Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments

Официальное название

Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments - Part 2

Обзор

Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs.

Вмешательства

• Диагностический тест Diagnostic tests of cochlear implant or acoustic hearing function
  Because the cochlear implant participants in the study will use cochlear implant 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 cochlear implant or acoustic hearing function. This will include perceptual tests of sound localization, speech understanding in noise, binaural fusion, and loudness comparisons.
• Поведенческое Targeted aural rehabilitation of the poorer performing ear
  Subjects will undergo listening practice on a tablet computer over headphones at home. For the test group, the aural rehabilitation will be targeted at the poorer ear. For the comparison control group, a sham aural rehabilitation will present speech to both ears.

Первичные конечные точки

• Perceptual responses to sound level [Срок оценки: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.]
• Speech understanding in the presence of masking sounds [Срок оценки: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.]
• Computed-tomography scan [Срок оценки: For CI users: CT scan will be collected from existing medical records with permission or taken after study enrollment. Measurements taken after study enrollment. Not collected for non-implanted listeners with acoustic hearing.]
• Electrode impedance (transelectrode impedance matrix) [Срок оценки: Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.]
• Electrically evoked compound action potentials (ECAPs) [Срок оценки: Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.]

Вторичные конечные точки (3)

• Sound Localization [Срок оценки: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.]
• Perceptual Fusion [Срок оценки: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.]
• Spectrotemporal ripple sensitivity [Срок оценки: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.]

Критерии участия

For Bilateral Cochlear Implant Users Arm:

Критерии включения

• two cochlear implants
• acquired their hearing loss during adulthood or late childhood (post-lingual onset)
• native English speaker
• primarily use oral language
• at least six months of cochlear implant use
• Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Критерии исключения

• people who do not use oral language will be excluded.
• people with less than six months of device use will be excluded
• other known disability or neurological disorder
• women who are pregnant will be excluded from the CT portion of the study
• people with any unaided audiometric tone-detection threshold better than 60 dB HL at standard audiometric frequencies (250-8000 Hz) in either ear will be excluded

For Unilateral Cochlear Implant User with Single-Sided Deafness Arm:

Критерии включения

• one cochlear implant in one ear and a second ear with some acoustic hearing
• acquired their hearing loss during adulthood or late childhood (post-lingual onset)
• native English speaker
• primarily use oral language
• at least six months of cochlear implant use
• Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Критерии исключения

• people who do not use oral language will be excluded.
• people with less than six months of device use will be excluded
• other known disability or neurological disorder
• women who are pregnant will be excluded from the CT portion of the study
• people with any unaided audiometric tone-detection threshold better than 60 dB HL at standard audiometric frequencies (250-8000 Hz) in the implanted ear will be excluded
• people with an acoustic pure-tone average threshold (octave frequencies 250-4000 Hz) > 30 dB HL in the non-implanted ear

For Non-Implanted Listeners with Acoustic Hearing Arm:

Критерии включения

• audiometrically normal hearing or near-normal hearing, or mild/moderate hearing loss
• Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Критерии исключения

• severe hearing loss
• other known disability or neurological disorder

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 · 2 центра

• Walter Reed National Military Medical Center — Bethesda
• University of Maryland, College Park — College Park

Идентификаторы

NCT: NCT06305039 · 2089705 · 1R01DC020506-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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