evening's presentation on Determining the Therapeutic Position of an Oral Appliance. Dr. Ruth Sheets will be leading this evening's webinar. She served as the chair of the AADSM task force and evaluated a variety of methods for identifying the therapeutic position of an oral appliance. Joining Dr. Sheets are two additional task force members, Dr. Greg Essek and Dr. Imran Patel. And now I'll turn it over to Dr. Sheets. Thank you, Dr. Feigenbaum. And thank you all for joining. Let me pull up the slides for you. This will just take me a couple of seconds here. Okay. So it is my pleasure to share with you the work of the task force on determining the therapeutic position of an oral appliance. I have no conflicts of interest to disclose, nor do any of the other members of the task force. Our objectives tonight are such that upon completion of the webinar, participants will be able to explain the process that the task force used to develop recommendations, to discuss the methods that clinicians may find useful in identifying the therapeutic position of an oral appliance, and to describe potential pathways to arrive at an oral appliance therapeutic position. Our target audience is primarily the largest subset of dental sleep medicine providers, specifically a qualified dentist. And the task force assumed a fundamental knowledge in dental sleep medicine, but also believes that the methods will be useful for all levels of practice. So just to give you a sense of the process and how much effort went into developing guidelines, let me just briefly summarize the timeline of our work. So this project began in August 2018, over two years ago, at which time the American Academy of Dental Sleep Medicine Board of Directors charged a task force to review studies and develop recommendations to assist in the identification of the therapeutic position of an oral appliance. Throughout that fall and into winter of 2019, task force members were identified. We had a list of several candidates, and they had to be vetted for conflicts of interest and availability and time to commit to the project. In the spring and fall, spring, summer, and fall of 2019, the task force then read and evaluated the literature, that is, the scientific studies that were uncovered in our literature search. In February 2020, just before the pandemic hit, we managed to get together in a face-to-face meeting to discuss the evidence and develop the guidelines. So the task force met over a three-day period where we discussed the evidence, which I will go into a little bit more detail momentarily, and developed guidelines at that meeting. Subsequent to that, the task force then drafted the guidelines and the manuscript, which was eventually published, submitted it to the AADSM Board of Directors for review and final approval. They sent it back to the task force for some minor revisions. No changes were made in the guidelines, but there were some requests made for verbiage changes and to make it a little bit more readable and accessible to a broader audience. So in the summer of 2020, the task force accomplished that. And finally, in the fall of 2020, in the October issue of the Journal of Dental Sleep Medicine, the guidelines were published. And those are the guidelines that I'm going to be discussing tonight. So let me review for you who the task force members were. I was the chair. Greg Essek, who will be on the panel tonight at the conclusion of our discussion, is from the University of North Carolina. Sherry Katz is in private practice in Atlanta, Georgia. She was also former president of the AADSM and has been very involved in leadership activities of the AADSM, as has Dr. Essek. Dr. Chun Kim is from Rancho Mirage, California, in private practice, limits his practice to the treatment of patients with TMD, oral facial pain, and sleep disorders. Dr. Mitch Levine, formerly in private practice as a board-certified orthodontist in Jacksonville, Florida, now faculty at the University of Tennessee in Memphis. Dr. Jarrett Gros-De-Deir, who is in Leawood, Kansas, in general practice. And Dr. Imran Patel, who is a hospital-based practitioner with a specialty training in oral and facial pain. So I am greatly indebted to these task force members for the time that they spent in this involved project, and without them, this could not have come to fruition. So let's start by defining what we mean by the oral appliance therapeutic position. It is a position of the mandible that achieves improvement of signed symptoms or objective indices of sleep-related breathing disorders. The determination of improvement is agreed upon by the patient, dentist, and medical provider using clinical experience and, when available, evidence-based approaches. At this position, the appliance can be used comfortably on a nightly basis. I also want to spend a slide here talking about terminology. We have chosen to use the phrase identification of therapeutic position, partly because over the years, the academy has used both the terms titration and calibration to refer to the same concept of finding the most appropriate position of the oral appliance to be efficacious. So to avoid that confusion, we've adopted this phraseology identification of therapeutic position. However, that is a mouthful, and on occasion, you will probably hear me use titration or titrate just to keep it a little bit simpler. I also want to point out that it was not within the scope of charge to the task force to try to identify or predict in advance treatment responders. So we're not going to be providing any guidelines in how to identify a responder before appliance therapy is initiated. We're simply going to talk about different methods that can be used once an appliance is delivered to try to identify the therapeutic position. Let's describe the process so that you can understand the hard work that went into developing these guidelines. It starts with a literature search, which was accomplished by the ADSM staff, to identify studies that describe methods used to identify the therapeutic position of an oral appliance. We also solicited member input to augment our list of methods that we derived from the literature search, and that occurred both at the last face-to-face annual meeting that we had in 2019 in the annual meeting discussion section. Some of you may have been there. And we also solicited ABDSM diplomats for additional methods that they may use to augment any list that we had already created. So a list of methods was created of the different strategies that could be used to identify a therapeutic position, and while this work was going on, simultaneously task force members were being trained in evaluating and scoring the scientific rigor of the articles that we identified. There were 154 peer-reviewed articles that were evaluated by the task force. They were identified through both PubMed and Google Scholar, and then additional articles were subsequently found through hand searching or some late updating of the literature search. This is a very rigorous process. I won't go into the detail of how that is accomplished, but it is thorough in terms of identifying articles that are well-designed studies. These articles describe studies in which participants were treated with adjustable oral appliances, some enabling vertical as well as horizontal adjustments. This is one of two citations that I'm including in the slides. I've left citations out for all the other comments that I'm going to make, but they are all present in the paper that I will show you momentarily. The task force used a modified RAND consensus process, and here is your citation if you wish to know the details of that process, and they used that process to determine the effectiveness of each method that we studied to identify its value in identifying the therapeutic position. This is also the process that the academy uses for developing other guidelines that you may have already seen. Each decision regarding the effectiveness of a method is based on the strength of research evidence, that is the literature or the studies, to support that method, and per the RAND consensus process, cost of treating or using that method was not taken into consideration in order to avoid bias. So each method was reviewed separately for its effectiveness and discussed separately in our face-to-face meeting in February of 2020. Each method was categorized by the strength of evidence that either supported it, was uncertain, or there was insufficient evidence to support the method that we evaluated. And at the conclusion of the review of all that evidence in each of those methods at our face-to-face meeting, the task force then put together a set of recommendations of what were considered the effective methods and forwarded it to the American Academy Board of Dental Sleep Medicine Board of Directors for final approval. This is the paper that came out in October of 2020, the Journal of Dental Sleep Medicine. So if you have access to this journal article, and if you wish all the details and prefer to see in writing what we're going to discuss tonight, you can go to this article. And the format of the article is that it discusses each of the methods, so each method is listed. It will describe the specific protocol for the use of each method, and it proposes a potential combination of methods to arrive at a therapeutic position. And this is what I am going to go into in detail tonight, is I'm actually going to go through each of these methods as time permits, review the protocol, and then show you at the end some potential pathways that you might use in employing these methods. So the structure of the guidelines for each method is that in this paper, the method is named and described, the goal of that specific method is specified, there is a stepwise protocol detailed for implementation of each specific method, the endpoint is defined for when you stop oral appliance adjustment or titration by that specific method, and finally, every method will end with the recommendation that the patient be referred to the sleep provider for evaluation of OA efficacy by the method or pathway that you, by the method that you would have used. So here are the supported methods based on the literature. We're going to talk about the initial mandibular position, evaluation of subjective symptoms, pulse oximetry, home sleep apnea tests, and polysomnograms. So let me start with initial mandibular position, which we defined, not surprisingly, as the starting position of the mandible when the oral appliance is delivered. So we considered that as the first step in identification of a therapeutic position. It is recorded as either a millimeter protrusion or percent maximum protrusive range. Studies were inconsistent, however, regarding the posterior reference point. Some stated that they used maximum intercuspation or habitual occlusion, others stated that they used maximum protrusion, and many didn't indicate which position, if any position, which position was used for that particular study. So the literature was not clear on the posterior reference point, and the task force is making a recommendation that henceforth any future studies on titration methodologies should standardize the posterior reference point to the most protruded position. That will make it much easier to compare future studies and future methodologies if we're starting from the same point. I want to spend a second talking about theranostic sleep data, which also has to do with identification of the initial mandibular position. Theranostic is a combination of the terms therapy and diagnostic, and it is used in many fields of medicine. In dental sleep medicine, it refers to the use of motorized systems in a sleep lab or in home to identify the most therapeutic position of the mandible while the patient is asleep. So there is some methodology out there regarding those motorized systems. So the protocol of the initial mandibular position, the goal is to determine the mandibular position at which the oral appliance will be delivered at the initiation of treatment. The initial mandibular position is captured by an interoclusal record that defines the construction bite, and you want to be sure that your instruction bite includes adequate vertical clearance to accommodate the curve of speed to permit device advancement. Based on the literature, the initial mandibular position ranges anywhere from 25 to 75 percent. 50 percent protrusion was the most frequently recommended to balance efficacy against side effects, and theranostic sleep data may be useful to expedite identification of the optimal position for the construction bite. Be aware, however, that theranostic sleep data may, the position derived from that, may not be initially tolerable for the patient and serves as a target position to achieve. Therefore, you may need to start with the mandible less advanced and incrementally advanced to the target position based on the findings of your theranostic sleep data. Also, be aware that some studies reported efficacy at lower or even at no advancement, meaning that no further subsequent advancement was indicated. So I know this is a little bit frustrating in trying to identify where you should start, but you need to recognize that one size does not fit all. Patients are different, and as you gain clinical experience, I think you will get more comfortable in determining where you, what might be an appropriate initial starting position for your individual patients. Let's talk about now the evaluation of subjective symptoms. The most common subjective symptoms are snoring, witness apneas, and daytime symptoms, daytime sleepiness, but there are many more, and you can read the paper to look at, to find other ones. It's important to use, when possible, standardized assessments or questionnaires of the symptoms that you're evaluating, and that allows comparison between time points. The goal of the evaluation of subjective symptoms used as a method to determine a therapeutic position is to eliminate or reduce symptoms consistent with sleep-related breathing disorders. It's important to obtain recent baseline information prior to the delivery of oral appliance. In other words, you don't want to depend on information you may have obtained at the consultation appointment, which may have occurred many months before. So it is important to get some recent baseline information just prior to delivering the oral appliance, and then you want to deliver the appliance and allow a one to four week acclimatization period. If after that period, signs and symptoms persist, and patient comfort permits, you can begin initiating advancement of the oral appliance in anywhere from a quarter to one millimeter increments. Now again, those increments are based on the literature and also will be determined by the design of your appliance. Some of them may not allow you to advance in increments as small as a quarter millimeter. Within 30 days and at regular intervals as needed, we recommend that you repeat the formal assessment of the signs and symptoms using the same questionnaires that you used at the initiation of treatment. The end point of this method is you will continue your incremental advancement until either signs and symptoms resolve or patient tolerance limits further adjustments. At that point, the final step then becomes to refer to the sleep provider for assessment of efficacy, or you may choose to continue with another method to refine identification of the therapeutic position. Pulse oximetry also includes high resolution pulse oximetry, and the oral appliance is adjusted until the oxygen desaturation index is reduced to a target level or further advancement is not tolerated by the patient. Target levels are determined in collaboration with the sleep provider, and what we're referring to is the percent of time that the oxygen desaturation level falls below 90 percent. Now recognize that oxygen desaturation index may be three or four percent, and sometimes that may be dictated by your reimbursement policies. Home sleep apnea tests is an unattended sleep study that measures a limited number of sleep parameters at a minimum oxygen oxyhemoglobin saturation, pulse, airflow, and effort. In the absence of an EEG, because home sleep apnea tests do not have those leads, it calculates respiratory event index rather than AHI, so your reports more likely are going to report an REI rather than AHI. It is often used in combination with resolution of signs and symptoms. There are limitations to the use of home sleep apnea tests, and they include diminished accuracy in patients with comorbidities, and they're not recommended in cases of suspected or diagnosed central sleep apnea, periodic limb movement disorder, insomnia, and narcolepsy. So here is the protocol when pulse oximetry and for the pulse oximeter and when HSAT is administered by the qualified dentist. Now be aware that not all states permit the use of HSAT. So this protocol is for dentists who are permitted to use HSATs in their states. So the goal is to achieve a reduction in or normalization of pulse oximeter or HSAT parameters and resolution of sleep-related breathing disorder after the signs and symptoms have been addressed. Prior to delivery of the oral appliance, again, we recommend that you obtain recent baseline parameter values using the same device that will be used during the interim adjustments. So again, we recommend that you first achieve the resolution of the signs and symptoms before you proceed with the pulse ox or the HSAT. And you want to use one of these devices to assess normalization or improvement of the respiratory parameters after you've improved your signs and symptoms. If your parameters have not reached target values, then continue oral appliance advancement. And your end point of advancement will be either when your target parameter values have been achieved or can no longer be improved, or patient comfort limits further advancement. And the final step, as in all of these steps, is to refer to the sleep provider for assessment of oral appliance efficacy. Polysomnograms were also deemed an effective method for identification of the therapeutic position. And it is used to clarify a further advancement is indicated despite resolution of the symptoms. And in some instances, the physician may also use the polysomnogram that was used for titration to evaluate treatment efficacy. Our protocol now differs slightly because polysomnograms, and in some states, HSATs can only be ordered by a physician. So the protocol is as follows. The goal is to achieve a reduction in, or normalization of HSAT parameters, or in-laboratory PSG parameters, and resolution of sleep-related breathing disorders after signs and symptoms, and any home testing that the dental office may have provided. The tests are ordered by the MD and typically attended by a sleep technologist. The dentist must provide written instructions to the sleep technologist on how to advance the appliance, the size of the incremental advancement, frequency of advancement, maximum number of advancements. Also need to provide the necessary accessories for the technologist to advance the appliance. The sleep technologist will record the time and the amount of advancement during the sleep study and include in the report. At the conclusion of the study, it is requested that the sleep technologist reset the oral appliance to the starting position at which the patient arrived with the appliance. The physician will review the report to identify the most appropriate oral appliance setting and communicate that information to the dental provider. Now I want to move into an uncertain method that was discussed and reviewed by the task force. And this is nasopharyngoscopy, which uses a scope to examine the airway in either awake patients under topical anesthesia or drug-induced sleep. Most studies aimed at identifying treatment responders rather than discussing how this technique could be effective for titration. And it is unknown in sleep endoscopy if anatomic changes in the airway with a simulated bite registration translates to OAT efficacy. So the task force was actually, could not arrive at a consensus about whether or not this should be a supported method. And in the instance where a consensus cannot be obtained, the method or the strategy is then categorized as an uncertain method. So at this time, we did not make any recommendations regarding the use of this method for titrating an appliance. And furthermore, this method is unlikely to be feasible or easily available to dental sleep medicine practitioners, but the task force has allowed that perhaps in the future and with more information, this may be a reasonable method for titration. We looked at several methods in which there was insufficient evidence to support identifying them as an effective means at this time. Maximum comfortable protrusion, I'm going to spend a little bit more time on. And we're talking about when we use maximal comfortable protrusion exclusively to determine the therapeutic position. And there do seem to be some practitioners out there that use this technique. So I'm going to spend a little bit more time talking about that momentarily. We looked at imaging techniques and we also looked at what was available on consumer sleep technologies. So maximum comfortable protrusion, when used as an exclusive means for identifying the therapeutic position, when it's used without consideration of symptom improvement at a lesser advancement. So this means that some practitioners may advance the mandible out to the most advanced position that the patient can comfortably tolerate without recognizing that potentially less advanced positions may be effective. Some patients, some studies suggest that patients respond to nominal advancement. And in some cases, less advancement is more efficacious than greater advancement. And the concern is that maximum comfortable protrusion may cause unnecessary dental adverse effects when the mandible did not need to be advanced that far. The task force does refer to the maximum comfortable protrusion, however, when we are talking about the upper limit of advancement for positioning based on other methods. So when we talk about the method is limited by the comfort of the patient being the maximum comfortable protrusion, that would be the limit at which you may have to stop some other methods because the patient can't tolerate further advancement. But as a sole method by itself, we did not recommend that method. Imaging techniques whose studies we looked at included lateral cephalometry. There were no studies on the use to identify oral appliance therapeutic position. It was more in look, these studies referred to trying to identify responders or predict responders. Pharyngometry, there are a number of studies out there on how pharyngometry could be used for screening and diagnosis, but none were found that could show how pharyngometry could be used to identify the effectiveness of, identify how effective it was in identification of an oral appliance therapeutic position. Consumer sleep technologies, they are evolving and promising, but at present studies were lacking on use of consumer sleep technologies to expedite determination of an oral appliance therapeutic position. So in the future, we anticipate that perhaps we'll see some studies regarding emerging technologies. So common themes across all of the supported methods include patient intolerance of additional oral appliance advancement may limit attainment of normalization of subjective and objective parameters. Target sleep parameter levels should be determined in collaboration with the patient and medical sleep provider, and may not always reflect normalization of subjective and objective sleep parameters. So even if we're unable to normalize completely our objective and objective sleep parameters, improvement is likely better than no treatment. And you also must recognize that in some cases, it may be necessary to abandon oral appliance therapy altogether if we simply can't get a reasonable outcome from oral appliances. So the deployment of the supported methods. Methods may be used alone. So we're talking about the methods that I described earlier, the supported methods, or in combination of one another. So the following slide, and you can see this also in the paper, suggests two pathways that are supported by evidence. And we also want to recognize that experienced practitioners may have developed personal pathways that differ from the potential pathways that we described below. So the pathways, I'm gonna talk about each of these separate. So when we talk about signs and symptoms only, we've named this pathway signs and symptoms only because as we go through the steps, which start with initial mandibular positioning, and then the resolution or improvement of signs and symptoms as described in the protocol, at that point, we do not use any other devices. So we're using signs and symptoms only before we refer for verification of treatment efficacy by a physician. So the paper and our recommendations may read a little bit confusing when you saw that we said it was improvement of signs and symptoms or objective indices that may have sounded like we were suggesting that you could use signs and symptoms only and once your patient demonstrated improvement there, that you had reached the therapeutic position. That is not what we intended. What we meant by that was that was the technique that the clinician used before sending for verification of treatment efficacy by the physician. However, the physician wishes to verify treatment efficacy. There is a multi-method positioning strategy, and this is where you can combine methods, always starting with the initial mandibular positioning, followed by resolution or improvement of signs and symptoms, and then deploying either pulse oximetry, high-resolution pulse oximetry, home sleep apnea tests administered by the qualified dentist or in certain states by the physician if necessary, or by polysomnograms ordered by a physician, and then verification of the treatment efficacy by the physician. So there were limitations to our recommendations and further recommendations on how to proceed for the future. So we were stymied a bit in not having a standardized definition of treatment success, leading the task force to be reluctant to specify target levels of respiratory parameters to achieve. For example, some may consider success deriving an AHI of less than five. Some may define success as an improvement by 50% and perhaps an AHI of less than 20. So there are different definitions of treatment success right now, and the task force did not want to tie anybody's hands by making a specific recommendation of target levels to achieve. We would also encourage studies that will add information about if there is any additional value of adding the steps of other devices such as PulseOx or HSAT to symptom resolution before we send for final verification by the sleep doc. That will take more time to add those additional steps, and we didn't see any head-to-head studies that compared resolution of signs and symptoms with signs and symptoms and additional objective tests before referring for final verification of efficacy. So it would be nice to see some studies where we could compare some methodologies head-to-head. Recommendations are further exploration of imaging techniques as a tool for efficient identification of effective target protrusion. We need to see whether or not some of the anatomic findings, how well they correlate with effective resolution of the sleep disordered breathing. Often anatomic findings don't correlate well with improvement of AHI, if you're using AHI as your gold standard. And as always, recommendations will need to be evaluated as research and technology evolves, and it's evolving very quickly so that we would anticipate in the future that there may be some more efficient and some more methods that could be added to our recommendations. So I would like to acknowledge that this work of over two years could not have been accomplished without the invaluable assistance of Heather Montague, the AADSM Research and Policy Development Manager, Becky Roberts, the AADSM Executive Director, and Corrine Vick, the AADSM Director of Clinical Services. So Dr. Feigenbaum, I'm ahead of you, and I hope you guys have some questions that we can take at this point. Are you all, are you ready for me to stop the slideshow and we'll take some questions for the panel? I guess we are. All right, there we go. I'll ask Dr. Essek and Dr. Patel to put on their audio and cameras. Yes, well, thank you all for your attention. I whipped through that, and I certainly exhort you to go to the original paper if that was too fast for you, and to have in writing those details that I reviewed with you. Okay, thank you for your presentation. If you have a question you would like to ask the speakers and are in full screen mode, you will need to exit full screen to access the Ask button to submit a question. Okay, so here's a question for you guys. How sensitive are the signs and symptoms with clinically significant reduction of sleep disorder breathing? How sensitive? I'm guessing is the question, I'm guessing the question means if we improve the signs and symptoms, what is the likelihood that we've also resolved the sleep disorder breathing? And Dr. Essek, I'm assuming that, do you think that's the interpretation of that in question? Yeah, absolutely. And we're familiar with Fernanda Almeida's study where she demonstrated that with just resolution of signs and symptoms, about 65% of the patients had attained normalization of their parameters. When they added polysomnograms, they were able to obtain up to about 95% normalization of the sleep parameters. So I hope that answers the question. And Dr. Essek or Dr. Patel, do you have other information or a little insight to what you think that question might mean? I think it's a great question and one that we know very little about. I mean, to my knowledge, no study has looked at sequential improvement in signs and symptoms and how that correlated with the progressive reduction of AHI. It just hasn't been done to my knowledge, but it should be, and it's a very important question. But as Rose, Dr. Sheets notes, that there are studies that indicate when signs and symptoms have been resolved, a significant proportion of patients will still benefit from additional advancement during objective testing and in particular polysomnography. Hey, I guess we can go on to the next one. What do you do when your patient claims to feel so much better, but the HSAT shows no improvement? What will the physician suggest when there is no objective evidence improvement in AHI or T90? Another very good question that we get a lot. And I think it goes back to exactly how are we defining success? I'm sure many of us have the experience of your patient feels great, and then they actually go off for an objective sleep study and they're not normalized. That's a real dilemma. And that was why as a task force, we were reluctant to specify very specific values of sleep parameters on objective testing because that may not be the only thing that's important. And I think there's a lot of discussion going on even in the medical community right now regarding whether or not AHI, oxygen desaturation, some of those sleep parameters are really what we should be shooting for. There are quality of life indices, which include resolution of signs and symptoms for sure. So I think this is an area that's really fraught with a lot of controversy right now. So I'm sure that's not a very satisfactory answer for that person, but Dr. Patel, you're in a hospital environment. Dr. Essek, how would you respond to that inquiry? That is a very good question. So this is a case by case situation where you see a patient says they feel better, but sleep study shows there is no improvement. And when I say it's a case by case, so if this patient was not tolerating continuous positive airway pressure machine and oral appliance was their next step, then the physician will evaluate and say, well, what other things matter for you? That's what I'm looking at. And the other factors such as improvement, and as Dr. Shi said, in quality of life indices and subjective sign and symptoms, those are also taken into consideration as it does improve as well. So it's a case by case situation for the patients in a situation like this. I think the first important thing to do is to determine whether you're comparing apples to apples or apples to oranges. Was the follow-up sleep test conducted similarly to the diagnostic sleep test? Both PSGs is one home test and one PSG. Are we dealing with the same proportion of supine sleep, particularly if there's supine dependency in the data, are we dealing with the same proportion of realm sleep? So first of all, determine if there's an explanation for the lack of an effect that has a technical or some explanation other than the appliance is simply not objectively working. If in fact two sleep studies would show, a sleep study with the appliance would show no objective improvement from the diagnostic sleep study and a proper comparison can be made of this data collected in the supine position and the realm sleep, so that the based on traditional metrics from a sleep study that the oral appliance wasn't working, I think probably then it would be time to consider a combination therapy and maybe using the oral appliance with CPAP to improve the efficacy of the CPAP therapy or the patient's tolerance to CPAP. These are personal opinions rather than the content or intent of the paper. Thank you, Dr. Essek, Dr. Patel, Dr. Feigenbaum, what else have we got? We got a lot of questions. Something I finished early. Yes, that came in handy. If the HSAT without EEG gives an REI, why does my HSAT call it an AHI? And that came up in our face-to-face meeting and my guess will be that the company maybe didn't think either that the dentist would realize there is a difference and AHI is based on being able to differentiate between awake and sleep stages. And right now, to my knowledge, and I will defer to Dr. Essek and Patel if it's any different, HSAT right now is not measuring brain waves and therefore cannot formally, by the definition of an AHI, report an AHI, which is the reason for the respiratory event index, which will always underestimate the AHI because it will also be recording awake time while the patient is being recorded. I think we also have to realize that the use of REIs, relatively new, probably less than five years, and many of the companies that make home sleep apnea testing device started making those many years ago and they simply are using the terminology that they used 20 years ago. I know of at least one device that's come on the market in the past two years that actually uses the REI instead of the AHI for a home test. If you look at the American Academy of Sleep Medicine, I guess before about 2015, the use of RDI was common for home devices instead of the AHI and then they changed the RDI to the REI. I can see how that would be confusing and it's important again to realize that REI is going to underestimate the true AHI because AHI is measured only during sleep and the home sleep apnea test only measures time in bed. Some of the newer ones may try to distinguish between awake time and sleep time but not based on brain waves. It's going to be time in bed, not sleep time, and time in bed is going to be longer than sleep time so your events are going to be over a larger denominator which is going to underestimate the number of events. I have another good question. I noticed no mention of the effects vertical dimension and how that's tested with protrusive. It doesn't get the results. We were anticipating a question on vertical and in fact, there was no literature specifically on vertical dimension with regard to titration. We did look at, there were three or four studies that did talk about changing the vertical dimension. However, these studies were imaging studies. They did not report any sleep parameters. There were no polysomnograms accomplished. They were strictly imaging so that we couldn't make and also one of the studies, in fact, the subjects were non-apnea lean men so they would not have been really representative of the type of patient that we see in our practices so it was very hard for us as a task force to derive any information regarding how adjustment of the vertical based on the very limited literature that was out there but I appreciate the question and for sure that has been another one of these ongoing discussions in terms of design and adjustment of oral appliances. Dr. Patel or Dr. Essek, do you have anything more you want to add? I know you remember our discussions about vertical in our face-to-face meeting last winter. And you covered everything, Dr. Schitt. There wasn't much to cover in the literature quite honestly and I do appreciate the opportunity to clarify that for the attendees that we specifically looked at that knowing that this is an area of great discussion and there was simply nothing there right now regarding titration. What was out there was really anatomic changes and at this point there's no real good evidence that shows that the anatomy is well correlated with the resolution of sleep disordered breathing. Dr. Essek, do you recall anything more from our discussions that weekend? Clearly the literature is not very helpful at all when it comes to vertical but after having said that I think we all know clinicians who do routinely vary the vertical as well as the amount of advancement in their titration protocols and feel confident that it is meaningful but we also know clinicians that never do that. Yeah and certainly the literature is begging for some really well-designed studies that might put this question to rest although knowing science and research it probably won't but it would be nice to have something to look at to at least give us some sense about what the impact of vertical adjustment is other than anatomic I would argue. Okay great. Next question. In relation to the comment on normalization of parameters how often is 50% AHI reduction versus less than five AHI used for efficacy? In the studies how I'm guessing the question is how often are the different definitions of success used and interesting enough some of the studies actually reported both the amount of success using both definitions. I can't actually specifically answer that. Dr. Essek, do you know what percentage? No, no I don't and we also saw the definition of success of a 50% reduction with the AHI less than 10 events per hour so there were even other definitions used in some of the studies. Our paper, the paper that was published in October lists the references and a lot of them if you would really like the specific answer to your question you can certainly look at that literature. There was a quite a bit of literature on that and again because definition of success was so variable it's hard to put a number that would be satisfying for our attendees I'm afraid. Many OSA patients can be asymptomatic. Also lack of correlation between AHI and EDS. What is the recommendation in such cases? Whoa. Yeah good questions. Yes they're very good questions and my first so again so Dr. Feigenbaum remind me were there no signs and symptoms? Well they're saying many are asymptomatic. Okay. So I assume they're saying that there are no signs and symptoms. Okay right because the first thing I was going to say is you definitely want to in order to ensure patient adherence you want to address signs and symptoms but if we're talking about asymptomatic patients I'm going to assume that this may be a patient that was referred say by the cardiologist who realizes that OSA may contribute to hypertension and has advised the patient this would be an enlightened cardiologist has advised the patient cardiologist has advised the patient that perhaps management of the OSA and we have seen this will improve or may improve their hypertension so at that point then I would say yeah that that's going to be a little tricky in terms of when do you stop how much do you titrate or how much do you continue advancement and this is where there might be an argument where you're not going to want to follow the pathway now of signs and symptoms and you're really going to have to I don't want to say you'd have to skip over them because sometimes our patients think they're asymptomatic and then you deliver an oral appliance and all of a sudden they went oh my gosh I didn't realize what a good night's sleep was so I would suggest that you still start with those signs and symptoms questionnaires or tools that you have at your disposal and go ahead and track over the next few weeks whether or not there is any change in those signs and symptoms or an improvement again sometimes our patients think they're asymptomatic and then realize that they did have problems and then you may want to move at this point to some of the other devices such as the pulse ox or the hsat to see if you're in the ballpark of an advancement before you send back we rely a lot most of many I would say most of our patients come in for complaints of symptoms so I think it's it's going to be the rare patient that comes in on referral from a cardiologist or say a psychiatrist for a depressed patient whose signs and symptoms may signs and symptoms of osa may mimic depression for example so a psychiatrist may send the patient in for examination so so those are a little bit trickier but I would still proceed with signs and symptoms and assessments just to verify that there's no change or maybe to uncover the fact that there is an improvement and also Dr. Sheets is like a second part to that question where I mentioned the lack of correlation between the hineds what was the question regarding that that is that I would argue is true was there a question about that yeah so I'll reread it uh it said many osa patients can be asymptomatic also lack of correlation between hi and eds and that's what is the recommendation in such cases so I just wanted to see if you want to address that part too I'm not sure oh so I guess suggesting that even if we have an improvement of daytime sleepiness we may not have an improvement is that what you're well I'm not saying the question but yes that's probably I mean I'm and Dr. Spital and I said do you think that's what that question is asking again the fact that there since there is since there is a poor correlation between the two that an improvement in in daytime sleepiness does what would be a poor guide to knowing that we've improved the I think that may be the question yes and so again I think that you know at that at that point you have you you may want to use a different pathway not the signs and symptoms alone and and and defer to either another device and see if you can get some kind of objective feedback regarding the changes that you see with your advancement I don't know Dr. Essek or Dr. Patel you about to say something Dr. Patel yeah I agree with you Dr. Seuss I think in a situation where the patient just completely says I don't have any signs and symptoms I was referred to you because there are certain you know for example as you said from cardiologists or other medical specialties through sleep medicine and so in that situation where you don't have anything to subjectively rely on then objective measures are the ones that we would look at and in situation again like this again is where serial pulse oximetries can be done or serial home sleep apnea tests can be done at every certain type after a certain amount of titration and that can be the factor we rely on in situations where there are no signs and symptoms yeah and that's where we would move to a different pathway from from that one yeah I think it's also very important to look at sleep quality the patients may may say they have no signs and symptoms but they may report better sleep quality waking up fewer times during the night to go to the bathroom dreaming more so there are a lot of things that they can tell you that suggest that there is some effect of the of the appliance excessive daytime sleepiness can be very problematic some of the literature indicates that only half of the people with sleep apnea have excessive daytime sleepiness in which case it's not going to be useful on the half that doesn't have excessive daytime sleepiness and some patients report no improvement in daytime sleepiness upon upon titration or use of an oral appliance so but again that's that's only one uh one one symptom I think you have to look at more than one yeah okay uh should the provider consider the characteristics of the oral appliance therapy device when determining the position um there are going to be differences um among devices um for example some have a finer titration mechanism in them and some but we but we certainly suggest that you use an appliance that has a that can um allow incremental adjustment of uh no more than of one millimeter or less um they're also going to be design differences in terms of the vertical as well um this task force was not tasked with actually making recommendations on appliance designs but those are certainly some of the considerations that might figure into how um for example what what incremental amount that you you may advance um I'm not sure whether or not I've really fully understood the question or if that answers the question and I don't know if Dr. Spital or Dr. Essek interpreted that question differently uh well I think there are some some uh companies that have argued you need less advancement with their appliance because in some sense it's more efficacious than another appliance and they make arguments based on the bulkiness of the uh the appliance or the encroachment on the tongue and many other factors uh but to my knowledge there have been no head-to-head clinical studies to really show that that indeed is the case. Great um in my state not mine but in my state HSATs are not allowed to be given by the dentist a pulse oximeter is okay to use instead to determine the optimal therapeutic position. I think that in that state and that is why we have two different protocols that may might have seemed redundant but we were aware that in some states HSST is not permissible by the dentist and so you really are left um with at least at this point in time and of the methodologies that we looked at with a pulse oximeter um there are certainly other um emerging technologies that may um make life easier for these for the dentists that are practicing in those states. I do think that some of the technologies that we've talked about and some of the methods may soon be obsolete um so it is important to recognize that this is a living document um and um that it will change as as the evidence accrues and as more technology is developed and emerges. So um I don't know if there's any better answer to that question that Dr. Essig or Dr. um Patel can provide. What would you suggest if in the in a state where they can't use HSAT? I would say it's it's time to go to to your dental state board and have a discussion um if they're saying that home sleep apnea test can't be used by a dentist um then the question would be can can pulse oximetry be used? As you pose well pulse oximetry is not diagnostic for sleep apnea so technically it is not a home sleep apnea test. The American Academy of Sleep Medicine uh um recommendation or uh requires a diagnostic test to include at least pulse oximetry airflow and respiratory effort. Medicare requires at least a three-channel device one of which has to be airflow for a diagnosis so according to the American Academy of Sleep Medicine and according to CMS pulse oximetry is not diagnostic for uh sleep apnea and you could argue is not technically a home sleep apnea test and you should be able to use it. At least that would be my argument.

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