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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04438538
Other study ID # 275749
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 20, 2020
Est. completion date December 31, 2021

Study information

Verified date July 2021
Source Norfolk and Norwich University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Norfolk & Norwich University Hospital Norwich Norfolk

Sponsors (3)

Lead Sponsor Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust Ménière's Society, University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To acquire data on existing Ménière's disease patients from three UK regions. 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 20 minutes
Primary An estimation of the prevalence and incidence of bilateral disease: 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. through study completion, an average of 1 year
Primary Putative risk factors for the conversion from unilateral to bilateral disease: 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. through study completion, an average of 1 year
Secondary 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). 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.
1 year
Secondary In conjunction with the Ménière's disease community, identify research questions which could be answered either using, or in collaboration with, a national registry. In conjunction with the Ménière's disease community, identify research questions which could be answered either using, or in collaboration with, a national registry. through study completion, an average of 1 year
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