Sleep Apnea Dental Istitute, LLC
 

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March 7th, 2010 Phoenix,AZ

The most outrageous complaint that we have received lately is from Dentists and Pulmonologists around the United States as well as a few other Countries that are stating that after going to classes put on by a certain Company and are making claims that they own the technology of the Pharyngometer as well as the Patents. Nothing could be further from the truth. They are unfortunately working with and in cahoots with an Organization known as the American Academy of Crainiofacial Pain (AACP). They are paying off a few hundred dollars for each unit that is purchased by a person who attended a class put on by AACP. In turn this Organization (AACP) is to and will promote this Companies product known as the Eccovision Combo Unit which is made up of the Pharyngometer & the Rhinometer. This then allows this Company to place a few basic salespersons (usually a female who usually dresses scantily) to promote sales in their classes and allow them to try and sell them their Companies products. These basic salespersons offer to sell their quackery & voodoo technology. Naturally, it is the intention to primarily sell the Combo Unit because this product has the largest profit margin in their inventory. Please don't misunderstand, though there is indeed some benefit to be derived from the field of Pharyngometry, 90 % of what they teach is just plain nonsense. The actual cost of the Pharyngometer to produce which was originally owned and produced by Hood Labs of Pembroke, MA who no longer deals with or has no ownership interest with the product, was a total cost of 2562.00 dollars. This Company today is offering this exact same machine for upwards of sixteen thousand dollars (16,000.00) or more for which they try to attach a useless 3D software CD for an additional two-thousand (2000.00)) or more as well as training for another twenty-five hundred (2500.00)as well as other sundries (such as the Pharyngometer Filter which needs to be replaced each and everytime the unit is to do a test. They sell these filter strips for 100 dollars for 50 strips which only costs them 2 cents a piece though you can actually use a piece of paper towel or a piece of toilet paper which works as well as if not better at a cost of virtually nothing.) which are used to work with this unit. In all, it is just plain thievery to sell this unit for anymore than five-thousand dollars (5000.00). When all is said and done your looking at an invoice of more than twenty-five thousand dollars (25,000.00). But no problem they say, they will let you lease it with a Company that gives them a kick-back for that. The best is when they tell you the Patients they are going to send you and how the machine will pay itself off in just a few months.

If you have been in this business for a few years try and remember back a few years ago when Itamar Medical was promoting the Ambulatory Sleep Apnea Testing Watch-Pat 100. A unit which the patient could take home bring back in the morning to their Doctor and get a result shortly on whether they had Sleep Apnea or not and what their AHI was without getting a long Sleep Study (PSG) in an uncomfortable Sleep Center. Another outfit known for its quakery known as Rondeau Seminars was promoting this PRODUCT called the WatchPat-100 and was paid a few hunderd dollars for each unit he sold. Within a very short time the WatchPat-100 no longer is sold though they added a few things like a useless microphone for snoring and now calls it the WatchPat-200 for twice the amount. No one pretty much buys this product anymore because there are far superior products out there. Most people learned from that experience.

REMEMBER THE OLD ADDAGE, IF IT'S TO GOOD TO BE TRUE !!!

It is the advice of this Web site to do your due diligence and seek out through research the best equipment for your practice and needs. There is much to choose from out there and a lot of competition. And honestly after I did some cursory research I found much better equipment with better efficacy. Make your choice wisely and don't let some slick salesperson sell you some useless piece of medical equipment that will of no use to you.

If there are any further questions please contact us @

contactus@sleepapneadocs.com

 

March 1st, 2010 - Phoenix, AZ

Disturbing new information has just recently been exposed from experts and Doctors who have studies and endless tests with the use of the Eccovision Pharyngometer. We have studied the results thoroughly and diligently & now believe that the documents we will be posting will finally debunk & set straight the reliability and integrity of the Pharyngometer.


The Pharyngometer is supposed to provide an accurate graphical representation of the upper respiratory airway to the glottis, though the use of acoustic signal processing technology. It is a dynamic test performed while the patient is breathing and coached through various maneuvers. This will determine overall the efficacy of the Oral Appliance treatment titration. Unfortunately, it appears that these recent studies just don’t support those theories of reliability and therefore may be doing more harm than good to your patient. Who after all, is the person you most want to diagnose and treat properly from this ever rising disease called Sleep Apnea. This disease has caused death to some prominent people as well as many others over the past years.

In essence, the physicians, dentists, and clinical personnel who use this as a diagnostic tool to get an accurate two dimensional representation of the nasal and oral airway are most probably getting false readings and wrong interpretations. Can we say MALPRACTICE !!!

 

PLEASE BE ASSURED THAT SADI WILL DO EVERYTHING IT CAN TO DILIGENTLY DETERMINE THE VALIDITY OF THESE NEWLY UNCOVERED FACTS.

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August 14th, 2009

The EccovisionTM Acoustic Reflection Pharyngometer provides a non-invasive assessment of the dimensions, structure and physiological behavior of the upper airway from the oral cavity to the hypopharynx while the patient breathes. This device is marketed as a screening method to quickly assess a patient for potential sites of sleep related upper-airway obstruction, and to better determine whether an oral appliance or CPAP is more appropriate for the patient.


The SNAP Testing System (SNAP Laboratories, Wheeling, IL) is another type of reflective acoustic device marketed as a screening and analysis system to locate the source of snoring and detect sleep apnea conditions. These devices were approved by the FDA based on 510(k) premarket notifications; thus, the manufacturers were not required to submit the evidence of efficacy necessary to support a premarket approval application.


POLICY


Acoustic pharyngometry (e.g., EccovisionTM Acoustic Pharyngometer), and versions of the SNAP TM Testing System using fewer than 3 channels are considered strictly experimental and investigational for screening, diagnosis, or treatment planning in persons with suspected or known obstructive sleep apnea (OSA) and for all other indications.

RATIONALE

Hatzakis et al (2003) found that the Eccovision pharyngometer does not reliably assess pharyngeal volumes. Gelardi et al (2007) assessed variations of pharyngometric parameters in patients with sleep disorders. The authors concluded that although not to be used as a standardized test, acoustic pharyngometry was proved to be a tool both in the determination of severity of OSA, and in post-operative monitoring of upper airway surgery in patients with sleep disorders only.

Acoustic Pharyngometers and SNAP Testing System

There is insufficient evidence that versions of the home SNAP testing device using fewer than three channels are as good as conventional sleep studies for diagnosis and treatment planning in patients with OSA.
Liesching, et al. (2004) compared the SNAP testing system to standard polysomnography to determine the accuracy of the SNAP testing system in detecting OSA. The investigators concluded that SNAP studies do not appear to accurately assess the severity of OSA.


Galer, et al. (2007) examined the clinical significance of the acoustic data channel (single channel) recorded by the SNAP home polysomnography system.
The investigators concluded that their findings suggest that analysis of snoring has limited utility in the evaluation of the patient with sleep apnea but may be able to select patients who would benefit from palatal procedures to reduce snoring. Guidelines on the use of portable monitoring devices for the diagnosis of obstructive sleep apnea from the American Academy of Sleep Medicine, the American Thoracic Society, and the American College of Chest Physicians (Chesson, et al., 2004) state that type 4 monitoring devices are not recommended in the attended or unattended setting. The guideline definition of type 4 monitoring devices would include the SNAP Testing System using less than 3 channels and acoustic pharyngometry.

 

A MUST READ FOR ANYONE

THINKING OF PURCHASING 3D SOFTWARE ?

 

From: "Sanjay R. Patel" < sanjay.r.patel@case.edu >
Cc: "Susan Redline" < susan.redline@gmail.com


I am writing to reiterate the discussion I had with you yesterday over the telephone. As you know, I work closely with Dr. Susan Redline and our group has been very interested in using the acoustic Pharyngometer which was developed by Hood Labs as a screening tool to assess sleep apnea predisposition in large populations. We were very excited to hear about the new SGS 3D software marketed by Sleep Group Solutions(SGS) suggesting three dimensional reconstructions could be generated from acoustic pharyngometry data. We contacted Rani Ben-David and Tamir Cohen, the president and vice president of Sleep Group Solutions(SGS) and had a long discussion over the telephone regarding our interests in pharyngometry and our excitement regarding what appeared to be a major advance in this measurement technique. Dr. Redline and myself each had numerous questions regarding the science behind how the three dimensional images were generated from the pharyngometry data. We also asked if we could get a copy of the software for a limited period of time in order to play with it and form our own opinion regarding the utility of the software for the sort of screening work we are interested in. Mr. Cohen asked that I put in writing our scientific questions which they would pass along to their scientists but did agree to allow us to try out their software. We wrote them our scientific questions in August 2006 and have yet to hear a response. With regards to the actual software, we were disappointed to find it came with next to no documentation. Our IT specialists were unable to get the program to load our pharyngometry data collected with the Eccovision equipment. In trying to read through the documentation that was provided and look through the functions that the software allows you to choose from I was left with the impression that the 3D software does not generate three-dimensional data from pharyngometry as their website advertises and they claim. Rather it was designed to allow the user to take the cross-sectional area by distance output from the Pharyngometer and manually rotate this 2-D curve to fit into whatever shape the user may want (for example to fit into the presumed airway location on a lateral neck x-ray). Without any response from the developers of the software to inform me otherwise, I am left with the conclusion that there is no scientific merit to this software. In addition, the poor documentation provided with the software means that even if the program did generate novel information, its utility would be severely limited by the inability of a user to obtain the output from the program. Thus, overall, we have been very disappointed in our interactions with Sleep Group Solutions. Please feel free to contact me if you wish to discuss our experience any further. In the meantime, we continue to be excited about the utility of pharyngometry and we plan to continue our research on using this tool to better understand the pathophysiology of obstructive sleep apnea. Sanjay R. Patel, MD, MS Assistant Professor of Medicine Divisions of Pulmonary, Critical Care and Sleep Medicine & Clinical Epidemiology Case Western Reserve University 11400 Euclid Avenue Cleveland, OH 44106 (216) 844-6258 Email: srp20@case.edu

 

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Dear Members and Friends of Sleep Apnea Dental Institute (SADI)

In keeping with The Sleep Apnea Dental Institutes desire to keep its clients and other health care professionals up to date on the latest information available regarding the treatment of obstructive sleep apnea with oral appliances, we would like to clarify some guidelines regarding The Practice Parameters from The American Academy of Sleep Medicine and The Dental Scope of Practice Protocols by The American Academy of Dental Sleep Medicine. An Area of question which has come up, has been in the type of testing acceptable, to be interpreted by the sleep medicine specialist, to diagnose obstructive sleep apnea. In both the Practice Parameters and the Dental Scope of Practice there is no question.
  
In accordance with the Practice Parameters by the American Academy of Sleep Medicine and the Dental Scope of Practice Protocols by the American Academy of Dental Sleep Medicine, the presence or absence of obstructive sleep apnea must be determined before initiating treatment with an oral appliance. The Practice Parameters and Dental Scope of Practice both state that obstructive sleep apnea be “identified by polysomnography, interpreted and diagnosed by a sleep physician.

According to these guidelines the dentist needs a diagnosis of OSA, made by a sleep medicine specialist, using a polysomnography, to initiate treatment with an oral appliance for a patient. Might I just add that Sleep Apnea Dental Institute is proud to say that we have on our team the finest Chief Medical Director in the Field of Sleep Medicine,
Board Certified in Internal Medicine, Pulmonary Disease and Sleep Disorders Medicine.
                                                 
 Exceptions to polysomnography are listed as;
1. Patients with severe symptoms, initiation of treatment urgent, polysomnography not readily available. (Within 72 hours) or (within 20 miles)
2. Patients not able to be studied in a lab.
3. Follow-up studies where diagnosis has already been established to check efficacy of treatment. 
 
The American Academy of Sleep Medicine has reviewed the available types of devices for evaluating sleep. In the current Practice Parameters of the American Academy of Sleep Medicine regarding devices, they have divided them into 4 types of monitoring devices for evaluating sleep. They are;
 
Type 1 Comprehensive standard overnight polysomnography in a sleep center or lab with a sleep technician in constant attendance. Parameters Measured- minimum of 7 parameters including EEG, EOG, chin EMG, ECG or heart rate, airflow, respiratory effort and oxygen saturation.
 
Type 2- Comprehensive portable polysomnography. Parameters Measured- polysomnography- with minimum of 7 parameters including EEG, EOG, chin EMG, ECG or heart rate, airflow, respiratory effort and oxygen saturation.(example Somte 8 channel with EEG lead, Somte PSG)
 
Type 3- Modified portable sleep apnea testing Parameters Measured- minimum of 4 parameters including ventilation (at least 2 channels of respiratory movement or respiratory movement and airflow), heart rate or ECG, and oxygen saturation. (Example Edentrace, Vitalog, Novasom QSG, Watchpat 100 & 200, Stardust by Respironics)
 
Type 4- Continuous single or dual bioparameters
Parameters Measured- 1 or 2 channels typically including oxygen saturation or airflow. (Example-Remmers, Snap Test, Overnight oximetery)
 
Types 1 and 2 are considered polysomnography.
  
Type 3 devices may be used for follow-up studies to prove efficacy of treatment, but not to be used for initial diagnosis of OSA. 
 
 As stated in the Dental Scope of Practice Protocols Medical- Dental Practice Protocols must continue to be promoted and implemented for the health and safety of our patients and to comply with our state licensure boards.   

On 9/12/07 there was a hearing for The Centers of Medicare Medicaid Services (CMS) review of the National Coverage Determination on CPAP Therapy for OSA. Part of this review considered portable testing (home testing) for OSA as a covered benefit. This will have an effect on the Practice Parameters and Dental Scope of Practice, but until we know if it will change permanantly, we must recommend incorporating Dental Sleep Medicine into your practices within the guidelines set forth by The American Academy of Sleep Medicine and The American Academy of Dental Sleep Medicine. 

New guidelines will be posted shortly.