Allen J. Moses D.D.S., Richard A. Bonato Ph.D. and Gloria L. Pacini R.D.H.

Abstract

The long axes of human condyles are angulated medially and slightly backward. A line through one condylar pole and projected to the midline will meet the line from the other side at approximately the anterior border of foramen magnum. The lateral and medial poles of the mandibular condyles are not in a linear plane. Mandibular movement based on translatory movement of the condyle against the disc and that of the disc in independent translatory movement against the glenoid fossa describes diarthrodial movement.

In human beings, unique in the animal kingdom for their upright bipodal posture, the most important function of the back and neck is to balance the head on the spinal column. Because of the dual function of the oropharynx as foodway and airway, it is essential that human beings be able to breathe during mastication. Adult humans lack the ability of most mammals to breathe and swallow at the same time. The mechanical advantage of the diarthrodial anterior translatory movement of the TMJs is to keep the airway patent during mastication.

Internal software in a 3D cone beam tomographic unit calculated each condylar angle relative to where each intracondylar line intersected a line perpendicular to the defined midline. Sleep group mean intracondylar angle was 5.4 degrees; intracondylar angle in the control group was 5.18 degrees. There was no statistically significant difference in overall intracondylar angle between the sleep group and non- sleep group. Intracondylar asymmetry is shown in this study to be the normal state in human beings and this being the case, translatory jaw movement would almost never occur in a straight midline linear plane.

Some devices which restrict mandibular protrusion to a midline linear plane to register the maxillomandibular relationship for an intraoral sleep appliance do not take into account the predominance of intercondylar asymmetry in humans. Their use would be biomechanically contraindicated. Polypropylene bite shims are shown that can be aligned so the mandible can freely slide in a protrusive path guided by muscle, ligaments, nerves and bony physical irregularities, rather than by an artificially imposed midline linear plane.

—————————————

Richard Bonato, Ph.D. is CEO and C-founder of BRAEBON Medical Corporation which sells medical devices for snoring and sleep apnea to sleep laboratories and dentists worldwide. He has no financial interest in bite shims or any bite registration products.
Allen J. Moses, D.D.S. and Gloria L. Pacini, R.D.H. are co-inventors of the bite shims shown in figure 10. They have a financial interest in their sales.

TMJ Mechanics

Temporomandibular joint (TMJ) movement in humans has been a controversial subject for over half a century. The application of proven biological and mechanical as well as 3-D computerized graphic representations to anatomic function has resulted in significant progress relative to understanding temporomandibular joint function. For many years it was thought that the human TMJ was capable of hinge function.^1,2,3,4 The reference in the older dental literature to the human TMJs as a ginglymoarthrodial (hinge-sliding) joint is testimony to this popular misconception.^{5,6,7,8,9,10,11,12,13,14,15} The TMJs of many lower animals do indeed function as a pure hinge (see Figure 1). The TMJs of animals are bilateral, joined as a functional unit by the body of the mandible. The requisite condition for bilateral hinge function to occur is that the hinges must be in a linear plane. Door hinges are an example of multiple hinges functioning as a mechanical unit in a linear plane. There are many animals whose jaws are capable of pure hinge function and whose mandibular condyles are in the same linear plane. They do not assume an upright bipodal posture and they do not have a flexible, compliant airway.

The long axes of human condyles are angulated medially and slightly backward (see Figure 2). A line through one condylar pole and projected to the midline will meet the line from the other side at approximately the anterior border of foramen magnum.¹⁶ The lateral and medial poles of the mandibular condyles are clearly not in a linear plane. Therefore, pure hinge movement of the human mandibular condyles is not mechanically possible (see Figures 3A & 3B).

The mandibular condyle in humans is a convex bony surface from front to back that articulates with the temporomandibular disc. No articular surfaces are perfectly flat and the surface curvatures vary from point to point. The temporomandibular disc in turn articulates with the glenoid fossa of the temporal bone. Mandibular movement is based on translatory movement of the condyle against the disc and that of the disc in independent translatory movement against the glenoid fossa. “The articulation of each side of the jaw is a composite that encloses two joints within its single capsule, an upper joint between articular eminence and disc and a lower joint between disc and mandibular condyle. In essence then it can be said that the functional joint articulation is a double-double joint.”¹⁷ This more accurately describes diarthrodial movement rather than ginglymoarthrodial movement.

Biological Evidence for Pure Diarthrodial TMJ Movement

The human tongue is unique among mammals. In humans the anterior 2/3 of the tongue is oriented horizontally in the mouth with the posterior 1/3 being oriented vertically in the oropharynx, when the human is standing or sitting erect. In human beings, unique in the animal kingdom for their upright bipodal posture, the most important function of the back and neck is to balance the head on the spinal column.

The head however, has a mobile part, the mandible, that needs constant counterbalancing as it moves about in its normal functions of speech, mastication and swallowing. The human oropharynx serves the dual function of foodway as well as airway and humans are unique for the ability to articulate speech. The flexible airway from the soft palate to epiglottis was certainly a major evolutionary change that facilitated speech. Creation of a flexible airway and highly innervated tongue is the defining characteristic that enables vowel sound creation. The benefits of speech with a flexible airway/foodway also engender the downside risks of apnea, snoring and choking.

Because of the dual function of the oropharynx as foodway and airway, it is essential that human beings be able to breathe during mastication. Adult humans lack the ability of most mammals to breathe and swallow at the same time because of the flexible airway and the posterior 1/3 of the tongue being vertical. If rotational TMJ movement were possible, the resulting masticatory hinge motion would close the airway during mastication. The mechanical advantage of the diarthrodial anterior translatory movement of the TMJs is to keep the airway patent during mastication. The anatomic evidence for pure diarthrodial movement is indeed very convincing.

Collapse of the tongue and/or soft palate on the airway during sleep explains the etiology of obstructive sleep disordered breathing (SDB). Design of an oral appliance for treatment of SDB involves finding a position of maximal airway patency during sleep. In assessing the maxillo-mandibular position of maximal airway patency, clinicians must consider the mechanics of jaw, tongue and lip positions. The chief basics of appliance design:

1. Mandibular advancement
2. Oral airway dilation
3. Maximize room for the tongue in the mouth
4. Prevent collapse of the tongue and/or soft palate on the airway
5. Optimize nasal breathing¹⁸

The Bony Anatomy of Condylar Translation

The directions and limits of mandibular movements are controlled by muscles, ligaments and nerves, but also by biomechanical restraints in the temporomandibular joints.19 Biomechanical restraints can be in relation to shape or function. Asymmetry of condylar angles could be a limiting factor to pure midline translatory movement of the mandible.

Eisenberger,²⁰ Christiansen²¹ and Yale²² have measured the intercondylar angle (ICA). The mean intercondylar angle in these papers was 139°, 129° – 132°, and 153° respectively. Eisenberger demonstrated no significant difference in the intercondylar distance between the dysfunctional group, the control group and the children’s group. These papers only reported the one intercondylar angle. They did not study or factor in condylar asymmetries. From a purely mechanical perspective, symmetrical condyles should be able to translate in a straight midline trajectory. Conversely, it is not logical to assume that translatory movement by asymmetric condyles could protrude the mandible in a straight midline trajectory.

There are certain situations in clinical treatment of temporomandibular disorders involving disc displacement or SDB where it might be of significance to determine whether the condyles could or should be directed protrusively in a midpoint linear plane, or whether the anatomic evidence is stronger that movement is more appropriately guided in an eccentric plane. The hypothesis being tested is whether intercondylar symmetry or asymmetry is the normal condition. If intracondylar asymmetry is the normal condition, might the extent of the asymmetry contraindicate the use of devices designed to record the maxillo-mandibular relationship for an intraoral sleep appliance that limit protrusive movement to a midline cranial plane? This is germane to the bite registration techniques employed by dentists worldwide for the fabrication of custom therapeutic oral appliances for the treatment of SDB. Consistent with previous research by Eisenberger et al. (1999),²³ it was hypothesized that no statistically significant difference in intracondylar angles would be found between a group of sleep apnea patients and a control group.

Method

Subjects

The data being presented is based on a retrospective study from the dental records of one author (AJM). Axial tomograms of the 33 most recent consecutive TMD/Sleep referral patients were analyzed as described above and the 33 randomly chosen general dental patients were identically analyzed as a control group. Appropriate releases were signed by all patients.

Data from two groups of 33 patients were retrospectively analyzed. The first group was referred for treatment of sleep apnea and included 25 men (sleep group mean age for men = 45.5 years) and 8 women (sleep group mean age for women = 58.3 years). The range of age is 18-71. The second group is a control group of patients, 17 men (non-sleep group mean age for men = 34.3 years) and 16 women (non-sleep group mean age for women = 33.0 years), seen during routine dental visits and evaluations. The range of age is 19-59.

Materials/Equipment

A three dimensional cone beam tomography unit (Imaging Sciences i-CAT® Next Generation Cone Beam 3D Dental Imaging) was utilized. Axial radiographic slices were located that revealed the maxillary dental midline, the superior surface of both condyles and the foramen magnum. These tomographic views were oriented on the monitor screen so that the midline was defined as passing through the dental midline (between teeth numbers 8 and 9) and the center of foramen magnum (see Figure 4). Lines were identified and drawn through the mesial and distal poles and the center point of each condyle (MB). Internal software (Anatomage Invivo 5 Anatomy Imaging Software) in the cone beam unit then calculated each condylar angle relative to where each intracondylar line intersected a line perpendicular to the defined midline (see Figure 5).

Results

To test the hypothesis that there would be no difference in intracondylar angles between the two groups, the left condylar angle was subtracted from the right condylar angle and an independent sample t-test was performed on the absolute value of the intracondylar angle differences. The sleep group mean intracondylar angle was 5.4 degrees (sd = 3.93) whereas the mean intracondylar angle in the control group was 5.18 degrees (sd = 3.41). For the sleep group intracondylar angles ranged from 0.2 degrees to 15.9 degrees. The control group intracondylar angles ranged from 0.0 degrees to 15.1 degrees. The t-test revealed no statistically significant difference in overall intracondylar angle between the sleep group and non-sleep group, t(64) = 0.24, p = 0.81 (see Figure 6).

Additional independent sample t-tests did not reveal any statistically significant difference in right condylar angle differences between the sleep group (mean=24.71, sd = 8.54) and non-sleep group (mean = 28.47, sd = 7.27), t(64) = –1.92, p = 0.06, or in left condylar angle differences between the sleep group (mean = 25.48, sd = 8.65) and non-sleep group (mean = 27.97, sd =7.13), t(64) = –1.27, p = 0.20 (see Figures 7 & 8).

Discussion

There does not appear to be any statistical difference between the study group of TMD/Sleep Patients and the control group. Both groups demonstrated similar intercondylar asymmetry. In fact, condylar symmetry appears to be the exception rather than the expectation. The average intercondylar asymmetry of the two groups combined is 5.36 degrees. If one assumes that the mechanics of protrusion are the same in all humans, then the study subject with an intercondylar asymmetry of 15.9 degrees employs the same mechanics to achieve protrusive translation as the person with a symmetric condylar relationship. Since the mandible is a single bone, the joints of each side are coordinated so that each contributes to every movement. The craniomandibular connection is one operating unit composed of right and left joint complexes.

The translatory component of joint movement is completely dependent on the shape of the articular eminence, according to Sicher and DuBrul.24 It is predictable that asymmetry of intercondylar angles also relates to asymmetry of the articular eminences of the temporal bones. Condyles, discs and eminences are in close contact in all movements and in all positions. This means that all movements of condyles with their discs must follow exactly the surfaces of the articular eminentia.25 Intercondylar asymmetry is shown in this study to be the normal state in human beings and this being the case, translatory jaw movement would almost never occur in a straight midline linear plane.

On the basis of the measurements from this study it would seem logical to assume that devices which restrict mandibular protrusion to a midline linear plane (see Figure 9) do not take into account the predominance of intercondylar asymmetry in humans. By their limitation of protrusive translation to a midline linear plane their use would be biomechanically contraindicated.

There are alternatives to devices that record the maxillomandibular relationship by physically guiding protrusive movement to a midline cranial plane. Polypropylene bite shims are shown (see Figure 10) that can be aligned so the mandible can freely slide in a protrusive path guided by muscle, ligaments, nerves and bony physical irregularities, rather than by an artificially imposed midline linear plane. Elimination of the artifactual effect of mechanical devices that restrict anterior movement in registration of the maxillo-mandibular relationship would be biologically beneficial in treatment with oral sleep appliances.

Conclusion

Based on the predominant finding of intercondylar asymmetry, the mandibular midline will most likely deviate to one side or the other in protrusive translatory movement, rather than follow a straight midline linear plane. Devices that limit translatory movement to a midline linear plane may not have a sound scientific basis. An alternative device to register the maxillomandibular relationship for intraoral sleep appliances was discussed that does not restrict normal biologic movement.

A prospective clinical study whose design directly tests the actual trajectory of unrestricted translatory protrusive mandibular movement appears to be indicated.

A prospective clinical study that tests the clinical efficacy of the bite shims versus one of the devices shown that directs protrusive translatory movement in a midline linear plane also appears to be indicated.

References

1. Zola, A, Morphologic Limiting Factors in the Temporomandibular Joint, Journal of Prosthetic Dentistry, 1963, Volume 13, Number 4, p733
2. Brekke, CA, Jaw function: Part 1, Hinge Rotation, Journal of Prosthetic Dentistry, v 9: 1959.
3. Cohen, R, The Hinge Axis and its Practical Application in the Determination of Centric Relation, Journal of Prosthetic Dentistry, 1960.
4. Griffin, CJ, Hawthorn, R, Anatomy and Histology of the Human Temporomandibular Joint, Monographs in Oral Science, 1975, 4:1–26.
5. Kreutziger, KL, Surgery of the Temporomandibular Joint, Oral Surgery, Oral Medicine, Oral Pathology, Vol 58, Issue 6, Dec 1984, p 637–646.
6. Luyk, NH, The Diagnosis and Treatment of the Dislocated Mandible, American Journal of Emergency Medicine, May 1989, Vol 7, Issue 3, p 329–335.
7. Israel, HA, Current Concepts in the Surgical Management of Temporomandibular Joint Disorders, Journal of Oral and Maxillofacial Surgery, March 1994, Vol 52, Issue 3, p 289–294.
8. Potter, JK, Vascularized Options for Reconstruction of the Mandibular Condyle, Seminars in Plastic Surgery, 2008, 22(3), p 156-160.
9. Coplane, J, Diagnosis of Mandibular Joint Dysfunction, Oral Surgery, Oral Medicine, Oral Pathology, September 1960, Vol 13, Issue 9, p 1106–1129.
10. Quinn, PD, Alloplastic Reconstruction of the Temporomandibular Joint, Selected readings in Oral and Maxillofacial Surgery, 2002, Vol 7.5.
11. Bayles, TB, The Temporomandibular Joint in Rheumatoid Arthritis, Journal of the American Medical Association, 1941, 116(26), p 2842–2845.
12. Michaud, TC, The Influence of Two Different Types of Foot Orthoses on First Metatarsophalangeal Joint Kinematics During Gait in a Single Subject, Journal of Manipulative and Physiological Therapeutics, January 2006, Vol 29, Issue 1, p 60–65.
13. Alomar, X, Anatomy of the Temporomandibular Joint, Seminars in Ultrasound, CT and MRI, June 2007, Vol 28, p 170-183.
14. Chan, TC, Mandibular Reduction, Journal of Emergency Medicine, May, 2008, Vol 34, Issue 4, p 435–440.
15. Lowery, LE, The Wrist Pivot Method, A Novel Technique for Temporomandibular Joint Reduction, Journal of Emergency Medicine, August 2004, Vol 27, Issue 2, p 167-170.
16. Gray’s Anatomy, 27th Edition, Henry Gray FRS, 1959, Lea and Febiger, Philadelphia.
17. Sicher’s Oral Anatomy by DuBrul EL. CV Mosby Co, St Louis, 7th Ed. 1980, p 184
18. Fitzpatrick, MF, et al., Effect of Nasal or Oral Breathing Route on Upper Airway Resistance During Sleep, Eur Respir J 2003; 22:827–832
19. Osborn, JW, The disc of the human temporomandibular joint: design, function and failure. J Oral Rehabil. 1985, Jul 12(4):279-93
20. Eisenburger, M, The human mandibular intercondylar angle measured by computed tomography, Archives of Oral Biology, Vol 44, Issue 11, Nov 1999, p 947–951.
21. Christiansen, E., Intra- and inter-observer variability and accuracy in the determination of linear and angular measurements in computed tomography: An in vitro and in situ study of human mandibles, Acta Odontologica Scandinavica, 1986, Vol. 44, No. 4, pp 221–229.
22. Yale, S, Laminagraphic cephalometry in the analysis of mandibular condyle morphology, Oral Surgery, Oral Medicine, Oral Pathology 14, 1961, pp 793–805.
23. Eisenburger, M, The human mandibular intercondylar angle measured by computed tomography, Archives of Oral Biology, Vol 44, Issue 11, Nov 1999, p 947–951.
24. Sicher’s Oral Anatomy by DuBrul EL. CV Mosby Co, St Louis, 7th Ed. 1980, p.192
25. Sicher’s Oral Anatomy by DuBrul EL. CV Mosby Co, St Louis, 7th Ed. 1980, p.192

Heading into its 77th year in business, Grass Technologies continues to update and innovate.

Long before the widespread awareness of sleep disordered breathing among patients and physicians alike, engineers at Grass Technologies were quietly plying their trade. The result is a rich tradition that keeps company officials looking forward, while never losing sight of their roots.

Marc R. Paliotta, BSEE, clinical product manager at Grass Technologies (an Astro-Med Inc Subsidiary), joined the venerable company in 1997 during the transition from analog to digital. In those 15 years, manufacturers have seen nothing less than a revolution in sleep diagnostics.

Revolution can be a good thing, but it frequently brings uncertainty. Paliotta acknowledges the ever-changing nature of the business, using a dose of cautious optimism that has served him well. That realistic outlook can be seen in the company’s product offerings, with in-lab diagnostics and out-of-center technologies equally embraced. “We cultivate traditional in-lab diagnostics and home sleep testing Type I, II, and III technologies,” says Paliotta.

A tradition of cutting-edge technology has done nothing to dim Paliotta’s commitment to old-school customer interaction. The philosophy can be seen in Grass Technologies’ enthusiasm for industry trade shows such as the Associated Professional Sleep Societies (APSS) Conference. “You get the much valued face-toface time with your customers,” explains Paliotta. “Whether it’s a little local show, a mid-size regional show, or a large national or international trade show such as APSS. The APSS is typically our biggest trade show of the year.”

Paliotta views every APSS show as a chance to show the company’s complete line from a hardware standpoint, in addition to the software that runs the entire product line. “This year, we’ll be showing the Comet-PLUS, which is our in-lab sleep diagnostic device,” enthuses Paliotta. “The AURA PSG is our type I/II out- of-lab device. The SleepTrek3 is our type III HST device. Those are the three complete product offerings we’re showing. The common software is called TWin and runs the entire Grass line.”

Looking Back, Surging Forward

Since going digital in the mid 1990s, Grass has been known for its amplifier systems. Maintaining a consistently high level of performance and supportability is at the heart of that reputation.

“We take it very seriously,” says Paliotta. “We’ve been able to incorporate the latest technology in industry to help meet the needs of our customers in the field. From the hardware and software perspective, we feel as a company we’re able to incorporate the needs of our customers into our products in a relatively short cycle working with our customers directly. Home sleep testing, for example, is an area everyone is interested in and where we are dedicating a good amount of time and effort.”

Grass is dedicating additional efforts toward IT Solutions in response to sleep labs‘ increasing dependence on IT departments for functions such as remote review, SQL databasing, and EMR integration. Grass acts as the liaison between the sleep labs and the IT departments, which leads to smoother integration and better IT Solutions.

The commitment to direct customer interaction comes from the same innovative tradition established long ago by company founder Albert Grass. Grass developed the first commercially successful electroencephalograph (EEG), a key component of neurophysiology and ultimately polysomnography (PSG).

The following is a chronology of the beginnings of EEG/PSG technology, and consequently, of Grass Instrument Company.

1934: A small grant is awarded to Dr. Frederic Gibbs for instrumentation to process electroencephalographic data. His goal is to apply the knowledge gained by Hans Berger and confirmed by Lord Adrian to clinical applications.

1935: Dr. Gibbs approaches Albert Grass, a recent graduate of MIT, to design three devices to amplify human EEG potentials. Grass does so, defining the foundation of Grass Instrument Company, and of EEG technology.

1936: While working at Harvard Medical School, Grass designs moving coil galvanometers, which enables the embryonic EEG instrumentation to accurately and reliably record the EEG frequencies on chart paper. The addition of these new galvanometers to his early amplifiers becomes the Grass Model I, used by Gibbs, Lennox, Davis and others. This same amplifier design was used by Cannon, Rosenbluth and Renshaw in early neuromuscular studies.

APSS Offerings for Grass Technologies Inc, an Astro-Med Subsidiary

Comet-PLUS® XL Lab-based PSG – Recording & Review System

Comet-PLUS XL is a complete PSG system designed to satisfy the needs of the physician’s office, hospital, or medical center. Ready to use, Comet-PLUS XL is supplied with the latest high performance PC.

These diagnostic systems consist of the high response 57-channel AS40-PLUS Amplifier System, a quick-disconnect head- box with electrode inputs designed especially for PSG, TWin PSG Record and Review Software, and powerful Panorama digital video. These flexible systems upgrade easily to also record EEG-type studies.

SleepTrek3, a 6-channel Portable Monitor

This small, lightweight physiological data recorder is specifically designed to assist the clinician in the diagnosis of sleep- disordered breathing. The out of center sleep testing device uses sensors to record oxygen saturation, pulse rate, airflow, snoring, respiratory effort and body position. The screener is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.

TWin®, a Windows-based Sleep Software Platform

Used in most systems including the review stations, Grass offers a search and query database manager as part of its standard offering. Other software options include an EMR/HL7 interface, a patient scheduling application, and frequency analysis trending software. Intralab scoring comparison and on-the-fly interpretation report building help complete the TWin software offering.

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

Could oral appliances someday supplant CPAP as a first-line defense against obstructive sleep apnea? The idea seems unlikely in 2012, but paradigm shifts in medicine are usually stealthy.

Change is slow because clinicians demand rigorous evidence before traditions are jettisoned. If that evidence continues to build, will physicians continue to embrace CPAP as the “gold standard,” or could the paradigm shift in this decade?

The fact remains that CPAP-intolerant patients are piling up, and dentists who specialize in sleep medicine want to help. Paying little attention to turf wars, tradition, or pondering paradigms, a growing number of sleep-focused dentists are working with primary care and sleep physicians to spread oral appliances to patients who need them.

Some sleep physicians simply have a bias against oral appliances, and that some are even content to refer patients for surgery before contemplating oral appliances. The American Academy of Sleep Medicine does not share that stance,” says Kent Smith DDS, a Dallas-based dentist who owns 21st Century Dental along with a sleep arm of the business called Sleep Dallas. “They suggest oral appliances prior to surgery. But it’s a fact that there are some sleep physicians who will never think of oral appliances—even for mild patients or primary snorers who would not qualify for CPAP.”

For Smith, it all comes down to: Will patients actually use the therapy? “I want the appliance with the best compliance,” says Smith. “And I would hope that at some point in the near future all of the different health professions will learn to work together to truly get the patient treated, without being as territorial as we seem to be right now. If we truly have the patients’ best interests in mind, we will educate them about all of the different therapies, and we will find what is best for each patient.”

What Really Works?

If dentists and sleep physicians are going to commit to oral sleep appliances, they want to know what works with some objective certainty. Executives at Dallas-based SomnoMed understood this desire and supported the development of SomnoMed MATRx™ (now FDA cleared) by Zephyr Sleep Technologies. Ralf Barschow, Global CEO of SomnoMed, touts the device as nothing less than a revolutionary breakthrough in the prediction of efficacy for the SomnoDent Mandibular Advancement Splint (MAS).

A typical MATRx scenario starts with a sleep physician who then refers the patient to a SomnoMed dentist to perform an oral examination and prepare the custom overnight oral appliance. From there, patients take the overnight appliance to a sleep lab, a sleep technician will titrate the patient’s mandibular position during the study, in response to apneas and hypopneas, with a goal to eliminate these events during REM sleep in the supine position.

To conduct a study with SomnoMed MATRx, the overnight appliance is attached to a small motor (50 grams) that is remotely controlled by a sleep technician. “Using this process, sleep technicians can clearly see whether the patient is a responder or non-responder to SomnoDent therapy,” says Barschow, who also serves as president of SomnoMed North America. “The MATRx is analogous to a CPAP titration. For the first time, we are providing a means of predicting whether patients are suitable for an oral appliance. If they are, we can help determine optimal protrusive distance for their SomnoDent once they are returned to their SomnoMed dentist for further titrations.”

Oral Appliances Here to Stay

Respect for oral appliance therapy has reached a greater acceptance. “After Seattle and San Antonio, Minneapolis was the third time SomnoMed had a strong presence at APSS,” said Anthony White, vice president, SomnoMed Marketing & Academy. “Sleep lab managers and sleep physicians came and said, ‘the MATRx is the missing link here. The ability to prospectively predict which patients would be appropriate for SomnoDent therapy in a polysomnographic environment means we can, with confidence, provide patients that cannot tolerate or adhere to CPAP a second chance at therapy.”

White believes clinicians will continue to embrace oral appliance sleep apnea therapies, but only patient-focused and evidence- based ideas will succeed. “Our products are backed by independent clinical studies validating their use,” adds White.

MAS Fosters Compliance

Loyal customers are already familiar with SomnoMed’s MAS treatments, each with different clinical indications aimed at OSA sufferers. These include the SomnoDent® Classic, SomnoDent® Flex, and SomnoDent® Edent for the Edentulous patient.

The SomnoDent® is a custom-designed oral device that has been the subject of numerous stringent, independent, evidence- based studies that satisfy the need for safe and effective OSA treatment. The SomnoDent® has a number of design features such as a streamlined design with minimal bulk, which maximizes lingual space, reduces gagging, and offers a comfortable treatment with a compliance rate of over 87% all night (Am J Respir Crit Care Med Vol 163. Pg 1457-1461, 2001).

The company touts an excellent fit in both upper and lower arches with anterior and posterior contact for a stable occlusion, which prevents tooth movement and minimizes temporomandibular joint (TMJ) discomfort and injuries.

The SomnoDent is constructed in two separate pieces that allow patients to open and close their mouth. This allows clear speech, yawning, and drinking without requiring patients to remove the appliance. The ability to communicate clearly while wearing the device is particularly appreciated by patients and their partners.

For more information visit www.somnomed.com