RecruitingNot Applicable

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

Denmark48 participantsStarted 2025-08-20

Plain-language 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.

Who can participate

Age range

3 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

video Head Impulse Test (vHIT)

Timeframe: Measured at baseline.

video Head Impulse Test (vHIT)

Timeframe: Measured at baseline.

video Head Impulse Test (vHIT)

Timeframe: Measured at baseline.

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

Timeframe: Measured at baseline.

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

Timeframe: Measured at baseline.

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

Timeframe: Measured at baseline.

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

Timeframe: Measured at baseline.

Trial details

NCT IDNCT06229717

SponsorGødstrup Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-08

Contact for this trial

Signe F Bønløkke, PhD student

+45 41405064 siband@rm.dk

View on ClinicalTrials.gov More Children, Only trials

Plain-language summary

Who can participate

Age range

3 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

video Head Impulse Test (vHIT)

Timeframe: Measured at baseline.

video Head Impulse Test (vHIT)

Timeframe: Measured at baseline.

video Head Impulse Test (vHIT)

Timeframe: Measured at baseline.

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

Timeframe: Measured at baseline.

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

Timeframe: Measured at baseline.

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

Timeframe: Measured at baseline.

Cervical Vestibular Evoked Myogenic Potential (cVEMP):

Timeframe: Measured at baseline.