Obstructive Sleep Apnea Prevalence in Patients With Chronic Obstructive Pulmonary Diseases

NCT04903639 | Completed DMC

• 1 other identifier: BenhaU123
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA

Keywords

COPD; OSA; OS; AHI

Outcome Measures

Primary Outcomes (2)

• prevalence of OSA in COPD patients

  number of AHI found during sleep study of COPD patients

  through study completion, an average of 1 year

• prevalence of OSA in COPD patients

  number of AHI found during sleep study of COPD patients

  through study completion

Study Arms (2)

obese COPD

COPD patient with BMI more than 30

Diagnostic Test: sleep study

non obese COPD

COPD patient with BMI less than 30

Diagnostic Test: sleep study

Interventions

sleep study DIAGNOSTIC_TEST

The polysomnography consists of electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), pulse oximetry, thoracic and abdominal straps, body posture sensor, nasal thermistor and nasal cannula to assess respiratory flow and pressure and bipolar channel limb movements (tibialis anterior). Electrodes and sensors were attached to patients by sleep physiologist. Data collection was obtained following signal perception by preprocessed computer (DOMINO Software, ver. 2.6.0; SOMNO Medics GmbH).

non obese COPD; obese COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• stable COPD patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Faculty of medicine, Benha University

Banhā, Alqalubia, 13511, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• M E Elnaggar, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of chest diseases, chest department, Faculty of Medicine, Benha University

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: May 26, 2021
• Study Start: August 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)