Vestibular DisorderVIS-FlandersNCT05061069
Vestibular Infants Screening-Flanders
A study testing cervical vestibular evoked myogenic potentials (cVEMP) in people with Vestibular Disorder and Hearing Impaired Children, run by University Hospital, Ghent at 19 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 24 months
- Conditions the study is for
- Vestibular Disorder, Hearing Impaired Children
- What is being tested?
- cervical vestibular evoked myogenic potentials (cVEMP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 19 sitesBelgium
- Study dates
- 1 Jun 2018to 11 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Flemish children with permanent congenital or delayed-onset hearing loss, which occurred before the age of 9 months, are included.
Who cannot join
- Children with temporary hearing loss (e.g. due to otitis media) are excluded.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Belgium19 sites
Algemeen Stedelijk Ziekenhuis
Aalst
Algemeen Ziekenhuis Maria Middelares
Aalst
Eargroup
Antwerp
Gasthuis Zusters Antwerpen
Antwerp
GZA Ziekenhuizen Campus Sint-Augustinus
Antwerp
University Hospital Antwerp
Antwerp
AZ Sint-Jan
Bruges
AZ Sint-Lucas Brugge
Bruges
Cliniques universitaires Saint-Luc
Brussels
Queen Fabiola Children's University Hospital
Brussels
Universitair Ziekenhuis Brussel
Brussels
Ziekenhuis Oost-Limburg
Genk
Ghent University Hospital
Ghent, East-Flanders, 9000
Sint-Lievenspoort Gent
Ghent
Jessa Hospital
Hasselt
Universitair Ziekenhuis Leuven
Leuven
AZ Delta
Menen
CAR Stappie
Ostend
AZ Turnhout
Turnhout
About this study
Official title: Implementation of a Standard Vestibular Screening Protocol for Hearing-impaired Infants in Flanders
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.
Read the detailed description
The implementation of a vestibular screening in hearing-impaired babies of six months old will timely discover vestibular problems to limit the impact on the (motor) development. The cervical vestibular evoked myogenic potential (cVEMP) technique will be used as a vestibular screening tool. Flanders is the first region worldwide that will implement a vestibular screening. All official Flemish reference centres of Kind en Gezin (Child and Family) will participate in this project.
Study purpose:
The final utilisation goal of this project is to limit the impact of a vestibular dysfunction on the (motor) development of children. Since hearing-impaired children have a higher risk for deficits of the vestibular (balance) organ, the researchers will focus on this vulnerable group.
This will be accomplished by:
- The implementation of a standard vestibular screening protocol in Flanders in hearing-impaired children at the age of 6 months, enabling early diagnosis of vestibular deficits and adequate referral for extensive vestibular testing, motor assessment and rehabilitation.
- Increasing the awareness for vestibular dysfunctions and its associated symptoms in hearing-impaired children among parents, teachers, paramedics, specialists and other social workers who are in close contact with hearing-impaired children. This should go hand in hand with more effective patient care, because adequate therapy will start sooner.
Methodology:
The aim of the project is to add a vestibular screening to the existing auditory screening programme (MAICO test). The following steps will be performed to guarantee an accurate vestibular follow-up in Flemish hearing-impaired children:
- In case of a 'refer' on the second MAICO test, Kind en Gezin (Child and Family) will refer the child to the reference centres of Kind en Gezin in Flanders.
- These reference centres will perform a diagnostic hearing test (brainstem evoked response audiometry: BERA) to confirm the permanent hearing loss (standard of care).
- Each child with a confirmed hearing loss (BERA 'refer') will be subjected to a vestibular screening at the age of six months (on average 120/year), combined with tympanometry, in that specific reference centre at the age of six months. The cervical vestibular evoked myogenic potential (cVEMP) technique will be used.
- In case of a refer on the vestibular screening (cVEMP 'refer'), the reference centres will refer the child for motor assessment and, if necessary, for rehabilitation.
- Conditions
- Vestibular Disorder, Hearing Impaired Children
- Being tested
- cervical vestibular evoked myogenic potentials (cVEMP)
- Keywords
- vestibular, balance, hearing loss, infants
- Medical subject headings
- Vestibular Diseases, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: cervical vestibular evoked myogenic potentials (cVEMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Jun 2018
- Primary completion1 Jul 2021
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter non-commercial interventional academic research
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, Universitaire Ziekenhuizen KU Leuven, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Queen Fabiola Children's University Hospital, AZ Turnhout, Gasthuis Zusters Antwerpen, GZA Ziekenhuizen Campus Sint-Augustinus, University Hospital, Antwerp, Jessa Hospital, Ziekenhuis Oost-Limburg, Algemeen Stedelijk Ziekenhuis, Algemeen Ziekenhuis Maria Middelares, AZ Delta, AZ Sint-Jan AV, AZ Sint-Lucas Brugge, Sint-Lievenspoort Gent, Center for Developmental and Hearing Disorders
- Responsible party
- Sponsor
- Investigators
- Leen Maes, Prof. Dr., Study director, University GhentIngeborg Dhooge, Prof. Dr., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061069
- Sponsor's protocol ID
- 2018/0435 (BC-2604)
- Other IDs
- T000917N
- Acronym
- VIS-Flanders
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2021
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared as data related to health of patients is included.
Publications
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.
PubMed 30849604Martens 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.
PubMed 33273502Dhondt 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.
PubMed 32590628Martens 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.
PubMed 35698886
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Standard Vestibular Screening Protocol for Hearing-impaired Infants in Flanders
- ClinicalTrials.gov ID
- NCT05061069
- Acronym / sponsor ID
- VIS-Flanders / 2018/0435 (BC-2604)
- Conditions
- Vestibular Disorder, Hearing Impaired Children
- Keywords
- vestibular, balance, hearing loss, infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, Universitaire Ziekenhuizen KU Leuven, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Queen Fabiola Children's University Hospital, AZ Turnhout, Gasthuis Zusters Antwerpen, GZA Ziekenhuizen Campus Sint-Augustinus, University Hospital, Antwerp, Jessa Hospital, Ziekenhuis Oost-Limburg, Algemeen Stedelijk Ziekenhuis, Algemeen Ziekenhuis Maria Middelares, AZ Delta, AZ Sint-Jan AV, AZ Sint-Lucas Brugge, Sint-Lievenspoort Gent, Center for Developmental and Hearing Disorders
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Posted 12 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The implementation of a vestibular screening in hearing-impaired babies of six months old will timely discover vestibular problems to limit the impact on the (motor) development. The cervical vestibular evoked myogenic potential (cVEMP) technique will be used as a vestibular screening tool. Flanders is the first region worldwide that will implement a vestibular screening. All official Flemish reference centres of Kind en Gezin (Child and Family) will participate in this project.
Study purpose:
The final utilisation goal of this project is to limit the impact of a vestibular dysfunction on the (motor) development of children. Since hearing-impaired children have a higher risk for deficits of the vestibular (balance) organ, the researchers will focus on this vulnerable group.
This will be accomplished by:
- The implementation of a standard vestibular screening protocol in Flanders in hearing-impaired children at the age of 6 months, enabling early diagnosis of vestibular deficits and adequate referral for extensive vestibular testing, motor assessment and rehabilitation.
- Increasing the awareness for vestibular dysfunctions and its associated symptoms in hearing-impaired children among parents, teachers, paramedics, specialists and other social workers who are in close contact with hearing-impaired children. This should go hand in hand with more effective patient care, because adequate therapy will start sooner.
Methodology:
The aim of the project is to add a vestibular screening to the existing auditory screening programme (MAICO test). The following steps will be performed to guarantee an accurate vestibular follow-up in Flemish hearing-impaired children:
- In case of a 'refer' on the second MAICO test, Kind en Gezin (Child and Family) will refer the child to the reference centres of Kind en Gezin in Flanders.
- These reference centres will perform a diagnostic hearing test (brainstem evoked response audiometry: BERA) to confirm the permanent hearing loss (standard of care).
- Each child with a confirmed hearing loss (BERA 'refer') will be subjected to a vestibular screening at the age of six months (on average 120/year), combined with tympanometry, in that specific reference centre at the age of six months. The cervical vestibular evoked myogenic potential (cVEMP) technique will be used.
- In case of a refer on the vestibular screening (cVEMP 'refer'), the reference centres will refer the child for motor assessment and, if necessary, for rehabilitation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter non-commercial interventional academic research
| Arm | Type | Receives |
|---|---|---|
| Infants with permanent hearing loss | Experimental | Diagnostic Test: cervical vestibular evoked myogenic potentials (cVEMP)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. |
Who may qualify
- Ages
- 4 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Flemish children with permanent congenital or delayed-onset hearing loss, which occurred before the age of 9 months, are included.
Key exclusion criteria (1 listed)
- Children with temporary hearing loss (e.g. due to otitis media) are excluded.
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 |
|---|---|---|
| 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. | Diagnostic test | Infants with permanent hearing loss |
Primary outcome
Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results.
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30849604Martens 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.
- Results publication: PubMed 33273502Martens 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.
- Results publication: PubMed 32590628Dhondt 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.
- Derived from this study: PubMed 35698886Martens 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.
- VIS-Flanders website for patients and health care workersLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared as data related to health of patients is included.
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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.
Leen Maes, Prof. Dr. study director
University Ghent
Ingeborg Dhooge, Prof. Dr. principal investigator
University Hospital, Ghent
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical vestibular evoked myogenic potentials (cVEMP) in people with Vestibular Disorder and Hearing Impaired Children, run by University Hospital, Ghent at 19 sites in Belgium.
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 1 inclusion and 1 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 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Belgium. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results. (time frame: 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.). 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 NCT05061069, which also lists 4 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 12 Feb 2025; AzTrials last refreshed its copy on 29 Oct 2026.