Study of the Radio-clinical Correlation of Endolymphatic Hydrops (CRHE)

March 28, 2025 updated by: University Hospital, Strasbourg, France
In patients presenting with symptoms of endolymphatic hydrops, signs of vestibular dilation are often found on MRI. Some patients present with these radiological signs without vestibular clinical signs, or signs other than those of hydrops. No study has yet investigated the radiological-clinical correlation of endolymphatic hydrops by selecting patients based on their imaging findings and then comparing them to the symptoms presented.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
        • Sub-Investigator:
          • Idir DJENNAOUI, MD
        • Contact:
        • Principal Investigator:
          • Christian DEBRY, MD, PhD
        • Sub-Investigator:
          • Claire THIBAULT, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult subject (≥18 years) presenting vestibular dilation on MRI

Description

Inclusion Criteria:

  • Adult subject (≥18 years)
  • Subject presenting vestibular dilation on MRI

Exclusion Criteria:

  • Subjects who have expressed opposition to the reuse of their data for scientific research purposes.
  • Subjects under legal protection
  • Subjects under guardianship or curatorship

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
Nystagmus observed on videonystagmoscopy
Time Frame: Up to 1 year

Nystagmus observed on videonystagmoscopy:

  • Unidirectional or multidirectional
  • Direction
  • Exhaustible or not
  • Perceptible or not
Up to 1 year

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

July 19, 2024

Primary Completion (Estimated)

December 19, 2025

Study Completion (Estimated)

December 19, 2025

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9306 (Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)

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.

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