NCT05419960 Audio-vestibular Evaluation of Children and Young Adults With Osteogenesis Imperfecta
| NCT ID | NCT05419960 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Osteogenesis Imperfecta |
| Study Type | OBSERVATIONAL |
| Enrollment | 44 participants |
| Start Date | 2022-12-22 |
| Primary Completion | 2027-12-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 44 participants in total. It began in 2022-12-22 with a primary completion date of 2027-12-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients between the ages of 12-20 years at the time of inclusion * Diagnosis of Osteogenesis Imperfecta of any type * Currently followed by a physician at the CRMR OI * Information and non-opposition of major patients, holders of parental authority and minor patients to participate in the study Exclusion Criteria: * Patients with hearing loss of alternate origin e.g. Cochlear nerve deficiency, atresia, etc. * Neurological or developmental deficits limiting participation * Cervico-occipital instability e.g. Chiari's malformation * Limitations in mobility of the spine e.g. scoliosis, spinal fractural fusion * Ophthalmologic pathologies e.g. strabism or severe refraction disorder * Patients under AME (State Medical Aid) * Protected adult patients, adults unable to express their consent, pregnant or breastfeeding women
Contact & Investigator
Natalie Loundon, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05419960 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 20 Years, studying Osteogenesis Imperfecta. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05419960 currently recruiting?
Yes, NCT05419960 is actively recruiting participants. Contact the research team at natalie.loundon@aphp.fr for enrollment information.
Where is the NCT05419960 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05419960 clinical trial?
NCT05419960 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Natalie Loundon, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 44 participants.