Normative Data of Vestibular and Postural Function in Danish Children

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 6 months to 10 years
• All sexes
• Healthy volunteers accepted
• Child

Study population: Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems (35 children in the age group from 6 months to 2 years, 30 children in the age group from 3 to 5 years, and 25 children from 6 to 10 years) are recruited in local nurseries, kinder gardens, and schools.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Children, Only, Vestibular Function

Being tested

video Head Impulse Test, Cervical Vestibular Evoked Myogenic Potential, Ocular Vestibular Evoked Myogenic Potential, Computerized Dynamic Posturography, Dizziness Handicap Inventory for patient caregivers

Keywords

Vestibular dysfunction, Balance problem, Children, Dizziness, Vestibular assessment, video Head Impulse Test, Vestibular Evoked Myogenic Potential, Computerized Dynamic Posturography, Quality of life

Medical subject headings

Dizziness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• video Head Impulse TestDiagnostic test

  Also called vHIT

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

• Cervical Vestibular Evoked Myogenic PotentialDiagnostic test

  Also called cVEMP

  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.

• Ocular Vestibular Evoked Myogenic PotentialDiagnostic test

  Also called oVEMP

  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.

• Computerized Dynamic PosturographyDiagnostic test

  Also called CDP

  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.

• Dizziness Handicap Inventory for patient caregiversOther

  Also called DHI-PC

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. video Head Impulse Test (vHIT)

   Outcome measures: Age-based norms for mean VOR gain

   Measured: Measured at baseline.

2. video Head Impulse Test (vHIT)

   Outcome measures: Age-based norms for VOR gain asymmetry in percent (%).

   Measured: Measured at baseline.

3. video Head Impulse Test (vHIT)

   Outcome measures: Description of saccades (overt and covert saccades)

   Measured: Measured at baseline.

4. Cervical Vestibular Evoked Myogenic Potential (cVEMP):

   Outcome measures: Age-based norms for latency P1 and latency N1 in milliseconds (ms)

   Measured: Measured at baseline.

5. Cervical Vestibular Evoked Myogenic Potential (cVEMP):

   Outcome measures: Age-based norms for rectified interpeak amplitude P1-N1

   Measured: Measured at baseline.

6. Cervical Vestibular Evoked Myogenic Potential (cVEMP):

   Outcome measures: Age-based norms for averaged EMG in µV

   Measured: Measured at baseline.

7. Cervical Vestibular Evoked Myogenic Potential (cVEMP):

   Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)

   Measured: Measured at baseline.

8. Ocular Vestibular Evoked Myogenic Potential (oVEMP):

   Outcome measures: Age-based norms for latency N1 and latency P1 in milliseconds

   Measured: Measured at baseline.

9. Ocular Vestibular Evoked Myogenic Potential (oVEMP):

   Outcome measures: Age-based norms for interpeak amplitude N1-P1 in µV

   Measured: Measured at baseline.

10. Ocular Vestibular Evoked Myogenic Potential (oVEMP):

    Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)

    Measured: Measured at baseline.

11. Computerized Dynamic Posturography (CDP)

    Outcome measures: Aged-based norms for Sensory Organization Test (SOT):

    • Average equilibrium score (ES) for SOT1-6. Equilibrium scores is the average of three trials for each of the six conditions SOT1-6.
    • The SOT Composite score. It is a weighted average of the six conditions (SOT1-6) with greater weight given to the more difficult conditions.
    • The preference score. The preference score = (SOT3 + SOT6) / (SOT2 + SOT5)).

    Measured: Measured at baseline.

12. Computerized Dynamic Posturography (CDP)

    Outcome measures: Aged-based norms for motor control test (MCT):

    • Mean latency of the medium and the big movement respectively in anterior and posterior direction measured in milliseconds.

    Measured: Measured at baseline.

13. Computerized Dynamic Posturography (CDP)

    Outcome measures: Aged-based norms for adaptation test (ADT):

    • Mean sway energy score of toes-up and toes-down respectively. The sway energy score quantifies the force magnitude required to overcome the postural instability.

    Measured: Measured at baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Jan 2024
2. Study start1 Jun 2025
3. Primary completionAug 2027 (estimated)
4. Study completionDec 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Children, OnlyStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.