Normal vestibular and balance measurements for Danish children aged 6 months to 10 years
Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
This project will test inner-ear balance and posture using child-friendly tests in Danish children aged 6 months to 10 years to create age-specific normal values.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 6 Months to 10 Years |
| Sex | All |
| Sponsor | Gødstrup Hospital Academic / other |
| Locations | 1 site (Herning) |
| Trial ID | NCT06229730 on ClinicalTrials.gov |
What this trial studies
This age-based cohort study will recruit children without known hearing or balance problems from local nurseries, kindergartens, and schools and bring them to Gødstrup Regional Hospital for testing. Each child will complete a brief questionnaire, hearing screening, video Head Impulse Test (v-HIT), cervical and ocular VEMP (cVEMP and oVEMP), and computerized dynamic posturography to measure vestibular and postural function. The protocol uses tests chosen for feasibility and validity in children to generate normative data across age groups. Having robust norms will allow clinicians to compare patient results against typical ranges for Danish children.
Who should consider this trial
Good fit: Children aged 6 months to 10 years with normal hearing, no history of dizziness or balance problems, and parental written consent are ideal candidates.
Not a fit: Children who already have known vestibular, inner ear, neurological, psychiatric, or significant visual/motor impairments, or who do not meet inclusion criteria, are unlikely to benefit directly from participation.
Why it matters
Potential benefit: If successful, the study will provide age-specific normative data that can help clinicians diagnose vestibular problems in Danish children more accurately.
How similar studies have performed: Similar pediatric protocols using v-HIT, VEMP, and posturography have been used internationally and are considered feasible and valid, but comprehensive Danish normative data are lacking.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Herning
- Gødstrup Regional Hospital — Herning, Denmark (Recruiting)
Study contacts
- Study coordinator: Signe F Bønløkke, PhD student
- Email: siband@rm.dk
- Phone: +4541405064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.