Results from the ATLAST clinical trial of the Winx Sleep Therapy System showed significant improvements in both apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) on the first night of treatment and following 28 days of Winx usage. The study also demonstrated high levels of patient adherence with Winx, as well as significant improvements in sleep architecture and subjective sleepiness.
“OSA is a major health care concern that impacts as many as 20 million Americans, the vast majority of whom remain undiagnosed and many of whom refuse treatment due to unwillingness to use continuous positive airway pressure (CPAP), the current standard of care,” said Ian M. Colrain, PhD, director of the Human Sleep Research Program at SRI International and lead author of the publication. “This poses a major issue, as untreated OSA can lead to motor vehicle accidents, exacerbation of serious health conditions, like heart disease, and increased risk of stroke. The Winx data are exciting because they show patients that respond to Winx are effectively treated and have a high nightly use of the therapy.”
The multi-center, prospective ATLAST study examined the safety, effectiveness, and tolerability of the Winx system in 63 patients ages 32 to 80 with mild, moderate, or severe OSA, with or without prior CPAP use.
Study participants underwent a sleep test at baseline with and without Winx treatment and again following 28 nights of treatment with Winx to determine ODI and AHI, which was calculated using American Academy of Sleep Medicine criteria by a blinded scorer. OSA symptoms were assessed with the Epworth Sleepiness Scale (ESS) and a modified Functional Outcomes of Sleep Questionnaire. Nightly usage of Winx was assessed objectively by the system console, which collected data on a standard data card.
The ATLAST study showed a significant reduction in AHI and ODI, improved objectively measured sleep parameters, reduced subjective daytime sleepiness, and provided better quality of life. A substantial proportion of patients responded to treatment with Winx, as defined by the prospectively identified clinical success criteria, and included mild, moderate, and severe OSA.
During the treatment period, patients averaged six hours of Winx use per night. The treatment was safe and durable with no severe or serious device-related adverse events.
“The ATLAST trial showed Winx to be a safe and effective way to improve the symptoms of all severities of OSA and its innovative design resulted in high patient satisfaction and treatment adherence,” said Steve Carlson, president and CEO of ApniCure. “Winx provides patients with an alternative treatment for OSA without the mask that can more easily fit into the user’s lifestyle.”