Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection (HYDROPS-CMV)

January 2, 2026 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Prevalence of Endolymphatic Hydrops in Patients With a History of Congenital Cytomegalovirus Infection With Symptomatic Cochleo-vestibular Involvement

The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.

Patients benefit as part of the care:

  • A clinical cochleo-vestibular examination
  • Functional otoneurological explorations: audiogram, caloric tests, vHIT, otolithic evoked potentials
  • From an uninjected brain MRI

Participation in this research entails the addition of an MRI sequence and an injection of contrast product (Gadovist®):

- 3D FLAIR MRI sequence dedicated to the exploration of the inner ear, lasting 6min30s, performed 4 hours after the initial injection of contrast product.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hopital Robert Debre
    • PARIS
      • Paris, PARIS, France, 75019
        • Hôpital Fondation Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a confirmed history of congenital CMV infection with symptomatic cochleo-vestibular dysfunction (mean hearing threshold> 20dB in at least one ear and / or functional abnormality in one or more areas at the vestibular level)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the prevalence of at least one endolymphatic hydrops in patients with a history of congenital CMV infection with symptomatic cochleovestibular dysfunction
Time Frame: 4 hours after the initial injection of gadolinium, at least for one of the two ears
Endolymphatic hydrops visualized with 3D FLAIR sequence in MRI
4 hours after the initial injection of gadolinium, at least for one of the two ears

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Actual)

April 22, 2025

Study Completion (Actual)

April 22, 2025

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Estimated)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPN_2021_23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endolymphatic Hydrops

Clinical Trials on sequence MRI 3D FLAIR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe