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NCT Number: NCT07156825

Adaptation of Pediatric Speech Audiometry Tests Into Other Languages

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.

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Key information

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University

Budapest, Hungary

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    The primary outcome measure is the correlation between Speech Recognition thresholds obtained with the adapted MATCH and the Pure Tone Audiometry thresholds (500 Hz, 1, 2, and 4 kHz).

Secondary outcomes

  1. Test-retest reliability (intraclass correlation coefficients, ICC)

    Time frame: Through study completion, an average of 1 year.

    Secondary outcome measures include test-retest reliability (intraclass correlation coefficients, ICC), to verify the reproducibility of the measurements.

  2. Diagnostic performance

    Time frame: Through study completion, an average of 1 year.

    ROC analysis will be used to establish optimal cut-off points for clinical decision-making and to quantify the diagnostic performance of the test.

Study contacts

Contact information is provided by the study sponsor or research team.

Gergely P. Vasvari, M.D.

CONTACT

[email protected]

+3614864981

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Collaborators

  • Budapest University of Technology and Economics

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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