Can MADs reduce nocturnal reflux
Research type
Research Study
Full title
Can Mandibular Advancement Device Treatment For Obstructive Sleep Apnoea Reduce Nocturnal Gastro-Oesophageal Reflux: A Feasibility Study
IRAS ID
304665
Contact name
Saoirse O'Toole
Contact email
Sponsor organisation
Guy's & St Thomas's Foundation Trust
ISRCTN Number
ISRCTN16013232
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
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. We will recruit 44 patients with both OSA and reflux who 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.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0157
Date of REC Opinion
25 Aug 2022
REC opinion
Further Information Favourable Opinion