Clinical trial NCT06229730: Normative Data of Vestibular and Postural Function in Danish Children
Official title: Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Children, Only
Vestibular Function
Keywords: Vestibular dysfunction
Balance problem
Children
Dizziness
Vestibular assessment
video Head Impulse Test
Vestibular Evoked Myogenic Potential
Computerized Dynamic Posturography
Quality of life
Lead sponsor: Gødstrup Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems (35 children in the age group from 6 months to 2 years, 30 children in the age group from 3 to 5 years, and 25 children from 6 to 10 years) are recruited in local nurseries, kinder gardens, and schools.

Brief summary: The goal of this age-based cohort study is to provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics. The participants will be children in the age of 6 months to 10 years, without any known hearing or balance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.

Detailed description: Balance problems in children are an overlooked issue in the Danish healthcare system. Dysfunction of the vestibular system, i.e. vestibular dysfunction (VD), can have significant consequences for children's development and quality of life.

Knowledge about the prevalence of vestibular impairment and normative data of vestibular function in the Danish pediatric population is missing.

The investigators aim for a child friendly and reliable vestibular test protocol in the study. According to the investigators studies as well as international reports, the investigators have chosen a vestibular test protocol with Video Head Impulse Test (v-HIT), cervical and ocular Vestibular Evoked Myogenic Potential (c and oVEMP) as the tests are feasible, valid, and child friendly. To evaluate overall balance ability, the children are tested on a Computerized Dynamic Posturography.

The aim of the study is to provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics.

Methods: The study is an age-based cohort study. Participants are children in the age of 6 months to 10 years, without any known hearing or balance problems. The participants are recruited in local nurseries, kinder gardens, and schools. All participants will go through a test protocol consisting of questionnaires, hearing screening and vestibular and postural assessments.

The primary endpoints are age-based norms for v-HIT, c and oVEMP, and posturographic results. The secondary endpoints are number of subjects with successful results of the vestibular test protocol and mean total Dizziness Handicap Inventory for patient caregivers (DHI-PC) score. A number of variables are collected such as demographics, developmental milestones, family history with focus on hearing and balance.

Eligibility criteria: Inclusion Criteria:

* Children in the age of 6 months -10 years
* Normal hearing
* No history of dizziness or balance problems
* Written informed consent from the parents.

Exclusion Criteria:

* Premature birth
* Existing or previous inner ear disease(s) or previous inner ear surgery
* Cholesteatoma or previous middle ear surgery
* Known or previous vestibular disorder (Vestibular schwannoma, Mb Meniere, vestibular neuritis or other known)
* Delayed gross motor development evaluated through milestones.
* Visual impairment to such a degree that the child is not able to maintain fixation on a dot one meter away.
* Congenital nystagmus
* Compromised eye muscle mobility
* A diagnose of any neurological disease.
* A diagnose of any psychiatric disease.
* VEMP-electrode allergy
* History of symptomatic head or neck trauma
* Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)

Primary outcomes:
measure: video Head Impulse Test (vHIT)
timeFrame: Measured at baseline.
measure: video Head Impulse Test (vHIT)
timeFrame: Measured at baseline.
measure: video Head Impulse Test (vHIT)
timeFrame: Measured at baseline.
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP):
timeFrame: Measured at baseline.
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP):
timeFrame: Measured at baseline.
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP):
timeFrame: Measured at baseline.
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP):
timeFrame: Measured at baseline.
measure: Ocular Vestibular Evoked Myogenic Potential (oVEMP):
timeFrame: Measured at baseline.
measure: Ocular Vestibular Evoked Myogenic Potential (oVEMP):
timeFrame: Measured at baseline.
measure: Ocular Vestibular Evoked Myogenic Potential (oVEMP):
timeFrame: Measured at baseline.
measure: Computerized Dynamic Posturography (CDP)
timeFrame: Measured at baseline.
measure: Computerized Dynamic Posturography (CDP)
timeFrame: Measured at baseline.
measure: Computerized Dynamic Posturography (CDP)
timeFrame: Measured at baseline.
Secondary outcomes:
measure: Dizziness Handicap Inventory for patient caregivers (DHI-PC):
timeFrame: Measured at baseline.
measure: Success rate of the vestibular test protocol
timeFrame: Measured at baseline
Other outcomes:
Locations:
Study officials:
affiliation: University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK
name: Therese Ovesen, Professor
role: STUDY_CHAIR
References: