ApniCure's Winx sleep therapy system has reported improvements in apnea-hypopnea index (AHI), a common measurement of sleep apnea severity, oxygen desaturation index (ODI), and sleep architecture and symptomatic measures of obstructive sleep apnea (OSA), in the ATLAST trial.
The FDA-cleared Winx system features a small and quiet console, flexible mouthpiece, power supply cord, mouthpiece holder, compact carry case and slim tubing set.
The Winx system uses oral pressure therapy (OPT) technology, a light, oral vacuum delivered through a slim tube connected to a soft mouthpiece, to provide a comfortable sleeping experience for patients suffering from OSA.
The mouthpiece and vacuum work together to gently pull the soft palate forward and stabilise the tongue, while increasing the size of the airway and allowing for natural breathing to occur during sleep.
The multi-centre prospective ATLAST study examined the safety, effectiveness and tolerability of the Winx system in 60 patients aged 32 to 80 with mild, moderate or severe OSA, with or without prior continuous positive airway pressure (CPAP) use.
In the trial, participants underwent laboratory polysomnography at baseline with and without Winx treatment and again following 28 nights of treatment with Winx to determine ODI and AHI.
The study demonstrated that the sleep apnea device showed a considerable reduction in AHI and ODI, improvement in sleep architecture and quality of life measures and was found to be safe and durable.
University of South Carolina School of Medicine, US, associate clinical professor and SleepMed chairman and chief medical officer, Richard Bogan, said that in the ATLAST trial, the Winx system improved the severity and symptoms of OSA, was shown to be safe and was associated with high nightly usage and patient satisfaction.
"Winx, which allows users to breathe naturally without a mask, represents a new, non-invasive alternative for some patients with OSA, a serious disease that is associated with long-term medical and social consequences," Bogan added.
The company plans to commercially launch the sleep therapy system in select US markets in 2012, with broader distribution in 2013.