Evaluating hearing and balance in children and young adults with Osteogenesis Imperfecta
Official title: Audio-vestibular Evaluation of Children and Young Adults With Osteogenesis Imperfecta
Run by Assistance Publique - Hôpitaux de Paris · NCT05419960 · Data updated 2026-11-12
This study is testing how Osteogenesis Imperfecta affects hearing and balance in kids and young adults aged 12 to 20 to better understand the condition's impact.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years to 20 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | December 22, 2022 |
| Main results expected | December 22, 2027 |
| Study ends | December 22, 2027 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT05419960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 12 to 20 years diagnosed with any type of Osteogenesis Imperfecta.
✕Probably not a fit
Patients with hearing loss from alternate origins or those with significant neurological or developmental deficits may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the presence of vestibular deficits in children and young adults aged 12 to 20 years with Osteogenesis Imperfecta (OI). Participants will undergo audiometric, immittance, and vestibular assessments, followed by CT or MRI scans if specific hearing loss types or vestibular deficits are identified. The study seeks to establish correlations between genetic types, severity of OI, and audiovestibular phenotypes, contributing to a better understanding of the condition's impact on hearing and balance.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management strategies for hearing and balance issues in patients with Osteogenesis Imperfecta.
How similar studies have gone: While some studies have reported correlations between Osteogenesis Imperfecta and vestibular deficits in adults, this specific approach in children and young adults is less explored.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital Necker-Enfants Malades
Paris, France Recruiting
Study contacts
- Principal investigator: Natalie Loundon, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Natalie Loundon, MD, PhD
- Email: natalie.loundon@aphp.fr
- Phone: 1 71 39 67 82
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This project will test whether REMS, a radiation-free ultrasound method, can measure bone mineral density in children and adolescents aged 5–18 who have conditions that weaken their bones.
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Pediatric safety follow-up after romosozumab treatment for osteogenesis imperfecta
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This project will follow children and adults with Osteogenesis Imperfecta to see how their heart structure and function change over a five-year period.
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This study tests if a special 6-month exercise program can help children and teenagers with Osteogenesis Imperfecta improve their energy levels and overall fitness.
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Effects of bisphosphonates on hearing loss in osteogenesis imperfecta
This study is testing if a medication called bisphosphonates can help adults with Osteogenesis Imperfecta type I who have hearing loss.
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Registry for Osteogenesis Imperfecta
This study is creating a registry to gather information from people with Osteogenesis Imperfecta to better understand the condition and improve how it's managed and treated.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.