Multi-level upper airway surgery in patients with moderate to severe obstructive sleep apnoea who have failed medical management.

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Obstructive sleep apnoea (OSA) is characterised by repeated upper airway obstructions during the night. OSA is associated with excessive daytime sleepiness, lower health status and studies suggest obstructed breathing and snoring in sleep are independent risk factors for high blood pressure, heart disease, stroke and mortality. Thus OSA is a serious and costly public health problem that is growing in prevalence because of population increases in both obesity and ageing. Continuous positive airway pressure (CPAP) therapy is the current treatment of choice for patients with OSA. CPAP is effective in decreasing sleepiness and improves quality of life in patients with OSA. Treatment of OSA with CPAP is cost-effective if worn, but CPAP is poorly tolerated by many patients who find the mask and pressure claustrophobic and uncomfortable. OSA can be effectively treated but poor treatment compliance is a major clinical problem and thus many patients are under treated or not treated at all. Upper airway surgery for OSA is widely used and reported in observational studies but there are few rigorous and randomized clinical trials to provide and validate these studies. The clinical effectiveness and cost effectiveness of this surgical intervention need to be validated. This study is a national, multi-centre, randomised, controlled trial with a recruitment target of 102 participants. Participants with OSA who have failed standard OSA treatments will be randomised into two groups: Group 1 will receive reconstructive surgery of the upper airway and Group 2 will receive the standard non-surgical care for OSA. Participants will undergo follow-up for 6 months. Study participants will be tested for OSA, daytime sleepiness levels, and quality of life improvements before the treatment and at 6 months follow-up. Magnetic resonance imaging of the upper airway will also be used on participants randomised to Group 1, before the surgery and at 6 months, with the aim of developing a prediction model for future patients who will benefit the most from surgery. The study will be carried out at five sites across Australia to examine the universal effect of this standardised surgical protocol. AIM: To establish for the first time whether or not upper airway surgery is clinically effective, safe and cost effective for patients with symptomatic OSA who have failed medical management HYPOTHESIS: Surgery will deliver a better treatment outcome than ongoing medical management of symptomatic OSA as measured by the improvement in Apnoea Hypopnea Index (AHI) and subjective and objective daytime sleepiness in patients who have failed CPAP treatment despite persistent, supervised attempts.