Health TrialsbyHealthPanel

Normative Data of Vestibular and Postural Function in Danish Children

ConditionsChildren, OnlyVestibular Function
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-10
SponsorGødstrup Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Children in the age of 6 months -10 years

Normal hearing

No history of dizziness or balance problems

Written informed consent from the parents.

Disqualifiers

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)

Trial 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 design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • video Head Impulse Test

    Diagnostic test

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

  • Cervical Vestibular Evoked Myogenic Potential

    Diagnostic test

    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 Potential

    Diagnostic test

    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 Posturography

    Diagnostic test

    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 caregivers

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Healthy children without hearing or balance problems5 interventions

Trial outcomes

Primary outcomes

1

video Head Impulse Test (vHIT)

Outcome measures: Age-based norms for mean VOR gain

Time frame
Measured at baseline.
2

video Head Impulse Test (vHIT)

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

Time frame
Measured at baseline.
3

video Head Impulse Test (vHIT)

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

Time frame
Measured at baseline.
4

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

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

Time frame
Measured at baseline.

Secondary outcomes

1

Dizziness Handicap Inventory for patient caregivers (DHI-PC):

Outcome measures: Mean total DHI-PC score. DHI-PC is a caregiver-reported 21-item questionnaire. 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.

Time frame
Measured at baseline.
2

Success rate of the vestibular test protocol

Number of subjects with successful results of each of the vestibular assessments.

Time frame
Measured at baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gødstrup Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now