Three- and 6-month data from the Australian first-in-man study evaluating the safety and efficacy of the HGNS System were presented by Peter Eastwood, PhD, as part of the session, “New Treatment Approaches for Lung Disease: Late Breaking Abstracts,” at the American Thoracic Society (ATS) 2010 International Conference. The findings show the HGNS System reduced the severity of OSA by an average of over 50%, as measured by the apnea-hypopnea index (AHI).

“These results demonstrate the potential benefits the HGNS System could provide to patients who do not tolerate continuous positive airway pressure (CPAP) therapy,” said Eastwood, senior research fellow at the West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, professor at the School of Anatomy and Human Biology, University of Western Australia, and an investigator with this study. “In most patients, the Apnex HGNS System reduced the severity of their OSA condition, allowing them to sleep better and feel better.”

Patients also experienced significant improvements in symptoms, as measured by multiple quality of life surveys. Patients tolerated the treatment well, with an average of 6.5 hours of use each night. There were no device failures during the study.

“These data give us confidence that the HGNS System works, patients use it, and patients sleep better because of it,” said Robert Atkinson, Apnex Medical president and CEO. “They have improved oxygen levels during sleep and are waking up less, which we believe can lead to better overall health. We are learning a tremendous amount about this new therapy, which we believe will lead to even better outcomes through therapy adjustment and patient selection. We are excited about our ongoing clinical trials in the United States and Australia, the results of which will support future applications for commercial approval.”

Source: Sleep Review

The Alice PDx is a diagnostic recording device with advanced features intended for obstructive sleep apnea (OSA) diagnosis and follow-up, and the diagnostic assessment of cardiorespiratory sleep disorders. It can be used in a patient’s home, an alternative care site, or a sleep facility.

According to Canon Communications, organizers of the awards competition, “entries are evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to their patients, and the ability of the product development team to overcome design and engineering challenges so that the product meets its clinical objectives.”

Representatives of Philips Respironics will be attending the award ceremony occurring June 9, at the Medical Design & Manufacturing (MD&M) East 2010 Conference and Exposition, in New York City.

Source: Sleep Review

Xiaoying Jiang from Fujian Medical University, Fuzhou, China, worked with a team of researchers to carry out the study in 14 healthy people exposed to recorded intensive care noise and equivalent light levels. She said, “Sleep disruption is common in intensive care unit patients and has been associated with impaired immune function, decreased inspiratory muscle endurance, extended mechanical ventilation, delirium and severe morbidity”.

The researchers measured sleep quality over four nights; one to get used to the new environment and one ‘baseline’ night, followed by two nights exposed to noise and light, one with eye masks and ear plugs and one without. To minimize any effects of ordering, the last two nights were randomized. According to Jiang, “The earplugs and eye masks were applied easily and remained in place and intact throughout the nights they were used. Use of plugs and masks resulted in more REM sleep, shorter REM latency and fewer arousals. Subjective measures of sleep quality were also significantly improved, and participants reported much less awareness of their surroundings when they were worn”.

Jiang concludes, “This study provides a reasonable basis for promoting the routine use of earplugs and eye masks for intensive care patients. Future studies should be designed to determine if this ultimately improves clinical outcomes”.

Source: Graeme Baldwin, BioMed Central via EurekAlert

Researchers funded by the National Space Biomedical Research Institute (NSBRI) have developed software that uses mathematical models to help astronauts and ground support personnel better adjust to shifting work and sleep schedules. Outside the space program, the software could help people who do shift or night work or who experience jet lag due to travel across time zones.

“The best methods that we know to help people operate at peak performance are first to ensure that they get adequate sleep, and second that their work schedules are designed to be aligned with the natural body clock,” said project leader Dr. Elizabeth Klerman, associate team leader for NSBRI’s Human Factors and Performance Team.

According to Klerman, a physician in the Division of Sleep Medicine at Brigham and Women’s Hospital in Boston and associate professor at Harvard Medical School, the software has two components. The Circadian Performance Simulation Software (CPSS) uses complex mathematical formulas to predict how an individual will react to specific conditions. CPSS also allows users to interactively design a schedule, such as shifting sleep/wake to a different time, and predicts when they would be expected to perform well or poorly.

The second component, known as Shifter, then “prescribes” the optimal times in the schedule to use light to shift a person’s circadian rhythm in order to improve performance at critical times during the schedule.

“If there is a mission event, such as a spacewalk, scheduled at one or two o’clock in the morning, what can we do to help the astronaut to be alert and functioning well at that time?” Klerman said. “Do we suggest a nap or caffeine? Do we shift their sleep/wake schedule? There are a variety of options that we would like to be able to provide.”

Scientists know that an individual’s performance and alertness are tightly regulated by several factors related to circadian rhythms and the sleep/wake cycle – length of time awake; the timing, intensity and wavelength of light; the amount of sleep the night before; and the body clock’s perception of time. As a result, most people are not able to operate at peak job performance in the late night or early morning hours.

The situation for International Space Station astronauts is complicated by the fact that they often face schedules that are not uniform. A shift in scheduled sleep/wake time, due to an event such as docking, could be as much as eight or nine hours, with the transition taking place over a short period of time. “These dramatic shifts in schedule not only affect the body’s ability to know what time it is, but also hinder the body’s ability to give the appropriate signals to a person trying to wake up or go to sleep,” Klerman said.

With the basic software program complete, the researchers are now working to individualize the model. They want to determine what personal data are needed in order to provide recommendations for individuals. Klerman said the information needed could be as simple as age, or it could require more complicated data.

The software can easily be adapted for use in many occupations. “This program may be helpful for anyone who has to work the night shift, rotating shifts or extended shifts,” Klerman said. “It could also help international travelers effectively deal with jet lag.”

Workers outside the space industry that could benefit directly are medical personnel, security or police officers, firefighters, those working in transportation such as long-haul truckers, and power plant operators. Klerman suggested that everyone could benefit indirectly from the modeling. “Our lives, including our safety, are impacted by those people who have jobs requiring shift work or extremely long hours and who may be at increased risk of accidents and errors affecting themselves or others,” she said.

Klerman added that lack of sleep can affect more than a person’s alertness and performance. It can impact overall health. Lack of sleep is associated with an increased risk of obesity, pre-diabetic conditions, reduced response to vaccines and changes in cardiovascular functions.

The mathematical modeling effort is one of several projects being conducted by NSBRI’s Human Factors and Performance Team to improve sleep and scheduling of work shifts, as well as determining which specific types of lighting can improve alertness and performance during spaceflight.

Source: Brad Thomas, National Space Biomedical Research Institute

The introduction of this interface allows the EHC solution to be used in the monitoring, management, and optimization of a patient’s adherence to their sleep therapy program. Specifically, the EHC interface is designed to enable care providers prescribing the CPAP device to remotely monitor and verify therapy compliance, which is required under new Medicare regulations for reimbursement of the services.

“This new system will not only provide an efficient means to satisfy the new Medicare PAP LCD requirements for adherence, but could also facilitate improved patient outcomes,” said Joe Howard, vice president of marketing at DeVilbiss Healthcare. “The Electronic House Call will allow providers to monitor the use of the IntelliPAP device and intervene rapidly in the event that the patient encounters any issues with their therapy. A critical component to establishing an adherent PAP patient is to provide education and support—both of which are offered through this revolutionary solution.”

The Electronic House Call solution allows health care providers to manage more patients without increasing staff overhead costs and to improve personalized care plans and vital statistics monitoring, while reducing the requirement for home and office patient visits, according to a statement from the company. Automated features can increase patient care plan compliance while improving patient medical condition monitoring and providing online disease and illness education. Using remote patient monitoring for chronic patient illness management can reduce the incidence of emergency hospitalizations and readmissions, minimize the severity of reoccurrences, improve condition outcomes for patients, and reduce the overall cost of patient care, company information stated.

IntelliPAP AutoAdjust CPAP System

The DeVilbiss IntelliPAP AutoAdjust CPAP System has been designed with patients and providers in mind, incorporating many of the recommendations solicited through research to optimize patient adherence. IntelliPAP’s combination of comfort, education and AutoAdjust technology helps to ensure patient compliance – all in a highly efficient platform that makes great business sense to you.

Highlight Features of IntelliPAP AutoAdjust CPAP System

• Now comes with SmartCode Remote Adherence Monitoring System, which allows providers and clinicians to remotely track compliance data on patients.
• Smallest surface of all leading CPAP devices with heated humidification system attached and among the quietest CPAPs on the market – only 26 dBA
• Introduction to CPAP therapy and Instructional video included
• Accommodates various tubing lengths (6 and 10 feet)
• Large, slip-resistant pads on bottom of unit to minimize movement on night table during the night
• Eight-foot power cord length provides greater positioning flexibility – no bulky power brick on cord
• Large, backlit LCD and easy-to-follow patient menu
• Auto on/off
• Delay pressure ramp eases the machine to the prescribed pressure
• ABOB output for psg (pressure, patient flow, leak flow, patient event markers, est. tidal volume)

Source: Sleep Review

Integrating a sleep disorder diagnostic tool into hospital cardiac care represents an important advance, as obstructive sleep apnea (OSA) impacts up to 50 percent of all heart disease patients.1 When sleep disorders are diagnosed and treated early, it has been shown to improve cardiac conditions. Left undiagnosed, sleep apnea can increase heart disease risks.

More than 80 percent of individuals with moderate-to-severe OSA have not been clinically diagnosed.2 Powered by the WideMed Ltd. Morpheus® Hx sleep apnea diagnosis program, MARS VSL enables OSA diagnosis right from the hospital bed. This transforms in-patient rooms into virtual sleep labs, and enables a bedside diagnosis by improving utilization of monitored data to provide diagnostic information. According to a recent Journal of Clinical Sleep Medicine study, connecting the WideMed automated sleep analysis system to hospital monitors achieves results highly correlated with the standard test conducted in sleep labs-polysomnography.3

“With MARS VSL, hospitals can quickly and effectively test cardiac patients for sleep apnea, utilizing existing physiological data for retrospective analysis,” said Dr. Matthias Weber, vice president and GM of Global Diagnostic Cardiology at GE Healthcare. “Eliminating this delay in sleep apnea diagnosis supports GE’s healthymagination vision for enhancing outcomes, enabling timely access to treatment and ultimately, reducing costs.”

MARS VSL automatically reports on clinical data that is critical for making a sleep apnea diagnosis, such as apnea hypopnea index, sleep staging and respiratory events. Following a sleep apnea diagnosis, an AutoPAP device can be immediately prescribed while the patient is still in the hospital. This increases the chance that OSA patients can begin treatment before other complications develop.

“MARS VSL will help the sleep community reach previously undiagnosed patients, helping improve outcomes by detection of sleep apnea in a critical-care setting, and put the patient on the road to the appropriate sleep-related therapy,” said Guarav Agarwal, GM of Respiratory Care at GE Healthcare. “Furthermore, MARS VSL will enable management of the patient rather than the management of the symptoms of this life-threatening disease.”

Quantitative Cardiac Monitoring From Any Connected Inpatient Bed

MARS VSL enables not only sleep apnea diagnostic testing, but also quantitative Holter analysis for in-hospital cardiac patients. Holter devices collect cardiac information from patient monitors and perform a quantitative analysis not traditionally performed in the monitoring environment. Because MARS VSL directly links into the GE Healthcare CARESCAPE™ CIC Pro-a central station monitor that assimilates real-time and historical patient data from multiple monitoring sources-a quantitative Holter analysis can now be immediately performed from any connected patient bed, without the need for locating and attaching additional monitoring equipment. Data can then be collected and analyzed anytime, anywhere and for any connected patient bed, then archived to enhance future clinical decision-making.

MARS VSL leverages the clinical heritage of Marquette® clinical monitoring and risk-detection analysis programs. Hospitals can use MARS VSL with existing cardiac technologies to enhance clinical workflow. It enables integration with systems such as:

• CARESCAPE™ Monitor B850 (via CARESCAPE CIC Pro central station)-the latest GE Healthcare bedside monitor that directly links clinical users to electronic medical records (EMRs), diagnostic images, lab results and real-time patient monitoring data, to support efficient clinical decision-making.
• MUSE® Cardiology Information System-a cardiac repository that facilitates ECG analysis and comparisons to the patient’s prior ECG, supporting improved workflow and more informed clinical decisions. MUSE is a central hub for cardiology records, which now incorporates both patient monitoring and MARS VSL clinical information, while continuing to enable connectivity into the electronic medical record.

MARS VSL Availability

MARS VSL is currently available for purchase in the U.S. The sleep apnea detection integration is initially available to U.S. medical centers, and will be rolled out to select European and Asian locations later in the year. Outside the U.S., medical centers can currently purchase MARS® Enterprise i, which integrates Holter ECG analysis with vital signs from clinical monitoring, helping to streamline cardiac diagnostics.

References

1 Milleran O, et al. Eur Heart J 2004 May; 25:728-734.

2 The Medical Cost of Undiagnosed Sleep Apnea. V. Kapur, et al. SLEEP, Vol. 22, No. 66, 1999.

3 An Automated Sleep-Analysis System Operated through a Standard Hospital Monitor. O. Amir, et al. Journal of Clinical Sleep Medicine, Vol. 6, No. 1, 2010.

Source: GE Healthcare

According to information from the ResMed Corp, the S9 Series combines treatment technology with novel controls in a stylish new design.

Drew Terry, senior director of product management said “Our goal in the development of the S9 was to create a system that offers more than any other device on the market-more comfort, more control, and more style-so users can feel confident about incorporating it into their lifestyle, and health care providers can be confident that their patients are receiving the highest quality of sleep apnea treatment,”

“In essence, the S9 represents a new approach to achieving patient compliance-making it as easy as possible for users to accept CPAP on their own terms. It puts them in control of the details that make the difference in their personal comfort, like EPR level and humidification settings. It has intuitive menus and dials to make it easy to adjust. It reduces noise to a virtual whisper, so it won’t disrupt a sleeping partner,” added Terry.

With the S9 Series, ResMed has introduced a number of improvements to their technologies, including Enhanced AutoSet and Easy-Breathe algorithms, and an improved Easy-Breathe motor. They’ve also incorporated a humidification system with Climate Control, which adapts to the user’s real-time environmental conditions. Additionally, they’ve introduced a tube design with the SlimLine tube, which virtually eliminates tube drag.

In market trials, users have responded enthusiastically. “I don’t feel the pressure changes as my needs increase. The breathing feels more natural, drops in EPR feel smoother, and I have zero rainout throughout the night,” reported one respondent.

The S9 has received accolades from clinicians as well. “With the S9, there’s a sense of value that other products on the market do not have. The engineering behind it is what appeals to me; not just what it looks like, but what it can do. The Easy-Breathe technology, in combination with Climate Control and the SlimLine tube … everything has come together to make it very easy for a patient to accept therapy,” commented Dennis Janes, RRT, of Alegent Health Home Medical Equipment.

In addition to the numerous clinical and comfort features, the S9 provides detailed data reporting for clinicians. A complete S9-compatible wireless compliance management package is available to streamline business efficiencies for ResMed customers.

Source: SleepReview

These interim results from the FREEDOM study compared patients’ responses to the Medical Outcomes Study (MOS) Sleep Survey and the International RLS Study Group Rating Scale (IRLS) at baseline and four months. Specifically, significant improvements identified in this planned interim analysis included:

• Overall sleep quality (as measure by the MOS Sleep Problems Indices I and II) significantly improved from baseline to month four. (Index I: P=<0.001; Index II: P<0.0001)
• Four of the 5 individual sleep scale s- sleep adequacy, daytime somnolence (or “drowsiness”), sleep initiation and maintenance, and respiratory disturbances displayed significant improvement.
• There was a significant reduction in the number of patients reporting RLS at 4 months compared to baseline. (P=0.02)
• Of those patients who experienced RLS at baseline (n=58), 36% no longer experienced RLS at month four.

Dr. Brigitte Schiller, MD, Acting Chief Medical Officer and Vice President of Scientific Affairs for Satellite Healthcare headquartered in Mountain View, CA, is one of the presenters of FREEDOM study data during the 30th Annual Dialysis Conference in Seattle.

“Various studies suggest a high prevalence of sleep-related disorders and RLS, among End-stage Renal Disease (ESRD) patients. These interim results from the ongoing FREEDOM study demonstrate the positive impact of daily home hemodialysis on these disorders, which can have a significant impact on patients’ quality of life,” says Dr. Schiller. “Quality sleep is essential, and to ESRD patients in particular, as it has been proven to affect other areas of patients’ overall health. Although these findings are only at four months, longer-term follow up is underway to determine whether the positive impact of daily home dialysis on sleep patterns and RLS persists at one year.”

“NxStage continues to invest in proving the wide range of clinical and quality of life benefits possible with more frequent hemodialysis,” says Jeff Burbank, CEO of NxStage Medical, Inc. “These results add to the growing evidence supporting daily home hemodialysis with our System One versus conventional, thrice-weekly in-center therapy.”

The ongoing FREEDOM study is the largest study of its kind to measure the clinical and economic benefits of daily home hemodialysis treatment, as compared to conventional, thrice-weekly in-center hemodialysis treatment for patients requiring dialysis therapy. All daily home hemodialysis patients in the FREEDOM study use the NxStage System One as their treatment delivery system, and all have Medicare as their primary insurance payer.

About NxStage Medical

NxStage Medical, Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of End Stage Renal Disease (ESRD) and acute kidney failure.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “expect,” “estimate,” “plan,” and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage’s filings with the Securities and Exchange Commission, including the Quarterly Report on Form 10-Q for the quarter ended September 30, 2009. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Source: NxStage Medical, Inc

“Mask comfort is essential to CPAP compliance, and comfort is comprised of multiple factors. Proper fit, a strong seal, a soft touch, and an unobtrusive appearance all have a role in the overall user experience,” says Bernadette McBrearty, Sr Product Director. “Sleeping with the Swift FX helps patients focus less on the mask and more on how great it feels to get healthy sleep.”

The Swift FX features a sliding buckle at the top of the head and Velcro side straps. The mask, which features silicone headgear, is designed with very few parts to improve assembly and cleaning.

“The chief advancement with the Swift FX is that the headgear is now made of a soft, pliable silicone material that gently cushions the face,” says McBrearty. “We believe this mask will have instant appeal.”

The Swift FX comes packaged with three cushion sizes-small, medium, and large-fitting up to 95% of users. An extra small cushion size is also available separately for users with petite noses.

The pliable silicone headgear molds to the contours of the face to maintain a stable seal, and the rotating tube adjusts freely so as not to disturb the user when turning over or shifting. A specialized vent design makes therapy delivery quiet, and a soft narrow cushion enhances comfort for side sleepers. ResMed also offers optional soft wraps to provide additional cushioning if desired. For further information go to the following webpage – http://www.resmed.com/int/products/swift_fx/swift-fx.html?nc=clinicians

Source: Sleep Review

Philips Respironics commercialized continuous positive airway pressure (CPAP) in 1985 and, soon after, exclusively developed bi-level airway pressure technology for treating obstructive sleep apnea (OSA). The first line effective treatment works by delivering a gentle flow of pressurized air through a mask to keep the airway open. The new Philips Respironics Sleep Therapy System combines 25 years of experience with state-of-the-art technology and new-to-market features that optimize comfort, care, and efficacy of therapy in patients. The system also provides new levels of control, compliance and efficiency to help healthcare professionals improve patient outcomes, grow their businesses and better manage their operating costs.

“Our new system is proof positive of our vision of working together with our provider customers to transform the home healthcare market to meet today’s challenges and tomorrow’s promise of improved care,” says Donald Spence, CEO of Philips Home Healthcare Solutions. “In designing the new system, we took a smarter approach to the entire sleep management process and married our clinically proven technologies together in one rigorously engineered device to better support patient care. It is our most sophisticated offering to date, and it comes at a time when patient compliance matters most.”

The new system provides a range of therapy options for mild to severe sleep apnea patients and helps providers recognize changing patient conditions that may require different treatment. With new advanced event detection software and expanded reporting capabilities, Philips Respironics Sleep Therapy System has the ability to recognize and report when a patient may be experiencing symptoms beyond OSA. A sophisticated three-layer algorithm distinguishes between obstructed and clear airway apneas and periodic breathing, such as Cheyne-Stokes Respiration. Medical professionals now have easy access to sleep assessment parameters typically found on diagnostic equipment.

These respiratory events can be verified by looking at detailed patient flow waveform data. There are multiple options for data transfer, including standard SD cards and new wireless and wired modem connections. The devices now include on-board memory storage for six months of compliance data (7 and 30 day averages) and five days of patient flow waveforms.

Philips Respironics Encore data management systems have been enhanced. The Web-based platform of EncoreAnywhere makes it quick and simple to obtain timely, accurate patient information and instantly change prescriptions or communicate from a secure-access Web site. Updates to the device are automatic, and summary and daily detail reports of therapy data — including patient flow and event reports — are arranged by time frame. The “Best 30” reports the best 30 consecutive days of greater than four-hour sessions. This information enables the provider to intervene more quickly and more effectively and instantly capture patient compliance data needed for reimbursement.

Adding to its contemporary design, lighted LEDs and a new LCD dial and push-button interface make the device simple to use and operate. About the size of a clock radio (7″ L x 5.5″ W x 4″ H; 18 cm L x 14 cm W x 10 cm H), components are built in to maximize patient comfort and device performance. The device is engineered with new Dry Box technology and a cleverly designed water chamber to keep water only where needed, while delivering consistent humidification. A technology breakthrough, System One Humidity Control, adjusts automatically for changes in room temperature and room humidity. Like cruise control in automobiles, patients select the desired humidity level in the mask, and advanced sensors gather the data required by the device to maintain these levels to enhance comfort and prevent rainout in changing environmental conditions.

Another major comfort enhancement, System One Resistance Control, adjusts pressure delivery to optimize comfort with every Philips Respironics mask. Beyond leak reporting, the device is set up to compensate for resistance characteristics caused by the various mask options available and operate as an integrated system.

Philips Respironics Flex Family of pressure relief technologies continues to evolve to meet patient and professional needs. The new device features an on-board Flex Demo mode to allow patients to experience the comfort of proven Flex technology firsthand. With Flex, an advanced Digital Auto-Trak algorithm detects the onset of inspiration and expiration to deliver the right amount of pressure relief and emulate natural breathing. Clinical studies show patients on Flex use their therapy on average more than four hours per night when using traditional CPAP.1 The newest enhancement, C-Flex+, is designed for advanced units when in fixed CPAP mode. It provides relief at the beginning of exhalation and softens the pressure transition from inhalation to exhalation. Philips Respironics backs the performance with the Flex Promise Program.

The new Philips Respironics’ CPAP and BiPAP devices include basic, compliance, and auto-adjusting models. Accessories include power supply, carrying case, power cord, filter kit, and integrated humidifier. The devices come with a 2-year, replace-with-new warranty, and are backed by Philips Respironics’ renowned service and support programs.

1 Aloia, M.S., et al., Chest 2005:127:2085-2093

For media inquiries, please contact:

Maryellen Bizzack
Director, Marketing and Communications
Philips Home Healthcare Solutions
Tel: +1 (724) 387-5006
E-mail: maryellen.bizzack@philips.com

About Royal Philips Electronics

Royal Philips Electronics of the Netherlands (NYSE: PHG, AEX: PHI) is a diversified Health and Well-being company, focused on improving people’s lives through timely innovations. As a world leader in healthcare, lifestyle and lighting, Philips integrates technologies and design into people-centric solutions, based on fundamental customer insights and the brand promise of “sense and simplicity”. Headquartered in the Netherlands, Philips employs approximately 116,000 employees in more than 60 countries worldwide. With sales of $38 billion (EUR 26 billion) in 2008, the company is a market leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as lifestyle products for personal well-being and pleasure with strong leadership positions in flat TV, male shaving and grooming, portable entertainment and oral healthcare.