Detroit Medical Center (DMC) has been selected as the first Detroit area hospital 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 (heart failure, heart rhythm disorders), stroke, and 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 show 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. 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
Detroit Medical Center will also be conducting a community health talk in September where interested patients can get more information and talk to the physicians involved in the clinical trial.
“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 M. Safwan Badr, M.D., Professor and Chief, Pulmonary Critical Care and Sleep Medicine, Department of Internal Medicine, DMC Harper University Hospital and Wayne State University School of Medicine.
“DMC 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,” Dr. Badr added.
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 fifteen U.S. adults has moderate to severe OSA.
About Inspire™ Upper Airway Stimulation (UAS) Therapy
Inspire Upper 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 handheld 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.