Welcome, everybody. I am Dr. Ari Wolfson, the moderator for this evening's webinar on combination therapy. I am joined with our speaker, Dr. Michael Adame. The AADSM does not endorse any services, products, devices, or appliances. The use, mention, or depiction of any services, products, devices, or appliances during the webinar should not be interpreted as an endorsement, recommendation, or preference by the AADSM. Any opinions expressed or communicated regarding any product, device, or appliance during the webinar is solely the opinion of the individual expressing or communicating that opinion and not that of the AADSM. Whenever possible, presentations should be supported by evidence. In incidents where evidence is lacking, speakers have been asked to verbally disclose that their presentation is case-based or based on clinical experiences so that you can use independent clinical judgment to make decisions for your practice and patients. And now, I'll turn it over to Dr. Adame. Hello, friends. It's an honor to do a webinar for our esteemed academy, and I'm hoping that by the end of my time here with you all today, I will be able to show why and how the terms combination therapy and synergy are equivalent. And I'll attempt to do that by sharing research on this topic while weaving in a little bit of my story in dental sleep medicine. All right, let's get started. So, I have no complex—I mean, just to disclose. And these are perhaps some ambitious objectives that we have for this evening. One is to understand one objective, at least, challenges we face in OSAPAP and OAT, review of literature pertaining to combination therapy, options of combination therapy, a preliminary study of combination therapy that I happen to be involved in. I'm going to review a conservative management workflow that we use in the sleep center that I work at, and case reports. I've got a couple of case reports to share with you all, and then some Q&A. All right, so here we go. So, the first and main objective this evening, if nothing else, is just that I hope to increase conversations between healthcare providers who are engaged in management of OSA, whereby they consider, as indicated, more treatment options for patients to help improve health outcomes. All right, let's get on to our next objective, which is the challenges that we face in OSAPAP and OAT. So, the first thing for OSA—and I understand this audience is highly cognizant of prevalence. However, in light of our topic today, I just think this can really be highlighted even more. And what I did here—and if you can indulge with me—is I combined four different studies with three, and I stratified them into three different stratifications. And so, the first three are essentially the same general population studies that OSA prevalence started with back in 93 for 20 years. And by the way, here female are blue, and male is red. I think we've all seen these studies. And this shows the increases in general population over those first 20 years. Then, in 2014, another study came out that I was interested in, because I was going to give a talk. It was about 2015. And as you all may know, I'm from the border in South Texas. And so, my community is about 80% Latino. So, I wanted to know if there was any studies that particularly highlighted the Latino population. And I did find a real nice study that did a multi—it was a multi-seminar trial of prevalence that was done. And as we can see here, as compared to 2013 general population studies, the Hispanic population prevalence is at least double in female and male. And that was very concerning to me. And my message to my audience back, you know, where I was, is that we need to be very alert when we're screening our patients. Be, you know, highly cognizant of the prevalence within our Latino population. Then, fast forward, the last two columns was a study done fairly recently, where a couple of years ago, they stratified this into age. And so, as we can see here in the general population, between ages 30 to 49, females are at almost 10% male at over 25. Yet, if we jump to 50 to 70 age group, we've got more than doubling of females at over 25, and males over 40. And so, I think we are reminded again that the prevalence in our population in general or not is very high. And this just is going to increase, I think, the need for more options. And I believe all of us are very fully aware of this as well. I think one of the reasons that the prevalence has increased is because of the obesity prevalence worldwide. This particular study focused on contrasting the UK and the USA. The summaries were on the bottom row here. And so, UK is, as you can see, pretty much in step with USA down in the lower right. The solid lines are the adults, male and female, and the broken lines are the children. So, we can see that sadly, their obesity has been increasing, the USA, of course, outpacing everyone. And I think until we control this trend, you know, we may not ever be able to see OSA prevalence decrease. Next challenges we face are the etiology of the disease and the available treatment. So, I think all of us have been now aware of the really intriguing phenotyping studies that are showing up. We're now understanding that OSA is highly heterogenic in its pathophysiology, meaning it has many anatomic and non-anatomic contributions. Phenotyping may improve treatment results. I think just currently, it's not very practical to do in a clinical setting, but I think we are closing that gap. Patients also have varied tolerances to treatments and limitations in treatment with both Pap and oral appliance, and we're going to dig into that a little bit more in just a moment. Therefore, another reason why it's just more beneficial to have multiple treatment options. And I liken it to a puzzle. Every patient comes in with a proposal that hasn't been put together yet, and our job is to help to try to put the pieces of that puzzle together. And I would be remiss if I did not mention this also as a challenge, and it's simply that we lack formal training in the disease and the treatment management of it in both medical school and dental schools. I think until we have more questions on national board exams, will we see, therefore, the core curriculum rise up to the level, but right now, we're still not where we should be. So there is a big gap to close, but I remain hopeful. And I would say before we leave this slide, the other, I think, challenge is that if we're not trained in this formally at the core curriculum level, we are certainly not trained on how to communicate with each other. And I think that as well is a big gap that we need to learn how to close as well. So digging into the Pap challenges that we do face, again, just in the topic that we're talking about tonight, I think good to review this. Aside from the obvious high pressure challenges that we face with Pap, we have patients that don't really appreciate the marks that leaves on their face or their hair, perhaps also rashes that they get on their skin or their hair, which is folliculitis. Pressure ulcers on the bridge of the nose, we see that from them tightening their masks so much. Additional challenges are due to air mask leaks, subconjunctival hemorrhage can happen with drying out of cornea. Aerophagia is certainly a symptom that a lot of patients do complain about as well. Claustrophobia, especially those with a military background as well. If we look at oral appliance challenges, while we are highly compliant, we do have challenges that could maybe limit the amount of protrusion that we can acquire. And that may be from patients who have had joint replacement, patients who have had, you know, who do currently have active TMJ or it becomes chronic. These just can present challenges to proper, you know, the calibration of the appliance. Perio, you know, where are we with the patient? Is it stable? Is it not? Does it need to be treated? We need to be very careful in this area as well. And edentulous patients, you know, it may not be contraindicated, but it could limit to some degree the amount of protrusion that we might be able to acquire with the patient. So these are challenges that we all face and why more options are necessary. And therefore, when we look at the literature on these challenges, I think all of us can agree, we've all seen many, many research, a lot of research published on pap intolerance and well-documented over 50%. We can find plenty of literature to support that. Then, but when we look at oral appliance, well, while tolerance is not necessarily the issue, if we look at its efficacy, I think we find here that we do see some differences. And if we take Dr. Sutherland's work on stratification of success of oral appliance therapy into three common definitions we see in the literature, for instance, if we take the definition of HIV-L05, for all patients that come into our office, mild to severe, we can expect maybe a little over a third of them to be able to achieve this result. If we lower the standard and increase the AHI to those that come, that we can acquire an AHI below 10 and a 50% reduction of AHI, we can see that maybe half the patients that come into our clinic, we can acquire this. If on the other hand, we lower the standard a little further and just say, hey, we just want to reduce AHI by 50%, we can improve our results by almost two-thirds of patients that come in. But in any case, we still have work to do for our patients, regardless of the definition. And so, when I came across this early in my career, you know, this was something that really was disheartening to me, that I was able to achieve the success that I was hoping with all my patients. And it prompted me to meet with sleep physicians. And together with our understanding of each other's shortfalls in our therapies, we embarked on a journey of combining therapies. And I will share more details about the results of a study that we did as a result of us just getting together to try to discuss what options we had. If we're reviewing literature for combination therapy, we find that when we look at multi-patient studies, and you know, that's something that's different, of course, from case reports. We've got plenty of case reports out there, and those are great to have. But when we look at multi-patient studies, we kind of have a limited amount. So, El Sol started things off back in 2011, and then Comiskey followed up with a little different kind of study looking at oral nasal versus nasal PAP with and without an oral device, so combining therapies nonetheless. So, when I was talking to my sleep physicians in the sleep clinic that I worked at about options, we had these two were currently the ones available to review and did allow us to then proceed forward with offering the therapy with some hope. As we were doing so, Degrees and Lou came along and offered some more data. And then we decided that we would offer as well an opportunity to maybe add to the data that was available and provide a study ourselves, which is the last one that's listed here. And I'll go over that detail with you in just a moment. Dr. Preen did add to this list, though his was a review of his patients. It wasn't necessarily a study per se, but it was a review of his patients and literature at the time. And so, it was just a number of patients that he did over 200 that was very impressive, that is nice to include in a multi-patient study, I think, because there's a lot to learn there. So, if we then look at the summary of benefits looking at the four primary, what I would consider studies that were done, clinical studies that were done, we see that lowering AHI, ODI, and PAP pressure is something you could assume would be something we would expect and that's been shown in the literature. But we've also seen improving sleep efficiency, slow-wave sleep, REM sleep, T90 as well. And then some of the quality of life indices like FosQ10 and ESS have been shown to be improved as well, as well as side effects, PAP side effects, such as high pressure. So, these are very promising things for combination therapy. And let's then take a look at what are the options for combination therapy. So, I'll ask you all to indulge with me that I informally refer to combination therapy as a type 1 or type 2 option. And so, in type 1 option is just simply the simultaneous use of an oral appliance with a mask, a medical mask that's available to the general public. They may change them out based on how they feel or like or dislike them, but they're just used simultaneously. Type 2, on the other hand, is with an interface and it's attached to the oral appliance, so more of a customized approach. So, if we look and take a dive into what options are currently on the market for type 2, we see that we have these four here that have been available. The TAPPAP has a CS version, a chairside version, which is a nasal pillow style. There's a CFM version, which is a custom face mask version, which has been available in the past. I've been looking at the option of acquiring one of these just to understand where we are with that. I currently don't understand if that's available anymore, but it has been. So, maybe someone in the audience knows more about this and can share with everyone, but that. So, I did use a few of those over the years, but I'm just not sure if they're available anymore. CPAP Pro has a version of these hoses with pillows on them that come with a prefabricated oral appliance that can be customizable, and then Shirazi has a hybrid version that is the same hoses with pillow attachment on it on an EMA-looking appliance. So, if we go on to this preliminary study that I was involved in, I just wanted to show the cover page that showed up last year in GDSM, but this is really the kind of inclusion criteria and workflow that we used. Essentially, what this was about was just a very, I would say, standard clinical setting that we wanted to show patients who come in with their difficulties in therapies on a daily basis. So, there was really not a lot of attention to pressure per se, and this is what we find to be very common. So, patients who had endured solo therapy, meaning PAP therapy and oral appliance therapy at different times, and then had become both intolerant to PAP therapy and then were sub-therapeutic with oral appliance therapy, meaning they had an AHI above 5, then they were invited to the study as long as they did have an ESS score above 10. And so, that allowed them to be a candidate. They were invited to the study. If they agreed to participate, then they were randomly assigned to type 1 and type 2, and then we followed them for two months. These patients, as usual, come in with different equipment. They have machines from different places. So, our study was going to be more focused on quality of life indices as we weren't able to standardize that equipment. The only thing we did do is standardize what they used during the study. The equipment they did, they all got dispensed on AutoPAP. That was the same company, same style. So, that we had some standardization there, but we were able to then qualify the quality of life indices and side effects that they had experienced from PAP, and were able to publish those. So, if y'all can indulge me for a moment here as I break down the quality of life graphs. So, ESS here on the left, and actually type 2 group is here on the left. So, this is the customized interface group. The pre-baseline, if you will, is a vertical white column followed by the, after two months, those scores are taken again. So, this is post-study. This is the type 1 group here, baseline, and next to it, post-study. And so, you can see that those scores did improve by lowering ESS. As well, FOSCU 10, same thing, type 2 here on the left, vertical column is baseline followed by post-study, and here, baseline on type 1, followed by post-study. So, these turned out to be statistically significant, so a much better increase in quality of life indices. If we look at the side effects that we inquired about, we had 16 side effects that we asked. The ones that were the most populated, I would say most experienced, was the first four, high pressure of the PAP, of the pressure itself, air from the mask leak issues, problems exhaling, and uncomfortable mask pressure. These were the highest scored, and patients needed to have a minimum score to enter the study of this area. Though we measured other side effects, if someone only came in because they had a disturbing noise about their PAP, they were really not invited to the study. We qualified it, but we did not, if that was their only complaint, then they were not invited to the study. They really needed to have an issue with something to do with pressure, air pressure, or mask. On the right here, this is a kind of a summary of like and dislike of solo therapy and combination therapy. So we can see here, uh, dislike, uh, dark areas much greater with PAP, uh, oral appliance here we see that much more like here with a little bit of mixture of dislike and, and in different combination therapy, we can see pretty similar and, and this is, um, disconnected groups. So this is type one and type two here, um, a lot of dislike pre baseline on PAP, uh, much improved with oral appliance and about the same with combination therapy. Some other observations that we had in our study was hours of use. So if we could, uh, quantify, um, the, the, the history of their use, cause some patients really didn't even use it very much, but where we could acquire, um, some history, it probably averaged between three and four hours, oral appliance therapy here at over just over seven hours, combination therapy is right about six hours. And this is in both groups. And if, um, uh, if I could turn your attention here to the right side of the right hand of the slide here on return to PAP therapy. So type one, uh, so those that were disconnected had an, we had an end of 15, 13 out of 15 completed the study at 86%. Type two was, uh, the connected group. So 13 out of 13 did complete the study. So, uh, what this shows is if I could put a gold star on all the observations we made, uh, this was certainly something that we weren't real surprised about because we saw this over and over, but this showed true in our study as well, that returning patients to PAP therapy, uh, is something that many patients were surprised about. The sleep physicians initially were surprised when we started doing this and it became just commonplace. So this is something where we really do expect to happen when we're talking to patients about the possibility of combining therapies is that to give it a try, they might be surprised. One other observation I do want to share with you about the study is AHI type one group is on the top type two is on the bottom here. The average of the two, uh, we can see here type one is blue, type two is orange. So type, um, so they both average little over 30 AHI at baseline in oral appliance titration. So they did not meet the metric of below five. So, um, so here we can see these patients average between 11 and 12 and in combination therapy, somewhere between three and four was the result of that. Then I thought for the purpose of this talk and because of the history of the, um, uh, the knowledge of the benefit of combination therapy, I thought I would, if you can indulge with me here, I'm a little latitude to share data from just my clinic, uh, which is focused on just high pressure patients. I reached back to the last nine patients with pressures of nine or more that were, that were documented at baseline. So in the second column here, you can see CPAP pressures at, at nine or more average 11 in, in this set, their AHI, um, that, that were coordinated with those patients. You can see the average at 41. And so interesting to note that we have some patients here with mild, mild AHIs, um, that are in, um, that are having fairly high pressure. So this is not unusual to see, um, if we then look at, um, then with combination, uh, what happens and we can see the Delta change here, average down to seven. So it's a little over four centimeters, water pressure change. So this is not unusual to see with patients. AHI, we can see post as well down to 2.5 on average, uh, compared to a baseline of 41. This is a very common findings, uh, in, in our, um, in our clinic. And I would say right now, um, probably we have a patient base that is about a third of my patients are in combination therapy. So this is just a really common option that we choose. My personal observations with combination therapy, there are many, but some, some of the highlighted ones I would, I would like to share are that, um, I typically find that once we combine, I'll start to retrieve the mandible in it. I would say at least two to three millimeters on average on every patient. Uh, and the idea here is, you know, since we calibrated the patient forward, uh, during oral appliance only, um, and we didn't, didn't acquire the results we wanted. Now that we've combined, there's no need perhaps to have the mandible protrude out so much. We can maybe decrease side effects from, from oral appliance therapy. So I'll start to retrieve them while keeping an eye on the, the efficacy. And so that's done by monitoring, um, their pap reports and that's done in coordinated coordination with, um, with the clinic. And so we do this in a, in a stepwise fashion until we get a, an optimal position for the patient. In addition, um, observation, decreasing side effects of pap therapy likely improves the matriculation back into pap therapy, as we showed, uh, in that slide with the gold star. Also type two seems to offer better stability as obviously because of, because of the foundation is not on the occipital head anymore, it's, it's, it's in the oral cavity and it's very stable and it reduces likelihood of leaks. Um, discussions on the use of combination therapy with referring physician has really improved the quality of our dialogue. And I have found physicians are very receptive to hear about, um, the idea that their, some of their patients may return to pap therapy and they will be continued to be monitored by them. Um, and as we can expect, uh, combination therapy is likely to improve health outcomes, which I think is why we're all doing this for our patients. I also wanted to share, um, some more work by, by Dr. Sutherland regarding, um, how combination therapy can, can come into play on, on a profile that, that was, um, shared with us in, in, in her study where she defined treatment effectiveness profile between pap and oral appliance therapy. And so we can see here that for CPAP, um, efficacy, um, on a review of, of, of studies that, that she did is, is considered to be about 90% for pap, but compliance is 50%. And so that's kind of a, a vertical, um, um, rectangle there. On the other hand, oral appliance therapy, and I believe her definition, uh, of success was used was the, the second one that we talked about earlier, which is, uh, HI of less than 10 with a 50, 50% reduction of HI. So we have an efficacy of 50%, uh, but compliance up to 90%. Here we have the, the rectangle on a horizontal, um, uh, uh, view there. So side by side, they look like that. If we were then to combine them and overlap them, we could consider that perhaps if we, if we were to use them together, that this, the footprint might, might look like this. Uh, however, if we, um, recall that in, in the study that we did, we had patients that, um, returned, um, to pap therapy, um, between type one and type two, probably over 90%. If we averaged the two, therefore, if we were to consider that matriculation back into pap therapy, we would have an increase in the footprint of, of those that, that, uh, we consider in combination therapy. And so hence, um, this is what I was referring to in my introduction as to how is that going to explain that the terms combination therapy and synergy are equivalent because really instead of a one plus one is two, it's kind of a one plus one is three scenario, uh, when we're using them together. Now I'd like to share a workflow that, um, we developed in, in, uh, in our, uh, in our clinic and it was really born out of the desire, um, for both that both the sleep physicians and I, uh, as we talked about earlier, you know, we were seeing the, um, the shortfalls of our therapy and we wanted to improve outcomes to, to, and we thought about creating a tool that we could use that was easy to follow and it would be able to be changed as needed. You know, physicians are, are used to using workflows and their treatment decisions. So this is a tool that was created as a result of, of, you know, that idea. Um, so, and, and if I, if I may then take a moment to just share a little backdrop as to how I got into this clinic, if you will, so I, you know, I've been, I've been a general dentist for 34 years and 15 years ago is when I got really interested in dental sleep medicine. Um, and I, I would, I reached out to the, to, to the sleep center. It seemed the obvious place to go to, to just start collaborating. And in a real short period of time, within, within a couple of years, they, they, um, they, they thought there was really a nice tool for them to include in their, for their patients. So they invited me to join them in the clinic, um, if as much time as I could. So I decided to spend a day, a week there. So that's what I had been doing for, for the last 10 years. I've been, been working and collaborating together with them. And after a few years, there is when we, we came up with this tool and we've been using it virtually ever since it has been changed, uh, some, but I was going to break it down to, to share with you what, what does this mean? Right. So for, for patients that come into their clinic, um, or to our clinic that were, um, going to be decided to go into pap therapy, uh, patients, and I will explain the colors here. So, so, so black will mean that patient meets criteria and moves forward. Uh, red means they don't meet criteria and they go back for reevaluation and a green are particularly patients who were in a split night. Let's say that would be the, the, the, the best example to explain where during split night, they ended up in either bi-pap or a high pap pressure. And they either, uh, the patient couldn't tolerate the pressure or the residual AHI was just very high. So that just embarked on, on another, um, another option for them, which was to use combination therapy immediately instead of waiting for solo therapy. But, um, so going into criteria for pap therapy. So patients that have an AHI RDI above 30, or if they have an AHI RDI below 30 and they have significant comorbidities and symptoms. So this obviously can be, um, interpreted very broadly by, by the physician. So they're, they're all, um, you know, independent and, and they will make a decision based on how they perceive the comorbidity and the symptom. Uh, so, so this, this could vary, or if their REM AHI is above 30, that's, that would also be an indication, or if their TD8 was more than five minutes, which, um, I believe Medicare will, uh, approve oxygen, uh, supplementation with, with this criteria. So that's what they use as well to determine pap therapy, or if the patient physician just prefer pap, um, that's, uh, that's, uh, an indication as well. Definition of success for pap therapy using the clinic with 70 hours of use per night for 70% of the nights for the week, uh, with an AHI below five. For oral appliance therapy, um, is you can imagine kind of the opposite where we have AHI RDI below 30 and no significant comorbidities or symptoms. So they're, again, uh, up to the discretion of the physician, um, with a TD8 below five minutes. So, um, uh, we see that's also possible if the RDI is above 30 with an AHI below five and a TD8 of zero minutes. So these are patients like UARS type patients, uh, and, and that would meet this criteria. Or if the patient or physician really perceive an intolerance to pap therapy right off the bat, then they will consider oral appliance therapy. Definition of success of oral appliance therapy, excuse me, is, um, the AACSM definition of 80% of the hours per night for five nights of the week with a therapeutic AHI of less than five. We can see here that green arrow comes over to oral appliance therapy from the pap therapy side because these are the ones with really high pap or bi-pap pressure and a residual AHI. So their, their idea is let's just get oral appliance started, let's get it calibrated, and then we're going to combine, uh, both of them together. We can see then, uh, those that were solo therapy, uh, failures, then will be offered to combine or with that, uh, high pressure scenario. Then once the option for combination therapy, uh, is given, then the patients can be choose type one or type two. Normally patients that, um, had, uh, pap therapy maybe in the past without a pro, a problem with their, their mask, they may be invited to type one. Um, if on the other hand, there was issues with the mask, uh, then type two, um, could, could be offered. Um, and, and if they, if they're successful, then a long-term care, uh, happens, if not, then perhaps a reevaluation for another option, for instance, surgery, you know, could be considered. So this is now the, the wheel, uh, equal workflow and in total again. All right. So, um, let's move on into case reports now. So the first case report is, um, a type one case report, a 51 year old Hispanic female of the BMI of 62, uh, her PMH of high blood pressure, restrictive lung disease, morbid obesity. She was referred to the sleep center to rule out OSA for pre-bariatric surgery clearance. This is probably October of that year, and she'd already been cleared and, uh, by her insurance to have surgery before the year's end. So we're within, you know, three months or less of the end of the year. And so there was a sense of urgency to, to get this done. She ended up having severe OSA, but, um, during, during that, uh, study, she, they were unable to find, uh, pressure or mask comfortable for the patient. Uh, so this is, this is, um, some, some of the documents here that we'll see. And I, I just want to show them just for point of reference, but what I do is I'll highlight the, the major metrics that are being looked at for decision-making. And so that's what we'll, we'll be focusing on here. So her AHI was 31, T90, 48.4, nadir 78. Uh, and they couldn't find, uh, any pressure or mask comfortable. So they refer her to me for oral appliance therapy. Um, so here's the patient with a 10 millimeter, uh, overjet, very retreated mandible. We can see, uh, enter open bites and spacing, very common in our patients. Um, and, and what I, what I did, and if I can back up one, but I did do, because of the sense of urgency, I did offer the patient a transitional appliance that, um, I thought would benefit, uh, her to get used to oral appliance and see if she could get used to this and then start to, um, protrude the mandible, um, while we're waiting for the custom appliance to come in, in hopes that we can get to a position that she's comfortable with, uh, by the time it, it arrives and we'll match that position or make sure it matches, uh, at that time. And I, I, I took a bite registration of about 50%. She was comfortable with that. So I started her at zero, uh, protrusion and we, we started to wind her forward, uh, to, uh, to 50% protrusion. So by the time oral appliance, uh, was, was, uh, received, we set her there and she seemed to be comfortable enough here that we went ahead and did a verification and it turned out that with an AHI of 83 and a deer of 80 and T90 of six, I talked to the C physicians. They said, let's, let's try to combine her now. And so we did a type one with a P10 mask and she was very compliant. This is her month of, of November, uh, of compliance. We can see her use was over four hours is a hundred percent, 11.4 centimeters average of pressure with an AHI of 0.3, uh, did an oximetry on her. So her ODI was 69, the deer 89, T90 was 0.1, um, and then, so she went and had surgery, uh, in, in early December, early mid December. And this is now December into January. Once she got home, started using combination again, we can see her compliance, uh, remains still high over four hours of a hundred percent with a little bit of drop in pressure of 10, eight and an AHI of 0.2. So in summary, uh, we can see at her baseline AHI of 31, no pressure available here, but in deer 78 and T90 48, um, oral appliance down to eight and the deer 80, T90 was six combination down to 0.3, 11.4 pressure with it in the deer of 90 and T90 0.1. She had surgery and then afterwards, um, 0.2, 10, eight and 91. And she's, she's continuing on combination. We're hoping that maybe with enough weight loss, we can go into solo therapy for her, uh, maybe oral appliance therapy. So we're still at that, at that stage with her, um, next case, case type two is a type two case with a 41 year old male, BMI 44. So more of a morbid obesity, severe OSA at AHI 67 and the deer 77, seasonal allergies. He ended up with folliculitis on the scalp due to, um, strap issues, uh, meds that he was on, loratadine, singular and flonase. So again, here's the documents from the sleep study, but, um, the diagnostic phase I highlighted here, the deer of 77, T90, 60, AHI of 67. During pep titration and the deer rose up to 84, uh, T90 of 16 and AHI of 13. And although, um, that at first glance does look like it's high, as you may know, when you do look at the broad data and some of the smaller time increments during titration phase, um, you can see many times that during the end of titration, the, the, uh, the pressure as it goes up, the AHI really goes down. But when you average the entire, uh, time, it does average higher. So yet it actually had a decent average, um, of AHI in the, in the final stages, but they, they decided on a CPAP of a pressure of 12. Um, then in three months, it was his follow-up and what's highlighted here in yellow, I basically summarized here that the patient discontinued use of PAP two months prior due to folliculitis. And so he, uh, had visited with a dermatologist. They put him on creams, they used barriers, nothing was working. So he basically discontinued therapy. Uh, here during assessment, uh, it was decided to refer to me due to intolerance of skin condition. Um, it, it does include here the sleep position that he may require. Uh, this should be hybrid therapy, uh, with nasal pillow supported by an oral appliance. So they already anticipated based on how severe he was, they might need to, um, to have a combination therapy. This is a folliculitis, what that looked like. This is the patient pre-op. Anterior open bite, again as typical. We did do a verification with oral appliance and got his AHI to 16, the deer 76, T90 of 30. And so we combined him using customized mask so we wouldn't have anything in his hair to touch. And so he was he really did not complain of pap pressure when he was using the pap. So I had I was not incentivized to really advance his mandible. So he has no advancement on his mandible at all. We can see his compliance report is really good at 100% with 12.9 centimeters of water. His leaks are 9.8. We like them to be less than 20. AHI 0.7. And his oximetry showed ODF 7, nadir 81, T90 0.7. So in summary, we see his baseline AHI of 67, nadir 77, T90 of 60. Pap only, he was down to 13, then nadir 84, T90 of 60. But he just couldn't use solotherapy with that mask. So oral appliance, then we see AHI of 16, nadir 76, T90 of 30. And in combination, we're able to get that AHI nice down to 0.7, nadir 81, T90 0.7. And that's where he remains today with no advancement in the mandible. So in conclusion, I would like to share a quote from Helen Keller, which speaks to the benefit of teamwork. Alone we can do so little, but together we can do so much. And as I mentioned at the start, my hope is that after this talk, that we have more conversations about options for therapy, which could possibly result in healthier outcomes for our patients. I have some contact information here, email and cell. Y'all feel free to reach out to me anytime. I believe in your packet, I have offered also a sample letter that I use when combination therapy might be recommended, that I, after verification of an oral appliance, this is what I would send to the physician. And I also have available a prescription that specifies combination therapy. If you prefer to have something like that as well, feel free to email or call me on that request. I'll be happy to supply that for you. It's been a pleasure. Again, thank you very much for hopefully for your attention tonight. Thank you. Thank you, Dr. Adame. That was great. If any audience members have any questions for our speaker, please submit your questions using the question and answer button at the bottom of the screen. I'll be asking the questions from top down, so please make sure to use the upvote feature to move your favorite questions to the top of the list. Also, in some instances, your questions may be answered by a moderator in writing, in which case you'll see a notice under your question with the phrase, tap to see moderator's answer. Let's get started. A question here is, can you explain the process of starting combination therapy if a patient is using CPAP? Do you take them off CPAP to calibrate the oral appliance first to get the appropriate setting, then send them to obtain the correct pressure with CPAP? With the oral appliance, is it better for the patient to just be on APAP so the pressure automatically adjusts? Yeah, that's a great question. And that is case by case. I would say some of the time, the patients who are very intolerant to PAP, we'll just have them set it aside. We'll go ahead and calibrate the oral appliance to a maximum forward position, per se, and then have them wear it. Because if the pressure's too high, it may take a while to open up the airway enough to drop the pressure. And as mentioned, yeah, we prefer patients to be on autopap. If there's an issue with insurance about that, we have the patient continue with CPAP, but we'll reset it at a lower setting. And that's guided by the physicians. They'll decide where that should be. And then we can climb up on the pressure as we go forward. So there's a lot of collaboration that has to happen with what technique to follow. Many times, though, I will have them use the combination from the beginning and then calibrate forward from there. So it depends on if we have a residual AHI, or is it just about the pressure that was a little bit high? So every case has to be thought through on what makes common sense for that patient. Thank you. I have another question here for you. Would you suggest adding OAT type one to existing CPAP and evaluate how they do? What is your criteria to determine whether to select type one versus type two treatment? Yeah, I'm not sure I understand the first part of the question. But I would say, selfishly, from a dentist point of view, I would love everyone to start oral appliance therapy, period, if they have OSA, and then add CPAP if necessary, and then titrate from there, right? Maybe one of these days, we'll be in that happy place. And the second part of the question was between type one, type two. Is that right? Yeah, so like the folliculitis case was easy, right? They had an issue with the allergy to the strap. So we went right into type two. I prefer to start type one, if at all possible. It's typically the least expensive way. And if we need to go to type two, then we'll matriculate that way. Sometimes it's obvious from the start, but I prefer patients to just try to find a master comfortable with, let's just combine therapy, and let's see how far we can get with it. If we need to go type two, we have that available. Great. And then I have a just a comment in here. Somebody was discussing your first case back to the open bite, the anterior open bite. And they said they noticed that the tongue protrudes due to high CPAP pressure. Is that something that you see as another side effect of PAP therapy? That the tongue protrudes because of the air pressure? Yeah, so, well, in that type, that first case, she had had not been on PAP therapy yet. But I would submit that, yes, the reason why there's an open bite is because the tongue is protruding instinctively. That would be, I think, a, you know, and, you know, perhaps, you know, something that would be considered, you know, clinically feasible to see. Patients who are suffering from OSA typically reposition their tongue forward while they're sleeping, perhaps to open their airway, and that can result in an open bite. So that way, why we see a lot of patients with open bites, right, it's probably just the instinct that the patient has while they're sleeping to push their tongue forward, open the airway, and as a result, we see a dental side effect. Great. And then another question here. If a patient is unsuccessful on OAT and was advanced to five millimeters, how much do you suggest should the patient be retreated before being sent for a titration study? Can you repeat that one more time? Yeah, so it says, if a patient was unsuccessful on OAT and was advanced to five millimeters, how much do you suggest should the patient be protruded before being sent for a titration study? I'm missing it. Yeah, so because normally, you know, the idea here is, right, you protrude the mandible, verify that. If they're not successful, there, combine them, then start retreating. Retreating the mandible, you know, can happen. Once pap therapy is successful and they're compliant, then you can start retreating the mandible, and that can be done in various ways. That can be depending on the equipment that they have. If they have an autopap, you can start dialing the patient back, you know, one millimeter per week to every two weeks, let's say, and those reports need to be redone, which can be done various ways. It just so happened that since I had access in my facility, I could call them up instantaneously anytime the patient came. If you have to work through the physician first, that can be a little more daunting, but the idea here is everyone's working together to try to get the least pressure with the least protrusion of the mandible, and sometimes it just takes time to sort through all of that. Usually, if you develop a good relationship with who's in charge of the pap therapy at a sleep clinic, they will be easy to work with, you know, instead of the physician. The physician usually gives them the leeway to work with pressures like this, and so you can communicate as you're decreasing the mandible protrusion on what does the therapy look like, what do the results look like, and so it's usually about combining first at that protruded position you have already acquired, and then dialing back slowly once they're already in combination therapy. Awesome. Next question is, how do you charge for a custom mask or a type 2 mask? Yeah, so, you know, just like anything else, you know, there's a fee you pay to get it, and then you decide, you know, how you want to charge from there. There's various ways to do it. I'll be happy to discuss that with you kind of one-on-one. It's probably not the right forum here to do that, so please reach out to me personally, and I can walk you through that. Great. Are there any recommended labs that you can fabricate appliances to existing CPAP, like with mask tubes? Do you know any labs to get training to do a combo type 2 appliance or mask? So, yeah, so they, so I would say the main way to do that now is the way the TAP system comes. So it already has the ability to remove the front plate and add the post by getting a kit. Just something pretty easily done by the dentist or the dentist staff, and so that would be the way to do it. You just do it yourself. You do it yourself in your practice. You could have a lab put it together, I suppose. I've never really done that, but it's best, I think once you see it, you see the kit, it's just pretty straightforward on how to put it together. So that's the only thing is you have an oral appliance that's already pre-made for that. Great. And then for patients stopping PAP therapy while starting antitreating OAT, are there issues with insurance stopping payment for PAP therapy due to compliance reports showing they're not being used? Yeah, no, that's a good question. So you do the best you can there. If there is a clause in their insurance about that, you'll have to ask them to try and continue using the best they can, and so that's why you want to kind of work through your calibration as quickly as you can. We have found that not to be a big problem. I think there's also letters that can be sent by the physician to the insurance that a patient is enduring therapy right now, because this happens to them a lot, right, at the beginning. They're trying to desensitize a patient to the mask issue, and so their data doesn't look good. And so they're used to having to communicate with the insurance that we just need some more time, and I know it takes an effort, but if everybody's willing, it can be done. Great. In cases where you're starting with oral appliance therapy but believe there's a possibility of needing combination therapy, do you choose an oral appliance to facilitate that, or do you find no difference in modifying different oral appliances, appliance types for combination therapy? Yeah, if I strongly feel that this patient is going to be combination therapy, I'll already choose an appliance that I think is ready to go. You know, that being said, you know, there's also a way to, I would say, find out, you know, how we could adopt an appliance to combination therapy that you currently are using. That's something I can discuss with somebody one-on-one as well, but the ready-made appliance is certainly the easiest way to go about it if you already anticipate that. Sometimes, though, you get caught, let's just say you're using a nylon appliance that wasn't ready to go yet. That could be difficult. That could be difficult. You might have to change an appliance to do combination. Do you have any suggestions to prevent bite changes long term? Any suggestions to prevent bite changes? Yeah, yeah, that's just kind of a general question about side effects of oral appliance therapy. I know that in the morning aligners, we have hope that they will. Some studies have been shown that that's necessarily the case, though I think it certainly can't hurt. So, you know, high compliance with morning aligners, physical therapy as well, as well, and just trying to avoid the extreme protruded movement of the mandible at all if you can. I have become very conservative in my patrician movements. I don't like to move them very much. I like to, you know, use combination therapy very, very quickly if the mandible is getting too far. So I'll recommend combination. Great. Have you encountered challenges with patients with frequent or severe sleep bruxism combination therapy? Yeah, you know, that can pose a challenge, of course. They're all going to be, you know, case by case. But I would submit that if you can get them into good therapy that tends to improve their bruxism, that's just a personal observation. Though some patients are just built to bruxism. And so, you know, you just have to be, you know, I would say, open with the patient about your observation that they have a very, very severe perifunctional habit that may introduce challenges to anything, oral appliance by itself, combination, and you're going to do the best you can. So usually it works out okay, but there are times that it can be a challenge, but at least you tried. If insurance has already paid for a CPAP, would they cover OAT and combination therapy? Yeah, I have found that many of them do, and that may be something that you just need to get preauthorization for. So that can be a challenge, and it may turn into an out-of-pocket, paper surface type expense, but that needs to be investigated with every insurance. Sure. This may or may not be the next question, applicable or askable, but which manufacturers do you order type twos from? Is there a supplier list that you have? Yeah, Airway Management is the main supplier for type two. So that's the TAPPAP system. They're currently the ones that are kind of made for this. So they're the go to at this point, though I did list the other CPAP Pro. I just have not tried them. I've seen them. I've looked at them. I just haven't used them yet. So those are the two main systems out there. Great. Next question is, do you think that the bite changers are more from a joint change rather than tooth change? Yeah. You know, there's probably others that are more able to answer questions like this. I think it's more teeth, inclinations, proclination, things like that. But that's something that probably someone else could also answer maybe better than me. And this is the last question I have currently in our queue. What percent of insurance companies do you see providing the benefit for both CPAP and or appliance components of combination therapy? I honestly haven't had really any rejection of that. I just don't think it's something you can assume will happen. There's always, you know, the possibility that an insurance company could come back. I just haven't had it happen to me yet. But I think it's always worth checking, get your authorization. So right now it seems favorable. I'm hoping one day, like I said, it will be very routine, you know, way of going about things for the betterment of the patient health outcome, which should reduce medical costs, I think. Do we have any other questions currently? I'll leave it open for another minute before we conclude. Are you in network with insurances? Yes. Okay. What is your experience with that, being in the networks? So we're just getting started. So ask me in about a year. This is something that has been, you know, I've been hoping and waiting for, for, you know, 15 years. So it's just started to happen. But I'm finally now in network. So I just, I can't tell you, give you any, you know, real good feedback yet. But at least I am in network. I think it's going to be better. Awesome. Great. So that is all the time we have for this evening. Thank you so much, Dr. Adami for your participation and great lecture. We appreciate your generosity tonight with your time and knowledge. And thank you for to all of the attendees for joining us.

combination therapy

sleep apnea

oral appliance therapy

positive airway pressure therapy

challenges

benefits

research

collaboration

individualized treatment