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

NCT06229717 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

  • Children, Only
  • Vestibular Disorder
  • Vestibular Function
  • Sensorineural Hearing Loss

Interventions

DIAGNOSTIC_TEST

video Head Impulse Test

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

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.

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.

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

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.

Sponsors & Collaborators

  • Gødstrup Hospital

    lead OTHER

Principal Investigators

  • Therese Ovesen, Professor · University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2028-08-31
Completion
2028-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06229717 on ClinicalTrials.gov