New implantable device for sleep apnea

6:26 AM, May 2, 2011   |    comments
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MAPLE GROVE, Minn. -- It's estimated one out of every 15 Americans has moderate to severe obstructive sleep apnea.

To treat it, many people try a machine called a CPAP, short for "continuous positive airway pressure."

But because some find it uncomfortable, up to half of those who try a CPAP machine give up on using it.

Now, there's a new treatment option on the horizon. It's being tested right here in the Twin Cities.

It's an implantable device much like a pacemaker.

To understand how it works it's important to understand what obstructive sleep apnea and CPAP machines are.

Gayle Fehr has many family members who use CPAP for obstructive sleep apnea, including her mother and brother.

She thinks she has obstructive sleep apnea too. She said, "I'm just tired a lot. I can drive, then all of a sudden I'll think, 'Oh boy. I'm getting sleepy and I know that's not good.'" She also has high blood pressure.

In mid-April, 51-year-old Fehr decided to have a sleep study done at the North Memorial Sleep Health Center in Maple Grove.

Electrodes were placed on her scalp, face, chest limbs and finger to monitor her brain activity, breathing, oxygen in the blood, heart rate and more.

Once she went to sleep, sleep technicians looked for apneas.

Apneas are pauses of ten seconds or more in breathing, caused by airway collapse, resulting in waking up several times an hour.

Fehr said, "My husband says sometimes, 'Is she breathing? No is she not.' And I just wake up a lot."

Obstructive sleep apnea can lead to heart disease, stroke, depression and maybe Fehr's high blood pressure.

If she's diagnosed with it, she said she'll try CPAP, which pushes pressurized air into a mask and then into a patient's airway to prevent the airway from collapsing during sleep.

Rik Krohn of Burnsville tried CPAP. He said, "I used it for about six months and finally just gave up." But he didn't want to.

Averaging 35 breathing stoppages an hour was not good for a man who already had one heart attack. Krohn said, "And I really didn't need that much more damage to my heart so that was really one of my biggest motivations."

Motivated to find an alternative, Krohn found one, although experimental, while reading the business section. It's a new implantable device made right here by a Maple Grove company called Inspire.

Designed like a pacemaker, and placed under the skin near the clavicle, Inspire Upper Airway Stimulation has one wire, a pressure sensor, which is placed between ribs to detect breathing rhythm.

A second wire then stimulates the hypoglossal nerve under the tongue to move the tongue out of the way as Krohn sleeps. It's operated by remote.

Krohn just holds the remote over the device implanted in his chest and clicks it on when he goes to bed. But it doesn't start working until after he falls asleep. He said, "About 20 minutes after you turn it on it kicks in so I'm not really aware of it until I wake up." He then turns it off when he wakes up.

Desperate for an alternative to CPAP, Krohn volunteered to be the first in the United States to try the Inspire device.

He's had it now for two years. He said his sleep apnea is now undetectable. He said, "I wake up in the morning happy, bright, and alert."

The device is not yet available to the public but those with obstructive sleep apnea may be able to try it if they qualify to participate in a new nationwide trial, a portion of which is being conducted at North Memorial.

North Memorial Sleep Health Center associate medical director Dr. Jason Cornelius said, "The patients that we're looking for are patients with moderate to severe sleep apnea who have previously failed or become intolerant to CPAP therapy."

The trial will look at the safety and effectiveness of the Inspire device. Cornelius said, "The exciting thing about the technology is it could be a way that patients who currently have no form of treatment could have success in treating this disease."

Before lying down for her sleep study, Fehr said the Inspire device is not something she would try. She said, "If you could do that with CPAP, why would you have surgery?"

But the next morning, after having tried CPAP for four hours, she said, "I didn't mind it at all at first. And then all of a sudden I had to have it off I've been told that's normal."

Fehr found out from her sleep study that she does indeed have sleep apnea.

North Memorial Sleep Health Center medical director Dr. Andy Vaaler looked at her read-out from the night before and said, "This isn't finally scored yet but it looks like it will be in the severe range, 40 to 50 times an hour a stoppage of breathing."

Fehr said, "It kind of makes sense. It's not great news but it's good to know there is something I can do about it."

The investigational Inspire Upper Airway Stimulation device is not available to her, even in trial, because she hasn't tried and failed at CPAP. Fehr hopes CPAP does work for her.

Although Krohn said he has experienced no side effects, researchers said they're still trying to determine whether there may be any from the device.

If you're interested in learning more about the Inspire Upper Airway Stimulation trial, also known as the STAR Trial, call 1-888-844-4811 or go to the STAR trial website.

(Copyright 2011 by KARE. All Rights Reserved.)

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