Grass Technologies Comet PSG and AURA PsG

Reviewed by Marietta B. Bibbs/MBB
Vice President and Director of Technical Development,
Sleep Management Centers, LLC, Fort Myers, FL

WHY I USE AND WILL CONTINUE TO USE GRASS PRODUCTS

I have been a longtime loyal user of Grass products. I started out many years ago using Grass Model 7, Model 8 and Model 78 analog polygraphs, and I have progressed with them as they have upgraded their technology. I was one of the first customers to purchase the Grass Heritage Systems with Gamma Software. This product was very stable. We used the same polygraphs from 1998 until 2006. As the Grass product line improved, I gained experience working with the Comet PSG systems and now with the AURA PSG product. Customer support is critical to me and they have a very skilled and know-ledgeable customer support team. What I hope to see is more development of products in the ambulatory arena. They have started this with the AURA PSG and AURA Lite. I hope that they continue to manufacture products in this area since the field seems to be leaning in this direction.

PRODUCT INSTALLATION AND IN-SERVICE TRAINING

The Grass Products are very user friendly and require very little detailed training. I have been able to use the products very easily with minimal orientation and training. Ahead of the in-service training, the Grass technical support staff provided applicable documentation and diagrams. This process helped us ensure the physical installation of the equipment would go smoothly. They also provided me with a schedule featuring in-service installation procedures which helped me plan staffing logistics for the training period. Practical training was given to the daytime and nighttime staff, and also our physicians. In fact, the Grass in-service staff even helped us acquire, score, and generate a report on the first patients recorded on their equipment.

KEY HARDWARE AND SOFTWARE PRODUCT FEATURES

Grass products are easy to comprehend and logical to people who have computer skills. Their hardware and software seems have been designed in a manner that is intuitive to work with, especially from a sleep diagnostic perspective.

From a hardware standpoint, the stability of the equipment and the lifetime warranty on the Grass products is very reassuring and was a key point in us continuing to use Grass equipment. The hardware also offers me various types of sleep studies, from a standard diagnostic or therapeutic PSG, to extended channel PSGs and MSLTs/MWTs. Their AURA PSG wireless system offers great comfort to the patient, particularly those having MSLTs or MWTs and patients with extended PSGs.

From a software standpoint, capabilities like their Sleep Staging/Scoring Comparison software and flexible sleep reports are very useful features. Interlab scoring comparisons are required for AASM accreditation, and the Grass scoring comparison helps facilitate this process. Their PSG reports are Word-based, which makes it easy to create different reports for specific physicians. Their new EKG analysis software looks like it will benefit the industry too. Cardiology aspects of the sleep study seem to becoming more and more important in the overall diagnosis and treatment of the patient.

CUSTOMER SUPPORT AND PRODUCT WARRANTY

The after-sale support is one of the best in the field. I have used a variety of PSG products, and no one beats their 24/7 customer support and lifetime product warranty. If one of their amplifiers becomes faulty (which is a rare occurrence), they offer repair at no charge. This is a big savings to the sleep lab, and other manufacturers do not offer a better warranty. Also, today’s sleep lab needs service and support 24 hours a day. With Grass, I can always speak with one of their knowledgeable technical support staff, day or night.

WideMed’s Morpheus Clinical Sleep Information System

Review by Richard K. Bogan, MD, FCCP
Chairman and Chief Medical Officer
SleepMed Inc
Columbia, SC

INTRODUCTION TO AUTOMATED PROCESSING OF THE BIOLOGICAL SIGNAL

In sleep medicine we monitor multiple signals. It is important for clinicians to understand the state of the individual, monitor what stage of sleep they are in, whether they are awake or not, and to also understand processes. The American Academy of Sleep Medicine (AASM) has recently revisited this because there have been many changes in the methodology for scoring, and in this specific case, human visual scoring. As humans, we are accustomed to seeing science advance and move towards more automated processing and I think that Morpheus® makes a great stride towards automated processing and scoring.

Morpheus, created by WideMed, Ltd., is the signal processing that monitors biological signals and it allows for an automated analysis of the biological signal. It also has the capability of allowing human supervision so that a human can look at the biological signal and critique studies performed by Morpheus. It provides the best of both approaches. It can incorporate up to 100% human supervision depending on the quality of the signal and the quality of the signal processing.

morpheus is an evolving software specializing in advanced signal processing that enhances the resolution. You can compare Morpheus to the amount of pixels there are in a digital photograph. The way I look at Morpheus is that there are a lot of pixels and therefore the resolution is very high in terms of looking at the biological signal, and also attached are the benefits of having R&K as well. R&K is basically a human analysis of biological signals that is based on the visual recognition of frequency and amplitude characteristics. Morpheus utilizes mathematics models and algorithms to provide a consistent automated scoring.

WIDEMED-SLEEPMED COLLABORATION

SleepMed is a diagnostic and therapeutic sleep company that currently operates approximately 150 sleep labs and will process over 70,000 sleep studies this year. WideMed created Morpheus to assist sleep centers in managing, streamlining and enhancing the data collection and analysis process.

WideMed and SleepMed have worked closely together for a number of months with the goal of providing a method of automated signal processing with human supervision. The new method SleepMed employs using Morpheus streamlines the process much more rapidly allowing more studies to be analyzed in the same period of time. A database is also available in Morpheus so that certain fields of information could be categorized, quantified and searched for future studies in order to understand biological processes and the state of individual.

WideMed’s engineers have expertise in mathematical models of signal processing. WideMed developed a multi-dimensional mathematical analysis of biological signals and by using this multi-dimensional mathematical model they are using robust engineering methodologies such as adaptive segmentation, fuzzy logic and hidden Markov models.

The artificial intelligence methodologies used include fuzzy logic algorithms that characterize the adaptive segments into different biological processes. So here, rather than the human looking at a biological signal we have a mathematical model that allows us to perform signal processing. And because of this signal processing and the mathematical model, we can compartmentalize the biological signal into segments, which is known as “adaptive segmentation”.

WideMed’s engineering skills and SleepMed’s clinical expertise developed algorithms to help interpret the signal processing. So again, you have multi-dimensional mathematical analyses of biological signals that are applied clinically, and by using various algorithms, what Morpheus does is it takes these segments and compartmentalizes them into 30-second chunks that are translated into the traditional R&K. It is like taking a foreign language and translating it into a language that we now know as R&K language.

MORPHEUS’ MULTI-DIMENSIONAL MATHEMATICAL MODEL

Sleep systems with automated scoring typically will use a mathematical model called Fast Fourier Transformation (FFT). Morpheus uses a different mathematical model that is all adaptive segmentation. Morpheus goes back and forth through the signal and identifies areas in the signal that have mathematical properties that are similar throughout the signal tracing. It will identify high frequency areas and low frequency areas, much as a human eye does.

So rather than just giving you a spectral analysis of the frequency and the amplitude characteristics and using a fake denominator, which is what FFT does, Morpheus uses this multi-dimensional mathematical model of adaptive segments so that it replicates what the human does in terms of looking at frequency and amplitude characteristics. At the same time, Morpheus will monitor the EMG of the electromonogram and eye movements, calculate the probability that there are changes in EMG activity and rapid eye movements (REM), and then correlate that data to determine the current state of the individual in terms of wake or sleep.

SUMMARY

The benefits that we gain through Morpheus are understanding processes about how the brain organizes sleep, controls the breathing, controls the legs and the periodic leg movements, controls the heart, and having the ability to look at the individual’s sleep state. We can translate all of that into the traditional human scoring where we have the automated processing as well. Ultimately, we are able to study sleep states and processes from a different language and a different prospective from a mathematical scientific methodology using human R&K scoring because it is human-supervised.

WideMed’s Morpheus Clinical Sleep Information System

Review by Richard K. Bogan, MD, FCCP
Chairman and Chief Medical Officer
SleepMed Inc
Columbia, SC

INTRODUCTION TO AUTOMATED PROCESSING OF THE BIOLOGICAL SIGNAL

In sleep medicine we monitor multiple signals. It is important for clinicians to understand the state of the individual, monitor what stage of sleep they are in, whether they are awake or not, and to also understand processes. The American Academy of Sleep Medicine (AASM) has recently revisited this because there have been many changes in the methodology for scoring, and in this specific case, human visual scoring. As humans, we are accustomed to seeing science advance and move towards more automated processing and I think that Morpheus® makes a great stride towards automated processing and scoring.

Morpheus, created by WideMed, Ltd., is the signal processing that monitors biological signals and it allows for an automated analysis of the biological signal. It also has the capability of allowing human supervision so that a human can look at the biological signal and critique studies performed by Morpheus. It provides the best of both approaches. It can incorporate up to 100% human supervision depending on the quality of the signal and the quality of the signal processing.

morpheus is an evolving software specializing in advanced signal processing that enhances the resolution. You can compare Morpheus to the amount of pixels there are in a digital photograph. The way I look at Morpheus is that there are a lot of pixels and therefore the resolution is very high in terms of looking at the biological signal, and also attached are the benefits of having R&K as well. R&K is basically a human analysis of biological signals that is based on the visual recognition of frequency and amplitude characteristics. Morpheus utilizes mathematics models and algorithms to provide a consistent automated scoring.

WIDEMED-SLEEPMED COLLABORATION

SleepMed is a diagnostic and therapeutic sleep company that currently operates approximately 150 sleep labs and will process over 70,000 sleep studies this year. WideMed created Morpheus to assist sleep centers in managing, streamlining and enhancing the data collection and analysis process.

WideMed and SleepMed have worked closely together for a number of months with the goal of providing a method of automated signal processing with human supervision. The new method SleepMed employs using Morpheus streamlines the process much more rapidly allowing more studies to be analyzed in the same period of time. A database is also available in Morpheus so that certain fields of information could be categorized, quantified and searched for future studies in order to understand biological processes and the state of individual.

WideMed’s engineers have expertise in mathematical models of signal processing. WideMed developed a multi-dimensional mathematical analysis of biological signals and by using this multi-dimensional mathematical model they are using robust engineering methodologies such as adaptive segmentation, fuzzy logic and hidden Markov models.

The artificial intelligence methodologies used include fuzzy logic algorithms that characterize the adaptive segments into different biological processes. So here, rather than the human looking at a biological signal we have a mathematical model that allows us to perform signal processing. And because of this signal processing and the mathematical model, we can compartmentalize the biological signal into segments, which is known as “adaptive segmentation”.

WideMed’s engineering skills and SleepMed’s clinical expertise developed algorithms to help interpret the signal processing. So again, you have multi-dimensional mathematical analyses of biological signals that are applied clinically, and by using various algorithms, what Morpheus does is it takes these segments and compartmentalizes them into 30-second chunks that are translated into the traditional R&K. It is like taking a foreign language and translating it into a language that we now know as R&K language.

MORPHEUS’ MULTI-DIMENSIONAL MATHEMATICAL MODEL

Sleep systems with automated scoring typically will use a mathematical model called Fast Fourier Transformation (FFT). Morpheus uses a different mathematical model that is all adaptive segmentation. Morpheus goes back and forth through the signal and identifies areas in the signal that have mathematical properties that are similar throughout the signal tracing. It will identify high frequency areas and low frequency areas, much as a human eye does.

So rather than just giving you a spectral analysis of the frequency and the amplitude characteristics and using a fake denominator, which is what FFT does, Morpheus uses this multi-dimensional mathematical model of adaptive segments so that it replicates what the human does in terms of looking at frequency and amplitude characteristics. At the same time, Morpheus will monitor the EMG of the electromonogram and eye movements, calculate the probability that there are changes in EMG activity and rapid eye movements (REM), and then correlate that data to determine the current state of the individual in terms of wake or sleep.

SUMMARY

The benefits that we gain through Morpheus are understanding processes about how the brain organizes sleep, controls the breathing, controls the legs and the periodic leg movements, controls the heart, and having the ability to look at the individual’s sleep state. We can translate all of that into the traditional human scoring where we have the automated processing as well. Ultimately, we are able to study sleep states and processes from a different language and a different prospective from a mathematical scientific methodology using human R&K scoring because it is human-supervised.

Braebon’s Pursuit Outcomes

Review by Sandra Lombardo, RPSGT, RT
President
Sleep Lab Consultants Inc.
Buffalo, NY

TRACKING AND CONSOLIDATING PATIENT INFORMATION


Braebon’s Pursuit Outcomes software virtually eliminates redundant data entry. Pursuit Outcomes significantly reduces the amount of time spent on redundant work required by the office staff, which allows for more time to be spent with patients. Many pieces of information reside in the patient’s electronic record that can be extracted in a number of different ways. It brings together all of the information on a patient into one spot and allows for very easy access to each patient.

Furthermore, it allows business owners to track referral activities, third party payers, procedures, turn-around times, and much more. The tracking system is very useful when going through the accreditation process by keeping a very organized and comprehensive record of each patient who has been evaluated, tested, and treated within the sleep lab. You can also compare patient and family medical history with diagnoses and treatment outcomes.

PATIENT SCHEDULING AND WORKFLOW MANAGEMENT

There are many features that make the Outcomes system unique. My favorite feature is the colorized graphic scheduler for patients that is very helpful to both the scheduling personnel and nighttime technical staff. Outcome’s ability to interface to the outside world allows it to communicate with a number of PSG systems, off-the-shelf software packages, and hospital IS systems.

I believe that workflow management software is paramount when operating a modern sleep lab. Outcomes actually tracks comprehensive workflow on each patient from the initial diagnostic phase through treatment and follow-up. The greatest benefit of Outcomes is that it allows very easy access to not only patient information, but also to facility information as well.

A STRONGLY RECOMMENDED COMPREHENSIVE PROGRAM

With the proper training, I have found Outcomes to be very simple to understand. It is very intuitive and easy to navigate with reduced keystrokes. Information can be found quickly and reports can be generated with only one or two mouse clicks. The software has 14 years of input from both existing and potential customers and that feedback has eliminated software bugs that are typical within a program this comprehensive.

The company has a number of full time programmers that are constantly enhancing Outcomes’ software, based on customer feedback. The only thing I can think of that it is missing is a DME module that is already in the plans to be released later on this year. Having worked with Braebon’s Pursuit Outcomes for a little over one year, I would definitely recommend it to any sleep facility, whether starting up or existing, hospital-based or freestanding, as a powerful tool to save money and to run operations more successfully.

Nihon Kohden’s Polysmith Version 5 with Polysuite Advanced Database

Review by Shane Szutenbach, RPSGT
Manager/Chief Technologist
Sleep Disorders Center, University of Chicago Medical Center
Chicago, I1

NIHON KOHDEN: A PRIMARY CHOICE

We have a relationship with Nihon Kohden that has lasted over 20 years, so the biggest factor in deciding to trial their sleep diagnostic systems was that we already owned Nihon Kohden EEG and sleep acquisition systems. We really felt like we knew the software and hardware enough to trust that what we were getting would be reliable and easy to use. Our experience has been that the service is dependable so changing to another company did not make sense to us. We work closely with the Nihon Kohden team. We communicate what we want in a system to them and the attention we receive is very positive; especially if we do not like something. They are quick to respond to our suggestions and concerns. An additional factor was that since all of our research affiliates are using Nihon Kohden’s Polysmith, staying on the same platform was very important to us.

KEY CHANGES IN THE POLYSMITH THAT MAKES LIFE A LOT BETTER

When we went from Polysmith version 4 to version 5, we purchased all new hardware which included their 912 dedicated PSG head boxes with built-in pulse oximetry. We also purchased a couple of the 921 head boxes with built-in pulse oximetry and end tidal CO2 modules.

We were so pleased that we purchased 2 additional 921 head boxes with the end tidal units and while both Polysmith version 4 and version 5 had the same intuitive functions, there were key changes that made everyone’s life a lot better.

First, the multi-trend plot which can be viewed by the techs acquiring the study at night can be edited so that artifacts are not put into the reports, such as a false pulse oximetry reading when a patient is unhooked for a break.

Next, another key change is how the actual data is acquired and stored because it has the ability to create smaller file sizes when archiving. And since the acquisition is more streamlined, the techs are also able to go into “look-back” to stage and score while the study is running with very little compromise in processing speed.

Another key feature that is very important to us is the Polysmith advanced database. The advanced database really ties everything together for us when we need to generate custom patient reports that perform very specific queries for our research.

Finally, what is great and useful is that Nihon Kohden sent a clinical specialist out for the week so that we were all trained on the new equipment.

NIHON KOHDEN’S CAP ONE MAIN STREAM EtCO2

In the past, we were using external devices which became somewhat difficult to calibrate. With the upcoming development of Nihon Kohden’s Cap One Main Stream device for end tidal CO2 sampling, when a tech begins to start a study and we perform our mechanical calibrations, all of the built-in DC devices such as the Etco2 and the pulse oximeters will automatically be calibrated. Furthermore, the great thing about the end tidal unit is that it is in real time, so there is no 6-10 second delay like other systems. The end tidal interface that goes onto the patient will be available in the future with a nasal pressure cannula so that you can monitor both the Etco2 signal and the nasal pressure transducer airflow signal as two separate channels. We have been working on the development of the Cap One sampling canula with Nihon Kohden so we are really excited to see it come out.

Compumedics’ Profusion PSG

Review by Donna Craig, RPSGT
Site Manager
Baptist Sleep Institute West
Knoxville, TN

BEST TECH SUPPORT IN THE INDUSTRY

A few factors we considered before purchasing the Compumedics equipment with Profusion PSG software included ease of use, product reliability and cost efficiency. Customer support after purchase was also an important factor and their after-sale support is excellent. On the rare occasions when we have had to send equipment in for repair, they were able to ship overnight to us replacement parts to be used until ours was fixed. Their tech support is probably the best in the industry. We basically wanted to purchase a system that has a good reputation within the Sleep community.

EQUIPMENT & SOFTWARE FEATURES THAT WILL AFFECT THE SLEEP MARKET

The Profusion PSG software comes with many great features. A few of those impressive features include automated scoring, hot keys for use while running the sleep study and while scoring, customized montages and built-in measuring tools for waveform clarification.

The automated scoring makes it quick and easy to generate a preliminary report immediately following the collection of the data during the study. This aids the medical staff by providing a quick overview of the studies done the night before and gives them an idea of the severity of any sleep disorder seen.

There are many hot keys for the ease of staging, insertion of tech comments throughout the night, and CPAP pressure adjustments. The ability to customize montages based upon the need of our Sleep Institute was an important factor in the decision-making process. We needed to be able to run a variety of studies based upon the individual needs of our patients.

The built-in measuring tools make it easy to distinguish between different types of waveforms whenever clarification is necessary. The most important feature however is the ability to score at the same time as data collection. This has drastically cut back on the amount of time it takes for us to finalize reports and get the results out to referring physicians and provide better care for our patients.

Equipment like this will drastically affect the sleep market by increasing the pressure put upon labs with less up-to-date equipment to move quicker and work harder at getting results out to patients and referring physicians in a timely manner. With more sleep facilities opening across the country, the ability to provide a quick-turn around time on study results becomes a very important factor when choosing the appropriate software.

USER-FRIENDLY SOFTWARE CUSTOMIZED TO MEET NEEDS

Profusion PSG is very user-friendly. With this software, scoring is very quick, easy and simple. Also, all reports can easily be customized to meet the needs of our Sleep Institute. A lot of the staff was anxious about learning how to use a new system after using another software program for many years. However, the entire staff was able to quickly learn the new program and was surprised at how easy it was to understand and use.

ENHANCED EFFICIENCY THROUGH TRAINING AND EDUCATION SESSIONS

Upon installation of the new equipment Compumedics provided a full week of hands-on training. After this training session they have a 24-hour tech-support line for any questions or problems that may arise day or night. Compumedics also hosts several training and education sessions throughout the year to enhance the efficiency and proficiency of the Profusion PSG software.

IMPROVED CONCORDANCES RUNNING WITH STAGING AND EVENT SCORING

The only area that currently needed any improvement Compumedics has already addressed. According to new guidelines set forth by the American Academy of Sleep Medicine, concordances must be run between scorers not only in regards to staging but also respiratory and leg movement events. With our current system we are only able to run concordance with stages. However with the new Profusion PSG 3, just released as this article is being published, concordances will be able to be run both with staging and other event scoring.

Sleep-Record Outsourcing No Yawning Matter – Chad Doucette

Looming Shortages of Registered Sleep Technologists Fuels a New Business Model that is Being Adopted by Sleep Labs Worldwide

Sleep disorders are like an epidemic sweeping across North America. According to Stanford University Center of Excellence for the Diagnosis and Treatment of Sleep Disorders, obstructive sleep apnea tops the list with an estimated 30 million Americans being afflicted. An estimated 12 million Americans twitch and kick their way through the night with restless legs syndrome and roughly 14 percent of Americans are afflicted with chronic insomnia. Nightmares, night terrors, sleepwalking, head banging and grinding teeth round out a partial list of growing sleep problems called parasomnias.

All this adds up to a sleepy if not cranky population. Fatigue is the most common problem that can lead to higher absenteeism, higher worker’s compensation, increased errors, diminished productivity and a host of costly workforce productivity issues. All this is putting tremendous pressure on sleep facilities. As the number of people dreaming of getting a good night’s sleep increases, more sleep facilities face mounting backlogs of patient’s sleep studies that need to be analyzed. Not surprisingly the pent-up demand for sleep tests is fueling a brand new red-hot trend in sleep medicine: Sleep-record outsourcing. An increasing number of leading hospitals and private sleep facilities are turning to this innovative business practice as a quick cure for staffing shortages, or as a long-term substitute for costly operational expenses. The benefits of record outsourcing are compelling:

  • Increased profitability
  • Heightened efficiency and productivity
  • Reduced overhead costs
  • Restored work/life balance for employees
  • Raise revenue by increasing the number of patients you can assess/treat
  • Improved patient services due to faster turnaround of completed sleep studies
  • Alleviates staff shortages during peak volume periods
  • Gain access to industry experts

In addition to these and other benefits, most sleep laboratories and hospitals will be motivated to incorporate sleep record outsourcing into their business practice as a proactive measure to deal with a looming staff crisis.

Easing Sleep Medicine’s Impending Staffing Shortage

In recent years, demand has outstripped the supply of registered sleep technologists. Lack of qualified staff has left many sleep laboratories working short staffed, many of them working excessive hours of overtime and being frequently called back to work after having completed their shift. Vacant positions are not filled or, in the case of many rural health districts, they are temporarily filled by laboratory aides or other department staff who cannot completely score patient’s studies. Shortages of technologist have also led to longer turn-around times for test results with staff feeling overwhelmed by the workload. In addition, a significant number of technologists will be eligible to retire in the next several years.

In response to this tsunami sized labor crisis, the numbers of scoring companies is expected to increase significantly over the next few years. Until recently the sleep industry has been slow to adopt outsourcing. However, the laws of supply and demand coupled with the proven benefits and cost effectiveness of outsourcing are widely expected to make this a normal if not preferred business practice to account for future growth and the onslaught of employee shortages.

“Who is Scoring My Sleep Studies?”

The sleep record scoring industry is a relatively new and innovative concept. Until recently, the only viable option available to sleep labs and hospitals was to use freelance technologists to score sleep studies on the side. Although this helped to ease some of the workload, a single technologist can only be stretched so far. Factor in concerns over HIPPA compliance and liability insurance coverage, and the single technologist option becomes a short term, stopgap measure at best. Over the past few years we have seen the emergence of some very reputable, value driven companies who place quality at the heart of their organization. As with any industry growth surge, we have seen some companies offering scoring services at very low rates with questionable quality controls and unregistered technologists performing the work. While the benefits of outsourcing are attractive, the key question that a facility should ask when thinking about outsourcing is “Who is scoring my sleep studies?”

Selecting a company that only uses registered technologists to manually score the entire study is a key factor for a successful outsourcing partnership. Scoring companies that do not hire registered technologists as scorers are not ensuring quality control or recognizing the importance of the RPSGT credentials. Cutting corners to save a few dollars by signing on companies whose studies are scored by unregistered technologists can place the quality and reputation of your facility in jeopardy. It is imperative that a standard be set in the outsourcing industry-one that ensures that only registered technologists perform the scoring of the entire sleep study. With the upcoming changes in AASM scoring criteria; this only solidifies the fact that hiring a reputable scoring company who keeps abreast with the changes in the industry and only uses registered technologists be mandatory.

Some sleep labs have considered an offshore option with the actual scoring being conducted in countries as far away as India. This method is tempting because of its cost effectiveness, but caution should be observed: it is critical to ensure these facilities are following the same internal standards established by your facility when it comes to HIPPA and patient security as well as the practice of hiring only registered technologists.

The concept of computer generated scoring has also emerged as a topic of debate. While this option is currently available, its adoption by the industry has not been widely accepted. Many sleep disorder laboratories have different protocols and procedures in conjunction with scoring to R&K standards and medical directors often have diverse perspectives regarding scoring of sleep studies. These factors can undermine the effectiveness of computer generated scoring and may make it difficult for this practice to find a solid home in the sleep medicine industry at this time. While we cannot discount advances in technology, the role of a registered sleep technologist cannot be easily replaced by a computer. As time progresses and continued advancement in technology occurs we may see automatic scoring becoming more of a reality that complements rather than replaces manual scoring of sleep studies.

Here is the bottom line: will your studies be scored by a registered technologist? If the answer is yes, then be sure to and ask for copies of the technologist’s certifications.

How to Make the Best Choice

Finding the right sleep record scoring company can be the difference between the success and failure of your sleep laboratory. How do you know which sleep scoring company is the best? One sure way is to assess the company’s industry reputation or ask for recommendations. Both are valid approaches and both mean you have to do your homework while establishing standards for your investigation to ensure you find the best company for the job.

Price is another consideration. Sleep laboratories, like the majority of healthcare departments, typically have limited budgets. However price needs to be considered in the context of quality, reliability and efficiency. Choosing the vendor with the cheapest service offering can be a shortsighted view that ultimately costs the sleep laboratory more money due to quality issues. More importantly, it can also damage the lab’s reputation.

Here is another important tip when selecting a scoring vendor: find out whether a team of registered technologists will change or will you have a select number specifically assigned to your account. The ability to select a scoring service that does not have a revolving number of technologists scoring on your account will allow your medical directors to become familiar with the scoring technologists while helping to ensure greater continuity and quality in the services provided. It takes time for new resources to ramp up and understand your expectations, so having a dedicated team is far more desirable.

Remember: when it comes to outsourcing, you are the customer. Be as diligent selecting a vendor as you want your referring physicians and patients to be with you. Your patients expect the best when it comes to the service you provide. Do not cut corners by aligning yourself with a company that does not put quality first. As the outsourcing industry continues to grow we can expect to see the emergence of industry standards that will mandate the use of registered technologists to score patient studies.

Outsourcing as a Long-Term Strategy

One thing is certain: sleep record scoring companies and the concept of outsourcing by sleep laboratories worldwide is here to stay. Staffing issues and the growing demand for sleep studies are forcing sleep laboratories worldwide to adopt this as the business model of choice. More sleep labs are “waking up” to the important benefits of outsourcing their studies – and in so doing they have been able to cut costs, free up internal resources and increase productivity. When hiring a scoring company, ensure you are working with qualified, registered technologists to ensure quality and to safeguard your own reputation. And finally, a reputable scoring company will act as an invaluable virtual extension of your team – and in so doing give you more reasons to sleep soundly knowing that your patients’ sleep studies are being analyzed by professional, knowledgeable resources. Pleasant dreams!

Chad Doucette
V.P. Sales and Marketing
Sleep Strategies Inc
Ottawa, Ontario

Should Sleep Labs Embrace Unattended Studies? – David Barone

Most sleep labs utilize polysomnography (PSG) as their sole methodology to diagnose nocturnal breathing disorders. Ambulatory tests (a.k.a. “home studies” or “unattended sleep studies”) are offered by various service providers and health networks as an alternative to rule-out sleep apnea or to confirm the presence and severity of the disease in patients presenting with indicative symptoms. Though hundreds of thousands of patients have been successfully diagnosed using unattended testing, many sleep labs shy away from such studies either out of fear that they may negatively affect the labs’ operations, or concerns that such studies may not provide adequate clinical outcomes.

Successful campaigns by the medical community and organizations like the American Academy of Sleep Medicine, the National Institute of Health and the National Sleep Foundation have contributed to increased awareness among the general public and healthcare practitioners, and to a growing demand for sleep services. With growing understanding of the significant prevalence of sleep apnea and its implications for other morbidities and patients’ quality of life, more physicians now actively screen their patients suspected of sleep apnea and refer them to sleep labs to establish definitive diagnosis and initiate treatments. The growing interest in sleep disorders, coupled with the introduction in recent years of new technologies designed specifically to diagnose sleep apnea in an unattended setting have stimulated an active debate about the role of alternative clinical pathways to the management of these patients. The issue received further urgency following a 2006 report by the Institute of Medicine which sta ted that ”polysomnography, the ‘gold standard’ procedure for the diagnosis of most sleep disorders, is not readily available for everyone who needs it.” The authors of the report stated that “access to portable diagnostic screening procedures and streamlining initiation of treatment would clearly be advantageous” and recommended that “the rationale application of technology needs to be coupled with a reexamination of the role of diagnostic testing in case identification and disease management, clarifying optimal use of objective physiological monitoring data, including data obtained from portable monitors, in clinical diagnosis and management algorithms.”1

A review sponsored by the American Thoracic Society, the American College of Chest Physicians and the American Academy of Sleep Medicine published in 2004 concluded that “given the available data, the use of portable devices was not recommended for general screening.”2 Other reports, some published more recently, reached different conclusions, suggesting that ambulatory studies, when properly utilized and operated by skilled professionals, may indeed add to the arsenal of diagnostic options available to practitioners. The Minneapolis-based Institute for Clinical Systems Improvement (ICSI) has recognized the importance of this issue, and in its 2006 guidelines3 stated that “in patients with a high pretest probability of obstructive sleep apnea (OSA), unattended portable recording for the assessment of obstructive sleep apnea is an acceptable alternative to standard polysomnogram in the following situations: (i) patients with severe clinical symptoms that are indicative of a diagnosis of obstructive sleep apnea and when initiation of treatment is urgent and standard polysomnography is not readily available; (ii) for patients unable to be studied in the sleep laboratory, and (iii) for follow-up studies when diagnosis has been established by standard polysomnography and therapy has been initiated.” The guidelines also state that “employment of portable monitoring as a second-best option is not likely to result in harm to patients with a high pretest probability of OSA, and may result in less risk than leaving the condition undiagnosed.”

While this debate will undoubtedly be further pursued by clinicians, researchers and health policy makers, it is apparent that clinical needs, shifts in healthcare environment and continuing technological developments will most likely lead to growing acceptance of simpler diagnostic options, requiring all sleep labs to assess their current service models and determine how to respond to the shifting landscape.

Studies published in recent years confirmed the performance and efficacy of home studies in the clinical diagnosis and management of sleep apnea. These studies documented acceptable sensitivity and specificity of tests, a high degree of patient acceptance and low failure rates, as well as comparable outcomes to PSG, achieved at considerably lower costs. 4,5,6 The NIH-sponsored Sleep Health Study7 and other studies demonstrated that even EEG measurements are feasible in the home environment. Yet, the inherent complexity associated with such recordings limited its use in the home setting, raising concerns by sleep specialists as to whether that lack of information about the patient’s sleep architecture and actual sleep time affect the analysis of disease severity. New devices using advanced technologies can now provide significant information about sleep, including determination of actual REM sleep, sleep time and sleep fragmentation, without measuring EEG. One of the more noticeable examples is the Watch -PAT, developed by Itamar Medical Ltd., which incorporates a sensor able to monitor minute changes in peripheral arterial vasomotion caused by apnea events. Coupled with a built-in actigraphy, the Watch-PAT provides a reliable and accurate determination of sleep, wake and REM states, and together with measures of heart rate and saturated blood oxygen, generates an accurate assessment of indices based on actual sleep time.8 Multiple studies validated the reliability of the device, its ability to recognize sleep and wake states, and its accurate measurement of apneic events when used either in the lab or at the patient’s home.9 The Watch-PAT points to the direction taken by other participants in the medical technology industry, responding to providers’ needs by developing a new generation of simple-to-use and patient-friendly devices. Such devices leverage advanced sensing, electronic and software technologies to provide a greater amount of clinically relevant and reliable information, the flexibility to ope rate cost-effectively in multiple points-of-service and lowering costs.

In-spite of the availability of new technologies offering alternatives to PSG and many publications evidencing their performance, the majority of patients suffering from sleep disorders are still sent to sleep labs, as referring physicians and patients recognize the medical expertise and broader resources available through these venues. Yet, a growing number of sleep labs are shifting their views from seeing home tests as a threat to patient care and at times, even to their own operations, to realizing that such technologies actually represent an opportunity to enhance and expand their services by rationally integrating PSG and portable tests. Some examples of how portable technologies are benefiting providers of sleep services and patients alike include:

Reducing waiting time. Many labs struggle with the growing demand for services that extends waiting time for patients suspected of sleep apnea to weeks and even months, frustrating patients and referring physicians alike. Any sleep lab faced with increasingly longer wait times can in a relatively short period of time, reduce it by qualifying patients who can be tested at home, applying its own clinical criteria for which patients are most suitable for such tests.

Addressing special needs. It is well-established that many patients referred to sleep labs fail to schedule a study, either because they are intimidated by the experience or simply consider spending an entire night in an outside testing facility too inconvenient. Other patients may have special medical or physical needs that limit their ability to undergo a study in a sleep lab, or given the choice, they simply prefer a test done in the privacy of their homes. Without an alternative to the in-lab PSG, many of these patients remain untreated. The home study route enables providers to offer to many of these patients a clinically acceptable solution, which, when appropriate, can be followed by an in-home APAP study, rather than leaving these patients untreated.

Responding to an immediate need. Most sleep labs schedule their patients weeks in advance and thus, when a situation requiring quick turnaround time arises (e.g. out-of-town patients, high risk cases, etc.), the unexpected need can be addressed with an at-home study rather than a shuffling of the schedule.

Supporting inpatient studies. Hospital-based sleep labs are requested from time-to-time to assess an inpatient located in an ICU, a CCU or another ward. The growing awareness of the prevalence of sleep apnea among CHF, diabetics and geriatric patients, which are prone to frequent hospitalizations, is leading to a surge in the need for in-hospital services. The ability to set up a sleep study for patients within minutes and without interfering with other support systems favors the use of the smaller portable devices. Furthermore, the auto-analysis software available with some of the newer portable systems provides diagnostic results within minutes after the data is complete, enabling the hospital’s staff to expeditiously incorporate the results into the ongoing care decisions.

Conducting follow-up studies. Many patients undergoing either positive pressure or oral appliance therapies require periodic testing to confirm the need for continuing intervention, or to determine an adjustment in treatment parameters. Presently, due to the over-extension of sleep labs and the reluctance of many patients to come to the lab for additional studies, many of them are under-managed following initial intervention. Employing a home study for an annual evaluation, or otherwise, when medically indicated, may optimally address such needs.

Evaluating pre-operative patients. Recognizing sleep apnea prior to surgical procedures may reduce the risk of post-operative complications for patients with this disease. Recently published guidelines by the American Society of Anesthesiologists,10 as well as proposed guidelines by JHACO11 to institute pre-op sleep apnea screening are expected to fuel a significant increase in the case loads involving such patients, which in many instances cannot be accommodated by existing sleep lab facilities. Rather than ignoring these clinical cases or losing such patients to other services, labs may offer the required quick turnaround service by offering a simplified home study, which will be adequate for most of these cases.

Pediatric testing. There is a growing body of literature pointing to the prevalence of sleep apnea among children, often diagnosed and treated inappropriately. Undiagnosed sleep apnea has been associated with behavior, cognitive and learning deficiencies among this population. Since most of these patients require an assessment of breathing disorders, home studies are most conducive clinically and operationally considering the inconvenience and often, parental participation, when conducting the test in a hospital-based facility.

Expanding outreach programs to referring physicians. Cardiologists, family practice physicians, otolaryngologists, bariatric surgeons and other specialists are gaining appreciation of the importance of testing patients for sleep breathing disorders. Sleep labs offering also home studies are able to respond to physicians requesting a simpler test for some of their patients, while still contributing their medical expertise and when appropriate, conducting subsequent diagnostic and treatment services.

An alternative to fixed-bed satellites. A growing number of labs are setting satellite operations, consisting of smaller labs, distant to the main facility. While these facilities enable the organization to capture additional referrals, they do carry a financial cost associated with setup and operation and at times, stretch an already thin staff. This challenge is especially acute in rural areas, as low population density cannot justify a sleep lab staffed by qualified technicians in each locale. Conducting a home test, at least for the initial diagnosis of such patients, is often the most clinically and financially prudent approach.

Employee screening. Some labs have already instituted or are considering expansion of their programs to the employer market, offering screening and diagnostic services to commercial drivers, shift workers, first responders and other employees engaged in critical tasks. Portable and user-friendly systems are an ideal technology and in most instances, the only practical solution for this emerging market.

After shunning home studies for a long time and viewing them as a competitive threat, a growing number of sleep labs are integrating home studies for some of the applications outlined above or other which suit their evolving needs. Adding portable studies to a sleep lab can be accomplished in most instances relatively quickly and with a minimal investment. Other than the acquisition cost of the devices themselves, there are little other up-front costs. Operational hurdles are minimal, since training sleep technologists on such devices is accomplished in a relatively short time, as this highly trained staff is already familiar with patient education, test preparation and data analysis, and with automatic or otherwise simplified scoring, existing staff is in most instances able to absorb the incremental home studies without additional headcount.

As more experience is gained, sleep labs will find out that home studies are not a threat to quality patient care, but rather an important modality that when properly utilized, augments the lab’s current services. Well-managed programs offering both PSG and home testing can gain tangible operational and marketing advantages, strengthen sleep labs’ competitive positions within their respective markets, improve their financial results and most important, enhance and expand quality patient care.

David Barone, MSc, MBA,
Principal, Boston MedTech Advisors, Boston, MA.
E-mail: dbarone@bmtadvisors.com

References

1. Institute of Medicine. Sleep Disorders and Sleep Deprivation, An Unmet Public Health Problem. April 2006.
2. Chesson et al. Practice Parameters for the Use of Portable Monitoring Devices in the Investigation of Suspected Obstructive Sleep Apnea in Adults. Sleep 2003; 26:907–913.
3. Pittman et al. Using a Wrist-Worm Device Based on Peripheral Arterial Tonometry to Diagnose Obstructive Sleep Apnea: In-Laboratory and Ambulatory Validation. Sleep 2004; 27:923–933.
4. Westbrook et al. Description and Validation of the Apnea Risk Evaluation System: A Novel Method to Diagnose Sleep Apnea-Hypopnea in the Home. Chest 2005; 128:2166–2175.
5. Townsend et al. Assessing Efficacy, Outcomes, and Cost Savings for Patients with Obstructive Sleep Apnea Using Two Diagnostic and Treatment Strategies. Sleep Diagnostic and Therapy, 2007: 1.
6. Iber et al. Polysomnography Performed in the Unattended Home Versus the Attended Laboratory Setting-Sleep Heart Health Study Methodology. Sleep 2004; 27:536–540.
7. Bar et al. Evaluation of a portable device based on arterial peripheral tonometry (PAT) for unattended home sleep studies. Chest, 2003; 123:695–703.
8. Herscovici et al. Detecting REM Sleep from the Finer: Automatic REM Sleep Algorithm based on Peripheral Arterial Tone (PAT) and Actigraphy. Physiol. Meas. 2006; 27:1–12
9. Pittman et al. Follow-Up Assessment of CPAP Efficacy in Patients with Obstructive Sleep Apnea using an Ambulatory Device Based on Peripheral Arterial Tonometry. Sleep and Breathing, 2006; 10:123–131.
10. 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; 104:1081–1093.
11. The Joint Commission on Accreditation of Healthcare Organizations. Potential 2008 National Patient Safety Goals and Requirements. December 4, 2006.

Sleep Scholar for Sleep Medicine Professionals