Sleep Disorders and Their Impact on Patients With Ménière's Disease

NCT ID: NCT07299578

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-19

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Sleep Disorder Ménière's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service d'ORL et de Chirurgie Cervico-faciale - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anne CHARPIOT, MD, PhD

Role: CONTACT

Phone: 33 3 88 12 76 41

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anne CHARPIOT, MD, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9380

Identifier Type: -

Identifier Source: org_study_id