What is this study about?
Obstructive Sleep Apnoea (OSA), a condition where airway collapse during sleep results in pauses in breathing, affects 24.5% of the UK population and results in daytime sleepiness, reduced quality of life and increased mortality rates. Over half of these patients will also have gastro-oesophageal reflux disease (GORD) where gastric contents escape back into the oesophagus causing pain, irritation and health complications. These conditions appear to be inter-related and Continual Positive Airway Pressure (CPAP) therapy, the gold standard treatment for OSA to prevent airway collapse, has been shown to reduce GORD. Mandibular Advancement Devices (MADs), a second line but increasingly used therapy for OSA where a gentle jaw thrust is maintained throughout the night, also limit airway collapse. However, whether MADs decrease GORD has not been tested. If they do, this may influence treatment decisions for the 45% of OSA patients who have GORD.
There is a growing body of evidence that Continuous Positive Airway Pressure (CPAP) therapy, the gold standard therapy for obstructive sleep apnoea, can reduce levels of gastro-oesophageal disease (11,14–16) by maintaining a patent airway, thus reducing intrathoracic pressure differentials. CPAP therapy increased the baseline lower oesophageal sphincter barrier pressure during sphincter relaxation and decreased the duration of sphincter relaxation (17). Mandibular advancement devices, also maintain a patent airway which may also have a similar impact on intrathoracic pressure differentials and duration of lower oesophageal sphincter relaxation. In addition, the greater compliance observed with mandibular advancement devices may mean that reflux is suppressed for a greater proportion of the night. However, both of these theories remain untested to date.
The overall aim of this project is to conduct a feasibility study to assess patient screening and recruitment rates, willingness to participate, acceptability of the multiple assessments needed to test for improvement in both conditions, and collection of information to inform sample size calculations for a definitive trial.
Contact
Dr. Saoirse O’Toole saoirse.otoole@kcl.ac.uk
Sponsor
Guy’s and St Thomas’s NHS Foundation Trust & King’s College London
Funder
National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) programme