Sleep Apnea 101
Sleep Apnea Treatment Gets a Wake-up Call
New devices hold promise for some patients who can’t breathe freely at night.
By Tammy Worth
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Nearly 18 million Americans are affected by obstructive sleep apnea, a condition that causes them to stop breathing as many as 30 times an hour while sleeping. There are effective mechanical treatments for sleep apnea, but many patients don’t tolerate them well. For them, availability of new devices may be a dream come true.
A neurostimulation device, known as THN Sleep Therapy, from ImThera Medical, has been approved by the Food and Drug Administration (FDA) for clinical trials, which are currently recruiting people with moderate to severe sleep apnea.
Another alternative is a device, called Provent Therapy, that patients insert into their nose before sleep. It creates positive airway pressure for relief of sleep apnea without the use of a mask or machine.
The FDA approved a new treatment called upper airway stimulation in 2014. It involves use of an implantable device that acts as a nerve stimulator. The device senses when a person stops breathing during sleep and stimulates muscles in the airway to keep it open.
“This is a revolutionary advance in the treatment of sleep apnea. It is very, very different from CPAP (continuous positive airway pressure), a pressurized mask,” says Maurits Boon, MD, assistant professor in otolaryngology and head and neck surgery, and co-director of the Voice and Swallowing Center at Thomas Jefferson University Hospital in Philadelphia, who was not involved with the development of the new device but one of the first to start recommending it to patients. “It is very effective and, for the right patients, much better tolerated than CPAP,” Dr. Boon says.
The device is meant for people who failed prior CPAP treatment, and have moderate to severe apnea, or are not willing to use CPAP. Potential adverse events that patients experienced during trials included uncomfortable tongue stimulation, and tongue weakness.
The sleep apnea treatment device, made by Minneapolis-based Inspire Medical Systems, is implanted during outpatient surgery. Patients turn it on before bed, and off when they wake, using a handheld remote. A small device implanted under the armpit tracks breathing patterns. When breathing stops, it tells another device implanted below the chin to stimulate muscles with an electrical signal, and keep the airway open.
Limitations of CPAP for Sleep Apnea
"Many of my patients struggle with CPAP," says Robert Rosenberg, DO, FCCP, sleep physician in private practice in Prescott Valley and Flagstaff, Arizona, and author of . "We work with them diligently and are usually successful. Sometimes a different type of mask or changing the pressure from the machine does the trick," says Dr. Rosenberg. But sometimes, he looks for alternative treatments like those mentioned above, or counsels patients to lose significant amounts of weight.
For some time, CPAP has been the go-to treatment for sleep apnea. The small machine provides air pressure to a mask that forces the airway open so patients can breathe more easily while sleeping.
CPAP is an effective treatment for most patients, but is not always comfortable for them. The air can cause severe dryness in the nose and mouth. Being strapped to a machine and wearing a large facial mask can make sleeping a challenge. In Rosenberg's experience, about 40 percent of patients on CPAP are not wearing it after one year.
Because of these issues, patients often don’t stick with a CPAP prescription. After four years, only about half of patients advised to use CPAP were still on the therapy, a small study found. Other studies have found that up to 83 percent of patients don’t wear the mask long enough, or they only use it occasionally.
For people who don’t respond to CPAP, surgery can sometimes be an option. It is only used in extreme cases and alters a person’s soft palate, tongue, jaw, uvula, or tonsils, depending upon the cause of the condition.
Patient Experiences With a Sleep Implant
Ivy Abersoll, a 70-year-old from Aitkin, Minnesota, had such severe sleep apnea that she couldn’t drive 30 miles without having to stop and take a nap. She would fall asleep before she could finish reading a single newspaper article and would nod off in the middle of conversations. Sleep tests showed she would stop breathing for more than a minute, take a few breaths, and then stop again repeatedly during the night.
Abersoll’s symptoms were similar to those of many others with sleep apnea. People with the condition can experience:
- chronic snoring
- sleep deprivation
- concentration and memory problems
- falling asleep at inappropriate times
The condition can also raise a person’s blood pressure and risk of heart attack, heart failure, and stroke.
Abersoll had used a CPAP, but says she never felt 100 percent in the morning. She would wake up with burning and sores inside her nose. The mask didn’t fit well and she never felt like she could get enough sleep.
Three years ago, Abersoll heard about a clinical trial for the new product, called Inspire upper airway stimulation therapy, and she jumped at the chance. She had the device implanted and said the choice changed her life.
“Now I’m awake in five hours and ready to go,” she says. “My head isn’t always foggy … life is normal for me now and I didn’t know what normal was before.”
Chris Wirtz, a 64-year-old from Cleveland, had surgery for her sleep apnea, but it was ineffective. She had also used the CPAP, but wasn’t happy with the machine. She even lost weight with the hope she would be able to go off of CPAP, but her doctor told her she would always need to wear the device.
“It’s odd having something stuck to your face at night,” Wirtz says. “I was closing in on 60 and this is not how I wanted to spend the rest of my life.”
Wirtz had the upper airway stimulation device implanted and says the change is like “day and night.” She feels great in the morning and enjoys being able to “roll all over the place” when she sleeps. She touts the treatment to her co-workers and her family. Wirtz was part of a clinical trial for the treatment, and her husband had hoped to joined her. He, however, didn’t qualify.
Are You a Candidate for an Implant?
Only 10 percent to 20 percent of sleep apnea patients are eligible to use the upper airway stimulation implant, Boon says. Patients who qualify must have:
- moderate to severe sleep apnea
- a body mass index (BMI) of 32 or less (a BMI over 30 is considered to be obese)
- the type of anatomy of the mouth and throat that will respond to the treatment
“It is not for every patient, but for those that it will work with, it is a home run,” says Boon.
Early study results on the implant have been promising. A study reported in the New England Journal of Medicine in 2014 included 126 patients. It was sponsored by the device manufacturer, but reviewed by independent physicians. By one year after the device implant, participants’ numbers of apnea episodes per hour had decreased by 68 percent. The number of times their blood oxygen levels dropped dramatically per hour also decreased by 70 percent. Participants’ also reported a better quality of life. Fewer than 2 percent of patients reported serious adverse events.
The implant and other new devices offer the patient additional options, says Rosenberg. "However people need to realize that the Provent device is, although relatively inexpensive, rarely covered by insurance.
Video: Waking up to Sleep Apnea
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