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Chairside Adaptation for Type 2 Combination Therap ...
Chairside Adaptation for Type 2 Combination Therap ...
Chairside Adaptation for Type 2 Combination Therapy
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Shareside adaptation for type two combination therapy. Again, I'm Dr. Kevin Wallace. I am a diplomat with the American Board of Dental Sleep Medicine, and I'm also the dental director at the Midwest Dental Sleep Center here in Chicago, and that's where I'm speaking from. A little bit about the disclaimer. I will mention the TAPPAP device, which is the predicate appliance for all combination therapies that I'm going to discuss tonight. And I want to say this. Wayne Gretzky, one of my favorite hockey players, he stated at one point that you miss 100% of the shots you don't take, and I want to extrapolate that to the patient care that I give here, and maybe to you too. When you see patients in your office and they're not completely responding to your therapy from oral appliance therapy, it's worth it to discuss these things with your medical colleagues and maybe introduce combination therapy. So take a shot. Take a chance in getting these patients treated. It's well worth your time and effort. So tonight, the objectives, I want to go through a couple of things with you. Let's look at the anatomy and maybe why these oral appliances aren't as effective as they could be. We'll look at patient selection for a combination therapy. Also the effectiveness, side effects, and compliance rates of the oral appliance versus a CPAP. The benefits of combination therapy. We'll look briefly at type one combination, but get a little bit more in depth with the type two combination. And we'll look at the fabrication techniques and materials for that type two combination. And which type of appliances are utilized, at least the ones that I utilize here. Are these appliances titrated and can the maxillary arch be used only or by itself? Very interesting. We'll look at a couple of insurance codes that are used and then future combinations with oral appliances that we'll look at a little bit more in depth too. So from the anatomy point, why do some of our appliances not work and some do? Well, when we're doing appliance therapy, we want to promote nasal breathing. So we have the patients that try to sleep with their mouth closed and their lips sealed. So as we see this in this illustration here, that the air enters the nasal cavity and proceeds to the turbinate. So we want to reduce that turbulence going through there. And that may involve some combination therapy with our ENT colleagues. But as the air passes through the nasal pharynx there and through down to the velopharynx, which is the uvula, that's where we get most of our effectiveness with the oral appliance, right in that area, in the velopharynx. As the air proceeds down to the oral pharynx and in this illustration, you can't see what that soft palate posterior tongue area. The tongue is pressed against the posterior wall there, but that's the second area that the oral appliance can be very effective. And then as the air proceeds down into the hypopharynx below the epiglottis, that's where we have the least effective part of our oral appliance therapy. But in these cases and in all these areas is where the CPAP has us beat. So combining these therapies can be a great addition to their therapy. We should also be aware of the sites of upper airway narrowing. So when we're looking at the sites of collapse, only about 18% collapse at the soft palate. And again, that's where we're gonna get the most effect. 82% have multiple sites of collapse. So we don't really know when these patients present to us where this collapse is actually going to happen. So we need some options moving forward. Generally, there's two therapies for obstructive sleep apnea. And we'll look at the nasal CPAP and the oral appliance. With the nasal CPAP, it's most efficacious, but it's poorly accepted and there's poor compliance with it. Oral appliances are not as efficacious with about 50% responding positively, but it's readily accepted and there's much better compliance, at least subjectively. And there's a very interesting study that shows objective compliance rates too. So how do we decide which is best for our patients? Well, let's look at how the CPAP works. CPAP is just pressurized air that's applied to the airway when we split and prevents the collapse during sleep. We do see side effects and compliance issues, but it's highly efficacious. But in compliance with CPAP is strongly correlated with symptomatic improvement. But only about 50% of the patients are using CPAP greater than the four hours per night after the six months. Higher pressures are associated with decreased compliance. And some side effects that we see with these are leakage, sore eyes, arophagia, poor mask fit and airway drying, which also can lead to poor compliance. So when we compare the two, CPAP and oral appliance, again, we see that compliance is only about 50%. And with oral appliance, which is a self-reported from these studies below, 76% of the patients report using the oral appliance after a year. 62% reported using the oral appliance after four years. And for those still using the appliance after five years, 90% have good adherence, meaning they use it for more than four nights, more than half the night. And the objective study that I was referring to is this one by DeVries, which showed that objective adherence with MAD and CPAP is comparable and consistent over time. So that was interesting. And they used a dorsal style appliance that was set at 70% maximum protrusion. The CPAP was an autopap and the masks were chosen by the patients for comfort, and they were able to use chin straps and humidifiers as needed. So that may have affected the outcomes here. Oral appliance efficacy is about 20 to 30% failure rate. So those are the patients that we really wanna target. And those are the patients that we will talk and speak with our medical colleagues about doing this combination therapy. Overall oral appliance success rates hovers around 50%. That includes the severe cases. But mild and moderate, if we're targeting those cases, it's about 75% successful. Severe is less than 50%, and it's also unpredictable. Position dependent obstructive sleep apnex are pretty well treated with the oral appliance. Although REM related obstructive sleep apnea is only about 12% of patients will have normalization. So we do need some options moving forward. How can we augment this efficacy? Well, we can call in our ENT colleagues and have them do some nasal surgeries. We can also talk to our sleep physicians and get them on to positive airway pressure. But a lot of times combining these therapies makes it a much more successful endeavor. So we don't wanna have an us versus them philosophy. We wanna be collaborators with these physicians and get our patients successfully treated. And the combination of these two therapies is exactly what it says. It's the oral appliances combined with the CPAPs. And why do we wanna do these? And who are these patients that we wanna target? Well, these are our failed oral appliance cases or the physician failed CPAP cases. And these can be due to high pressures, air leakage and comfort related issues. Combining these two therapies has the potential for reducing CPAP pressure. It also improves velopharyngeal patency with the oral appliance and less pressure is required because of that. We see reduced leakage and less cumbersome BASC interface because there's no straps involved when we combine them with the type two therapy. We see improved efficacy and compliance which means greater effectiveness overall. So what type of research has been done so far? Well, several case studies have been done and those have evaluated comfort, compliance and effectiveness. But I wanna take a look at a couple of these and I'll show you a couple of these two pilot studies that have been done. One by El Sol in 2010 and one by DeVrys in 2016. And a little bit of summary of both of these just in the DeVrys study, he utilized a TAP-PAP or a connected device which we'll call the type two device. And the El Sol study used a non-connected Herbst appliance which is the type one device. And they found, both of these studies found that several patients preferred hybrid therapy to conventional CPAP, although there was no difference in efficacy between traditional CPAP and combination therapy. But CPAP pressures were reduced when they were combined and they both agreed that future studies should investigate the impact of hybrid therapy long-term. So let's look at the DeVrys study and here it is with the combination this we'll call type two because it is connected. The aim was to determine whether the hybrid therapy is an adequate alternative to conventional CPAP in CPAP tolerant patients with moderate to severe obstructive sleep apnea. So these patients were already using and complying with their CPAP. Seven patients who tolerated the CPAP therapy despite those high pressures were treated with hybrid therapy. And what they found was that at the start of therapy the mandible was advanced 60 to 70% of the maximum protrusion and the CPAP pressures were reduced to six centimeters of water. And then after an adjustment period of two to four weeks the jaw was advanced and pressures were adjusted as dictated by symptomatic relief. And after about three months, the effectiveness was assessed by home-based PSG and questionnaires. And out of those seven patients five used the hybrid therapy for the full three months. And out of those seven patients four preferred the hybrid therapy and reported it as more comfortable and effective. And very importantly, the pressure could be reduced from 11 to 6.4 centimeters of water with the hybrid therapy without compromising efficacy. In the El Sol study, he took 10 patients which were both CPAP intolerant and MAD failures. And he found increased adherence over the CPAP as a standalone treatment. He found decreased AHI and decreased CPAP pressures which were all made the cases more successful. And he concluded that combination therapy of the oral appliance and nasal CPAP is effective in normalizing respiratory disturbances of sleep apnea in selected OSA patients. So that's very interesting. And another interesting paper that was presented at the a couple of years back at the AADSM meeting was by Dr. White and Dr. Essig showed that even without lowering the pressure substantially CPAP tolerance can be improved and severe obstructive sleep apnea fully treated using a MAD that physically supports and stabilizes the position of the nasal pillows. And he said that these results are important because a patient with severe OSA who is unhappy to comply with CPAP has no other viable treatment option. And this therapy offers patients a significant improvement in quality of sleep, which leads to improved moods performance and overall outlook on life. So at the clinic where I'm currently at at Midwest Dental in Chicago, Dr. Hogue who presented this lecture or this webinar previously compiled some data and he evaluated 67 patients who had undergone combination therapy. And the patients may have utilized the oral appliance and CPAP therapy either connected or not connected. And approximately 50 of the 67 patients completed a pretreatment PAP titration PSG and a combination therapy PSG. So we had data on all these patients. With the pretreatment findings had the PAP pressures range from five to 20 centimeters. And that's basically the range of a CPAP machine. At post-treatment, he saw an average decrease of 24% or three centimeters of water. That number three may not seem like a lot but if you're familiar with CPAP or know anybody that wears a CPAP that pressure difference can mean all the world between compliance and non-compliance. So quickly, let's just take a look at the type one combination. And this is done with, again with the CPAP worn independently of the oral appliance but they use both at the same time. And a study was done again that showed that this combination does achieve mandibular stabilization. It's easy to implement in your practice. There's no special training with this. The management of the CPAP is done by the doctor. So you don't have to manage that at all. And the cost and insurance and share time is a known and constant variable. So for type two, which is combined and connected there's no straps to hold the mask in place. Mandibular advancement is not necessary although it's advised from the device study we saw patients set at 70%. Other studies have ranged that I've seen from 60 to 80% of mandibular advancement. There's a little bit of special training with this device and you need to be familiar with PAP therapy in general. The chair time does vary depending on the connection type. So this is a TAPPAP system. I'm gonna concentrate on this middle picture here where we see the nasal pillow supported by the oral appliance here. These other devices on the left and right or it could be custom mask fits which are very beneficial also but I won't be getting into that in this lecture today. So with the connected device and this one I'm gonna talk about with the TAPPAP is connected to a midline traction device. And what you see here is in the center picture again is the connection kit and it's a very easily assembled chair side. And what you do, if you can see here you would just remove these two screws which hold this face plant in front here and you connect this bar to the other plate and attach it to the front of the oral appliance. Now that bar would then accept this collet, which then accepts the nasal pillows. All of this combination can be then set in the mouth. Sorry. And you just adjust the nasal pieces to get them to fit comfortably. You also, you'll seat the oral appliance and make sure that that's comfortable also. You want to make sure that that's centered. And the other thing that's very important that Dr. Hogue brought up here was this blue arrow is pointing to some excess acrylic that he used to kind of reinforce this connection. And he did that because he found after many times of taking the oral appliance in this combination therapy in and out, insertion and removal, he did see some little cracks or fractures in the appliance in the anterior region. So he has his assistants bulk this area up and it's found to just increase strength over time. A case study was done and this was a 47 year old male with a connected combination. Diagnostic split night was done. On the first half of the night, he was found to have an AHI of 80. And with CPAP treatment at 16 centimeters of water, they were able to bring him down to 34. Then they used the connected device and they were able to bring the AHI down way down to seven. And also the CPAP pressures reduced and then 80% of protrusion of the mandibular device. So that was a very successful case. So can we connect this? Can we do this connection to other devices? Well, yeah, we can do this to acrylic devices. It is a pretty ingenious setup here. And this is again from Dr. Hogue's clinic. And I'm gonna go through just how he did this to attach these nasal pillows to an acrylic device, which is very useful. So as you see here on the bigger picture on the right, I'm gonna call that the connected device to the oral appliance. You see there's a little acrylic here that connects the whole thing together to the nasal pillows, which can make this the type two connected device. So how did he do that? So on the left here, this again is the, for the midline traction devices, that's the bar and the connector piece here. But what he did here was he used this in the, and I'm pointing to this thermoquill device here. He warmed that up and he put that underneath the, let's say, for example, the HERPS device, which you may have to disconnect to do this adequately. But he warmed that up and he put that under the device. And he was able to measure that and get this front piece, this connector centered. And he also then connected the nasal pillows to that. And then on the right here is the nasal pillow connection. You really can't see that, but there's a tube in there and there's some nasal pillows with a connection there. So he made that connection and took that thermoacrylic device here. And he was able to cut that or separate that right here with the separating disc. And then he took some thermoplastic beads and he warmed those up. He made like a little, made it into a little ball and he connected this device, this front piece here to the thermoacrylic beads. And he then Vaseline the six anterior front teeth. He was able to mold that to those teeth while keeping that nasal mask piece in place and centered. And once those beads got hard, which was showed here with turning white, he was able to take that off and then apply that to the patient's model. And then he seated that on the model with the connector and he sent that to the lab where they connected this piece to the oral appliance. So you wanna send the oral appliance along with this. And he was able to have that connected to the oral appliance. And what he got back was this device here. So you'll see the connection right here to the, for this demonstration, it's the Herbst appliance. And he was able to connect the mask here and then on delivery, all you need to do is seat the oral appliance and get these masks, the nasal masks and the pillows in a comfortable position, tighten the screw, and then you'll have the patient connected to the CPAP. This is done chair side and have them sit there for a few minutes, maybe 10, 20 minutes and check for leakage and make sure that that's not gonna leak out. And that's the basically how that is done. So it's a very useful device, very successful device. And it's able to be done chair side with these appliances. Now, can we do these to other types? Let's say you're using a nylon device. I have heard that there are labs that can do that, but you'll have to speak to the lab by yourself and see if that can be done by your lab. But that's something that I have seen done. So there are some codes that we use with this device and they're the A7033, 34 and 35, and these are all billed out. And what that custom hybrid interface that I just explained how we did that is generally a self-pay item. So you wanna take a look at that too. Now, I found that a good reference website is the ResMed website, and they can actually show you how this is billed and how often that you have to replace these parts. So for post delivery, you wanna make sure that regardless of the type, either type one or type two, it's advisable to send the patient back to the physician for a CPAP retitration study. And that's to assess the new therapeutic levels of pressure. And you may find that there's gonna be some reduction in pressure, which will enable that patient to use the appliance and in combination with the CPAP more effectively. If you're using an autopap, which may be used instead of the regular CPAP, retitration may not be required because the physicians can monitor that remotely. But patients should still be seen periodically in your office to evaluate the integrity of the appliance and the connection, any return of symptoms, and any side effects that are due from the oral appliance. Let's look at a case study of a dorsal connected device. The patient was a 74 year old white male, a BMI of 38, and his chief complaint was he couldn't tolerate the PAP machine. He did have a significant medical history of hypertension, hypercholesterolemia, and coronary artery disease. And he had a fully edentulous upper and lower implant supported denture. His maximum protrusive range was about 14 millimeters. His diagnostic sleep study showed an AHI of 15 and a NADER of 72%. And the oral appliance titration study actually made him worse. So we needed some options moving forward. So he did connect it as a type two connection and they found that at 13 centimeters of water that the patient was successfully treated and brought him down into a mild range. So that's the type one and two connections combination therapy. And I want to just elaborate a little bit here on future combinations with oral appliances in terms of behavioral, surgical options, myofunctional therapy, and any other future like EPAP and medications that also can be combined with oral appliances. So let's look at behavioral changes, which can be either positional devices or weight loss. For positional therapy, a follow-up sleep study may reveal that the sleep apnea is incompletely treated when the patient is sleeping supine. So resolution may only occur when we have the patient sleeping laterally. So positional devices, which are readily available, can benefit these patients. Positional dependent sleep apnea ranges from 50 to 60% of all patients diagnosed with sleep apnea. And it's defined as a 50% reduction in AHI when sleeping laterally versus supine. Retrospective analysis reveals greater efficacy of oral appliances in patients with positional sleep apnea. These devices are used to discourage supine sleep and many types are available. And they can be used as a primary form of therapy in patients that refuse or were unsuccessful with CPAP or oral appliances. And here's a couple of examples that you may know about already, especially this one here with the tennis balls. This was taped in or put into a baggy and pinned to the back of a T-shirt. I personally like this one. I have this one and patients tell me they like it also, but it's a pregnancy pillow. They make this style. They also make one that's like a candy cane. It's about half this size. And that's also very comfortable. I like it because it's soft. It's something soft that you can roll into. These devices on the bottom can be successful, although I've found that they are a little bit uncomfortable because it's just like, it's almost like rolling over a speedball. So we do see decreased compliance in patients that use positional therapy as a primary treatment because they find it's uncomfortable. And we do see also residual symptoms present even in lateral sleep. So research indicates that compliance does increase in patients whose symptoms and OSA were resolved with the use of a positional device. And a study by Deltjens with a device that actually vibrated showed that these two therapies together can lead to increased efficacy and greater reduction in AHI compared to using only one treatment modality. And what this one is here is a belt that accepts a little vibrating device. And you have to train this over a period of time where when you present in the supine position, it does vibrate and it trains you to move over when you feel that sensation. So what can we say about all of this? So in those patients who have not seen adequate resolution of their sleep apnea and with the use of an oral appliance by itself, their PSG does reveal a positional component to their sleep apnea. The positional device used in conjunction with an oral appliance can provide further improvements. So perceived subjective improvements equal greater compliance. Weight loss is interesting too, as we'll see in a slide in a minute here, but severity of the OSA can be attenuated by the weight loss. Improvement in AHI as a result of weight loss may be related to the maxomandibular soft tissue volume. Oral appliances tend to be more effective in patients with a lower BMI. In patients whose OSA is in completely resolved with the use of an oral appliance may see greater reductions in AHI with weight loss. And there are several studies to back that up. In this study by Pappard, he analyzed data from the perspective Wisconsin sleep cohort study of middle-aged adults, where they looked at 690 randomly selected employed Wisconsin residents, which were evaluated twice a year at four, twice at four-year intervals with PSG. And an interesting stat that you can pull out to your patients here is that relative to a stable weight, a 10% weight loss predicted a 26% decrease in the AHI. So that's important. And you can discuss this with your patients that any type from mild, moderate, or severe, when they do lose weight, it does help with the oral appliance success. And even with sometimes with very mild cases, it can put them under the threshold for sleep apnea. And what are the roles of surgery? So they can be either adjunctive or salvage. With adjunctive surgeries, we can facilitate the CPAP or oral appliance use. And in salvage cases, we can use that in place of the CPAP or oral appliance. So here's an interesting picture. On the left here, we see a complete collapse of the nasal valves on inhalation. And then after some nasal surgery, we see complete patency of the airway, which can completely help with oral appliance success. So how does that affect sleep disordered breathing? How does nasal obstruction affect sleep disordered breathing? Well, nasal obstruction is associated with mouth breathing, which can decrease the efficacy of the oral appliance therapy. Reported complaints of nasal obstruction in female patients is associated with reduced efficacy. And that's found from a Marklin paper. Surgery to lower nasal airway resistance in CPAP non-adhered patients lowers the effect of CPAP pressure and improves compliance. That's important to realize also. A higher nasal airway resistance is associated with poor response to oral appliance therapy also. Large studies have shown that nasal obstruction and chronic rhinitis is an independent risk factor for habitual snoring, non-restorative sleep, and daytime sleepiness. And increased nasal resistance is an independent risk factor for OSA CPAP intolerance and oral appliance failure. And in a study by Zheng, he looked at 38 patients that were treated with oral appliance devices and 26 were responders. The AHI was reduced from 20 to 6.7. 12 non-responders, the AHI went down from 23.9 to only 22. And he found that nasal resistance and BMI were the only two predictors of treatment response. Non-responders also had a significant increased nasal resistance in the supine position. So what about UPPP patients? And I do see these frequently and they come in and they're still snoring or they still have residual sleep apnea. So what can we do with these patients? Well, we can talk about combination therapy with these people and discuss oral appliance and how we can augment this. What they found was an adjustable oral appliance does appear to be effective mode of therapy when used to control obstructive sleep after an unsuccessful UPPP. And they saw 18 patients where this was successful. And the benefits of this combination can be decreased AHI, increased NADER, and a resolution of subjective symptoms and daytime sleepiness. Hypoglossal nerve stimulation can also be done, which is an implanted nerve stimulator. And it's generally a pacemaker for the hypoglossal nerve, which when activated will protrude the tongue forward and open the airway posteriorly. It's a surgically implanted device, and this was approved by the FDA for treatment in 2014. And a study by Lee showed that with combination therapy with the oral appliance and the hypoglossal nerve stimulation, that the stimulation parameters may be reduced. And so it's sort of like analogous to the pressure requirements for CPAP when oral appliance is combined in the type two or one therapies. Oral appliances should provide sufficient anterior room to accommodate the tongue during HNS therapy. So what they showed here was PSG data from pre-treatment was at 43.7 per hour. And with the hypoglossal nerve stimulator, it was brought down to 11.6. With oral appliance only from 43.7 down to 29.2. And with the combination below threshold at 2.1 per hour. So great success with that. The lowest oxygen saturation was at 86%, and the time below 90 was reduced from 33% to below 1%. Great case. What about biofunctional therapy? This is a neuromuscular re-education of the oral facial muscles through a series of exercises. And this is designed to eliminate oral habits, improve static and dynamic tongue positions, improve lip seal, which is important for our therapies, enhance nasal breathing, and it can repattern the stomatognathic muscle function, promote proper chewing and swallowing. So is there any evidence that this works? Well, they did a meta-analysis and what they found was that the myofunctional therapy can decrease AHI by about 50% in adults and 62% in children. Lowest oxygen saturation, snoring, and sleepiness outcomes improved in adults. So they thought that myofunctional therapy could also serve as an adjunct therapy with the oral appliance. And future combinations with the oral appliance, we may see EPAP in the oral appliance and medications. So with the expiratory positive airway pressure, the brand name is the Bongo now, it's applies to the nostrils, it's a silicone inserts that go into the nostrils and it provides increased pressure on expiration that helps to maintain airway patency. There's about a 50% response rate with this. They've done a couple of studies, but they also found that the MATA and EPAP does provide complimentary actions to the airway. And it may be a possible option for patients incompletely treated by oral appliance, but still refuse or remain intolerant with the CPAP. What about medications? Well, Monolucast, which is Singular, brand name Singular, is a leukotriene that is a type of anti-inflammatory drug is a leukotriene receptor antagonist. And leukotrienes are primary inflammatory mediators in the respiratory system. A study was done in pediatric patients, not adults, but in pediatric patients, they saw that there was an increased number of these receptors in adenotonsillar tissue. And the use of this resulted in greater than 50% reduction in AHI in about 62, 63% of the participants, which again, were pediatric patients. Other medications we may see already, and these are used to treat any residual daytime sleepiness that you might have with your oral appliance patients, modafinil or modafinil, amphetamines, dextroamphetamines, all can be used to treat the residual daytime sleepiness. Dronabinol, which is a synthetic cannabinoid can provide neuromodulation in the respiratory system. And a preliminary study showed that Dronabinol did increase airway stability and decreased hypoxemia in patients with OSA. And this was a very interesting study by Danny Eckert, which has future potential, but they used a combination of amoxetine and oxymutinin, which showed that they can reduce the number of obstructive events by almost 63%. Improved oxygen overnight desaturations was improved and it enhanced geneoglossus muscle activity also. So that's another future benefit of medications in combination with the oral appliance. So that's my webinar for this evening. I wanna thank all of you for joining me and I hope you learned something from this and we'll use, I guess, the rest of the time for some questions. Well, thank you so much, Dr. Wallace. That was very informative. I definitely learned quite a few things. So let's jump directly to Q&A. The first question is, actually this is a question by quite a few people, at least 14, if not more. What percentage of the time will you use non-connected combination therapy? I see a lot of patients that are semi-compliant with their CPAP. So if they can do that, and I discussed this upfront with them, we don't know if the oral appliance is going to be effective right off the bat. So I need to have them use their oral appliance with the CPAP until we get a treatment PSG with the oral appliance. So I'll kind of have them use both if they can. And then if we find that the oral appliance is successful, then they can have that discussion with their physician. They could either not use the CPAP or they can use it in combination with the oral appliance. So I do see with successful treatment, yes, they'll stop using the type one combination. And that percentage ranges. We do see some failures with the oral appliance. So then we'll have to discuss the type two conversion to a type two device, yes. Thank you. So the next question is, when and how do you determine when to do the combination therapy? So again, with oral appliance failures, again, you'll test them once you get them into the range that you think is going to be most successful with subjective relief, test them. And if they do fail, and if you're at the end of your oral appliance treatment, then you can discuss that with a, I generally have the patients back into the office and discuss that titration study. And then we'll go into their options and talk about what we can do either type one or type two. If they're previous CPAP failure patients, then we know that we're going to go directly into the type two situation with the oral appliance. So the next question is, how is this billed? Would insurance pay for this? And specifically under the same and similar clause that I believe Medicare has. Yes, great question. Yeah, so that's, I would refer you to that slide with the coding and also the ResMed site is a very good source for this type of information. The part that's generally not covered is the attachment. The physical attachment is a chair side procedure and that's self-paid generally. Okay. And then the next question is, can dentists prescribe etomoxetine and oxybutadiene in patients refractory to treatment with MAD? I have approached, I'm sorry, my slides going in and out. I have approached a number of primary care physicians and sleep specialists. And for a variety of reasons, they're not willing to prescribe it when it would be an obvious benefit to the patients. Please comment on this. Yes, yeah, I don't prescribe that. I'm not aware of that I can prescribe that. I do have physicians that may be amenable to that. You'll just have to speak with your physicians and maybe, you know, it's almost like opening the discussion with sleep physicians about oral appliances. Some may or may not be aware of this study and you'll just have to open their eyes to this and see if they're amenable to do that for you. I personally don't do that. I don't prescribe those medications. Okay, our next question is, does Bongo have to be prescribed by a physician? Yes, yes, it does, it does. Okay, then why is the TAP appliance the preferred appliance for use in combination therapy? It's not necessarily the preferred appliance, although it is the predicate device. And that was the first device that was used for the combination therapy. When you're using that device, it's just a very, very simple setup. There's a little kit that I showed you there and it's a matter of unscrewing something and screwing something into the front portion of that maxillary device. Very simple to use. But again, as you know, when you're practicing sleep medicine like this, dental sleep medicine, you're not gonna be able to put everybody into a midline traction device. So you'll be into these acrylic devices and now these nylon devices. And I personally haven't done any of the nylon devices, although I know labs can do that. But with this technique that Dr. Hogue showed us here, this chair side application with the TAP device attaching to the acrylic devices, you can open a whole nother world of treatment with these other devices. And just an extension to that question, if patient is an active puncher and grinder, that sideway movement, does that disturb that whole contraption? Great question. I have a very, very severe Bruxer who's been in a combination type two, I'm sorry, an acrylic device for years. And I have not had an issue with a midline traction device, maybe. I don't have a patient that's in that device particularly that's a big grinder, but theoretically you could have those issues. And I mentioned a little bit with that setup, Dr. Hogue did kind of strengthen the six anteriors with a little bit of extra acrylic. And he found that that was successful in keeping these things together. So our next question regarding type one combo, is there any consideration with the CPAP nasal mask and the type two MAD appliance such as tap three telescopic lateral dorsal wing? Yeah. So yeah, I mean, that's the big issue with the CPAP is the mask and the mask fits and how to get these comfortable for people. So that is a hurdle. And that's something that the physicians can supply them or their DME providers can go through different masks. There's so many different masks that can be used in combination with our type one therapy. But the type two kit that we see here is just, there's no contact with the face other than a seat into the nostrils and they're very comfortable. So I would have, if there is an issue with the mask, I would have the patient either discuss that with their physician or their DME provider and see if there's something that can be done. I know that they do want to, when they come out into the home and do these visits that they're given a few choices but I think they just have to ask questions. There's many, many types of masks out there. And the last question I have here is, is the bamboo disposable and how long does it last and how do you fit it? Also, who fits it? Yeah, great question. It's prescribed by the physician and I believe, and I've visited the website a fairly long time ago, but there are small, medium and large nasal pieces that you can change. I do have one, I've tried it myself. And one of the issues with using it with oral appliances is that the patients are at least in the study that I read, it's a little uncomfortable and I did find that. So you've really got to, you change those little nasal pieces. They're different sizes, small, medium and large. Get something that comfortably fits. You might have to go through a few nights that kind of test these things. And especially if you're using it with the oral appliance, yes, it can be a little cumbersome, but they do, it's similar to the CPAP, they make a strap that you can actually connect these things and hold it onto the face, almost like a little chin strap to hold these in place. But go through it and see there might be a way that dental sleep medicine providers can prescribe that. But that's a great question that can be answered by visiting their website. Actually two more questions popped up and since we're doing so well with time, I'm gonna go ahead and ask them. The first one is, why does the mat need to be flat plane? Could you do combination therapy using an appliance with occlusal pads? With occlusal tabs? Pads. Oh, sure. Yeah, that's just, you can modify that. The reason why he said it needed to be a flat plane was when he sat that thermoplastic device, that little bite plane, that's flat. So you can theoretically cut that to length and fit it to make sure it's not impinging on any of those pads or even length, they cut it completely off. And you can just go right ahead to those thermoplastic beads and get it to fit that. So there's ways to get around that, yes. Okay, and the next question is, I have prescribed nasal APAP for number of patients, including the Bongo device. Should I not be doing that? I was not aware that it should be prescribed by a physician alone. Well, that may have changed. So if you're prescribing it and you were able to do it, then I would continue to do it. Again, there was a little thing I read that if you subscribe to their website and get through to them, you may be able to be a prescriber for that device, yes.
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