Sleep Disorders and Their Impact on Patients With Ménière's Disease
ConditionSleep Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of intracranial surgery or degenerative neurological disease.
No prior sleep medicine consultations.
Trial population
Adult (≥18 years) followed for Ménière's disease in the ENT department at Strasbourg University Hospital between June 1, 2019, and January 31, 2021.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Vertigo-related disability Score AAO-HNS
* Vertigo-related disability score AAO-HNS (American Academy of Otolaryngology-Head and Neck Surgery Functional Scale) * Vertigo is considered debilitating if the score is greater than 3 out of 6.
Time frame
1 hour after consultationSponsors and contacts
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Source ClinicalTrials.gov