Implantable device to control sleep apnea wins FDA approval
The concept of even a single night of restful and uninterrupted shuteye is the stuff of dreams for people with sleep apnea. The disorder is defined by the interruption of regular breathing or obstruction of the airway during sleep, often associated with loud gasping breaths or snoring. Doctors say it can lead to an array of serious health complications.
Now the Food and Drug Administration has taken a step to help the snoring and chronically weary get a better night's sleep. The FDA has just approved the Inspire Upper Airway Stimulation, a neurostimulator device that's similar to a pacemaker. Inspire, which is implanted in the chest, has a small generator, a sensing lead and a stimulator. A patient also receives a remote control to turn the therapy on before bedtime and off in the morning. When the device is activated it senses the person's breathing patterns.
"We actually stimulate one of the nerves that goes to the upper airway by an implantable device, and this helps hold the airway open during sleep," Dr. B. Tucker Woodson of the Medical College of Wisconsin, told CBS News' Danielle Nottingham.
In clinical trial of the device on 126 patients, 68 percent experienced less sleep apnea and 70 percent had a reduction in oxygen desaturation as well as improved function in the daytime, according to the paper published in the New England Journal of Medicine in January.
Inspire has been approved for individuals with moderate or severe obstructive sleep apnea who are not able to use a Continuous Positive Airway Pressure (CPAP) device, the external mask that's often recommended for patients with the disorder. Many patients find the CPAP uncomfortable and don't use it consistently.
The company says that while the Inspire device is internal it's actually less invasive than other possible treatments, such as surgery.
According to the National Sleep Foundation, more than 18 million American adults have sleep apnea. The condition has a higher prevalence among men than women, and is most common with African American and Hispanic individuals.
Sleep apnea can increase a person's risk for a number of serious health conditions, such stroke, dementia, cardiac arrest and obesity.
Daniel McKee, who is enrolled in the Inspire study at the Medical College of Wisconsin, has struggled with sleep apnea for a number of years. "I complained to my doctor of daytime tiredness, I was just extremely exhausted throughout the day," he told CBS News. "I would wake up in the middle of the night, and couldn't tolerate it any longer."
McKee says the device has improved his quality of life - both in his dreams and when he's wide awake. "I sleep better at night, I wake up more refreshed. I don't snore anymore," he said.
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