Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
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: Surgery with RobOtol®, Conventional manual surgery.
- Кому может быть актуально
- Состояния в реестре: Severe to Profound 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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Обзор
The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment. To do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients/year). Patient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.
Подробное описание
In the case of severe (70 to 90dB loss) and profound (\>90dB loss) hearing loss, when conventional hearing aids no longer provide sufficient benefit, cochlear implantation remains the only possible solution for hearing rehabilitation. In implanted patients, a clear improvement in communication in silence is observed, but almost all patients have difficulty understanding speech in noisy environments. Cochlear implantation involves inserting an electrode holder into the cochlea during a surgical procedure under general anesthesia. The insertion of the electrode holder must be as minimally traumatic as possible in order to preserve the cochlear structures and avoid post-operative fibrosis that could impact the auditory outcomes.
The conventional method of this surgery is the manual insertion of the electrode holder. In recent years, robotic assistance, the RobOtol®, has been developed with the aim of avoiding the jerks of the surgeon's hand and improving the precision of the insertion. RobOtol® has had its CE marking since 2016 and is used in several hospitals in France and abroad.
Вмешательства
- Процедура Surgery with RobOtol®
Patient having cochlear implantation surgery with RobOtol®. - Процедура Conventional manual surgery
Patient having conventional manual cochlear implantation surgery
Первичные конечные точки
- Auditory performance in noise with the cochlear implant [Срок оценки: At 6 months post-implantation]
Вторичные конечные точки (12)
- Hearing performance in noise after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes [Срок оценки: At 3 and 6 months post-implantation]
- Hearing performance in noise under ecological conditions after robotic cochlear implantation compared to conventional manual cochlear implantation [Срок оценки: At 3 and 6 months post-implantation]
- Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for words [Срок оценки: At 3 and 6 months post-implantation]
- Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes [Срок оценки: At 3 and 6 months post-implantation]
- The subjective benefit on tinnitus after robotic cochlear implantation compared to conventional manual cochlear implantation [Срок оценки: At 3 and 6 months post-implantation]
- The subjective benefit on quality of life after robotic cochlear implantation compared to conventional manual cochlear implantation [Срок оценки: At 3 and 6 months post-implantation]
- The position of the electrode array in the cochlea during manual and robotic insertions [Срок оценки: At day one post -implantation]
- The impact of a translocation on auditory performance in silence and in noise [Срок оценки: At 3 and 6 months post-implantation]
- The effort of listening in silence and in noise after manual and robotic insertions assessed with the Speech, Spatial and Qualities of Hearing Scale (SSQ) [Срок оценки: At 3 and 6 months post-implantation]
- The effort of listening in silence and in noise after manual and robotic insertions assessed with a visual analog scale [Срок оценки: At 3 and 6 months post-implantation]
- The preservation of residual hearing after cochlear implantation in cases with residual hearing before surgery [Срок оценки: At 30 days, 3 months and 6 months post-implantation]
- The presence of postoperative vertigo in case of robotic cochlear implantation compared to manual implantation [Срок оценки: At 7 days, 3 months and 6 months post-implantation]
Критерии участия
Критерии включения
- Adult patient ≥ 18 years old
- Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with intelligibility ≤70% for Fournier dissyllabic words, in free field, at 60dB with adapted hearing aids.
- Patient able to understand the information note and give written consent
- Affiliation to a French social security system
Критерии исключения
- Patient who does not speak French
- Etiologies of deafness known to be of bad prognosis (auditory neuropathy, congenital profound deafness, immediate post-meningitis profound deafness, vestibular schwannoma on the side of the ear to be implanted)
- Impossibility of testing the effect of the cochlear implant alone on hearing results (cochlear implantation in the context of unilateral deafness or fluctuating deafness)
- Cochlear implantation requiring the use of a perimodiolar electrode holder.
- Pregnant and breastfeeding women
- Patients wearing electronic devices, in direct connection with the brain or nervous system
- Patient included in another interventional study (Jardé 1)
- Patient under legal protection (guardianship or curatorship) or deprived of liberty
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Другое
Центры проведения
Франция · 1 центр
- Groupe Hospitalier Pitié-Salpêtrière — Paris
Идентификаторы
NCT: NCT06248398 · APHP211330 · 2023-A00837-38