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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07299578

Acronym

SoM

Enrollment

100

Registered

2025-12-23

Start date

2024-07-19

Completion date

2026-01-31

Last updated

2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders

Keywords

Sleep Disorder, Ménière's Disease

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Vertigo-related disability Score AAO-HNS	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.

Countries

France

Contacts

Primary ContactAnne CHARPIOT, MD, PhD

anne.charpiot@chru-strasbourg.fr33 3 88 12 76 41

Outcome results