Hearing LossNCT06567613
Validation of a Swiss German Language Test for Children
An observational study of Hearing Loss, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.
Trial summary
The aim of this study is to validate a Swiss German children's language test. Standard values for the speech intelligibility of Swiss German monosyllables and disyllables for children with normal hearing aged 4-6 years are recorded. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Speech test
- How many people
- 180 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 10 Oct 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children without hearing loss
Who may be able to join
- Native Swiss German speakers
- Hearing threshold better than 20dB HL at 0.5, 1, 2 and 4kHz
- Written informed consent by the parents
Who cannot join
- Hearing loss
- Cognitive impairment
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Universitätsspital Basel
Basel, 4031
Inselspital Bern
Bern, 3010
Kantonsspital Luzern
Lucerne, 6016
Universitätsspital Zürich
Zurich, 8091
About this study
The aim of this study is to validate a Swiss German children's language test. Standard values for the speech intelligibility of Swiss German monosyllables and disyllables for children with normal hearing aged 4-6 years are recorded.
- Conditions
- Hearing Loss
- Being tested
- Speech test
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech testDiagnostic test
Also called Hearing screening
The hearing screening ensures normal hearing before enrollment. The speech reception threshold for swiss german mono- and bisyllable words is determined in an adaptive procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech reception threshold for monosyllabic words
Speech Reception Threshold (SRT) measured in decibel sound pressure level (dB SPL), with lower scores indicating better hearing
Measured: Single visit at baseline
Speech reception threshold for bisyllabic words
Speech Reception Threshold (SRT) measured in decibel sound pressure level (dB SPL), with lower scores indicating better hearing
Measured: Single visit at baseline
Secondary outcomes (2)
Speech reception threshold in noise for monosyllabic words
Speech Reception Threshold (SRT) measured in decibel signal-to-noise ratio (dB SNR) with lower scores indicating better hearing
Measured: Single visit at baseline
Speech reception threshold in noise for bisyllabic words
Speech Reception Threshold (SRT) measured in decibel signal-to-noise ratio (dB SNR) with lower scores indicating better hearing
Measured: Single visit at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start10 Oct 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, University Hospital, Zürich, Luzerner Kantonsspital
- Responsible party
- Sponsor
- Investigators
- Christoph Schmid, Principal investigator, Inselspital Bern, Berne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567613
- Sponsor's protocol ID
- 2024-00463
- Other IDs
- 5739
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is only shared anonymously and aggregated
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Swiss German Language Test for Children
- ClinicalTrials.gov ID
- NCT06567613
- Acronym / sponsor ID
- 2024-00463
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, University Hospital, Zürich, Luzerner Kantonsspital
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Aug 2024 (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 aim of this study is to validate a Swiss German children's language test. Standard values for the speech intelligibility of Swiss German monosyllables and disyllables for children with normal hearing aged 4-6 years are recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children without hearing loss
Key inclusion criteria (3 listed)
- Native Swiss German speakers
- Hearing threshold better than 20dB HL at 0.5, 1, 2 and 4kHz
- Written informed consent by the parents
Key exclusion criteria (2 listed)
- Hearing loss
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech testAlso: Hearing screeningThe hearing screening ensures normal hearing before enrollment. The speech reception threshold for swiss german mono- and bisyllable words is determined in an adaptive procedure. | Diagnostic test | – |
Primary outcome
Speech reception threshold for monosyllabic words
Time frame: Single visit at baseline
Speech Reception Threshold (SRT) measured in decibel sound pressure level (dB SPL), with lower scores indicating better hearing
Speech reception threshold for bisyllabic words
Time frame: Single visit at baseline
Speech Reception Threshold (SRT) measured in decibel sound pressure level (dB SPL), with lower scores indicating better hearing
2 secondary outcomes
Speech reception threshold in noise for monosyllabic words
Time frame: Single visit at baseline
Speech reception threshold in noise for bisyllabic words
Time frame: Single visit at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. Data is only shared anonymously and aggregated
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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. This study is not recruiting at the moment.
Christoph Schmid principal investigator
Inselspital Bern, Berne University Hospital
4 sites 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, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.
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 2 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: finished, as of the sponsor's last update on 7 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 4 sites in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech reception threshold for monosyllabic words (time frame: Single visit at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.