Tag Archives: sleep apnea

Sleeping Pill Use Tied to Poorer Survival for Heart Failure Patients


Study also found heightened odds for heart trouble in patients taking benzodiazepine sleep aids

Existing Heart Problems Worsened by Sleeping Pills?

A new study from the European Society of Cardiology suggests that heart failure patients who use sleeping pills may be heightening their cardiac concerns, or worse yet, even causing death.


“Sleeping problems are a frequent side effect of heart failure and it is common for patients to be prescribed sleeping pills when they are discharged from hospital,” study author Dr. Masahiko Setoguchi explained in a news release from the European Society of Cardiology. “Given that many heart failure patients have difficulty sleeping, this is an issue that needs further investigation in larger studies.”


According to a summary, a Japanese team examined the medical records of 111 heart failure patients admitted to a Tokyo hospital from 2011 to 2013. The patients were followed for up to 180 days after they left the hospital. “Patients who took sleeping pills — drugs called benzodiazepine hypnotics — were eight times more likely to be readmitted to hospital for heart failure or to die from heart-related causes than those who did not take sleeping pills, the researchers found”.


Heart failure patients “who use sleeping pills, particularly those who have sleep-disordered breathing, should be carefully monitored,” Setoguchi concluded.

“The results from this small, single-center study raise a potential alarm about the use of benzodiazepines in a heart failure population,” added Dr. Sean Pinney, director of the advanced heart failure and cardiac transplant program at The Mount Sinai Hospital in New York City.


For full press release click here

Source: European Society of Cardiology

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SomnoMed Appoints New President

Somnomed Ltd appoints new head for North American Region

SomnoMed announced the appointment of Kien T. Nguyen as President for SomnoMed Inc., the US subsidiary of SomnoMed Limited.

Kien has a lifelong career in the healthcare industry, working for leading companies such as Stryker Corporation, Kinetic Concepts, Inc. (KCI) and various medical device divisions of Johnson & Johnson. Most recently, he was Vice President and General Manager of OtisMed, a business unit of Stryker Orthopaedics, a division of the $8 billion Stryker Corporation. At KCI, he fulfilled various functional Vice President positions, including Global Portfolio Management, Global Research & Ideation, and Global Marketing of the Active Healing Solutions division, with revenues responsibilities of $1.4 billion. Most of his earlier career was spent with Ethicon, Inc., a Johnson & Johnson company, where he held roles in product development, product marketing, clinical sales and finally as Worldwide Marketing Director for the biosurgical business unit within Johnson & Johnson Wound Management.

SomnoMed is a public company providing diagnostic and treatment solutions for Sleep-related Breathing Disorders including obstructive sleep apnea, snoring and bruxism. SomnoMed was commercialized on the basis of extensive clinical research. Supporting independent clinical research, continuous innovation and instituting medical manufacturing standards has resulted in SomnoDent® becoming the state-of-the-art and clinically proven medical oral appliance therapy for obstructive sleep apnea. SomnoDent® is the most comfortable and effective design and treatment solution for over 100,000 patients in 22 countries. For additional information, visit SomnoMed at http://www.somnomed.com.

Read Full Annoucement

Related posts:

  1. SomnoMed to Pass 100,000 Sleep Apnea Patient Milestone
  2. SomnoMed racks highest sales of SomnoDent® devices to date
  3. SomnoMed Registered to Provide United States Military SomnoDent Therapy

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North East Sleep Society (NESS) Annual Meeting, Newport RI

NESS 25th Anniversary Meeting

Newport, RI — April 1-2, 2011

The purpose of the 25th annual North East Sleep Society (NESS) meeting is to bring together members of AASM-affiliated state sleep societies in ten northeastern states and other sleep professionals to foster regional networking and educate sleep professionals in the latest innovations in the study of sleep disorders. Speakers include thought leaders in sleep medicine discussing developments in conditions impacting restful sleep in adults, adolescents, and pediatrics to include insomnia, shift work, RLS, circadian rhythm, OSA and how comorbidities such as diabetes, obesity, pregnancy, and cardiovascular disease impact treatment strategies. Attendees will gain understanding of where sleep medicine began and what to expect into the future as well as difficulties with consistently and comparatively scoring respiratory events.

Visit the NESS website

Friday, April 1

9:00-12:30: Registration
10:30-12:30: Exhibits Open
11:30-12:30: Lunch
12:30-1:00: Introduction: Sleep Medicine 25 Years Ago * — Richard Millman, MD
1:00-2:00:  & Cardiovascular Disease: What Have We Learned Over The Last 25 Years?— Stuart Quan, MD (moderator: Richard Millman, MD)
2:00-3:00: OSA & Diabetes — Naresh Punjabi, MD (moderator: Richard Millman, MD)
3:00-3:15: Break
3:15-4:15: Behavioral vs Pharmacological Therapy for Adult Insomnia * — Gary Zammit, PhD 
(moderator: Donn Posner, PhD)
4:15-5:15: The Elephant in the Nursery: Different Perspectives on Insomnia in Children * — 
Judith Owens, MD (moderator: Donn Posner, PhD) 
5:15-6:30: Exhibits Open w/Wine, Cheese & Cocktails
6:30-9:00: Dinner/Keynote: The Impact of Sleep Deprivation & Shift Work on Medical Errors— 
Charles Czeisler, MD, PhD (moderator: Mary Carskadon, PhD)

Saturday, April 2

6:30-7:30: Breakfast & Exhibits
7:30-8:30: Split Session

Pediatric Scoring Issues — Patrick Sorenson MA, RPSGT (moderator: Robin Moore, RPSGT, REEGT) 
Sleep Apnea & Pregnancy * — Ghada Bourjeily MD (moderator: Katherine Sharkey, MD, PhD)

8:30-8:45: Room Change
8:45-9:45: Split Session

Why Are Sleep Studies Important in Bariatric Surgery? — Richard Millman, MD 
(moderator: Robin Moore, RPSGT, REEGT)
School Start Times * — Kyla Wahlstrom PhD (moderator: Katherine Sharkey, MD, PhD)

9:45-10:15: Break
10:15-11:15: RLS — Arthur Walters, MD (moderator: Alice Bonitati, MD)
11:15-12:15: The Future of Sleep Medicine * — Barbara Phillips, MD (moderator: Alice Bonitati, MD)
12:15-12:30: Wrap-up & Box lunch

APA credit denoted with *

Risk Management Topics:
The Impact of Sleep Deprivation & Shift Work on Medical Errors (Dinner / Keynote)
Why Are Sleep Studies Important in Bariatric Surgery?

Brand Takes Center Stage – Sleep Solutions Becomes NovaSom

slepp1 Brand Takes Center Stage   Sleep Solutions Becomes NovaSom may have changed its name to NovaSom and moved the company from California to Delaware, but the company’s intense focus remains the same.

More than a year after taking the reins at the largest national service provider of tests, Richard Hassett, MD, believes the time is ripe for a change. Specifically, the CEO of Sleep Solutions has decided to switch the company’s name to NovaSom®, a move designed to build on the familiar testing brand.

Changing a well-known moniker is no small decision, but Hassett believes the new name better reflects the company’s commitment to providing accurate and cost effective home tests. Factoring in some annoying name similarities to competitors and the change became a no-brainer. “Other entities had the name ‘Sleep Solutions’ as some part of their name, and that could potentially be confusing,” says Hassett. “If we were ever going to make a change, now was the time. At the same time, we reincorporated the company from California to Delaware.”

Recent years have seen a steady climb for the NovaSom® brand in its role as a full-service model for home sleep testing. The actual unit is a small device used in the home and typically shipped to patients via overnight carrier. After that, it is returned to the company when the patient completes testing, ideally for three nights. Upon return of the device the data are downloaded and the results are interpreted by a qualified or board-certified sleep physician. Results are provided to the prescribing physician within 48 hours.

The NovaSom Home Sleep Test is a Type III portable cardio-respiratory monitor with FDA clearance for of adults with possible . Predictive accuracy of the test, night for night, has been established in two peer-reviewed publications comparing the device to PSG.¹,²

Three sensors record the same five physiological parameters that use to diagnose OSA: , , heart rate, airflow (oral & nasal), and snoring. The first sensor is a belt that goes around the chest to determine respiratory excursions. The second is an oxygen sensor on the finger, and finally a sensor beneath the nose detects the snoring sound and air flow. This acoustic airflow sensor is a patented device utilizing noise cancellation technology, which has demonstrated a highly linear relationship to the Hans Rudolph pneumotachograph – a standard of airflow measurement used by pulmonologists.

Clinicians appreciate the unit’s capacity to store data for three nights, and users benefit from the device’s ability to literally speak via mechanical voice. “Similarly to a GPS, the NovaSom device talks patients through the procedure,” explains Hassett. “Even if patients have not had access to the Web site or seen the instruction materials that come with the test, the device will actually talk them through the set up and operation.” The company also provides technical and clinical services 24⁄7 by credentialed sleep technologist.

The consumer friendly nature of the test can mean the difference between diagnosis and failure. After all, says Hassett, potential patients often shy away from sleep labs, preferring the comfort and privacy of their own home. Factor in NovaSom’s lower price and it all points to more patients with proper diagnoses.

“Clinicians are starting to realize that we have a massive public health epidemic on our hands with OSA, and the community can’t handle all the patients,” says Hassett. “The fact that the device has the capacity for three nights of data eliminates the high false negative rate which is a problem with any one-night test, whether it is home or lab based. This turns out to be an advantage for providers and patients.”

Hassett and NovaSom’s customers believe the secret lies in the product’s ability to overcome the inevitable night-to-night variability that can hamper sleep testing results. “It’s been known for a long time that there was a burden of false negatives with one-night tests, perhaps even more so with labs than at home because of how daunting, unfamiliar, and uncomfortable it is to achieve natural sleep in the lab environment,” says Hassett. “With the 3-night test, we pick up a significant number of patients after the first night that would have been missed. With the high false negatives after one night tests, it just makes more sense.”

Provider education teams from NovaSom are dedicating time and energy to increasing awareness among (PCPs), ENTs, and pulmonologists. Since there are so many more PCPs out there, they have so far naturally benefitted a bit more from these educational efforts.

Particularly for uncomplicated patients at the primary level, PCPs are the main portal for a variety of patients with many different apnea severities. “We read statistics that say 7 out of 8 people with OSA are undiagnosed and unaware,” says Hassett. “Most providers in America do not have the level of vigilance for this condition that its public health implications would warrant.”

By now the statistics are familiar, but no less staggering. The costs and co-morbidities seem to multiply every year, and Hassett believes medical research will continue to confirm these findings. “We provide the resources that primary care physicians need to identify people at risk for OSA and determine appropriate candidates for both in-home and laboratory tests,” says Hassett. “We have a field-based medical education force and have made significant investments in CME and non-CME educational programs, aimed at primary care.”

The NovaSom home sleep test is offered as a turnkey service. There is no capital investment required of physicians. NovaSom provides rigorous infection controls, biomedical inspection, testing and calibration for each device in between patient uses, ensuring that every test sent to a patient will function accurately. Physicians view detailed study results through the online MediTrack® system.

“NovaSom has a large client care team and offers live clinical/technical support, 24 hours a day, 7 days a week, to patients undergoing the home sleep test,” adds Roger Richardson, vice president, Operations, for NovaSom. “We try to make testing as easy as possible, and are committed to raising consumer awareness of OSA through http://www.apnea.com.”

NovaSom, Inc. is fully accredited by The Joint Commission‘s Ambulatory Care Program, is a Medicare-approved Independent Diagnostic Testing Facility (IDTF), and is registered with the .


  1. Claman D, et al; Otolaryng Head Neck Surg 2001; 125: 227–230.
  2. Reichert JA, et al; Sleep Med 2003; 4: 213–218.

Richard Hassett, MD CEO NovaSom, Inc. http://www.novasom.com.

ScreenShot070 Brand Takes Center Stage   Sleep Solutions Becomes NovaSom

A Wake-Up Call to Sleepy Workers

Marietta Bibbs, BA, RPSGT, Manager, Sleep Disorders Center

Did you know that lack of sleep can be deadly?  The loss of sleep can often be related to several issues, but the various causes of sleepiness can have a cumulative effect.  Any combination of these causes can greatly increase one’s risk for a fatigue-related workplace accident or an automobile accident.  The cause of sleepiness is most often related to undiagnosed or untreated sleep disorders, but there are other causes that are less often thought about.  These include sleep loss from restriction or too little sleep, interrupted or fragmented sleep, chronic sleep debt, circadian rhythm factors associated with driving patterns, work schedules, time spent on a task, using sedating medications and consuming alcohol when one is already tired.

Loss of sleep leads to daytime fatigue and poor functioning during the day.  Fatigue has a great impact not only in our workplace, but also in our daily lives.  The impact of fatigue leads to impaired reaction time, poor judgment and decision making,  problems with information processing and short-term memory, decreased performance, vigilance and motivation and increased moodiness and aggressive behaviors. Many hours of productivity are lost at work because of a chronically-sleepy population.

All of us are at risk for daytime fatigue and sleepiness since we require adequate sleep in order to function at peak.  Once we succumb to fatigue, we are at greater risk of having a microsleep–an unintentional episode of sleep that usually lasts 2-3 seconds but can last up to 30 seconds or more.  The most frightening thing about microsleep is that it can occur without your knowledge.  Only a few seconds of sleep is sufficient time for you to fall asleep at your desk, run off the road while driving or drift into another lane.

The population at greatest risk for fatigue and chronic sleep deprivation is those with undiagnosed and untreated sleep disorders like obstructive .   Other at-risk populations include young people under the age of 25, shift workers—particularly those working the night shift, and people who work long hours.  Commercial drivers (especially long-haul drivers) and business travelers who spend time driving or flying across time zones may be jet-lagged and have a greater tendency to fall asleep at inappropriate times.

Several tragedies and work-place accidents have been related to chronic fatigue and sleepiness—the Exxon Valdez accident, Three-Mile Island Accident, the ConAir Plane Crash and the Continental Connection Crash near Buffalo, New York in 2009 when pilot error lead to the death of 50 people.  Later investigations by the NTSB concluded that the pilots’ performance was likely impaired because of fatigue.  On the day of the flight, the captain commuted hundreds of miles and the first officer commuted from the other side of the country prior to reporting for duty.  The NTSB concluded that both pilots used an inappropriate facility during their last rest period before the accident flight.

New Jersey was the first state to enact a law (Maggie’s Law) that addresses drowsy driving.

The law was enacted in memory of 20-year-old Maggie McDonnell who was killed by a driver who fell asleep while driving and hit Maggie’s car head-on. The driver admitted that he had been awake for 30 hours and had been using drugs.  Maggie’s Law states that a sleep-deprived driver qualifies as a reckless driver who can be convicted of vehicular homicide. Several states now have similar laws in which drowsy driving can be a criminal offense. Driving drowsy also significantly increases the legal risks employers face from extended hours of operation.

March 7-13 is National Sleep Awareness Week.  Make a commitment to getting enough sleep at all times, but use this week to really focus on what you need to do to get the sleep you need.  Here are a few tips to better sleep and a better quality of life.

Ø    Don’t skimp on your sleep.  Go to bed at the same time and get up at the same time

Ø    If you are unable to fall asleep when you go to bed, get up and engage in a boring activity until you are sleepy.

Ø    Use the bedroom for sleep and sex only—no watching TV or having laptops in bed

Ø    Avoid driving long distances when you would normally be asleep

Ø    Avoid alcohol and medications that could make you drowsy when you are at work or when you need to drive

Ø    Avoid caffeine at night

Ø    If you are sleeping at night but tired during the day, consult your Physician

Ø    Have a sleep study if you snore and have high blood pressure, morning headaches, or excessive daytime sleepiness despite sleeping your typical hours or if you have any unusual nighttime behaviors while asleep, as noted by a bed partner .

East Coast Lab Preps for Potential

Image1 East Coast Lab Preps for Potential

New York-based Winthrop Center made the difficult decision to switch database vendors in an effort to remain a step ahead of progress.

By any measure, the Winthrop Sleep Disorders Center, Garden City, NY, brings a wealth of experience to the relatively young field of sleep medicine. As Associate Director of the Winthrop Sleep Disorders Center, Claude Albertario, RPSGT, has helped the academic facility evolve from modest roots in the late 1980s to its current position as a respected laboratory in the Northeast.

Leveraging their knowledge and experience gained over more than two decades, the hospital recognized the need to expand in 2006. Albertario seized the opportunity to take a long, hard look at equipment needs. The investigation led the 26-year sleep veteran to only consider systems with database constructs that could change with the times.

Expand and Integrate

Later in 2008, the () came out with the H5 guideline that requires all , even for those not getting a study, to be amassed in a central database. As a result, going beyond a mere “ acquisition” system suddenly became a top priority. “As an academic institution, we typically like to keep things in-house, so we did not go with a web-based design,” says Albertario. “However, we did want the ability to interact from the outside through the Internet.”

Narrowing it down to two major database systems was relatively easy, since virtually everything else was cobbled together using third party databases. “We wanted something integrated and cohesive,” says Albertario. “The push over the edge was the solidarity of what the vendor showed us they could provide. The Grael High-Definition /EEG system and their nexus system had what we wanted, as well as the potential to grow as technology changed.”

As the first accredited and paperless laboratory in the world (1990), Winthrop officials knew early on that patients in the population-dense Long Island region wanted not only the best, but the latest. Cutting edge technology kept people coming back and fueled an expansion from four beds at the turn of the century, to eight beds in their new facility—with all recordings digitally recorded and managed. “Our institution has allowed us to plug into the archiving infrastructure used for and Cardiology, thereby allowing digitized, seamless, online archiving”, says Albertario.

Keeping the door open for new millennium technology gave Compumedics the slight advantage in a competitive market. Vendor representatives simply could not “fake it” at Winthrop. “They had to know their stuff,” confirms Albertario. Albertario questions vendors with vigor, because he knows that better equipment/database management leads to real-world results, such as decreased turnaround time for patients, while strongly appealing to referral sources. With Compumedics, the idea is to adapt to whatever challenges the industry may throw, while continuing to evolve technologically.

“You have to know sleep, and Compumedics has a good clinical understanding of what we do,” says Albertario. “We have not even finished installing all of the elements, such as digital audio and next-level digital video. The cameras are installed, but the higher-grade software is not written as of yet. I see where they are going with multi-screen video capabilities— one screen zoomed into the face, one into the legs, and all synchronized. They offer it in their EEG platform, so I know it is on the horizon as promised,” says Albertario.

Like a Hotel

Even though the market changes and reimbursement changes with it, Winthrop officials are poised to help the 7.5 million patients on geographic Long Island. Moreover, when these residents show up, the facility they walk into does not look like a laboratory in the slightest. “We literally built a hotel,” says Albertario. “One of the inspectors upon opening the door to a bedroom said, ‘You literally built the Winthrop Hotel.’ And, anybody who visits says the same thing.”

In a state that boasts “The city that never sleeps,” it is appropriate to also open “the hotel” for daytime guests. “We realized that a special segment of our market, and one that not many facilities touch upon, is the shift-worker market,” explains Albertario. “We staff the laboratory around the clock, and every day we have the ability to perform daytime PSGs for patients who sleep and work in this 24 hour New York market.”

Added services and capabilities mean that more in-depth clinical trials are on the horizon for Winthrop, a prospect that officials welcome in the coming years. “We believe we are perfectly poised to help the academic world, and the clinical realm of those New Yorkers who seek treatments and understanding of sleep disorders,” adds Albertario. “In fact, those who have recently visited from Australia and Europe, realize how much thought we have actually put into this facility and comment on our ability to keep all of the technology in the background, thusly allowing the design team’s calming and soothing accents and highlights to shine through. It has truly been a labor of love for all parties involved, says Albertario, a once-in-a-career kind of thing.

Claude Albertario, RPSGT, is associate director of the Sleep Disorders Center, Winthrop-University Hospital, Mineola, NY. Albertario began his career in Sleep Medicine at New York Hospital’s Institute of Chronobiology, after obtaining his undergraduate training in Psychobiology at SUNY Purchase. He obtained his RPSGT credential in 1990. As an early advocate of digital recording methods, he spearheaded the effort to become the first accredited, paperless sleep center in the world (1990). He helped form the New York State Society of Sleep Medicine in 1998, and presently serves as its secretary. His research interests revolve around his invention, z-ratio, a unified metric of sleep/wake (http://www.zzzratio.com). Albertario is also a sleep apnea sufferer.

The Heart of the Matter: with Home Sleep Testing

The Somté testing (HST) device by Compumedics addresses the technological challenges of home studies while its sophisticated ECG capabilities help set the device apart from its peers.

When engineers from Australia-based Compumedics developed the Somté, they knew cardiology was likely to play a growing role within sleep medicine. With this in mind, they developed a Holter-type sleep system that earned a 2006 Frost & Sullivan award for Technology Leadership.

Since that time, interest in sleep disorders and testing has exploded from all sectors of medicine. Combining diagnostics with the optional capability for Holter ECG monitoring and pulse transit time results, is one way to recognize this new reality. Most other HST units do not have the option, because they don’t record electrocardiography (ECG) signals.

Jeff Kuznia, Vice-President of North American Sales and Marketing for Compumedics
, says the unit’s ability to record reliable data means that the equipment fits well into the Type 3 recorder market. Holter ECG monitoring exists as a stand-alone product, but the software development required to combine it with sleep makes it difficult for other companies to make a similar device.

Compumedics’ involvement in the Sleep-Heart Health Study sparked the original Holter idea, and there are no regrets—but still some work to do. “ Most cardiologists are aware of the connection between sleep disordered breathing and cardiovascular disease. However I do not believe that many have firsthand experience with managing sleep disorders, and may not appreciate the impact that sleep disorders have on cardiovascular disease, but also the effect of treating Sleep Disordered Breathing ‘SDB’ when it comes to managing many patients who suffer from complex hypertension or cardiac arrhythmias.”

Sleep Diagnosis & Therapy spoke with Kuznia about a wide-ranging discussion on the future of testing. Topics such as reimbursement and clinical efficacy are driving the market, but what shape will these changes make, and how will new discoveries alter diagnostic testing?
somte units The Heart of the Matter: with Home Sleep Testing

Data is out there, but from a scientific standpoint, the issue is still one of determining causality. There definitely is clear interaction between these processes, and a lot of people with cardiovascular disease have OSA or develop CSA. However, the evidence is inconclusive in showing SDB actually leads to cardiovascular disease. If you have cardiovascular disease, chances are increased that you have SDB, which should be treated. In many patients, treating SDB improves the status of their cardiovascular disease, or improves the ability to manage that disease, but what caused the other has not been determined. With respect to “hard science” this question may be viewed as rhetorical as hopefully either diagnosis warrants treatment.

One of the advantages of the Somté is it has some flexibility and capabilities that a lot of the other products don’t have that are in that class. It is one of the few units that has a built-in display that allows the technician to verify the quality of the recording prior to sending the patient away, avoiding a wasted recording night. It’s easy for the patient to set it up in most cases, the Somté uses the best methods of measuring respiratory data, with built-in RIP technology.  It’s also one of the few units that provide additional inputs to record limb movement.

You’ve got the ability to look at body position with the Somté if you so desire, and you can add in these high frequency channels. There are two of them, and the original concept was they would be used for ECG, but when we released the product we made it flexible enough so they could be used for a channel of EEG or EMG, and we’ve got people that are looking at this and saying this would be a very good thing to monitor Bruxism for instance.

An operational advantage of the system is that you can preconfigure the unit for the recording. The patient can put it on themselves, and does not have to interact with the unit because it will turn on automatically, record the data, and then turn off. A lot of the people that send the units out to patients will preprogram the unit to turn on at night and shut off in the morning. All patients have to do is hook themselves up, and they do not have to worry about touching the unit and turning it on and off. So in some cases patients may come to the sleep clinic or the physician’s office, get wired up, and then they can test to make sure that everything looks good before they go home.

It’s small, lightweight, and it’s easy to wear. Some of the units out there for home studies are still fairly large and bulky. There is a comfort factor to this that comes into play, and I think we’ve addressed that effectively.

The vast majority of sleep professionals believe that testing is valid and appropriate in certain populations, and that it can be done reliably. There are concerns still amongst some that if everybody was evaluated with a test that we would be missing other factors and other issues involved with their symptoms, such as co-existing sleep disorders. That being said, if you go to your primary care physician complaining of stomach pain and are treated and he/she missed the fact that you had an ear infection, does this constitute “bad medicine”? It is one of these things where there are still questions in the mind of the marketplace that would only be answered when testing is done in larger numbers.

If more people are doing testing, and have a larger volume of experience, the general consensus of the marketplace may shift because they would might experience more success, or they would be able to determine when it would not be successful and be able to more clearly state which set of patients need to be done in the lab.

We have been telling ourselves for the last 20-plus years that the number of people in the population with undiagnosed sleep disorders is large. If we are claiming that 80% of the people with sleep disorders are currently not diagnosed and treated, than there is this population of people not being cared for in our health care system. The thought was that if we had more testing being done, we would reach more patients with sleep disordered breathing and treat them, and that would be a cost effective way of managing this particular part of the health care challenge.
We don’t have a good handle on whether that is true or not. The economics are driven from the reimbursement end, whether it is Medicare or other third party payers. They look at the growth of sleep diagnostics and the cost of ongoing treatment, and are concerned at the cost and not necessarily the benefit. Anytime a diagnostic procedure or a treatment procedure has rapid growth, it puts a spotlight on it and payors look and say we maybe need to manage this more aggressively.

The issue is that if, or maybe when, reimbursement drops in the clinical lab, will it necessarily push people to doing more sleep studies in the home? This is unclear because the reimbursement at the home level is also relatively low, and so, from a business operations standpoint, to provide testing services in a manner that you can more than cover your costs is still a challenge for a lot of practitioners.

There is definitely a role for testing in the whole milieu of sleep medicine, and clearly there are a lot of people, including physicians, insurers, and patients, that are very strong advocates for that approach. The concern in the minds of many sleep professionals is that sleep medicine and managing patients with obstructive is not within the general training of most internal medicine physicians and most family practitioners. You are going to have family practitioners and internists with no sleep medicine training, caring for patients who may require more complex management than just prescribing a CPAP pressure. That is precisely the reason that sleep centers should be looking at expanding into it [home testing] because it keeps the profession in the sleep home testing market.

I think you can expand trucking industry to transportation in general. The airline industry is definitely another example and here you’ve got other complicating issues. You’ve got shift work compounded with potentially a pilot that may have OSA.  Clearly anything involving hazardous waste material or in the broad category of transportation is certainly a legitimate testing population.

It is still unclear what role testing plays in that arena. For instance, the truck drivers: one of the concerns is that if you would give a recorder to a truck driver and say, “put this on and bring it back in the morning after you have slept all night,” is that the truck driver is going to take that unit home and place it on his kid and not necessarily on himself. This is one situation where it may need to be a monitored study, since you need to verify whom the recording was actually done on.

One other population is those patients who are already diagnosed, that are already on treatment but have not been reevaluated for a while. Once a patient is diagnosed with and we have put them on treatment, we often don’t know how effective the treatment is long term, or if it needs to be adjusted. This has been one of the issues with tracking compliance in the usage of CPAP over time; in many cases those patients are not retested to see if their treatment is still valid, or if it is effective from an objective standpoint. testing is an ideal way to do cost-effective follow-up.

Jeff Kuznia, RRT, RPFT
Compumedics USA Inc
Charlotte, NC

Somté Software Package Includes:

• full waveform review;
• automatic respiratory event detection and statistics (central apnea, obstructive apnea, mixed apnea, hypopnea, • SpO2 desaturation events and artifacts);
• oximetry analysis;
• full manual event editing capabilities (deletion, reclassification, marking new);
• event searching;
• ability to view patient information; and
• comprehensive report generation with user definable template
• full disclosure printing
• Optional ECG Analysis with arrhythmia detection, classification, heart rate variability and ST-Segment measurements and statistics.

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Apnea and Sedation: A Potentially Dangerous Mix

Sleep apnea is on the rise and health professionals must implement a perioperative and periprocedure sleep apnea management program to reduce patient risk. 2

Mechanics of Sleep Apnea
Upper airway collapse is worsened during the perioperative and periprocedural care of a patient, especially if they receive premedication, general anesthesia, anxiolytics, antiemetics, and opioid analgesia.1,2,4,5  The result of decreased pharyngeal tone is reduced ventilation and oxygenation, causing hypoxia and hypercapnia, which inhibits the arousal response associated with each apnea incident of apnea. Airway obstructions also strain heart and lung function.

Premedication with drugs such as benzodiazepines has muscle relaxing effects on the upper airway musculature, causing a reduction of the posterior pharyngeal airway. The result is increased risk for hypoventilation, hypercapnia, and hypoxemia necessitating monitoring of oxygenation and ventilation.

There is considerable risk associated with premedications for procedures done outside the operating room, because we often underestimate the need for monitoring cardiovascular changes in these patients.  Capnography is a non-invasive alternative to ABGs and detects real time changes in carbon dioxide. Additionally, patients receive outpatient procedures and are sent home to recover shortly after procedure.  
Determining readiness for discharge requires defining risk factors for sleep apnea or sleep deprivation.  Routinely assessing discharge criteria will reduce the risk for problems at home.

On an intra-operative basis, these patients frequently have more difficult intubations and extubations.   They have a greater chance for adverse events due to hypoxemia, high or low blood pressure, cardiac arrythmias and aspiration pneumonias, as seen in the post anesthesia recovery unit (PACU). Discharge delays in the PACU are more likely due to an inability to maintain oxygenation at desirable levels for discharge, resulting in increased clinical care for nurses, anesthesiologists, and respiratory therapists.

Due to the risk for cardiopulmonary arrest, patients often require a discharge from PACU to a higher level of care for more exhaustive monitoring of their ventilation and increased sedation that can include telemetry, observation care for 7 hours or overnight, and even intensive care.1,2,5

Sleep patterns are changed significantly in patients recovering in a critical care unit. They have frequent interruptions that will worsen the effects of sleep deprivation, increasing the impact on sleep-disordered breathing. Treatment with positive air pressure will improve the outcome of patients with cardiac and respiratory co-morbidities, and the implications of this are significant, because sleep-disordered breathing is such a common (frequently untreated and undiagnosed) chronic disease of middle-aged adults.5

No Time to Relax
Anesthetics, analgesic, and sedative drugs produce increased muscle relaxation of the throat and tongue, and in someone at risk for sleep apnea, may create an airway blockage. When administering anesthetics, the surgeon anesthesiologist may need to alter the type and dosages of medications received to protect the breathing responses.  Post surgical pain management may also require adjustment to prevent diminished breathing. As a result, narcotic pain medication or sedation will be balanced to prevent respiratory depression.

Surgery of the upper abdomen, breast, chest, or upper airway can complicate matters for patients at risk for sleep apnea by causing increased respiratory discomfort. Respiration is shallow with these surgical procedures, and increased pain adds to this discomfort when trying to breath.

When being cared for in a supine position, added risk occurs from the relaxation of the muscles in the posterior airway. Unless contraindicated, the head of the bed should be elevated 20-30 degrees to lessen some of the force placed on the posterior airway.

Positive air pressure may be required to support breathing after surgery or after a procedure requiring sedation or pain medication, especially if depressed respiration due to decreased ventilation becomes a concern.

Deep Sleep Suffers
Patients at risk for sleep apnea experience less time in the deep levels of sleep, reducing the body’s natural capacity for healing and pain control. As a consequence, these processes work less effectively.

The states of NREM (non-rapid eye movement) and REM (rapid eye movement) each perform a different function, and both are crucial to overall daytime effectiveness. Going to sleep is like descending a stairway.  As brain activity slows, we transition into NREM sleep until we reach deep sleep. When in deep sleep, pulse and respiratory slows, blood pressure drops, muscles relax, and growth hormone is released to facilitate physical healing, enhanced pain control, and physical rejuvenation.

About every hour and a half we come out of deep sleep into REM sleep, an active state of sleep.
REM sleep is crucial since our breathing, blood pressure, pulse rate, and blood flow to the brain all increase during this phase. During REM sleep, our peripheral muscles are atonic.

REM presents a challenge to sustain breathing, oxygenation, and cardiac stability in patients at risk for sleep apnea. Clinical functions all become more difficult to sustain because apneic events are longer during REM, oxygen desaturation is lower, and more cardiac arrhythmias are noted during REM sleep. Since the longest REM period occurs in the early morning hours between 4:00 – 6:00 AM, we need to closely monitor our patients during this time.

Every stage of the health care continuum that provides sedation should implement sedation-related apnea management guidelines. This program will reduce patient risk, reduce medical liabilities, and create additional sleep apnea patient disease management revenue streams for related health professionals. 7

Christopher VuSleep Advoacate
The author is a staff writer for
Sleep Diagnosis and Therapy

1.    den Herder C, Risks of general anaesthesia in people with obstructive sleep apnoea. BMJ 2004; 329:955-9.
2.    Estfan B, Respiratory function during parenteral opioid titration for cancer pain. Palliative Medicine. 2007; 21: 81-6.
3.    Feinsilver, SH, A sleeping giant:  sleep-disordered breathing in the coronary care unit. Chest 2005; 127: 4-5.
4.    Morgenthaler TI, Practice parameters for the use of autotitrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome:  an update for 2007.  An American Academy of Sleep Medicine report.  Sleep. 2008 Jan 1; 31 (1): 141-7.
5.    Practice Guidelines for the Perioperative Management of Patients with Obstructive Sleep Apnea.  A report by the American Society of Anesthesiologists Task Force on Perioperative Management of Patients with Obstructive Sleep Apnea.  Anesthesiology 2006; 104:1081-93.
6.    Preventing and managing the impact of anesthesia awareness. Sentinel Event Alert Joint Commission on Accreditation of Healthcare Organizations October 6, 2004; Issue 32.

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Beyond the S9: VPAP™ Tx Lab System

vpaptxlab1 Beyond the S9: VPAP™ Tx Lab System

As the marketing push for ResMed’s S9™ Series reverberated around the 24th APSS (American Professional Sleep Societies) meeting in San Antonio, the San Diego-based company’s VPAP™ Tx Lab System quietly began to build its own momentum. Billed as an “all-in-one” titration solution for sleep labs, the unit contains all ResMed therapies, including adaptive servo-ventilation (Adapt SV), which treats central , mixed apneas, and periodic breathing.

According to Elizabeth Little, VPAP Tx Product Manager at Resmed, most people were surprised to hear the system includes all ResMed’s therapies. They expected Adapt SV to remain separate, and were pleasantly surprised to see it in the mix. “Our goal with the VPAP Tx was to build a product that would be easy for sleep techs to use and extremely comfortable for patients,” said Little. “We studied the work flow of technicians, and minimized the number of steps they need to take. Swapping out the bedside device for one therapy mode vs another was cumbersome, and the way to eliminate that was to put all of our superior therapies in one system. We put lab technicians’ needs at the forefront when developing this product.”

Throughout the conference, Little kept up a continual dialogue with sleep technicians and lab managers about the finer points of the new system. Little reports that many technicians were very impressed with the highly intuitive software. Among the most popular features were the therapy default settings, which are customizable and automatically reset to baseline pressure upon startup, eliminating a step for the tech, and preventing them from accidentally startling the patient with a blast of pressure. Additionally, she pointed out the “Detailed Settings Report,” which provides a complete record of all changes made to therapy during the night, giving them visibility to the performed by the techs, and allowing them to identify areas where training is needed.

A bilevel function delivers two treatment pressures—one for inspiration and one for expiration—and provides control over a variety of bilevel therapy modes. This integrated approach is a first for ResMed, and Drew Terry, senior director, product management, sleep SBU, says that a few months into the launch has seen many labs convert to the new unit with success. “The techs like the easy layout,” enthuses Terry. “They can go from CPAP mode to bi-level mode during the testing process, and it does it in an intelligent way—giving full control while also making recommendations. New technicians won’t spend a lot of time figuring out how to set things up. It’s automatic but it also allows you to make any necessary adjustments.”

After sleep lab technicians use the VPAP for titration, patients may ultimately go home with an S9 CPAP. Those that opt for this route will get many of the same features and technologies that served them during testing. “They can sleep with the Easy-Breathe Waveform, which synchronizes pressure with natural breathing patterns,” says Terry. “They will get the same ultra-quiet therapy in the home that they experienced in the lab. By maintaining consistency between the lab and home therapy, you are maximizing the patient’s chance for success.”

vpaptx2 Beyond the S9: VPAP™ Tx Lab System

Competitive Concerns
On the home care side of the sleep business, HME providers were left reeling in July when CMS announced new winning bid prices in the competitive bidding program. Unless legislative remedies derail the program, home care providers in 9 of the nations metropolitan areas will take a 32% cut in their allowable for CPAP units in 2011.

Currently, sleep labs must refer all CPAP patients to an HME to fulfill the prescription. “Some reports have shown that more people are considering dispensing, and that is something sleep lab owners may consider when looking at all the forces on their business,” says Terry. “Getting into the home care side of the business is another opportunity, and I think a lot of people are considering it. It’s a relatively small percentage of labs that are doing it right now—probably less than 20%. It’s a different business than running a lab.”

It is a competitive business environment for labs and many labs are looking for additional ways to serve their patients and grow their business. “They are considering how they might include in their service offerings,” says Terry. “Although the revenue for a home test is less than what the in-lab tests are, labs are looking at that as a way to bring in additional patients who maybe would not have come into the lab anyway.”

S9 Still in Spotlight
Despite reimbursement uncertainties, trade show season has been kind to San Diego-based ResMed as the company continues to market its S9™ flow generators. The makers of the Swift and Mirage CPAP masks are spreading news of the S9‘s treatment technology in an attempt to create maximum value, an attribute that company officials say is even more important during uncertain times. “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 treatment,” said Terry.

Terry says the S9 represents a new approach to patient compliance, essentially making it easier 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,” adds Terry. “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. And it comes in a stylish design that looks like something they want to have at their bedside.”

With the S9 Series, ResMed has introduced a number of improvements, including Enhanced AutoSet™ and Easy-Breathe algorithms—and an improved Easy-Breathe motor for low noise levels. The S9 provides detailed data reporting for clinicians, and a complete S9-compatible wireless compliance management package to streamline business efficiencies. A humidification system with Climate Control intelligently adapts to the user’s real-time environmental conditions to provide optimum performance and humidification delivery. An innovative SlimLine™ tube eliminates tube drag.

Ultimately, the S9 is a large part of the overall push toward greater innovation in what will surely be a huge decade for sleep medicine. Companies big and small are all angling to serve the growing market, and Terry acknowledges that competition is fierce.


Elizabeth Little is Product Manager Sleep, based with ResMed in San Diego, CA.

For more information, visit www.resmed.com

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