Patients complain that the CPAP machines are noisy and the masks are uncomfortable.
There may soon be several new treatments for sleep apnea patients to choose from. None involve the annoying face mask from a CPAP machine.
The major therapy for sleep apnea, a condition in which people stop breathing during sleep, is CPAP, or continuous positive airway pressure. With CPAP, patients breathe in pressurized air through a face mask attached to a hose and bedside pump. While it has proved remarkably effective, anywhere from 30% to more than half of patients can’t or won’t use CPAP as directed by their doctors, studies say. Some patients complain that the machines are noisy and the masks are uncomfortable.
The new treatments include nasal attachments, devices that suck the tongue forward and surgical implants that deliver stimulation to a nerve near the base of the tongue.
Doctors see these as alternatives—rather than replacements—for CPAP. In studies so far, the new therapies haven’t been directly compared with CPAP, but their efficacy rates aren’t as high. “While they all are promising treatments, I would say CPAP, CPAP, CPAP,” says Robert Basner, director of the cardiopulmonary sleep and ventilatory disorders center at Columbia University Medical Center. (He received a research grant from a CPAP manufacturer in 2011.)
For many patients with obstructive sleep apnea, during sleep the soft palate and the tongue relax back into the airway, closing it off. Blood oxygen levels drop. The person is momentarily jolted awake, what’s called a partial arousal, and breathing is restored. This can happen dozens of times each hour. With CPAP, pressurized air is blown into the nose and mouth, keeping the airway open.
Debbie Hart was diagnosed with sleep apnea six years ago and her doctor prescribed her a CPAP machine to treat it. CPAP “was just extremely uncomfortable,” says the 61-year-old from Plano, Texas, who is retired from her family’s financial-services business. “I didn’t like it because it went over my nose and mouth and I have a little claustrophobia.” She also wasn’t a fan of the strap marks the device left on her face when she woke up in the morning. “There were some vanity issues,” she says. She abandoned the CPAP machine after about three months.
Last year, Ms. Hart saw a different sleep medicine specialist who was participating in a clinical trial of the Winx sleep therapy system, manufactured by ApniCure Inc., a medical device company based in Redwood City, Calif. She says Winx works for her.
Winx, which was approved by the Food and Drug Administration in March 2012, uses negative pressure to pull the soft palate and tongue forward, which opens the airway. Patients wear a flexible mouthpiece—it looks a bit like an athlete’s mouth guard—attached to a slim piece of tubing and a bedside console.
In company-funded studies, Winx worked for about half of the patients who tried it. It is best for people whose apnea is caused by a collapse of the soft palate. (It is hard for patients to know exactly where the airway collapse is occurring.)
The company plans to unveil a new version in 2014 targeted at a wider population of apnea patients, says Matt Vaska, founder, chairman and chief technology officer of ApniCure. He invented Winx after his father was diagnosed with sleep apnea.
Only a handful of insurance companies now cover Winx, which costs about $1,000, and the device is only available in limited markets, including Columbus, Ohio, and Syracuse, N.Y. ApniCure expects Winx to be more widely available in 2014.
Some sleep therapists say they are intrigued by a new therapy that is also the most invasive. At least two companies are testing implantable devices that keep the airway open during sleep by stimulating the hypoglossal nerve, which runs just beneath the base of the tongue. The device is surgically implanted under the skin of the chest. One lead extends to the middle of the chest and another extends up to the neck and encircles the hypoglossal nerve.
During sleep, the device electrically stimulates the nerve with each round of breath. Patients use a remote control to turn the device on when they’re ready to sleep and off after waking up. (They can feel a tingling sensation or mild muscle contraction when they turn it on.)
Inspire Medical Systems Inc., a device maker in Maple Grove, Minn., is testing one of the nerve stimulation systems. Its device’s battery is expected to last between eight and 10 years, says Randy Ban, senior vice president, external operations.
Small, initial studies have shown that Inspire’s device is most effective for a subset of patients who have a certain type of soft-palate collapse and are not significantly obese. There is a risk of infection and the device can malfunction, the studies show. Inspire’s device is approved in Europe; the company is applying for FDA approval. Another company, San Diego-based ImThera Medical Inc., is testing a similar therapy.
Some doctors expect that the implantable devices will only be appropriate for patients with severe apnea who can’t tolerate CPAP. There’s also some concern about potential long-term side effects of continuously stimulating the hypoglossal nerve.
Another alternative to CPAP takes only a few seconds to put on. Provent, which was approved by the FDA in 2008 and requires a prescription, sticks onto the nostrils. (A patient applies a new pair each night.) It uses what is called EPAP (for expiratory positive airway pressure). The device, manufactured by San Jose, Calif.-based Theravent Inc., has tiny valves that open when patients breathe in and close when they breathe out, creating pressure that props the airway open. A monthly supply costs about $65, though it isn’t generally covered by insurance.
It doesn’t work for people who breathe through their mouth. Theravent has also unveiled a similar device, though with a lower level of resistance, for snoring. The FDA approved it in 2012, and it is available without a prescription.
Doctors note that CPAP itself has improved greatly in recent years. Masks are smaller and more comfortable and newer models include quieter motors and hydrated air. “The old machines we used to tell people [sounded like] a window fan, but it really was a window fan with noisy blades,” says M. Safwan Badr, professor and chief of the division of pulmonary, critical care and sleep medicine at Wayne State University School of Medicine, and president of the American Academy of Sleep Medicine. “Now you barely hear it.” Other traditional treatments for sleep apnea include dental devices that move the lower jaw forward and surgery to remove airway obstructions.
About 18 million Americans have sleep apnea, according to the National Sleep Foundation, a nonprofit research and advocacy group. The major symptoms are loud, frequent snoring and sleepiness during the day. Those who are obese and have health conditions like heart failure and diabetes are at greater risk.
A growing body of research shows that sleep apnea markedly raises the risk of heart disease and stroke. People with the condition are also more likely to suffer from depression and be in car accidents.
“We used to think it was more of a nuisance. Now we know it affects quality of life and quantity of life,” Dr. Badr says.
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