Normative Data of Vestibular and Postural Function in Danish Children

Children, Only Clinical Trial

— VASIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06229730
• Other study ID #: SFB-2-2023
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: Gødstrup Hospital
• Contact: Signe F Bønløkke, PhD student
• Phone: +4541405064
• Email: siband[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

Inclusion Criteria:

• Children in the age of 6 months -10 years

• Normal hearing

• No history of dizziness or balance problems

• Written informed consent from the parents.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Children, Only

Intervention

Diagnostic Test:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gødstrup Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	video Head Impulse Test (vHIT)	Outcome measures: Age-based norms for mean VOR gain	Measured at baseline.
Primary	video Head Impulse Test (vHIT)	Outcome measures: Age-based norms for VOR gain asymmetry in percent (%).	Measured at baseline.
Primary	video Head Impulse Test (vHIT)	Outcome measures: Description of saccades (overt and covert saccades)	Measured at baseline.
Primary	Cervical Vestibular Evoked Myogenic Potential (cVEMP):	Outcome measures: Age-based norms for latency P1 and latency N1 in milliseconds (ms)	Measured at baseline.
Primary	Cervical Vestibular Evoked Myogenic Potential (cVEMP):	Outcome measures: Age-based norms for rectified interpeak amplitude P1-N1	Measured at baseline.
Primary	Cervical Vestibular Evoked Myogenic Potential (cVEMP):	Outcome measures: Age-based norms for averaged EMG in µV	Measured at baseline.
Primary	Cervical Vestibular Evoked Myogenic Potential (cVEMP):	Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)	Measured at baseline.
Primary	Ocular Vestibular Evoked Myogenic Potential (oVEMP):	Outcome measures: Age-based norms for latency N1 and latency P1 in milliseconds	Measured at baseline.
Primary	Ocular Vestibular Evoked Myogenic Potential (oVEMP):	Outcome measures: Age-based norms for interpeak amplitude N1-P1 in µV	Measured at baseline.
Primary	Ocular Vestibular Evoked Myogenic Potential (oVEMP):	Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)	Measured at baseline.
Primary	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.
Primary	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.
Primary	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	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.	Measured at baseline.
Secondary	Success rate of the vestibular test protocol	Number of subjects with successful results of each of the vestibular assessments.	Measured at baseline