Examining inner ear conditions in patients with congenital CMV infection
Prevalence of Endolymphatic Hydrops in Patients With a History of Congenital Cytomegalovirus Infection With Symptomatic Cochleo-vestibular Involvement
This study is testing how congenital CMV infection affects the inner ear in patients by looking for specific conditions and using advanced imaging techniques.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05229744 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with a history of congenital cytomegalovirus (CMV) infection, assessing the prevalence of endolymphatic hydrops. Participants undergo standard cochleo-vestibular examinations and functional otoneurological tests, along with an MRI sequence specifically designed to explore the inner ear. The study aims to enhance understanding of the relationship between congenital CMV infection and inner ear dysfunction. The addition of a contrast agent during MRI is intended to improve imaging quality and diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates include patients over 6 months old with a confirmed history of congenital CMV infection and symptomatic cochleo-vestibular dysfunction.
Not a fit: Patients with contraindications to MRI or those who have received gadolinium injections in the past week may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic methods and management strategies for patients with cochleo-vestibular dysfunction related to congenital CMV infection.
How similar studies have performed: While this approach is relatively novel, similar studies have explored the effects of congenital CMV on hearing and vestibular function, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 6 months old * With a history of confirmed congenital CMV infection * Suffering from symptomatic cochleo-vestibular dysfunction (average hearing threshold\> 20dB in at least one ear and / or abnormal functioning of one or more sectors at the vestibular level) * For adult patients, having received informed information about the study and having signed a consent to participate in the study * For minor patients written consent of the two holders of the exercise of parental authority * Affiliate or beneficiary of a social security scheme Exclusion Criteria: * Patient benefiting from a legal protection measure * Pregnant or breastfeeding woman * Contraindication to MRI (implanted electrical device, metallic foreign body, claustrophobia) * Patient with a proven allergy to gadolinium * Injection of gadolinium in the previous 7 days * Known impairment of renal function ((estimated GFR \<60 mL / min / 1.73 m²)
Where this trial is running
Paris and 1 other locations
- Hôpital Fondation Adolphe de Rothschild — Paris, France (Recruiting)
- Hôpital Robert Debre — Paris, France (Recruiting)
Study contacts
- Study coordinator: amélie YAVCHITZ
- Email: ayavchitz@for.paris
- Phone: 0148036454
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.