouble sources 3) Proportion of unsuccessful repairs and 4)Proportion of complex repairs. Reductions in all 4 reflect a positive change.
Change from Baseline to final appointment in each hearing aid condition will be assessed. Participants will take an unaided baseline at the start of the trial. Measure will be repeated at the end of each intervention (3-5 weeks after each fitting).
Study Arms (2)
Hearing Aid Fitting Order A
EXPERIMENTALParticipants wear hearing aids with a high level of signal manipulation, followed by a low level of signal manipulation
Hearing Aid Fitting Order B
EXPERIMENTALParticipants wear hearing aids with a low level of signal manipulation, followed by a high level of signal manipulation
Interventions
Hearing aid will be programmed to a high level of signal manipulation.
Hearing aid will be programmed to a low level of signal manipulation.
Eligibility Criteria
You may qualify if:
- 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 greater than or equal to 30 dB in each ear
- 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)
- Diagnosis of dementia Alzheimer's type or amnestic mild cognitive impairment (minimum MoCA score of 18).
- Living at home
- Minimum Grade 10 education
- Able to provide own consent as evaluated by the Consent Assessment.
You may not qualify if:
- 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
- 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
- Positive history of major psychiatric disorder (e.g. schizophrenia, significant untreated depression)
- Co-enrolled in other intervention studies targeting hearing, language, or communication strategies
- Conductive hearing loss pathology, congenital hearing loss, or fluctuating hearing loss
- Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northwestern University
Chicago, Illinois, 60611, United States
Northwestern University
Evanston, Illinois, 60208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pam Souza, PhD
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants are randomly assigned to Hearing Aid fitting order A or B. One group will have the higher level of signal manipulation for the first session while the other group will start with the lower level of signal manipulation. Each group will then be given the other signal manipulation strategy. Outcome data will be collected by individuals blinded to which signal modification strategy the participant is using.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair
Study Record Dates
First Submitted
January 10, 2020
First Posted
January 27, 2020
Study Start
July 1, 2021
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share