Ménière's Disease Registry

NCT04438538 | Completed DMC

• 1 other identifier: 275749
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Ménière's Disease

Keywords

patient reported questionnaires; audiometric; vestibular; radiological tests

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• 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).

  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.

  through study completion, an average of 1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• University of East Anglia: collaborator
• Ménière's Society: collaborator

Study Sites (1)

Norfolk & Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Meniere Disease

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• John Phillips, Consultant

  Norfolk & Norwich University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: June 19, 2020
• Study Start: June 20, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-07

Locations

GB (1)