Combination therapy with mandibular advancement splint and continuous positive airway pressure (CPAP) for sub-optimally treated obstructive sleep apnoea

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Obstructive sleep apnoea (OSA) is common and an important contributor to cardiovascular disease, stroke, and depression. The first line treatment for OSA is continuous positive airway pressure (CPAP) which is highly effective in treating OSA. However, up to 50% of patients are unable or unwilling to tolerate CPAP. Nasal masks are most frequently used, however oronasal masks covering the nose and mouth, may be chosen due to patient preference, nasal obstruction or air leak through the mouth. There is growing evidence suggesting that oronasal masks are less effective in controlling OSA. Patients using oronasal masks are a clinically difficult group of patients to treat, often requiring higher CPAP pressures, with significant mask leaks, a higher residual AHI and lower adherence to treatment. Mandibular Advancement Devices (MAD) are emerging as an alternative treatment particularly in patients with mild to moderate OSA, CPAP intolerant OSA and primary snorers. The O2Vent T is a custom-made MAD with an enclosed airway that allows airflow through the device. Like all MADs, the lower jaw is brought forward to stabilize the upper airway, however unlike other devices, patients can also breathe through the device while the jaw position stabilized. This may be of benefit to those with nasal obstruction and a tendency to mouth breathe i.e. patients using oronasal masks. Our aim is to assess whether treatment effectiveness can be improved with combination CPAP and MAD, in a group of patients with OSA who are sub-optimally treated with CPAP using an oronasal mask. Treatment effectiveness is a clinical decision based on factors including compliance, residual Apnoea-Hypopnea Index (AHI), pressure requirements and leak. We hypothesize that compared to CPAP with oronasal mask, combination therapy will result in: a) Lower pressure requirements b) Lower AHI c) Lower leak d) Better compliance Participants will be monitored for CPAP efficacy and compliance using their oronasal mask for 4 weeks using an auto-titrating CPAP (APAP). They will be fitted with a customized MAD (O2Vent T) and then use this in combination with their APAP (combination therapy) for a further 4 week period. Further advancement of the MAD may need to occur if clinically indicated (ie for a period of 4 to 12 weeks maximum). Treatment effectiveness between the groups will be compared using downloaded data from the participants APAP machines. This will include AHI, pressure requirements, usage and leak, which will all be downloaded from the participants APAP machines at the end of the relevant treatment periods.

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