Endolymphatic HydropsHYDROPS-CMVNCT05229744
Prevalence of Endolymphatic Hydrops With a Hitory of Congenital Cytomegalovirus Infection
An observational study of Endolymphatic Hydrops, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial summary
The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Endolymphatic Hydrops
- What is being tested?
- sequence MRI 3D FLAIR
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 18 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Dec 2022to 22 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Fondation Adolphe de Rothschild
Paris, PARIS, 75019
Hôpital Robert Debre
Paris, 75019
About this study
Official title: 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.
Read the 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.
- Conditions
- Endolymphatic Hydrops
- Being tested
- sequence MRI 3D FLAIR
- Keywords
- CMV
- Medical subject headings
- Endolymphatic Hydrops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequence MRI 3D FLAIRDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of at least one endolymphatic hydrops in patients with a history of congenital CMV infection with symptomatic cochleovestibular dysfunction
Endolymphatic hydrops visualized with 3D FLAIR sequence in MRI
Measured: 4 hours after the initial injection of gadolinium, at least for one of the two ears
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start15 Dec 2022
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Why it stopped: The study was discontinued due to lack of inclusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endolymphatic HydropsStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229744
- Sponsor's protocol ID
- GPN_2021_23
- Acronym
- HYDROPS-CMV
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2021
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Endolymphatic Hydrops in Patients With a History of Congenital Cytomegalovirus Infection With Symptomatic Cochleo-vestibular Involvement
- ClinicalTrials.gov ID
- NCT05229744
- Acronym / sponsor ID
- HYDROPS-CMV / GPN_2021_23
- Conditions
- Endolymphatic Hydrops
- Keywords
- CMV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to lack of inclusion.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The management of patients with a history of congenital CMV infection (whether symptomatic or asymptomatic at birth) is modeled on their usual management.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sequence MRI 3D FLAIRParticipation 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 | Device | – |
Primary outcome
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
Results and safety
The study was stopped early (reason given: The study was discontinued due to lack of inclusion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endolymphatic Hydrops, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued due to lack of inclusion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.