OSANCT05605431
Predictors of OSA in Patients With COPD
An observational study of OSA and COPD, run by Cairo University at 1 site in Egypt.
Trial summary
Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea(OSA) are common disorders ,the co-existence of both conditions is called overlap syndrome Smoking , obesity , airway resistance and inflammation are considered risk factors for both conditions ,interestingly either COPD and OSA are associated… Read more about this study
- Who is it for?
- Ages 25 to 76 years
- What is being tested?
- Polysomnography
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 30 Nov 2020
- 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 25 to 76 years
- All sexes
- Adult, Older adult
Study population: two groups , COPD with OAS ( OVERLAP SYNDROME) COPD without OSA
Who may be able to join
- All stable COPD patients
Who cannot join
- Patients with end organ failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Obstructive Sleep Apnea in Patients With Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea(OSA) are common disorders ,the co-existence of both conditions is called overlap syndrome Smoking , obesity , airway resistance and inflammation are considered risk factors for both conditions ,interestingly either COPD and OSA are associated with increased cardiovascular complications with further increased risk in overlap syndrome Multiple theories could explain that one disorder can predispose or exaggerate the other. For example, in COPD cigarette smoking and inhaled steroids are linked to myopathy of upper airway dilator muscles. Moreover in core-pulmonale redistribution of edema fluid in supine position during sleep can also contribute to or exacerbate OSA .
On the other hand , OSA patients might smoke frequently and more heavily to compensate for excessive daytime sleepiness and to help them to lose weight , which results in exaggerated airway inflammation and exacerbate COPD. Rationale of the study was to assess the prevalence and predictors of OSA among patients with stable COPD.
- Being tested
- Polysomnography
- 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.
PolysomnographyDiagnostic test
over nightSleep study
| Study group | Role | What they receive |
|---|---|---|
| COPD associated with OSA | Not described Receives: Diagnostic Test: Polysomnography | |
| COPD without OSA | Not described Receives: Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening for OSA among COPD
to assess the percentage of OSA among COPD patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Mar 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 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 Cairo 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Kamal Ibrahim Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605431
- Sponsor's protocol ID
- MS-81-2020
- Status last verified
- Jun 2023
- First submitted
- 29 Oct 2022
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Obstructive Sleep Apnea in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05605431
- Acronym / sponsor ID
- MS-81-2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 4 Nov 2022 (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.
Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea(OSA) are common disorders ,the co-existence of both conditions is called overlap syndrome Smoking , obesity , airway resistance and inflammation are considered risk factors for both conditions ,interestingly either COPD and OSA are associated with increased cardiovascular complications with further increased risk in overlap syndrome Multiple theories could explain that one disorder can predispose or exaggerate the other. For example, in COPD cigarette smoking and inhaled steroids are linked to myopathy of upper airway dilator muscles. Moreover in core-pulmonale redistribution of edema fluid in supine position during sleep can also contribute to or exacerbate OSA .
On the other hand , OSA patients might smoke frequently and more heavily to compensate for excessive daytime sleepiness and to help them to lose weight , which results in exaggerated airway inflammation and exacerbate COPD. Rationale of the study was to assess the prevalence and predictors of OSA among patients with stable COPD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD associated with OSA | – | Diagnostic Test: Polysomnography |
| COPD without OSA | – | Diagnostic Test: Polysomnography |
Who may qualify
- Ages
- 25 to 76 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- two groups , COPD with OAS ( OVERLAP SYNDROME) COPD without OSA
Key inclusion criteria (1 listed)
- All stable COPD patients
Key exclusion criteria (1 listed)
- Patients with end organ failure
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 |
|---|---|---|
| Polysomnographyover nightSleep study | Diagnostic test | COPD associated with OSA, COPD without OSA |
Primary outcome
screening for OSA among COPD
Time frame: 6 months
to assess the percentage of OSA among 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 27 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for OSA
RecruitingObservational study
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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DRonabinol Treatment of OSA
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and COPD, run by Cairo 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 1 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 27 Jun 2023. 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?
screening for OSA among COPD (time frame: 6 months). 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 27 Jun 2023.