SYS-CON MEDIA Authors: Liz McMillan, Sean Houghton, Glenn Rossman, Ignacio M. Llorente, Xenia von Wedel

News Feed Item

New England Journal of Medicine Study Finds Upper-Airway Electronic Stimulation Effective for Obstructive Sleep Apnea

UH Case Medical Center one of U.S. and European clinical trial sites showing marked improvements for sleep apnea sufferers

CLEVELAND, Jan. 8, 2014 /PRNewswire/ -- Results published in a new study in the Jan. 9 issue of the New England Journal of Medicine report that mild electronic stimulation therapy to the upper airway during sleep is effective in reducing obstructive sleep apnea (OSA).

In the Stimulation Therapy for Apnea Reduction (The STAR Trial) study, researchers tested an implantable electronic stimulation device called Inspire™ Upper Airway Stimulation (UAS) therapy, designed to significantly reduce the burden of obstructive sleep apnea by delivering stimulation to the hypoglossal nerve timed to each breathing cycle. The mild stimulation is intended to restore tone during sleep to the muscles that control the base of tongue, preventing the tongue from collapsing and obstructing the airway during sleep. 

"This device is a first-of-its-kind therapy and has the potential to help the many people suffering from moderate to severe sleep apnea who are unable to use or cannot tolerate CPAP (continuous positive airway pressure)," said Kingman Strohl, MD, senior author of the study and pulmonologist at University Hospitals Case Medical Center and Professor of Medicine at Case Western Reserve University School of Medicine. "At a year following surgical implantation, patients experienced substantial decreases in the number of interruptions of sleep by apnea, and improvements in symptoms of waketime sleepiness, snoring and quality of life."  Lead author is Patrick J. Strollo, MD, of the Division of Pulmonary Allergy and Critical Care Medicine at the University of Pittsburgh.

The Phase III safety and efficacy study was conducted at multiple American and European clinical sites.  There were 126 participants, 83 percent of whom were men. To enroll, the research participants had to have moderate to severe sleep apnea and be unable to accept or adhere to CPAP therapy.  In addition, the patients could not be too heavy (a BMI less than 32), a range of apneas severity in the moderate to moderately severe level, and evidence that the sleep-related obstruction might be at the level of the tongue. 

"These selection criteria require careful team assessments of each patient by the surgeon and the sleep specialist," Dr. Strohl said.  "And to optimize the stimulation there was a new skill needed in the sleep laboratory to adjust the electrical stimulation over a couple of nights."

Objective outcomes were measured on two scales:  The apnea-hypopnea index (AHI; the number of apnea or hypopnea events per hour) and the oxygen desaturation index (ODI; the number of times per hour of sleep that the blood oxygen level drops by more than four percent). At 12 months, the median AHI score decreased 68 percent and the ODI score decreased 70 percent. Most participants reported a reduction of sleep apnea effects and improved quality of life. 

After the 12-month assessment, a substudy compared 23 participants who continued with the therapy compared with 23 participants who had the therapy withdrawn for a week.  The withdrawal group experienced a sharp rise in their median AHI score, along with snoring and fatigue, indicating that the stimulation by the device was the agent for effectiveness.

According to Dr. Strohl, the results are very encouraging. "While many patients have found help with CPAP, some patients struggle with CPAP or cannot tolerate the mask, and thus remain untreated," he said.  "The severity of OSA in this group might not be easily managed by oral appliance or surgery.  Upper-airway stimulation could provide an effective alternative," he said.

At home, patients control when the Inspire therapy is turned on and off using a handheld programmer.  In contrast to other surgical procedures to treat sleep apnea, Inspire therapy does not require removing or permanently altering an OSA patient's facial or airway anatomy. 

More than 18 million Americans suffer from OSA, which is characterized by repeated episodes of upper airway collapse during sleep. Patients with OSA stop breathing frequently during sleep, often for a minute or longer. Daytime sleepiness, depression, weight gain, increase in industrial accidents and diminished quality of life are all commonly observed in people who suffer from OSA as a result of fragmented sleep patterns.  

"Studies have shown that sleep apnea is as prevalent as adult diabetes and asthma and the consequences of OSA range from disruptive to life-threatening cardiac problems," said Dr. Strohl, principal investigator for the UH Case Medical Center site.  Phase II safety and planning studies were performed at the Louis Stokes Cleveland VA Medical Center.  For the Phase III efficacy STAR trial, seven patients participated from UH Case Medical Center. Jonathan Baskin, MD, Clinical Assistant Professor of Otolaryngology and Head & Neck Surgery at Case Western Reserve University School of Medicine and at both the Louis Stokes Cleveland VA Medical Center and UH Case Medical Center, performed pre-surgical assessments and the implantation for both studies.

All data on Inspire UAS therapy are under regulatory review by the FDA. There is a provisional approval for the therapy in Europe. "We expect a careful assessment by the FDA for this first in-class therapy," said Dr. Strohl. The study was funded by Inspire Medical Systems. 

About University Hospitals
University Hospitals, the second largest employer in Northeast Ohio, serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians in 16 counties. At the core of our health system is University Hospitals Case Medical Center, one of only 18 hospitals in the country to have been named to U.S. News & World Report's most exclusive rankings list: the Best Hospitals 2013-14 Honor Roll. The primary affiliate of Case Western Reserve University School of Medicine, UH Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopaedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University. UH Case Medical Center is the 2012 recipient of the American Hospital Association – McKesson Quest for Quality Prize for its leadership and innovation in quality improvement and safety. For more information, go to www.uhhospitals.org

SOURCE University Hospitals Case Medical Center

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Verizon Enterprise Solutions is simplifying the cloud-purchasing experience for its clients, with the launch of Verizon Cloud Marketplace, a key foundational component of the company's robust ecosystem of enterprise-class technologies. The online storefront will initially feature pre-built cloud-based services from AppDynamics, Hitachi Data Systems, Juniper Networks, PfSense and Tervela. Available globally to enterprises using Verizon Cloud, Verizon Cloud Marketplace provides a one-stop shop fo...
SYS-CON Events announced today that IDenticard will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada...
SYS-CON Media announced today that Aruna Ravichandran, VP of Marketing, Application Performance Management and DevOps at CA Technologies, has joined DevOps Journal’s authors. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done. Aruna's inaugural article "Four Essential Cultural Hacks for DevOps Newbies" discusses how to demonstrate the...
The move in recent years to cloud computing services and architectures has added significant pace to the application development and deployment environment. When enterprise IT can spin up large computing instances in just minutes, developers can also design and deploy in small time frames that were unimaginable a few years ago. The consequent move toward lean, agile, and fast development leads to the need for the development and operations sides to work very closely together. Thus, DevOps become...
SYS-CON Media announced today that Sematext launched a popular blog feed on DevOps Journal with over 6,000 story reads over the weekend. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done. Sematext is a globally distributed organization that builds innovative Cloud and On Premises solutions for performance monitoring, alerting an...
ScriptRock makes GuardRail, a DevOps-ready platform for configuration monitoring. Realizing we were spending way too much time digging up, cataloguing, and tracking machine configurations, we began writing our own scripts and tools to handle what is normally an enormous chore. Then we took the concept a step further, giving it a beautiful interface and making it simple enough for our bosses to understand. We named it GuardRail after its function - to allow businesses to move fast and stay sa...
SYS-CON Events announced today that Windstream, a leading provider of advanced network and cloud communications, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Windstream (Nasdaq: WIN), a FORTUNE 500 and S&P 500 company, is a leading provider of advanced network communications, including cloud computing and managed services, to businesses nationwide. The company also offers broadband, p...
SYS-CON Events announced today that AIC, a leading provider of OEM/ODM server and storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. AIC is a leading provider of both standard OTS, off-the-shelf, and OEM/ODM server and storage solutions. With expert in-house design capabilities, validation, manufacturing and production, AIC's broad selection of products are highly flexible and are conf...

ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ --  IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's

The BPM world is going through some evolution or changes where traditional business process management solutions really have nowhere to go in terms of development of the road map. In this demo at 15th Cloud Expo, Kyle Hansen, Director of Professional Services at AgilePoint, shows AgilePoint’s unique approach to dealing with this market circumstance by developing a rapid application composition or development framework.
SYS-CON Events announced today Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
"BSQUARE is in the business of selling software solutions for smart connected devices. It's obvious that IoT has moved from being a technology to being a fundamental part of business, and in the last 18 months people have said let's figure out how to do it and let's put some focus on it, " explained Dave Wagstaff, VP & Chief Architect, at BSQUARE Corporation, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud strategy and programs. In this Power Panel at 15th Cloud Expo (http://www.CloudComputingExpo.com...
"Our premise is Docker is not enough. That's not a bad thing - we actually love Docker. At ActiveState all our products are based on open source technology and Docker is an up-and-coming piece of open source technology," explained Bart Copeland, President & CEO of ActiveState Software, in this SYS-CON.tv interview at DevOps Summit at Cloud Expo®, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, discussed the underlying factors that are driving the economics of intelligent systems. Discover ...