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Clinical Trials/NCT04903639
NCT04903639CompletedNot Applicable

Obstructive Sleep Apnea Prevalence in Patients With Chronic Obstructive Pulmonary Diseases

Benha University1 site in 1 country100 target enrollmentStarted: August 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
prevalence of OSA in COPD patients

Study Overview

Brief Summary

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.

Detailed Description

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).

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • stable COPD patients

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

prevalence of OSA in COPD patients

Time Frame: through study completion

number of AHI found during sleep study of COPD patients

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marwa Elsayed Elnaggar

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

Benha University

Study Sites (1)

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