Children, OnlyVASICNCT06229717
Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss
An observational study of Children, Only and Vestibular Disorder, run by Gødstrup Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Children, Only, Vestibular Disorder, Vestibular Function
- What is being tested?
- video Head Impulse Test, Cervical Vestibular Evoked Myogenic Potential and Ocular Vestibular Evoked Myogenic Potential
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Aug 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Gødstrup Regional Hospital
Herning, 7400
Signe F Bønløkke, PhD Student, siband@rm.dk
About this study
Official title: 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.
Read the 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.
- Being tested
- video Head Impulse Test, Cervical Vestibular Evoked Myogenic Potential, Ocular Vestibular Evoked Myogenic Potential, Computerized Dynamic Posturography, Dizziness Handicap Inventory for patient caregivers
- 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
- Medical subject headings
- Vestibular Diseases, Hearing Loss, Sensorineural, Hearing Loss, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video Head Impulse TestDiagnostic test
Also called vHIT
For v-HIT, the Synapsys v-HIT Ulmer device is used.
Cervical Vestibular Evoked Myogenic PotentialDiagnostic test
Also called cVEMP
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 PotentialDiagnostic test
Also called oVEMP
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 PosturographyDiagnostic test
Also called CDP
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.
Dizziness Handicap Inventory for patient caregiversOther
Also called DHI-PC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
video Head Impulse Test (vHIT)
Outcome measures: mean VOR gain
Measured: Measured at baseline.
video Head Impulse Test (vHIT)
Outcome measures: VOR gain asymmetry in percent (%)
Measured: Measured at baseline.
video Head Impulse Test (vHIT)
Outcome measures: description of saccades (overt and covert saccades)
Measured: Measured at baseline.
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
Outcome measures: latency P1 and latency N1 in milliseconds (ms)
Measured: Measured at baseline.
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
Outcome measures: rectified interpeak amplitude P1-N1
Measured: Measured at baseline.
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
Outcome measures: averaged EMG in μV
Measured: Measured at baseline.
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
Outcome measures: left-right asymmetry ratio in percent (%)
Measured: Measured at baseline.
Ocular Vestibular Evoked Myogenic Potential (oVEMP):
Outcome measures: latency N1 and latency P1 in milliseconds
Measured: Measured at baseline.
Ocular Vestibular Evoked Myogenic Potential (oVEMP):
Outcome measures: interpeak amplitude N1-P1 in μV
Measured: Measured at baseline.
Ocular Vestibular Evoked Myogenic Potential (oVEMP):
Outcome measures: left-right asymmetry ratio in percent (%)
Measured: 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: 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: 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: Measured at baseline.
Secondary outcomes (2)
Vestibular dysfunction
Prevalence of vestibular dysfunction
Measured: Measures at baseline
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: Measured at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start20 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Fiil Bønløkke, Gødstrup Hospital
- Investigators
- Therese Ovesen, Professor, Study chair, University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229717
- Sponsor's protocol ID
- SFB-3-2023
- Acronym
- VASIC
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
- ClinicalTrials.gov ID
- NCT06229717
- Acronym / sponsor ID
- VASIC / SFB-3-2023
- Keywords
- Vestibular dysfunction, Balance problem, Children, Hearing Loss, Dizziness, Vestibular assessment, video Head Impulse Test, Vestibular Evoked Myogenic Potential
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with sensorineural hearing loss | – | 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 caregiversChildren 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 |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video Head Impulse TestAlso: vHITFor v-HIT, the Synapsys v-HIT Ulmer device is used. | Diagnostic test | Children with sensorineural hearing loss |
| Cervical Vestibular Evoked Myogenic PotentialAlso: cVEMPFor 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. | Diagnostic test | Children with sensorineural hearing loss |
| Ocular Vestibular Evoked Myogenic PotentialAlso: oVEMPFor 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. | Diagnostic test | Children with sensorineural hearing loss |
| Computerized Dynamic PosturographyAlso: CDPTo 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. | Diagnostic test | Children with sensorineural hearing loss |
| Dizziness Handicap Inventory for patient caregiversAlso: DHI-PCDHI 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 | Children with sensorineural hearing loss |
Primary outcome
video Head Impulse Test (vHIT)
Time frame: Measured at baseline.
Outcome measures: mean VOR gain
video Head Impulse Test (vHIT)
Time frame: Measured at baseline.
Outcome measures: VOR gain asymmetry in percent (%)
video Head Impulse Test (vHIT)
Time frame: Measured at baseline.
Outcome measures: description of saccades (overt and covert saccades)
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
Time frame: Measured at baseline.
Outcome measures: latency P1 and latency N1 in milliseconds (ms)
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
Time frame: Measured at baseline.
Outcome measures: rectified interpeak amplitude P1-N1
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
Time frame: Measured at baseline.
Outcome measures: averaged EMG in μV
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
Time frame: Measured at baseline.
Outcome measures: left-right asymmetry ratio in percent (%)
Ocular Vestibular Evoked Myogenic Potential (oVEMP):
Time frame: Measured at baseline.
Outcome measures: latency N1 and latency P1 in milliseconds
Ocular Vestibular Evoked Myogenic Potential (oVEMP):
Time frame: Measured at baseline.
Outcome measures: interpeak amplitude N1-P1 in μV
Ocular Vestibular Evoked Myogenic Potential (oVEMP):
Time frame: Measured at baseline.
Outcome measures: left-right asymmetry ratio in percent (%)
Computerized Dynamic Posturography (CDP)
Time frame: Measured at baseline.
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)).
Computerized Dynamic Posturography (CDP)
Time frame: Measured at baseline.
Outcome measures: Motor Control Test (MCT): • Mean latency of the medium and the big movement respectively in anterior and posterior direction measured in milliseconds.
Computerized Dynamic Posturography (CDP)
Time frame: Measured at baseline.
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.
2 secondary outcomes
Vestibular dysfunction
Time frame: Measures at baseline
Dizziness Handicap Inventory for patient caregivers (DHI-PC):
Time frame: Measured at baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Therese Ovesen, Professor study chair
University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children, Only and Vestibular Disorder, run by Gødstrup Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Signe F Bønløkke, PhD student (+45 41405064, siband@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
video Head Impulse Test (vHIT) (time frame: Measured at baseline.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.