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Набор скоро начнётся NCT05624983

Exploration of High Frequency Otoacoustic Emissions and Developmental Language Disorders

Без фазы С лечением Language Development Disorders

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: acoustic otoemisions, Otoscopy, Audiometry, Tympanometry.
Кому может быть актуально
Состояния в реестре: Language Development Disorders. Базовые параметры: 2 лет — 17 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

Among the objective non-invasive audiological explorations the distorsion products of otoacoustic emissions (DPOAE) allow to quickly assess the function of the cochlear outer hair cells (without the active participation of the subject). This technique is used in newborn screening. While humans are able to perceive sounds in a frequency range of 20Hz to 20kHz, routine clinical audiological assessment is only concerned with frequencies between 1-4kHz. This obscures the importance of high frequencies (HF) which can be easily assessed by DPOAEs. In young children, the perception of these high frequencies could also play an important role in language acquisition. The main objective of this study is to evaluate the relationship between subtle high-frequency hearing impairment, as assessed by the DPOAE (non-invasive, rapid and simple audiological test), and language delay or difficulties in a pre-, peri- and school-age pediatric population.

Вмешательства

  • Диагностический тест acoustic otoemisions
    TOAE and DPOAE
  • Диагностический тест Otoscopy
    presence of earwax checked by video otoscop
  • Диагностический тест Audiometry
    Hearing Threshold will be measured with the AD528 interacoustics
  • Диагностический тест Tympanometry
    Tympanic mobility will be measyred with the Titan interacoustics

Первичные конечные точки

  • HF DPOAE measurement [Срок оценки: Day 1]
Вторичные конечные точки (5)
  • Presence or absence of HF DPOAE [Срок оценки: Day 1]
  • Functional status of the middle ear [Срок оценки: Day 1]
  • Determination of the average hearing loss (baseline pure tone audiometry) [Срок оценки: Day 1]
  • Laterality of hearing loss at the DPOAE level with a classification into 3 groups [Срок оценки: Day 1]
  • Severity and type of language impairment assessed by the EVALO/ EVALEO [Срок оценки: day 1]

Критерии участия

Inclusion Criteria for case (children with language disorder):

  • Normal hearing (after an audiometry test, even if an ENT consultation has been carried out beforehand and if the doctor has not found any hearing problem, as defined in the NF EN ISO 70292017-04 standard, and according to an average hearing loss calculated according to the BIAP <20dB HL)
  • Free and informed consent of the parental authority and the patient
  • Affiliated to the social security system
  • Presenting a developmental language acquisition disorder (score according to the EVALO / EVALEO test)
  • For children between 15 and 17 years of age, completion of the EVALEO test before their 16th birthday

Inclusion Criteria for control (children without language disorder) :

  • Normal hearing (after an audiometry test, even if an ENT consultation has been performed beforehand and if the doctor has not found any hearing problem, as defined in the NF EN ISO 70292017-04 standard, and according to an average hearing loss calculated according to the BIAP <20dB HL)
  • Free and informed consent of the parental authority and the patient
  • Enrolled in the social security system

Критерии исключения

  • Hearing disorder identified during the inclusion visit (presence of cerumen or foreign body in the earwax plug or foreign body in the external auditory canal, tympanometry suggesting a middle ear disorder, audiometry with thresholds outside the normal thresholds outside the normal range (0-20dB HL), absence of responses in (0-20dB HL), absence of responses in acoustic otoemissions or acoustic distortion products) on conversational frequencies between 500Hz and 4kHz.
  • Declaration by the parents of an ENT follow-up for a hearing disorder and/or a speech therapy for a language disorder
  • Refusal of participation evoked by the subject

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • CHU Clermont-Ferrand, UMR INSERM 1107 — Clermont-Ferrand

Идентификаторы

NCT: NCT05624983 · RBHP 2022 SARRET

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗