Borgess Research Institute, in collaboration with Health Care Midwest ENT and Sleep Health is participating in a pivotal clinical study to evaluate the safety and effectiveness of a new investigational therapy for patients with moderate to severe obstructive sleep apnea (OSA). The STAR trial (Stimulation Therapy for Apnea Reduction) is being 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. Borgess Research Institute is one of the first sites in the United States to start the study.
Only a clinical research study staff member can determine if you are eligible for this research study. For more information on this topic, including a free community health talk to be held in August, call 1.888.847.8753 or go to www.TheStarTrial.com.
“More than 18 million Americans suffer from OSA, which is characterized by repeated episodes of upper airway collapse during sleep,” said Mark Goetting, Medical Director, Borgess Sleep Disorders Center. “Patients with OSA stop breathing frequently during sleep, often for half 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 attacks, heart failure, heart rhythm disorders), stroke, and diabetes.”
Continuous Positive Air Pressure (CPAP) applied through a nasal mask is the current standard treatment.
“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 most common treatment for obstructive sleep apnea,” Dr. Goetting said. “However several recent studies show that CPAP compliance can be as low as 50 percent because of the nasal mask restrictions, 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 should visit research.borgess.com, call 1-888-844-4811, or visit www.theSTARtrial.com.
“Studies have shown that sleep apnea is as prevalent as adult diabetes and asthma, and the consequences of Obstructive Sleep Apnea 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. Goetting. “ Dr. Goetting and Borgess Research Institute were 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 fifteen U.S. adults has moderate to severe OSA.


