NCT07299578 Sleep Disorders and Their Impact on Patients With Ménière's Disease
| NCT ID | NCT07299578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Sleep Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-07-19 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07299578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07299578 currently recruiting?
Yes, NCT07299578 is actively recruiting participants. Contact the research team at anne.charpiot@chru-strasbourg.fr for enrollment information.
Where is the NCT07299578 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT07299578 clinical trial?
NCT07299578 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 100 participants.