Tiny implant may ease sleep apnea

A new treatment for adults with obstructive sleep apnea may help some patients get a better night's sleep without using a mask at night or getting extensive surgery.

Certain non-obese patients with moderate to severe sleep apnea now have the option to get a surgically implanted system to help keep their airway open at night.

The Inspire Upper Airway Stimulation system was approved by the U.S. Food and Drug Administration in April for people age 22 and older. It's installed during outpatient surgery and can be wirelessly turned off and on by the patient, using a remote.

Inspire consists of a small, pacemaker-like device with leads (wires) attached to it that's implanted into the upper chest. The system senses breathing and stimulates the hypoglossal nerve that controls the tongue, moving it forward so that the patient's airway stays open when it needs to.

"The hypoglossal nerve is the main nerve that moves the tongue," said Dr. Andrew Gould, a Louisville surgeon who performed Kentucky's first Inspire surgery earlier this month. Inspire is designed to help patients whose "tongue falls backwards and blocks off their airway, so that when they try to breath in, it's obstructed and their oxygen levels drop, and it stresses out their heart, and they wake up tired, and it has a lot of negative health effects."

Sleep apnea can lead to loud snoring and increase the risk of serious health conditions, such as high blood pressure, stroke, diabetes and heart failure, according to the National Heart, Lung, and Blood Institute.

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The goal of treatment is "to improve a person's sleep and then also their health because when you treat someone's untreated sleep apnea, other disease processes improve," said Gould, who's with Advanced ENT and Allergy. Also, "their work productivity improves," and they can avoid getting into accidents related to sleepiness, he said.

Prior to receiving the system, which is produced by Inspire Medical Systems of Minnesota, patients must receive an anatomical evaluation to make sure they're good candidates for the system, Gould said.

With this device, "all we're doing is moving the tongue forward," Gould said. "If that fixes the problem, then they'll do very well, but if they have other areas of obstruction, then it wouldn't be effective."

Patients have to have failed — or been unable to tolerate — positive airway pressure treatments, such as using a CPAP (continuous positive airway pressure) machine that requires wearing a mask while sleeping.

Though CPAP is the gold standard therapy, some people can't tolerate it. For example, they might be too claustrophobic to wear the mask or might be unable to find one that fits their anatomy appropriately, Gould said.

And surgical options have tended to be more extensive than Inspire requires and "primarily removed or altered the anatomy," Gould said. Inspire "doesn't do that. It leaves your anatomy intact. We're just stimulating your nerve."

Pleasure Ridge Park resident Fred Harley had surgery earlier this week to receive the Inspire system. Though it hasn't been turned on yet, Harley's wife, Brenda, said she and her husband have "high hopes" that it will improve his sleep apnea. "He wouldn't have done it if he didn't think it would work," she said.

Fred Harley, who declined to be interviewed so soon after surgery, had tried a similar device before as part of a research study and it worked well, so he decided to get Inspire, his wife said. He also liked the idea that Inspire had FDA approval since that meant the $30,000 procedure would be covered by insurance, she said.

Inspire was found to be effective in a clinical study involving 126 participants in more than 20 sites, according to the FDA. The system "provided the majority of patients with significant reductions in the severity of their obstructive sleep apnea and improvements in their quality of life," the administration noted, but it is requiring additional research on safety and effectiveness.

The surgery

During the Inspire procedure, "we make an incision just below the jaw and then we make an incision just under the collarbone and then we make a little incision just under the main muscle on your chest — the pectoralis muscle — over a rib, so there's three incisions," Gould said.

The Inspire system has a sensing lead (a little wire that runs under the skin) that attaches to the rib and senses when you breathe and sends a signal to the implant, and the device then sends a signal to the hypoglossal nerve in the upper neck. When that nerve is stimulated, the tongue moves forward, opening the airway up, he said.

After surgery, a sleep doctor follows up with the patient to make sure the device gets adjusted properly. "We'll do a sleep test with the device in place and with our trained technicians who can tweak it exactly," said Dr. David Winslow, a sleep medicine specialist in Louisville who collaborates with Gould and will be part of future research on the Inspire system. The stimulation that patients receive should be "just low enough so it doesn't wake them up but just high enough where you're opening up the airway ... to get the right flow pattern that we will see on the sleep test."

Winslow, of Sleep Medicine Specialists, said he's excited to have Inspire to add to other options, such as losing weight or getting a dental device to treat sleep apnea.

"This is just a tool that we're going to have for those folks who have not responded to the other modalities ... and just really can't do anything else and are struggling," he said. "We feel like this is going to be helpful" for them.

But Inspire isn't without risks. For example, it could negatively impact patients' ability to pronounce words and lead to lower lip weakness, but that would be uncommon, Gould said. There's also a possibility of infection and other problems, such as tongue soreness and headache.

Both Gould and Winslow have prior experience with a similar device — from a different company, Apnex Medical. Though local patients, such as Harley, were "very happy" with that device, the company ultimately pulled the plug on it, Winslow said. A news report said it was because of disappointing results that made FDA approval unlikely.

"They had a few more failures, and I think that's why the FDA wanted them to do some more studies," Winslow said. "I think if this (Apnex Medical) company had done more studies, they'd have gotten approved also. They just weren't willing to put any more money in it."

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THE TREATMENT

Name: The Inspire Upper Airway Stimulation system

Who it's for: Non-obese adults with moderate to severe obstructive sleep apnea. Patients must be evaluated to make sure they're good candidates and have the kind of anatomy that's well-suited for the procedure.

Possible risks: Some risks include pain and discomfort; temporary tongue weakness; sore throat; headache; nausea; infection; tongue abrasion; mouth dryness; and speech issues. If the device has to be removed, surgery is required.

Estimated cost: $30,000; expected to be covered by insurance.

More information:http://www.inspiresleep.com