Vestibular Infants Screening-Flanders

NCT05061069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2025-02-12

Study results available
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Summary

Hearing-impaired children are at risk for a vestibular impairment, as the auditory and vestibular end organs are closely related. Although this can compromise a child's development on many levels, vestibular testing is not routinely performed in this vulnerable group. This project aims to give each congenitally hearing-impaired child in Flanders (Belgium) access to a basic vestibular screening at a young age and set an example for other regions worldwide.

Conditions

  • Vestibular Disorder
  • Hearing Impaired Children

Interventions

DIAGNOSTIC_TEST

cervical vestibular evoked myogenic potentials (cVEMP)

cVEMPs are ipsilateral, short latency, inhibitory myogenic potentials that assess otolith (mainly saccular) function and the integrity of the inferior branch of the vestibular nerve.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    collaborator OTHER
  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    collaborator OTHER
  • Queen Fabiola Children's University Hospital

    collaborator OTHER
  • AZ Turnhout

    collaborator OTHER
  • Gasthuis Zusters Antwerpen

    collaborator OTHER
  • GZA Ziekenhuizen Campus Sint-Augustinus

    collaborator OTHER
  • University Hospital, Antwerp

    collaborator OTHER
  • Jessa Hospital

    collaborator OTHER
  • Ziekenhuis Oost-Limburg

    collaborator OTHER
  • Algemeen Stedelijk Ziekenhuis

    collaborator OTHER
  • Algemeen Ziekenhuis Maria Middelares

    collaborator OTHER
  • AZ Delta

    collaborator OTHER
  • AZ Sint-Jan AV

    collaborator OTHER
  • AZ Sint-Lucas Brugge

    collaborator OTHER
  • Sint-Lievenspoort Gent

    collaborator UNKNOWN
  • Center for Developmental and Hearing Disorders

    collaborator UNKNOWN
  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Leen Maes, Prof. Dr. · University Ghent

  • Ingeborg Dhooge, Prof. Dr. · University Hospital, Ghent

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-07-01
Completion
2022-08-11

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05061069 on ClinicalTrials.gov