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Набор по приглашению NCT06734039

Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

Без фазы С лечением Hearing Loss, Unilateral Cochlear Implants Hearing Loss, Sensorineural Single-Sided Deafness (SSD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Programming of cochlear implant audio processor frequency settings.
Кому может быть актуально
Состояния в реестре: Hearing Loss, Unilateral, Cochlear Implants, Hearing Loss, Sensorineural, Single-Sided Deafness (SSD). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Impact of Anatomy-Based Frequency (ABF) Allocations on Early Performance Outcomes in MED-EL Cochlear Implant Recipients

Обзор

The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.

Подробное описание

Participants will be randomized into a starting frequency setting at device activation or shortly after device activation for the first three months of device use. After 3 months listening experience, participants will be randomized into different frequency settings and tested before and after a period of listening experience. Participant outcomes for each of the multiple frequency settings will be evaluated using standard clinical speech testing and through questionnaires designed to capture information about patient sound quality and quality of life.

Вмешательства

  • Устройство Programming of cochlear implant audio processor frequency settings
    Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software

Первичные конечные точки

  • Percent correct on AzBio Sentences in Noise [Срок оценки: 3 to 7 months]
  • Cochlear Implant Quality of Life - 35 Profile (CIQoL 35) [Срок оценки: Enrollment to 7 months]
Вторичные конечные точки (7)
  • Post-operative Audiogram [Срок оценки: Enrollment and 12 months]
  • Percent Correct on Az Bio Sentences in Noise [Срок оценки: 12 months]
  • Percent Correct on Consonant Nucleus Consonant (CNC) Words [Срок оценки: 3 to 12 months]
  • Subjective feedback questionnaire [Срок оценки: Enrollment to 12 months]
  • Psychoacoustic Testing of Sound Quality and Preference [Срок оценки: 7 months]
  • Cochlear Implant Quality of Life- 35 Profile (CIQoL35) [Срок оценки: 12 months]
  • Decisional Regret Scale [Срок оценки: 3 to 12 months]

Критерии участия

  • At least 18 years of age
  • Is a cochlear implant candidate as deemed by the participating center
  • Implanted (or to be implanted) unilaterally with a MED-EL cochlear implant with moderately severe or better acoustic hearing in the contralateral ear.
  • For patients who are already implanted, device activation must have occurred within 2 weeks of enrollment
  • Patients with moderate contralateral hearing loss or greater must utilize a hearing aid in the contralateral ear.
  • Programmed with electric-only stimulation in the implanted ear
  • The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz
  • Post-operative CT scan allows for completion of OTOPLAN analysis
  • ABF settings possible at defaults in clinical programming software
  • Minimum of 10 active electrodes at activation
  • Programmed using a Fine Structure coding strategy
  • English is the primary language
  • Willing and able to comply with all scheduled procedures as defined in the protocol

Критерии исключения

  • Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study
  • Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use
  • Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 6 центров
  • University of Iowa — Iowa City
  • University of Kansas Medical Center — Kansas City
  • University of North Carolina — Chapel Hill
  • MED-EL Corporation — Durham
  • Oregon Health and Science University — Portland
  • Thomas Jefferson University — Philadelphia

Публикации

  • Shannon CM, Schvartz-Leyzac KC, Dubno JR, McRackan TR. Determinants of Cochlear Implant Satisfaction and Decisional Regret in Adult Cochlear Implant Users. Otol Neurotol. 2023 Dec 1;44(10):e722-e729. doi: 10.1097/MAO.0000000000004028. Epub 2023 Oct 19. PMID 37853774
  • Sturm JJ, Ma C, McRackan TR, Schvartz-Leyzac KC. Frequency-to-Place Mismatch Impacts Cochlear Implant Quality of Life, But Not Speech Recognition. Laryngoscope. 2024 Jun;134(6):2898-2905. doi: 10.1002/lary.31264. Epub 2024 Jan 12. PMID 38214299
  • Kurz A, Herrmann D, Muller-Graff FT, Voelker J, Hackenberg S, Rak K. Anatomy-based fitting improves speech perception in noise for cochlear implant recipients with single-sided deafness. Eur Arch Otorhinolaryngol. 2025 Jan;282(1):467-479. doi: 10.1007/s00405-024-08984-4. Epub 2024 Sep 19. PMID 39299967
  • Fan X, Yang T, Fan Y, Song W, Gu W, Lu X, Chen Y, Chen X. Hearing outcomes following cochlear implantation with anatomic or default frequency mapping in postlingual deafness adults. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):719-729. doi: 10.1007/s00405-023-08151-1. Epub 2023 Aug 7. PMID 37548704
  • Kurz A, Herrmann D, Hagen R, Rak K. Using Anatomy-Based Fitting to Reduce Frequency-to-Place Mismatch in Experienced Bilateral Cochlear Implant Users: A Promising Concept. J Pers Med. 2023 Jul 8;13(7):1109. doi: 10.3390/jpm13071109. PMID 37511722
  • Creff G, Lambert C, Coudert P, Pean V, Laurent S, Godey B. Comparison of Tonotopic and Default Frequency Fitting for Speech Understanding in Noise in New Cochlear Implantees: A Prospective, Randomized, Double-Blind, Cross-Over Study. Ear Hear. 2024 Jan-Feb 01;45(1):35-52. doi: 10.1097/AUD.0000000000001423. Epub 2023 Oct 12. PMID 37823850
  • Dillon MT, Canfarotta MW, Buss E, Rooth MA, Richter ME, Overton AB, Roth NE, Dillon SM, Raymond JH, Young A, Pearson AC, Davis AG, Dedmon MM, Brown KD, O'Connell BP. Influence of Electric Frequency-to-Place Mismatches on the Early Speech Recognition Outcomes for Electric-Acoustic Stimulation Users. Am J Audiol. 2023 Mar;32(1):251-260. doi: 10.1044/2022_AJA-21-00254. Epub 2023 Feb 17. PMID 36800505
  • Tan CT, Martin B, Svirsky MA. Pitch Matching between Electrical Stimulation of a Cochlear Implant and Acoustic Stimuli Presented to a Contralateral Ear with Residual Hearing. J Am Acad Audiol. 2017 Mar;28(3):187-199. doi: 10.3766/jaaa.15063. PMID 28277210

Идентификаторы

NCT: NCT06734039 · US2401 MED-EL ABF

Первоисточники (государственные реестры)

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