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NCT Number: NCT07299578

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Anne CHARPIOT, MD, PhD

CONTACT

[email protected]

33 3 88 12 76 41

Anne CHARPIOT, MD, PhD

PRINCIPAL_INVESTIGATOR

Claire THIBAULT, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Vertigo-related disability Score AAO-HNS

    Time frame: 1 hour after consultation

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne CHARPIOT, MD, PhD

CONTACT

[email protected]

33 3 88 12 76 41

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: SoM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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