RecruitingNAINTERVENTIONAL

Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal

If you have sleep apnea and use a CPAP machine, this study might be for you. We know CPAP works well, but sometimes it's hard to use all the time, like when you're traveling or have a cold. When people stop CPAP even for a short time, their sleep apnea symptoms and heart health problems can quickly come back. This study wants to find out if using a special mouthguard, called a mandibular advancement device (MAD), can help fill the gap when you need to take a break from your CPAP. The mouthguard gently moves your jaw forward to keep your airway open. Researchers will compare people using the MAD during a short break from CPAP to those who don't use anything, to see if the MAD can keep symptoms and health issues at bay.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Angers

Enrolment target

Start

05 Mar 2024

Estimated completion

01 Nov 2026

Sleep Apnea, Obstructive Endothelial Dysfunction

What is this study about?

If you have a condition called obstructive sleep apnea, you'll know it can cause problems like feeling tired during the day and can even affect your heart. The main treatment for sleep apnea is usually a CPAP machine, which helps keep your airway open while you sleep. While CPAP is very effective, some people find it difficult to use all the time. For example, if you have a stuffy nose, or are away from home, you might need to take a break from your machine.

However, doctors have found that even short breaks from CPAP can cause sleep apnea symptoms and related health problems, like changes in blood pressure, to return quickly. This study is exploring a way to help people manage these breaks. They are looking at a device called a mandibular advancement device (MAD), which is a custom-fitted mouthguard. It works by gently holding your lower jaw and tongue forward while you sleep, which helps keep your airway open.

The main aim of this study is to see if using this mouthguard during a short two-week break from your CPAP machine can help stop your sleep apnea symptoms and other health issues from coming back. The researchers want to compare people who use the mouthguard during this break with those who don't, to understand how well the mouthguard works as a backup plan. This could be a really helpful way for people with sleep apnea to maintain their health even when they can't use their CPAP.

Key takeaways

This study explores using a mouthguard (MAD) as a temporary backup for CPAP.
It aims to see if the MAD can prevent sleep apnea symptoms and health issues during short CPAP breaks.
Participation involves a two-week break from your CPAP machine.
You'll have health check-ups before and after this two-week period.
The study could help improve how people manage sleep apnea in real-life situations.

Who may be eligible?

This study is looking for people aged 18 to 75 who have severe obstructive sleep apnea. To join, you must have been using a CPAP machine for at least 12 months, for an average of more than 5 hours a night. You also need to have felt very sleepy during the day when you first started treatment.

There are certain reasons why you might not be able to join. For instance, if you have very severe sleepiness at the start of the study, or if your sleep apnea involves certain types of breathing problems called 'central apneas'. Also, if you have other serious heart or breathing conditions, or if you are very overweight (with a BMI of 35 or higher), you might not be suitable.

Finally, if you have any medical reasons that would prevent you from using the special mouthguard (MAD), you won't be able to take part. The study team will check all these details carefully to make sure the study is safe and appropriate for everyone involved.

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 75 years old?
Have you been diagnosed with severe sleep apnea?
Have you used a CPAP machine for at least 12 months, for more than 5 hours each night?
Did you feel very sleepy during the day before you started CPAP treatment?
Do you have any serious heart or lung conditions?
Are you happy to try a special mouthguard if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a thorough check-up at the hospital during a day visit. This will involve various tests, including checking your blood pressure, taking blood and urine samples, having an ECG (heart trace), and filling out some questionnaires. You'll then be randomly placed into one of two groups: either the 'MAD group' or the 'control group'. If you're in the MAD group, you'll have an appointment with a specialist to custom-make and fit your mouthguard.

After all these initial steps, you'll be asked to stop using your CPAP machine for two weeks. During these two weeks, if you're in the MAD group, you'll use your custom mouthguard every night. If you're in the control group, you won't use any specific treatment for your sleep apnea during this time.

At the end of the two weeks without CPAP, you'll have a second set of assessments, just like the first ones. This will involve an overnight stay in the hospital's sleep lab, where they will monitor your sleep (this is called a PSG). If you're in the MAD group, this sleep study will be done while you are using your mouthguard. Once this final assessment is complete, the study finishes, and you'll go back to using your CPAP machine as usual.

Potential risks and benefits

Taking part in a study like this could help researchers understand better ways to manage sleep apnea, potentially benefiting many people in the future. For you, it might offer a chance to try a different approach to your sleep apnea care. However, there are potential risks, such as experiencing the return of sleep apnea symptoms and related health issues during the two weeks you are not using CPAP, especially if you are in the control group. There might also be some discomfort from the mouthguard if you are in the MAD group. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Angers University Hospital
Verified postcode
Angers, France· Recruiting

Common questions

What is a CPAP machine?

A CPAP machine helps people with sleep apnea by blowing air gently through a mask to keep their airway open while they sleep.

What is a mandibular advancement device (MAD)?

A MAD is a custom-made mouthguard that gently pushes your lower jaw and tongue forward to open up your airway and help you breathe better during sleep.

Why is this study important?

This study aims to find out if the MAD mouthguard can help prevent sleep apnea symptoms and health problems from returning when people need a short break from their CPAP machine.

Will I have to stop using my CPAP machine completely?

You will only stop your CPAP for a short period of two weeks during the study. Afterwards, you will go back to using it as normal.

Will I know if I'm getting the mouthguard or not?

You'll be randomly assigned to either the group that gets the mouthguard or the group that doesn't. This is done by chance, like flipping a coin, so it's fair for everyone.

How to find out more

wojciech trzepizur, MD PHD

wotrezpizur@chu-angers.fr +3380575272 Official trial record

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