Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
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: FS4 then TFS4 (cochlear implant), TFS4 then FS4 (cochlear implant).
- Кому может быть актуально
- Состояния в реестре: Sensorineural Hearing Loss, Bilateral, Bilateral Hearing Loss. 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
- Франция
- 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
Comparison of Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.
Обзор
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise. Secondary objectives: Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.
Подробное описание
Introduction:
Cochlear implantation allows the rehabilitation of profound bilateral deafness, restoring speech perception and verbal communication when the traditional hearing aid no longer provides satisfactory hearing gain. A cochlear implant includes an electrode array and its functioning is based on the principle of cochlear tonotopy: Each electrode encodes a frequency spectrum according to its position in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to the apical electrodes). The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands via bandpass filters corresponding to the number of electrodes in the implant. During the fitting these bands can be modified by the audiologist.
Bimodal hearing refers to the use of a CI in one ear with a HA on the contralateral side. This association allows for adults and children a better perception of speech in quiet and in noise, a better perception of music, hearing comfort, better sound quality, better localization of sound and, consequently, a better quality of life compared to unilateral CI alone. However, there is great variability in the integration process; while some bimodal users show substantial benefits, others receive little or no benefit.
This variability could be due to the mismatch of frequencies (tonotopic shift) between the CI and the contralateral HA.
Recently MED-EL has developed an "anatomy-based fitting" (ABF) strategy based on the tonotopy that allows, from a postoperative scanner, to calculate the theoretical characteristic frequency of neurons stimulated by each electrode contact and to transmit this information to the fitting software of the CI.
This strategy (TFS4) could therefore allow a better integration of information in bimodal hearing and in particular improve the speech recognition in noise compared to a default strategy (FS4).
Main objective:
For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.
Secondary objectives:
Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.
Plan of the study:
It is a prospective open monocentric randomized crossover study: Measures will be done on the patient at 6 weeks and 12 weeks post-activation.
Вмешательства
- Устройство FS4 then TFS4 (cochlear implant)
Cochlear implant with default fitting then with tonotopy-based fitting - Устройство TFS4 then FS4 (cochlear implant)
Cochlear implant with tonotopy-based fitting then with default fitting
Первичные конечные точки
- Speech recognition in noise [Срок оценки: at 6 weeks post-activation]
- Speech recognition in noise [Срок оценки: at 12 weeks post-activation]
Вторичные конечные точки (4)
- Speech recognition in quiet [Срок оценки: at 6 weeks post-activation]
- Speech recognition in quiet [Срок оценки: at 12 weeks post-activation]
- Auditory skills experienced by the patient [Срок оценки: at 6 weeks post-activation]
- Auditory skills experienced by the patient [Срок оценки: at 12 weeks post-activation]
Критерии участия
Критерии включения
- Adult patient (>= 18 years old) speaking French
- Patient who fulfils the criteria for cochlear implantation
Критерии исключения
- retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
- patient with residual hearing < 70 dB hearing level (HL) at 500 Hz and 1000 Hz on the contralateral ear
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
- Двойное слепое
- Основная цель
- Другое
Центры проведения
Франция · 1 центр
- CHU Saint-Etienne — Saint-Etienne
Идентификаторы
NCT: NCT05955469 · MEDEL_COTONBIM_StEtienne_study