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

NCT07299578 | Recruiting

• 1 other identifier: 9380
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders

Keywords

Sleep Disorder; Ménière's Disease

Outcome Measures

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.

  1 hour after consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• History of intracranial surgery or degenerative neurological disease.
• No prior sleep medicine consultations.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Meniere Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Anne CHARPIOT, MD, PhD

CONTACT

33 3 88 12 76 41; anne.charpiot@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 23, 2025
• Study Start: July 19, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)