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Идёт набор NCT07156825

Adaptation of Pediatric Speech Audiometry Tests Into Other Languages

— Наблюдательное Hearing Loss Screening

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hearing Loss, Screening. Базовые параметры: 2 лет — 7 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
Венгрия
Следующий шаг
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Официальное название

Methodological Guide for the Adaptation of Pediatric Speech Audiometry Tests Into Other Languages

Обзор

The objective of this study was to offer a comprehensive framework for the adaptation of speech audiometric tests into other languages. To date, this is the first universal protocol of its kind that systematically considers linguistic, phonological, and audiological aspects. The present paper provides a protocol and an example for adaptation and standardization of the Mainzer Audiometric Test for Children (MATCH) to another language.

Подробное описание

To evaluate auditory function in children, speech audiometry is widely used in routine clinical settings across many countries. However, appropriate test materials are not available in several languages to date. Adapting a speech audiometry test to another language poses a significant challenge. The objective of this study was to offer a comprehensive framework for the adaptation of speech audiometric tests into other languages. To date, this is the first universal protocol of its kind that systematically considers linguistic, phonological, and audiological aspects.

The present paper is a methodological study for instrument translation; it provides a protocol and example for adaptation and standardization of the Mainzer Audiometric Test for Children (MATCH) to another language. The prospective adaptation process is divided into six phases: identifying test items and validating picture recognizability among children; ensuring linguistic conformity by comparing the phoneme distribution of the test vocabulary to spontaneous speech reference data; recording the speech material in a sound-treated environment following International Organization for Standardization (ISO) standards; equalizing the intelligibility of the recorded items through speech recognition testing in adults; standardizing the test on a cohort of normal-hearing children aged 3-6 years, stratified by age; finally, the diagnostic validity of the adapted test is evaluated by comparing speech recognition thresholds to pure-tone audiometry results in a clinical sample. Additionally, to determine sensitivity, specificity, and optimal cutoff points for detecting hearing loss, ROC analysis is used.

Первичные конечные точки

  • Correlation between SRTs obtained with the adapted MATCH and the PTA thresholds (500 Hz, 1, 2, and 4 kHz) [Срок оценки: Through study completion, an average of 1 year.]
Вторичные конечные точки (2)
  • Test-retest reliability (intraclass correlation coefficients, ICC) [Срок оценки: Through study completion, an average of 1 year.]
  • Diagnostic performance [Срок оценки: Through study completion, an average of 1 year.]

Критерии участия

Критерии включения

  • Age: limits for age groups: 2-4,5; 4,5-5,5; 5,5-7, respectively.
  • For control goups: normal hearing verified by pure tone audiometry and tympanometry
  • For hearing-impairment groups: stable sensorineural hearing loss confirmed by audiological diagnostics

Критерии исключения

  • Children presenting with symptoms of upper respiratory tract infections
  • Known speech-language developmental disorders
  • Cognitive disorders

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Венгрия · 1 центр
  • Semmelweis University — Budapest

Публикации

  • Schirkonyer V, Keilmann A, Harmuth C, Wachtlin B, Rader T, Bohnert A. The new Mainz speech test for children 3-7 years old (MATCH) : Design, standardization, and validation. HNO. 2020 Jan;68(Suppl 1):43-49. doi: 10.1007/s00106-019-00793-0. PMID 31915885
  • Vasvari GP, Hacki T, Vicsi K, Schirkonyer V, Tamas L, Gaborjan A. Developing the Hungarian version of the MATCH test from the original German language: an evidence-based protocol for the translation, cultural adaptation and validation of paediatric speech audiometry tests from one language into another. BMJ Open. 2026 Apr 29;16(4):e112452. doi: 10.1136/bmjopen-2025-112452. PMID 42055609

Идентификаторы

NCT: NCT07156825 · SE 312/2021

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗