FDA Approves New Technology for Sleep Apnea

Do you suffer from obstructive sleep apnea, but are unable to use the CPAP mask that helps keep airways open using mild air pressure?

The U.S. Food and Drug Administration (FDA) recently approved a new type of sleep therapy called Inspire Upper Airway Stimulation (UAS) that is especially designed for folks, who are unable to use the CPAP (Continuous Positive Airway Pressure) machine for different reasons, according to Jeremy Tabak, M.D., medical director of Baptist Sleep Center at Galloway and Baptist Hospital’s Sleep Diagnostic Center.

The FDA approval of the device quickly followed a New England Journal of Medicine study that showed the efficiency and effectiveness of the new device, Dr. Tabak says.

What’s more, Baptist Health is in the process of evaluating patients who might qualify for this innovative treatment, according to Rolando Molina, M.D., an ear, nose and throat surgeon affiliated with Baptist Health. 

What is obstructive sleep apnea?

Approximately, 18 million Americans have obstructive sleep apnea (OSA), according to the National Sleep Foundation.

OSA is a common sleep disorder that involves lapses in breathing during sleep. OSA occurs when muscles relax when you’re asleep, which causes the soft tissue in the back of the throat to collapse and block the airway. Pauses in breathing can last from 10 seconds to a minute or more, and end when the body briefly awakes to gasp for air. This cycle continues all night long. A person with severe OSA may stop breathing hundreds of times throughout a night

Why is sleep apnea a potential health risk?

Research shows that an individual with poorly managed OSA is at increased risk for heart attack, stroke, weight gain, high blood pressure, heart failure and falling asleep while driving. Sleep apnea can also be disruptive to one’s everyday activities, causing depression, spousal issues, irritability and daytime fatigue.

What are the current treatment options?

If you have sleep apnea, your physician may recommend one of the following options: weight loss, oral (dental) appliances, surgery to remove obstructions, or the use of the CPAP machine and mask.

“A high percentage of patients — about 50 percent — are not compliant with the CPAP mask,” Dr. Molina says.

What is the newly approved therapy?

The Inspire therapy — the first of this kind — works by stimulating the tongue at the back of the throat, thereby clearing away blockage created by the tongue during sleep, Dr. Tabak says.

The process involves three components:

• A neurostimulation device the size of a pacemaker, implanted in the chest area during surgery.
• A sensor that detects your chest movements
• An external remote, a small, hand-held device that turns the therapy on before sleep.

“When activated, Inspire therapy senses breathing patterns and delivers mild stimulation to key airway muscles, which keeps the airway open during sleep,” according to a statement from the manufacturer.

Who is a candidate for this type of treatment?

Patients must meet several criteria to qualify for the neurostimulator device, including unsuccessful attempts to use the CPAP machine. What’s more, your doctor must determine if your tongue is blocking airways during sleep. If that is the case, and you are moderately overweight with a Body Mass Index no higher than 32, you might be a candidate.

“This new technology is not meant to replace the CPAP machine,” Dr.  Molina says. “If your existing therapy works for you, you should continue.”