Natalie Morin
President & CEO, Sleep Strategies

Examine the evolution of sleep record outsourcing and you will gain some key insights into the changing operational practices of sleep labs and hospitals. What began as a strategy to alleviate sleep study backlogs and prevent year-long-plus wait times for patient diagnosis, has now morphed into an ongoing, virtual partnership. Perhaps the most revealing indication of this once niche industry’s recent maturation is how it has performed throughout the economic crisis. “Where so many industries have had to make cutbacks in the last three to four years, our business has been on the rise. It comes down to the fact that ours is one of those rare companies that actually help our partners save money in very concrete, immediate ways,” says Natalie Morin, President and CEO of Sleep Strategies Inc.

Morin is encouraged by the resilience of sleep record outsourcing— an industry she helped found over 12 years ago. Forecasts indicate that what began as an economically-driven shift in business practices is likely here to stay. “It might have taken a recession to motivate sleep lab managers to con sider novel budget cutting measures, but now that they see how sleep scoring quality can improve while overhead is reduced, it just makes sense to make the change permanent,” explains Morin. Prior to the economic crisis, sleep record outsourcing was certainly on the rise. “But at a slower pace,” says Morin, going on to explain, “Hospitals were acknowledging that they needed expertise they didn’t have in-house, specifically with finding qualified staff. Then the economic crisis comes along, and many sleep labs are forced to change their business practices by cutting labour costs and increasing efficiencies. So we saw a real spike in late-2008 and again in 2009 and then once again in 2010. At this point, it feels like the onslaught of new business is here to stay.”

The concept is simple. Companies like Sleep Strategies house a large team of RPSGTs—who are all certified specialists in the scoring of sleep studies, which facilitate the accurate diagnosis of sleep disorders. With the ongoing rise of sleep disorders, the demand for quick turnaround of these studies is essential. Many sleep labs and hospitals are opting to keep their operations patient focused—attending to the collection of data through overnight sleep monitoring—while diverting the analysis of data to trusted external partners like Sleep Strategies. The beauty of this arrangement is that it’s mutually beneficial. The use of third-party scoring companies with certified technologists allows sleep labs to reduce recruitment, hiring, training and several other overhead costs. It’s also become so widely adopted because the sole-focus nature of this sector leads to improved accuracy and efficiency, which ultimately allows these labs to improve patient care.

Manar Sleiman
Associate Product Manager
Fisher & Paykel Healthcare
Irvine, CA

Claims of “most comfortable” are common among CPAP mask manufacturers, but “one size fits most” is a more practical aim that engineers at Fisher & Paykel (F&P) Healthcare say they have tackled in earnest. Officials at Irvine, Calif-based F&P believe the new nasal pillow mask called the Pilairo will live up to the “one size” claim, and Manar Sleiman, associate product manager, says patients will also appreciate the comfort.

THREE KEY COMPONENTS

The Pilairo is not on the market yet in the United States, but sleep lab directors and physicians will have a chance to lay hands on it during the 26th Annual Meeting of the Associated Professional Sleep Societies (Sleep) in Boston from June 9 – 13. “Our technology in this new mask is remarkable,” says Sleiman. “We have three key components—comfort, seal, and ease of use.”

According to Sleiman, the Pilairo air pillow seal is made of microfine medical grade silicone, and it is .04 inches at its thinnest point. “Soft like a rose pedal,” she says.

The mask is ergonomically designed to self inflate with CPAP flow while gently enveloping the nose. “The Pilairo provides versatility to fit a variety of nasal shapes and sizes,” says Sleiman. “It’s essentially a double seal. It is specifically designed to hover over the nose, which makes it extremely forgiving of any movement, while still maintaining a seal.”

F&P engineers say this type of design allows for one size of seal to fit most patients with no need for small, medium, or large varieties. “Sleep physicians and techs don’t have to worry about fitting the patient,” adds Sleiman. “This is the go-to mask that can self adjust to the patient’s nose as it envelopes it.”

So-called “StretchWise” head gear material is only required for attachment, rather than stability. “Most interfaces have straps and adjustments for the head gear,” enthuses Sleiman. “Our air seal hovers over the face, so you don’t really need anything to hold it in because it’s stable. It’s a soft elasticized thread that stretches over a wide range with little change to the force applied. It’s perfect for sleep lab techs who often go in with lights out to adjust and put masks on patients. They literally do not have to turn on the light. They can put on the mask and be good to go.”

For more information about the Pilairo CPAP mask, visit http://www.fphcare.com/

INTRODUCING THE PARTNERS IN COMPLIANCE MANAGEMENT WEBSITE

As homecare providers, clinicians, and sleep lab staff deal with the challenges of tracking patient compliance and managing their patients’ compliance requirements, they are turning more and more to manufacturers for products, knowledge, and services. With that in mind, Philips Respironics recently launched the Partners in Compliance Management website which is designed for healthcare team members involved in patient compliance management. The site can be accessed at: www.sleepapnea.com/picm

WHAT INFORMATION CAN BE FOUND ON THE WEBSITE?

The website has three focused areas: a Resource Center, Best Practices and Protocols, and Training. Educational and product- oriented videos, documents, and tools have been posted to the website in easy-to-access sections.

If a customer is interested in learning more about the EncoreAnywhere patient management system, the System One therapy device, or our available modem solutions, materials can be found within the resource center. If a customer wants more information on reimbursement coding and coverage, or wants to learn details about topics such as our bi-level rescue program or motivation enhancement therapy, documents are located within our “Best Practices & Protocols” section. These documents are designed to help customers achieve a simplified, systematic approach to managing their patients’ compliance requirements, and help increase staff efficiency.

The Training section of the website offers webinars, audio tutorials, and videos that help walk customers through the specific capabilities of the EncoreAnywhere web-based patient compliance system in order to maximize the efficiency of tracking patient compliance.

NEW TOOLS TO HELP WITH PATIENT COMPLIANCE MANAGEMENT

Three training videos that walk a patient through the process of setting up a modem with a therapy device in the home were recently added to the Training section of the website. Another new tool, an interactive modem calculator, also was recently added to the Resource section. The videos guide a patient through the process of setting up an in-home wired or wireless network connection, or a pulse oximetry connection to the therapy device.

The interactive calculator offers customers an easy method for assessing the savings that can be achieved when modems are used to transmit patient data from a therapy device. New tools and materials will be added to the website on an ongoing basis as they are developed.

WHAT ARE SOME OF THE BIGGEST CHALLENGES IN PATIENT COMPLIANCE MANAGEMENT?

One of the biggest challenges is simply being able to validate if patients are being compliant with their sleep therapy. Other challenges include knowing when reimbursement criteria has been met and facilitating staff efficiency while maintaining a viable patient compliance management program. As an ally and resource to our customers, we offer products, technologies, and solutions such as the Partners in Compliance Management website, to help meet these challenges.

The Partners in Compliance Management website can be accessed at: www.sleepapnea.com/picm

Paul Venizelos, M.D. ,¹ Siarhei Ramaniuk,¹ Theodore Bellezza, RPSGT,² Sarah Weimer, BME,² Joseph Lamont, RPSGT,² Michael Papsidero, M.D., FACS² and Hani Kayyali, MS, MBA²

¹West Region Sleep Center, 15805 Puritas Rd, Cleveland, Ohio 44135.
²CleveMed, 4415 Euclid Avenue, Cleveland, Ohio 44103.

Abstract

Study Objective: to assess the feasibility and accuracy of a web-based home sleep testing (HST) system for sleep apnea evaluation in the home.

Introduction: Sleep Disordered Breathing (SDB) affects more than 40 million patients with serious health and economic costs. Overcrowded sleep labs, patient resistance to sleep outside of their homes, and long-term disease management emphasize the need for a simple and cost effective solution for home sleep assessment.

Methods: The technology consists of a web portal (e-Crystal PSG) that allows users such as administrators, registered technologists and interpreting physicians to schedule studies, upload monitor data from any PC, and access raw data for scoring and interpretation irrespective of their physical location. Workflow is further streamlined via email notifications alerting users of the various stages of study progress: scheduled, device programmed, data uploaded, scored, interpreted, and finalized. The web portal interfaces to a seven (7) channel HST monitor (SleepView) that follows AASM channel set guidelines. To assess feasibility, the system was tested on 6 patients at a local sleep center; each patient underwent two (2) studies: in-lab full PSG on the first night followed by at-home SleepView study. The following day, the patient returned the equipment. Data from the SleepView and morning questionnaire were uploaded to the web portal, scored by a Registered Polysomnographic Technologist (RPSGT), interpreted and electronically signed by a sleep physician.

Results: All 6 studies generated high fidelity recordings with no loss of data or replacement to the sensors. All patients were able to hook themselves up, successfully. The ability to detect Obstructive Sleep Apnea (OSA) via SleepView matched in-lab PSG studies (Cutoff, AHI>5). To assess disease severity (normal, mild/moderate, severe), both in-lab and at-home studies showed identical evaluations except for one patient who was diagnosed as severe in the lab (AHI=44) and mild/moderate in the home (AHI=20).

Conclusions: a new web-based study management solution that permits streamlined expansion of HST was developed and tested successfully. Data from the SleepView monitor was of high quality when compared to in-lab PSG, and its ease-of-use facilitated self-administration in the home. The flexibility of the system may be particularly suited for HST deployment in large geographical areas where a streamlined process is required.

Introduction

Obstructive Sleep Apnea (OSA) occurs when the upper airway collapses during the night, which fragments sleep and leads to excessive daytime sleepiness. The mechanism for airway occlusions is not yet fully understood; however, it is widely accepted that reduced neck muscle tone combined with abnormal pharyngeal anatomy and excessive fat tissue make the airways vulnerable to collapse during negative inspiratory drive. A report by the National Commission on Sleep Disorders Research (1) shows that 12-20 million Americans suffer from OSA leading to more than 200,000 car crashes per year and 1/3 of fatal trucking accidents due to fatigue. The financial cost impact is also staggering. Estimated direct annual cost for OSA is $16 billion.2,3 OSA has also been linked to cardiovascular and cerebrovascular implications making the disorder even more alarming than originally thought.4 In a study by Dyken et al., sleep apnea was five times as frequent in patients with ischemic or hemorrhagic strokes.5 Therefore, sleep disorders in general and OSA in specific present a serious national healthcare concern.

One of the most important and widely used indicators of OSA severity is the Apnea Hypopnea Index (AHI), which is defined as the average number of apneas and hypopneas episodes per hour based on a minimum of 2 hours of recorded sleep. New regulations by the Center of Medicare and Medicaid Services (CMS) allowed the use of total recording time instead of total sleep time for ambulatory home studies since portable monitors do not typically record sleep state. In that case, the resultant output is named the Respiratory Disturbance Index (RDI). Typically, AHI (or RDI) > 30 indicates severe OSA, while mild to moderate OSA patients show AHI (or RDI) between 5 and 30. AHI < 5 suggests normal breathing and is typically a target for successful OSA therapy. According to AASM 2007 guidelines, apnea is defined as total cessation of airflow for at least ten seconds, while hypopnea is defined as a drop of 30% or more in airflow or thoracoabdominal effort for at least ten seconds combined with oxygen desaturations of 4% or more. Therefore, the proper calculation of AHI requires the measurement of multiple parameters: airflow, respiration effort, and saturation level.

Home Sleep Testing per AASM Guidelines

A task force assigned by AASM concluded that home sleep testing can indeed facilitate and improve patient care provided that HST is done properly, which includes the acquisition of the appropriate type of physiological signals. The parameters recommended by the task force are: pulse oximetry, heart rate, airflow (cannula), and respiratory effort using Respiratory Inductive Plethysmography (RIP). Additionally, the AASM strongly recommends the use of another airflow sensor (thermistor) for oral breathing and apnea confirmation. Due to the complexity of the disease, the AASM guideline also requires qualified interpretation of the HST study by a sleep physician. These guidelines have been adopted as the basis for HST reimbursement by the Center for Medicare and Medicaid Services (CMS) and many other insurance carriers. Therefore, fulfilling these recommendations is important for proper medical evaluation as well as to meet many insurance requirements.

Fig. 1. Screen shots of the web portal (e-Crystal PSG), which is a sleep study management software that facilitates many aspects of HST deployment.

Although business models and care pathways that can best utilize HST remain in flux, the adoption of HST is expected to dramatically expand in the US. Therefore, technologies that offer high quality information combined with efficient workflow for patients, providers and payers, especially on a large scale, will be needed in the future.

Methods

The new technology consists of two components (manufactured by CleveMed): a web portal (e-Crystal PSG), and a wearable patient monitor (SleepView). E-Crystal PSG (Figure 1) is a web-based data management software that streamlines the various operations of HST including scheduling, device data upload, study archival, upload of additional data such as morning questionnaires, scoring and interpretation, all via the internet. To further streamline the workflow, e-Crystal PSG sends email notifications to users alerting them of study progress status. For example, once the study has been uploaded, a notification is sent to the assigned scorer for action, and once scoring is completed a similar notification is sent to the interpreting physician.

By internet-enabling the entire operation, the system opens up HST usage to more qualified resources allowing them to conduct various aspects of the workflow at different times and from various locations, thus improving overall efficiency. This can be useful for HST deployment for wide area coverage. For instance, national or even regional implementation by a healthcare provider may require study scheduling to happen in an administration center, device preparation and data upload by a nurse at a practice close to the patient (like a Primary care Physician Practice), scoring by RPSGT in a sleep laboratory, and interpretation by a sleep physician in his/her clinic.

The other component of the system is SleepView (Figure 2), which measures 7 parameters: pulse ox, chest effort (respiratory inductive plethysmography), airflow (pressure), airflow (thermistor), body position, snore, and heart rate. The patient hooks themselves up with the pulse ox, cannula, thermistor, and wraps the belt around their chest (the belt is already connected to the SleepView). The remaining signals are measured internally (do not require external sensors): body position measured by an accelerometer, snore is derived from airflow pressure, and heart rate is measured from pulse oximetry. Light indicators check the proper sensor attachment. Improper sensor connection will light up the respective indicator alerting the patient to adjust the sensor. The unit was pre-programmed to be turned on and off based on the patient’s typical sleep schedule.

Fig. 2. Above – SleepView patient unit. Below – SleepView worn by a patient illustrating the hookup.

More extensive testing of the system that covers many sites will be done at a later date; however, in order to gain early feedback and assess feasibility and accuracy, the system was tested in a community based sleep laboratory environment.

Clinical Protocol – 6 patients diagnosed with OSA at West Region Sleep Center were recruited for next night at-home testing. After describing the study and obtaining consent, the patient was instructed on device use and given the SleepView monitor including a hookup instructions sheet. Next day, the patient returned the equipment to the sleep lab with a completed questionnaire regarding system’s ease-of-use. Data were uploaded to the web portal, and scored by the same registered sleep technologists who scored the in-lab PSG’s. All studies (6) were interpreted by the same board-certified sleep physician.

Results

The web portal was found to be very useful by the technologist and interpreting physician. Some recommendations to improve the workflow were made including expanding email notifications and availing the sleep report to the ordering physician.

2 of 6 patients were male (33%). Age ranged from 26 to 55 years old (average was 43 years old). All recordings (6/6) were completed successfully; no sensors fell off or needed replacement. All patients were able to hook themselves up using the attached instructions and a brief training in the sleep lab.

A typical recording is shown in Figure 3, which displays episodes of obstructive hypopnea, and central apnea. The at- home system showed an identical ability to detect the disease when compared to the lab studies using a cutoff AHI = 5 (sensitivity of 100% and specificity of 100%). To assess disease severity (normal < 5, 5 = mild/moderate < 30, severe = 30), both in-lab and at-home studies showed identical evaluations except for one patient who was diagnosed as severe in the lab (AHI=44) and mild/moderate in the home (AHI 20).

Fig. 3. Home sleep recordings using SleepView showing central apnea (left) and obstructive hypopnea (right).

Discussion

A web-based data management software that interfaced to a 7 channel HST monitor was developed and tested in an in-lab environment successfully. More extensive research that tests the system in a national HST deployment is underway elsewhere. In this study, the software was used to facilitate HST evaluation of the SleepView monitor and to provide early feedback about the feasibility and functionality as viewed by a community-based sleep laboratory. The web-based operation functioned as expected and was able to conduct the necessary evaluation.

The finding that in-home studies generated very high accuracy in detecting the presence of OSA when compared to in-lab PSG is not surprising because the SleepView monitor utilizes a channel set and measurement methodology that is identical to that used in sleep laboratories, which is a channel set that is also recommended by the AASM. What is more revealing behind at-home and in-lab comparisons, however, relates to other factors that may influence signal quality, particularly the sensor hookup. The high accuracy of this study confirms the reliability of the sensor hookup process in Sleep View and the simplicity of its self-administered nature. Finally, disease severity findings showed one in six home recordings with lower severity than the in-lab diagnosis. This is not surprising as underestimation of disease severity is typical in HST because RDI is calculated based on total recording time, not total sleep time, which lowers the overall index.

This research, while preliminary, supports the use of a new simplified and effective home technology for sleep apnea evaluation. We believe the future expansion of HST will require three core competences: 1) reliable and easy to use home technology that avoids duplicative and costly in-lab confirmation, 2) improved workflow efficiency among the various stakeholders that are expected to participate in HST such as national sleep management companies, out-of-center operations and other healthcare providers, and 3) a continued central role of the sleep physician in supervising and managing the disease. The SleepView / e-Crystal PSG system provides the necessary infrastructure for these core competencies.

Acknowledgements
This development effort was funded by grants from the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS).

Literature Cited
1. Wake up America: A National Sleep Alert. Report of the National Commission on Sleep Disorders Research, 1993 
2. Frost and Sullivan Marketing Report, 2001, A071–56 
3. Feedback Research Services, Sleep Screening and Testing Markets, Marketing report, August 2001 
4. Kryger, “Principles and Practice of Sleep Medicine”, Third Edition, Saunders, 2000 
5. Dyken et. al., “Investigating the relationship between stroke and sleep apnea”, Stroke 1996;27: 401–407