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Идёт набор NCT05985473

Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement

Без фазы С лечением Deafness Neurosensory

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: audiological measurements, Objective and subjective audiological measurements, Evaluation of the denoising methods REFINED.
Кому может быть актуально
Состояния в реестре: Deafness Neurosensory. 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
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Обзор

Individuals with Auditory Neuropathy Spectrum Disorders (ANSD) represent 1-10% of adults with hearing loss. These individuals have little or no benefit from current hearing aids because ANSD is a continuum of hearing impairments due to synaptic or neural dysfunction in the peripheral and central parts of the auditory pathways, which impairs temporal information processing without necessarily affecting auditory sensitivity. There is a need to find ad-hoc denoising methods, based on the expert knowledge of audiologists, to improve the noise comprehension performance of these patients. Implemented denoising methods, based on artificial intelligence, will also greatly benefit more standard hearing loss cases.

Подробное описание

Longitudinal study consisting of multiple visits with multiple examinations over a total duration of approximately 3 years per ANSD participant and 1 year per normal hearing participant.

* normal hearing participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests), Follow-up Visit 1 (Noise Comprehension Tests) * ANSD participant : year 1 : Inclusion visit, Phenotyping visit (Audiological tests), Follow-up Visit 1 (Noise Comprehension Tests) year 2 : Follow-up Visit 2 (Noise Comprehension Tests) year 3 : Follow-up Visit 3 (Noise Comprehension Tests)

Вмешательства

  • Другое audiological measurements
    audiological measurements
  • Другое Objective and subjective audiological measurements
    Objective and subjective audiological measurements
  • Другое Evaluation of the denoising methods REFINED
    Evaluation of the denoising methods REFINED

Первичные конечные точки

  • Comparison of percentage of words correctly repeated by participants (ANSD and controls) [Срок оценки: 3 years]
Вторичные конечные точки (7)
  • Auditory Brain Response (ABRs) [Срок оценки: 3 years]
  • Percentage of words correctly repeated by participants with different angles of separation of speech and noises sources [Срок оценки: 3 years]
  • Percentage of phonemes correctly repeated by participants (Verbo-Frequential Audiometry in the presence of calibrated noise: the DODELE AVfB test) [Срок оценки: 3 years]
  • Percentage of words correctly repeated by participants at different sound level of noise [Срок оценки: 3 years]
  • Myogenic vestibular evoked potentials (cervical VEMP or c-VEMP). [Срок оценки: 3 years]
  • Subjective evaluation of listening comfort using a visual analog scale [Срок оценки: 3 years]
  • Subjective evaluation of listening efficiency using a visual analog scale [Срок оценки: 3 years]

Критерии участия

Критерии включения

For all participants:

  • Age greater than or equal to 18 years,
  • French mother tongue,
  • Have an average tonal hearing loss (calculated according to the BIAP method) < 30 dB HL, on headphones, for each ear,
  • Be professionally active, not be pre-retired and not be unemployed
  • Be affiliated with a social security plan,

For participants with TSNA:

\- Have degraded comprehension in noise (threshold of Intelligibility in Noise > 3 dB compared to the norm).

For controls:

\- Have normal comprehension in noise (Intelligibility in Noise threshold ≤ 3 dB from the norm).

Критерии исключения

For all participants:

  • Have a conductive or mixed hearing loss, which is when the hearing loss affects both the outer and/or middle ear and the inner ear.
  • Have an asymmetric hearing loss, i.e. a difference in average hearing loss between the left and right ear greater than 30 dB,
  • Have sequelae of ear infections and/or a history of ENT disease that permanently affects hearing (vestibular schwannoma, Meniere's disease, sudden or fluctuating deafness, congenital hypoacusis)
  • Being under guardianship,
  • Being deprived of liberty by judicial or administrative decision, or being subject to legal protection.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • CEntre de Recherche et d'Innovation en Audiologie Humaine — Paris

Идентификаторы

NCT: NCT05985473 · 2022-016 · 2023-A00140-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗