Chronic Obstructive Pulmonary Disease ExacerbationPhase 3NCT07047092
Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
A Phase 3 study testing Non-invasive Ventilation (NIV) and Continous Positive Airway Pressure (CPAP) in people with Chronic Obstructive Pulmonary Disease Exacerbation and Obstructive Sleep Apnea Exacerbation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a major public health problem with 212.3 million prevalent cases of COPD worldwide and 3.3 million deaths related to COPD in 2019. Obstructive sleep apnoea (OSA) is the most common sleep disordered breathing. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Exacerbation, Obstructive Sleep Apnea Exacerbation
- What is being tested?
- Non-invasive Ventilation (NIV) and Continous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2026to Oct 2030
- Phase
- Phase 3
- 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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and < 85 years
- Patient with a diagnosis of COPD according to GOLD guidelines
- Patient admitted for an acute exacerbation of COPD requiring acute NIV or invasive ventilation or high-flow therapy (pH <7.35 with PaCO2 >45mmHg/6kPa)
- Patient that has been weaned from acute NIV or invasive ventilation or high flow therapy
- Patient with an overnight polygraphy or polysomnography performed 2 to 30 days following weaning from acute NIV or invasive ventilation showing an obstructive apneahypopnea index >=15/h. For patients already diagnosed with OSA, results from their prior sleep study will be retrieved. If not accessible, overnight polygraphy or polysomnography will be repeated.
- Affiliated to the National Health Patients affiliated or, beneficiary of social security, excluding AME (Aide Médicale d'État)
- Patient who has read and understood the information letter and signed the consent form
Who cannot join
- Patient with NIV treatment
- Patients who decline any use of NIV or CPAP in the home setting
- Significant psychiatric disorder or dementia that would prevent adherence to study protocol
- Tobacco use <10 pack-year
- Expected survival <12 months due to any condition other than COPD.
- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- Pregnant or breastfeeding women
- Patient already involved in an interventional research protocol that would impact the outcome measured in the current protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospital Pitié-Salpêtrière - Sleep unit, R3S Departement
Paris, 75013
Maxime PATOUT, MD PhD, +331 42 16 77 08, maxime.patout@aphp.fr
About this study
Chronic obstructive pulmonary disease (COPD) is a major public health problem with 212.3 million prevalent cases of COPD worldwide and 3.3 million deaths related to COPD in 2019. Obstructive sleep apnoea (OSA) is the most common sleep disordered breathing. It is estimated that almost 1 billion adults have OSA worldwide.
Given the increasing prevalence of obesity, co-morbid OSA is frequently seen in patients with COPD. Co-morbid OSA has been shown to increase mortality, to reduce quality of life and to favour acute exacerbation of COPD. For those admitted for a life-threatening exacerbation of COPD requiring an intensive care admission for acute hypercapnic failure, they are more likely to get readmitted. For those admitted for an acute exacerbation in any ward, they are more likely to be re-admitted for another exacerbation within 180-days if their OSA is not treated.
Unfortunately, data regarding the best management of OSA in patients with co-morbid COPD are lacking as they were often excluded from clinical trials involving patients with COPD. Therefore, CPAP or NIV are administered without scientific evidence establishing which treatment is the most appropriate.
Read the detailed description
Patients admitted for a severe exacerbation of COPD that required NIV or invasive ventilation or high flow therapy will be screened for the trial once they reach clinical stability that allow weaning of NIV, invasive ventilation, or high flow therapy.
The screening visit will take place during a standard consultation between 2 days following admission for acute hypercapnic respiratory failure and no later than 30 days following the discharge from the acute ward.
The inclusion visit will be performed no later than 30-days following discharge from the acute ward.
Follow-up visits will be performed at 3, 6 months after inclusion with a +/-14 days window.
Visits will be conducted in the hospital unless patient is unable to attend due to medical condition or healthcare crisis (infectious pandemic for example). In that case, a remote consultation will be performed to retrieve data available without physical attendance.
- Being tested
- Non-invasive Ventilation (NIV), Continous Positive Airway Pressure (CPAP)
- Keywords
- Chronic Obstructive Pulmonary Disease, Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Non-invasive Ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Ventilation (NIV)Device
Patients will receive a dedicated training for the use of their NIV in the home setting. The training is the same provided in the usual care of patients established on NIV. They will choose a home care provider for the delivery of NIV as per standard care in France. A telemonitoring of adherence to NIV will be performed.
Continous Positive Airway Pressure (CPAP)Device
Patients will receive a dedicated training the use of their CPAP in the home setting. The training is the same provided in the usual care of patients established on CPAP. They will choose a home care provider for the delivery of CPAP as per standard care in France. Follow-up of CPAP will be performed according to standard care in France and will therefore include a telemonitoring of adherence to CPAP.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Ventilation (NIV) | Experimental | Patients randomised to the intervention arm will be established on NIV before discharge to home. Receives: Device: Non-invasive Ventilation (NIV) |
| Continuous Positive Airway Pressure (CPAP) | Active comparator | Patients randomised to the control arm will be established on CPAP before discharge to home. Receives: Device: Continous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death.
Reduction of severe exacerbation of COPD or death, defined by the time to occurrence of (i) death from any cause or (ii) hospitalization in relation to severe exacerbation of COPD during a follow up of 12 months after randomization.
Measured: 0-12 months from inclusion
Secondary outcomes (18)
Evaluate the benefit of NIV over CPAP regarding control of sleep disordered breathing
Control of sleep disordered breathing, defined as evolution between baseline and 1 year follow-up of the following combined criteria :
- Apnea-hypopnea index (whilst unsupported breathing at baseline and when using the treatment overnight)
- 3% Oxygen desaturation index (whilst unsupported breathing at baseline and when using the treatment overnight)
- Proportion of time spent with SpO2 <90% (whilst unsupported breathing at baseline and when using the treatment overnight)
- Change in 3% Oxygen desaturation index between baseline at 3- and 6-months follow-up when using the treatment overnight
- Proportion of time spent with SpO2 <90% at 3 months and 6 months when using the treatment overnight.
Measured: 0-12 months from inclusion
Quality of life of NIV over CPAP
HRQOL compared at 3 months follow-up using HRQOL questionnaires.
Measured: At month 3
Quality of life of NIV over CPAP
HRQOL compared at 12 months follow-up using HRQOL questionnaires.
Measured: At month 12
Quality of sleep of NIV over CPAP (Pittsburgh Sleep Quality Index).
Change in quality of sleep will be assessed using quality of sleep evaluation scales (Pittsburgh Sleep Quality Index).
Measured: From Day 1 to Day 90
Quality of sleep of NIV over CPAP
Change in quality of sleep will be assessed using quality of sleep evaluation scales (Epworth Sleepiness Scale).
Measured: From Day 1 to Day 90
Quality of sleep of NIV over CPAP (Insomnia Severity Index).
Change in quality of sleep will be assessed using quality of sleep evaluation scales (Insomnia Severity Index).
Measured: From Day 1 to Day 90
Quality of sleep of NIV over CPAP
Change in quality of sleep will be assessed using the difference from baseline and one-year follow-up using quality of sleep evaluation scales (Pittsburgh Sleep Quality Index).
Measured: From Day 1 to Day 365
Quality of sleep of NIV over CPAP
Change in quality of sleep will be assessed using the difference from baseline and one-year follow-up using quality of sleep evaluation scales (Epworth Sleepiness Scale).
Measured: From Day 1 to Day 365
Quality of sleep of NIV over CPAP (Insomnia Severity Index).
Change in quality of sleep will be assessed using the difference from baseline and one-year follow-up using quality of sleep evaluation scales (Insomnia Severity Index).
Measured: From Day 1 to Day 365
Quality of sleep of NIV over CPAP in centres that will perform overnight polysomnography
Quality of sleep,defined by variations between day 1 and 1 year in objective measures of sleep quality in centres that will perform overnight polysomnography : proportions of light, deep and REM sleep, wake since sleep onset, awakenings, arousals, sleep efficacy, sleep efficiency.
Measured: From Day 1 to Day 365
Respiratory function benefit of NIV over CPAP
Respiratory function defined as change in gas exchange from baseline (Pa02, PaCO2) and 1 year: Arterial blood gas (ABG) will be measured during daytime and will be performed after 30 min on room air).
Measured: From Day 1 to Day 365
Respiratory function benefit of NIV over CPAP
Respiratory function defined as change in Forced Expiratory Volume 1, at 1 year.
Measured: At month 12
Exercise capacity benefit of NIV over CPAP
Exercise capacity defined as change in distance walked during a 6MWT. 6MWT will be performed at discharge and at each follow-up visit. 6MWT will be performed according to ERS guidelines.
Measured: At month 3
Exercise capacity benefit of NIV over CPAP
Exercise capacity defined as change in distance walked during a 6MWT at 1 year. 6MWT will be performed at discharge and at each follow-up visit. 6MWT will be performed according to ERS guidelines.
Measured: At month 12
Benefit of compliance and tolerance of NIV over CPAP
Compliance of the treatment, defined as Daily use / % of day used >4hours / side effect questionnaire, assessed at each visit.
Measured: From Day 1 to Day 90
Benefit of compliance and tolerance of NIV over CPAP
Compliance of the treatment, defined as Daily use / % of day used >4hours / side effect questionnaire, assessed at each visit.
Measured: From Day 1 to Day 180
Benefit of compliance and tolerance of NIV over CPAP
Compliance of the treatment, defined as Daily use / % of day used >4hours / side effect questionnaire, assessed at each visit.
Measured: From Day 1 to Day 365
Benefit of NIV over CPAP regarding usefulness of CPAP/NIV data to predict COPD severe acute exacerbation.
Change in breathing frequency or other extractable parameters that may predict the onset of a severe exacerbation.
Measured: At month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start3 Jun 2026
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease ExacerbationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047092
- Sponsor's protocol ID
- NOCOCA
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT07047092
- Acronym / sponsor ID
- NOCOCA
- Keywords
- Chronic Obstructive Pulmonary Disease, Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Non-invasive Ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 2 Jul 2025 (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) is a major public health problem with 212.3 million prevalent cases of COPD worldwide and 3.3 million deaths related to COPD in 2019. Obstructive sleep apnoea (OSA) is the most common sleep disordered breathing. It is estimated that almost 1 billion adults have OSA worldwide.
Given the increasing prevalence of obesity, co-morbid OSA is frequently seen in patients with COPD. Co-morbid OSA has been shown to increase mortality, to reduce quality of life and to favour acute exacerbation of COPD. For those admitted for a life-threatening exacerbation of COPD requiring an intensive care admission for acute hypercapnic failure, they are more likely to get readmitted. For those admitted for an acute exacerbation in any ward, they are more likely to be re-admitted for another exacerbation within 180-days if their OSA is not treated.
Unfortunately, data regarding the best management of OSA in patients with co-morbid COPD are lacking as they were often excluded from clinical trials involving patients with COPD. Therefore, CPAP or NIV are administered without scientific evidence establishing which treatment is the most appropriate.
Detailed description
Patients admitted for a severe exacerbation of COPD that required NIV or invasive ventilation or high flow therapy will be screened for the trial once they reach clinical stability that allow weaning of NIV, invasive ventilation, or high flow therapy.
The screening visit will take place during a standard consultation between 2 days following admission for acute hypercapnic respiratory failure and no later than 30 days following the discharge from the acute ward.
The inclusion visit will be performed no later than 30-days following discharge from the acute ward.
Follow-up visits will be performed at 3, 6 months after inclusion with a +/-14 days window.
Visits will be conducted in the hospital unless patient is unable to attend due to medical condition or healthcare crisis (infectious pandemic for example). In that case, a remote consultation will be performed to retrieve data available without physical attendance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Ventilation (NIV) | Experimental | Device: Non-invasive Ventilation (NIV)Patients randomised to the intervention arm will be established on NIV before discharge to home. |
| Continuous Positive Airway Pressure (CPAP) | Active comparator | Device: Continous Positive Airway Pressure (CPAP)Patients randomised to the control arm will be established on CPAP before discharge to home. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and < 85 years
- Patient with a diagnosis of COPD according to GOLD guidelines
- Patient admitted for an acute exacerbation of COPD requiring acute NIV or invasive ventilation or high-flow therapy (pH <7.35 with PaCO2 >45mmHg/6kPa)
- Patient that has been weaned from acute NIV or invasive ventilation or high flow therapy
- Patient with an overnight polygraphy or polysomnography performed 2 to 30 days following weaning from acute NIV or invasive ventilation showing an obstructive apneahypopnea index >=15/h. For patients already diagnosed with OSA, results from their prior sleep study will be retrieved. If not accessible, overnight polygraphy or polysomnography will be repeated.
Key exclusion criteria (8 listed)
- Patient with NIV treatment
- Patients who decline any use of NIV or CPAP in the home setting
- Significant psychiatric disorder or dementia that would prevent adherence to study protocol
- Tobacco use <10 pack-year
- Expected survival <12 months due to any condition other than COPD.
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 |
|---|---|---|
| Non-invasive Ventilation (NIV)Patients will receive a dedicated training for the use of their NIV in the home setting. The training is the same provided in the usual care of patients established on NIV. They will choose a home care provider for the delivery of NIV as per standard care in France. A telemonitoring of adherence to NIV will be performed. | Device | Non-invasive Ventilation (NIV) |
| Continous Positive Airway Pressure (CPAP)Patients will receive a dedicated training the use of their CPAP in the home setting. The training is the same provided in the usual care of patients established on CPAP. They will choose a home care provider for the delivery of CPAP as per standard care in France. Follow-up of CPAP will be performed according to standard care in France and will therefore include a telemonitoring of adherence to CPAP. | Device | Continuous Positive Airway Pressure (CPAP) |
Primary outcome
Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death.
Time frame: 0-12 months from inclusion
Reduction of severe exacerbation of COPD or death, defined by the time to occurrence of (i) death from any cause or (ii) hospitalization in relation to severe exacerbation of COPD during a follow up of 12 months after randomization.
18 secondary outcomes
Evaluate the benefit of NIV over CPAP regarding control of sleep disordered breathing
Time frame: 0-12 months from inclusion
Quality of life of NIV over CPAP
Time frame: At month 3
Quality of life of NIV over CPAP
Time frame: At month 12
Quality of sleep of NIV over CPAP (Pittsburgh Sleep Quality Index).
Time frame: From Day 1 to Day 90
Quality of sleep of NIV over CPAP
Time frame: From Day 1 to Day 90
Quality of sleep of NIV over CPAP (Insomnia Severity Index).
Time frame: From Day 1 to Day 90
Quality of sleep of NIV over CPAP
Time frame: From Day 1 to Day 365
Quality of sleep of NIV over CPAP
Time frame: From Day 1 to Day 365
Quality of sleep of NIV over CPAP (Insomnia Severity Index).
Time frame: From Day 1 to Day 365
Quality of sleep of NIV over CPAP in centres that will perform overnight polysomnography
Time frame: From Day 1 to Day 365
Respiratory function benefit of NIV over CPAP
Time frame: From Day 1 to Day 365
Respiratory function benefit of NIV over CPAP
Time frame: At month 12
Exercise capacity benefit of NIV over CPAP
Time frame: At month 3
Exercise capacity benefit of NIV over CPAP
Time frame: At month 12
Benefit of compliance and tolerance of NIV over CPAP
Time frame: From Day 1 to Day 90
Benefit of compliance and tolerance of NIV over CPAP
Time frame: From Day 1 to Day 180
Benefit of compliance and tolerance of NIV over CPAP
Time frame: From Day 1 to Day 365
Benefit of NIV over CPAP regarding usefulness of CPAP/NIV data to predict COPD severe acute exacerbation.
Time frame: At month 12
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 9 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Non-invasive Ventilation (NIV) and Continous Positive Airway Pressure (CPAP) in people with Chronic Obstructive Pulmonary Disease Exacerbation and Obstructive Sleep Apnea Exacerbation, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 7 inclusion and 8 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 9 Jun 2026. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Maxime PATOUT, MD, PhD (01 42 16 77 09, maxime.patout@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death. (time frame: 0-12 months from inclusion). 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 9 Jun 2026.