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New treatment option for Chronic Obstructive Pulmonary Disease Exacerbation
Official title Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
ClinicalTrials.gov ID: NCT07047092
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 84
You may be able to join if
- 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 \ 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...
You likely can't join if
- 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)
See the full eligibility criteria
- 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 \ 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...
- 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
- 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 treatment research protocol that would impact the outcome measured in the current protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.