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临床试验/NCT07299578
NCT07299578招募中不适用

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

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月19日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Vertigo-related disability Score AAO-HNS

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Vertigo-related disability Score AAO-HNS

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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