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临床试验/NCT01354756
NCT01354756终止不适用

Validation of Apnea LinkTM (ResMed Corporation, Poway, California) for Sleep Apnea Syndrome Screening in a Bariatric Population

Centre Hospitalier Universitaire Saint Pierre0 个研究点目标入组 9 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
9
主要终点
Number of patients with correct diagnosis of OSA with ApneaLink. Therefore, we will compare apnea-hypopnea index measured with ApneaLink with apnea-hypopnea index measured during polysomnography.

研究概览

简要总结

Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric surgery. There is a need for alternative screening tools for sleep apnea detection in the pre-operative period. The investigators would like to compare ApneaLink and complete polysomnography in this population.

详细描述

OSA can occur in up to 78% of patients undergoing bariatric surgery(1). Moderate to severe case will benefit from CPAP therapy, that can help avoiding post-operative complications(2).

In this population, the investigators propose complete attended in-hospital polysomnography (PSG)in patients with a clinical high probability of OSA.

According to obesity epidemics (3), waiting list for PSG in sleep labs is every day longer.

The investigators want to assess sensitivity and specificity of a new portable screening tool, ApneaLink, to detect OSA in a bariatric population.

Design:

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • obese patients
  • > 18 years old
  • in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening

排除标准

  • pulmonary, neurologic, neuromuscular disease
  • < 18 years old

结局指标

主要结局

Number of patients with correct diagnosis of OSA with ApneaLink. Therefore, we will compare apnea-hypopnea index measured with ApneaLink with apnea-hypopnea index measured during polysomnography.

时间窗: 2 weeks

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Bruyneel

Chef de Clinique

Centre Hospitalier Universitaire Saint Pierre

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