PITTSBURGH, Pa. (Ivanhoe Newswire) – As many as 18 million Americans suffer from sleep apnea. It causes them to repeatedly stop breathing during sleep, leading to daytime fatigue and an increased risk of heart attack, stroke, and high blood pressure. Now, help is on the way.
Every night for five years, Kathy Gaberson donned a facemask — connected to hoses and compressed air. This continuous positive airway pressure machine, or CPAP, was the best treatment available for Gaberson’s sleep apnea, which had been steadily wrecking her health.
“I was driving my car locally and stopped at a stop sign and fell asleep at the stop sign,” Gaberson told Ivanhoe.
Dr. Ryan Soose is studying a new implantable device, the Inspire upper airway stimulation therapy.
“The device itself is a pacemaker-like device that is placed just under the skin of the right upper chest,” Ryan Soose, MD, Director, University of Pittsburgh Medical Center Division of Sleep Surgery, told Ivanhoe.
The Inspire is connected to an electrode that stimulates the nerve of the tongue, preventing the narrowing of the throat.
“The patient has a remote control to turn it on and off when they want to use it,” Dr. Soose said.
Gaberson felt a slight tingling in her throat when the device turned on, but said the feeling didn’t keep her from getting great sleep for the first time in years.
“I woke up in the morning refreshed,” Gaberson explained.
A study from the New England Journal of Medicine reports that two-thirds of the patients using the upper airway stimulation device had control of their sleep apnea, meaning less daytime sleepiness, improvements in snoring, and better quality of life.
The batteries can last about five to ten years, and there is a simple procedure to replace them when they do run out.
BACKGROUND: Over 18 million Americans suffer from sleep apnea. Sleep apnea is a sleep disorder characterized by abnormal pauses in breathing or instances of abnormally low breathing, during sleep. Each pause in breathing, called an apnea, can last from a few seconds to a few minutes, and may occur 5 to 30 times or more an hour. When this happens it means that the brain and the rest of the body may not get enough oxygen. Sleep apnea is diagnosed with an overnight sleep test called a polysomnogram, or "sleep study." If left untreated, sleep apnea can lead to high blood pressure, stroke, heart failure, heart attacks, diabetes, and depression. (Source: http://www.webmd.com)
CAUSES: Sleep apnea can be caused by excess weight, neck circumference, and some other causes include:
• A narrowed airway
• Being male
• Being older
• Family history
• And race in people under 35 years old, blacks are more likely to have obstructive sleep apnea.
Standard treatments can include weight loss, upper airway surgeries, oral appliances, and continuous airway pressure (Source: www.mayoclinic.com)
NEW TECHNOLOGY: The Inspire upper airway stimulation therapy is kind of like a pacemaker. It’s placed under the skin in the right upper chest. There’s a sensor that monitors the patients breathing. It’s connected to an electrode that stimulates the nerve in the tongue which prevents the narrowing of the throat. It delivers stimulation to the hypoglossal nerve timed to each breathing cycle. Some patients may feel a slight tingling in the throat. The device is permanent. After one year, patients had a 70 percent reduction in sleep apnea and significant reductions in daytime sleepiness. (Source: University of Pittsburgh)
Ryan Soose, MD, Director of the Division of Sleep Surgery and Assistant Professor of the Department of Otolaryngology at the University of Pittsburgh School of Medicine, talks about the Inspire device for sleep apnea.
What’s happening to a patient who has sleep apnea?
Dr. Soose: During sleep everyone's throat, what we call the upper airway, gets a little bit narrower and more collapsible. But in some people, for a whole variety of reasons and factors, that throat or upper airway gets too narrow and too collapsible where it starts to vibrate and that’s the noise of snoring. And in others it gets narrow enough where it actually starts to restrict airflow, which then can increase the work of breathing, drop oxygen levels, disrupt sleep, and raise your blood pressure. That’s when we call it sleep apnea.
So this is really a quality of life issue as well?
Dr. Soose: Sleep apnea has a major impact on quality of life and it has also been shown to affect work productivity as well as moodiness and irritability. It may even cause unnecessary marital strain requiring separate bedrooms as a result of the snoring. In addition to the health risks that have been documented, sleep apnea in many patients has a major impact on their functioning quality of life.
What are the treatments?
Dr. Soose: The most common treatment at this point is CPAP or continuous positive airway pressure. CPAP by far has the most research of being the most effective tool at both improving the symptoms and quality of life as well as lowering those health risks. CPAP is a mask connected to a machine that applies positive pressure. It’s basically an air compressor that adds pressure to each breath that the patient takes. The narrow and collapsible airway is then propped open with air pressure. Although it has by far the most research behind it, only about half of the patients are able to tolerate it and use it on a regular basis to achieve those results.
Why is that?
Dr. Soose: The reason that many patients are unable to achieve benefit or tolerate the CPAP has to do with a whole variety of factors. Many patients have side effects due to the mask and the air pressure and the equipment itself. The discomfort and/or sleep disruption from the equipment itself often then results in continued sleep disturbance and an inability to continue to use it long term.
How does the Inspire device work?
Dr. Soose: The Inspire device works primarily by sending a gentle stimulation to the nerve that works the tongue. The device itself is a pacemaker-like device that’s placed just under the skin of the right upper chest. There’s a little sensor that monitors the patient’s breathing patterns during the night and there’s gentle stimulation then applied to the nerve of the throat based on those breathing patterns. The device itself is connected to an electrode that stimulates the nerve of the tongue. When patients are awake it feels like a gentle tingling or stimulation of the tongue itself, however it is not painful. And the device is completely controlled by the patient. So it’s off during the day not doing anything at all and the patient has a remote control to turn the device on and off when they want to use it during sleep.
What if the patient forgets to turn it on?
Dr. Soose: If the patient forgets to turn it on it would be very similar to not putting in your mouth piece or not using your CPAP machine. We hope with further advances in technology the devices down the road will be able to automatically come on when the patient goes to sleep and even auto adjust during the night. But at this point in time the device requires the patient to turn it on with a remote control and then when they wake up in the morning they turn it off.
You described it again as a like a tickling almost; wouldn’t that keep patients awake?
Dr. Soose: Right, one of the early concerns when this technology was developed years ago was that the stimulation itself will keep patients awake. But we have a lot of good research now over the years and prior feasibility studies as well as the new New England Journal of Medicine article which show the stimulation itself does not cause arousals or disruptions from sleep.
Is this for someone with serious sleep apnea?
Dr. Soose: The patients that seem to benefit most in this research study were patients with moderate to severe sleep apnea who were intolerant and unable to achieve benefit with CPAP therapy.
What are the benefits to having this therapy to other therapies?
Dr. Soose: The inspire upper airway stimulation therapy differs from traditional medical devices like CPAP or dental devices in that the device itself is implanted under the skin so there’s no external hardware. It does not involve strapping anything on to the face or putting a mouth piece inside the mouth, which is where a lot of the discomfort and side effects occur with those other devices. At the same time it’s also a surgical treatment, however it differs from other traditional surgeries in that there is no cutting or rearranging of tissue inside the throat. This is all external to the throat and just implanted under the skin. Because of that, the invasiveness and risk of the procedure is far lower than what we have seen with traditional surgical techniques. The recovery of this procedure was quite minimal with very little discomfort and little down time compared to most of the traditional airway surgeries that are done inside the throat or with the jaw structure.
This is designed to be a permanent structure within the body?
Dr. Soose: The Inspire device itself is technically reversible meaning the device could be removed if needed or was no longer functioning, however it is designed to be a long term or indefinite treatment option. The current battery life we estimate is roughly five to ten years which is similar to other pacemaker devices.
When a battery runs out is it a matter of an operation to replace it or how does that work?
Dr. Soose: In five or ten years if and when the battery needs to be replaced there’s a pretty simple procedure to update and swap out that technology.
Is it a game changer?
Dr. Soose: This is a very fascinating and new way to treat sleep apnea and I really think it is a game changer. Inspire therapy is certainly not a ‘fix-all’ and is not for every patient with sleep apnea, however, it is a very promising new therapy and I think it will make a nice addition to the other tools in our tool box to allow us to successfully treat patients.