RecruitingOBSERVATIONAL

Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome

This study focuses on people who have heart disease or are at high risk of developing it and also have a common sleep disorder called obstructive sleep apnea (OSA). OSA causes breathing to stop and start during sleep. We know that OSA is very common in people with heart problems. The study aims to understand how well patients stick with and tolerate two different treatments for OSA: CPAP (a mask that provides air pressure) and a mouth device (mandibular advancement device, MAD). CPAP is the usual treatment, but it can be hard to use. The mouth device is an alternative that might be more comfortable. We want to see how these treatments fit into people's daily lives and if they help manage their sleep apnea effectively.

At a glance

Status

Recruiting

Sponsor

University Hospital, Montpellier

Enrolment target

Start

14 Feb 2025

Estimated completion

15 Feb 2026

Obstructive Sleep Apnea Coronary Disease Cardiovascular Diseases

What is this study about?

This study is for people who have been diagnosed with heart disease, particularly problems with their heart arteries, or who are at a very high risk of developing heart problems. It also focuses on people who have a common sleep problem called obstructive sleep apnea (OSA). If you have OSA, your breathing repeatedly stops and starts while you're asleep because your airway gets blocked.

OSA is very common, affecting between 4% and 25% of the general population. However, it's much more common in people with heart conditions, affecting between 40% and 80% of them. It's important to treat OSA, especially if you have heart problems, to help improve your overall health and well-being.

There are two main treatments for OSA. One is called Continuous Positive Airway Pressure (CPAP), where you wear a mask over your nose and/or mouth while you sleep, which gently blows air to keep your airway open. The other is a Mandibular Advancement Device (MAD), which is a custom-made mouthguard that shifts your lower jaw slightly forward to open up your airway. This study wants to find out how easy it is for patients with heart conditions to use and tolerate these treatments, especially since CPAP can sometimes be difficult for people to get used to.

Key takeaways

This study helps people with heart conditions and sleep apnea.
It compares how well patients use CPAP and a mouth device (MAD) for sleep apnea.
The goal is to find out which treatment is easier to stick with and more comfortable.
Understanding this can help improve care for many patients in the future.
Your current sleep apnea treatment will be observed, not changed by the study.

Who may be eligible?

You might be able to join this study if you have coronary artery disease (a type of heart disease) or are at a very high risk of heart problems. This could include people with high blood pressure that has started to affect their organs, or people with diabetes who are at high risk. Your heart condition should be stable, meaning you don't have very severe or unstable heart failure.

In addition, you need to have moderate to severe obstructive sleep apnea (OSA). If you're in the group using the mouth device (MAD), it means you either can't use CPAP or find it too difficult. If you're in the group using CPAP, you'll already be using this treatment.

Unfortunately, you cannot join the study if you have very severe or unstable heart failure, serious mental health conditions, or if you are pregnant or breastfeeding. You also can't take part if you are involved in another medical study or are unable to be followed up during the study period.

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.

Do you have heart artery disease or are you at very high risk of heart disease?
Have you been diagnosed with moderate to severe obstructive sleep apnea (OSA)?
If you use CPAP, are you currently using it for your OSA?
If you use a mouth device (MAD), was it prescribed because you couldn't use CPAP?
Is your heart condition stable (not very severe or unstable heart failure)?

Answer every question to see your result.

What does participation involve?

This study focuses on how people already using CPAP or the MAD device are getting along with their treatment. The study aims to look at how well you're sticking to your treatment, how comfortable it is for you, and how easy you find it to use. This information will be collected through regular check-ups and by gathering data on your treatment usage. The exact details of visits and duration will be explained by the study team, but the main goal is to understand your real-world experience with your sleep apnea treatment.

Potential risks and benefits

Taking part in this study may help us understand which treatments for sleep apnea are best tolerated and most effective for people with heart conditions. This knowledge could help other patients in the future. As the study focuses on existing treatments, the main risks are generally related to the therapies themselves, which your doctor will have already discussed with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU de MONTPELLIER
Verified postcode
Montpellier, France· Recruiting

Common questions

What is obstructive sleep apnea (OSA)?

OSA is when your breathing is interrupted many times during sleep because your airway gets blocked. This can make you feel very tired during the day.

What is CPAP?

CPAP stands for Continuous Positive Airway Pressure. It's a common treatment for OSA involving a mask you wear at night that delivers air pressure to keep your airway open.

What is a Mandibular Advancement Device (MAD)?

A MAD is a special mouthguard that you wear while sleeping. It gently moves your lower jaw forward to help keep your airway clear.

Why is this study important for people with heart disease?

OSA is very common in people with heart conditions. This study helps us learn which sleep apnea treatments are easiest to use and most effective for them, which can improve their overall health.

Will I receive new treatment in this study?

This study is looking at how well people use and tolerate treatments they are already receiving for OSA – either CPAP or a MAD device.

How to find out more

Cindy FRANCOIS

c-francois@chu-montpellier.fr 06 84 31 62 08 Official trial record

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