Normative Data of Vestibular and Postural Function in Danish Children (NCT06229730) | Clinical Trial Compass
RecruitingNot Applicable
Normative Data of Vestibular and Postural Function in Danish Children
Denmark90 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range
6 Months – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study seems to be collecting normal reference data for vestibular tests like vHIT, cVEMP, oVEMP, and posturography in healthy Danish children — does my child actually have a vestibular problem that might benefit from this kind of testing, or would their time be better spent on diagnostic tests with our own care team?
2Since this trial is described as 'Phase NA' and appears to be a normative data study rather than a treatment trial, what exactly would my child be asked to do during tests like the video Head Impulse Test and the balance platform testing, and are there any discomforts or risks involved for a child?
3The study is recruiting in Denmark — is this study even accessible to us given where we live, and if so, would participating give my child any direct clinical benefit or feedback about their own vestibular function?
4Because this trial is building reference data for healthy children, would my child need to be free of vestibular or balance problems to participate, and how does that affect whether this is relevant to our situation?
5If my child does have a suspected vestibular issue, are the tests being used in this study — like cVEMP, oVEMP, and computerized posturography — something we should be pursuing through a specialist outside of this trial rather than waiting to see if participation is an option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.