Clinical trial NCT05554692: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hearing Loss
Cochlear Hearing Loss
Hearing Loss, Sensorineural
Aging
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Vanderbilt University
First posted: 2022-09-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Perceptual forward-masking recovery
timeFrame: 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.
measure: Perceptual gap detection thresholds
timeFrame: 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.
measure: Perceptual duration discrimination thresholds
timeFrame: 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.
measure: Perceptual amplitude discrimination thresholds
timeFrame: 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.
measure: Speech perception
timeFrame: 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.
measure: Amplitude modulation detection performance
timeFrame: 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:
measure: Electrically evoked compound action potential (ECAP)
timeFrame: 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.
measure: Electrically evoked compound action potential (ECAP) forward masking recovery
timeFrame: 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.
measure: Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V amplitude
timeFrame: 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.
measure: Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V latency
timeFrame: 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.
measure: Cortical auditory evoked potential - N1 and P2 amplitude
timeFrame: 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.
measure: Cortical auditory evoked potential - N1 and P2 latency
timeFrame: 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.
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland, College Park
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Matthew J. Goupell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, College Park
name: Samira B. Anderson, PhD
role: STUDY_DIRECTOR
affiliation: University of Maryland, College Park
name: Sandra Gordon-Salant, PhD
role: STUDY_DIRECTOR
References: