Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

Официальное название

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

Обзор

The goal of this prospective cohort study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss. The main hypothesis of the study is that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss. The participants will be children in the age of 3-10 years with sensorineural hearing loss. The test protocol consists of questionnaires 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.

In particular, children with sensorineural hearing loss are at risk of developing VD. Hence, VD has been reported in 14 % to 91 % of children with sensorineural hearing loss. The close anatomical and embryological relationship between the hearing system and the vestibular system may of course explain this correlation.

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 investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss.

Hypothesis: The investigators expect that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss.

Methods: The study is a prospective cohort study. Participants are a prospective, unselected group of children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss. The participants are recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark.

All participants will go through a test protocol consisting of questionnaires and vestibular and postural assessments.

The primary endpoints are results of v-HIT, c and oVEMP, and posturography, which are compared to normative values. The secondary endpoints are prevalence of vestibular dysfunction 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 han

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)

• Vestibular dysfunction [Срок оценки: Measures at baseline]
• Dizziness Handicap Inventory for patient caregivers (DHI-PC): [Срок оценки: Measured at baseline.]

Критерии участия

Критерии включения

• Children in the age of 3-10 years
• Uni- or bilateral sensorineural hearing loss > 20 dB bone conduction pure tone average measured at frequencies 0.5, 1, 2, 4 kHz
• Written informed consent from the parents.

Критерии исключения

• Previous inner ear surgery
• 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
• 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: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Дания · 1 центр

• Gødstrup Regional Hospital — Herning

Идентификаторы

NCT: NCT06229717 · SFB-3-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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