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NCT Number: NCT06229717

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

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.

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Key information

Conditions

Children, Only Dizziness Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Sensorineural Hearing Loss Signs and Symptoms Vestibular Diseases Vestibular Disorder Vestibular Function

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gødstrup Regional Hospital

Herning, 7400, Denmark

Location status: Recruiting

Location contact

Signe F Bønløkke, PhD Student

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

video Head Impulse Test

Diagnostic Test

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

Other names: vHIT

Cervical Vestibular Evoked Myogenic Potential

Diagnostic 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.

Other names: cVEMP

Ocular Vestibular Evoked Myogenic Potential

Diagnostic 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.

Other names: oVEMP

Computerized Dynamic Posturography

Diagnostic 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.

Other names: CDP

Dizziness Handicap Inventory for patient caregivers

Other

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

Primary outcomes

  1. video Head Impulse Test (vHIT)

    Time frame: Measured at baseline.

    Outcome measures: mean VOR gain

  2. video Head Impulse Test (vHIT)

    Time frame: Measured at baseline.

    Outcome measures: VOR gain asymmetry in percent (%)

  3. video Head Impulse Test (vHIT)

    Time frame: Measured at baseline.

    Outcome measures: description of saccades (overt and covert saccades)

  4. Cervical Vestibular Evoked Myogenic Potential (cVEMP):

    Time frame: Measured at baseline.

    Outcome measures: latency P1 and latency N1 in milliseconds (ms)

  5. Cervical Vestibular Evoked Myogenic Potential (cVEMP):

    Time frame: Measured at baseline.

    Outcome measures: rectified interpeak amplitude P1-N1

  6. Cervical Vestibular Evoked Myogenic Potential (cVEMP):

    Time frame: Measured at baseline.

    Outcome measures: averaged EMG in μV

  7. Cervical Vestibular Evoked Myogenic Potential (cVEMP):

    Time frame: Measured at baseline.

    Outcome measures: left-right asymmetry ratio in percent (%)

  8. Ocular Vestibular Evoked Myogenic Potential (oVEMP):

    Time frame: Measured at baseline.

    Outcome measures: latency N1 and latency P1 in milliseconds

  9. Ocular Vestibular Evoked Myogenic Potential (oVEMP):

    Time frame: Measured at baseline.

    Outcome measures: interpeak amplitude N1-P1 in μV

  10. Ocular Vestibular Evoked Myogenic Potential (oVEMP):

    Time frame: Measured at baseline.

    Outcome measures: left-right asymmetry ratio in percent (%)

  11. 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)).

  12. 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.

  13. 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.

Secondary outcomes

  1. Vestibular dysfunction

    Time frame: Measures at baseline

    Prevalence of vestibular dysfunction

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

    Time frame: Measured at baseline.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Signe F Bønløkke, PhD student

CONTACT

[email protected]

+45 41405064

Sponsors and collaborators

Lead sponsor

Gødstrup Hospital

Other

Registry information

Official study title

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

Acronym: VASIC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 29, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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