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RECRUITING
NCT05419960

Audio-vestibular Evaluation of Children and Young Adults With Osteogenesis Imperfecta

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The aim is to determine whether vestibular deficits are present in OI, then to establish whether a correlation exists between genetic type, severity of OI and audiovestibular phenotype. OI patients aged 12 to 20 years will undergo an audiometric, immittance, and vestibular assessment. When hearing loss is conductive or mixed or in cases where vestibular deficits are identified, a CT scan without injection will be performed. In case of sensorineural hearing loss or abnormal CT results, an MRI will be performed.

Key Details

Gender

All

Age Range

12 Years - 20 Years

Study Type

OBSERVATIONAL

Enrollment

44

Start Date

2022-12-22

Completion Date

2027-12-22

Last Updated

2025-09-12

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Vestibular Assessment

During the usual hearing assessment (immittance testing and pure-tone and speech audiometry) carried out by patients, a vestibular assessment will be done for the study to detect vestibular disorders: * Videonystagmography (VNG) Is the study of eye movement with the help of infrared googles. * Subjective Visual Vertical (SVV) The patient is asked to orient a line on the vertical axis. * Video Head Impulse Test (vHIT) * Cervical and Ocular Vestibular Evoked Myogenic Potential (cVEMP and oVEMP)

DIAGNOSTIC_TEST

Petrous bone Computed Tomography (CT)

For patients diagnosed with hearing loss, whether conductive, mixed, and/or a vestibular deficit, a CT scan (without injection) will be proposed for their care. Petrous bone Computed Tomography (CT) is an imaging technique used as the standard method of evaluation of the boney structures in the ear.

DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI)

Patients that have done a CT and for who CT results was abnormal, will additionally require an MRI for their standard care. Magnetic Resonance Imaging (MRI) is an imaging technique used as the standard method of evaluation of the cochlear, retrocochlear and central and peripheral nervous system. An injection of Gadolinium contrast media will be used to enhance certain recordings.

Locations (1)

Hôpital Necker-Enfants Malades

Paris, France