Sleep ApneaSLEEPOVEANCT05958563
Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)
A study testing continuous positive airway pressure treatment in people with Sleep Apnea and COPD Exacerbation, run by University Hospital, Angers at 15 sites in France.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) are both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sleep Apnea, COPD Exacerbation, Overlap Syndrome
- What is being tested?
- continuous positive airway pressure treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 15 sitesFrance
- Study dates
- 9 Jan 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age or older
- Grade of 2 or higher on the modified Medical Research Council scale (which ranges from 0 to 4, with higher grades indicating more severe dyspnea)
- A post-bronchodilator forced expiratory volume in 1 second (FEV1) of less than 70% of the predicted value, and a postbronchodilator ratio of FEV1 to forced vital capacity (FVC) of less than 0.70.
- Documented history of at least one moderate or severe COPD exacerbation during the previous year
- Clinical suspicion of OSA (based on a STOP-bang questionnaire >3),
- Have a telephone or a tablet or accept to use one during the study,
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- Willing and able to comply with all study procedures,
- Subjects covered by or having the rights to medical care assurance.
- An apnea-hypopnea index [AHI], ≥15 per hour based on a full night polysomnography and no significant central apneas (<5 central apneas per hour of sleep
Who cannot join
- Severe daytime sleepiness (Epworth sleepiness Scale >14/24 and/or frequent sleepiness while driving or patient escaping a sleep-onset accident within the last 12 months),
- Severe unstable cardiovascular disease (heart failure with FEVG≤45%, recurrent cardiac arrhythmia, instable coronary heart disease or stroke),
- Patient on long-term oxygen therapy or non-invasive ventilation
- Previously documented severe hypercapnia (PaCO2 ≥ 50mm Hg)
- Previously diagnosed and treated OSA
- Any rehabilitation program or any lung volume reduction procedure planned in the oncoming year
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- Pregnancy, breastfeeding
- Bad understanding of the French language,
- Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites, 15 recruiting
- Recruiting
Angers University Hospital
Angers
TRZEPIZUR Wojciech, 02 41 35 36 95, WoTrzepizur@chu-angers.fr
- Recruiting
Bordeaux University Hospital
Bordeaux
GRASSION Léo, 05 57 65 63 38, leo.grassion@chu-bordeaux.fr
- Recruiting
Brest University Hospital
Brest
LE MAO Raphael, 02 98 34 73 47, raphael.lemao@chu-brest.fr
- Recruiting
AP-HP -Henri Mondor Hsopital
Créteil
BOYER Laurent, 01 49 81 26 90, laurent.boyer@aphp.fr
- Recruiting
Dijon University Hospital
Dijon
GEORGES Marjolaine, 0380293772, marjolaine.georges@chu-dijon.fr
- Recruiting
Grenoble University Hospital
Grenoble
PEPIN Jean-Louis, 0476768473, jpepin@chu-grenoble.fr
- Recruiting
Le Mans Hospital
Le Mans
GOUPIL François, 02 43 43 43 45, fgoupil@ch-lemans.fr
- Recruiting
Nancy University Hospital
Nancy
CHAOUAT Ari, 03 83 15 40 21, a.chaouat@chru-nancy.fr
- Recruiting
AP-HP - Pitié Salpetrière Hospital
Paris
PATOUT Maxime, 01 42 16 78 84, Maxime.patout@aphp.fr
- Recruiting
Bichat Hospital - AP-HP
Paris
FRIJA-MASSON Justine, 01 40 25 52 83, justine.frija@aphp.fr
- Recruiting
Poitiers University Hospital
Poitiers
BIRONNEAU Vanessa, 05.49.44.44.74, vanessa.bironneau@chu-poitiers.fr
- Recruiting
Reims University Hospital
Reims
LAUNOIS Claire, 03 26 78 76 14, claunois@chu-reims.fr
- Recruiting
Polyclinique Saint Laurent
Rennes
PRIGENT Arnaud, 02 99 25 65 35, arnaud.prigent@hstv.fr
- Recruiting
Strasbourg University Hospital
Strasbourg
KESSLER Romain, 03 69 55 06 45, romain.kessler@chru-strasbourg.fr
- Recruiting
Toulouse Universty Hospital
Toulouse
SEDKAOUI Kamila, 05 67 77 18 32, sekaoui.k@chu-toulouse.fr
About this study
Official title: Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS) SLEEPOVEA
Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) are both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). This association is then referred to as Overlap Syndrome (CO-OS). Data from observational studies suggest that this association may have an additive or even synergistic negative impact on patient's prognosis. Indeed, in a cohort of patients diagnosed as having a CO-OS, patients who did not receive specific treatment for OSA had a 76% increased risk of death compared to patients treated with continuous positive airway pressure (CPAP) and a 2-fold increased risk of acute COPD exacerbation. In another cohort of patients with both OSA and severe oxygen treated COPD, untreated patients for OSA had a 5-fold increased risk of death compared to patients treated with CPAP. There are strong signals from observational studies in support of a beneficial impact of CPAP therapy on respiratory outcomes in patients with CO-OS. However, those findings are not supported by any controlled study. It is difficult to directly transpose the observational data to current clinical practice in the context of the recent studies on the impact of CPAP on OSA prognosis. Indeed, data from similar observational OSA cohorts have reported a major impact of CPAP on the overall survival and cardiovascular outcomes in patients with OSA. Ten years later, this impact has not been confirmed by several randomized studies. To date, there is no consensus on a systematic screening and, if present, management of OSA in patients with COPD. The need for specific research on that field was emphasized in 2018 in an official American Thoracic Society Research Statement which recommends "randomized trials that compare clinical outcomes among patients with Overlap Syndrome whose OSA is treated to clinical outcomes among patients with Overlap Syndrome whose OSA is untreated".
Read the detailed description
This study is an open labeled parallel group randomized controlled trial. The patients will be recruited within the pneumology consultations of the participating centers. Patients meeting the pre-inclusion criteria and having no exclusion criteria will be included in the study and will undergo a polysomnographic sleep recording (PSG).
Patients with apnea hypopnea index (AHI) <15 / hour and/or significant central apneas (≥5 central apneas per hour of sleep) during PSG will be excluded from the study.
Patients with moderate to severe OSA (AHI ≥15 /h) and no significant central apneas will undergo baseline evaluation (ABG, 6 minute walking test, FEV1 and questionnaires) and then will be randomly assigned to receive 1 year of CPAP treatment (CPAP group) or no treatment of OSA (control group) according to a 1:1 allocation using a computer-generated randomization list stratified by site and OSA severity with permuted blocks of random sizes.
Visit at 3,6 and 9 months: the following outcomes will be assessed: COPD exacerbations (number, date and severity), cardiovascular events, death and questionnaires.
Visit at the end of the study (12 months): the following outcomes will be assessed: COPD exacerbations (number, date and severity), cardiovascular events, death, questionnaires, ABG, 6 minute walking test, FEV1.
Statistical analysis for primary and secondary outcomes will be performed on an intention to treat basis. A per-protocol analysis will be also performed in patients with an average objective CPAP use of at least 4 hours per day. Pre-specified sensitivity analysis will be conducted according to age, gender, body-mass index, OSA and COPD severity.
- Conditions
- Sleep Apnea, COPD Exacerbation, Overlap Syndrome
- Being tested
- continuous positive airway pressure treatment
- Keywords
- sleep apnea, copd, overlap syndrome
- Medical subject headings
- Sleep Apnea Syndromes, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressure treatmentDevice
CPAP treatment for one year
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | Experimental | Continuous positive airway pressure (CPAP) for one year Receives: Device: continuous positive airway pressure treatment |
| Control group | No intervention | No CPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
annual rate of COPD exacerbations
COPD exacerbations will be captured using the EXACT-PRO diary. COPD exacerbations will be defined as a worsening of two or more of dyspnea, sputum purulence or sputum volume for at least two consecutive days and captured using an electronic diary (EXACT-PRO) for mild exacerbation or during clinical visits for moderate and severe exacerbations.
Measured: 12 months
Secondary outcomes (13)
Annual rate of moderate to severe COPD exacerbations and severe COPD exacerbations
The type of treatment provided for a COPD exacerbation will determine the severity of the exacerbation. It will be categorized as mild (involving worsening of symptoms for >2 consecutive days), moderate (leading to treatment with glucocorticoids, antibiotics, or both), or severe (leading to hospital admission)
Measured: 12 months
Times to the first COPD exacerbation of any severity
COPD exacerbations will be captured using the EXACT-PRO diary. COPD exacerbations will be defined as a worsening of two or more of dyspnea, sputum purulence or sputum volume for at least two consecutive days and captured using an electronic diary (EXACT-PRO) for mild exacerbation or during clinical visits for moderate and severe exacerbations.
Measured: 12 months
Times to the first COPD exacerbation of the first moderate or severe COPD exacerbation
The type of treatment provided for a COPD exacerbation will determine the severity of the exacerbation. It will be categorized as mild (involving worsening of symptoms for >2 consecutive days), moderate (leading to treatment with glucocorticoids, antibiotics, or both), or severe (leading to hospital admission)
Measured: 12 months
Times to the first COPD exacerbation of the first severe COPD exacerbation
The type of treatment provided for a COPD exacerbation will determine the severity of the exacerbation. It will be categorized as mild (involving worsening of symptoms for >2 consecutive days), moderate (leading to treatment with glucocorticoids, antibiotics, or both), or severe (leading to hospital admission)
Measured: 12 months
Annual rate of non-fatal cardiovascular events
non-fatal myocardial infarction, non-fatal stroke, coronary artery bypass surgery, and percutaneous transluminal coronary angiography
Measured: 12 months
Mortality rate
deaths
Measured: 12 months
Measurement of the quality of life
Saint George's Respiratory Questionnaire
Measured: 12 months
Dyspnea
modified Medical Research Council scale
Measured: 12 months
Functional respiratory
forced expiratory volume in one second
Measured: 12 months
exercise capacity
6 minutes walking test
Measured: 12 months
Daytime sleepiness
Epworth Sleepiness Scale
Measured: 12 months
Subjective sleep quality
Pittsburgh sleep quality index
Measured: 12 months
Arterial blood gases
Partial pressure of oxygen and carbon dioxide
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start9 Jan 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control study
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958563
- Sponsor's protocol ID
- 49RC21_0377
- Acronym
- SLEEPOVEA
- Status last verified
- Apr 2025
- First submitted
- 12 Jul 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS) SLEEPOVEA
- ClinicalTrials.gov ID
- NCT05958563
- Acronym / sponsor ID
- SLEEPOVEA / 49RC21_0377
- Conditions
- Sleep Apnea, COPD Exacerbation, Overlap Syndrome
- Keywords
- sleep apnea, copd, overlap syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Ministry of Health, France
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 24 Jul 2023 (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 both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). This association is then referred to as Overlap Syndrome (CO-OS). Data from observational studies suggest that this association may have an additive or even synergistic negative impact on patient's prognosis. Indeed, in a cohort of patients diagnosed as having a CO-OS, patients who did not receive specific treatment for OSA had a 76% increased risk of death compared to patients treated with continuous positive airway pressure (CPAP) and a 2-fold increased risk of acute COPD exacerbation. In another cohort of patients with both OSA and severe oxygen treated COPD, untreated patients for OSA had a 5-fold increased risk of death compared to patients treated with CPAP. There are strong signals from observational studies in support of a beneficial impact of CPAP therapy on respiratory outcomes in patients with CO-OS. However, those findings are not supported by any controlled study. It is difficult to directly transpose the observational data to current clinical practice in the context of the recent studies on the impact of CPAP on OSA prognosis. Indeed, data from similar observational OSA cohorts have reported a major impact of CPAP on the overall survival and cardiovascular outcomes in patients with OSA. Ten years later, this impact has not been confirmed by several randomized studies. To date, there is no consensus on a systematic screening and, if present, management of OSA in patients with COPD. The need for specific research on that field was emphasized in 2018 in an official American Thoracic Society Research Statement which recommends "randomized trials that compare clinical outcomes among patients with Overlap Syndrome whose OSA is treated to clinical outcomes among patients with Overlap Syndrome whose OSA is untreated".
Detailed description
This study is an open labeled parallel group randomized controlled trial. The patients will be recruited within the pneumology consultations of the participating centers. Patients meeting the pre-inclusion criteria and having no exclusion criteria will be included in the study and will undergo a polysomnographic sleep recording (PSG).
Patients with apnea hypopnea index (AHI) <15 / hour and/or significant central apneas (≥5 central apneas per hour of sleep) during PSG will be excluded from the study.
Patients with moderate to severe OSA (AHI ≥15 /h) and no significant central apneas will undergo baseline evaluation (ABG, 6 minute walking test, FEV1 and questionnaires) and then will be randomly assigned to receive 1 year of CPAP treatment (CPAP group) or no treatment of OSA (control group) according to a 1:1 allocation using a computer-generated randomization list stratified by site and OSA severity with permuted blocks of random sizes.
Visit at 3,6 and 9 months: the following outcomes will be assessed: COPD exacerbations (number, date and severity), cardiovascular events, death and questionnaires.
Visit at the end of the study (12 months): the following outcomes will be assessed: COPD exacerbations (number, date and severity), cardiovascular events, death, questionnaires, ABG, 6 minute walking test, FEV1.
Statistical analysis for primary and secondary outcomes will be performed on an intention to treat basis. A per-protocol analysis will be also performed in patients with an average objective CPAP use of at least 4 hours per day. Pre-specified sensitivity analysis will be conducted according to age, gender, body-mass index, OSA and COPD severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control study
| Arm | Type | Receives |
|---|---|---|
| CPAP group | Experimental | Device: continuous positive airway pressure treatmentContinuous positive airway pressure (CPAP) for one year |
| Control group | No intervention | –No CPAP treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 40 years of age or older
- Grade of 2 or higher on the modified Medical Research Council scale (which ranges from 0 to 4, with higher grades indicating more severe dyspnea)
- A post-bronchodilator forced expiratory volume in 1 second (FEV1) of less than 70% of the predicted value, and a postbronchodilator ratio of FEV1 to forced vital capacity (FVC) of less than 0.70.
- Documented history of at least one moderate or severe COPD exacerbation during the previous year
- Clinical suspicion of OSA (based on a STOP-bang questionnaire >3),
Key exclusion criteria (9 listed)
- Severe daytime sleepiness (Epworth sleepiness Scale >14/24 and/or frequent sleepiness while driving or patient escaping a sleep-onset accident within the last 12 months),
- Severe unstable cardiovascular disease (heart failure with FEVG≤45%, recurrent cardiac arrhythmia, instable coronary heart disease or stroke),
- Patient on long-term oxygen therapy or non-invasive ventilation
- Previously documented severe hypercapnia (PaCO2 ≥ 50mm Hg)
- Previously diagnosed and treated OSA
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 |
|---|---|---|
| continuous positive airway pressure treatmentCPAP treatment for one year | Device | CPAP group |
Primary outcome
annual rate of COPD exacerbations
Time frame: 12 months
COPD exacerbations will be captured using the EXACT-PRO diary. COPD exacerbations will be defined as a worsening of two or more of dyspnea, sputum purulence or sputum volume for at least two consecutive days and captured using an electronic diary (EXACT-PRO) for mild exacerbation or during clinical visits for moderate and severe exacerbations.
13 secondary outcomes
Annual rate of moderate to severe COPD exacerbations and severe COPD exacerbations
Time frame: 12 months
Times to the first COPD exacerbation of any severity
Time frame: 12 months
Times to the first COPD exacerbation of the first moderate or severe COPD exacerbation
Time frame: 12 months
Times to the first COPD exacerbation of the first severe COPD exacerbation
Time frame: 12 months
Annual rate of non-fatal cardiovascular events
Time frame: 12 months
Mortality rate
Time frame: 12 months
Measurement of the quality of life
Time frame: 12 months
Dyspnea
Time frame: 12 months
Functional respiratory
Time frame: 12 months
exercise capacity
Time frame: 12 months
Daytime sleepiness
Time frame: 12 months
Subjective sleep quality
Time frame: 12 months
Arterial blood gases
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure treatment in people with Sleep Apnea and COPD Exacerbation, run by University Hospital, Angers at 15 sites in France.
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Trzepizur, MD PhD (+33680575272, wotrzepizur@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
annual rate of COPD exacerbations (time frame: 12 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 13 Apr 2025.