|By PR Newswire||
|January 8, 2014 05:15 PM EST||
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
Advances in technology and ubiquitous connectivity have made the utilization of a dispersed workforce more common. Whether that remote team is located across the street or country, management styles/ approaches will have to be adjusted to accommodate this new dynamic. In his session at 17th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., focused on the challenges of managing remote teams, providing real-world examples that demonstrate what works and what do...
Feb. 5, 2016 07:00 PM EST Reads: 145
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 5, 2016 04:00 PM EST Reads: 107
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
Feb. 5, 2016 04:00 PM EST
With microservices, SOA and distributed architectures becoming more popular, it is becoming increasingly harder to keep track of where time is spent in a distributed application when trying to diagnose performance problems. Distributed tracing systems attempt to address this problem by following application requests across service boundaries, persisting metadata along the way that provide context for fine-grained performance monitoring.
Feb. 5, 2016 03:45 PM EST Reads: 759
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 5, 2016 03:00 PM EST
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 5, 2016 02:45 PM EST
SYS-CON Events announced today that Fusion, a leading provider of cloud services, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry's single source for the cloud. Fusion's advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including clou...
Feb. 5, 2016 02:30 PM EST Reads: 684
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Feb. 5, 2016 02:00 PM EST Reads: 111
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 5, 2016 01:30 PM EST Reads: 321
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Feb. 5, 2016 01:30 PM EST Reads: 303
The maker of automated server migration software reports sales bookings increased 460 percent year-over-year and last week IDC forecast spending on public cloud services will grow to more than $141 billion in 2019. Seems (at last) we are at the tipping point where enterprises are adopting cloud in a big way opening opportunities for those who can help with the transition.
Feb. 5, 2016 01:27 PM EST
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 5, 2016 01:15 PM EST Reads: 316
@DevOpsSummit taking place June 7-9, 2016 at Javits Center, New York City, and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
Feb. 5, 2016 01:00 PM EST Reads: 487
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
Feb. 5, 2016 12:00 PM EST Reads: 510
Your business relies on your applications and your employees to stay in business. Whether you develop apps or manage business critical apps that help fuel your business, what happens when users experience sluggish performance? You and all technical teams across the organization – application, network, operations, among others, as well as, those outside the organization, like ISPs and third-party providers – are called in to solve the problem.
Feb. 5, 2016 12:00 PM EST Reads: 660