Morton Plant Mease in Study of New Sleep Apnea Treatment

Implantable Device Designed to Offer Relief for Patients 

CLEARWATER, Fla., (October 14, 2015) -- The Sleep Disorders Centers at Morton Plant Mease HealthCare are participating in a clinical trial to determine whether a novel medical device might help people who have moderate to severe obstructive sleep apnea and who are not finding relief through positive airway pressure (PAP) therapy or other treatments.

The clinical trial will test a method for treating obstructive sleep apnea called targeted hypoglossal nerurostimulation (THN) therapy. The study utilizes the aura6000 System™ from ImThera Medical Inc., an implantable device that delivers mild electrical pulses to the hypoglossal nerve, which controls the muscles of the tongue.

“As the nerve is stimulated, it increases muscle tone to the tongue so that it does not fall back into the airway,” said Dr. Mitchell Miller, Principal Investigator for the study site. “This device is designed to make it easier for air to flow through the airway, allowing people to sleep with fewer interruptions.”

In people with obstructive sleep apnea, their breathing pauses during sleep because the airway has become narrowed or blocked. Loud snoring can be a sign of sleep apnea, but not everyone who snores has sleep apnea. Other factors that may increase risk include: obesity; large neck or collar size (17 inches or more in men, and 16 inches or more in women); and large tongue.

Left untreated, sleep apnea can cause anxiety and depression; poor performance at work or school; and daytime sleepiness. Untreated obstructive sleep apnea may lead to or worsen heart disease, heart arrhythmias, heart failure, high blood pressure, diabetes or stroke.

“We know that sleep apnea can cause or exacerbate serious health problems,” said Dr. Miller. “We are proud to be the only site in Florida using the aura6000 System™ and offering patients who have not found relief elsewhere an opportunity to try this new approach.”

The aura6000 implantable device can be turned off with a handheld remote control during the day. The device is about the size of a wristwatch face and is implanted under the skin above the collar bone during surgery.

Study participants must be 18 or older, have moderate to severe obstructive sleep apnea, and not able to tolerate PAP therapy or alternative treatments (oral appliances, positional devices or surgery). Potential participants are not able to be implanted if they have another active, implantable device or have body mass index (BMI) of 35 or higher. Certain other medical conditions may also exclude study participation.

About Morton Plant Mease
Nationally recognized for health care excellence, Morton Plant Mease Health Care is dedicated to providing community owned health care services that set the standard for high-quality, compassionate care. Morton Plant Mease Health Care is comprised of the following hospitals – Morton Plant, Clearwater; Mease Dunedin, Dunedin; Mease Countryside, Safety Harbor and Morton Plant North Bay, New Port Richey. For more information about Morton Plant Mease, go to baycare.org/about-us/morton-plant-mease

About BayCare Health System
BayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 13 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. Inpatient and outpatient services include acute care, primary care, imaging, laboratory, behavioral health, home care, and wellness. Our mission is to improve the health of all we serve through community-owned, health care services that set the standard for high-quality, compassionate care. For more information, visit BayCare on the Web at www.BayCare.org