Sleep Apnea Study Shows Need for Better Treatment Options than CPAP

George Clinical recently lead the China component in the world’s first large CPAP device trial. The trial is called the SAVE study (Sleep Apnea CardioVascular Endpoints Study). CPAP stands for continuous positive airway pressure and is the device most widely prescribed for those with sleep apnea. This study involved participants who have obstructive sleep apnea (OSA), which is a common condition and is associated with an increased risk of cardiovascular disease. There had been a great deal of uncertainty leading up to this trial as to the effectiveness of CPAP machines for the prevention of cardiovascular disease in patients with sleep apnea.
 
About the SAVE Trial
 
The SAVE trial was a multi-centre, open label, parallel, prospective, randomised, controlled trial of CPAP treatment plus standard care versus standard care alone, in 2717 high CVD risk subjects with moderate-severe OSA. The trial, funded by the National Health and Medical Research Council (NHMRC) of Australia, aimed to determine the effects of CPAP treatment over a two to seven year follow-up period on new cardiovascular events, including myocardial infarction, stroke and cardiovascular death.
 
SAVE Trial Findings in China
 
For the China-Australia collaborative of the SAVE Trial, George Clinical developed a program of research that aimed to establish the benefits of treatment of obstructive sleep apnea when it comes to cardiovascular impact on health. They determined that in China there is much less awareness about obstructive sleep apnea compared to other developed countries. In addition, another deterrent to CPAP treatment in China is that it is cost prohibitive. The combination of being unaware of the problem and the treatment being beyond the means of many sufferers who are even aware of the problem, the majority of obstructive sleep apnea cases in China go undetected and untreated.
 
George Clinical’s China Component
 
George Clinical’s parent company, the George Institute for Global Health tapped them to run the project management and site monitoring operations for the China component of the SAVE Trial. The trial was conducted at 48 recruiting sites in China where 1,714 patients participated. George Clinical’s sites were the highest recruiting for the global study. Of the 2717 patients recruited, George Clinical’s China sites recruited 63% of total patients; Australia and New Zealand, the next best performing country, recruited just 12.5% of participants. 70% of George Clinical’s China sites were in the top ten recruiting sites for the entire study.
 
Results of the SAVE Study
 
In a large group of adults with both cardiovascular disease and moderate-to-severe obstructive sleep apnea, the use of CPAP therapy had no significant effect on the prevention of recurrent serious cardiovascular events, despite significantly reduced sleepiness and other symptoms of obstructive sleep apnea and improved quality-of-life measures. This shows the need for new treatment options for obstructive sleep apnea as well as more testing of CPAP machines.

The quality of the data and study design were sufficient for an article published in the New England Journal of Medicine (NEJM).
 
About George Clinical

George Clinical is a leading independent Asia-Pacific based clinical research organisation (CRO) with global capabilities, differentiated by scientific leadership, innovation and extensive investigator networks. With staff operating in 13 countries, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device and diagnostic customers, for all trial phases, registration and post-marketing trials. George Clinical combines scientific and clinical leadership with expert trial delivery capability to create a distinctive world-class service. George Clinical’s parent company is The George Institute on Global Health.