NCT06567613

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

August 20, 2024

Last Update Submit

January 5, 2026

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

  • Speech reception threshold for monosyllabic words

    Speech Reception Threshold (SRT) measured in decibel sound pressure level (dB SPL), with lower scores indicating better hearing

    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

    Single visit at baseline

Secondary Outcomes (2)

  • Speech reception threshold in noise for monosyllabic words

    Single visit at baseline

  • Speech reception threshold in noise for bisyllabic words

    Single visit at baseline

Interventions

Speech testDIAGNOSTIC_TEST

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.

Also known as: Hearing screening

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children without hearing loss

You may qualify if:

  • Native Swiss German speakers
  • Hearing threshold better than 20dB HL at 0.5, 1, 2 and 4kHz
  • Written informed consent by the parents

You may not qualify if:

  • Hearing loss
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6016, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Schmid

    Inselspital Bern, Berne University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 23, 2024

Study Start

October 10, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data is only shared anonymously and aggregated

Locations

CH(4)