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临床试验/NCT04011358
NCT04011358撤回不适用

Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study

Centre Hospitalier Régional d'Orléans2 个研究点 分布在 1 个国家开始时间: 2021年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Apnea Hypopnea index >5/hour

研究概览

简要总结

This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.

详细描述

There will be two groups of 50 patients. One with Retinal Vein Occlusion, and the other one, with no Retinal Vein Occlusion will be chosen from the consultation.

The compared group will be paired on different criteria including hypertension, ocular hypertension, diabetes, sex, age.

They will all spend a night at home with a Sleeping Monitor (Nox T3) in order to evaluate if they have an Obstructive Sleep Apnea.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • All patients with an Retinal Vein Occlusion for one group (patients)
  • All patients with no Retinal Vein Occlusion for the other group (control)
  • Non-inclusion Criteria:
  • Severe Insomnia
  • Neuromuscular Disease with respiratory muscle impairment
  • Chronic opioid medication
  • Pregnancy women.
  • Patient under guardianship

排除标准

  • 未提供

结局指标

主要结局

Apnea Hypopnea index >5/hour

时间窗: Hour 12

Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home.

次要结局

  • Berlin Questionnaire sleep test(Hour 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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