An interventional study of cervical vestibular evoked myogenic potentials (cVEMP) in Vestibular Disorder and Hearing Impaired Children, sponsored by University Hospital, Ghent. Completed at 19 sites in Belgium. Open to participants aged 4 Months to 24 Months. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Diagnostic
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.
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:
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:
172 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's enrollment of 301 is above the median of 44 across 130 interventional studies indexed under Vestibular Diseases.
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Exclusion Criteria:
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)
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.
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.
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 vestibular screening was offered to all Flemish infants with permanent hearing loss around the age of 6 months in 1 of the 25 reference centers involved in the UNHSP.
| Milestone | Infants With Permanent Hearing Loss |
|---|---|
| Started | 301 |
| Completed | 301 |
| Not completed | 0 |
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.
| Participants | Infants With Permanent Hearing Loss |
|---|---|
| Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results. | 35 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infants With Permanent Hearing Loss | — | — | — |
301 infants were screened, 47 were excluded for analysis, so the cVEMP data of 254 infants was eventually included and analyzed.
| Age, Categorical(Participants) | Infants With Permanent Hearing Loss |
|---|---|
| <=18 years | 301 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(months) | Infants With Permanent Hearing Loss |
|---|---|
| Mean | 7.4 ± 2.4 |
| Sex: Female, Male(Participants) | Infants With Permanent Hearing Loss |
|---|---|
| Female | 153 |
| Male | 148 |
| Race and Ethnicity Not Collected(Participants) | Infants With Permanent Hearing Loss |
|---|
| Region of Enrollment(participants) | Infants With Permanent Hearing Loss |
|---|---|
| Belgium | 301 |
| Infant with permanent hearing loss(Participants) | Infants With Permanent Hearing Loss |
|---|---|
| Count of participants | 301 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data will not be shared as data related to health of patients is included.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent