Experiment could revolutionize sleep apnea treatment

Milwaukee ear, nose and throat specialist ready to head national study of condition

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Posted: 10/8/07

MILWAUKEE (MCT) - It's midnight and foggy, not unlike the way Brad Hays will feel when he gets out of bed in the morning. Hays, 55, is doing what he has done every night for more than a decade: prodigiously snoring, an activity that occasionally pauses with a momentary interruption of breathing.

"Often I have dreams of a situation where I'm suffocating," Hays said. "I wake up sometimes gasping for air."

As someone with moderate to severe sleep apnea, Hays' dream is a daily reality as he is starved of air more than 100 times a night.

These episodes of snoring, airway closing and interrupted sleep have driven Hays to sign up for an experimental surgery in which a small device would be implanted under his chin.

It's a novel approach that raises a big question: Will it revolutionize treatment of a condition that affects an estimated 12 million Americans?

As part of a national study that is headed up by a Milwaukee ear, nose and throat specialist, Hays is one of only a handful of people in the country to be implanted with the device.

"We need surgeries with fewer side effects that can be done under local anesthesia," said B. Tucker Woodson, a professor of otolaryngology at the Medical College of Wisconsin and principal investigator of the U.S. clinical trial of the device.

Although the clinical trial requires the device be implanted while the patients are under general anesthesia, Woodson said once the device is approved, the operation can be done with local anesthesia.

Woodson is a consultant to Aspire Medical, the company that makes the device and is funding the trial.

Michael Friedman, director of sleep surgery at Rush University Medical Center in Chicago, said a big advantage to the device is that it is adjustable. To get the airway open more, the device can be progressively adjusted in later office visits. He said he doubted that it will be "a magic cure-all."

Still, because so many people with sleep apnea go untreated, partly because of the invasiveness of other surgeries or their inability to tolerate the non-surgical approach of using air pressure masks that fit over the nose, the device could be attractive to many people with untreated apnea.

Known as the Advance System, the device is implanted through a small incision under the chin. It is designed to open the airway by deploying a barbed implant in the back of the tongue and connecting it by an adjustable tether to an anchor that is screwed in the jaw bone.

"It's about as invasive as a root canal," Woodson said as he prepped for Hays' surgery.

The U.S. clinical trial is expected to be completed in November 2008 after 40 people have been implanted with the device. FDA approval of the device is not expected until the trials are completed.

Two days after the surgery, Hays, a retired Secret Service and Alcohol, Tobacco and Firearms agent, had a small amount of swelling under his chin. But otherwise, he felt good, he said.

Doctors say the full benefit of the device normally is not noticed until it is adjusted in an office visit a couple weeks after the surgery.

Hays' wife said she noticed a change the next night.

"It was a different kind of snoring," she said. "It wasn't the constant deeper snore. It was lighter. He wasn't whistling through his nose."

If his apnea and snoring improve even more after the device is adjusted, it could be enough to return nighttime peace to their Greenfield, Wis., household.