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:
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.
