Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH).

Basque Health Service0 个研究点目标入组 815 人开始时间: 2009年3月1日最近更新: 2013年2月7日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 815
主要终点: Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The diagnosis of OSASH requires expensive sleep tests that generate long waiting lists, so we need simplified and rapid diagnostic tools. The ApneaLinkTM, is a device that allows the assessment of respiratory events by measuring the flow ventilation with a nasal cannula connected to a pressure transducer.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients 18 to 75 years of both sexes.
•clinical suspicion of OSAH defined as subjects with breathing pauses during sleep and / or asphyxiated sounds, with or without excessive daytime sleepiness as measured by the Epworth scale and who have asked for a sleep test to rule out OSAH.
•Informed consent signed by the patient.

排除标准

•Place of residence more than 100 km from the hospital.
•inability to perform psychophysical study at home.
•cardio-vascular disease, cerebro-vascular or respiratory or acute severe unstable as to preclude the proper conduct of studies at home and / or PSG in the laboratory.
•Patients with chronic insomnia or recognize sleep less than six hours.
•Patients with depression (both point 4 and 5 are the potential causes of false negatives in a PR for lack of sufficient sleep time).
•nasal obstruction complete or nearly complete, which prevents obtaining a quality signal with MicroMESAM

结局指标

主要结局

Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方

Basque Health Service

申办方类型

Other Gov

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