Adaptation of Pediatric Speech Audiometry Tests Into Other Languages

NCT ID: NCT07156825

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-05

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Hearing Loss Screening

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 N

Children 2 - 4,5 years of age; with normal hearing

No interventions assigned to this group

Group 2 N

Children 4,5 - 5,5 years of age; with normal hearing

No interventions assigned to this group

Group 3 N

Children 5,5 - 7 years of age; with normal hearing

No interventions assigned to this group

Group 1 P

Children 2 - 4,5 years of age; with impaired hearing

No interventions assigned to this group

Group 2 P

Children 4,5 - 5,5 years of age; with impaired hearing

No interventions assigned to this group

Group 3 P

Children 5,5 - 7 years of age; with impaired hearing

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Budapest University of Technology and Economics

OTHER

Sponsor Role collaborator

Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gáborján Anita

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anita Gaborjan, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

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Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Gergely P. Vasvari, M.D.

Role: CONTACT

+3614864981

References

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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.

Reference Type BACKGROUND
PMID: 31915885 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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SE 312/2021

Identifier Type: -

Identifier Source: org_study_id

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