Hearing LossNCT07156825
Adaptation of Pediatric Speech Audiometry Tests Into Other Languages
An observational study of Hearing Loss and Screening, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Screening
- How many people
- 120 participants
- Where
- 1 siteHungary
- Study dates
- 5 Aug 2024to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 2-7, with normal hearing in case of control groups and with stable sensorineural hearing loss in case of hearing-impairment groups.
Who may be able to join
- 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
Who cannot join
- Children presenting with symptoms of upper respiratory tract infections
- Known speech-language developmental disorders
- Cognitive disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Methodological Guide for the 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.
Read the 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.
- Conditions
- Hearing Loss, Screening
- Keywords
- Audiometry, Speech, Speech Perception, Speech Reception Threshold Test, Speech Intelligibility, Speech, Auditory Threshold, Child, Preschool
- Medical subject headings
- Hearing Loss, Speech, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 N | Children 2 - 4,5 years of age; with normal hearing | |
| Group 2 N | Children 4,5 - 5,5 years of age; with normal hearing | |
| Group 3 N | Children 5,5 - 7 years of age; with normal hearing | |
| Group 1 P | Children 2 - 4,5 years of age; with impaired hearing | |
| Group 2 P | Children 4,5 - 5,5 years of age; with impaired hearing | |
| Group 3 P | Children 5,5 - 7 years of age; with impaired hearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 1 year.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start5 Aug 2024
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Budapest University of Technology and Economics
- Responsible party
- Principal investigator, Dr. Gáborján Anita, Semmelweis University
- Investigators
- Anita Gaborjan, M.D., Ph.D., Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156825
- Sponsor's protocol ID
- SE 312/2021
- Status last verified
- Jan 2026
- First submitted
- 6 Aug 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It can be given out only in case of special request, with the permission of the study participants or their legal representatives.
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.
PubMed 31915885Vasvari 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.
PubMed 42055609
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodological Guide for the Adaptation of Pediatric Speech Audiometry Tests Into Other Languages
- ClinicalTrials.gov ID
- NCT07156825
- Acronym / sponsor ID
- SE 312/2021
- Conditions
- Hearing Loss, Screening
- Keywords
- Audiometry, Speech, Speech Perception, Speech Reception Threshold Test, Speech Intelligibility, Speech, Auditory Threshold, Child, Preschool
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Budapest University of Technology and Economics
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 N | – | –Children 2 - 4,5 years of age; with normal hearing |
| Group 2 N | – | –Children 4,5 - 5,5 years of age; with normal hearing |
| Group 3 N | – | –Children 5,5 - 7 years of age; with normal hearing |
| Group 1 P | – | –Children 2 - 4,5 years of age; with impaired hearing |
| Group 2 P | – | –Children 4,5 - 5,5 years of age; with impaired hearing |
| Group 3 P | – | –Children 5,5 - 7 years of age; with impaired hearing |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 2-7, with normal hearing in case of control groups and with stable sensorineural hearing loss in case of hearing-impairment groups.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Children presenting with symptoms of upper respiratory tract infections
- Known speech-language developmental disorders
- Cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 31915885Schirkonyer 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.
- Derived from this study: PubMed 42055609Vasvari 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.
- Individual participant dataSharing planned: No. It can be given out only in case of special request, with the permission of the study participants or their legal representatives.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anita Gaborjan, M.D., Ph.D. principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Screening, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gergely P. Vasvari, M.D. (+3614864981, vasvari.gergely.pal@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07156825, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.