Continuous Positive Pressure Versus Bi-level in Overlap Syndrome (NCT03766542) | Clinical Trial Compass
UnknownNot Applicable
Continuous Positive Pressure Versus Bi-level in Overlap Syndrome
70 participantsStarted 2019-01-01
Plain-language summary
Continuous positive airway pressure (CPAP) became the established treatment for overlap syndrome (OS). It has been showed that the survival benefits of CPAP favored hypercapnic patients. When considering hypercapnic stable COPD patients, survival benefits occurred when the use of bi- level ventilation therapy was targeted to significantly reduce hypercapnia.
This highlights the relevance of hypercapnia and hypoventilation correction. Thus, the purpose of this study is to compare the use of CPAP to Bi-level ventilation in hypercapnic OS patients, since the later may correct not only the airway patency but also increase the magnitude of each breath.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* COPD (FEV1/FVC \< 70 (post-BD) and history of smoking - 10 PPY)
* FEV1\< 80% and COPD symptoms
* AHI ≥ 15 events/hour
Exclusion Criteria:
* Persistent hypercapnic respiratory failure with acidosis (defined as pH \<7.30 after bronchodilators)
* Hypoxia requiring long term oxygen therapy
* BMI \> 35 kg/m2
* Previously-initiated long term non-invasive positive pressure ventilation
* Other lung disease resulting in respiratory symptoms
* Age \<40 years
* Pregnancy
* Malignant comorbidities
* Patients undergoing renal replacement therapy
* Restrictive lung disease causing hypercapnia
* Severe heart failure, unstable angina and severe arrhythmias
* Inability to comply with the protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.