跳至主要内容
临床试验/NCT05554692
NCT05554692Enrolling By Invitation不适用

Peripheral and Central Contributions to Auditory Temporal Processing Deficits and Speech Understanding in Older Cochlear Implantees

University of Maryland, College Park1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
1
主要终点
Amplitude modulation detection performance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Enrolled Participants - Older adults with cochlear implants

Experimental

Individuals who already use at least one cochlear implant.

干预措施: Diagnostic tests of cochlear implant function (Diagnostic Test)

Enrolled Participants - Adults with typical hearing

Other

Control group to provide baseline or comparison data

干预措施: Diagnostic tests of auditory function (Diagnostic Test)

结局指标

主要结局

Amplitude modulation detection performance

时间窗: 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 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.

Perceptual duration discrimination thresholds

时间窗: 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.

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

时间窗: 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.

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.

Perceptual forward-masking recovery

时间窗: 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.

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

时间窗: 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.

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.

Speech perception

时间窗: 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.

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.

次要结局

  • 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.)
  • 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.)
  • 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.)
  • Cortical auditory evoked potential - N1 and P2 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.)
  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Goupell

Professor, Department of Hearing and Speech Sciences

University of Maryland, College Park

研究点 (1)

Loading locations...

相似试验