Sleep Disorders and Their Impact on Patients With Ménière's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sleep Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study of Sleep Disorders and Their Impact on Patients With Ménière's Disease
Overview
Ménière's disease was first described by Prosper Ménière in 1861 as a balance disorder originating in the inner ear. It is diagnosed based on a characteristic clinical triad of low-frequency hearing loss, tinnitus, and vertigo attacks. The underlying cause is thought to be a pressure imbalance in the inner ear between the endolymphatic and perilymphatic sectors. The prevalence of Ménière's disease ranges from 34 to 190 per 100,000 inhabitants. The physiology of Ménière's disease is not yet fully understood. It appears that sleep disorders may be related. In its 2016 report on Ménière's disease, the French Society of Otolaryngology (SÖL) recommends sleep studies for patients with Ménière's disease. However, these recommendations are based on few studies, which is why we wanted to conduct this research. The main hypothesis is the existence of a link between debilitating vertigo and sleep disturbances in patients with Ménière's disease. In cases of more significant sleep disturbances in patients with debilitating Ménière's disease, it is important to focus more thoroughly on these disturbances during ENT consultations, which are an integral part of effective multidisciplinary care.
Primary outcome measures
- Vertigo-related disability Score AAO-HNS [Time frame: 1 hour after consultation]
Eligibility criteria
Inclusion criteria
- Adult (≥18 years)
- Patient followed for Ménière's disease in the ENT department at Strasbourg University Hospital between June 1, 2019, and January 31, 2021.
Exclusion criteria
- History of intracranial surgery or degenerative neurological disease.
- No prior sleep medicine consultations.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Service d'ORL et de Chirurgie Cervico-faciale - Hôpitaux Universitaires de Strasbourg — Strasbourg
Identifiers
NCT: NCT07299578 · 9380