Normative Data of Vestibular and Postural Function in Danish Children — VASIC  

Children, Only Clinical Trial

Official title: Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Children, Only

• NCT number: NCT06229730
• Study type: Observational
• Source: Gødstrup Hospital
• Contact: Signe F Bønløkke, PhD student
• Phone: +4541405064
• Email: siband@rm.dk
• Status: Not yet recruiting
• Start date: February 2024
• Completion date: December 2027