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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Saoirse O’Toole
+44 20 7188 7188
saoirse.otoole@kcl.ac.uk


Dr Gabriella Wojewodka
-
gabriella.wojewodka@kcl.ac.uk


Study Location:

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Be Part of Research - Trial Details - Can the mandibular advancement devices used for sleep apnoea reduce night time reflux?
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Can the mandibular advancement devices used for sleep apnoea reduce night time reflux?

Recruiting

Open to: All Genders

Age: Adult

London

Medical Conditions

Obstructive sleep apnoea and nocturnal gastro-oesophageal reflux

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This project tries to help with two serious problems that patients often suffer from at the same time: Obstructive Sleep Apnoea (OSA) where parts of the airway collapse during sleep and gastro-oesophageal reflux disease (GORD) where stomach acids backtracks into the mouth causing pain, chronic cough, sore throat and tooth erosion. OSA affects 24.5% of the population and 45% of these suffer from GORD. It is thought that blocking the airway increases pressure in the stomach, forcing acid into the mouth until the patient breathes again. Our PPI group have informed us that if you can manage the sleep apnoea, you can also reduce the stomach acid reflux. CPAP, the gold standard treatment for OSA has been shown to reduce night-time reflux but this has never been tested for Mandibular Advancement Devices, a not-as-effective therapy that is better tolerated by patients. MADs. As nobody has investigated this before, we need to assess practical things, like if a patient can wear reflux checking devices and sleep devices at the same time. We will see if there will be any problems experienced in the patient journey of the trial and sort through any problems that may come up when multiple teams need to work together.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Feb 2023 31 Dec 2024

Publications

2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-076661 (added 25/08/2023)

Participants will receive CPAP therapy or a MAD. We will check their reflux levels and sleep breathing at nighttime while they are wearing ther devices and compare them with their reflux levels at start of the trial. When we are confident that the trial design is good and patients are happy participating in it, we will apply for funding for a bigger trial to check if the MAD can reduce reflux, improve patient’s quality of life and if this will represent a cost saving to the NHS.


Patients with both OSA and reflux.

You can take part if:



You may not be able to take part if:


1. Pregnancy or breast feeding2. Unable or unwilling to stop GORD medication 2 days prior to assessment or unable to undergo manometry and pH impedence testing3. Known liver disease or oesophageal/gastric varices4. Previous surgery or intervention for reflux such as fundoplication5. Any previous treatment for oesophageal neoplasia.6. Unable/unwilling to tolerate either a CPAP mask or a mandibular advancement device7. Medical history likely to impact on attendance or 24-hour impedance testing8. Participation in other research within previous 30 days


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Guy’s Hospital
    Oral Clinical Research Unit, FoDOCS
    London
    SE1 9RT

There is no direct, immediate benefit to you from taking part in this research study. However, you will receive your assessment and treatments over a shorter time period, be offered both types of treatment and have increased information about your sleep device and whether it also helps your reflux. You will also have helped the dental and medical profession gain a better understanding of how sleep treatments impact on gastric reflux.
We do not know how easy it will be for patients to manage the gastric reflux pH testing, the sleep study and wear their device to treat their sleep condition at the same time. It has been done before but the comfort of this for patients has not been reported on. We think it will be slightly harder for those in the CPAP group as the facemask and pH probe may put pressure on the skin at night-time. However, everything will be done to make it as comfortable as possible. There are no lasting side effects and everything we use is standard of care and safe.

Dr Saoirse O’Toole
+44 20 7188 7188
saoirse.otoole@kcl.ac.uk


Dr Gabriella Wojewodka
-
gabriella.wojewodka@kcl.ac.uk



The study is sponsored by Guy's and St Thomas' NHS Foundation Trust and funded by NIHR Central Commissioning Facility (CCF).



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Read full details for Trial ID: ISRCTN16013232

Or CPMS 53478

Last updated 03 April 2024

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