Peripheral and Central Influences on Auditory Temporal Processing & Speech Perception in Older Cochlear Implantees

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Diagnostic tests of cochlear implant function
  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.
• Диагностический тест Diagnostic tests of auditory function
  The intervention here will be to carry out diagnostic tests of hearing. This will include perceptual tests of temporal discrimination and speech understanding.

Первичные конечные точки

• Perceptual forward-masking recovery [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (6)

• Electrically evoked compound action potential (ECAP) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 latency [Срок оценки: 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.]

Критерии участия

For Cochlear Implant arm:

Критерии включения

• 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

Критерии исключения

• 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:

Критерии включения

• audiometrically normal hearing, near-normal hearing, or mild/moderate hearing loss.

Критерии исключения

• severe hearing loss
• history of neurological disorders
• history of middle-ear disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Maryland, College Park — College Park

Идентификаторы

NCT: NCT05554692 · 1781406 · R01DC020316

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗