Treating Sleep Apnea: FDA Approves New Device

Sandra Adamson Fryhofer, MD


August 29, 2014

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Hello. I'm Dr. Sandra Fryhofer. Welcome to Medicine Matters. The topic: A new treatment option for sleep apnea, an implantable upper airway stimulator, is now FDA-approved.[1] Here's why it matters.

Sleep apnea is common. More than 18 million adults have it. Although loud snoring is the symptom that bed partners complain about most, excessive daytime sleepiness is the symptom most experienced by those who have it. In sleep apnea, the airway becomes blocked or totally collapses. Breathing starts and stops. Pauses in breathing can last seconds to minutes.

Meanwhile, the body is not getting enough oxygen. This puts stress on the heart and other organs and increases the risk for high blood pressure, heart attack, stroke, heart failure, and diabetes. Diagnosis of sleep apnea requires evaluation of signs and symptoms as well as a sleep study.

Incidence of sleep apnea is on the rise. The most likely reason is obesity. Excess weight around your airway can trigger sleep apnea. Sleep apnea is often more common in men, those with a family history, and in those over 60 years of age. Alcohol, tranquilizers, and sedatives relax muscles in your throat and thus increase symptoms. It is also more common in smokers because inflammation from smoking also inflames the airway and increases the likelihood of blockage.

New evidence-based guidelines from the American College of Physicians (ACP) recently looked at treatment options.[2] The guidelines say to stay away from surgery. The evidence is insufficient and there are risks. They recommend weight loss if needed and using continuous positive airway pressure (CPAP). CPAP machines use a facemask to deliver a stream of air that keeps the airway open so that the body can get oxygen.

Unfortunately, some patients find CPAP machines cumbersome and uncomfortable and won't use them. The ACP guidelines then suggest MAD, a mandibular advancement device, as an alternative treatment option. MAD devices keep your throat open by bringing your jaw forward.

And now there is a new treatment option. The FDA has just approved upper airway stimulation therapy (UAS) for those with moderate to severe sleep apnea who can't tolerate CPAP. UAS is a neurostimulator that is implanted in the upper chest. It is turned off and on using a handheld remote control. The device senses breathing patterns and gently stimulates key airway muscles to keep the airway open during sleep. FDA approval of this new therapy is based on the STAR study, stimulation therapy for apnea reduction, the results of which were published in the New England Journal of Medicine.[3] Patients receiving this implanted stimulator had 68% reduction in apnea events, 70% reduction in oxygen desaturation, and better daytime functioning.

For Medicine Matters, I am Dr. Sandra Fryhofer.


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