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Набор скоро начнётся NCT06776393

Longitudinal Non-invasive Analysis of VOCAle Cord Function Based on Trans-laryngeal Ultrasound Acquisitions and Voice Recordings

Без фазы С лечением Postoperative Dysphonia

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: ultrasound.
Кому может быть актуально
Состояния в реестре: Postoperative Dysphonia. 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
Список центров уточняется — проверьте первичный протокол.
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 main objective of VOCALISE study is to propose a new approach allowing a better characterization of postoperative dysphonia. This involves associating with dynamic translaryngeal ultrasound optimized acquisitions of the vibration of each vocal fold in phonation simultaneously with voice recordings. A software program to analyze the displacement of arytenoids, markers of substitution of the vocal cords, will be developed to finely quantify the mobility of laryngeal structures, by combining classical methods of motion analysis and deep learning methods. This approach will be evaluated to follow speech therapy rehabilitation in patients with post-operative dysphonia following recurrent nerve injury.

Подробное описание

Dynamic translaryngeal ultrasound (dTLUS), a non-invasive and inexpensive technique, has emerged in recent years as an alternative to nasofibroscopy for assessing vocal cord paralysis. This paralysis is the major risk (3 to 5%) associated with cervical surgery (100,000 procedures per year in France). Initial work by our consortium has demonstrated the performance of dTLUS after thyroid or parathyroid surgery in the early diagnosis of vocal cord paralysis. The aim of VOCALISE is to propose a new approach for better characterisation of post-operative dysphonia. This involves combining optimised dTLUS acquisitions with acquisitions of the vibration of each vocal cord during phonation, simultaneously with voice recordings. Software will be developed to analyse the displacement of the arytenoids, which are surrogate markers for the vocal cords, in order to quantify the mobility of laryngeal structures in fine detail, using a combination of conventional motion analysis methods and deep learning methods.

This approach will be evaluated to monitor speech therapy rehabilitation in patients with post-operative dysphonia following a lesion of the recurrent nerve.

Вмешательства

  • Другое ultrasound
    "Dynamic translaryngeal Ultrasound Motion mode ultrasound of the laryngeal region during phonation Acoustic recordings VHI questionnaires "

Первичные конечные точки

  • To evaluate the contribution of translaryngeal ultrasound combined with acoustic and perceptual measurements of voice and speech classically used in speech therapy for the rehabilitation of patients with dysphonia following surgery. [Срок оценки: 6 months]
Вторичные конечные точки (3)
  • To visualise arytenoid motion in subjects with shadow artifact using the standard dTLUS approach, by optimising dTLUS acquisitions including curvilinear probe acquisitions, gel cushion acquisitions and lateral mode acquisitions. [Срок оценки: 6 months]
  • To visualise arytenoid motion in subjects with shadow artifact using the standard dTLUS approach, by optimising dTLUS acquisitions including curvilinear probe acquisitions, gel cushion acquisitions and lateral mode acquisitions. [Срок оценки: 6 months]
  • To visualise arytenoid motion in subjects with shadow artifact using the standard dTLUS approach, by optimising dTLUS acquisitions including curvilinear probe acquisitions, gel cushion acquisitions and lateral mode acquisitions. [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Patient over 18 years of age
  • Obtaining patient's free and informed consent
  • Patients with dysphonia following cervical surgery and referred for speech therapy
  • Social security scheme membership (beneficiary or entitled), excluding MA

Критерии исключения

  • Known preoperative history of recurrent nerve paralysis (PR)
  • History of laryngeal or vocal cord tumour
  • Surgical complications preventing proper assessment of postoperative vocal cord mobility (tracheotomy, tracheal resection).
  • Patients with a history of thyroid or parathyroid surgery or cervicotomy for another pathology
  • Patient under guardianship or guardianship or deprived of liberty or under safeguard of justice
  • Pregnant or nursing patient
  • Patient does not read or has vision problems
  • Cognitive and/or auditory impairment preventing

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06776393 · APHP240029

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗