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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sensorineural Hearing Loss; Children, Only; Vestibular Disorder; Vestibular Function
• Intervention / Treatment: Diagnostic test: video Head Impulse Test; Diagnostic test: Cervical Vestibular Evoked Myogenic Potential; Diagnostic test: Ocular Vestibular Evoked Myogenic Potential; Diagnostic test: Computerized Dynamic Posturography; Other: Dizziness Handicap Inventory for patient caregivers

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.

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Signe F Bønløkke, PhD student; Phone Number: +45 41405064; Email: siband@rm.dk

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • Recruiting
    • Gødstrup Regional Hospital
    • Contact: Signe F Bønløkke, PhD student; Email: siband@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children with sensorineural hearing loss; 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

Diagnostic test: video Head Impulse Test; For v-HIT, the Synapsys v-HIT Ulmer device is used.; Other Names: vHIT; Diagnostic test: 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.; Other Names: cVEMP; Diagnostic test: 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.; Other Names: oVEMP; Diagnostic test: 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 Names: CDP; 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.; Other Names: DHI-PC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
video Head Impulse Test (vHIT)	Outcome measures: mean VOR gain	Measured at baseline.
video Head Impulse Test (vHIT)	Outcome measures: 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: latency P1 and latency N1 in milliseconds (ms)	Measured at baseline.
Cervical Vestibular Evoked Myogenic Potential (cVEMP):	Outcome measures: rectified interpeak amplitude P1-N1	Measured at baseline.
Cervical Vestibular Evoked Myogenic Potential (cVEMP):	Outcome measures: averaged EMG in μV	Measured at baseline.
Cervical Vestibular Evoked Myogenic Potential (cVEMP):	Outcome measures: left-right asymmetry ratio in percent (%)	Measured at baseline.
Ocular Vestibular Evoked Myogenic Potential (oVEMP):	Outcome measures: latency N1 and latency P1 in milliseconds	Measured at baseline.
Ocular Vestibular Evoked Myogenic Potential (oVEMP):	Outcome measures: interpeak amplitude N1-P1 in μV	Measured at baseline.
Ocular Vestibular Evoked Myogenic Potential (oVEMP):	Outcome measures: left-right asymmetry ratio in percent (%)	Measured at baseline.
Computerized Dynamic Posturography (CDP)	Outcome measures: 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.
Computerized Dynamic Posturography (CDP)	Outcome measures: 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: 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 Outcome Measures

Outcome Measure	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.	Measured at baseline.
Vestibular dysfunction	Prevalence of vestibular dysfunction	Measures at baseline

Collaborators and Investigators

• Sponsor: Gødstrup Hospital
• Investigators: Study Chair: Therese Ovesen, Professor, University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Children; Hearing Loss; Dizziness; Vestibular dysfunction; Computerized Dynamic Posturography; Balance problem; Vestibular assessment; video Head Impulse Test; Vestibular Evoked Myogenic Potential
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Labyrinth Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vestibular Diseases; Hearing Loss; Hearing Loss, Sensorineural; Dizziness; Physiological Phenomena; Evoked Potentials, Motor; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Vestibular Evoked Myogenic Potentials
• Other Study ID Numbers: SFB-3-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No