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临床试验/NCT05491967
NCT05491967已完成不适用

Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) With Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis

Centre Hospitalier de Valence1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2021年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
1
主要终点
morbimortality vascular criteria

研究概览

简要总结

a monocentric,non interventional, prospective study to compare cardiovascular risk in patients with Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis.

详细描述

The first-line treatment of severe Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) is nocturnal ventilation with Continuous Positive Airway Pressure (CPAP). and The second-line treatment is the mandibular advancement orthosis (MAO)].

CPAP is the most effective treatment to reduce the apnea-hypopnea index (AHI). However, its tolerance is sometimes difficult, causing many discontinuations.

The purpose of this review is to evaluate a vascular morbimortality criteria:

  • Cardiovascular: myocardial infarction, heart failure, rhythm disorder
  • Neurological: transient or non transient stroke
  • ophthalmologic: anterior ischemic optic neuropathy, occlusion of the central artery or central retinal vein occlusion

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis
  • Age ≥ 18 years old
  • Read, write and understand the French language

排除标准

  • Patient under guardianship, deprived of liberty, safeguard of justice
  • Refusal to participate in research

结局指标

主要结局

morbimortality vascular criteria

时间窗: up to 6 months

Presence or absence of ophthalmologic event

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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