Hearing Aids and the Brain
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hearing aids
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring auditory perception, hearing
Eligibility Criteria
Inclusion Criteria:
- 50 years of age or older
- Bilateral, mild to moderately severe hearing loss
- Inexperienced hearing aid users
Exclusion Criteria:
- Subject deciding that they do not wish to wear hearing aids as necessitated per study protocol
- Audiometric thresholds that suggest research stimuli would not be audible
- Conductive hearing loss and/or other significant ear or hearing problems
- Non-native English speakers
- Conditions or circumstances that would preclude a participant from wearing hearing aids consistently or finishing the study
- An inability to perform or complete the experimental tasks
Sites / Locations
- VA Portland Health Care System, Portland, OR
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hearing aids
Arm Description
All study participants will be fit with hearing aids.
Outcomes
Primary Outcome Measures
Evoked potential latency
Latency will be measured in milliseconds
Evoked potential amplitude
Amplitude will be measured in microvolts
Frequency following response magnitude
Magnitude of response measured in nanovolts
Frequency following response timing
Timing measured by cross-correlation between stimulus and response
Ongoing electroencephalography power
EEG power as a function of frequency recorded during words-in-noise measure
Montreal Cognitive Assessment score
Assessment score from 1 to 30
Reading Span
Percent correct recall on working memory task
Hearing aid usage
Data logging from the hearing aid will provide usage in hours per day
Word-in-noise perception testing
Signal-to-noise ratio at which participant correctly understands 50% of speech in noise using WIN test
Listening invested/required effort
Participants' rating of the effort required (0-9) and invested (0-9) for listening task
Working memory testing
Performance on auditory working memory task
Glasgow Hearing Aid Benefit Profile (GHABP)
Participants rating on five-point scale their perceived initial (i.e., unaided) hearing disability, initial handicap, aided benefit, aided handicap, HA use and HA satisfaction in four listening situations
Secondary Outcome Measures
Full Information
NCT ID
NCT03279510
First Posted
August 23, 2017
Last Updated
March 23, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03279510
Brief Title
Hearing Aids and the Brain
Official Title
Hearing Aids and the Brain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hearing aids are being fit on inexperienced hearing aid users and the short-term and long-term effects are measured. This research aims to improve understanding of the individual factors that contribute to receiving benefit from hearing aids and lead to more individualized treatment of hearing loss.
Detailed Description
Hearing aids are used to improve audibility for patients with hearing loss and improve speech perception. In addition to these immediate benefits, amplification has the potential to have long-term effects on higher level auditory processing abilities, such as cognition or other abilities required for complex listening tasks. These long-term acclimatization effects are not well understood and merit further behavioral and physiological examination. Hearing aids will be fit on inexperienced hearing aid users and outcome measures will be used to determine immediate and long-term effects of hearing aids. This research may provide a more detailed view of individual differences that contribute to receiving benefit from a hearing aid and may lead to more individualized treatment of hearing loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
auditory perception, hearing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hearing aids
Arm Type
Experimental
Arm Description
All study participants will be fit with hearing aids.
Intervention Type
Device
Intervention Name(s)
hearing aids
Intervention Description
Subjects are fit with hearing aids.
Primary Outcome Measure Information:
Title
Evoked potential latency
Description
Latency will be measured in milliseconds
Time Frame
Approximately 1 year
Title
Evoked potential amplitude
Description
Amplitude will be measured in microvolts
Time Frame
Approximately 1 year
Title
Frequency following response magnitude
Description
Magnitude of response measured in nanovolts
Time Frame
Approximately 1 year
Title
Frequency following response timing
Description
Timing measured by cross-correlation between stimulus and response
Time Frame
Approximately 1 year
Title
Ongoing electroencephalography power
Description
EEG power as a function of frequency recorded during words-in-noise measure
Time Frame
Approximately 1 year
Title
Montreal Cognitive Assessment score
Description
Assessment score from 1 to 30
Time Frame
Approximately 1 year
Title
Reading Span
Description
Percent correct recall on working memory task
Time Frame
Approximately 1 year
Title
Hearing aid usage
Description
Data logging from the hearing aid will provide usage in hours per day
Time Frame
Approximately 1 year
Title
Word-in-noise perception testing
Description
Signal-to-noise ratio at which participant correctly understands 50% of speech in noise using WIN test
Time Frame
Approximately 1 year
Title
Listening invested/required effort
Description
Participants' rating of the effort required (0-9) and invested (0-9) for listening task
Time Frame
Approximately 1 year
Title
Working memory testing
Description
Performance on auditory working memory task
Time Frame
Approximately 1 year
Title
Glasgow Hearing Aid Benefit Profile (GHABP)
Description
Participants rating on five-point scale their perceived initial (i.e., unaided) hearing disability, initial handicap, aided benefit, aided handicap, HA use and HA satisfaction in four listening situations
Time Frame
Approximately 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
50 years of age or older
Bilateral, mild to moderately severe hearing loss
Inexperienced hearing aid users
Exclusion Criteria:
Subject deciding that they do not wish to wear hearing aids as necessitated per study protocol
Audiometric thresholds that suggest research stimuli would not be audible
Conductive hearing loss and/or other significant ear or hearing problems
Non-native English speakers
Conditions or circumstances that would preclude a participant from wearing hearing aids consistently or finishing the study
An inability to perform or complete the experimental tasks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis J. Billings, PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Hearing Aids and the Brain
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