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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.
Balance problems in children are an overlooked issue in the Danish healthcare system. Dysfunction of the vestibular system, i.e. vestibular dysfunction (VD), can have significant consequences for children's development and quality of life.
Knowledge about the prevalence of vestibular impairment and normative data of vestibular function in the Danish pediatric population is missing.
The investigators aim for a child friendly and reliable vestibular test protocol in the study. According to the investigators studies as well as international reports, the investigators have chosen a vestibular test protocol with Video Head Impulse Test (v-HIT), cervical and ocular Vestibular Evoked Myogenic Potential (c and oVEMP) as the tests are feasible, valid, and child friendly. To evaluate overall balance ability, the children are tested on a Computerized Dynamic Posturography.
The aim of the 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.
Methods: The study is an age-based cohort study. Participants are children in the age of 6 months to 10 years, without any known hearing or balance problems. The participants are recruited in local nurseries, kinder gardens, and schools. All participants will go through a test protocol consisting of questionnaires, hearing screening and vestibular and postural assessments.
The primary endpoints are age-based norms for v-HIT, c and oVEMP, and posturographic results. The secondary endpoints are number of subjects with successful results of the vestibular test protocol and mean total Dizziness Handicap Inventory for patient caregivers (DHI-PC) score. A number of variables are collected such as demographics, developmental milestones, family history with focus on hearing and balance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| video Head Impulse Test | Diagnostic Test | For v-HIT, the Synapsys v-HIT Ulmer device is used. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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): |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Signe F Bønløkke, PhD student | Contact | +4541405064 | siband@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Therese Ovesen, Professor | University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gødstrup Regional Hospital | Recruiting | Herning | 7400 | Denmark |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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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):
| 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. |
| Measured at baseline. |
| Success rate of the vestibular test protocol | Number of subjects with successful results of each of the vestibular assessments. | Measured at baseline |
| ID | Term |
|---|---|
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058585 | Vestibular Evoked Myogenic Potentials |
| ID | Term |
|---|---|
| D019054 | Evoked Potentials, Motor |
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
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