Normative Data of Vestibular and Postural Function in Danish Children (VASIC)

Gødstrup Hospital

Status: Enrolling

Conditions: Vestibular Function; Children, Only

Treatments: Diagnostic Test: Computerized Dynamic Posturography; Diagnostic Test: Cervical Vestibular Evoked Myogenic Potential; Diagnostic Test: Ocular Vestibular Evoked Myogenic Potential; Diagnostic Test: video Head Impulse Test; Other: Dizziness Handicap Inventory for patient caregivers

Study type: Observational

Funder types: Other

Identifiers

NCT06229730

SFB-2-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 6 months to 10 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

90 participants in 1 patient group

Healthy children without hearing or balance problems

Description:

Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools.

Treatment:

Other: Dizziness Handicap Inventory for patient caregivers

Diagnostic Test: video Head Impulse Test

Diagnostic Test: Ocular Vestibular Evoked Myogenic Potential

Diagnostic Test: Cervical Vestibular Evoked Myogenic Potential

Diagnostic Test: Computerized Dynamic Posturography