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临床试验/NCT04903639
NCT04903639已完成不适用

Obstructive Sleep Apnea Prevalence in Patients With Chronic Obstructive Pulmonary Diseases

Benha University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年8月1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
100
试验地点
1
主要终点
prevalence of OSA in COPD patients

研究概览

简要总结

The conjunction of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) is known as Overlap Syndrome (OS). The coexistence of these diseases have cardiovascular morbidity and mortality. The aim of this study is to assess the prevalence of OSA in COPD patients. 100 COPD patients (obese and non-obese) performed sleep questionnaires and polysomnogram.

详细描述

300 patients were enrolled in this prospective observational study who were attended at chest department, outpatient clinic Benha university hospitals for follow up between August 2018 and October 2020. According to medical history, clinical examination and pulmonary function tests, only stable COPD patients (100 patients) were included. The research ethics committee at the faculty of medicine has approved the study and all patients provided informed consent before participation.

COPD patients were divided according to their body mass index (BMI) into two groups ; group A: 50 obese COPD patients (BMI ≥30 kg/m2) and group B: 50 non obese COPD patients (BMI ≤ 29.9 kg/m2).

Inclusion criteria: COPD patients were diagnosed according to the Global initiative for chronic obstructive pulmonary disease on the basis of (GOLD, 2017). Included patients who had chronic cough, sputum production, dyspnea and /or a history of exposure to risk factors for the disease and confirmed by the presence of a post bronchodilator forced expiratory volume in the 1st second/forced vital capacity (FEV1/FVC) < 70% .

Exclusion criteria included patients with COPD exacerbation, patients with decompensated heart failure, thyroid dysfunction, ears, nose and throat (ENT) causes of OSA or patients with impaired hepatic and renal function.

COPD patients were characterized by their postbronchodilator FEV1 into mild (FEV1 ≥ 80% anticipated), moderate (50%≤FEV1 < 80% anticipated) and severe (30%≤FEV1 < 50% anticipated).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • stable COPD patients

排除标准

  • patients with COPD exacerbation
  • patients with decompensated heart failure
  • patients with thyroid dysfunction
  • ears, nose and throat (ENT) causes of OSA
  • patients with impaired hepatic and renal function

结局指标

主要结局

prevalence of OSA in COPD patients

时间窗: through study completion

number of AHI found during sleep study of COPD patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Elsayed Elnaggar

Assistant professor of chest diseases, chest department, Faculty of Medicine, Benha University

Benha University

研究点 (1)

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