If you don’t have it, you most likely know one of the millions of people with sleep apnea, the condition that disrupts breathing and most often occurs when something in the throat is “too big, too floppy, or relaxes too much” during sleep, says Dr. Tod Huntley, a surgeon and researcher with St. Vincent Health in Indiana. Mask therapy known as continuous positive airway pressure (CPAP) is indeed the gold standard for treating for sleep apnea. But new technology may be a real game-changer in coming years for the nearly 50 percent of patients who can’t—or won’t—wear the mask.
CPAP therapy “works wonderfully” to keep air flowing to the lungs, the expert continues. “But it’s no better than a coin toss as to whether someone will use it as recommended or end up with a very expensive paperweight. That’s why we are doing all this research: to find the best, safest, and least painful solutions.”
The research that Dr. Huntley is referring to currently centers on two new ways to keep the airway open: a pacemaker-like device called the hypoglossal nerve stimulator that moves the tongue slightly forward with each breath during sleep and is about “two years from primetime”, and robotic surgery to precisely shave away extra tissue that gained FDA approval in December 2010. Here’s more about promising therapies.
Implanted Pacing Device
“As a surgeon, I want to treat sleep apnea effectively and also compassionately,” says Dr. Huntley. “Hypoglossal nerve stimulation (HNS) is exciting to me because, unlike the surgeries we do now for sleep apnea, it’s potentially an outpatient procedure, it causes minimal pain, and it offers long-term effectiveness.”
Similar to the way cardiac pacemakers stimulate the heart muscle, HNS triggers tongue muscles to pull away from the back of the throat when the person inhales during sleep.
Here’s how: A pulse generator with two wires is implanted over the right chest. One wire goes over the ribcage to sense respirations. The other travels into the neck and fits around the hypoglossal nerve that controls tongue movement. When the system senses breathing, it stimulates the tongue to pull away.
“An intriguing finding is that hypoglossal nerve stimulation affects not only the tongue, but, in the best-treated patients, also seems to pull the soft palette forward and open up the rest of the throat, treating the problem on two fronts,” says Dr. Huntley.”
So what’s next? Two companies are conducting clinical trials on a nerve stimulator for sleep apnea: Inspire Medical Systems, Inc., and Apnex Medical, Inc., where Dr. Huntley is a medical advisor but not an investor. On August 2, Apnex received the go-ahead for its pivotal study at a dozen sites in the U.S., Europe, and Australia. If all goes as anticipated, their device will hit the market in fall or winter of 2013.
Click here for clinical trial updates, purpose, eligibility, locations, and contacts.
Doctors are also treating sleep apnea by removing tonsils and excess tissue with a type of robotic surgery approved in December 2010 and typically used to remove cancerous growths at the back of the throat.
In robotic procedures, surgeons peer at high-definition images to remotely control instruments much smaller and more dexterous than human hands, notes Dr. Huntley. “It’s the best way we have to remove tissue precisely and less invasively and I believe there’s a definite place for it in the treatment sleep apnea. We’re just trying to figure out its role.
“Again, if we knew the hands-down best approach for treating sleep apnea, we wouldn’t be looking at all these approaches. Do we pull the jaw forward? Do we pull the tongue forward, move it, or hook up a nerve stimulator to it? Is some combination of the above? We just don’t have the full answer yet, but we’re definitely working on it.”