Normative Data of Vestibular and Postural Function in Danish Children

Condition(s) studied

Investigational drug(s) / intervention(s)

video Head Impulse Test: For v-HIT, the Synapsys v-HIT Ulmer device is used.

Cervical 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.

Ocular 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.

Computerized 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.

Dizziness 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.

Study 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

Primary outcome measure(s)

• video Head Impulse Test (vHIT) — Measured at baseline.
  Outcome measures: Age-based norms for mean VOR gain
• video Head Impulse Test (vHIT) — Measured at baseline.
  Outcome measures: Age-based norms for VOR gain asymmetry in percent (%).
• video Head Impulse Test (vHIT) — Measured at baseline.
  Outcome measures: Description of saccades (overt and covert saccades)
• Cervical Vestibular Evoked Myogenic Potential (cVEMP): — Measured at baseline.
  Outcome measures: Age-based norms for latency P1 and latency N1 in milliseconds (ms)
• Cervical Vestibular Evoked Myogenic Potential (cVEMP): — Measured at baseline.
  Outcome measures: Age-based norms for rectified interpeak amplitude P1-N1
• Cervical Vestibular Evoked Myogenic Potential (cVEMP): — Measured at baseline.
  Outcome measures: Age-based norms for averaged EMG in µV
• Cervical Vestibular Evoked Myogenic Potential (cVEMP): — Measured at baseline.
  Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)
• Ocular Vestibular Evoked Myogenic Potential (oVEMP): — Measured at baseline.
  Outcome measures: Age-based norms for latency N1 and latency P1 in milliseconds
• Ocular Vestibular Evoked Myogenic Potential (oVEMP): — Measured at baseline.
  Outcome measures: Age-based norms for interpeak amplitude N1-P1 in µV
• Ocular Vestibular Evoked Myogenic Potential (oVEMP): — Measured at baseline.
  Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)
• Computerized Dynamic Posturography (CDP) — Measured at baseline.
  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)).
• Computerized Dynamic Posturography (CDP) — Measured at baseline.
  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.
• Computerized Dynamic Posturography (CDP) — Measured at baseline.
  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.

Trial sites (1)

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