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.

Ménière's Disease Registry

Ménière's Disease

Ménière's disease is an inner ear disorder characterised by recurrent episodes of
spontaneous vertigo, fluctuating hearing loss and tinnitus, often with a feeling of
fullness in the ear. The exact aetiology remains unknown. Ménière's disease is estimated
to have a prevalence of 0.25% in the UK (around 162,000 individuals) (Tyrrell 2016) and
is associated with significant physical, psychological and socioeconomic morbidity
(Anderson 2001, Tyrrell 2014).

There is a substantial lack of knowledge regarding many aspects of Ménière's disease,
including a fuller understanding of epidemiological aspects of the disease, aetiological
factors, pathogenesis, clinical course and treatment outcomes. The James Lind Alliance
cites Ménière's disease as the theme for four of their top ten priorities for addressing
uncertainties in the field of balance disorders (JLA 2018).

There is mounting unease regarding the definition of Ménière's disease as a single
clinical entity. Many consider it to represent the final pathway of a number of
individual disease processes. This is reflected by the progressive and varied development
of diagnostic criteria over the last few decades (Gurkov 2016). It is in the context of
these observations that Ménière's disease is likely to represent a heterogeneous clinical
condition defined only by small groups of common, but not always mandatory, symptoms.
Understanding how Ménière's disease may exist as a cluster of clinical sub-types is key
to allowing further research into its underlying pathophysiological mechanisms, and the
targeting of specific treatment strategies; as well as allowing a better understanding of
the physiology of the inner ear micro-environment (Phillips 2018).

This project will provide the initial steps necessary to set-up a UK Ménière's disease
registry by primarily investigating a single clinical subtype of Ménière's disease:
bilateral disease. The development of bilateral Ménière's disease has significant
implications for short and long-term opportunities for treatment and rehabilitation; this
in turn has significant implications for communication and employment. Previous
literature on bilateral disease has offered widely ranging estimates of the likelihood
that it will occur in cases where unilateral disease is confirmed, and no clear
predictors have been identified (Huppert 2010). However, it is a sub-type which is
relatively well-defined with standard internationally agreed criteria for diagnosis.

In areas of research such as this, the implementation of bespoke data collection
platforms and national registries have been demonstrated to be both effective and
efficient (Mandavia 2017). The use of national registries has many advantages over
conventional data collection methods. When implemented correctly, national registries can
allow the appraisal of a more representative sample of the target population.
Furthermore, a national approach broadens the opportunities both for participation among
the patient population to be served by such a venture, and for public engagement and
dissemination activities.

A national registry would allow the identification of features at presentation that
predict disease course and long-term outcome, improving the understanding of disease
progression, treatment response, and underlying aetiology. A UK Ménière's disease
registry would also provide a resource for broad and far reaching research into Ménière's
disease beyond that of defining clinical sub-types. Registries offer other benefits to
patients, carers (including partners and family), researchers, clinicians and other
individuals that are involved with the provision of services for those affected by the
condition being studied. Individual hospitals and the NHS as a whole can use registry
data to improve the services they offer. Individual patients and carers can use
registries to learn more about their condition and this can lead to a better
understanding of how people's lives are affected. It is anticipated that this work will
lead to further registry development and expansion with a broad remit of aims via further
awards from major research funders.

To develop the 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.

This project will require the retrospective collection of data from existing Ménière's
patients.

Potential participants with a diagnosis of probable or definite unilateral or bilateral
Ménière's Disease as defined by the 2015 edition of the American Academy of
Otolaryngology-Head and Neck Surgery (AAO-HNS) criteria (Goebel 2016) in their hospital
records will be identified at ENT secondary care and private clinics. Potential
participants must have received a diagnosis of Ménière's Disease within the previous 10
years or have received a new diagnosis during the recruitment window of the study.
Unilateral and bilateral Ménière's disease will be defined as follows:

Unilateral Ménière's Disease

At least two episodes of vertigo each lasting at least 20 minutes, where each episode is
associated with aural symptoms in a single ear.

Bilateral Ménière's Disease

At least two episodes of vertigo each lasting at least 20 minutes, where each episode is
associated with aural symptoms in both ears.

Data will include contemporaneous and historical information regarding medical and
relevant social/occupational history, audiometric data, vestibular testing data,
radiological data and symptom specific and health related quality of life questionnaires.
Clinical data will be requested, collected and extracted locally and entered directly
into the Study Dataset managed by Norwich Clinical Trials Unit at the University of East
Anglia.

Participants will be offered the option of completing the study questionnaires online or
on paper (for entry by a member of the research team). No additional outpatient
appointments outside normal care pathways will be required.

The full dataset will be composed of three components:

  1. Medical history. This will be completed by the participant onto a predefined data
     collection form - see additional document: MDR_NVPQ

  2. Symptom questionnaires. These will be completed by the participant

  3. Audiometric, Vestibular and Radiological test results. This will be completed by the
     local investigator team.

The investigators anticipate that participants will spend no longer than 60 minutes to
complete the necessary forms and questionnaires.

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.

Risk Factors for the Development of Bilateral Ménière's Disease and the Establishment of a National Ménière's Disease Registry.

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

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.

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.

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.

In conjunction with the Ménière's disease community, identify research questions which
could be answered either using, or in collaboration with, a national registry.

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.

Ménière's Disease Registry

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status