Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease (NCT03215420) | Clinical Trial Compass
CompletedNot Applicable
Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease
France41 participantsStarted 2016-09-08
Plain-language summary
The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH) in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional explorations, namely electrocochleography and dephasing of acoustic distortion products (which are modified by the EH).
The research hypothesis is that the examinations will show agreement in the diagnosis of EH, and that the results obtained (quantitative values) will vary in the same direction over time and during flares of MD.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* persons who have provided written consent
* persons aged 18 to 75 years
* persons with certain, probable or possible Meniere's disease according to the international classification AAO-HNS
Exclusion Criteria:
* persons without health insurance cover
* adults under guardianship
* persons with a history of hypersensitivity to the active substance or to one of the excipients of the contrast agent used for the MRI or to any gadolinium chelate
* pregnant or breast-feeding women
* severe acute or chronic kidney failure
* other identified causes of cochleo-vestibular syndromes
* Impossibility to follow-up or carry out any of the examinations necessary for the protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography
Timeframe: day one
2
Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products
Timeframe: day one
3
Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T