A Pacemaker For Healthy Sleep

A new implant can help patients who have severe sleep apnea and can’t tolerate the CPAP machine

As a sleep specialist and pulmonologist for more than 30 years, James A. Daly III, MD, has seen a lot of fads come and go in his field. When he heard about a new device that could treat moderate to severe sleep apnea patients without a continuous positive airway pressure, or CPAP, machine, he waited for more data on outcomes.

“I was skeptical at first,” Dr. Daly recalls. “But doggone it, it has shown to work exceptionally well.”

The device, called Inspire, is a hypoglossal nerve stimulator that is implanted in the patient’s chest and uses sensors to make sure the person’s airways are open as they take a breath in. There’s no mask and no hose.

“Inspire is a very good option for certain patients,” Dr. Daly says.

Obstructive Sleep Apnea

Those patients often come to Dr. Daly because they or their spouse noticed that they snore loudly or stop breathing for a moment during sleep. This breathing disorder is called sleep apnea, and its more common type is obstructive, in which the throat collapses and blocks a person’s airways. Obstructive sleep apnea can cause:

• Daytime fatigue and sleepiness—easily falling asleep watching television, in meetings, or even while driving
• Morning headaches
• Dry mouth or sore throat
• Loud snoring (though not all snoring is caused by sleep apnea)
• Feelings of irritability or depression

Beyond these symptoms, untreated sleep apnea can put patients at risk for serious illness.

“Poor sleep and snoring is what brings people in,” explains otolaryngologist Tyler DeBlieux, MD, of Georgia Ear, Nose and Throat Specialists. “But there are silent aspects that patients may not perceive, including a higher risk of stroke and heart attack.”

Alternative To CPAP

A highly effective treatment for obstructive sleep apnea is the CPAP machine. The device sits by the bed and connects through a hose to a mask that the person wears throughout the night. The machine increases the air pressure in the throat to keep the airways open. The design of CPAP machines has improved significantly over the last 10 years, becoming quieter and allowing for a variety of masks for the best fit. It is still the most common treatment.

“I used to joke with patients that I’m a CPAP jockey,” Dr. Daly says with a laugh. “But there are some patients who can’t tolerate these forms of non-invasive therapy, whether it’s a CPAP or a dental appliance.”

With no mask to wear and no bedside machine to hook a hose to, the Inspire device may be a patient’s best option to keep their sleep apnea from being left untreated.

However, not all patients are appropriate for the device. For example, a person’s weight can affect how their airways collapse, so the device has shown not to be effective for patients with a Body Mass Index of 34 or higher. Dr. Daly will discuss the Inspire option with patients who appear to be good candidates and then will refer them to an ENT such as Dr. DeBlieux, who performs the procedure.

But first, Dr. DeBlieux performs a sleep endoscopy to confirm that the Inspire device will work successfully with the patient’s airways.  The hypoglossal nerve, which the Inspire stimulates, is part of the tongue. So if a patient’s airway collapse begins high up in the nose, the device won’t work.

How It Works

Once a patient is deemed a good candidate, Dr. DeBlieux can schedule the procedure, which is done on an outpatient basis, meaning the patient goes home the same day and typically experiences a quick recovery with minimal pain.

The Inspire is implanted in the patient’s chest, usually on the right side. Its placement and function is very similar to what the pacemaker does for the heart.

“The Inspire is a generator in the chest with two sensors,” Dr. DeBlieux explains. “One sensor goes down into the chest between the ribs. Every time you take a breath in, it sends a signal up through the neck to the other sensor at the hypoglossal nerve. As you breathe in, the stimulation moves your tongue forward, opening up the throat and alleviating the obstructive sleep apnea.”

The Inspire is controlled by a remote and can be pre-programmed to optimize its effectiveness while remaining comfortable for the patient. About six weeks after surgery, when the body is completely healed, the patient will return to Dr. Daly to go through a process called titration.

“We work with patients on operating the Inspire and also conduct a sleep study to make sure the device is working most effectively for that individual patient,” Dr. Daly says. “For example, for some patients the stimulation needs to start off lightly so that they can fall asleep, and then after a set amount of time, the signal can rise to its target level.”

Both Dr. DeBlieux and Dr. Daly have been impressed with the device’s programming ability to tailor treatment to what is best for each patient.

“You can even pause it if you get up to go to the bathroom,” Dr. Daly says. “Now that’s sophisticated!”

More Than Good Sleep

Improvement in sleep is clearly important, but for both Dr. Daly and Dr. DeBlieux it is the prevention of stroke and heart attack that makes this new option so crucial. They don’t want anyone to be left untreated due to the inability to use a CPAP machine.

“I had a patient who took a lot of convincing to wear a CPAP, and she gave me her best college try,” Dr. Daly recalls. “But then we talked about Inspire, and she was determined to be a candidate and received the implant. She uses it every night and couldn’t be more pleased.”