Swedish Begins Patient Enrollment for Obstructive Sleep Apnea Clinical Trial

Swedish Begins Patient Enrollment for Obstructive Sleep Apnea Clinical Trial

SEATTLE, May 9, 2011 – Swedish has been selected to participate in a pivotal clinical study to evaluate the safety and effectiveness of a new therapy for patients with moderate to severe obstructive sleep apnea (OSA). The STAR trial (Stimulation Therapy for Apnea Reduction) will be conducted at leading medical centers across the United States and Europe, and will evaluate the efficacy of Inspire™ Upper Airway Stimulation (UAS) therapy, an implantable therapy that works with the body’s natural physiology to prevent airway obstruction during sleep.

More than 18 million Americans suffer from OSA, which is characterized by repeated episodes of upper airway collapse during sleep. Patients with OSA stop breathing frequently during sleep, often for a minute or longer. Daytime sleepiness, depression, weight gain, increase in industrial accidents and diminished quality of life are all commonly observed in people who suffer from OSA as a result of fragmented sleep patterns. Furthermore, OSA is associated with the development of systemic hypertension, cardiovascular diseases (e.g., heart failure and heart rhythm disorders), stroke as well as diabetes.

Current treatment options for OSA include weight loss, CPAP, oral appliances and surgeries. CPAP (Continuous Positive Air Pressure) applied through a nasal mask is the current standard of treatment for OSA. However, several recent studies have shown that CPAP compliance can be as low as 50 percent because of the nasal mask constriction, discomfort and inconvenience.

The STAR trial will enroll CPAP intolerant patients (patients unable or unwilling to make CPAP therapy work). To be eligible for screening and inclusion in the STAR trial, patients must:

  • Have failed or not tolerated CPAP
  • Have moderate to severe obstructive sleep apnea
  • Have a body mass index of less than 32

Those who suffer from OSA who would like to receive more information about enrolling in the STAR trial can call 1-888-229-0678 or visit www.theSTARtrial.com.

“Studies have shown that sleep apnea is as prevalent as adult diabetes and asthma and the consequences of OSA range from disruptive to life-threatening. While CPAP can be very effective to treat OSA, for many patients it is simply too difficult to comply with, and thus ineffective,” said Dr. Sarah Stolz, M.D., medical director of Sleep Medicine Associates. “Swedish was selected to participate in this study because of our extensive experience in treating patients who suffer from sleep apnea. We look forward to contributing to this important research to determine whether Inspire therapy can help the many people suffering from OSA with limited treatment options.”

About Obstructive Sleep Apnea (OSA)

OSA is a common sleep disorder that occurs when the tongue and other soft tissues of the throat relax and obstruct the airway during sleep. Apnea events can occur multiple times per hour throughout the night, disrupting normal sleep. People suffering from OSA report significant daytime sleepiness and impaired quality of life. Depending on the degree of severity, OSA can be a potentially dangerous condition. OSA has been linked with increased risks for cardiovascular disease, weight gain and accidents resulting from daytime drowsiness. It is estimated that one in 15 American adults has moderate to severe OSA.

About Inspire TM Upper Airway Stimulation (UAS) Therapy

InspireUpper Airway Stimulation (UAS) therapy is a dynamic, implantable therapy that works with the body’s natural physiology to prevent airway obstruction during sleep. While the OSA patient sleeps, Inspire therapy is designed to deliver physiologically timed, mild stimulation to the hypoglossal nerve on each breathing cycle. The stimulation is intended to restore tone to the muscles that control the base of the tongue, preventing the tongue from collapsing and obstructing the airway. Patients control when the therapy is turned on and off via a hand-held programmer. In contrast to other surgical procedures to treat sleep apnea, Inspire therapy does not require removing or permanently altering an OSA patient’s facial or airway anatomy.

About The STAR Trial

The STAR trial is a global, multi-center clinical trial which will assess the safety and effectiveness of Inspire Upper Airway Stimulation (UAS) therapy in patients who suffer from moderate to severe obstructive sleep apnea (OSA). The trial will be conducted at leading medical centers throughout the United States and Europe. For more information on The STAR trial, visit www.STARtrial.com.

Upcoming Community Health Talk at Swedish/First Hill

A free community health talk on The STAR trial is being held in the Swedish Education and Conference Center at Swedish/Cherry Hill (500-17th Ave., Seattle, first floor of the James Tower) on Thursday, June 9 from 6-8:30 p.m. (6-6:30 p.m. reception, followed by the presentation and questions from 6:30-8:30 p.m.). To RSVP, simply call 1-888-229-0678.

About Swedish

Swedish has grown over the last 100 years to become the largest, most comprehensive non-profit health provider in the Greater Seattle area. It is comprised of four hospital campuses; emergency departments and ambulatory care centers in Issaquah, Redmond and Mill Creek; Swedish Visiting Nurse Services; and Swedish Medical Group – a network of more than 70 primary-care and specialty clinics located throughout the Greater Puget Sound area. Swedish recently opened a new emergency department and medical office building (MOB) on its Ballard campus and will open a new MOB and hospital in Issaquah in mid-July 2011. In addition to general medical and surgical care, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiovascular care, cancer care, neuroscience, orthopedics, high-risk obstetrics, pediatric specialties, organ transplantation and clinical research. For more information, visit www.swedish.org. In 2007, Swedish embarked upon an ambitious $100 million fundraising campaign. Campaign investments are used to support a wide-variety of initiatives throughout the health-care system, including cancer, heart and vascular, women and children, neurosciences, and orthopedics as well as programs to support underserved populations. To date, the campaign has secured gifts totaling more than $74 million. For more information or to support the campaign, visit www.campaignforswedish.org.


Media Coverage

  • To watch video of and read the transcript from a related story that KING TV (Channel 5; NBC) aired on July 11, click here


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