Study Confirms Provent® Therapy Effectively Treats Sleep Apnea Patients Who Are Non-Compliant with CPAP Therapy
BELMONT, Calif., Feb. 14, 2011 -- A peer reviewed study in the February issue of Sleep Medicine concluded that Provent® Sleep Apnea Therapy, a non-invasive, disposable nasal device, significantly improved obstructive sleep apnea (OSA) - as measured by the number of breathing disruptions during sleep - in more than half of patients, leading them to feel more alert during the day. The study was conducted in patients who had either refused or were non-compliant with CPAP (Continuous Positive Airway Pressure) therapy.
The study, conducted at St. Luke's Hospital Sleep Medicine and Research Center in Chesterfield, Missouri, near St. Louis, included 59 patients and is titled "A convenient expiratory positive airway pressure nasal device for the treatment of sleep apnea in patients non-adherent with continuous positive airway pressure."
Provent Therapy was accepted by eighty percent of patients who were not using CPAP regularly or were untreated. CPAP therapy requires wearing a mask that is connected to an air blower while sleeping. The study also found that Provent Therapy improved blood oxygen saturation and resulted in less daytime sleepiness as measured by the Epworth Sleepiness Scale. Treated patients reported feeling less sleepy during the day and having better quality of life. Patients that completed the study reported using Provent Therapy more than ninety percent of total sleep hours, representing very high treatment adherence.
"CPAP therapy is the standard of care for the treatment of obstructive sleep apnea, but a large percentage of patients are not able to tolerate it and express dissatisfaction with their treatment options. The data from this study indicate that the Provent Device is a beneficial treatment for approximately forty percent of patients who are unwilling or unable to tolerate CPAP therapy," said James K. Walsh, PhD, Executive Director of the Sleep Medicine and Research Center at St. Luke's Hospital in Missouri.
"These findings are significant as millions of people in the US are currently not being treated for their OSA. As these people go untreated, they are at higher risk of serious conditions such as hypertension, stroke and heart attacks," added Dr. Walsh, who is also President of the Sleep Research Society.
Sleep Apnea: A Dangerous Condition
Obstructive sleep apnea is the most common type of sleep-disordered breathing. In patients with OSA, the airway collapses during sleep when the muscles that hold the airway open relax. People with this disorder can stop breathing while sleeping---in some cases hundreds of times each night---usually for periods of ten seconds or longer. Although some people with sleep apnea don't know they have the condition, they snore and may wake themselves up as they gasp for air. It is often their sleep partner who is aware of these symptoms and will urge them to go to the doctor.
It is estimated that more than 40 million Americans suffer from sleep apnea. Sleep apnea can cause fatigue, early morning headaches, irritability, lack of concentration, and contributes to depression, learning and memory difficulties, and sexual dysfunction. Importantly, many recent studies have shown that OSA is associated with high blood pressure, irregular heartbeat, heart attack, stroke and diabetes.
Unfortunately, OSA often goes undiagnosed and therefore untreated. Of the patients that do receive treatment, most are prescribed a CPAP machine. While extremely effective at treating OSA if worn as directed, more than half of all patients stop treatment with CPAP due to its cumbersome nature. Provent Therapy was developed to help patients who do not accept CPAP therapy and can benefit from a non-invasive and clinically effective technology.
About Provent Sleep Apnea Therapy
Provent Therapy is a prescription device indicated for the treatment of obstructive sleep apnea. It is an easy to use, disposable treatment that works across mild, moderate and severe OSA. Provent Therapy is cleared by the FDA and has been clinically proven in numerous published studies to reduce sleep apnea and improve oxygenation. The device utilizes Ventus Medical's proprietary MicroValve technology that uses the patient's own breathing to create expiratory positive airway pressure (EPAP) to keep the airway open during sleep. Prior to going to sleep, the patient places the small Provent Device on each nostril. The device adheres to the skin using a hypoallergenic adhesive. When the patient breathes in through the nose, the valve opens allowing nearly unobstructed airflow. When exhaling, the valve closes, limiting airflow, increasing expiratory pressure to keep the airway open and prevent breathing disruptions. For more information, please visit www.proventtherapy.com.
About Ventus Medical
Ventus Medical is a privately-held medical device company dedicated to providing non-invasive medical solutions for people with sleep-disordered breathing. Based on its innovative MicroValve technology and patented designs, Ventus Medical has developed a unique line of clinically-proven medical devices to address the continuum of sleep disorders from severe obstructive sleep apnea to snoring. Ventus Medical devices work by creating expiratory positive airway pressure (EPAP). The company markets FDA-cleared, prescription-only Provent Therapy, a discreet, easy-to-use nasal device, for the treatment of obstructive sleep apnea and is developing an over-the-counter device for snoring.