Clinical trial NCT06229717: Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss
Official title: Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Children, Only
Vestibular Disorder
Vestibular Function
Sensorineural Hearing Loss
Keywords: Vestibular dysfunction
Balance problem
Children
Hearing Loss
Dizziness
Vestibular assessment
video Head Impulse Test
Vestibular Evoked Myogenic Potential
Computerized Dynamic Posturography
Quality of life
Lead sponsor: Gødstrup Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A prospective, unselected group of children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark. We intend to include all consecutive children fitting the inclusion and exclusion criteria.

Brief summary: 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.

Detailed 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: video Head Impulse Test (vHIT)
timeFrame: Measured at baseline.
measure: video Head Impulse Test (vHIT)
timeFrame: Measured at baseline.
measure: video Head Impulse Test (vHIT)
timeFrame: Measured at baseline.
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP):
timeFrame: Measured at baseline.
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP):
timeFrame: Measured at baseline.
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP):
timeFrame: Measured at baseline.
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP):
timeFrame: Measured at baseline.
measure: Ocular Vestibular Evoked Myogenic Potential (oVEMP):
timeFrame: Measured at baseline.
measure: Ocular Vestibular Evoked Myogenic Potential (oVEMP):
timeFrame: Measured at baseline.
measure: Ocular Vestibular Evoked Myogenic Potential (oVEMP):
timeFrame: Measured at baseline.
measure: Computerized Dynamic Posturography (CDP)
timeFrame: Measured at baseline.
measure: Computerized Dynamic Posturography (CDP)
timeFrame: Measured at baseline.
measure: Computerized Dynamic Posturography (CDP)
timeFrame: Measured at baseline.
Secondary outcomes:
measure: Vestibular dysfunction
timeFrame: Measures at baseline
measure: Dizziness Handicap Inventory for patient caregivers (DHI-PC):
timeFrame: Measured at baseline.
Other outcomes:
Locations:
Study officials:
affiliation: University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK
name: Therese Ovesen, Professor
role: STUDY_CHAIR
References: