RecruitingNAINTERVENTIONAL

Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.

This study is for adults with a breathing condition called Obstructive Sleep Apnoea, which causes repeated pauses in breathing during sleep. Many people use a special mouthguard, called a Mandibular Advancement Appliance (MAA), to help with this. While these mouthguards are effective, they only work if you wear them. Researchers want to find out if giving people extra support helps them use their mouthguard more regularly compared to those who receive standard care. They also want to understand why some people find it easier to use their mouthguard than others. This information could help more people benefit from their treatment in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

Start

06 Dec 2019

Estimated completion

01 Jun 2026

Obstructive Sleep Apnea

What is this study about?

If you have a condition called Obstructive Sleep Apnoea (OSA), you might experience periods where your breathing stops or gets very shallow while you're asleep. This happens because the soft tissues at the back of your throat relax too much and block your airway. A common treatment for OSA is a special mouthguard, often called an anti-snoring mouthguard or a Mandibular Advancement Appliance (MAA), which works by gently holding your jaw forward during sleep to keep your airway open. These devices can be very helpful, but they only work if you wear them as advised.

This study aims to discover if offering extra support and information helps people use their anti-snoring mouthguard more consistently. Researchers are comparing two groups: one group will receive standard information and care, while the other will get additional support, such as educational materials and video. By comparing these groups, the study hopes to understand if these extra efforts make a difference in how often people wear their mouthguards.

Beyond simply looking at how much the mouthguards are used, the study also wants to understand *why* some people use them regularly and others don't. Things like your mood, how you feel about your treatment, your social life, and even your personality might play a role. By understanding these factors, the researchers hope to develop better ways to help future patients get the most out of their treatment for Obstructive Sleep Apnoea.

Key takeaways

Targets adults (40+) with Obstructive Sleep Apnoea (OSA).
Compares extra support versus standard care for anti-snoring mouthguard use.
Aims to understand why some people use their mouthguard more than others.
Participation involves keeping a diary and wearing a mouthguard with a sensor.
Could help improve OSA treatment for many people in the future.
You can change your mind and leave the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult aged 40 or older with a confirmed diagnosis of Obstructive Sleep Apnoea (OSA). You must also have been referred by your doctor to receive an anti-snoring mouthguard (Mandibular Advancement Appliance) as part of your treatment. It's also important that you can understand, read, and write in English, though support with a translator might be available.

However, there are reasons why you might not be able to join. For example, if you don't have enough healthy teeth to properly fit the mouthguard, or if your teeth and gums aren't in good condition. If you currently have pain or problems with your jaw joints (called Temporomandibular Disorder, or TMD), you wouldn't be able to take part. Also, if you've used an anti-snoring mouthguard before or if you have epilepsy, this study wouldn't be suitable for you.

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?
Have you been diagnosed with Obstructive Sleep Apnoea (OSA)?
Has your doctor referred you for an anti-snoring mouthguard (MAA)?
Do you have good dental health, with enough teeth?
Have you *never* used an anti-snoring mouthguard before?
Do you *not* have epilepsy or current jaw pain/problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be given detailed information about the study to read and will have the chance to ask any questions. If you're happy to proceed, you'll sign a consent form. You'll then be randomly placed into one of two groups: either the 'Intervention Care' group, which receives extra support and information about your condition and mouthguard, or the 'Standard Care' group, which receives the usual care provided by your clinic.

Throughout the study, you'll be asked to keep a sleep diary where you'll note down how long you sleep and how often you use your mouthguard. Your mouthguard will also contain a tiny sensor that records how long you wear it, giving a more accurate picture. At the beginning, some basic information like your age, gender, weight, and neck size will be taken. You'll also complete some questionnaires about your mood, social support, and how well you're sleeping and living. If you're in the Intervention Care group, you might also have knowledge checks and watch a short video. The study will involve follow-up appointments at around 3 and 6 months to check on your progress and collect the sensor data. Towards the end, some participants will be invited for a one-to-one chat to share their experiences.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving extra support and information to help you use your anti-snoring mouthguard more effectively, which could improve your sleep and overall health. You would also be contributing valuable information that could help many other people with Obstructive Sleep Apnoea in the future. Potential risks are generally low, mainly involving the time commitment for appointments and questionnaires, and any minor discomfort from wearing the mouthguard, which would be managed by your clinical team. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal London Dental Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Obstructive Sleep Apnoea (OSA)?

OSA is a condition where your breathing repeatedly stops or becomes very shallow while you're asleep, due to your airway temporarily collapsing.

What is an anti-snoring mouthguard (MAA)?

It's a special dental device worn at night that gently holds your lower jaw forward to keep your airway open and improve breathing during sleep.

How long will the study last?

The main follow-up for collecting data will be over 6 months, but there might be some contact for the Intervention Care group up to around 5 months (21 weeks).

Will I know which group I'm in?

Yes, you will be told if you are in the group receiving extra support or the group receiving standard care.

Do I have to pay to join the study?

No, you will not have to pay to participate in the study. All study-related care and materials are provided free.

How to find out more

Ama Johal

a.s.johal@qmul.ac.uk 0207 377 7686 Official trial record

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