Sleep HealthCenters to Manage Sleep Program for Trucking Company

After a successful pilot program, Gordon Trucking has chosen Sleep HealthCenters to provide a nationwide comprehensive sleep apnea screening and treatment program. The program is designed to enhance roadway safety by improving the health of commercial drivers through education, diagnosis and treatment of sleep apnea.

According to the National Sleep Foundation (NSF), it is estimated that insomnia, obstructive sleep apnea (OSA), narcolepsy, excessive daytime sleepiness and restless legs syndrome plague an estimated 40 million Americans. The Federal Motor Carrier Safety Administration (FMCSA) has publicly announced a focus on fatigue in commercial drivers, specifically addressing the potential impact of sleep apnea. Regulations surrounding these issues are possible.

Gordon Trucking has a history of supporting the health and wellness of their drivers. Managing sleep apnea is another important step in Gordon’s efforts to improve driver fitness. The driver screening program is expected to begin before the end of the year.

“Gordon has a tradition of long-term safety efforts and we are committed to offering our drivers a sophisticated sleep apnea screening program.” said Scott Manthey, vice president of safety for Gordon Trucking. “We are confident that Sleep HealthCenters has the expertise to provide us with the most comprehensive screening program available to keep our drivers and roadways safe.”

“Healthy sleep is vital to employee wellness and safety, but for trucking companies, it can be difficult to implement a program for employees who live in different places, are constantly moving around the country, have different primary care physicians and maybe even different health insurance coverage,” says Dr. Lawrence Epstein, chief medical officer at Sleep HealthCenters, based in Brighton, Massachusetts.

Sleep HealthCenters works with a network of affiliated and highly qualified sleep medicine providers to serve drivers around the country, guaranteeing that employees will have minimal wait times for diagnosis, treatment and follow-up care.

“Our network of sleep specialists and respiratory therapists help the patient select an appropriate treatment and monitor their response to therapy.” says Sleep HealthCenters’ CEO Paul Valentine, “Our proprietary web-based system, called PAPCenter, allows us to monitor each patient’s device utilization even though they may see different therapists while they are on the road in different states. All therapists are licensed in the state in which they treat Gordon Trucking patients, and the clinical standards of care are standardized throughout the program to ensure the patient receives the highest level of reliable and predictable service.”

Sleep HealthCenters, based in Massachusetts, has a system of comprehensive sleep medicine centers and clinics. The company currently runs 26 facilities in Arizona, Connecticut, Massachusetts and Rhode Island and is affiliated with academic medical institutions such as Brigham and Women’s Hospital and Beth Israel Deaconess Medical Center, both in Boston.

Gordon Trucking was founded in 1946 in Pacific, Washington and is today one of the leading U.S. long haul carriers with over 1,500 drivers nationally. Gordon Trucking is privately owned and managed by the Gordon Family. Larry Gordon, president and CEO purchased Gordon Fast Freight from his father in 1984 and formed what is known today as GTI. For more information on GTI, please visit their website at

SOURCE Sleep HealthCenters

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RoundTable Healthcare Partners Acquires Majority Stake in Salter Labs

RoundTable Healthcare Partners (“RoundTable”), an operating-oriented private equity firm focused exclusively on the healthcare industry, announced today that it has acquired a majority interest in Salter Labs (“Salter”).   Founded in 1976 by Peter Salter, Salter is a leading manufacturer of disposable respiratory and sleep diagnostics products used in both the home medical and acute care markets.

“Salter represents an exciting opportunity for RoundTable to enter the respiratory market,” said Lester B. Knight, Founding Partner and Co-Chairman of RoundTable.  “We are looking forward to partnering with the management team and employees of Salter as they expand on their successful track record of developing and marketing innovative products.”  Mr. Knight will serve as Salter’s new Chairman.

“RoundTable is an ideal partner for Salter,” stated Mr. Salter. “Their extensive experience in the medical consumables industry and their strategic insight will be extremely valuable to Salter as it continues to execute its growth strategy.”

To finance the acquisition of Salter and further growth opportunities, RoundTable facilitated the successful completion of new senior credit facilities and a private placement of senior subordinated notes.  The senior credit facilities were led by GE Commercial Finance Healthcare Financial Services, and included the PrivateBank.  Salter’s senior subordinated notes were acquired by RoundTable Capital Partners II (“Capital Fund II”), RoundTable’s second captive subordinated debt fund.  Capital Fund II is a dedicated subordinated debt fund that makes fixed rate subordinated debt investments alongside the equity investments of RoundTable’s equity funds. As part of the transaction, Bolder Capital acquired a minority equity stake alongside RoundTable, in addition to a portion of the senior subordinated notes.

RoundTable’s investment strategy targets companies in the healthcare industry that fall within the expertise and experience of the firm’s operating and transaction principals. Salter is RoundTable’s first platform investment from both its recently closed $600 million Fund III and its recently closed $200 million Capital Fund II.

About RoundTable Healthcare Partners
RoundTable Healthcare Partners, Lake Forest, IL, is an operating-oriented private equity firm focused exclusively on the healthcare industry.  RoundTable partners with companies that can benefit from its extensive industry relationships and proven operating and transaction expertise.  RoundTable has established a successful track record of working with owner/founders, family companies, management teams, entrepreneurs and corporate partners who share a vision and believe in the value creation potential of its partnership model.  RoundTable currently manages $1.9 billion in capital, including three equity funds totaling $1.5 billion and two subordinated debt funds totaling $400 million.  More information about RoundTable Healthcare Partners can be found at

About Salter Labs
Salter Labs is a leading manufacturer of medical consumables and equipment in the multi-billion dollar home medical and acute care respiratory consumables markets and has been supplying innovative and proprietary medical consumables and equipment for over 30 years.  The Company develops, manufactures and sells primarily single-use, disposable products that help homecare providers and hospitals measurably improve outcomes and the quality of care.  Salter holds more than 31 patents, a significant number of copyrights and has numerous patent applications pending.  Salter Labs products are sold domestically to approximately 5,000 home healthcare providers including the local branches of national homecare companies such as Lincare, Apria and Rotech.

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CMS posts Round 1 Competitive Bidding Contract Supplier list

DMEPOS Competitive Bidding Contract Supplier List in CPAP Devices, Respiratory Assist Devices, and Related Supplies and Accessories.


1,217 contracts awarded to suppliers of medical equipment and supplies selected through competitive bidding in nine areas; program saves money for beneficiaries while preserving access to high quality items.

The Centers for Medicare & Medicaid Services (CMS) today released the list of the 356 suppliers that have contracts with Medicare to provide certain medical equipment and supplies to beneficiaries in nine communities across the U.S. at competitive bid rates. This new program, authorized by Congress, is expected to save Medicare and its beneficiaries nearly $28 billion over 10 years.

“We are pleased that Medicare beneficiaries living in the nine first round communities will be saving money and will continue to receive high quality service and supplies from the suppliers who were awarded contracts in Medicare’s competitive bidding program,” said CMS Administrator Donald Berwick, M.D. “Each of these contract suppliers has met our stringent standards, so beneficiaries can be assured they will receive their equipment and supplies from legitimate and quality suppliers at prices that are more in line with the current market.”

The new competitive bidding program goes into effect on January 1, 2011, for beneficiaries in the Charlotte, Cincinnati, Cleveland, Dallas, Kansas City, Miami, Orlando, Pittsburgh and Riverside areas (more detail on locations below). This program used bids from suppliers that represented the local, competitive marketplace to lower the costs for certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) for Medicare beneficiaries to obtain medical items and supplies. Because beneficiaries pay 20 percent coinsurance on the payment amount for DMEPOS, they will directly benefit from the lower prices. Based on bids submitted by these suppliers, beneficiaries and Medicare will see prices, on average, 32 percent lower than Medicare currently pays for the same items.

CMS awarded 1,217 DMEPOS competitive bidding program contracts with 356 suppliers. The contract suppliers have 662 locations to serve Medicare beneficiaries in these competitive bidding areas. All contract suppliers were required to comply with Medicare enrollment rules, be licensed and accredited, and meet financial standards. 76 percent of contracts were awarded to suppliers already furnishing contract items in the local area.

Additional contract suppliers have furnished other items in the local area or furnished contract items in other areas: fully 97 percent of contracts were awarded to suppliers already established in the competitive bidding area, the product category, or both. Small suppliers, those with gross revenues of $3.5 million or less as defined for the DMEPOS competitive bidding program, make up about 51 percent of the contract suppliers. CMS received 6,215 bids from 1,011 suppliers during a 60-day bidding period last year.

To take advantage of the lower prices for the items that were part of the competitive bidding program, Medicare beneficiaries living in one of the competitive bidding areas who have ongoing need for a DMEPOS supplier may need to choose a new supplier if their current supplier is not a contract supplier and they wish to have Medicare continue to cover their equipment and supplies. A beneficiary may, in some situations, also be able to continue to receive certain items from a grandfathered supplier. Grandfathered suppliers are non-contract suppliers that provide certain rented equipment under the terms of the program.

CMS will now launch a comprehensive public education effort to ensure that beneficiaries, healthcare professionals, and others have the information they need to understand the new program. This effort will include mailings to beneficiaries, a full range of Internet-based and printed program information, and educational teleconferences. In addition, the 1-800-MEDICARE customer service representatives and case workers will be ready to assist beneficiaries.

CMS will also be monitoring program implementation closely. Monitoring methods will include:

  • beneficiary surveys,
  • active claims analysis,
  • local surveillance and resolution of any program issues by CMS Regional Offices and local ombudsmen, and
  • contract supplier reporting and tracking and analysis of complaints and inquiries.

In addition, the Competitive Acquisition Ombudsman will respond to complaints and inquiries from suppliers and beneficiaries about the application of the program and issue an annual Report to Congress.

“Medicare contract suppliers signed contracts that included terms such as protections to ensure that they will furnish beneficiaries with necessary equipment and quality customer service, starting on January 1, 2011,” said Berwick. “Medicare will hold contract suppliers to their obligations and will take action to address any contract performance problems.”

Consumers, physicians and other providers can find a list of Medicare contract suppliers in the nine initial areas of the program by visiting (under “Resource Locator” select “Medical Equipment and Supplies”) or by calling 1-800-MEDICARE (TTY users should call 1-877-486-2048). People can also visit the local offices of the various partner groups for help in finding a Medicare contract supplier, such as their State Health Insurance and Assistance Program, Area Office on Aging and a number of community organizations that can provide information on the program.

The Medicare DMEPOS Competitive Bidding Program was established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and the program was briefly implemented in 2008 in 10 areas before it was temporarily delayed. The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), enacted on July 15, 2008, terminated the supplier contracts in effect at the time, temporarily delayed the program and made certain limited changes to the program. MIPPA also required CMS to conduct the competition again for Round One in 2009, and delayed competition for Round Two in 70 additional metropolitan statistical areas (MSAs) until 2011 and in additional areas of the country until after 2011. The Affordable Care Act of 2010 expands the number of Round Two MSAs from 70 to 91 areas.

With the exception of Puerto Rico, the Round One Rebid was required to be in the same areas in which the program was briefly implemented in 2008. These areas are:

  • Charlotte — Gastonia — Concord (North Carolina and South Carolina)
  • Cincinnati — Middletown (Ohio, Kentucky and Indiana)
  • Cleveland — Elyria — Mentor (Ohio)
  • Dallas — Fort Worth — Arlington (Texas)
  • Kansas City (Missouri and Kansas)
  • Miami — Fort Lauderdale — Pompano Beach (Florida)
  • Orlando — Kissimmee (Florida)
  • Pittsburgh (Pennsylvania)
  • Riverside — San Bernardino — Ontario (California)

The Round One Rebid was required to include the same items as the 2008 program except that negative pressure wound therapy items and Group 3 complex rehabilitative power wheelchairs are excluded. These items include:

  • Oxygen, Oxygen Equipment, and Supplies
  • Standard Power Wheelchairs, Scooters, and Related Accessories
  • Complex Rehabilitative Power Wheelchairs and Related Accessories (Group 2 only)
  • Mail-Order Diabetic Supplies
  • Enteral Nutrients, Equipment and Supplies
  • Continuous Positive Airway Pressure (CPAP) Devices, Respiratory Assist Devices (RADs), and Related Supplies and Accessories
  • Hospital Beds and Related Accessories
  • Walkers and Related Accessories
  • Support Surfaces (Group 2 mattresses and overlays in Miami-Ft. Lauderdale-Pompano Beach, FL only)

For additional information about the Medicare DMEPOS Competitive Bidding Program, please

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Sleepwalking Parasomnia Lawsuit – Man awarded 10million Euro

A businessman has been awarded 10m euro damages – the highest libel award in the history of the Irish state – after an incident in which he sleep-walked naked.

Donal Kinsella, 67, from Dunleer, County Louth, took the case against his former employer, Kenmare Resources. The company published a press release insinuating he made inappropriate advances to a colleague in Africa. Mr Kinsella had appeared naked at her bedroom door three times. The incident happened at a meeting in Mozambique in 2007.

The court heard that he had been drinking, taking painkillers and had a habit of sleep-walking and not wearing pyjamas. The company issued a press release in July 2007 which, the court agreed, defamed Mr Kinsella. He sued the company and its chairman, Charles Carvill, who is based in Well Road, Warrenpoint, Northern Ireland, The press release said he was being asked to resign from the company’s audit committee and referred to an “incident”. An investigation by an independent solicitor on behalf of the company had found there was no conscious attempt on Mr Kinsella’s part to enter the woman’s room and no improper motive in opening her door.

Mr Kinsella was merely sleep-walking.

Lawyers for Mr Kinsella urged the jury to award him big damages, claiming the company had aggravated matters by accusing him of being a liar and a perjurer. Mr Kinsella was awarded 9m euros in damages and 1m euros in aggravated damages.

The award is the highest for defamation in the history of the Irish state.

Source BBC

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Evolution of Theory on Oral Appliances and Exercises for Sleep Apnea and Snoring

Patient exercises have been shown in two randomized controlled studies to be effective for reducing both the symptoms and severity in patients with moderate obstructive sleep apnea syndrome. A study by Puhan,1 et. al. involved lessons to practice and play the didgeridoo, a wind instrument that involves voice control as well as breath control. Regularly playing the didgeridoo, 5.9 days per week for an average playing time of 25.3 minutes per day, for a four month period of time reduced the average Apnea/Hypopnea Index (a measure of severity) by almost 50% (22.3 to 11.6) and lowered the sleepiness (symptom) from an average Epworth Sleepiness Scale score of 11.8 to 7.4. Guimares,2 et al, showed in a randomized controlled trial that oropharyngeal exercises developed for the treatment of OSAS significantly reduced the AHI (severity) and subjective symptoms as well. The exercises, derived from speech therapy, consisted of isometric and isotonic involvement of muscles of the tongue, soft palate, and lateral pharyngeal wall. The exercise set consisted of activities simulating suction, swallowing, chewing, breathing and speech. The target effects are soft palate elevation, tongue protrusion and mandibular elevation to keep the lips together. This study was not designed to explore the exact mechanism by which the signs and symptoms were improved. It does demonstrate that daytime exercises alter muscle tone during sleep.

Reflex Activity
The oral cavity, the tongue and the pharynx are functionally integrated to perform such vital and complex life functions as breathing, drinking, masticating, swallowing, and speaking. The sensory receptors that innervate these parts are constituents of reflex systems that reflect a huge range of complexity. These oropharyngeal reflexes are in fact critical to maintaining life. Reflexes in the upper airway are protective by preventing aspiration, facilitating vocalization, transporting boluses of food and water and protective of breathing by maintaining a patent airway.

Genioglossus, the main tongue muscle, is a protruder. It has an important role in airway protection and maintenance of airway patency, especially in patients with obstructive sleep apnea. Styloglossus and hyoglossus are tongue retruders. Activation of genioglossus under hypoxic and hypercapnic conditions brings about tongue protrusion and pharyngeal air- way dilation.3,4 In a study by Mateika,5 et. al. the styloglossus and hyoglossus were also coactivated in response to hypoxia and hypercapnia. This coactivation is the response of complex reflex activity between tongue protruders, tongue retruders and chemical in the central nervous system. A reflex is defined as the sum total of any particular involuntary activity.6 Specific sensory inputs can subconsciously induce motor responses that have reciprocal effects on different motoneuron pools. Reflexes provide relatively hard wired circuits through the central nervous system to control a set of often antagonistic muscles for co-ordination of a given response, such as a swallow. The motor neurons and the Golgi tendon system are part of a neurologic feed- back loop for maintaining muscle tone.

A reflex reaction is conditioned not by one reflex arc but many. Coordination is part of the reflex. According to Sherrington,7 “the main secret of nervous coordination lies in the compounding of reflexes”. Learning is involved in establishing many reflexes. Reflexes elicited from stimulating the oral region alter recruitment of lip, tongue and jaw muscles. The type of sensory stimulus determines the type of reflex elicited – from simple reflexes to complex behavior affecting oral and pharyngeal regions. Motor neurons responsible for the reflex activity of the head and neck are located in the brainstem – medulla, pons and midbrain.

The tongue is a complex muscular organ. Extrinsic tongue muscles attach to at least one bone and function to alter the shape of the tongue. Intrinsic tongue muscles have both their origin and insertion in muscle. They protrude, retrude and move the tongue laterally. The chief tongue protruder, the genioglossus muscle is extrinsic. The electromyographic activity of genioglossus has been shown to be in phase with respiration when awake or in a resting state.8 Changes in mandibular posture have a direct effect on tongue activity and may relate to the role of the tongue in airway maintenance.9 Reflexes elicited from stimu- lating the oral region alter recruitment of lip, tongue and jaw muscles. The type of sensory stimulus determines the type of reflex elicited – from simple reflexes to complex behavior affecting oral and pharyngeal regions.

An important part of the research of A. J. Miller10 has been description and study of reflexes controlling orofacial func- tion. Relative to tongue protrusion Miller has identified five tongue reflexes. Tongue reflexes are activated from motoneurons from three cranial nerves: hypoglossal, trigeminal and glossopharyngeal.

Jaw-Hypoglossal Reflex7
The hypoglossal nerve (XII) is the only motor nerve to the genioglossus muscle. Stimulation of the medial branch of the hypoglossal nerve causes genioglossus protrusion. The jaw-hypoglossal reflex is that stimulation of the inferior alveolar nerve (VIII) causes firing of hypoglossal motoneurons, a phe- nomenon that could not be activated by direct stimulation of the hypoglossal nerve. The hypoglossal motoneurons in this reflex protrude the tongue. Passive opening of the mandible by a sleep appliance increases the activity of genioglossus muscle. The position of the mandible in a sleep appliance affects tongue posture and the amount of protrusion. Forward protrusion of the tongue helps maintain a patent airway. Oral appliances for sleep apnea should be conceived to facilitate this reflex by a non-restrictive, open anterior design.

Masseter-Hypoglossal Reflex7
Direct stimulation of the masseteric nerve (V ) contracts the III masseter muscle. The masseter-hypoglossal reflex is that masseteric nerve stimulation also inhibits polysynaptic firing of hypoglossal motoneurons to retrusive tongue muscles. A passive jaw opening beyond rest position stimulates the masseter to shorten, eliciting reproducible inhibition of tongue muscle retrusion that lasts as long as the jaw is open. Stimulation of this reflex can be easily incorporated into oral sleep appliances to inhibit tongue retrusion while the appliance is worn in the mouth.

Lingual-Hypoglossal Reflex7
The lingual nerve is a branch of the third and largest division of the trigeminal nerve (V) with a mostly sensory function. Mechanical stimulation of the surface of the tongue by light probing or scraping can induce multiple reflexes involving such functions as opening the jaws, closure of the glottis, elevation of the palate and some degree of tongue retru- sion, but mostly tongue protrusion. The lingual-hypoglossal reflex, triggered by tongue stimulation, depends on the site of the sensory input. Stimulation of the medial branch of the hypoglossal nerve innervates intrinsic tongue muscles and brings about protrusion. The lingual-hypoglossal reflex can be facilitated by a prior conditioning reflex and thus trained by exercise. Stimulation of this reflex can also be incorporated into oral appliance design.

Glossopharyngeal-Hypoglossal Reflex7
The glossopharyngeal nerve contains sensory fibers that innervate the lateral border of the posterior 1⁄3 of the tongue. Stimulation of the lateral border of the posterior 1⁄3 of the tongue induces reflex discharges in hypoglossal motoneurons that cause the tongue to protrude and that also inhibit retrusive hypoglossal motoneurons.

Tongue–Tongue Reflex7
The lingual nerve provides sensory innervations to the tip of the tongue. The tongue-tongue reflex is that touch or stroking on the tip of the tongue stimulates hypoglossal motoneurons that cause the tongue to orient toward the stimulus.11 The more intense the stimulation, the higher the probability of tongue movement toward the source. Mechanical stimulation of the dorsal surface of the tongue will induce the same reflex as direct stimulation of the lingual sensory nerve. Coordination of the tongue-tongue relies heavily on exteroceptors on the tongue surface. Stimulation of this reflex can be incorporated into the design of oral sleep apnea appliances.

Screen shot 2010 11 14 at 11.58.33 PM Evolution of Theory on Oral Appliances and Exercises for Sleep Apnea and Snoring

Fig. 1. The Moses, an open anterior, adjustable, FDA cleared oral airway dilator.

It would seem to be a reasonable assumption based on the Moses study and the cited studies on exercises that the operative mechanism by which airway dilation works in both cases is stimulation of hypoglossal reflexes. Reflex training during the day by exercises has a carryover effect during sleep. The reflex effect of oral appliances works as long as the appliance remains in the mouth. Hypoglossal reflexes operate at a site apart from the origin of the stimulus.

The effectiveness of oral appliances at treating OSA is well documented in the scientific literature.19,20,21,22,23 The effectiveness of exercise training is well demonstrated in the two articles cited.1,2 Neither methodology alone appears to be better than CPAP when using PSG measures; however, in a recent paper, Chan & Cistulli24 presented data that patient compliance, acceptance and comfort is better with oral appliances than CPAP .

Screen shot 2010 11 14 at 11.58.52 PM Evolution of Theory on Oral Appliances and Exercises for Sleep Apnea and Snoring

Fig. 2. Left image above is a posterior view of a three dimensional volumetric reconstruction of the patient’s airway without MAD. Right image is a posterior view of a three dimensional reconstruction of the patient’s airway with MAD properly positioned in the mouth. The increase in size of the airway is substantial and obvious. The appliance used in the figure on the right is The MosesTM.

The old idea that oral appliances are merely mandibular advancement devices, moving the tongue forward to pre- vent its collapse on the airway is an oversimplification. It does not account for the dilation of the sides and back of the pharynx visible on the 3-D computerized cone beam image with The MosesTM in place. The multidimensional airway dilation cannot be accounted for solely by active anterior movement of the mandible and the attendant passive pull- forward of the tongue base. Consideration and testing of oral appliance therapy in terms of their effect on airway dilation by reflex stimulation is warranted. It would seem that there is no downside or risk to a clinical strategy of a treatment protocol combining the two methodologies of oropharyngeal exercises and oral appliance therapy. It would also seem that future controlled trials to objectively evaluate the combined effects of oral appliances and exercises is warranted.

1. Puhan MA, Suarez A, Lo Cascio C, Zahn A, Heitz M, Braendli O, Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomized controlled study. BMJ, doi:1136/ bmj.38705.470590.55 (23 Dec. 2005).
2. Guimares KC, Drager LF, Genta PR, Marcondes BF, Lorenzo- Filho G, Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. 179: 962–966, 2009.
3. McEvoyRD,PopovicRM,SaundersNA,WhiteDP,Effectsofsustain ed and repetitive isotonic hypoxia on on ventilation and geniogloos- sal and diaphragmatic EMGs. J APPL Physiol, 81:866–875, 1996.
4. Strohl KP, Hensley MJ, Hallet M, Saunders NA, Ingram RH, Activation of upper airway muscles before onset of inspiration in normal humans. J Appl Physiol. 49:638–642, 1980.
5. Mateika JH, Millrood DL, Kim J, Rodriguez HP, Samara GJ, Response of human tongue protrudor and retractors to hypoxia and hypercapnia. Am J Crit Care Med 160: 1976–1982, 1999.
6. Dictionary 7. Sherrington C, “The Integrative Action of the Nervous System” Yale University Press, 1906. 8. Sabolsky JP, Butler JE, Fogel RB, Taylor JL, Trinder JA, White DP, Gandevia SC, Tonic and phasic respiratory drives to human genioglossus motoneurons during breathing. J Neurophysiol, 95:2213–2231, 2006.
9. Blom S, Afferent influences on tongue muscle activity. Acta Physiol Scand. Vol 49 (Suppl 170) 1–97, 1960.
10. Miller AJ, Oral and pharyngeal reflexes in the mammalian nervous system: Their diverse range in complexity and the pivotal role of the tongue. Crit Rev Oral Biol Med, 13(5):409–425, 2002.
11. Weiffenbach JM, Discrete elicited motions of the newborn’s tongue. In: “Oral sensation and Perception” ed. Bosma JF, US Govt Printing Ofc , p232–243, 1972.
12. Isono S, Tanaka A, Nishino T, Effects of tongue electrical stimu- lation on pharyngeal mechanics in anesthetized patients with obstructive sleep apnea. Eur Respir J, 14:1258–1265, 1999.
13. Miki H, Hida W, Chonan T, Kikuchi Y, Takishima T, Effects of submental electrical stimulation during sleep on upper airway patency in patients with obstructive sleep apnea. Am Rev Respir Dis, 140: 1285–1289, 1989.
14. Edmonds LC, Daniels BK, Stanson AW, Sheedy PF, Shepard JW, The effects of transcutaneous electrical stimulation during wake- fulness and sleep in patients with obstructive sleep apnoea. 146: 1030–1036 , 1992.
15. Decker MJ, Haaga J, Arnold JL, Atzberger D, Strohl KP, Functional electrical stimulation and respiration during sleep. J Appl Physiol, 75:1053–1061, 1993.
16. Guilleminault C, Powell N, Bowman B, Stoohs R, the effect of electrical stimulation on obstructive sleep apnoea syn- drome. Chest, 107:67–73, 1995.
17. Schwartz AR, Eisele DW, Hari A, Testerman R, Erickson D, Smith PL, Electrical stimulation of the lingual mus- culature in obstrudctive sleep apnoea. J Appl Physiol, 81:643–652, 1996.
18. Moses AJ, Bedoya JA, Learreta JA, Case study of the ana- tomic changes effected by a mandibular advancement device in a sleep apnea patient. Sleep Diagnosis and Therapy 5:1, 30–34, 2010.
19. Schmidt-Nowara WW, Mead TE, Hayes MB, Treatment of snoring and obstructive sleep apnea with a dental orthosis. Chest, 99:1378–1385, 1991.
20. IchiokaM, Tojo N, Yoshizawa M, A dental device for the treatment of sleep apnea: a preliminary study. Otolaryngol head Neck Surg, 104: 555–558, 1991.
21. Eveloff SE, Rosenberg CL, Carlisle CC, Millman RP, Efficacy of a Herbst mandibular advancement device in obstructive sleep apnea. Am J Resp Crit Care Med 149: 905–909, 1994.
22. Clark GT, Arand D Chung E, Tong D, Effect of anterior mandibular positioning on obstructive sleep apnea. Am Rev Resp Dis 147: 624–629, 1993.
23. Bonham PE, Currier GF, Orr WC, Othman J, Nanda RS, The effect of a modified functional appliance on obstruc- tive sleep apnea. Am J Orthod Dentofacial Orthop, 94: 384–392, 1988.
24. Chan ASL, Cistulli PA, Oral appliance treatment of obstructive sleep apnea: an update. Current Opinion in Pulmon Med, 2009, 15: 591–595.

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The Dental Decade of Obstructive Sleep Apnea Treatment

It wasn’t a scientific survey, but if the level of discourse at the recent APSS meeting was any indication, sleep physicians are warming up to dental sleep medicine.

Flex with new logo The Dental Decade of Obstructive Sleep Apnea Treatment

The decade of dental of sleep medicine may have quietly kicked off in the halls of this year’s Associated Professional Sleep Societies’ meeting in San Antonio. In a marked change over last year, vendors have encountered acceptance where they had previously found reluctance.

SomnoMed, an Australia-based dental sleep medical com- pany and makers of the SomnoDent® MAS devices saw the subtle shift firsthand. It started with an overall tone of positiv- ity that quickly morphed into an infectious enthusiasm. At last year’s APSS in Seattle they were still getting questions about clinical data and people asking about white papers and publi- cations. This year, they heard totally different questions, such as: ‘Where do I find SomnoMed to work with?’.

The new line of inquiry amounts to a huge shift in a rel- atively short amount of time. A year ago, attendees wanted proof, but this year more are convinced. The new mindset is at least partly due to a concerted educational effort on the part of SomnoMed and others. Focused communication to the medi- cal market has hammered home the message that oral appli- ance therapy is backed by solid evidence, with more to come in the near future.

Ralf Barschow, CEO of SomnoMed agrees that medical acceptance is higher than last year, but he believes clinicians will ultimately embrace oral therapies on a much larger scale. Along with greater acceptance, Barschow noticed a lot more traffic coming to their booths this year, with serious inquiries outnumbering the casual fact finders. “We had more people taking contact details and networking than at any other time. I would characterize the interest as sensational.”

Next year’s APSS will be held in Minnesota and could be another milestone that mirrors the situation with home sleep testing. The analogy with works because just like that facet of sleep medicine, dental therapy has taken time to settle in and gain acceptance with certain segments of the market. Full polysomnograms were once considered infinitely superior to home tests, just as it was once considered unthink- able that oral appliances could be a better choice than CPAP.

Now people realize that patients are different and options are a positive development. SomnoMed’s latest innovation the RCMP (Remote Controlled Mandible Positioner) allows physi- cians in the PSG setting, along with a technician, to basically titrate throughout the night to determine whether the therapy will work, and to determine where the bite must be to get the optimal results.

“The unit is completely integrated into the software and the tech is already familiar with the oral appliance for titra- tion,” says Barschow, who’s company custom fabricates the SomnoDent® MAS, a mandibular advancement splint. “It plugs right into the channel and literally, instead of titrating to pressures, it is titrating to advancement in millimeter fraction increments—similar to the way our device can be advanced.”

As a company, it’s all part of SomnoMed’s effort to be viewed as more than just a therapy piece. Instead, the com- pany is looking for a way to determine efficacy, compliance and spread education. There is a SomnoMed Academy, which is an educational entity that generates continuing education credits for the dental and medical fraternity. It started out in the therapy market and the therapy arena.

who wish to get involved can contact the company and purchase a starter kit with collateral materials and three devices. Participating dental professionals may choose to reg- ister for an Awaken Seminar, which is a 2-day continuing edu- cation event that teaches how to prescribe oral appli- ance therapy. “We explain why and how they need to interact with the medical community to get a proper diagnosis,” says Barschow. “However, we have always maintained, and will continue to maintain that it is the physician’s role to treat the patient, diagnose the patient, and once oral appliance therapy is deemed appropriate treatment—it goes over to the dental arena for the fitting of the device. Patient care is for the physi- cian, and diagnosis is for the physician.”

Choice is Key
Like the burgeoning industry, SomnoMed is offering more options to customers. Currently, there are three MAS gold standard products which have been developed, each with dif- ferent clinical indications aimed at OSA sufferers. These in- clude the SomnoDent® MAS Classic, SomnoDent® MAS Flex, and SomnoDent® MAS Edent for the Edentulous patient.

The SomnoDent® MAS is a custom designed sleep apnea oral appliance and has been the subject of numerous strin- gent, evidence-based studies that satisfy the need for a safe and effective treatment for OSA. The SomnoDent® MAS has a number of design features such as: a streamlined design with minimal bulk, which maximizes the size of the lingual space and reduces gagging.

The company touts an excellent fit in both upper and lower arches with anterior and posterior contact for a stable occlu- sion, which prevents tooth movement and minimizes term- pero-mandibular joint discomfort and injuries. The MAS is constructed in two separate pieces that allow patients to open and close their mouths. 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.

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Positional Apnea in a 73-Year Old Male with Atrial Fibrillation

This is the case of a 73-year old male who was diagnosed by the local heart institute with atrial fibrillation. The patient was under outpatient care of both a cardiologist and family doctor. Bedpartner interview did not report a history of snor- ing nor any history of breathing difficulties during the night. However, the patient reported awakening nightly around 0300 to 0400 with the inability to return to sleep because of height- ened arousal. The patient underwent a procedure at the heart in- stitute which induced normal cardiac sinus rhythm, but atrial fibrillation returned within two weeks. The patient is currently taking Coumadine (warfarin). Based on this history, and the known association between obstructive sleep apnea and atrial fibrillation,1 the patient agreed to a simple home sleep apnea screening test using the MediByte Jr.

Home Sleep Screening
The MediByte Jr. is an easy-to-use Type 3 home sleep apnea recorder which complies with new guidelines by using the same technology in the comfort and convenience of the home as is used in sleep laboratories worldwide. The MediByte Jr. records blood oxygenation and pulse rate using transmission SpO2, oro- nasal airflow via internal pressure transducer, snoring vibrations from airflow, thoracic respiratory effort using RIP technology, and importantly, body position. The raw data is fully disclosed, identical to that recorded in , and there is no data processing using proprietary black-box algorithms. The device is capable of recording for one nine-hour night or two consecutive nine-hour nights. Cost per study is approximately seven dollars and published data have found high sensitivity, specificity and correlations of 0.92 between the MediByte and PSG.2

A registered polysomnographic technologist (RPSGT) spent approximately seven minutes instructing the patient in how to apply the MediByte Jr recorder and biosensors. All home sleep apnea data was scored by an RPSGT using scoring guidelines published by the American Academy of Sleep Medicine.3 Total recording time for the baseline night was six hours and 45 minutes. Contrary to subjective reports, the patient had severe obstructive apneas and hypopneas while supine, but was within normal limits during nonsupine sleep. The supine respiratory disturbance index (RDI) was 45.5 and the nonsupine RDI was 1.5 (see Figure 1). The patient slept 49.2% of the night sleeping on his back. Although time between 90% to 100% SpO2 was 99.9% of the entire night, there were 112 SpO2 desaturations of ␣ 4%. The results of the study were explained to the patient and also provided to both the family doctor and cardiologist. Treatment options were discussed with the patient. The patient had no desire to use CPAP therapy and opted to initially attempt positional treatment.

Fig 1CS1 Positional Apnea in a 73 Year Old Male with Atrial Fibrillation

Positional Therapy
Positional therapy involved sewing two street hockey balls (cost about three dollars) into the back of a shirt. Positive feedback about treatment was received from the patient during a follow-up phone call 72-hours post baseline recording. The patient reported he was now sleeping through the night awakening at 0600 rather than during the middle of night. A subsequent home sleep apnea recording with treatment was performed approxi- mately three weeks after the baseline test. It was originally hoped that the positional treatment would reduce the RDI to a mild or moderate level, at which point therapy could be combined with oral appliance treatment (the patient was adamantly opposed to CPAP therapy). However, the results of treatment were striking in their effectiveness and are shown in Figure 2. Total recording time was six hours and 19 minutes. The supine respiratory disturbance index (RDI) dropped to 0.0 (from a baseline of 45.5) with the patient spending 0% of the night sleeping on his back. Total nonsupine RDI was 4.0 which was within normal limits. Time between 90% to 100% SpO2 was 100% of the entire night, but more importantly the number of SpO2 desaturations of ␣ 4% plummeted to one (from a baseline of 112). The patient reported better sleep, increased energy, and overall satisfaction with treatment. Additional follow-up recordings will be performed to monitor continued treatment success.

Fig 2CS Positional Apnea in a 73 Year Old Male with Atrial Fibrillation

Successful Outcomes
This case study illustrates the cost-effective approach to successful home sleep apnea screening. It also shows the vital importance of recording body position and how subjective reports may be qualified using objective, empirical data. Home diagnosis and monitoring of` sleep apnea is a valid tool which should be used with a suitable patient population to extend sleep medicine practice into the community. The successful outcomes associated with positional therapy are not surprising, and are consistent with a recent study which concluded “positional therapy is equivalent to CPAP at normalizing the AHI in patients with positional OSA, with similar effects on sleep quality and nocturnal oxygenation.”4

Richard A. Bonato, Ph.D., Co-Founder and CEO, Corporation, Kanata, Ontario,
Learn about MediByte Jr. at


1. Somers VK, White DP, Amin R, Abraham WT, Costa F, Culebras A, Daniels S, Floras JS, Hunt CE, Olson LJ, Pickering TG, Russell R, Woo M, Young T. Sleep apnea and cardiovascular disease: an American Heart Association/American College of Cardiology Foundation scientific statement. Circulation. 2008; 118:1080 –1111.
2. Driver, HS, Bjerring KA, Toop F, Pereira E, Stewart SC, Munt P, Fitzpatrick MF. Evaluation of a Portable Monitor Compared with Polysomnography for the Diagnosis of Obstructive Sleep Apnea. Poster presentation at Sleep 2009: Seattle.
3. Iber, C, Ancoli-Israel, S, Chesson, A, Quan, SF. The Manual for the Scoring of Sleep and Associated Events: Rules, Terminology, and Technical Specification, 1st ed, American Academy of Sleep Medicine, Westchester, Illinois 2007.
4. Permut, I, Diaz-Abad, M, Chatila, W, Crocetti, J, Gaughan, J, D’Alonzo, G, Krachman, S. Comparison of Positional Therapy to CPAP in Patients with Positional Obstructive Sleep Apnea. Journal of Clinical Sleep Medicine. 2010; 6: 238–243.

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CPAP Tubes – Hybernite (the Unsung Heroes)

Flashy CPAP units and masks dominate the sleep technology landscape, but the right tubes can mean the difference between compliance and failure.

Manufacturers are always looking to build a better mousetrap, but what if the trap already works? The solution may lie in improving the parts while leaving the fundamental design essentially unchanged. Plastiflex engineers and market experts examined the sleep technology market and determined that their expertise in industrial tubing systems could bolster the all-too-common weaknesses found in CPAP systems

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A New Solution for CPAP Tubing
After an exhaustive fact-finding period that took company officials to numerous trade shows and visits with industry leaders, designers narrowed down CPAP tubing complaints to condensation and comfort. According to Rik Langerock, marketing manager for Plastiflex Healthcare, condensation in the breathing circuits was a persistent problem, and a key area where his Belgium-based company could make a difference.

“We spoke to many different people in the supply and value chain and it was condensation in the respiratory tubes that we found to be significant,” says Langerock. “A second related need was about bringing more comfortable air to the patient.”

Comfort usually means warmer and/or more humid air, and this is where Plastiflex is able to use its considerable expertise. Other factors such as mask materials and proper fit play a role, but Langerock and his team were determined to only tackle what they knew best. “You must understand what matches with your core competency as a company,” says Langerock. “Our core competence is in the design and manufacturing of hose systems solutions.”

® Rainout Control (ROC) System
Plastiflex engineers ultimately came up with the ® Rainout Control (ROC) System, which includes the proprietary ® Heated Breathing Tube (HBT) and ® Power Supply Unit (PSU). The HBT connects to the PSU via a plug and-play connector, with copper wires embedded in the tubing wall. These wires generate heat that maintains air temperature inside the tube, ultimately warding off problematic condensation. The wires are positioned for uniform heating along the tube’s entire length, a system that avoids water droplets on the wall of the tube and the resulting accumulation of moisture.

Targeting America and Europe is no small endeavor, but Langerock says the relative simplicity of the message will likely resonate on both continents. The ® ROC consists essentially of two main parts; one is a heated breathing tube and the other is a power supply. With standard conical connectors, Langerock is confident that the ® ROC can fit the role of a universal solution that can be fully integrated into any humidifier— including all types of masks that use standard tubes. “We have been working on this for a long time obtaining all the regulatory approvals,” says Langerock. “Plastiflex Healthcare is ISO 13485 and QSR certified, as are our manufacturing locations. This makes us a Tubing System Original Equipment Manufacturer (OEM) with the ability to sell tubing systems under our own brand like or work closely with other manufacturers for customized products.”

Langerock reiterates that the ® ROC is a universal heated breathing tube system. “It is also stand alone,” adds Langerock. “The system itself does not take power or require power to be taken from the humidifier. It takes the energy straight out of the socket in the wall via the PSU. A second important feature is that the system is independent. It is not specific to one type of device. It works with all humidifiers that currently use standard tubing. As long as you are using standard tubing, which is 99% of the market, all those devices can also work with the .”

Hybernite Tubing Tubes   The Unsung Heroes

Hidden Benefits
Tubes are not often the focus of large marketing pushes, but extolling the virtues of proper accessories is a message that Plastiflex officials hope will find a home. At its core, Langerock believes that increasingly sophisticated clinicians, and even patients, will demand the best products for their therapy. “These tubes will improve the comfort of the patient,” says Langerock. “You will have no more condensation in the tube, no more gurgling noises, and far less pressure fluctuations.”

Avoiding condensation means users can optimize the humidity output of humidifiers for better personal comfort and improved clinical efficacy. “The result of not having condensation is being able to turn up your humidifier instead of turning it down,” explains Langerock. “Another factor for the patient is the convenience and ease of use. The industry also knows that there are factors that will contribute to better compliance, and humidification is an important contributor.”

For , the convenience of so-called plug and play fosters a universal solution for the heated breathing tube. Sleep centers may even be interested in conducting their titrations in combination with heated humidification and a heated tube. “There is literature that says that heated humidification in combination with heated tubing lowers titration pressure *,” adds Langerock. “So, from that perspective, our tubes give sleep technicians an opportunity to do more titrations with humidification.”





*Massengill, J. and Lewis K.L.Effect of humidification and titration pressures on obstructive sleep apnea. Sleep. Volume 32, Abstract Supplement, 2009 A217


Plastiflex Healthcare is a division of Plastiflex Group NV. Plastiflex Group is the world leader in the development and manufacturing of flexible hose system solutions for floor care, pool, white goods and industrial applications. Plastiflex Group has 9 manufacturing locations – 3 in Europe – 3 in Asia/Pacific – 3 in North America. Plastiflex Healthcare is a new venture within Plastiflex and focuses on identifying, developing and marketing new products and technologies in the area of respiratory care, particularly sleep disorders, Non Intrusive Ventilation (NIV) and critical care ventilation. Plastiflex Healthcare is QSR compliant, ISO 13485 and Annex II – Directive 93/42/EEC (design controls) certified.



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