|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
"We got started as search consultants. On the services side of the business we have help organizations save time and save money when they hit issues that everyone more or less hits when their data grows," noted Otis Gospodnetić, Founder of Sematext, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 29, 2015 11:45 PM EDT Reads: 1,022
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, explained the best practices of continuous testing at high scale, which is rele...
Jul. 29, 2015 11:45 PM EDT Reads: 1,367
"We have been in business for 21 years and have been building many enterprise solutions, all IT plumbing - server, storage, interconnects," stated Alex Gorbachev, President of Intelligent Systems Services, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 29, 2015 10:45 PM EDT Reads: 1,027
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
Jul. 29, 2015 05:30 PM EDT
"We specialize in testing. DevOps is all about continuous delivery and accelerating the delivery pipeline and there is no continuous delivery without testing," noted Marc Hornbeek, Sr. Solutions Architect at Spirent Communications, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 29, 2015 05:15 PM EDT Reads: 363
How do you securely enable access to your applications in AWS without exposing any attack surfaces? The answer is usually very complicated because application environments morph over time in response to growing requirements from your employee base, your partners and your customers. In his session at @DevOpsSummit, Haseeb Budhani, CEO and Co-founder of Soha, shared five common approaches that DevOps teams follow to secure access to applications deployed in AWS, Azure, etc., and the friction an...
Jul. 29, 2015 04:30 PM EDT Reads: 499
"Alert Logic is a managed security service provider that basically deploys technologies, but we support those technologies with the people and process behind it," stated Stephen Coty, Chief Security Evangelist at Alert Logic, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 29, 2015 04:15 PM EDT Reads: 328
Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology. Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve. Digital Transformation means: handling all the data types being found and created in the organizat...
Jul. 29, 2015 04:00 PM EDT Reads: 1,070
The essence of cloud computing is that all consumable IT resources are delivered as services. In his session at 15th Cloud Expo, Yung Chou, Technology Evangelist at Microsoft, demonstrated the concepts and implementations of two important cloud computing deliveries: Infrastructure as a Service (IaaS) and Platform as a Service (PaaS). He discussed from business and technical viewpoints what exactly they are, why we care, how they are different and in what ways, and the strategies for IT to tran...
Jul. 29, 2015 03:15 PM EDT Reads: 396
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Jul. 29, 2015 03:15 PM EDT Reads: 241
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
Jul. 29, 2015 03:00 PM EDT Reads: 468
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of pro...
Jul. 29, 2015 03:00 PM EDT Reads: 1,258
Container technology is sending shock waves through the world of cloud computing. Heralded as the 'next big thing,' containers provide software owners a consistent way to package their software and dependencies while infrastructure operators benefit from a standard way to deploy and run them. Containers present new challenges for tracking usage due to their dynamic nature. They can also be deployed to bare metal, virtual machines and various cloud platforms. How do software owners track the usag...
Jul. 29, 2015 02:30 PM EDT Reads: 109
With SaaS use rampant across organizations, how can IT departments track company data and maintain security? More and more departments are commissioning their own solutions and bypassing IT. A cloud environment is amorphous and powerful, allowing you to set up solutions for all of your user needs: document sharing and collaboration, mobile access, e-mail, even industry-specific applications. In his session at 16th Cloud Expo, Shawn Mills, President and a founder of Green House Data, discussed h...
Jul. 29, 2015 02:30 PM EDT Reads: 326
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affect t...
Jul. 29, 2015 02:00 PM EDT Reads: 1,172