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
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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