Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
Primary Purpose
Hearing Loss, Sensorineural, Dementia of Alzheimer Type, Amnestic Mild Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High level of signal manipulation
Low level of signal manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring mild cognitive impairment
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Sites / Locations
- Northwestern UniversityRecruiting
- Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hearing Aid Fitting Order A
Hearing Aid Fitting Order B
Arm Description
Participants wear hearing aids with a high level of signal manipulation, followed by a low level of signal manipulation
Participants wear hearing aids with a low level of signal manipulation, followed by a high level of signal manipulation
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04240561
First Posted
January 10, 2020
Last Updated
March 27, 2023
Sponsor
Northwestern University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT04240561
Brief Title
Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
Official Title
Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Dementia of Alzheimer Type, Amnestic Mild Cognitive Impairment
Keywords
mild cognitive impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized cross-over Trial
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hearing Aid Fitting Order A
Arm Type
Experimental
Arm Description
Participants wear hearing aids with a high level of signal manipulation, followed by a low level of signal manipulation
Arm Title
Hearing Aid Fitting Order B
Arm Type
Experimental
Arm Description
Participants wear hearing aids with a low level of signal manipulation, followed by a high level of signal manipulation
Intervention Type
Device
Intervention Name(s)
High level of signal manipulation
Intervention Description
Hearing aid will be programmed to a high level of signal manipulation.
Intervention Type
Device
Intervention Name(s)
Low level of signal manipulation
Intervention Description
Hearing aid will be programmed to a low level of signal manipulation.
Primary Outcome Measure Information:
Title
Change In Speech Intelligibility (%Correct)
Description
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).
Time Frame
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).
Title
Change in Conversation Analysis of Communication Breakdown
Description
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.
Time Frame
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kendra Marks, Au.D.
Phone
847-467-0897
Email
kendra.marks@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pam Souza, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Marks, AuD
Phone
847-467-0897
Email
kendra.marks@northwestern.edu
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Marks
Phone
847-467-0897
Email
kendra.marks@northwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
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