Welcome to Open Airwaves, a podcast brought to you by the American Academy of Dental Sleep Medicine, where we have clinical discussions on dental sleep medicine-related topics. I am your host, Dr. Tanya DeSanto. I am joined today by our guest, Dr. Sims Tompkins. Dr. Tompkins received his dental degree at the Medical University of South Carolina. He continued his education at Temple University in Philadelphia, where he earned his certificate in orthodontics, as well as an MS and MSD degree. Dr. Tompkins is a diplomat of both the American Board of Orthodontists and the American Board of Dental Sleep Medicine. He has been involved with dental sleep medicine since 1991, and now treats about a hundred patients a year with oral appliances for their obstructive sleep apnea. As early as 2011, Dr. Sims was involved in some early trials for hypoglossal nerve stimulation. And I think from here on, we will call it HNS. When he was asked to provide a six-style retainers to protect teeth from tongue movements on patients undergoing the procedure. More recently, Dr. Sims has been working with local sleep doctors to improve efficacy and reduce side effects of their HNS patients. In this episode, we're going to explore Dr. Tompkins' experience in helping recipients of HNS improve their outcomes and the role that all qualified dentists might play in this very important treatment collaboration. Welcome, Dr. Tompkins, and thank you so much for joining us. I'd like to dive right in, and I'd like to start out by talking about, can you just describe who is a candidate for Inspire and a little overview on how does it work for those of us that are unfamiliar with it? Well, great. Well, thank you so much for that introduction. I'm glad to be here with you. The Inspire therapy process, the first of all is, who is a candidate? The other night I was watching the TV, and I saw several commercials about Inspire Treatment. The company is certainly getting their name out there, which is the first step. As someone has learned from the treatment, the next step is to consult their sleep position to see if they're eligible. The eligibility requirements are adult over 22 years old, moderate to severe OSA, which is an HI of 15 to 65, body mass index equal to or below 33, difficulty accepting or adhering to CPAP therapy, then no significant comorbidities like a neuromuscular disease or severe cardiopulmonary disease, and then no pronounced upper airway anatomic abnormalities like huge tonsils, adenoids, et cetera, and then no complete concentric collapse of the airway at the soft palate, and that's seen with the DICE procedure. Now once a patient is eligible and is a candidate, the actual surgery with the Inspire device is about a 60 to 90 minute procedure. Now the Inspire device consists of three components. One, you have the implant pulse generator. You have the pressure sensor to detect respiration, and then you have a stimulation lead that attaches to the hypoglossal nerve. The implant pulse generator is the pacemaker-like component that houses the battery as well as the processor, which analyzes the inputs from the pressure sensor to deliver the stimulation to the hypoglossal nerve. It's positioned about three fingers below the clavicle on the right side. The pressure sensor is placed between the internal and external intercostal muscles along the lateral chest wall. The pressure sensor allows for the analysis of chest wall motion, which allows a processor to signal the end of exhalation and the start of inhalation. And finally, the stimulation lead is attached to the specific branches of the hypoglossal nerve. This lead is placed by making a two centimeter incision below the inferior bore of the mandible. Now the surgery procedure for placement of the Inspire device, like I said, takes between 60 and 90 minutes. And so the first stage, the surgeon accesses the hypoglossal nerve and places a stimulator cuff on the protrusive branches. Now these branches are located and they use like a little neuromonitoring unit, basically a small stimulator. And that way they can detect which fibers protrude the tongue because those are the fibers that you want to stimulate. The second stage is placement of the implant pulse generator. And then third stage is placement of the sensor in the right lateral chest wall. And at this time, the surgeon will test the device to ensure that it's properly working and to observe that the stimulation cuff is placed on the correct branches of the hypoglossal nerve. As we remember from anatomy, there are no colors or numbers in the internal musculature or organs or anything. So that's why he has that little stimulator to test which is the most advantageous branches to place them on. I think it's really important too, that we all understand the role that dentists can play to increase HNS efficiency or even rescue unsuccessful cases. I'd really like for you to elaborate more on that. Okay. Yeah. So after surgery, the next step is after the placement of the Inspire device, they're seen by their sleep physician for a one month post-surgical period or post-op visit. And at that time, the device is activated and the patient is given a remote and is instructed to gradually increase the voltage levels as tolerated over a two to three month period. The data is downloaded and the sleep physician will perform an in-lab titration to fine tune the voltage settings. A new sleep study is then performed to quantify the data and this allows for further adjustments as needed. And that is where on some of these patients, roughly 10% are not getting the numbers that they would like. So that's when we see them in our office or we get referred for oral appliance therapy to work as an adjunct to their surgical procedure. So tell me a little bit about, you mentioned something about the sleep doctor determines the voltage level in the clinic one month later. So they turn on test mode. Then what do they do? Just advance it a millivolt each time and then they wait, are they looking for a threshold level or are they trying to figure out where the tongue is moving forward? Is that a process? That's a great question. So the Inspire device goes from 0.1 to five volts and it is increased by 0.1 or one millivolt at a time. So in the clinic, once the patient has brought their threshold up to where they can tolerate the highest voltage without any discomfort, what they do is they have them come into their lab and they actually test it in test mode and stimulate the branches and as the tongue protrudes to the end on or to the top edge of the lower incisors or slightly right for that. I mean, they're not stimulating it so it sticks five feet out of their mouth. So it's just a very minor or not a very invasive type of activation. And so that's what they're looking for and seeing how the patient, A, what voltage performs this task and two, can the patient tolerate it? And I know that I've heard a little bit about patients doing this on their own after the surgery and they are instructed to do this on their own in increments over a period of like one or two weeks. Is that true? How does that work? Yes. What they want, at time of surgery, they test it, but they don't turn it on for a month and then for that month to two month period, they're actually basically as they're increasing their voltage, they wait for about a week at a time in between in increments. They don't do it daily. They do a week at a time. So the body, the musculature and everything can adapt to it. And at the end of that trial, when they're seen in the office by the physician, they actually download the data and the physician can look at her screen and decide which number was more advantageous. Now typically the most I've seen, the range typically is 2.7 to 3.1 volts and 3.1 is probably the higher end that I personally have seen. But that when they start there, they start like at one and so they go over a period of time and increasing it just for, and again, it's for patient comfort. And that's how they dictate or determine what is the best threshold. And I've had several people that after titration, the higher number was, they were worse than they were at a lower number. So then I have a question about efficacy testing. So to me, it would seem logical. The only way you could really test this would be a PSG because you would have to allow for active calibration. Is that right? I mean, you wouldn't do like a home sleep study because you wouldn't be able to engage that or do they do both or how does, what is the normal protocol? The initial one, they do get back into the lab and they do a more thorough exam. However, their followup after the adjustment at that in lab titration, they will allow them to do the home study looking for HI and the oxygen saturation. So your experience is you're reading these efficacy results on a home sleep study then? Correct. Usually? Hmm. Do you think it would make a difference though, if they could have the PSG and allowing for this active calibration, would that make, would that turn the results a little bit more in favor? You know, I'm not really sure. I would think though, you know, cause in the lab when they are doing it live, they're noticing, you know, how far the tongue is protruding and like I said, it's on some, the more isn't necessary, the better. It depends on the direction and you know, this is a unilateral device and so they, you know, usually you do don't, you know, you protrude a little bit to one side or the other. But I have seen, I mean, from what I've discussed with these physicians is that, you know, the activation part is more, their data is patient comfort is number one, but then two, they can also turn down the voltage, but increase the frequency, you know, it's electrical impulses. And so they can fine tune it and change a couple different parameters to kind of help things too. Yeah. I have read that there's, I didn't mean to cut you off. I've read that there's like a delay and a ramp feature. Are patients taught how to do that? Well, now this, they don't, now this compared to a CPAP, they don't have like a true, you know, it doesn't increase on its own over time. I mean that they, they have to, they have to set it and it's a setting that, that does not ramp up. I mean, it's, when they set it, that's, that's what it is for that period of time until they manually until they manually adjust it. So Dr. Tompkins, let's just go over this four phases of treatment to make sure I'm understanding this okay. So the first phase is the surgery where they are identifying branches of the hypoglossal nerve, making sure it's motor and protrusive only, nothing sensory. And they're putting a cuff on those branches and then activating the device to confirm that they have only activated protrusive. And the protocol suggests that we stimulate the voltage that's set during this surgery just so that the tip of the tongue is up to the incisal edges, correct? And that's the surgical procedure and that's finished then. Okay. And then after they finished that procedure, now it's time for the sleep doctor after a month to do the clinical visit, the followup, correct? That's correct. Okay. So the sleep doctor determines if the voltage level in the clinic one month later with the patient awake, they turn on the test mode and then they start adjusting things. That's correct. One millivolt each little increment. One millivolt at a time by the week. So then the optimal position with the tongue protruding or just beyond the teeth. So that's the one month visit. So then we go through this acclimation period of 30 to 60 days and that is the home calibration kind of like we're used to doing with oral appliance therapy. So that's when the patient is in charge of the device, correct? That is right. They have a remote that they can adjust. Okay. And then following the 60 days, we want to know the results. So then the efficacy testing comes into play with the sleep study and then it's determined from there. Okay. I just wanted to make sure that we had this step, these steps correct and correct in my head. So because it's really important for us is sleep dentists to make sure that we get efficacy. We want to increase the efficacy with an oral appliance because sometimes it's not just palliative but it's actually getting better results as you're going to show us later in some cases. So that's. That is correct. That's fascinating. So how do these patients, how do they find their way to your office from the efficacy testing? Like where do you get involved and introduced into these cases? Well basically the sleep physician, the cases I see are the patients that haven't responded to the HNS therapy as they had hoped for. And so the numbers aren't as, basically they're poor results as they would call it. They didn't get at least cut by 50% or decrease in HAI by 50% or below 15. So that's the first group. Now the second one is as they are doing these tests, I mean the in-lab titrations, the protrusion of the tongue, they have noticed on some that the tongue will not raise above the level of the incisors and actually pushing into the lingual aspect of those incisors. So they have sent patients to me for, to increase the vertical dimension to give, to allow the tongue to have a little bit more tongue space. So those are the, probably the main two areas that I have seen to, that I've got, I've had patients referred to me. And then the third would be if they have to, if they've had their intensity of that device of the stimulator turned up too high, they cannot tolerate it. And so then we see, and with that, they see some tongue soreness and aggravation from the pressure put in on the lingual aspect of the incisors and from the pressure of the tongue. So they are, that's another area. Those three areas is what the physician has sent to me have been the main problem areas that I have seen on referral from the sleep physician. So, you know, I'm thinking about this and, you know, we do combination cases so often with, you know, CPAP and oral appliance so that the pressures from the CPAP can come down when you combine the therapy with an oral appliance. So I'm, I'm, I'm feeling a lot of similarities here with Inspire, the same thing, like you would have less voltage if you do the combination case with an oral appliance, is that correct? That's what we have found that they can allow, you know, especially since they cannot go past a certain level, they will back down the voltage and then allow the oral appliance. And as we'll talk about later, not just have the opening for the tongue, but then actually advance the mandible like we do in our normal treatment every day. Nice. Nice. Well, I think, do you have a case you can start talking about? Is there, can we talk about your first case and you can explain a little bit about how this all comes together? Yeah. Now, now one, one such person is, I'll call her Susan, Susan F. She originally presented with a BMI of like 31, but her HI was 42.3 and that's pre-Inspire placement. She had the Inspire device placed and it reduced her AHI to 26.7, but she was still having discomfort with her tongue, even though it was more, you know, the pressure and it's not like I said, it's not sensory, it's not true pain, but it's a soreness. And then she was actually rubbing against her incisors. She also had, you know, so she had an in-office citration and it lessened the intensity. They lessened the intensity of the voltage and her AHI actually improved to 12.2. However, her oxygen, her problem is her oxygen saturation was under 89% for roughly 50% of the time, which is, as we know, is unacceptable. And so she was actually put on two liters of oxygen at night, which did help. However, she was not getting, she was still had daytime sleepiness and not, not feeling very well. And so was sent to us for oral appliance therapy, mainly to improve her tongue space, to allow her tongue to come a little bit more forward. And so for one, her discomfort, but then two to actually open up to see if, if it would help, you know, the tongue have a little bit more room. So we delivered her appliance and I opened it, you know, we actually had a vertical opening of three millimeters with her and, but we left her in just centric. We did not advance it. We just had her in a neutral position with vertical opening. Her AHI was the same after that, they did a little study after that, a home study. And so the sleep physician asked me to advance it slightly. So I advanced it three millimeters and this reduced her AHI to 0.7 and it improved her oxygen saturations as well. She still is on, her oxygen was cut down and they're trying to wean her off of that now because of her numbers being so, so good. So she actually was only three minutes under 89% at the time, I mean, taking off her oxygen. So she's off her oxygen right now? She's not on supplements? She is now. She is. She is now. And that's why she's still, you know, 3%, I mean, three minutes under 89 and their goal is to, you know, to get zero, but, but from, from going to what was a 40, you know, you know, from one 42.3 down to 0.7, I mean, her physician is extremely happy and she is too. She feels better and, you know, her tongue's not sore because the appliance actually covers, you know, as we know, covers the teeth. So it kind of helps with the comfort, you know, you know, of pushing hard against the teeth. So it kind of killed two birds with one stone, really. Great results. Really. She's probably having daytime sleepiness. Has she symptoms resolved as well? Yes. She is much, much better. That's great. And then what is the follow-up for Susan? Would she go and get annual sleep studies? Is this something, like what's the protocol for following up once you and your physician feel that the case is successful? Now what her physician does, she'll follow up at six months and she'll do a home study then. And based on that, if the numbers are still in the good range, she'll move it to one year follow-ups. And she'll actually come to us as needed, like a yearly checkup if needed for adjustment or just to make sure everything's doing okay from her aspect. So can you then describe for us your usual clinical process when these patients present to your office? So what is that like when someone is now sitting in your office? What's the next step? With these patients, this is basically like our everyday patient anyway, you know, what we're looking at. So, you know, we do our exam and everything, but the one factor on pretty much all these patients that have been referred has been tongue space. So for me, looking at the vertical component and, you know, as an orthodontist, I see a lot of people that have deep anterior overbites. And that is one thing, even if you had leeway space and relax your jaw, you're still gonna have an anterior overbite. So I think it is important to have the open up the vertical dimension somewhat to help that tongue have somewhere to go. And that's just what I've seen. Now, you know, not everyone is like that, but that is one thing I've seen. So after our evaluation, so at delivery, usually what we'll do is add, and I like it in the anterior region, and add some acrylic. So basically it's the old salt and pepper technique like as we did in dental school to build up the anterior, or actually the cuspid-bicuspid area is where I like it. So if they do close or keep closed, then they have about a three millimeter vertical opening in the front. And that's what I have seen has actually helped with the tongue space and tongue soreness because now the tongue has somewhere to go and won't push against the back of the teeth. I typically like using a bilateral traction appliance, and that's just my personal preference. Now, of course, with patients with no posterior mandibular teeth, use more of the Herpes type appliance. But why I like that bilateral traction appliance is as you advance that, the mandible, the actual appliance keeps things fairly closed. You know, I mean, like with a Herpes type style appliance, the more you open the vertical, the more autorotation or distal rotation in the mandible you have, which kind of almost defeats the purpose if you're not wearing elastics with it to let the jaw kind of go, you know, to occlude the airway. So with this, I think it serves two purposes. One, you're opening the airway, but by opening it, you're actually advancing it. So the more that you open the vertical, actually the more the mandible does come a little bit forward. And so for me and my hands, those two factors have helped me or helped my patients a great deal. Yeah, I would, the design features are really important because you're trying to prevent the posterior rotation of the mandible, and you can use acrylic and chair side, take care of these patients in your office right then and there. It's not like you're sending it to a lab or anything. So that's, that makes a lot of sense. So what is your goal then, if you could summarize that? My goal, I mean, really is the same as if they had not had this HNS device placed. I mean, we want to improve, definitely improve the HI. We want to help the oxygen saturation levels, improve the quality of life of the patient. So those three things are still the goal. And it's interesting to note that, our goal with an oral appliance with severe cases is to reduce the HI by greater than 50%. Well, the HNS surgery, their main goal, they want to do the same. I mean, the understanding is that they're not going to cure and we're not curing the illness anyway, but I mean, to get them under five, well, and all of them is not practical. So what they want to do is cut it by greater than 50% and or try to get it below the HI under 15. And those are really the same goals that we use. And we're not doing the surgery, we're having an oral appliance, which is a reversible procedure. So yeah, so I think my goals are the same. It goes hand in hand with them, but tongue space to me, that's why the vertical is important to give the patient more tongue space to allow the Inspire device to do its thing, to allow the tongue to protrude or give it room to protrude. And then the second would be to slightly advance the mandible to improve the efficacy of the treatment. So I'm just summarizing this in my head here. So the strategies of using an oral appliance to support hypoglossal nerve stimulation, we're number one, reducing the side effects associated with the tongue motion by increasing the space or providing a smooth pathway forward, correct? Right, that's correct. And then we're also trying to reduce the degree of millivolts needed for this adequate tongue protrusion. And that's reducing the AHI by stabilizing the mandible in a place that's safe. And then potentially managing tooth movement associated with protrusion. Can you elaborate on that a little bit? I would think that would be an issue. That's a great question too that we hadn't really talked about. As you mentioned in your kind introduction that I've been involved with sleep medicine since 1991. And why I was involved so early is because the founder of, well, really sleep med is here in Columbia with me. And I was on his advisory committee. And so what was neat about that is I had a great introduction early on to sleep medicine and the pros and cons of everything. So the reason I brought up working with his advisory board or being on the advisory board with Dr. Bogan is that he was involved early on in 2011 and 12 with HNS stimulation devices. In particular, this one that is not an Inspire device. And they had me involved not from the oral appliance therapy standpoint, however, but from being an orthodontist. And they wanted me to make for both the placebo and the live patients, which I didn't know which was which, make ESSIC retainers so that they were worried that there may be a chance of tooth movement. Because as an orthodontist, we know, I know that it only takes 50 to 150 grams of force to move a tooth. You know, technically it has to be light continuous force is how they move. Well, with the tongue and with the Inspire device, every time the patient inhales, that tongue is pushing forward. So you're talking about anywhere from 15 to 18 times a minute, that light force being pushed on these anterior teeth. And so that was a great question because the more that is stimulated in theory, the more it could push these teeth and actually flare or move the mandibular and or maxillary anterior teeth. Wow, that's interesting that you had that input and you had that input from the early stages and the inaugural part of Inspire. That's really, that's awesome. I wanted to see if we could talk about maybe one of your other cases where this was an issue. Yes, I'll call her Nancy S. She initially had an AHI of 55 and, but a low BMI. She's not, she's about five feet tall and just a feisty fun person. Her post after her surgery, after her Inspire placement, her HI was 7.3, but she complained of a bunch of tongue soreness. So the device was titrated and the HI was worse as they went up in voltage. So they brought it, you know, they had to bring it back down and then they said, okay, 7.3 isn't that bad. Well, then she presented three months later and said, my teeth are moving. And they had actually, the lower anterior teeth had actually flared and spaced. And so I was referred to patient twofold. One was to help with the tongue soreness, but then two to help realign the teeth. So what I did is made some, you know, aligners for about, you know, two, two and a half months to retract and close and reposition those lower anterior teeth. And at the same time, at that last position, then fabricated her oral appliance, which we, like before, I told you added vertical dimension because the tongue was pushing on those lower anterior teeth. So one, it would let the tongue go above those lower incisor teeth, but then also acted like a retainer. The appliance acts like a retainer to keep her from moving. And it's pretty neat to know that after we did that and we slightly advanced her, opened her and advanced her, her HI ended up at 3.5. So we actually saved two things for her. One, her tongue, I mean, she's happy. Her tongue soreness is non-existent and now she has room for her tongue and she, her teeth are being held in place and not being moved with the tongue pressure, so. So then Dr. Tompkins, if you're straightening her teeth before you're addressing her palliative issues, like, is she okay with having those issues while her teeth are being straightened? Because you really are correcting the problem secondarily to the misalignment. Yeah, well, so with her, remember her HI went to 7.3 so from a clinical standpoint, they were, I mean, it was above five, but it was still so much better than it was before. But then two, having the thinner material on the teeth was a lot smoother to her tongue. So it took that out of the equation, because you're not having the sharp edge. So you actually had them covered to begin with. And so the only discomfort she had was the slight distal movement of the teeth that closed the anterior space. So she was happy pretty much the whole time. I mean, she was certainly happy her teeth were back aligned, but then she was even more happy with the added reduction in AHI. Great result, great result. Yes, that one was great. So, you know, when you think about it, you're just one doctor in one part of the world helping your patients, right? I mean, but do you think this is a fairly common problem, especially when we see the number of these HNS patients in these cases continually increasing in the wake of this aggressive direct-to-consumer marketing campaign that you're, it's on TV, everybody knows about it. It's like a catchword now. Everybody hears about Inspire. You know, what are your thoughts on that? Again, that's a great question. You know, at the end of the day, it's still surgery. And I think if we look at all the surgeries out there, to me, this is one of the least invasive for the patient, I would think. Now, it's still surgery though, and that's the bottom line. And so, as in anything, you know, if you look at the numbers or post-treatment year or two, three years out, you know, 8% of the patients complain of discomfort when the device is stimulated. And again, it's not from the sensory, but it's just from the constant movement of the muscle. You know, 20% of the patients experience some of the tongue soreness that we've talked about, and which is a pretty significant, I don't know, that's a fifth of the patients. You know, and at this point, the protocol with this is not to place any type of, if they're not using oral appliance, but not even placing, like we talked about, ESSIC retainers or anything like that, that is not part of their protocol at this point. You know, but if you still have increased soreness of the tongue, I think there's different ways that can be maybe looked at. You know, and then about a third, I think, is, you know, they're gonna be non-responders, they're not gonna respond as well to the therapy or the treatment as they had hoped. And that has to do with either, you know, the higher the HI, and then of course, the BMI has been, is huge. And talking to the physicians, they have lowered from originally case acceptance, usually at first it started, if you had a BMI of 40 or below, they would accept you. Now they've moved it to 33 or to 30 and below, because the higher the BMI, the least likely they are to respond to this surgery. And so, you know, and then that same group, if it's not, if they're not feeling any positive effects, they're not gonna use it. They're not gonna turn their Inspiron at night. It's just much like the CPAP or any other kind of treatment, even though it's a surgical option and not a reversible option. So, you know, there are, and so that the happy, the good part about it, or the intrigue or the acceptance with it, would be it is a less invasive surgery. So if you're gonna do surgery, and that's how talking with my patients, you know, I tell them, I said that two really, CPAP and oral appliance therapy are reversible. At the end of the day, you don't wear them, you're just like you were. However, surgery is surgery. And, you know, you're actually changing something. And, you know, no matter what the surgery is. So that's how, you know, I've brought it with my patients and talked to them. And, but that, at the end of the day, there's still some risks, some, you know, you gotta, each person has to weigh out the risk benefit ratio for that particular person. You said something that was very impactful. More than 35% of these patients that undergo hypoglossal nerve stimulation are non-responders. And this number is worse if you only look at men with higher AHI and BMI. But that's so, that's so important because not only as sleep dentists, are we helping for palliative reasons, but we are helping to improve results because combining these, if I'm understanding this correctly, this combination therapy with HNS treatment along with an oral appliance, we're gonna go into that window. I mean, if 35% of these cases are not responding to HNS surgeries, we need to help. We can be an asset to these physicians because we can go in and help their results. So they need us and we need to partner with them, not just for palliative reasons, but to get clinical success. If I'm understanding that correctly, 35% of these cases are not successful. That's huge to me. Correct. For all the marketing that they're doing, that's what the research is showing. Right, right. And one of the local physicians that I work with here, I think she has 70 Inspire patients. And she says that she knows that no less than 10, but higher than that 15 or so percent. She's already sent me 10%, she said. And she said that she's targeted a few more. And so you're looking at, and those are the non-responders, or the ones that aren't using the appliance like they're supposed to or having issues. And so you're exactly right. This combination therapy, so it is key. And it is key to build the relationships with the local physicians and really to educate them. And I think most of them, we've been doing this long enough now, around here at least, they know the benefits of oral appliance therapy. Matter of fact, they're doing that first line versus CPAP, whereas years before they said, oh no, CPAP's first line. However, and so we've made a lot of strides in oral appliance therapy over the last 15, 20 years. So it's been fun. It's amazing because you always hear about when you're starting an oral appliance for a patient, one of the biggest questions is, did you fail CPAP? Well, it's almost gonna be a thing. I mean, did you fail Inspire or are you a non-responder? I mean, there is a reason an oral appliance is a very valid option here. And I think that it's important to stress that it's much more than just palliative therapy, but actually getting better results for these non-responders. That's an interesting, I mean, I picked up on that right away when you said that. Can you talk about another case for us? Yeah, speaking of someone who's a non-responder, we had a patient move to our area who actually had an Inspire place three to four to five years ago in Jacksonville, Florida. And so when he moved here, he went to the sleep physician and they did an in-lab or they did a study. We turned it on and did a study and his numbers, he was a 55 HI to begin with. And even after implementation, once he got here and they did it, he was still 55. And so they tried an in-lab titration with him, but he could not tolerate the increase. And so he was at basically the max level that it would do any good. So in his mind, he's thinking that the Inspire is a waste of time and he actually wants his removed. Now, I mean, he really told me, for some reason he said, I don't want it in my body. But he came to us, he was referred to us and we made him an oral appliance. And the two things that we've done before, A, we opened the vertical for tongue space and then we slightly brought him forward. Now, we saw him a month later and he was having a little bit of unilateral jaw issue, which was from the appliance, not from his Inspire. Soreness, because I wanted to differentiate the two because they do get a lot of submandibular soreness once that device, that HNS device is activated. But this was actually from the oral appliance. So we adjusted the vertical and made sure that he was symmetric with his protrusion. And he came back a month later and he was much, much better. They did a study and he actually had gone down to, I think he was one, we got him to a 15. Now, that 15 AHI was with his Inspire and the oral appliance. But he wants, he has a physician, he wants to do another study and turn his Inspire off and see what he does with just the appliance. Again, wanting to get rid of his appliance. So, I mean, his, excuse me, his HNS device and keeping his oral appliance. So he wants the oral appliance and does not really, so he's hoping that we can do it without the surgery. So looking at his history, I don't know what he did before five, 10 years ago, whether if he tried oral appliance therapy because he wasn't around here and he didn't, and the physician didn't know, so. I really want to know the results of that. That's fascinating. That's like the mystery at the end, you know? That's great. Yes. That's a great, great, great case. You know, I was thinking, we know last year a major U.S. insurance carrier, I think actually two, they put a policy in place that patients would need to have an oral appliance, a trial run before being approved for hypoglossal nerve stimulation therapy. And then they retracted that policy very shortly after that. In fact, the Journal of Dental Sleep Medicine just published an article defining the AADSM position on the trial of an oral appliance. So we'll attach that into the show notes along with a opinion piece on why it makes sense to do a trial of OA, you know, put the appliance in as a trial as opposed to like the invasiveness of surgery that you were talking about moments ago. Have you ever had patients that were interested in hypoglossal nerve stimulation who were referred to to consider oral appliance therapy first before embarking on surgery? Have you ever had that situation happen? That's a great question. Actually, I've had one patient really ask about it, but not in place of oral, you know, most of the patients I see have tried CPAP. So I think those are the patients that are willing to do anything to get rid of that machine. And of course, we're a little biased in our field, but because they hadn't tried, but this is their initial appointment that they have not tried the oral appliance, you know, and so the ones I see is on the couple I've seen is really the patients that I don't think that I bring it up to that I don't know if I can help them. And what I mean by that is that the number of teeth in the dentition, you know, or periodontal concerns or things like that, that I don't think, and I've told several patients, I said, I think I can do more harm than good with an oral appliance because you, you're not qualifying as far as I'm concerned. So I do think those patients, I do say, okay, well then go back, go to the CPAP. And then they, if they said, no, I'm not never going to do that. Then I bring up the, you know, hypoglossal nerve stimuli, you know, the inspire type treatments, because again, to me, that is a lesser invasive surgery than the other options that are out there. You know, and a lot of them come in and they do ask about it. They say, well, what are my treatment options? And I do go through them. I do go through the non-invasive and invasive treatments. And a lot of them have, like I said, I saw them on TV the other night, they see the commercials, the direct to consumer commercials that, you know, that bring up awareness to these, especially the inspire device, you know, so that's, that's my thing. So mainly for them to come in and ask about, or for me to talk about it, it's, you know, those are the, those are my criteria. You know, I'm, I, of course I want to cure everyone as we all do, because I love what we do. And I know the quality of life they're going to have. And I've, I've had more than, I can't tell you how many patients said, I'll put a billboard with me up there. And, and, and the other thing, I mean, how many marriages we've saved with, with this, with the snoring and the breathing part too. But, but no, anyway, that, that's the main thing is that with this surgery, I haven't, like I said, I, I bring it up as part of, you know, our, our routine, because I'm going to tell them everything what's out there for them. But, but they usually are inclined. Now going back to the insurance company, you know, the only thing I can think about why they would not do it is because I would do anything again, not to have surgery. So why not try the least invasive thing? Plus it costs, it would cost the insurance companies less. So you would assume that it wouldn't be bad. But yeah, that it's kind of sad or interesting because I do think, me personally, I would do exactly what, what our, our paper says, or, you know, that article in our journal says is that I would do the least invasive thing before I get cut. I know, I thought it was really interesting that they retracted that. Not, I mean, it was maybe like six or eight weeks after I felt like it was so quick. I was really surprised by that. I never understood that. So do you know, you have so much experience working with these doctors and you've got such a good flow. Do you, can you suggest anything like describing ways that all of us can connect with like ENT or physicians and let them know like how, you know, we can help you increase your results and we can help you with your efficacy and you know, we, we can be an asset to you. Well, that's a, that's a great question too. And I, again, I was fortunate that especially with the, with a large pulmonary group, I was on the advisory committee early on. And so then another large pulmonary group here in town, one of the, one of the physicians had gone to undergrad with me and we were lab, biology lab partners. And so when he got back in town, we started discussing and then it was funny, two of his partners kind of poo-pooed it and said, ah, you're, you know, it's almost like when I applied for medic, you know, Medicare the first time as a, as a provider, they said, oh, you're a dentist. You don't know anything. You know, we all, we've all heard it. But you know, they just didn't know anything about it then. And that was in, that was in the late 2000s too. Now though, my, my, my advice would be to, you know, especially now that then Spire is, is out and a lot of these physicians are saying, okay, well you can do surgery now instead of CPAP, you know, I don't want them to forget about their oral appliance and their patients. So what I would suggest is to contact them and ask them. And with that one group, even though he was a friend of mine, his three partners came in and I, I went at lunchtime and showed him a quick little slide show and told them what we do, how we do it. And, and, and, and they, and they understand anatomy and they get it. And, and they laugh because, you know, CPAP adherence is after three to six months drops less than 50%. I mean, it's, it's, I couldn't wear one. And so this is, you know, you can take this on and I'll tell them, I said, I can take this on a trip with me. I can put it in my pocket and go through, you know, TSA and don't have to have this machine and put it to the side. I mean, I mean, I'm not going to, you know, we all know the pros and cons of the benefits versus, you know, CPAP. However, but now that this, this, they're pushing this a little bit more as the surgical option. And like I said, if it was a hundred percent, it'd be great, but you know, 67%, you know, I still think so. My thing would be to talk about that because I think they still want, they want the best for their patients and for just education is the best way to do it. And then if you could just meet with them. And speaking of education, maybe it would be a good idea. I'm thinking in my head, like I could formulate a letter to these physicians and, you know, I'll have the video and the show notes from this podcast. I'll have references I can reference and I can fabricate a letter and get out there and do a dry run and, and show these physicians how I can help them and gather a referring source of ENT doctors or pulmonologists just like you've done. So I think that's a really good start also. Can you also, can you, can you share some takeaways from the patients that you've treated in these combination oral appliance therapy cases, along with hypoglossal nerve stimulation, this hybrid therapy, giving some rough percentages maybe of the complaints or the degree of success, just a few pearls that you can offer to all of us. Yeah. I mean, I think of the patients I've seen, so of course the ones with Inspire Therapy that I have seen, they haven't responded the way they should have. So luckily they're looking for help. And so some of them are frustrated and some of them not. So, and so in our discussion with them, it, one thing we talk about is that how I think we can help with that. So is, you know, I can say, look, this, this, this has helped you X amount. If we use this oral appliance, which is really non-invasive, it could, it could help it. It could, you know, increase or, you know, increase your, your, your quality of life. And, but I think of the ones I've seen, like I said before, at least 10% to 10 to 15% of the Inspire patients are going to need something. And, and so with, with my look, my, my take on things is that again, it's just like we do with, with our, our normal patients that hadn't had the Inspire, you know, I want to tell them the pros and cons, but, but what we can do. And, and, but I go do it with three things. One, as I talk about the tongue space, how we can help them with their appliance, with the tongue space to, with bringing the mandible forward, just like we do every day, which will help increase the airway space and help stabilize the airway. And then three, covering the teeth for patient, for the comfort of the appliance. And so those, I mean, so percentage, you know, if you're looking at that, I think the most, those would be the goals. And I think though, if you're looking at, you know, the, the percentage, I think the ones I've had that the physician I just talked about, we looked at six really in depth and four of the six had their HI well below 10 at the end. And, and two of them are a little bit higher than that, but they were still in the very mild range and they were severe ahead. And so they were really, the physician had been really pleased and the patient has been really pleased because they know that they've improved their quality of life. That's a true success for sure. Yes. I just think that those cases you talked about, we can really learn a lot from because they all had different issues. You know, there were a couple referred for different reasons. You know, we already talked about the tongue space and, and tongue soreness and things like that. But most of these patients have more than one thing going on. They, you know, and so when I looked at my treatment for these, on all eight cases, I did increase the vertical on them because the number one complaint or request from the physician was more tongue space or room for the tongue. So and then on those six of them, we had, I advanced as well, and they had improved efficacy studies after the fact. And then the other two improved adherence because we got, we lowered the stimulation doses of those patients. And so the tongue was more comfortable and they tolerated their Inspire device much better. Also reviewing these cases, if you looked at the averages, so, you know, it was pretty much equal male to female. Most of them had a BMI of around 30 and, you know, the age range, the low was 52, the high was 72. And, you know, and then, like I said, one that we had, I had that couldn't stand any kind of stimulation increase. Actually, two of them couldn't, couldn't do that. And then, but one of them, remember, ended up with like a 15 at the end with just the appliance and with his lower stimulation. But another point to note is, you know, as I went through these numbers, I actually got on the phone with my, one of my referring physicians and we talked about the numbers and she almost had an aha moment. And what, what she was saying is that what she does is for her titration process, she'll do it several times. And I guess we do the same thing with oral appliance therapy as well, but she'll do it several times and it's still not get what she wants. And so what her thought process has changed to is she said, you know, I might want to send you that patient sooner in the titration process. So we've kind of learned, which has been a great tool for both of us to kind of see where this is heading. I also talked to the, the, the rep for the Inspire device that she goes into the OR with the ENTs and she was so excited to find out that we were helping with these patients again, because they're, you know, a third of them aren't responding as well as they want them to. And so they want these patients to succeed. And if we can help them, I think that's, you know, really great. So again, that goes back to your relationship to your referring physician. So it's, it's, it's been, you know, it's been, it's been a pretty good retrospective to kind of look to see, you know, what's, what's been happening. And one thing I would change after talking to her too, though, I think with those patients I had now, not just open the vertical, but I do think I would advance initially those patients now. And that's what I think she said. She's found that she thinks a little bit of advancement definitely would help them too. So. This whole summary of your cases had to have just so impressed those physicians. I would think this would improve your referral sources tremendously just, just by doing that. I mean, that's impressive. Who's doing that right now? I mean, that's in their eyes, this is probably the first time they've ever seen a compilation of data like this, you know, with their cases. It's amazing. And that's powerful. So that's, that's wonderful to hear. When you were talking about the patient that wanted to get his appliance removed, his, I'm sorry, the hypoglossal nerve stimulator and spire piece removed, I should reword that. That's not risk-free, like they don't take out the leads, right? How does that work if you actually had to get it removed? I've never heard of that. Well, you know, it's funny because, you know, during the process, it takes, you know, 60 to 90 minutes for the procedure, but you're doing, you're making an incision in the, in the rib, in the, in the, in the right rib cage, because you're putting the sensor in between the intercostal muscles. So you have to go remove that. And what they do when they actually put it in, they tunnel underneath from there. Remember, so you're looking at your, you're looking at the right lateral wall of your chest and they're putting the generator three fingers below the right clavicle. So they're actually tunneling in there to put the lead. And then they tunnel up through the neck and they make it about a two millimeter, two centimeter incision in the, right in front of the submandibular gland underneath the, in the chin and dissect down to the, the glossus muscle to put the actual stimulator cuff on. And so the main thing to have it, so it's a surgery to take, take the appliance out. And I think, you know, with, with that, you would just take the process route, which is located up under your clavicle and not mess with the other two, because then you're digging and you're worried about, you know, scar tissue from the original placement and, or hurting any nerve damage, trying to pull or, you know, the lead out, you know, because as we know, as you heal, it's more likely going to adhere to that lead. So, you know, it, it was kind of funny because I was in the office when, when, when I'm up as, when, when the physicians was going through the titration with the, with the hyponatural nerve stimulator, and you could see her for the mouth, you know, her underneath her chin move as it was stimulated, didn't bother her, but you could see it. And as her tongue came forward and, and, and so it's kind of funny just to, to, to look at that and to see how it works and knowing all the components. So yeah, I, you know, to have it removed, I don't know if I would want to do that because I think that it'd be more risk than, than not. So. Now you talk about the test cases. I mean, I think it's interesting to know that, well, you know, there's a video component to this podcast that people can actually see this, but it is unilateral stimulation. So tell me, I think there was a company coming out where it was going to be bilateral stimulation soon as well. Am I right about that? Yeah. So what, you know, originally in 2014, there were three companies that were going through clinical trials and Aspire was the only one that, that received FDA approval. So now they're in the group I'm working with here. Remember, I told you that he started sleep med. And so Dr. Bogan has been, been on the front end from the medical sleep medicine part. And he was one of the first people board certified that he does a lot of their trials. And he is actually working on two now. One is, is unilateral, but the other one is a bilateral that goes underneath behind the chin and it is Bluetooth controlled. He didn't say anything about what, what, what the results are now, but he's right in, right in the middle of it. But going back to what you're saying is, yeah, you know, cause you're only telling one side and now doing the surgery, at least they're trying to get more toward the medial or the middle part of the tongue, which you can, you know, you can, you know, if you go way lateral within, you're going to deviate more to the left. So the more you can get to the center of those protrusive fibers, the more it'll be straight, but it's still going to be a unilateral protrusion. And so, and that's one thing we didn't talk about, but you know, in my office when, you know, they have a remote and they can actually, some of them have a delay on the remote. And what I mean is that it's kind of like the CPAP, you know, it won't come on right when you go to bed, but it'll turn on in 30 minutes. Same thing with this Inspire device. They can set it with a delay. So that lets them fall asleep first and then it'll turn on. But there is a pause button. So they can actually, before I see the patient, they can actually turn their appliance on. I mean, turn the device on their stimulator device on and pause it to let it halt. And then when they see me, they can unpause it and it'll show how that tongue deviates to one side or another. I had one patient who had a pretty strong deviation to the left because I was telling you, remember, I added some vertical in the cuspid first by cuspid area. Well, it was going right into one of those vertical buildups I made. And so I had to adjust that to allow for the, for the tongue to protrude in that tongue space. So that's what's important with that. But they do have a pause, what I didn't mention earlier, that you can have them in your office to see exactly how that tongue is moving and protruding. That's interesting. I'm curious how much, how, when you're talking about opening the vertical dimension, talk about how that works. How do you determine that with these patients? I mean, are there instances where there's drooling and side effects and how much do you know to open it? What, what do you do with that? That's a great question. You know, yeah, cause I don't want to, you know, I want to open up foot basically and I have their mouth wide open, but I typically try to get an anterior opening of at least two millimeters. Now, again, we've talked about those patients with deep bites. Well, if you think about someone with a deep anterior overbite, if you just protrude end on, they're naturally open, they're vertical, you know, as it comes down the eminence, the condyle comes down the eminence. So, you know, so that's only, that'd be only about a two millimeter opening, but I try to get a little bit, two to three millimeter vertical opening in that area. And the second part is again, using that, the traction oral appliance that goes from the maxillary, you know, anterior to the posterior mandibular posterior to the maxillary anterior, you know, as that comes forward, it helps kind of keep things closed. It kind of keeps your jaw closed versus gaping open. Like, like we talked about earlier with the distal rotation of the mandible with, with like a Herpz style type appliance. And so usually I have not seen those side effects, like the drooling or things because their lips or their mouth stays closed as it comes forward. It kind of holds it. It's almost like a little vertical component to it too, but that style or that design helps keep that closed versus gaping open. So to minimize the side effects that normally opening the vertical would cause. Thank you so much, Dr. Tompkins. I think this review of your cases and personal clinical results will be very interesting to all the listeners, but the techniques that you use in your office may not be successful for everyone. I hope that this discussion leads to future research on this subject matter, and that could all guide us in our clinical processes in the future. I can see where this is headed. Thank you so much for all of your insight and your time today. I enjoyed it. Thank you very much for having me.

hypoglossal nerve stimulation

obstructive sleep apnea

Inspire therapy

dental sleep medicine

CPAP therapy

surgical process

oral appliance therapy

sleep physicians

combination therapy

patient care