Some people with moderate-to-severe sleep apnea could soon have an additional treatment option for their sleep disorder.


A new study published today in the New England Journal of Medicine[1] detailed the results of a phase III trial testing the safety and efficacy of mild electronic stimulation therapy for treating obstructive sleep apnea. The trial showed that the treatment method was effective at reducing the effects of sleep apnea.


The method involves surgically implanting a device, called Inspire Upper Airway Stimulation therapy, that stimulates the hypoglossal nerve (which leads to the tongue muscle). This stimulation increases muscle tone, which in turn activates the tongue muscle to open up the airway.


Obstructive sleep apnea[2] occurs when there is obstruction of the airway during sleep, leading to pauses in breathing that cause disrupted sleep and, thus, daytime fatigue.


The mild electronic stimulation therapy method is different from other currently available sleep apnea treatment options. One option, continuous positive airway pressure[3] (CPAP), works by pressurizing the upper airway to keep the airway open -- this is considered the gold standard of treatment for obstructive sleep apnea because "no matter where there's airway collapsibility, if a seal is properly attained, you're going to get the airway open during sleep," Strollo said. Another treatment option is oral appliance therapy, which is when the lower jaw is actually moved forward to mechanically open the airway. This new treatment, however, is the first to involve electrical stimulation to stimulate the muscles.


sleep apnea treatment

Photo Credit: Inspire Medical Systems


However, the lead author of the study, Dr. Patrick J. Strollo, M.D., director of the Sleep Medicine Center at the University of Pittsburgh Medical Center, explained to HuffPost that CPAP should still be considered the best treatment option for people with sleep apnea, and this method will likely not replace CPAP anytime soon.



The new method "is not for everybody, and the gold standard for treatment for moderate to severe sleep apnea is still CPAP," said Strollo, who is also a professor of medicine and clinical and translational science at UPMC. "But there are clearly patients out there who are struggling for alternatives, who cannot tolerate positive pressure."


Strollo explained that the participants of this study -- 126 in total, 83 percent of them men, recruited across 22 sites around the country -- were carefully selected based on certain criteria.


"We intentionally recruited people who could not tolerate positive pressure -- this is a group of patients who are very vulnerable for health outcomes left untreated," Strollo said. Other requirements for enrollment in the study included having moderate to severe sleep apnea, having a body mass index less than 32, having moderate to moderately severe apneas (pauses in breathing), and having signs that the cause of their sleep apnea is related to obstruction at the level of the tongue.


Strollo and his colleagues determined efficacy of the treatment method via two parameters: apnea-hypopnea index, which is the number of apnea events in an hour, and oxygen desaturation index, which is the number of times blood oxygen level drops more than 4 percent in one hour of sleep.


After 12 months of the therapy, researchers saw a 68 percent decrease in apnea-hypopnea index score and a 70 percent increase in oxygen desaturation index score.


Researchers then conducted a sub-study after the 12 months, where they compared the apnea-hypopnea index scores of 23 people who continued with the therapy with those of 23 people who stopped the therapy for a week. They found that those who who went without the therapy for a week had increases in their apnea-hypopnea index scores, and also experienced more snoring and fatigue, compared with those who didn't withdraw from the therapy.


Strollo noted that some participants reported pain and/or discomfort after the surgery to implant the device, which is common after an operation, but he said that the pain level was nowhere near that which is commonly reported after upper airway surgery. In addition, researchers did not find evidence that the device led to any long-standing problems with the tongue (aside from some instances of tongue weakness immediately after the implantation). Strollo also noted that all patients had the device implanted by a team made up of a sleep doctor and an otolaryngologist -- and that it was not difficult to sufficiently train otolaryngologists to effectively perform the implantation.


While the study was funded by Inspire Medical Systems, Strollo said that an independent statistician reviewed the data. Next, the researchers will have a formal panel meeting with the Food and Drug Administration, where they'll make a decision about how to proceed with further trials.



Also on HuffPost:




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  • Sleep Apnea May Increase Depression Risk


    The under diagnosed sleep condition takes a <a href="http://www.huffingtonpost.com/2012/03/30/sleep-apnea-depression-risk_n_1391707.html">serious toll on the mood</a>, according to March research from the CDC. In fact, men with sleep apnea were more than twice as likely and women more than five times as likely to feel hopeless, lose interest in their regular activites and display other signs of clinical depression, Health.com reported. Snoring did not seem to be associated with depression. Luckily, the very same <a href="http://www.huffingtonpost.com/2012/06/15/sleep-apnea-treatment-depression-cpap_n_1597703.html">treatment for sleep apnea may also ease depression</a>, according to Cleveland Clinic research.




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    There is a growing body of research supporting a link between the presence of sleep apnea and <a href="http://www.huffingtonpost.com/2012/05/24/sleep-apnea-diabetes-type-2-_n_1539933.html">metabolic disorders like diabetes</a>, HuffPost reported in May. Both moderate and severe obstructive sleep apnea were found to be predictors of the disease. A previous study found that people with sleep apnea had more than <a href="http://news.yale.edu/2007/05/24/sleep-apnea-increases-risk-heart-attack-and-diabetes">double the risk of developing diabetes</a>.




  • Sleep Apnea May Increase Cancer Risk


    Not only do people with sleep apnea have a <a href="http://well.blogs.nytimes.com/2012/05/20/sleep-apnea-tied-to-increased-cancer-risk/">higher risk of developing cancer</a>, but they also have a higher risk of dying from the disease, the <em>New York Times</em> reported. Two studies in May examined this link. One found people with sleep apnea had a 65 percent higher change of developing any kind of cancer. The second found that disordered breathing contributed to a five-times higher rate of dying from the disease.




  • Sleep Apnea May Sap Your Libido


    Excessive sleepiness is certainly enough to kill the mood, but research suggests that sleep apnea in particular has an effect on sexual function in both men and women. It may <a href="http://well.blogs.nytimes.com/2011/10/10/really-the-claim-sleep-apnea-causes-sexual-problems/">drive down sex hormones</a> like testosterone in a way that can extinguish the flame for women and cause erectile dysfunction in men, according to the <em>New York Times</em>. And while the typical treatment -- a CPAP machine -- is not exactly an aphrodisiac, Dr. Michael J. Breus writes, it can help not only with sleep apnea, but <a href="http://www.huffingtonpost.com/dr-michael-j-breus/sleep-apnea_b_1661687.html">with the sexual side effects as well</a>.




  • Sleep Apnea May Increase Stroke Risk


    Researchers have long studied the link between the sleep disorder and the risk of stroke, but a small recent study found that 51 of 56 stroke patients evaluated -- or <a href="http://www.huffingtonpost.com/dr-michael-j-breus/sleep-apnea_b_1342311.html">91 percent of patients</a> -- had sleep apnea, Dr. Michael J. Breus wrote for HuffPost. More research is still needed to determine just what role disrupted breathing plays in this elevated risk.




  • Sleep Apnea Increases Accident Risk


    It's not rocket science -- excessive sleepiness during the day leads to sleepier drivers who are at a higher risk of crashing. But a 2008 study found that people with sleep apnea have double the risk of being in a car accident and are <a href="http://www.sciencedaily.com/releases/2008/02/080218214401.htm">three to five times more likely to be in a serious crash</a>. The study was the first to examine the severity of car crashes among people with sleep apnea, and found that even mild disordered breathing was linked to increased risk.




  • Sleep Apnea Is Linked To Pregnancy Complications


    Granted, Perry doesn't have to worry about this particular concern. While sleep apnea is often perceived as a problem predominately for men, <a href="http://www.huffingtonpost.com/2012/08/16/sleep-apnea-in-women-may-_n_1779127.html">women are not immune</a>. And, in fact, sleep apnea presents unique complications for women. A recent study found that women with sleep apnea were more likely to develop high blood pressure during their pregnancies, to require a C-section birth and their babies were more <a href="http://www.huffingtonpost.com/2012/09/21/sleep-apnea-in-pregnancy-_n_1903534.html">likely to be admitted to the neonatal intensive care unit</a>.




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