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May 13, 2014 at 8:00 AMComments: 0 Faves: 0

Bye Bye, CPAP? FDA Approves New Sleep Apnea Treatment: Inspire Upper Airway Stimulation

By Jeffrey VanWingen M.D. More Blogs by This Author

Unfortunately, sleep apnea is an under-recognized and under-appreciated condition. To put things in perspective, sleep apnea has been linked to car crashes, industrial disasters, depression, stroke, diabetes, heart disease and premature death. In facts, The U.S. Center for Disease Control (CDC) has declared sleep apnea and other sleep insufficiency disorders a public health epidemic. With numbers on the rise and no perfect cure, advancements in the treatment of sleep apnea are being hotly sought after.

This month, the U.S. Food and Drug Administration (FDA) approved an implantable device for the treatment of sleep apnea - but does it work? And if so, is it safe?

Sleep Apnea at a Glance

Sleep apnea is most simply defined as a stoppage in breathing during sleep that leads to low levels of oxygen in the body. There are two types of sleep apnea, central and obstructive. 

  • Central sleep apnea (CSA) is less common and involves a problem with the nerve signals from the brain that control the muscles of breathing. 
  • Obstructive sleep apnea (OSA) occurs when the tissues of the airway collapse during sleep-time inspiration.  
OSA, much more common than CSA and is associated with obesity and distortion of normal anatomy such as recessed chin and increased girth of the neck. Sleep apnea blocks air from reaching the lungs during sleep. This causes oxygen levels to decrease at times to dangerous levels. The body responds with waking and eventual gasping. Sleep is disturbed, especially the deep, restorative cycles, giving a person a fraction of the sleep for the time they invest in the bed. To test for sleep apnea, a person presents to a sleep lab where sleep is observed and measured in the form of brain waves and oxygen levels. Sleep apnea is diagnosed when an adequate number of "apnea-hypopnea" episodes are achieved per hour. This is otherwise known as the apnea-hypopnea index, or AHI.

Current Therapies

Sleep apnea is currently treated primarily with a continuous positive airway pressure device, or CPAP. This device involves a machine that generates air flowing though a mask that pushes the airway open during inspiration, giving it a little extra oomph to bring air to the lungs. For milder cases, appliances that go in the mouth during sleep to enhance airflow can be used. If a person cannot tolerate the CPAP, surgery can be performed to remove redundant tissues and the uvula (that thing that hangs down). Success rates for the surgery, however, are less than perfect.  

The New Inspire Upper Airway Stimulation Device

The Inspire device is a fully implanted neurostimulation device. In other words, it stimulates the nerve-muscle junction of key muscles that stimulate the airway to stay open and breathing to occur without obstruction. This relatively small device has a sensor that detects breathing patterns and reacts to disordered breathing by stimulating the muscles to produce more functional breathing during sleep. The Inspire is surgically implanted into the back of the throat and is activated by a remote control for sleep time.

Does It Work?

Prior to FDA approval, a 12 month trial was performed, the results of which were published in the New England Journal of Medicine last January. 126 subjects who had difficulties with CPAP and who had moderate to severe sleep apnea were chosen for the study. The device was tested both actively and then in an unactivated phase. As expected, AHI scores did not change when the device was not activated. When actively used, however, the average AHI decreased from 29.3 to 9.0.  This is significant in that a score of 15 is generally considered significant sleep apnea.  Conclusions can be drawn that by decreasing the AHI significantly, the important factors of decreased daytime sleepiness, elevated mood and improved health should follow.  The withdrawal rate due to complications was less than 2%.

Who Is Eligible?

Now that the device is approved by the FDA, it is a matter of time before is becomes available.  This date is estimated to be in the second half of 2014. Doctors will need to be trained on implanting the device and this may take some time and so far the FDA has given the approval only for those with obstructive sleep apnea  in the moderate to severe category and who have failed a trial of CPAP.

For more information, visit http://www.inspiresleep.com/

Sources:

1. http://www.inspiresleep.com/

2. N Engl J Med 2014; 370: 139-149

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