Exacerbation prevention in patients with both chronic obstructive pulmonary disease and obstructive sleep apnoea
People who have both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnoea often experience more frequent and severe lung flare-ups. This UK trial investigates whether using a nighttime positive airway pressure (PAP) machine helps prevent these chest flare-ups. Participants will be placed by chance into one of two groups for 12 months. One group receives their standard NHS COPD care, while the other group receives standard care plus a home PAP machine to wear while sleeping. The PAP machine gently blows air through a mask to keep the airways open overnight. Taking part involves three 45-minute clinic visits over one year and a short 10-minute phone call each month. The study aims to help doctors understand the best way to support people living with both conditions and improve their overall health.
At a glance
What is this study about?
Chronic obstructive pulmonary disease (COPD) causes long-term breathing problems, while obstructive sleep apnoea (OSA) causes your airway to narrow or close briefly while you sleep. When a person has both conditions together, it is known as overlap syndrome. People with both conditions often suffer from frequent chest flare-ups, which can mean sudden worsening of breathlessness, more coughs, and stressful hospital admissions.
Doctors currently treat sleep apnoea with a machine called positive airway pressure, or PAP. A PAP machine gently pumps room air through a soft mask worn over your nose or mouth at night. This air pressure stops your throat from closing while you rest. While PAP is commonly used for sleep apnoea on its own, doctors do not yet know for sure whether it helps prevent COPD chest flare-ups.
This study aims to answer that question. By comparing patients who use a PAP machine alongside their standard COPD treatment against those who receive standard COPD care alone, researchers hope to see if protecting the airway at night keeps the lungs healthier during the day.
Finding an answer could change the way the NHS cares for people with COPD and sleep apnoea. If the machine helps prevent flare-ups, it could mean fewer emergency hospital visits, better sleep, and a much better quality of life for thousands of patients.
Key takeaways
- The trial tests whether nighttime PAP breathing machines reduce chest flare-ups in people with both COPD and sleep apnoea.
- Participants are randomly chosen to receive either standard COPD care alone or standard care with a home PAP machine.
- The study lasts for 12 months and involves three 45-minute clinic visits and short monthly telephone calls.
- Everyone in the trial receives high-quality NHS breathing care and expert support throughout the year.
- Taking part is voluntary, and you can leave at any time without your regular care being affected.
Who may be eligible?
This study is open to adults who have been diagnosed with both moderate-to-severe COPD and moderate-to-severe obstructive sleep apnoea. To take part, you must also be prone to chest flare-ups, meaning you have had at least one severe flare-up needing hospital care, or at least two moderate flare-ups treated by your GP, in the last 12 months.
You cannot join the study if your sleep apnoea causes severe daytime sleepiness that makes everyday tasks like driving unsafe, because clinical guidelines state you should already be receiving treatment right away. You also cannot take part if you are a professional driver with severe daytime sleepiness, or if your doctor has already decided that you must use a nighttime breathing machine.
Finally, people who have very high carbon dioxide levels in their blood (a specific type of severe breathing failure) or who are already taking part in another clinical treatment trial are not able to join.
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.
- I have been diagnosed with moderate-to-severe COPD.
- I have been diagnosed with moderate-to-severe obstructive sleep apnoea.
- I have had at least one hospital-treated flare-up or two GP-treated flare-ups in the last 12 months.
- I do not suffer from severe daytime sleepiness that makes driving unsafe.
- I am not already using a home breathing machine like PAP or NIV.
- I am not currently taking part in another clinical treatment trial.
What does participation involve?
If you decide to take part, you will be in the study for 12 months. You will be placed into one of two groups by computer selection (randomisation). Both groups receive excellent standard NHS COPD care, which includes checking your inhalers, exercise advice, stopping-smoking support, and vaccinations. One group will also receive a home PAP machine with a tailored mask, full training, and guidance on how to use it comfortably during sleep.
Taking part involves three face-to-face visits at the clinic: one at the start, one after 3 months, and a final visit at 12 months. Each visit takes about 45 minutes and involves simple breathing checks, filling in health questionnaires, and discussing your symptoms. In between these visits, a researcher will call you once a month for a 10-minute check-in to see how you are feeling and review any health visits or machine use. If you are given a machine, the team will check in remotely within the first 30 days to make sure the mask fits well.
Potential risks and benefits
Locations (15)
- St Thomas' Hospital (Leading sponsor site)City onlyLondon, England
- Royal Free HospitalApproximateLondon, England
- Freeman HospitalApproximateNewcastle upon Tyne, England
- John Radcliffe HospitalApproximateOxford, England
- James Cook University HospitalCity onlyCleveland, England
- St Bartholomew’s HospitalUnverifiedLondon, England
- Birmingham Heartlands HospitalUnverifiedBirmingham, England
- Pinderfields General HospitalUnverifiedWakefield, England
- St James's HospitalUnverifiedLeeds, England
- Northern General HospitalUnverifiedSheffield, England
- Lister HospitalUnverifiedStevenage, England
- University Hospital AintreeUnverifiedLiverpool, England
Common questions
What is a PAP machine?
A PAP (positive airway pressure) machine is a small, quiet bedside device that gently pumps room air through a soft mask while you sleep, keeping your breathing passages open.
Will I definitely get a PAP machine if I join?
No. A computer randomly decides whether you get the PAP machine plus standard care, or standard COPD care on its own. This fair comparison is the only way to test if the machine truly helps.
Will my normal COPD medications change?
All participants will continue to receive full, best-practice NHS COPD treatment, including regular inhalers, lifestyle advice, and care plans.
What if I find the mask uncomfortable?
The research team will work closely with you to adjust the fit, try different mask styles, or add warm moisture to the air. If you still cannot tolerate it, you can stop using it.
Can I leave the study early?
Yes. You are free to stop participating at any time. Your decision will not change the standard of healthcare you receive from your doctor or hospital.
How to find out more
David Smith
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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