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Recruiting NCT07156825

Adaptation of Pediatric Speech Audiometry Tests Into Other Languages

Observational Hearing Loss Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hearing Loss, Screening. Basic parameters: 2 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Hungary · 1 center
  • Semmelweis University — Budapest

Publications

  • 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

Identifiers

NCT: NCT07156825 · SE 312/2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗