RecruitingNAINTERVENTIONAL

Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)

This study explores if using a breathing machine called Continuous Positive Airway Pressure (CPAP) can prevent serious flare-ups of chronic obstructive pulmonary disease (COPD) in people who also have obstructive sleep apnea (OSA). Both conditions are common, and when they occur together, it's called Overlap Syndrome (CO-OS). Previous observations suggest that untreated OSA in people with CO-OS might lead to worse health outcomes, including more COPD flare-ups and a higher risk of death. However, these findings haven't been proven in carefully controlled studies. This research aims to fill that gap by comparing patients with CO-OS who use CPAP with those who don't, to see if CPAP truly offers a protective benefit against COPD exacerbations.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Angers

Enrolment target

500

Start

09 Jan 2024

Estimated completion

01 Jan 2028

Sleep Apnea COPD Exacerbation Overlap Syndrome

What is this study about?

This study is trying to understand if using a special breathing machine called CPAP (Continuous Positive Airway Pressure) can help people who have both COPD (a long-term lung disease) and sleep apnea (a condition where breathing stops and starts during sleep). When someone has both, it's called Overlap Syndrome, and it's quite common.

Doctors have noticed that people with Overlap Syndrome who don't get treatment for their sleep apnea might have more serious health problems. This includes having more frequent and severe flare-ups of their COPD — those times when breathing suddenly gets much worse and they might need hospital care. Some studies have even hinted that not treating sleep apnea could raise the risk of dying sooner for these patients. However, these observations haven't been tested in careful studies where groups are compared directly, making it hard to be truly certain.

That's why this study is so important. It wants to find out, once and for all, if using CPAP for sleep apnea can actually reduce the number of serious COPD flare-ups and improve other health outcomes for people with Overlap Syndrome. By conducting a well-planned study, researchers hope to get clear answers that will help doctors decide on the best treatment for these patients.

Key takeaways

This study investigates if CPAP helps reduce COPD flare-ups in people with both COPD and sleep apnea.
It's a randomized study, meaning you might get CPAP or not, by chance.
Participation involves an overnight sleep study and regular check-ups for one year.
The goal is to get clear answers on treating 'Overlap Syndrome'.
Findings could improve care for many people with these conditions.

Who may be eligible?

To join this study, you need to be at least 40 years old. You must have COPD that causes breathing difficulties, and a doctor's diagnosis confirming your lung function is consistent with COPD. You should also have had at least one serious COPD flare-up in the past year.

Crucially, you'll need to have obstructive sleep apnea (OSA) that is considered moderate to severe, which will be confirmed by an overnight sleep study. You also need to be able to use a phone or tablet for the study and be willing to follow all study instructions.

There are also some reasons why you might not be able to join. These include having very severe daytime sleepiness, serious unstable heart problems, already using long-term oxygen or other breathing machines, having very high carbon dioxide levels in your blood, or having previously been diagnosed and treated for sleep apnea. Other reasons include being pregnant or breastfeeding, or if you have certain planned lung treatments.

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 40 years old or older?
Do you have COPD that causes breathlessness, and have you had a serious COPD flare-up in the last year?
Are you suspected of having sleep apnea, and would you be willing to have an overnight sleep study?
Do you have a phone or tablet you can use, and are you willing to attend all study appointments?
Are you NOT pregnant or breastfeeding, and do you NOT have severe heart problems or previously treated sleep apnea?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have a full overnight sleep study to confirm if you have moderate to severe sleep apnea. If you do, you'll then be randomly assigned to one of two groups: either you'll receive a CPAP machine to use for one year, or you won't receive sleep apnea treatment for that year. You won't get to choose which group you're in.

Throughout the year, you'll have visits at 3, 6, 9, and 12 months. During these visits, the study team will check on your health. They'll ask about any COPD flare-ups you've had, other health events, and your general well-being through questionnaires. At the 12-month visit, they will also repeat some lung function tests and blood tests. The study lasts for a total of 12 months.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving treatment for your sleep apnea which may improve your overall health, or contributing important information that could help others with Overlap Syndrome in the future. However, there's always a possibility that the treatment might not help you personally, or that you might experience side effects from using CPAP, though these are typically mild. If you are in the group that doesn't receive CPAP, you won't get any direct treatment benefit for your sleep apnea during the study period. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (15)

Angers University Hospital
Verified postcode
Angers, France· Recruiting
Bordeaux University Hospital
Verified postcode
Bordeaux, France· Recruiting
Brest University Hospital
Verified postcode
Brest, France· Recruiting
AP-HP -Henri Mondor Hsopital
Verified postcode
Créteil, France· Recruiting
Dijon University Hospital
Verified postcode
Dijon, France· Recruiting
Grenoble University Hospital
Verified postcode
Grenoble, France· Recruiting
Le Mans Hospital
Verified postcode
Le Mans, France· Recruiting
Nancy University Hospital
Verified postcode
Nancy, France· Recruiting
AP-HP - Pitié Salpetrière Hospital
Verified postcode
Paris, France· Recruiting
Bichat Hospital - AP-HP
Verified postcode
Paris, France· Recruiting
Poitiers University Hospital
Verified postcode
Poitiers, France· Recruiting
Reims University Hospital
Verified postcode
Reims, France· Recruiting

Common questions

What is Overlap Syndrome?

Overlap Syndrome is when someone has both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) at the same time.

What is CPAP?

CPAP stands for Continuous Positive Airway Pressure. It's a machine that helps people breathe more easily while they sleep, especially if they have sleep apnea.

Will I definitely get the CPAP treatment if I join?

No, you will be randomly assigned to either receive CPAP or not receive sleep apnea treatment for the study period. It's like flipping a coin.

How long will the study last if I join?

The study will last for one year from the time you are assigned to a group, with several follow-up visits during that period.

Can I stop participating in the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

How to find out more

Wojciech Trzepizur, MD PhD

wotrzepizur@chu-angers.fr +33680575272 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.