A therapeutic device surgically implanted in sleep apnea patients reduced the severity of their episodes by 70 percent, decreased daytime sleepiness, and improved their overall quality of life, according to a University of Pittsburgh-UPMC study published Wednesday in the New England Journal of Medicine.
The first-of-its-kind, yearlong clinical trial involved 126 patients with moderate to severe obstructive sleep apnea who underwent the outpatient surgical implantation of the upper-airway stimulation system. It is designed to sense breathing patterns and deliver mild stimulation to a patient's airway muscles to keep the airway open during sleep.
Inspire Medical Systems of Minneapolis, which funded the study, developed the device, which stimulates the nerve of the tongue during sleep, thereby enlarging and stabilizing the airway and improving control of breathing. The surgery involves implanting a stimulation electrode on the hypoglossal nerve, a lead between rib muscles to detect breathing effort and a neurostimulator in the upper right chest, just below the clavicle. Patients used a controller, similar to a TV remote, to turn on the device at night and off during the day.
The surgeries were performed by otolaryngologists at 22 academic and private centers in the United States and Europe. In Pittsburgh, otolaryngologist Ryan Soose, director of the UPMC Division of Sleep Surgery, performed 13 of the surgical implantations at UPMC Mercy.
With completion of the clinical trials, the next step is to present findings to the U.S. Food and Drug Administration, said Patrick Strollo, medical director of the UPMC Sleep Medicine Center and lead author of the study. Should the FDA approve the device, it could become an option within a year, said Dr. Strollo, a faculty member at Pitt's medical school.
He said the findings were "robust" in safety and efficacy. "It is gratifying to get good results like this. The data we have right now from this trial is that this would be an option for those patients for whom we struggle for a solution."
Sleep apnea affects 12 million Americans, two-thirds of them men. Currently, the most widespread treatment is continuous positive airway pressure (CPAP) in which a patient wears a breathing mask tethered to a machine while sleeping. While that therapy remains the "gold standard," Dr. Strollo said, the implanted device provides a heretofore unavailable option for patients for whom CPAP is ineffective or uncomfortable.
"I think it's certainly a new tool for a very common problem. We haven't had a new tool for quite some time. The findings are very favorable. I hope the FDA sees it in a similar light."
Two of the trial subjects who received their implants at Mercy, Kathy Gaberson of Forest Hills and Al Friedl of Rootstown, Ohio, said the new device performed beyond their best hopes.
Ms. Gaberson, 67, said after receiving the implant her short-term memory significantly improved, her apnea episodes dropped from 23 times an hour to two, and her quality of life improved greatly.
"All I can say is I wish I had the device from the beginning. For me, it was much more effective in treating my sleep apnea than the CPAP machine," said Ms. Gaberson, who was first diagnosed with sleep apnea in 2007.
She recently had to have the device removed as a precaution when she was hospitalized with an unrelated health issue.
"I'm in mourning for the loss of the device. I'd love to have it reimplanted. I'd have the surgery in a heartbeat, that's how well it worked for me."
Mr. Friedl, 82, said he used CPAP from 2003-08 but "I never got used to it. For some people it can be very good, but for me it wasn't. I kept looking for other alternatives. A mouth guard helped, but it was still lousy and I never slept through the night."
He said he applied for the clinical trial because "it was something new and I was anxious to try it. I simply had nothing to use. It's been wonderful.
"Before, they used to ask me, 'When was the last time you slept through the night?' and I couldn't remember. Now, I can't tell you the last time I didn't sleep through the night. It's had nothing but positive effects."
Michael A. Fuoco: mfuoco@post-gazette. comr or 412-263-1968. First Published January 8, 2014 5:11 PM