Normative Data of Vestibular and Postural Function in Danish Children

NCT06229730 | Recruiting

• 1 other identifier: SFB-2-2023
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Children, Only; Vestibular Function

Keywords

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

Outcome Measures

Primary Outcomes (13)

• video Head Impulse Test (vHIT)

  Outcome measures: Age-based norms for mean VOR gain

  Measured at baseline.

• video Head Impulse Test (vHIT)

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

  Measured at baseline.

• video Head Impulse Test (vHIT)

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

  Measured at baseline.

• Cervical Vestibular Evoked Myogenic Potential (cVEMP):

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

  Measured at baseline.

• Cervical Vestibular Evoked Myogenic Potential (cVEMP):

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

  Measured at baseline.

• Cervical Vestibular Evoked Myogenic Potential (cVEMP):

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

  Measured at baseline.

• Cervical Vestibular Evoked Myogenic Potential (cVEMP):

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

  Measured at baseline.

• Ocular Vestibular Evoked Myogenic Potential (oVEMP):

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

  Measured at baseline.

• Ocular Vestibular Evoked Myogenic Potential (oVEMP):

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

  Measured at baseline.

• Ocular Vestibular Evoked Myogenic Potential (oVEMP):

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

  Measured at baseline.

• 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 at baseline.

• 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 at baseline.

• 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 at baseline.

Secondary Outcomes (2)

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

  Measured at baseline.

• Success rate of the vestibular test protocol

  Measured at baseline

Study Arms (1)

Healthy children without hearing or balance problems

Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools.

Diagnostic Test: video Head Impulse Test; Diagnostic Test: Cervical Vestibular Evoked Myogenic Potential; Diagnostic Test: Ocular Vestibular Evoked Myogenic Potential; Diagnostic Test: Computerized Dynamic Posturography; Other: Dizziness Handicap Inventory for patient caregivers

Interventions

video Head Impulse Test DIAGNOSTIC_TEST

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

Also known as: vHIT

Healthy children without hearing or balance problems

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.

Also known as: cVEMP

Healthy children without hearing or balance problems

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.

Also known as: oVEMP

Healthy children without hearing or balance problems

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.

Also known as: CDP

Healthy children without hearing or balance problems

Dizziness Handicap Inventory for patient caregivers OTHER

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.

Also known as: DHI-PC

Healthy children without hearing or balance problems

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Children in the age of 6 months -10 years
• Normal hearing
• No history of dizziness or balance problems
• Written informed consent from the parents.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gødstrup Hospital: lead

Study Sites (1)

Gødstrup Regional Hospital

Herning, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Dizziness

Interventions

Vestibular Evoked Myogenic Potentials

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Evoked Potentials, Motor; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena

Study Officials

• Therese Ovesen, Professor

  University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK

  STUDY CHAIR

Central Study Contacts

Signe F Bønløkke, PhD student

CONTACT

+4541405064; siband@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 29, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)