Peripheral and Central Influences on Auditory Temporal Processing & Speech Perception in Older Cochlear Implantees
Peripheral and Central Contributions to Auditory Temporal Processing Deficits and Speech Understanding in Older Cochlear Implantees
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
August 3, 2022
CompletedFirst Submitted
Initial submission to the registry
August 31, 2022
CompletedFirst Posted
Study publicly available on registry
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 25, 2025
March 1, 2025
4.6 years
August 31, 2022
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Outcomes (6)
Electrically evoked compound action potential (ECAP)
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.
Electrically evoked compound action potential (ECAP) forward masking recovery
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.
Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V amplitude
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.
Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V latency
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.
Cortical auditory evoked potential - N1 and P2 amplitude
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.
- +1 more secondary outcomes
Study Arms (2)
Enrolled Participants - Older adults with cochlear implants
EXPERIMENTALIndividuals who already use at least one cochlear implant.
Enrolled Participants - Adults with typical hearing
OTHERControl group to provide baseline or comparison data
Interventions
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.
The intervention here will be to carry out diagnostic tests of hearing. This will include perceptual tests of temporal discrimination and speech understanding.
Eligibility Criteria
You may qualify if:
- cochlear implant in one or both ears
- post-lingual onset of deafness
- + years cochlear implant experience
- use of Cochlear-brand implants
- implanted after 2004
You may not qualify if:
- 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:
- audiometrically normal hearing, near-normal hearing, or mild/moderate hearing loss.
- severe hearing loss
- history of neurological disorders
- history of middle-ear disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland, College Park
College Park, Maryland, 20742, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew J. Goupell, PhD
University of Maryland, College Park
- STUDY DIRECTOR
Samira B. Anderson, PhD
University of Maryland, College Park
- STUDY DIRECTOR
Sandra Gordon-Salant, PhD
University of Maryland, College Park
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Hearing and Speech Sciences
Study Record Dates
First Submitted
August 31, 2022
First Posted
September 26, 2022
Study Start
August 3, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
March 25, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Following publication, available for at least seven years.
- Access Criteria
- Investigators whose proposed use of the data has been approved by an independent review committee
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.