Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
This study investigates the best treatment for obstructive sleep apnoea (OSA) in individuals with Chronic Obstructive Pulmonary Disease (COPD) who have recently been hospitalised for a severe flare-up. Both COPD and OSA are common conditions, and having both can make flare-ups more likely and serious. Crucially, there's not enough clear evidence to guide doctors on the best breathing machine for OSA in this group. This study aims to find out if Non-invasive Ventilation (NIV) or Continuous Positive Airway Pressure (CPAP) is more effective. Participants will have their breathing monitored, use one of the machines at home, and have follow-up appointments to see how they are doing and if it helps prevent future hospital stays.
At a glance
What is this study about?
If you have Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnoea (OSA) together, you might find that you get more flare-ups of your COPD. Both conditions are quite common, and when they happen together, it can make managing your breathing much harder, sometimes needing hospital stays. We know that if OSA isn't treated, people with both conditions are more likely to end up back in hospital after a serious COPD flare-up.
Doctors currently use special breathing machines like Non-invasive Ventilation (NIV) or Continuous Positive Airway Pressure (CPAP) to help with OSA. However, there isn't much research specifically looking at which of these treatments works best for people who have both COPD and OSA, especially after a severe flare-up. Many previous studies have actually left people with both conditions out, meaning we don't have good information to guide decisions.
This study aims to fill that gap. We want to compare NIV and CPAP to see which one helps people with COPD and OSA stay healthier and less likely to need readmission to hospital after a serious breathing problem. By taking part, you could help us understand the best care for many other people like you in the future.
Key takeaways
- This study compares NIV and CPAP for sleep apnoea in people with both COPD and OSA.
- It focuses on patients who've recently had a serious COPD flare-up needing hospital care.
- The aim is to find which treatment best helps prevent future hospital stays.
- Participants will use a breathing machine at home and have follow-up visits.
- You can discuss with your doctor if this study might be right for you.
Who may be eligible?
This study is looking for adults aged between 18 and 84 years old who have been diagnosed with COPD according to common medical guidelines. You would also have recently been in hospital for a severe COPD flare-up that needed help with your breathing, such as NIV, invasive ventilation, or high-flow oxygen, and you are now stable enough to come off that support.
Crucially, we're looking for people who also have moderate to severe obstructive sleep apnoea (OSA). This needs to be confirmed by a recent sleep test or a sleep test done during the study. You also need to be able to understand the study information and be willing to sign a consent form to take part. Unfortunately, we can't include people who refuse to use NIV or CPAP at home, or if you have certain severe mental health conditions, short expected survival, or are pregnant or breastfeeding.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 84 years old?
- Do you have a diagnosis of COPD?
- Have you recently been in hospital for a severe COPD flare-up needing breathing support?
- Do you have obstructive sleep apnoea (OSA) or are willing to have a sleep test?
- Are you able to understand study information and willing to use a breathing machine at home?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you join this study, we'll first check if you're suitable after you've recovered from your acute hospital stay for COPD. This check will happen during a standard doctor's appointment, between 2 days after coming off breathing support and up to 30 days after leaving the hospital.
After you officially join, you'll be given either a Non-invasive Ventilation (NIV) machine or a Continuous Positive Airway Pressure (CPAP) machine to use at home. You'll then have follow-up visits after 3 months and again after 6 months. These visits will typically be at the hospital, but if you can't come in due to health reasons or a major event (like a pandemic), some information might be collected over the phone. The total duration of your active participation, including follow-up, will be around 6 months.
Potential risks and benefits
Locations (1)
- Hospital Pitié-Salpêtrière - Sleep unit, R3S DepartementVerified postcodeParis, France· Recruiting
Common questions
What's the main goal of this study?
The main goal is to find out if NIV or CPAP is better at treating sleep apnoea in people with COPD after a serious flare-up, hoping to improve health and reduce hospital visits.
What are NIV and CPAP?
They are both types of breathing machines that help keep your airways open while you sleep, making it easier to breathe.
How long will I be in the study?
You'll be in the study for about 6 months, including follow-up appointments.
Do I have to use a machine every night?
Yes, if you join, you'll be asked to use one of the assigned breathing machines regularly at home.
Can I leave the study at any time?
Yes, you are free to leave the study at any point without it affecting your usual medical care.
How to find out more
Maxime PATOUT, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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