OSANCT04903639
Obstructive Sleep Apnea Prevalence in Patients With Chronic Obstructive Pulmonary Diseases
An observational study of OSA, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA
- What is being tested?
- sleep study
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Oct 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- stable COPD patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
All patients included in this study were subjected to full history taking, physical examination (general including BMI and neck circumference (NC), local chest examination, oral and ENT), questionnaires [The Epworth Sleepiness Scale (ESS) which translated to Arabic, STOP-Bang Questionnair (SBQ), modified medical research council (mMRC) breathlessness scale which was translated ta Arabic, spirometry which was done using JAEGER carefusion Germany 234 GmbH Lelbnizstr .7, 97204 Hoechberg, Germany. Spirometry was done during stability of the disease. Echocardiography, liver, kidney and thyroid function tests were done .Overnight Polysomnography (PSG) (SOMNO Screen Plus; SOMNO Medics GmbH, Randersacker, Germany). 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).
Patients considered having OSA if they had apneic episodes occurred in the existence of respiratory muscle effort and lasted 10 seconds or more, or have a combination of apneas and hypopneas. The apnea-hypopnea index (AHI) is gotten from the absolute number of apneas and hypopneas separated by the total sleep time. Cutoff levels on AHI incorporate 5-15 episodes per hour for mild, 15-30 episodes per hour for moderate and more than 30 episodes per hour for severe OSA
- Conditions
- OSA
- Being tested
- sleep study
- Keywords
- COPD, OSA, OS, AHI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep studyDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| obese COPD | COPD patient with BMI more than 30 Receives: Diagnostic Test: sleep study | |
| non obese COPD | COPD patient with BMI less than 30 Receives: Diagnostic Test: sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of OSA in COPD patients
number of AHI found during sleep study of COPD patients
Measured: through study completion, an average of 1 year
prevalence of OSA in COPD patients
number of AHI found during sleep study of COPD patients
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Aug 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Elsayed Elnaggar, Benha University
- Investigators
- M E Elnaggar, MD, Principal investigator, Assistant professor of chest diseases, Faculty of Medicine, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903639
- Sponsor's protocol ID
- BenhaU123
- Status last verified
- Jul 2021
- First submitted
- 22 May 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD could be shared depending on personal request
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Prevalence in Patients With Chronic Obstructive Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT04903639
- Acronym / sponsor ID
- BenhaU123
- Conditions
- OSA
- Keywords
- COPD, OSA, OS, AHI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
All patients included in this study were subjected to full history taking, physical examination (general including BMI and neck circumference (NC), local chest examination, oral and ENT), questionnaires [The Epworth Sleepiness Scale (ESS) which translated to Arabic, STOP-Bang Questionnair (SBQ), modified medical research council (mMRC) breathlessness scale which was translated ta Arabic, spirometry which was done using JAEGER carefusion Germany 234 GmbH Lelbnizstr .7, 97204 Hoechberg, Germany. Spirometry was done during stability of the disease. Echocardiography, liver, kidney and thyroid function tests were done .Overnight Polysomnography (PSG) (SOMNO Screen Plus; SOMNO Medics GmbH, Randersacker, Germany). 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).
Patients considered having OSA if they had apneic episodes occurred in the existence of respiratory muscle effort and lasted 10 seconds or more, or have a combination of apneas and hypopneas. The apnea-hypopnea index (AHI) is gotten from the absolute number of apneas and hypopneas separated by the total sleep time. Cutoff levels on AHI incorporate 5-15 episodes per hour for mild, 15-30 episodes per hour for moderate and more than 30 episodes per hour for severe OSA
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese COPD | – | Diagnostic Test: sleep studyCOPD patient with BMI more than 30 |
| non obese COPD | – | Diagnostic Test: sleep studyCOPD patient with BMI less than 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- stable COPD patients
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep studyThe 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). | Diagnostic test | non obese COPD, obese COPD |
Primary outcome
prevalence of OSA in COPD patients
Time frame: through study completion, an average of 1 year
number of AHI found during sleep study of COPD patients
prevalence of OSA in COPD patients
Time frame: through study completion
number of AHI found during sleep study of COPD patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No. IPD could be shared depending on personal request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M E Elnaggar, MD principal investigator
Assistant professor of chest diseases, Faculty of Medicine, Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of OSA in COPD patients (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.