Objective Measurement of Hearing Aid Benefit
Primary Purpose
Auditory Perceptual Disorders, Age-related Hearing Loss
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hearing aid amplification algorithms
Sponsored by
About this trial
This is an interventional treatment trial for Auditory Perceptual Disorders
Eligibility Criteria
Inclusion Criteria:
- Aims 1 and 2 age ranges: 18-35 and 60-75
- Aim 3 age range: 50 to 85
- Aims 1 and 2 hearing levels: 1) Normal hearing thresholds defined as pure-tone thresholds ≤ 20 decibel (dB) hearing level (HL) from 125 to 4000 Hz and ≤ 30 dB HL at 6000 and 8000 Hz bilaterally, or 2) Mild to moderate sensorineural hearing loss defined as thresholds within 5 dB of 30 dB HL at 500 Hz, 50 dB HL at 1000 and 2000 Hz, and 60 dB HL at 4000 Hz.
- Aim 3 hearing level: Symmetric hearing thresholds with no interaural difference ≥ 15 dB HL at ≥ 2 frequencies.
- Intelligent Quotients ≥ 85 based on the Wechsler Abbreviated Scale of Intelligence (Psychological Corp., New York)
- Scores ≥ 24 on the Montreal Cognitive Assessment
Exclusion Criteria:
- Neurological disorders
- Middle ear pathology
- Nonnative English speakers
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Effects of hearing aid algorithms
Arm Description
Neural processing and cognitive effort will be assessed in individuals who listen to stimuli generated with linear and fast-acting compression hearing aid algorithms and with actual hearing aids.
Outcomes
Primary Outcome Measures
Neural response fidelity
Neuroelectric and neuromagnetic responses are recorded to amplified one-minute speech samples. Reconstruction of the speech envelope will be performed using a linear reconstruction matrix estimated via boosting. Reconstruction success is measured by the linear correlation between the reconstructed and the acoustic speech envelope.
Secondary Outcome Measures
Cognitive effort
Cognitive effort is inferred from pupillometry data Growth-curve analysis will be used to determine pupil response amplitude.
Full Information
NCT ID
NCT04431622
First Posted
March 17, 2020
Last Updated
May 16, 2022
Sponsor
University of Maryland, College Park
1. Study Identification
Unique Protocol Identification Number
NCT04431622
Brief Title
Objective Measurement of Hearing Aid Benefit
Official Title
Objective Measurement of Hearing Aid Benefit
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
This study did not receive funding
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, College Park
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hearing loss is a critical health concern in the rapidly aging population, affecting approximately 22 million older individuals in the United States. Yet, only 30% of individuals who would benefit from the use of hearing aids regularly use them. This project aims to improve the benefit of hearing aids for older adults through incorporation of objective neural measures to assess effects of hearing aid algorithms.
Detailed Description
Hearing loss is among the top three major health conditions in older adults and has been identified as a major modifiable risk factor for dementia. It is therefore imperative that older adults receive effective treatment for hearing loss in a timely manner to prevent losses in social, emotional, and cognitive function. The current hearing aid fitting is based on audiometric thresholds, but this approach does not account for large individual differences in auditory temporal perception and cognitive ability that may affect speech understanding in challenging listening environments. At present, there is a gap in knowledge of how best to fit hearing aids for individual listeners. The long-term goal is to improve the benefit of hearing aids for older adults so that they can maintain independence and quality of life. The overall objective of this proposal is to identify the neural temporal processing mechanisms associated with individual differences in hearing aid benefit in older adults with similar audiograms. The investigators will use the innovative approach of combining complementary neural and behavioral measures to assess the effects of hearing aid amplification on speech perception and effortful listening. The central hypothesis is that the neural representation of the temporal envelope of speech can be used to predict hearing aid benefit in older adults with hearing loss. The central hypothesis will be tested through the pursuit of three aims: (1) Measure the extent to which amplification distorts the neural and perceptual processing of temporal cues; (2) Quantify reductions in temporal envelope tracking and increases in cognitive effort associated with amplification algorithms that distort the temporal envelope of the speech signal; and (3) Investigate the use of objective physiological measures of temporal processing to predict hearing aid benefit. The expected outcome is the development of an objective, neurophysiological tool for use in the design and fitting of advanced algorithms to maximize speech perception in a variety of listening environments. This outcome is expected to have a positive impact on the treatment of hearing loss and its sequelae in older adults, because it will lead to a better understanding of the neural mechanisms contributing to successful use of hearing aids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Perceptual Disorders, Age-related Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Effects of hearing aid algorithms
Arm Type
Experimental
Arm Description
Neural processing and cognitive effort will be assessed in individuals who listen to stimuli generated with linear and fast-acting compression hearing aid algorithms and with actual hearing aids.
Intervention Type
Device
Intervention Name(s)
Hearing aid amplification algorithms
Intervention Description
The investigators will use stimulus waveforms that have been amplified and recorded for each individual's hearing loss. These waveforms will be created using Desired Sensation Level, Version 5-C hearing aid targets on a continuum of increased signal manipulation. The NIH-funded open hearing aid platform will be used to provide precise control over hearing aid parameters to create waveforms with linear and fast-acting compression amplification. A third set of waveforms will be created using a current clinical hearing aid that uses typical noise reduction and compression parameters. Investigating the effects of hearing aid algorithms in young normal-hearing and older normal-hearing listeners will aid in interpretation of these effects in the older hearing-impaired listeners.
Primary Outcome Measure Information:
Title
Neural response fidelity
Description
Neuroelectric and neuromagnetic responses are recorded to amplified one-minute speech samples. Reconstruction of the speech envelope will be performed using a linear reconstruction matrix estimated via boosting. Reconstruction success is measured by the linear correlation between the reconstructed and the acoustic speech envelope.
Time Frame
Immediately post-treatment
Secondary Outcome Measure Information:
Title
Cognitive effort
Description
Cognitive effort is inferred from pupillometry data Growth-curve analysis will be used to determine pupil response amplitude.
Time Frame
Immediately post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aims 1 and 2 age ranges: 18-35 and 60-75
Aim 3 age range: 50 to 85
Aims 1 and 2 hearing levels: 1) Normal hearing thresholds defined as pure-tone thresholds ≤ 20 decibel (dB) hearing level (HL) from 125 to 4000 Hz and ≤ 30 dB HL at 6000 and 8000 Hz bilaterally, or 2) Mild to moderate sensorineural hearing loss defined as thresholds within 5 dB of 30 dB HL at 500 Hz, 50 dB HL at 1000 and 2000 Hz, and 60 dB HL at 4000 Hz.
Aim 3 hearing level: Symmetric hearing thresholds with no interaural difference ≥ 15 dB HL at ≥ 2 frequencies.
Intelligent Quotients ≥ 85 based on the Wechsler Abbreviated Scale of Intelligence (Psychological Corp., New York)
Scores ≥ 24 on the Montreal Cognitive Assessment
Exclusion Criteria:
Neurological disorders
Middle ear pathology
Nonnative English speakers
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication of data and other research products shall occur during the project, if appropriate, or at the end of the project, consistent with practices in our field. De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. Research products from this project will be archived at the Digital Repository at the University of Maryland (DRUM) unless a more appropriate facility can be identified. DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse. All records in DRUM are assigned a persistent Digital Object Identifier (DOI) to support consistent discovery and citation. The project description will be automatically indexed in Google Scholar to support global discovery.
IPD Sharing Time Frame
Available at the end of the project for an indefinite period.
IPD Sharing Access Criteria
For the research products available to the public, there are no conditions on reuse or redistribution beyond the attribution and credit norms of the scientific community. In the event that reviewers or researchers wish to examine data containing direct or indirect identifiers, they will be required to conform to the terms of a data use agreement. The agreement will prohibit redistribution of sensitive data.
Learn more about this trial
Objective Measurement of Hearing Aid Benefit
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