An observational study in Hearing Loss and Screening, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged 2 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Semmelweis University · Observational
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.
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.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 192 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 2-7, with normal hearing in case of control groups and with stable sensorineural hearing loss in case of hearing-impairment groups.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children 2 - 4,5 years of age; with normal hearing
Children 4,5 - 5,5 years of age; with normal hearing
Children 5,5 - 7 years of age; with normal hearing
Children 2 - 4,5 years of age; with impaired hearing
Children 4,5 - 5,5 years of age; with impaired hearing
Children 5,5 - 7 years of age; with impaired hearing
Correlation between SRTs obtained with the adapted MATCH and the PTA thresholds (500 Hz, 1, 2, and 4 kHz)
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).
Time frame: Through study completion, an average of 1 year.
Test-retest reliability (intraclass correlation coefficients, ICC)
Secondary outcome measures include test-retest reliability (intraclass correlation coefficients, ICC), to verify the reproducibility of the measurements.
Time frame: Through study completion, an average of 1 year.
Diagnostic performance
ROC analysis will be used to establish optimal cut-off points for clinical decision-making and to quantify the diagnostic performance of the test.
Time frame: Through study completion, an average of 1 year.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — It can be given out only in case of special request, with the permission of the study participants or their legal representatives.
Started Aug 2024 (actual). Primary completion is estimated for May 2026, 21 months after the start.
Of 77 non-industry observational studies under Hearing Loss, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 179. This study's planned 21 months is below that.
Counting every sponsor, half of 98 studies reached it within 42 months; a quarter within 15 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
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