An implant is offering a new form of relief for people struggling to sleep through the night because of obstructive sleep apnea.
Those with the condition often snore loudly or gasp for air when their throat collapses, temporarily cutting off the airway – a problem that can occur hundreds of times a night and prevent adequate oxygen from getting to the brain and body.
An upper airway stimulator, called Inspire, can now help sufferers breathe normally by sending an electrical signal to the nerve that controls the back of the tongue, said Dr. Rachel Cain, a partner with Southwestern Colorado Ear, Nose and Throat Associates at Mercy Regional Medical Center.
“It gives the tongue just enough muscle tone to keep it from falling back in to the throat and obstructing the airway,” said Cain, a surgeon.
When an airway is cut off, someone with sleep apnea will wake up, sometimes fully or sometimes just enough to allow some stimulation to the neck muscles, she said.
The constant disruption of sleep can leave people chronically fatigued and increase the risk of heart attack, stroke, dementia, memory loss and premature death, she said.
Clinton Pribble, 42, has obstructive sleep apnea and sometimes wakes up gasping for air and with numbness in his extremities. Like many others with the condition, he also snores, the Bloomfield, New Mexico, resident said.
“You wake up with a sore throat from snoring so hard,” he said.
People who receive effective treatment can see the quality of their sleep improve as well as the quality of their life.
Often, life gets better for a patient’s bed partner, too, Cain said.
“Someone lying next to their bed partner who is snoring and gasping for air and not breathing all night and flopping around – that’s a big issue,” she said.
An alternative to CPAP machinesAbout half of the patients who come to Cain’s clinic because they are snoring have sleep apnea, she said. Nationally, more than 18 million adults have the condition, according to the American Sleep Foundation.
The most common treatment option for people with obstructive sleep apnea is a machine that keeps the airway open by blowing air into the upper airways through a mask or nosepiece. In some cases, patients may have surgery to help open the airway. For example, some patients, children in particular, may need their tonsils removed to help open their airway.
However, the continuous positive airway pressure machines, also called CPAP machines, work for only about half of the patients who need them, Cain said.
Patients may have claustrophobia, take the CPAP mask off while sleeping or wake up frequently because of the machine, she said.
Pribble tried the CPAP machine, but he didn’t like fighting with its hose.
“I would wake up with it blowing in my face. It just was more of a hassle,” he said.
He also tried a device to pull is tongue forward and one to pull his jaw forward, he but didn’t like those either.
That’s part of the reason why he is interested in getting an Inspire implant, he said. He expects to have the device put in after the first of the year.
A five-year clinical trial of 126 patients found the implant significantly reduced the number of times each hour patients’ airways closed, from 30 to about 9 events in the first year, according to a study published in the New England Journal of Medicine.
Cain received approval from Mercy to start surgically implanting the device. Since then, she has completed one surgery in Durango and other patients are waiting to have the procedure done. She also completed the procedure as a resident at the Mayo Clinic in Phoenix.
To determine if a patient is a good fit for the device, she will put a flexible fiber-optic camera into a patient’s nose and down into the airway while they are sleeping so she can see how the throat is collapsing.
In general, as long as stimulation of the muscles in the back of the tongue will open the throat, the Inspire device will be effective, she said. However, it cannot open throats that are closing concentrically, she said.
How the implant worksTo implant the device, Cain must make three incisions to put in the machine’s three components.
The nerve stimulator is placed around the hypoglossal nerve in the upper neck, right under the jaw, she said.
A generator is placed in the upper chest to send an electrical pulse to the nerve. A sensor is placed near the ribs so that it can signal to the generator that the patient is about to take a breath so the generator can send an electric pulse. The three components are connected by flexible wires that run underneath the skin.
Once implanted, patients control the device with a remote control.
Patients turn the device on before going to sleep, but it doesn’t start working right away. The devices are pre-programmed with a delay that allows patients to go to sleep before they start working.
The generator is also programmed to automatically turn off after a certain period, in case the patient loses the remote, she said.
If left on, the device could make it difficult to speak because the patient doesn’t have full control of their tongue, she said. Tongue discomfort is also one of the most common side effects, however, most patients do not experience discomfort after healing from surgery.
To help patients adjust to the stimulation at night, Cain will set the implant at the lowest voltage setting at first.
About two months after the procedure, patients will come in for an overnight sleep study to adjust the voltage of the device, she said.
While the device is still relatively new, more major medical centers nationally are embracing it and so are insurance companies, she said.
Without insurance, the device can cost about $30,000, the CEO of Inspire Medical Systems told the Minneapolis Star Tribune.
Cain will work with patients to request prior authorization from insurance companies to cover the procedure, she said.
mshinn@durangoherald.comThis story has been updated to correct the name of the Minneapolis Star Tribune.