Evaluating hearing and balance in children and young adults with Osteogenesis Imperfecta
Audio-vestibular Evaluation of Children and Young Adults With Osteogenesis Imperfecta
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 |
|---|---|
| Enrollment | 44 (estimated) |
| Ages | 12 Years to 20 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05419960 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 12 to 20 years diagnosed with any type of Osteogenesis Imperfecta.
Not a fit: Patients with hearing loss from alternate origins or those with significant neurological or developmental deficits may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris
- 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
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.