RecruitingNAINTERVENTIONAL

Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Oropharyngeal Cancer.

This study is investigating a special mouthpiece, called a Mandibular Advancement Device (MAD), for people who have been treated for throat cancer and are now experiencing snoring or sleep apnoea (brief stops in breathing during sleep). Many people treated for throat cancer, especially with radiotherapy, find they snore or have disturbed sleep due to breathing issues. This can lead to tiredness and affect their quality of life. The research aims to see how comfortable this device is for these patients and how much it helps reduce their snoring and improve their breathing during sleep. The study is a mixed design study, meaning it will gather different types of information to understand the device's effects.

At a glance

Status

Recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

Start

03 Feb 2023

Estimated completion

30 Dec 2025

Oral Cancer Pharynx Cancer Sleep Apnea Snoring Oral Squamous Cell Carcinoma

What is this study about?

When you have treatment for throat cancer, sometimes the tissues in your mouth and throat can change. These changes, especially after radiotherapy, might make you more likely to snore or experience something called sleep apnoea. Sleep apnoea is when your breathing briefly stops and starts again many times while you're asleep. Both snoring and sleep apnoea can lead to poor sleep, making you feel very tired during the day and can sometimes be noisy for others.

Doctors at the CHUM hospital have noticed that a lot of their patients who have had treatment for throat cancer, particularly those where the cancer was linked to the human papillomavirus (HPV), are struggling with these sleep problems. Throat cancer linked to HPV has become more common, especially in men. Snoring affects many people, and sleep apnoea can affect up to 4% of the general population, and even more in older people. If sleep apnoea isn't treated, it can sometimes be serious.

This study is looking into whether a special device, called a Mandibular Advancement Device (MAD), can help. This device is a bit like a mouthguard you wear at night. It gently moves your jaw forward, which can help keep your airway open and reduce snoring and sleep apnoea. The researchers want to understand how comfortable patients find this device and how well it helps with their sleep problems after throat cancer treatment. This could potentially help many people improve their sleep and overall well-being.

Key takeaways

This study evaluates a special mouthguard (MAD) for snoring/sleep apnoea.
It's for people treated for throat cancer, especially after radiotherapy.
The goal is to improve sleep quality and reduce tiredness.
Participation involves wearing a device and attending assessments.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with throat cancer. You must have received radiotherapy treatment in the hospital's radiation oncology department for your cancer. Crucially, you should also be experiencing snoring or brief pauses in your breathing while you sleep.

There are certain reasons why you wouldn't be able to join the study. For example, if you are pregnant or breastfeeding, you won't be able to take part. Also if you don't have enough teeth to hold the mouthguard in place, you wouldn't be suitable. If you are taking certain medications like strong painkillers (opioids) or anxiety medicines, or if you have severe depression, uncontrolled high blood pressure, or have had a stroke in the past, you cannot join. People who are already using a CPAP machine for sleep apnoea, or who have ongoing, intense pain in their mouth or face, or are taking medication for insomnia, also won't be eligible. Lastly, if you use a lot of alcohol or drugs, you would also not be able to participate.

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 18 years old or older?
Have you been diagnosed with throat cancer and had radiotherapy?
Do you snore or stop breathing briefly during sleep?
Are you not pregnant or breastfeeding?
Do you have enough teeth to hold a special mouthguard?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will check how well a special mouthguard, called a Mandibular Advancement Device (MAD), works for you. You would visit the clinic for assessments where doctors will measure your snoring and breathing during sleep, likely using special equipment. They will also check how you are feeling and if the device is comfortable. You would wear the MAD device during your sleep. The study will monitor your progress over a period to see if your sleep improves. The exact number of visits and the full duration of your involvement would be explained in more detail by the study team.

Potential risks and benefits

Participating in this study might offer you the benefit of less snoring and improved breathing during sleep, which could lead to better rest and less tiredness. This special mouthguard could also help keep your airway open more effectively. Potential risks could include some discomfort from wearing the device, or changes in your bite, though these are usually temporary. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHUM
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is a Mandibular Advancement Device (MAD)?

It's a custom-fitted mouthguard that gently moves your lower jaw forward to help keep your airway open during sleep, reducing snoring and improving breathing.

Why is this study important for people with throat cancer?

After throat cancer treatment, some people struggle with snoring and sleep apnoea. This study aims to find a comfortable and effective way to help them sleep better.

Will I have to pay to use the device?

Clinical trials usually cover the cost of the study device or treatment, but you should confirm this with the study team.

How long will I need to be in the study?

The exact length of the study will be explained by the research team, but it will involve several visits to assess your progress.

What happens if the device doesn't work for me?

The study team will monitor your progress closely. If the device isn't helping or is uncomfortable, they will discuss other options with you, and you can withdraw from the study.

How to find out more

Gilles Lavigne, DMD, PhD

gilles.lavigne@umontreal.ca 514-343-2310 Official trial record

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