Medical breakthrough in Wisconsin: FDA approves new Sleep Apnea treatment

MILWAUKEE, WI -- Getting a good night of restful sleep is often one of life's great challenges.

Obstructive Sleep Apnea poses a deadly risk to the health of those impacted by the disorder. However there is a brand new treatment that just cleared a major hurdle.

Sleep Apnea has been called a silent killer. It is commonly linked to obesity, high blood pressure, increased risk of stroke, diabetes, as well as a number of other health concerns.

Traditional treatment is not always popular with those afflicted. However a new form of treatment was just approved by the U.S. Food and Drug Administration  on April 30 to treat the sleeping disorder, which impacts an estimated 22-million Americans. The procedure was first performed right here by Froedtert Hospital and the Medical College of Wisconsin.

\"I didn't know what sleep apnea was,\" Daniel McKee told CBS 58. \"I just noticed, and I complained to my doctor, about daytime tiredness. I was just extremely exhausted throughout the day.\"

McKee was hardly alone in not knowing why he always felt so tired during the day. It was only after he was diagnosed with obstructive sleep apnea that he learned just how severe an issue he faced due to his lack of sleep. As it turns out, restless sleep is far more than just an inconvenience.

\"Sleep loss is a health crisis, along with obesity,\" warned Froedtert Hospital and the Medical College of Wisconsin Division of Sleep Medicine chief Doctor B. Tucker Woodson . \"Both of them are major health problems. We're now becoming a real sleep-deprived society.\"

For the last ten years, Doctor Woodson has been working on an alternative to the traditional treatment of sleep apnea. Many, who suffer from the condition, use a mouth appliance to keep the tongue from making it difficult to breathe while asleep.

Some use a device, called a CPAP, that creates constant air pressure in order to maintain proper breathing. The problem is, those methods do not work for everyone and some choose not to even use them due to discomfort.\"

\"I would put it [CPAP device] on and start at low pressure, and I would get off to sleep,\" said McKee. \"Bottom line, I'd wake up in the middle of the night and I couldn't tolerate it any longer.\"

McKee's frustrations led him to a new study, conducted by Dr. Woodson. McKee was selected to be one of the 126 test subjects to undergo an experimental procedure.

\"We have a new treatment,\" Dr. Woodson told CBS 58. \"A nerve stimulater that actually augments the normal nerve activity during sleep. And it helps hold the airway open.\"

Froedtert Hospital and the Medical College of Wisconsin have been involved, clinically, in the project for ten years. Dr. Woodson said they were the first institution in the U.S. and North America to actually implant, and treat, someone with the device called Inspire. Basically it triggers the tongue to move and create a clear passageway for breathing.

\"There's a main implant in the chest,\" described McKee. \"And there's a sensor down in my rib cage area, and also the electrode attached to my tongue.\"

A remote is placed against the implant in the chest and the user can activate it, pause and stop the implant with the simple push of a button. It also offers a timer, so it starts after you fall asleep. CBS 58 asked McKee how invasive the procedure is.

\"I wasn't sure what I was getting into at the time,\" confessed McKee. \"[But] it wasn't that invasive. I mean it was a little bit more than I thought it was. But still, all in all it wasn't that invasive.\"

Dr. Woodson backed up McKee's claim that it really is not that invasive, as far as surgeries go. And the benefits?

\"In a recent New England Journal [of Medicine] article, based on a multi-center, multi-country study -- we actually had a 70 percent success rate with the device,\" said Woodson.

\" I sleep better at night,\" McKee said. \"I wake up more refreshed. I don't snore any more, or for the most part -- which that was the number one thing.\"

We asked McKee if he would be willing to tell others it is worth checking into.

\"Oh sure.,\" he confirmed. \"I would recommend it. I mean it may not be for everybody, but it is for me. It is for a lot of people like me.\"

Besides improved health, there is always the added benefit of a happier marriage too.

\"One of the things that was very exciting about this, is it did a great job treating snoring,\" Woodson said with a smile. \"And yes, the spouses were very happy.\"

Sleep loss should not be taken lightly. Dr. Woodson told CBS 58 that people don't really appreciate that it is a bona fide health problem. Now that the implant has received FDA approval, it clears the way for health insurance providers to consider covering the treatment in the future.


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