Peripheral and Central Influences on Auditory Temporal Processing & Speech Perception in Older Cochlear Implantees
Primary Purpose
Hearing Loss, Cochlear Hearing Loss, Hearing Loss, Sensorineural
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic tests of cochlear implant function
Diagnostic tests of auditory function
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Loss
Eligibility Criteria
For Cochlear Implant arm:
Inclusion Criteria:
- cochlear implant in one or both ears
- post-lingual onset of deafness
- 1+ years cochlear implant experience
- use of Cochlear-brand implants
- implanted after 2004
Exclusion Criteria:
- use of non-Cochlear-brand cochlear implants
- no use of oral language
- pregnant women are not eligible for the imaging portion of the study.
- residual acoustic hearing with unaided thresholds <90 dB HL at more than two standard audiometric frequencies
- other known disability or neurological disorder
For Typical Hearing arm:
Inclusion Criteria:
- audiometrically normal hearing, near-normal hearing, or mild/moderate hearing loss.
Exclusion Criteria:
- severe hearing loss
- history of neurological disorders
- history of middle-ear disorders
Sites / Locations
- University of Maryland, College Park
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Enrolled Participants - Older adults with cochlear implants
Enrolled Participants - Adults with typical hearing
Arm Description
Individuals who already use at least one cochlear implant.
Control group to provide baseline or comparison data
Outcomes
Primary Outcome Measures
Perceptual forward-masking recovery
Basic measurement of temporal processing - A masker stimulus encountered before a probe/target stimulus can affect the perception of the probe stimulus to a greater/lesser degree depending on their separation in time and their absolute and relative levels. Percent correct discrimination as a function of time separation and level manipulations, as measured from a behavioral response, will be reported.
Perceptual gap detection thresholds
Basic behavioral measurement of temporal processing - The ability to detect a silent gap within a stimulus typically varies depending on frequency and level characteristics of the stimulus in which the gap is embedded and also with the hearing history and age of the listener. Gap detection threshold is the shortest gap duration that can be reliably detected under a given set of conditions and is typically reported in milliseconds.
Perceptual duration discrimination thresholds
Basic measurement of temporal processing - Perceptual duration discrimination thresholds summarize a listener's ability to tell apart stimuli that differ in temporal extent. Percent correct discrimination as a function of duration difference, overall stimulus duration, and level manipulations, as measured from a behavioral response, will be reported.
Perceptual amplitude discrimination thresholds
Basic measurement of auditory processing - Perceptual amplitude discrimination thresholds summarize a listener's ability to tell apart stimuli that differ in level. Percent correct discrimination as a function of level difference size and average level, as measured from a behavioral response, will be reported.
Speech perception
Word discrimination, consonant, vowel, and sentence perception tests. The ability to discriminate between and identify recorded words, phonemic contrasts, and sentences will be assessed behaviorally. Results are reported in terms of percent correct words or phonemes.
Amplitude modulation detection performance
Measure of ability to perceive amplitude modulation using modulation depth thresholds. Amplitude modulation detection performance summarizes a listener's ability to detect the presence of slower-changing amplitude variations applied to a faster-varying carrier signal. The modulation depth of the resulting combined signal can vary between 0 to 100% of the carrier signal with larger values indicating more extreme amplitude fluctuation. This research reports on the amount of modulation that can be detected as a function of different modulator and carrier frequencies, as well as overall stimulus level, as assessed via behavioral report.
Secondary Outcome Measures
Electrically evoked compound action potential (ECAP)
ECAP amplitude growth function slopes will be used to predict perceptual performance. This measure uses clinically-available software to track the growth in auditory nerve response (peak-to-peak amplitude) as input level is varied from threshold to the maximal level at which the signal is comfortably loud. The slope of input-output function will be measured for each electrode along the electrode array of each CI study participant. Steeper slopes (measured in microvolts/current unit) will be interpreted as indicating better neural health of the associated auditory neurons.
Electrically evoked compound action potential (ECAP) forward masking recovery
Electrophysiological measurement of auditory nerve refractory time. This measure will be used to predict perceptual performance. Detection thresholds will be measured as masker and probe inputs are varied among a fixed set of levels and the interval between masker and probe is adjusted in duration.
Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V amplitude
Wave V from the ABR is a reflection of brainstem/midbrain processing. We will measure Wave V amplitude (microV) as the masker and probe levels and masker-to-probe interval are varied. This will be used to predict perceptual performance.
Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V latency
Wave V from the ABR is a reflection of brainstem/midbrain processing. We will measure Wave V latency (ms) as the masker and probe levels and masker-to-probe interval are varied. This will be used to predict perceptual performance.
Cortical auditory evoked potential - N1 and P2 amplitude
Cortical (N1 and P2) amplitude (microV) in response to sound will be used to predict perceptual performance. This is an obligatory response from the auditory cortex that indicates sound detection.
Cortical auditory evoked potential - N1 and P2 latency
Cortical (N1 and P2) latency (ms) in response to sound will be used to predict perceptual performance. This is an obligatory response from the auditory cortex that indicates sound detection. There is evidence that this latency varies as a function of aging.
Full Information
NCT ID
NCT05554692
First Posted
August 31, 2022
Last Updated
September 22, 2022
Sponsor
University of Maryland, College Park
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT05554692
Brief Title
Peripheral and Central Influences on Auditory Temporal Processing & Speech Perception in Older Cochlear Implantees
Official Title
Peripheral and Central Contributions to Auditory Temporal Processing Deficits and Speech Understanding in Older Cochlear Implantees
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, College Park
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Vanderbilt University
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
Older adults who use cochlear implants to address hearing loss show wide variation in benefit. This research investigates the role of normal aging, the health of peripheral and central auditory pathways, and positioning of the cochlear implant electrode array in contributing to this variability. A range of input types from simple auditory signals to spoken sentences is used to examine these questions.
Detailed Description
This research aims to understand age-related temporal processing in older cochlear-implant (CI) users. The overall objective is to disentangle the peripheral and central contributions to age-related temporal processing deficits in this population. The central hypothesis is that age-related speech perception deficits are explained by unique contributions from peripheral and central auditory functions, significantly affecting outcomes in older CI users.
The central hypothesis will be tested by determining (1) the extent to which temporal processing of simple signals from single-electrode stimulation can be explained by aging and the peripheral electrode-to-neural interface; (2) the extent to which speech perception can be explained by aging and the peripheral electrode-to-neural interface; (3) the extent and manner in which central auditory compensation overcomes peripheral processing deficits that contribute to age-related performance declines in CI subjects.
Outcome measures collected in this project include behavioral measures of speech and auditory perception and electrophysiological responses.
Also collected are questionnaire-based reports of history of CI device use, cognitive screening measures, and imaging-based information regarding electrode placement in the cochlea.
Better understanding of the locus of age-related temporal processing deficits in this population will aid in developing age-specific guidance regarding CI candidacy, programming, and rehabilitation, thereby improving expected benefit and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Cochlear Hearing Loss, Hearing Loss, Sensorineural, Aging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enrolled Participants - Older adults with cochlear implants
Arm Type
Experimental
Arm Description
Individuals who already use at least one cochlear implant.
Arm Title
Enrolled Participants - Adults with typical hearing
Arm Type
Other
Arm Description
Control group to provide baseline or comparison data
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic tests of cochlear implant function
Intervention Description
Because the subjects in the study will use CI devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of CI function. This will include perceptual tests of temporal discrimination and speech understanding.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic tests of auditory function
Intervention Description
The intervention here will be to carry out diagnostic tests of hearing. This will include perceptual tests of temporal discrimination and speech understanding.
Primary Outcome Measure Information:
Title
Perceptual forward-masking recovery
Description
Basic measurement of temporal processing - A masker stimulus encountered before a probe/target stimulus can affect the perception of the probe stimulus to a greater/lesser degree depending on their separation in time and their absolute and relative levels. Percent correct discrimination as a function of time separation and level manipulations, as measured from a behavioral response, will be reported.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Perceptual gap detection thresholds
Description
Basic behavioral measurement of temporal processing - The ability to detect a silent gap within a stimulus typically varies depending on frequency and level characteristics of the stimulus in which the gap is embedded and also with the hearing history and age of the listener. Gap detection threshold is the shortest gap duration that can be reliably detected under a given set of conditions and is typically reported in milliseconds.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Perceptual duration discrimination thresholds
Description
Basic measurement of temporal processing - Perceptual duration discrimination thresholds summarize a listener's ability to tell apart stimuli that differ in temporal extent. Percent correct discrimination as a function of duration difference, overall stimulus duration, and level manipulations, as measured from a behavioral response, will be reported.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Perceptual amplitude discrimination thresholds
Description
Basic measurement of auditory processing - Perceptual amplitude discrimination thresholds summarize a listener's ability to tell apart stimuli that differ in level. Percent correct discrimination as a function of level difference size and average level, as measured from a behavioral response, will be reported.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Speech perception
Description
Word discrimination, consonant, vowel, and sentence perception tests. The ability to discriminate between and identify recorded words, phonemic contrasts, and sentences will be assessed behaviorally. Results are reported in terms of percent correct words or phonemes.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Amplitude modulation detection performance
Description
Measure of ability to perceive amplitude modulation using modulation depth thresholds. Amplitude modulation detection performance summarizes a listener's ability to detect the presence of slower-changing amplitude variations applied to a faster-varying carrier signal. The modulation depth of the resulting combined signal can vary between 0 to 100% of the carrier signal with larger values indicating more extreme amplitude fluctuation. This research reports on the amount of modulation that can be detected as a function of different modulator and carrier frequencies, as well as overall stimulus level, as assessed via behavioral report.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Secondary Outcome Measure Information:
Title
Electrically evoked compound action potential (ECAP)
Description
ECAP amplitude growth function slopes will be used to predict perceptual performance. This measure uses clinically-available software to track the growth in auditory nerve response (peak-to-peak amplitude) as input level is varied from threshold to the maximal level at which the signal is comfortably loud. The slope of input-output function will be measured for each electrode along the electrode array of each CI study participant. Steeper slopes (measured in microvolts/current unit) will be interpreted as indicating better neural health of the associated auditory neurons.
Time Frame
Time Frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. Not collected from NH listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Electrically evoked compound action potential (ECAP) forward masking recovery
Description
Electrophysiological measurement of auditory nerve refractory time. This measure will be used to predict perceptual performance. Detection thresholds will be measured as masker and probe inputs are varied among a fixed set of levels and the interval between masker and probe is adjusted in duration.
Time Frame
Time Frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. Not collected from NH listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V amplitude
Description
Wave V from the ABR is a reflection of brainstem/midbrain processing. We will measure Wave V amplitude (microV) as the masker and probe levels and masker-to-probe interval are varied. This will be used to predict perceptual performance.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V latency
Description
Wave V from the ABR is a reflection of brainstem/midbrain processing. We will measure Wave V latency (ms) as the masker and probe levels and masker-to-probe interval are varied. This will be used to predict perceptual performance.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Cortical auditory evoked potential - N1 and P2 amplitude
Description
Cortical (N1 and P2) amplitude (microV) in response to sound will be used to predict perceptual performance. This is an obligatory response from the auditory cortex that indicates sound detection.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Title
Cortical auditory evoked potential - N1 and P2 latency
Description
Cortical (N1 and P2) latency (ms) in response to sound will be used to predict perceptual performance. This is an obligatory response from the auditory cortex that indicates sound detection. There is evidence that this latency varies as a function of aging.
Time Frame
Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For Cochlear Implant arm:
Inclusion Criteria:
cochlear implant in one or both ears
post-lingual onset of deafness
1+ years cochlear implant experience
use of Cochlear-brand implants
implanted after 2004
Exclusion Criteria:
use of non-Cochlear-brand cochlear implants
no use of oral language
pregnant women are not eligible for the imaging portion of the study.
residual acoustic hearing with unaided thresholds <90 dB HL at more than two standard audiometric frequencies
other known disability or neurological disorder
For Typical Hearing arm:
Inclusion Criteria:
audiometrically normal hearing, near-normal hearing, or mild/moderate hearing loss.
Exclusion Criteria:
severe hearing loss
history of neurological disorders
history of middle-ear disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J. Goupell, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samira B. Anderson, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sandra Gordon-Salant, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Study Director
Facility Information:
Facility Name
University of Maryland, College Park
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. De-identified data relevant to the project will be disseminated to researchers on and off-campus by request and review of the PI.
After publication, research products from this project will be archived at the Digital Repository at the University of Maryland(DRUM). 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.
IPD Sharing Time Frame
Following publication, available for at least seven years.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee
Learn more about this trial
Peripheral and Central Influences on Auditory Temporal Processing & Speech Perception in Older Cochlear Implantees
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