Normative Data of Vestibular and Postural Function in Danish Children

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест video Head Impulse Test
  For v-HIT, the Synapsys v-HIT Ulmer device is used.
• Диагностический тест 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.
• Диагностический тест 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.
• Диагностический тест 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.
• Другое 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 hand

Первичные конечные точки

• video Head Impulse Test (vHIT) [Срок оценки: Measured at baseline.]
• video Head Impulse Test (vHIT) [Срок оценки: Measured at baseline.]
• video Head Impulse Test (vHIT) [Срок оценки: Measured at baseline.]
• Cervical Vestibular Evoked Myogenic Potential (cVEMP): [Срок оценки: Measured at baseline.]
• Cervical Vestibular Evoked Myogenic Potential (cVEMP): [Срок оценки: Measured at baseline.]
• Cervical Vestibular Evoked Myogenic Potential (cVEMP): [Срок оценки: Measured at baseline.]
• Cervical Vestibular Evoked Myogenic Potential (cVEMP): [Срок оценки: Measured at baseline.]
• Ocular Vestibular Evoked Myogenic Potential (oVEMP): [Срок оценки: Measured at baseline.]
• Ocular Vestibular Evoked Myogenic Potential (oVEMP): [Срок оценки: Measured at baseline.]
• Ocular Vestibular Evoked Myogenic Potential (oVEMP): [Срок оценки: Measured at baseline.]

Вторичные конечные точки (2)

• Dizziness Handicap Inventory for patient caregivers (DHI-PC): [Срок оценки: Measured at baseline.]
• Success rate of the vestibular test protocol [Срок оценки: Measured at baseline]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Дания · 1 центр

• Gødstrup Regional Hospital — Herning

Идентификаторы

NCT: NCT06229730 · SFB-2-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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