RecruitingNCT06229730

Normative Data of Vestibular and Postural Function in Danish Children

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

Sponsor

Gødstrup Hospital

Enrollment

90 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

Children, Only Vestibular Function

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.

Eligibility

Min Age: 6 MonthsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cervical Vestibular Evoked Myogenic Potential, Computerized Dynamic Posturography, and others for people with children, only and vestibular function. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Months to 10 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTvideo Head Impulse Test

For v-HIT, the Synapsys v-HIT Ulmer device is used.

DIAGNOSTIC_TESTCervical Vestibular Evoked Myogenic Potential

For cVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.

DIAGNOSTIC_TESTOcular Vestibular Evoked Myogenic Potential

For oVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.

DIAGNOSTIC_TESTComputerized Dynamic Posturography

To evaluate functional balance of the children and the relative contributions of the vision, proprioception, and vestibular system a CDP from Virtualis (Virtualis, Montpellier, France) is used.

OTHERDizziness Handicap Inventory for patient caregivers

DHI is a caregiver-reported 21-item questionnaire. It is designed to evaluate the perceived quality of life and handicap resulting from dizziness and unsteadiness for the pediatric population. For each question there are three possible answers: yes, sometimes or no. Each answer provides respectively 4, 2 and 0 points. The total DHI scores range from 0 to 84 with higher score being consistent with more limitation and more severe handicap. Scores under 16 are characterized as no limitation or handicap. A score from 16-26 present a mild perceived handicap and mild limitations. A DHI-score between 26-43 is classified as a moderate problem, and a score above 43 describes a severe perceived handicap and severe limitations.