NCT06229717

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
30mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Aug 2025Dec 2028

First Submitted

Initial submission to the registry

January 8, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

January 8, 2024

Last Update Submit

August 21, 2025

Conditions

Children, OnlyVestibular DisorderVestibular FunctionSensorineural Hearing Loss

Keywords

Vestibular dysfunctionBalance problemChildrenHearing LossDizzinessVestibular assessmentvideo Head Impulse TestVestibular Evoked Myogenic PotentialComputerized Dynamic PosturographyQuality of life

Outcome Measures

Primary Outcomes (13)

  • 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 Outcomes (2)

  • Vestibular dysfunction

    Measures at baseline

  • Dizziness Handicap Inventory for patient caregivers (DHI-PC):

    Measured at baseline.

Study Arms (1)

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 TestDiagnostic Test: Cervical Vestibular Evoked Myogenic PotentialDiagnostic Test: Ocular Vestibular Evoked Myogenic PotentialDiagnostic Test: Computerized Dynamic PosturographyOther: Dizziness Handicap Inventory for patient caregivers

Interventions

video Head Impulse TestDIAGNOSTIC_TEST

For v-HIT, the Synapsys v-HIT Ulmer device is used.

Also known as: vHIT
Children with sensorineural hearing loss
Cervical Vestibular Evoked Myogenic PotentialDIAGNOSTIC_TEST

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.

Also known as: cVEMP
Children with sensorineural hearing loss
Ocular Vestibular Evoked Myogenic PotentialDIAGNOSTIC_TEST

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.

Also known as: oVEMP
Children with sensorineural hearing loss
Computerized Dynamic PosturographyDIAGNOSTIC_TEST

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.

Also known as: CDP
Children with sensorineural hearing loss
Dizziness Handicap Inventory for patient caregiversOTHER

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.

Also known as: DHI-PC
Children with sensorineural hearing loss

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gødstrup Regional Hospital

Herning, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Vestibular DiseasesHearing Loss, SensorineuralHearing LossDizziness

Interventions

Vestibular Evoked Myogenic Potentials

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Evoked Potentials, MotorEvoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological Phenomena

Study Officials

  • Therese Ovesen, Professor

    University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK

    STUDY CHAIR

Central Study Contacts

Signe F Bønløkke, PhD student

CONTACT

+45 41405064siband@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 29, 2024

Study Start

August 20, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)