Vestibular and balance testing for children with sensorineural hearing loss
Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
This project will test if common balance and inner-ear tests can find vestibular problems in children aged 3–10 who have sensorineural hearing loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 3 Years to 10 Years |
| Sex | All |
| Sponsor | Gødstrup Hospital Academic / other |
| Locations | 1 site (Herning) |
| Trial ID | NCT06229717 on ClinicalTrials.gov |
What this trial studies
This prospective cohort enrolls unselected children aged 3–10 with unilateral or bilateral sensorineural hearing loss at Gødstrup Regional Hospital. Participants complete caregiver questionnaires and child-friendly vestibular and postural tests including video Head Impulse Test (vHIT), cervical and ocular VEMP (cVEMP and oVEMP), and computerized dynamic posturography. The investigators expect 20–30% of participants to show abnormal vestibular test results. Standard exclusions include prior inner-ear surgery, significant visual impairment, congenital nystagmus, compromised eye movement, electrode allergy, recent head/neck trauma, or medications that alter vestibular outputs.
Who should consider this trial
Good fit: Children aged 3–10 with unilateral or bilateral sensorineural hearing loss (bone conduction pure tone average >20 dB at 0.5, 1, 2, 4 kHz) whose parents provide written consent are ideal candidates.
Not a fit: Children with prior inner-ear surgery, severe visual impairment, congenital nystagmus, compromised eye movements, VEMP electrode allergy, recent head or neck trauma, or on medications that alter vestibular outputs are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could help identify children with hidden vestibular problems earlier so they can receive balance-focused therapy and support sooner.
How similar studies have performed: Previous pediatric reports show vestibular dysfunction in 14–91% of children with sensorineural hearing loss and vHIT and VEMP are established, child-friendly tests, though prevalence estimates vary widely.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Herning
- Gødstrup Regional Hospital — Herning, Denmark (Recruiting)
Study contacts
- Study coordinator: Signe F Bønløkke, PhD student
- Email: siband@rm.dk
- Phone: +45 41405064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.