NCT05061069

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

19 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

Study Start

First participant enrolled

June 1, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

February 12, 2025

Completed
Last Updated

February 12, 2025

Status Verified

January 1, 2025

Enrollment Period

3.1 years

First QC Date

September 9, 2021

Results QC Date

November 15, 2022

Last Update Submit

January 22, 2025

Conditions

Vestibular DisorderHearing Impaired Children

Keywords

vestibularbalancehearing lossinfants

Outcome Measures

Primary Outcomes (1)

  • Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results.

    The primary outcome measure is the number of hearing-impaired infants in Flanders with abnormal vestibular screening results according to the degree, laterality, and onset of hearing loss. Abnormality of the vestibular screening results is based on the rectified interpeak amplitude values of the cVEMP (cervical vestibular evoked myogenic potentials) responses.

    Each infants will be subjected to the screening at the age of six months. In case of inconclusive results during the first screening, the screening will be repeated within three months after the first screening moment.

Study Arms (1)

Infants with permanent hearing loss

EXPERIMENTAL

Each infant with permanent hearing loss in Flanders will be offered a vestibular screening by means of the cVEMP (cervical vestibular evoked myogenic potentials) test to screen for vestibular deficits.

Diagnostic Test: cervical vestibular evoked myogenic potentials (cVEMP)

Interventions

cervical vestibular evoked myogenic potentials (cVEMP)DIAGNOSTIC_TEST

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.

Infants with permanent hearing loss

Eligibility Criteria

Age4 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Flemish children with permanent congenital or delayed-onset hearing loss, which occurred before the age of 9 months, are included.

You may not qualify if:

  • Children with temporary hearing loss (e.g. due to otitis media) are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

Location

Algemeen Stedelijk Ziekenhuis

Aalst, Belgium

Location

Algemeen Ziekenhuis Maria Middelares

Aalst, Belgium

Location

Eargroup

Antwerp, Belgium

Location

Gasthuis Zusters Antwerpen

Antwerp, Belgium

Location

GZA Ziekenhuizen Campus Sint-Augustinus

Antwerp, Belgium

Location

University Hospital Antwerp

Antwerp, Belgium

Location

AZ Sint-Jan

Bruges, Belgium

Location

AZ Sint-Lucas Brugge

Bruges, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, Belgium

Location

Queen Fabiola Children's University Hospital

Brussels, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Sint-Lievenspoort Gent

Ghent, Belgium

Location

Jessa Hospital

Hasselt, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, Belgium

Location

AZ Delta

Menen, Belgium

Location

CAR Stappie

Ostend, Belgium

Location

AZ Turnhout

Turnhout, Belgium

Location

Related Publications (4)

  • Martens S, Dhooge I, Dhondt C, Leyssens L, Sucaet M, Vanaudenaerde S, Rombaut L, Maes L. Vestibular Infant Screening - Flanders: The implementation of a standard vestibular screening protocol for hearing-impaired children in Flanders. Int J Pediatr Otorhinolaryngol. 2019 May;120:196-201. doi: 10.1016/j.ijporl.2019.02.033. Epub 2019 Feb 25.

    PMID: 30849604BACKGROUND

  • Martens S, Dhooge I, Dhondt C, Vanaudenaerde S, Sucaet M, Rombaut L, Boudewyns A, Desloovere C, Janssens de Varebeke S, Vinck AS, Vanspauwen R, Verschueren D, Foulon I, Staelens C, Van den Broeck K, De Valck C, Deggouj N, Lemkens N, Haverbeke L, De Bock M, Oz O, Declau F, Devroede B, Verhoye C, Maes L. Vestibular Infant Screening (VIS)-Flanders: results after 1.5 years of vestibular screening in hearing-impaired children. Sci Rep. 2020 Dec 3;10(1):21011. doi: 10.1038/s41598-020-78049-z.

    PMID: 33273502RESULT

  • Dhondt C, Maes L, Rombaut L, Martens S, Vanaudenaerde S, Van Hoecke H, De Leenheer E, Dhooge I. Vestibular Function in Children With a Congenital Cytomegalovirus Infection: 3 Years of Follow-Up. Ear Hear. 2021 Jan/Feb;42(1):76-86. doi: 10.1097/AUD.0000000000000904.

    PMID: 32590628RESULT

  • Martens S, Dhooge I, Dhondt C, Vanaudenaerde S, Sucaet M, Van Hoecke H, De Leenheer E, Rombaut L, Boudewyns A, Desloovere C, Vinck AS, de Varebeke SJ, Verschueren D, Verstreken M, Foulon I, Staelens C, De Valck C, Calcoen R, Lemkens N, Oz O, De Bock M, Haverbeke L, Verhoye C, Declau F, Devroede B, Forton G, Deggouj N, Maes L. Three Years of Vestibular Infant Screening in Infants With Sensorineural Hearing Loss. Pediatrics. 2022 Jul 1;150(1):e2021055340. doi: 10.1542/peds.2021-055340.

    PMID: 35698886DERIVED

Related Links

MeSH Terms

Conditions

Vestibular DiseasesHearing Loss

Interventions

Vestibular Evoked Myogenic Potentials

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Evoked Potentials, MotorEvoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological Phenomena

Results Point of Contact

Title
Prof. Dr. Leen Maes
Organization
Ghent University
leen.maes@ugent.be
093324066

Study Officials

  • Leen Maes, Prof. Dr.

    University Ghent

    STUDY DIRECTOR

  • Ingeborg Dhooge, Prof. Dr.

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Multicenter non-commercial interventional academic research
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 29, 2021

Study Start

June 1, 2018

Primary Completion

July 1, 2021

Study Completion

August 11, 2022

Last Updated

February 12, 2025

Results First Posted

February 12, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared as data related to health of patients is included.

Locations

BE(19)