跳至主要内容
临床试验/NCT01026207
NCT01026207终止不适用

Validation of a Portable Monitoring Device for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Chronic Obstructive Pulmonary Disease

Associação Fundo de Incentivo à Pesquisa2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2009年8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
72
试验地点
2
主要终点
to evaluate the accuracy of a portable monitoring device (Stardust - STD) in the detection of patients with chronic obstructive pulmonary disease (COPD).

研究概览

简要总结

Introduction:

The prevalence of overlap between Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea Syndrome (OSAS) is around 10%. This overlap syndrome is an important issue because is related to nocturnal desaturation and its complications. The use of portable monitoring devices (PM) for the diagnosis of OSAS was recently accepted as an alternative to full-night polysomnography (PSG). However, there are not studies evaluating the PM recording in COPD patients to detect or exclude OSAS.

Objective:

To evaluate if a PM (Stardust®, Respironics, Inc, USA) could accurately measure the apnea-hypopnea index (AHI) in COPD patients with a suspicion of OSAS.

详细描述

Patients will be recruited from the Pneumology outpatient clinic of UNIFESP, Patients had been diagnosed with COPD in GOLD's stages II and III, were stable (no COPD exacerbation in the last three months), were using bronchodilators without a dose change during that period, and had symptoms suggestive of OSAS (loud snoring, reported breathing pauses during sleep and excessive sleepiness). We excluded patients with other sleep-related disorders, a diagnosis and/or previous treatment for OSAS, severe cardiovascular disorders or neuromuscular disease and those using oxygen, psychotropic drugs, alcohol or other drugs of abuse.

Patients will undergo two assessments of sleep, randomly determined: 1) PM at home for one night, 2) PM in the sleep laboratory simultaneously to the PSG. Three apnea-hypopnea index (AHI) values will be obtained and analyzed: a) AHI from PM at home, b) AHI from PM in the laboratory, and c) AHI from the PSG. Analyses of all evaluations will be performed by two trained technicians, blinded to study details.

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

入选标准

  • Presence of Chronic Obstructive Pulmonary Disease stage II and III of Global Initiative for Chronic Obstructive Lung Disease, stable for three months, and with symptoms suggestive of Obstructive Sleep Apnea Syndrome.

排除标准

  • Presence of Chronic Obstructive Pulmonary Disease stage II and III

结局指标

主要结局

to evaluate the accuracy of a portable monitoring device (Stardust - STD) in the detection of patients with chronic obstructive pulmonary disease (COPD).

时间窗: 2 years colect data

compared Portable monitoring device with polysomnography in COPD patients

次要结局

未报告次要终点

研究者

发起方
Associação Fundo de Incentivo à Pesquisa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Lia Azeredo-Bittencourt

Prof Dr Lia Rita Azeredo Bittencourt

Associacao Fundo de Incentivo a Psicofarmcologia

研究点 (2)

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