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Ménière's Disease Registry (MDR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04438538
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : July 17, 2020
Sponsor:
Collaborators:
University of East Anglia
Ménière’s Society
Information provided by (Responsible Party):
Norfolk and Norwich University Hospitals NHS Foundation Trust

Brief Summary:

Recent research has suggested that Ménière's disease may be a consequence of a number of individual conditions rather than developing from a single cause. This means that determining the different conditions that cause Ménière's disease will help the investigators to provide effective treatments. Experience from other similar medical conditions has taught the investigators that the best method to identify different causes of a condition is via a process called 'clinical subtyping'.

The investigators intend to set up a large Ménière's disease database in order to allow then to subtype Ménière's disease. More specifically, the proposed project aspires to achieve two aims. The investigators intend to investigate a sub-type of Ménière's disease, bilateral disease, i.e. both ears affected. The study hopes to identify what features predict an individual developing bilateral Ménière's disease. Secondly, to test the feasibility of expanding the database across the whole of the UK to involve all Ménière's disease patients. This will allow many other features of Ménière's disease to be used to establish sub-types and help predict the best treatment for individual patients.


Condition or disease
Ménière's Disease

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors for the Development of Bilateral Ménière's Disease and the Establishment of a National Ménière's Disease Registry.
Actual Study Start Date : June 20, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with Dizziness
All trial participants are within this group. All trial participants will either have a diagnosis or a suspected diagnosis of Ménière's Disease in order to take part.



Primary Outcome Measures :
  1. To acquire data on existing Ménière's disease patients from three UK regions. [ Time Frame: 20 minutes ]
    Participants will be asked to complete a non-validated Ménière's disease questionnaire about their Ménière's disease including demographics, history, symptoms including triggers of Ménière's disease related vertigo attacks, comorbidities, current treatment and past treatments tried for Ménière's disease

  2. An estimation of the prevalence and incidence of bilateral disease: [ Time Frame: through study completion, an average of 1 year ]
    The investigators should identify candidate risk factors that would increase or decrease the chances of developing bilateral disease. These could be further tested in a study of incident (i.e. newly occurring) cases of Ménière's disease followed prospectively in time. However, the initial set of risk factors should allow us to start the process of characterising the bilateral subtype and further understanding it aetiology.

  3. Putative risk factors for the conversion from unilateral to bilateral disease: [ Time Frame: through study completion, an average of 1 year ]
    The proportion of individuals with unilateral Ménière's disease that develop bilateral Ménière's disease after defined periods of time. Ultimately, it would be useful if the investigators could inform patients that, for example, if they haven't developed bilateral disease after a defined number of years from referral to secondary care, their chance of developing bilateral disease is less than a defined percentage.


Secondary Outcome Measures :
  1. Development of methods and infrastructure for a national registry by recruiting participants from three distinct urban and rural regions within the UK (Norfolk, Leicestershire and London). [ Time Frame: 1 year ]

    This will include an appraisal of a number of practical processes of recruitment, such as data acquisition, data processing and data management. This will inform future stages to expand the infrastructure to support a registry for widespread national use.

    More generally, the process of patient identification, recruitment, data collection and management will be the start of a much larger and broader national registry.


  2. In conjunction with the Ménière's disease community, identify research questions which could be answered either using, or in collaboration with, a national registry. [ Time Frame: through study completion, an average of 1 year ]
    In conjunction with the Ménière's disease community, identify research questions which could be answered either using, or in collaboration with, a national registry.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 or over with a definite or probable diagnosis of Ménière's disease. These will be collated from NHS hospitals and the corresponding clinician's private clinics.
Criteria

Inclusion Criteria:

  • Adults aged 18 and over.
  • A probable or definite diagnosis of unilateral or bilateral Meniere's disease as defined by the 2015 edition of the American Academy of Otolaryngology-Head and Neck Surgery (Goebel 2016)
  • A willingness to provide consent for data from health records to be used for research purposes.

Exclusion Criteria:

  • Unable to provide consent
  • Unable/unwilling to complete questionnaires

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438538


Contacts
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Contact: John Phillips, Consultant +44 1603 286770 john.phillips@mac.com
Contact: Catherine Wright +44 1603 647332 Catherine.wright@nnuh.nhs.uk

Locations
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United Kingdom
Norfolk & Norwich University Hospital Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: John Phillips         
Contact: Catherine Wright         
Sponsors and Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
University of East Anglia
Ménière’s Society
Investigators
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Principal Investigator: John Phillips, Consultant Norfolk & Norwich University Hospitals NHS Foundation Trust
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Responsible Party: Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04438538    
Other Study ID Numbers: 275749
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norfolk and Norwich University Hospitals NHS Foundation Trust:
patient reported questionnaires
audiometric
vestibular
radiological tests
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases