From 724 candidates initially screened, the STAR trial implanted and prospectively evaluated 126 moderate-to-severe OSA patients who had difficulty using or adhering to CPAP therapy:
- 83 percent of the participants were men, the mean age was 54.5 years, and the mean body-mass index was 28.4.
- All patients underwent surgery to implant the device. The device stimulates the nerve of the tongue during sleep, thereby enlarging and stabilizing the airway and improving control of breathing.
- Surgical implantation of the upper-airway stimulation system was performed by otolaryngologists at 22 academic and private centers, including Ryan Soose, M.D., of UPMC Ear, Nose and Throat specialists.
- The device was implanted in three areas: a stimulation electrode was placed on the hypoglossal nerve, which provides innervation to the muscles of the tongue; a sensing lead was placed between rib muscles to detect breathing effort; and a neurostimulator was implanted in the upper right chest, just below the clavicle bone.
- Patients used a "controller" to turn on the device at night, so it is only used when the patient sleeps. The Inspire UAS therapy device is designed to sense breathing patterns and deliver mild stimulation to a patient's airway muscles to keep the airway open during sleep.
- Using various sleep-disorder measuring systems, patients were found to experience 68 to 70 percent fewer sleep-apnea episodes per hour.
"My short-term memory has improved significantly, and the surgery has made a huge difference in my quality of life," said Kathy Gaberson, one of the study participants who used the Inspire therapy. "My apnea episodes went from 23 times an hour to just two."
Ryan Soose, M.D., director of the UPMC Division of Sleep Surgery and assistant professor at the University of Pittsburgh School of Medicine, explains the first clinical trial to evaluate the use of upper airway stimulation for sleep apnea.
(Photo Credit: UPMC)
This image shows how the Inspire® Upper Airway Stimulation Therapy device works.
(Photo Credit: Inspire)
Source: University of Pittsburgh Schools of the Health Sciences