UF Health becomes first in the region to treat sleep apnea with FDA-approved implant

University of Florida Health has become the first health system in the region to offer a new Food and Drug Administration-approved upper airway stimulation device to help patients suffering from moderate to severe obstructive sleep apnea.

The first procedure was successfully completed on Oct. 27 by John D. Harwick, M.D., FAAOA, a board-certified otolaryngologist in head and neck surgery at UF Health ENT Allergy – Hampton Oaks and the sole physician at UF Health trained to implant the device at this time.

“Some of the most common daytime complaints for those suffering from obstructive sleep apnea are fatigue, inability to concentrate and irritability because of a disrupted sleep cycle,” Harwick said. “CPAP, although very effective, is difficult for many patients to use. For the right patient population, the implant is very effective in treating this condition.”

More than 18 million Americans are estimated to have obstructive sleep apnea, a sleep disorder that occurs when patients intermittently stop breathing during sleep, according to the National Sleep Foundation. When this occurs throughout the sleep cycle, sleep is disrupted, resulting in daytime fatigue and increased risk for heart disease, high blood pressure and stroke.

The condition, which occurs when throat muscles relax during sleep and block a person’s airway, is treatable. However, according to a study conducted in Canada, approximately one-half of individuals with sleep apnea do not comply with the most common form of therapy — continuous positive airway pressure, or CPAP, a mask that delivers air pressure and is worn while sleeping.

The new stimulation device, produced by Inspire Medical Systems Inc, is similar to a pacemaker and consists of three components: a small generator, a breathing sensor lead and a stimulation lead which is placed over the hypoglossal nerve in the upper neck. The device stimulates nerve branches in the tongue to keep a person’s airway open during sleep. All three parts are controlled by a handheld sleep remote that is turned on to activate the therapy during sleep. Once implanted, the device monitors a person’s breathing and sends a mild stimulation to the nerves of the tongue when it notices a cessation of breathing.

UF Health is one of only three academic centers in Florida with staff trained to use the technology.

“As an academic research institution, we are fortunate to have access to these new and innovative tools that will tremendously impact the lives of those suffering from obstructive sleep apnea,” Harwick said. “Patients are likely to see a significant increase in their quality of life and decrease in cardiovascular risks.”

As part of the therapy, staff members at the UF Health Sleep Center also monitor each patient’s breathing pattern. Thirty days after the implant is placed, the patient is seen at the center to program the device based on the patient’s sleep study results.

To qualify for the procedure, candidates must have been diagnosed with moderate to severe obstructive sleep apnea, must be age 22 or older, cannot use CPAP and must have a body mass index of 32 or less.