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Adaptation of Pediatric Speech Audiometry Tests Into Other Languages

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07156825
Enrollment
120
Registered
2025-09-05
Start date
2024-08-05
Completion date
2026-07-01
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Screening

Keywords

Audiometry, Speech, Speech Perception, Speech Reception Threshold Test, Speech Intelligibility, Speech, Auditory Threshold, Child, Preschool

Brief summary

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.

Interventions

None listed

Sponsors

Semmelweis University
Lead SponsorOTHER
Budapest University of Technology and Economics
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between SRTs obtained with the adapted MATCH and the PTA thresholds (500 Hz, 1, 2, and 4 kHz)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

MeasureTime frameDescription
Test-retest reliability (intraclass correlation coefficients, ICC)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.
Diagnostic performanceThrough 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.

Countries

Hungary

Contacts

CONTACTGergely P. Vasvari, M.D.
vasvari.gergely.pal@semmelweis.hu+3614864981
PRINCIPAL_INVESTIGATORAnita Gaborjan, M.D., Ph.D.

Semmelweis University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026