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RECRUITING
NCT06229717

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

Sponsor: Gødstrup Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 10 Years

Study Type

OBSERVATIONAL

Enrollment

48

Start Date

2025-08-20

Completion Date

2028-12

Last Updated

2025-08-26

Healthy Volunteers

No

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.

Locations (1)

Gødstrup Regional Hospital

Herning, Denmark