Chapters Transcript Transoral Neuromuscular Electrical Stimulation Therapy for Sleep Apnea Course: NYU Langone Multidisciplinary Evaluation and Individualized Treatment of Sleep Disorders It's a pleasure to be here. Thank you for the organizers. And um I will start with my talk. I'm gonna talk for a few minutes and then I'm gonna pass this around. Probably many of you never saw this uh device, but I would like you to look at me first so I will not do it. So my first question is a non-medical question. Um, and I know there are some, uh, dancers here in the audience. Anybody knows about the movie Billy Elliot? Yeah, good movie, yes, so there's a story about a, a child who wanted to be a ballet dancer and the, the family his father who was a widow had a position at the time in northern England because he was a boy, um, and, um, so finally when he wins the fight and he goes to the National Academy in London. Uh, during this, uh, audition, they ask, what is it it feels when you, when you dance? And he said electricity. So he was feeding electricity. So, uh, this talk and the next talk is gonna be all about electricity and uh. Let's hope that we can all feel like Billy Elliott at the end and uh yes, correct. So we use electricity, the neurologists use electricity for some stimulation to treat pain. Cardiologists, of course. So, and uh we gonna talk about electricity and I will be talking about this device. How many of you never had a exposure or. Opportunities to treat patients with this? Anybody? Never? OK, so I'll do my best. I'm not an expert in this because this is new, so I have probably 10 to 12 patients, but I wanted to review that, uh, this device because I think it's very interesting and in many cases, I think it's surprising me in, in a good way. I'm a consultant for and at EMR Medical. I don't have any conflict of interest, but I, I do consultation for a watchpad device that we're not gonna talk about today. So with this uh selective intelligence audience, I'm not going to expand on this. Those are different components risk factors, and we all understand crani facial configuration, muscle tone, heart failure, obesity, and the impact that this has in sleep apnea and the opportunities for treatment and uh we have a good ENT here who will. They would already give us um. Interesting information and the next one is gonna be about, um, you know, how inspired. So, um, I consider myself a doctor of the night. Uh, and I'm going to be talking about a device that is being, is used during the day, yes, and contrary, I think the hypoglossal nerve stimulation use it during sleep. So we, I think we, uh, understand the areas of concern, an obstructive airway, uh, retropalatal retrolingual, and the, the treatment is intended to open the space. Uh, the geno glosso, everybody talks about the geno glossos, that's the area of interest, both for the inspired, I think, and also for the excite OSA and we'll. Discuss and details the opportunities that we can use during the day with this device, um. To improve snoring and, and mild sleep apnea. Again, in the control of the upper airway, we have uh forces that they open the airway and there are forces that they close the airway. Some of them that other thing we talk much is lung volume, strict traction that is important and is an important factor in obesity, um, but in general, the things that I will focus on is the intralumittal negative pressures when you make an effort, that negative pressure collapses, you know, sucks in the airway and uh increases collapsibility. And the extra luminal positive pressure that has an impact on a generation of attractive apneas and hypopnias and and respiratory for arousals is fat deposition, a small mandible, large tons adenoid posture, and of course lower muscle tone, genoglossal muscle tone. The pharyngeal diator muscles that we can focus on is again the geno glossus. The activity of the juglossus is uh reflexive so the more negative pressure that you make an effort to overcome the resistance, the more you're supposed to have recruitment. But sometimes the recruitment, if you have a very high arousal thresh is not enough to open the airway. So it's a balance between those, those forces, the recruitment to increase the activity of the geno glosses and hypoglossals. No activate respiratory neuron, open the airway more. And then the other muscle that we are interested is tensor palatini, that has a more tonic activity and it's a muscle that helps you to keep the airway awake, uh, awake, uh open while awake. Interesting enough, when you look at dental appliances, for example, we know the presence of a dental appliance in the, in the mouth increases the tonicity of the geno glosses and also has an impact on increasing the tonicity of the tenso palatini. otherwise would be only tonic while awake. When we talk about um all the different phenotypes and endotypes. Yes, and the area that I would like to focus on is in this uh area here, and they were talking about risk factors and you can see obesity uh all these risk factors that I want to go and waste time and detail. Then you have pathophysiologic mechanisms that creates obstructive apnea, uh, syndrome and possible treatment options and uh we know that we have mandu advancement that used for small airway, um. Low lung volumes we usually use CPAP is to improve um um volumes and in this particular area hypoglossal nerve accumulation um. The device that I'm gonna talk about is about stimulating that. This nerve while awake during the day. Yes, so the, the literature about the trans-oral neuromuscular electrical stimulation therapy for sleep apnea is very recent. The number of studies, they're not very, very high and the experience is also limited. So I can. I will review what uh what is available and then I'll tell you my own personal experience and how do I use this device. So this is the device. Sorry. I'm gonna pass it around. It has two components. Two components. This is the brain. Yeah, this is what is said. Electrical generator. And this is the electrode. These people need to get it once if you don't break it, you keep it, it's gonna work for years and this part needs to be replaced every 3 months according to every year regulations because the electricity will debilitate the ability to transfer electrical impulse to the tongue and uh this is one that is clean. I'm gonna show you where you put it on and then I'm gonna take it out and but you're gonna touch this one. So of course. Uh, yeah, you're welcome. So this goes in the mouth and you have 2 electrodes here and 2 down here. Yeah, so I'm not gonna put this here. Yes, but this hangs from here and you keep this for 20 minutes. It's above your tongue. The tongue goes like this inside. So this is the tongue. So there are portions of the tongue where they get in contact with this electrode and the other here that's how you transmit electricity, OK? Yeah, OK. Correct. Then you can open the box. The, the other thing that uh Maybe that's really it. Yeah, you you. And this box is very important for patients for you to know that there is a cup. And you take it out to connect, but when you need to clean it every. Uh, they have to use it for 20 minutes, you have to put this here so you make sure no water comes inside. OK. And then you wash this with a cloth. That's all you need, OK. Thank you. So the background information, yes, mild, is for mild sleep apnea and primary snoring. So some of these numbers, I, I would say I agree with them, but especially uh when patient is symptomatic in some details. So mild sleep apnea is very common in the United States, approximately 54 million of adults from age 30 to 69 have sleep apnea and of this 30 million, they have mild degree of sleep apnea. 5 to 14.9 and we know if a patient are asymptomatic, we don't know what that means, not necessarily they will have requirement for treatment until unless you have some medical special considerations that you worry about, uh, but those patients with MaloSA when they are symptomatic, they're more likely to have poor quality of life than controls increase chances to have hypertension. More likely to have fasting glucose or prediabetes and 33% more likely to be diagnosed with diabetes in the future. Remember that sleep apnea is a longitudinal condition, so I test you today after Thanksgiving, you put 7 pounds. Now my test doesn't mean anything and after 1 year, doesn't mean anything. And the other the other way around is also possible, yes, you lose significant weight. Now you don't have it anymore from severe, you go to mild. So it's a dynamic population that you have to follow. In general, if you follow the American Academy, the medicine recommendations for treatment-based devices, yes, um, from primary snoring mild, moderate to severe OSA, yes, you have positional devices for mild to moderate, uh, oral appliances, I would say that I will expanded to severe because the American Academy and Dental Sleep Academy, they also recommend the use of dental devices. For severe apnea when the patient is unable, unwilling or, or fails the ability to tolerate CPAP. So we use dental appliances for severe also. And of course, CPAP, if you have comorbidities. Insurance like Medicare will required for an apnea hypo. I mean, in this more than 15 to have comorbidities, otherwise you don't get CPAP and positive, uh, you know, CPAP, um, and other devices that I'm not gonna talk right now, uh, implantable devices uh are used for, you know, different degrees of sara. So the excite OSA or trans oral muscular stimulation is a daytime therapy. Yeah, so it's easy to use, but compliance is always an issue, so motivation with patients and to make sure you're on top of them, that they use it regularly, it can make a difference. Yeah, so it's indicated for primary snoring in MSA there are some trials, yes, to see if this device can be used for moderate OSA but they're not FDA approved yet, so, um, I'm not going to talk about because I don't know what to say about. And um like anything else, things that are FDA approved, they're not always. Paid by insurance, so it's a little challenging, but luckily it's not as expensive as uh you know, other devices. So how does it work? As you can see there is an app for everything. Yes, these days. And uh it is really very helpful. So there is a device, there is an app. And how does it work? The role of these devices the following. Think about the upper airway muscles, yes, especially the genial glossus as we, uh, discussed previously and now. The genial glossus is, is activity is a necessity to have upper airway opening and it's sufficient. We target the genial glossus with the hypoglossal nerve stimulation and this is why targeted the same. When you look at muscle fibers, I'm not an expert, what I know there are 3 types of fibers, yes, and if you see here. Uh, force or strength and endurance and think for a minute if you. You introduced me as a soccer player, thank you, but the lower extremity muscle. Volume and activity of a soccer player, professional, it looks different from a marathon runner. And in reality, if a marathon runner tries to play soccer, he's gonna get injured, and the, the soccer player is gonna try to run the marathon, he will never win. All right, so the uh. This is an impact of this device on the distribution presence and, and percentages of um these muscle fibers after you use the device. Uh, the more you have type 2B. Fast twitch glycolytic, the more strength you have, yes, and the more you have type one slow twitch, you have more endurance. Yeah, so what do you think you need for this device to work? Strength or endurance? Anybody. Huh? Both Uh, no. Endurance Yeah, endurance. That's what I thought, but yeah. And it, it, it supports the research supports the what it works and effectiveness is endurance. And if you think for a minute. Uh You sleep for 8 hours. So strength is not gonna work, so you need endurance to be able to maintain uh that uh upperway. So the, if you look at patients, if you compare here, yes, and blue is a type of fibers, yes, uh, type 1, type 2 and type 3, patients with sleep apnea untreated, yes, they have less type 1 fibers. And detente And then patients um and uh untreated, yes, and patients with control without sleep apnea, they have more type 1 and you see the inverses also too the type 2 B fibers in a patient who has sleep apnea, it is untreated has more but it has less. Yes, and the over the type one. Is that clear? Means patients with sleep apnea without treatment. Yes, they have less type one fibers and more of the ones that doesn't help you to maintain airway opening during sleep. The and this is in in vitro faigability studies and the, the reason I like to present this data because the scientists behind this that I'm not one of them include people like Gul Malotra so they are very, very um reliable people. Behind these trials that I have a lot of confidence and let's see what happens at the end. So, uh, the role of Glosso and OSA would, we, we, we already spoke about this strength, this is mta for you, yeah, endurance, and you have controls, yes, and then patients with uh with OSA and then you hear here the. for endurance. The controls, they have more and the patient with sleep apnea, they have less. So what is the idea of using this uh device? So the intraoral electrode with the stimulation is intended to change that relationship between type 1 and type 2B or we used to call it 3 fibers. By doing this electrical stimulation daily. Yes, and then we'll, I'll show you the frequencies later, but there for 20 minutes I use it there's 4 sets, two low frequencies that repeat and then higher frequencies in in crescendo and, and then the um hypothesis was by changing the configuration and the relationship between type 1 and 2B fibers that this could have an impact in the upper airway for patients with primary snoring or myelose. Well, the clinical experience. So again, apps for everything. So you, the patient needs to get The device It comes with a first electrode. You have a nap 20 minutes every day. It's very important that you put it in the back, not on the tips of the tongue, because the back of the tongue is what you have, what you need to have more impact. The front of the tongue fibers is completely different from the back, and it's on the back of the throat. That you need to create this stimulation. To provoke a physiologic chain. It's uh one time every day and the app will tell you if you're not using it, and if you fail, it's gonna make you to go back to start from scratch. And then, and I think it's important because um uh I, I think about like 8.5 ago, they were asking for 2 months. It seems like now the research supports they need to use daily for 6 weeks. So you have to make sure when people travel, we know our patients to travel frequently. The device is small enough that you can put it in your backpack and goes with you. And then, maintenance is twice a week. For how long? Forever Yes, almost like Manjaro. Yes, forever, talking about the impact of things. Um, this, uh, device makes me remember, I don't know if you remember the, uh, trial with the DJG 2 instrument. Yes, so we did a 26 read with just some pipes of plastic, uh, um, we tried to reproduce the digitid do uh it did introduce an instrument and I think in Australia that you do circular breathing that makes you to make a significant strength in your tongue. So, um, talking about myofacial training, so it seems like this device is not the only thing that you can do, but this really helps you with the consistency. It's really uncomfortable to travel with the DGD do. I can tell you that. uh, and this is twice a week, uh, forever. The other thing that you, you, this uh device instead of software they were smart enough that they have uh airport scales, um, you know, fatigue scales, and you can track yourself how you feel and, and the device also will track, as you can see, the sessions, the days. And uh this that, you know, that you're going in every week and if you don't, if you're in the maintenance period and you're not using it twice in a week, this phone will wake you up. It says, you better use it today, you're gonna lose the truck. And those are the frequencies when you put it on, and also the, you know, 3 Hz, 3 Hz, 10 and 20, so it's 5 minutes, 55 and 5, and you feel it, it's very, you know, I use it myself to see how you feel and it's very interesting. It's not painful because you have the ability to regulate the uh intensity. So uh you can, you know, the range of the stimulation is 1 to 15 and patients at the beginning, nobody will tolerate 13 or 14 or 12. So you start at low. If you put out at 1, you may not feel anything, usually 34, and after 23 days you may be in 5. So after 2 weeks you should be able to go to the highest number tolerated the tolerance of stimulation varies of patient for patient, uh, and from the very limited number of patients that I tried, none of them said. I don't tolerate this because you can adjust it. What they can tell you that they think it's not working, that's a different story. Uh, but they have to use it at the highest tolerated level, and when you tolerate it, if you're not at the maximum after maybe 2 weeks' maintenance, now you can tolerate more. So you always challenge yourself because I think it's important, putting on the place in the back of the tunnel. Uh, the other thing that, uh, it's important. How do you monitor compliance? So you have a portal. There's apps for everything. There are portals for everything. So I hope uh as insurances they may approve this. We already started in, I think it's North Carolina or South Carolina is already approved by Medicare, Medicaid and uh this is a device that you can use and hopefully will be uh available by other carriers, but you can have your own portal as a, as a provider and have all your patients listed and The device doesn't work unless you're connected to the internet. And uh I will report to the database so you can monitor the patient and, and if you are proactive and you see that somebody's dropping and they don't use it, then you can communicate with them and try to restart again. Sometimes they don't use it for valid reasons, uh dental work or any other things, you know, infection, but I, I think you can go back. If you lose track, you can go back to scratch and then you can have to do your 6 weeks again. So at least uh look at the clinical trials, data, yes, um. In all cases, the source data is um Maintained that there's a signifier Medical is a is a company uh I know a PhD who is based in London that is now in the West Coast, so I'm sure it's gonna be in probably in San Diego in ATS and uh uh and again the, the studies are done by uh smart people. So what is the impact on snoring clinical trials and so you have bed partner reported, so this is a bed partner reported a snoring severity scale from 0 to 1. And with the use of the device there's a reduction of 39%. This 115 patients. Yes, and remember when you look at threshold and when we talk about sound and snoring, remember that um that, you know, significant reduction uh is objectively measured, yes, and looking at three different levels, more than 40, more than 45, and more than 50 and 40 decibels is a threshold that the World Health Organization recognizes a nice time pollution. So we try to target, you know, to decrease the noise and this is what you see at different levels and the reduction can go from 40%, 52% and 50%. So it is not down to zero snoring, but it's a significant uh reduction in snoring. And for patients with primary snoring, that you're not gonna order CPAP or sometimes they can pay for a dental appliance, but it's expensive. Um, this is an opportunity to use and then we'll talk about what do I do when snoring is residual with other devices. So this is a, this is a multi-center trial in the UK in, in, in Europe, and you see uh impact on OSA severity. So the AI reduction, remember this is for mild patients, yes, so overall, uh 10.2 to 6, but when you look at the responders, the people who they do better. Yes, there is a reduction from 1044 to 5.0, so it becomes in a normal range and there is a reduction of snoring. What I noticed in the, in the few patients that I tried, the key point for me, especially in male patients, is the number of reductions of nocturia, and that's what I think for me is a sign. If a bed partner doesn't complain as much or it snoring is very soft. And the patient tells me, I, you know, I wake up only once to go to a bathroom now. To me it's meaningful. Yes, I'm not saving a life, I might be saving a marriage. Um. Yeah, and then, uh, when you look at the UCSD there's another trial. There's only 11 patients, there was a significant reduction there in AHI from 17.7. Um, so, We have to remember when we look at CPAP uh and we look at compliance of a memory card, that's the compliance of the CPAP it's not the compliance of the patient because if you use CPAP for 4 hours and UHI is 2, now you sleep 3 hours without CPAP, nobody tells you what the HI is. You can go back to your sleep study and see what the HI was and extrapolate. The patient doesn't have, you know, it may be compliant for insurance purposes. Now the insurance will continue paying for supplies, but the message of 4 hours is very bad and these numbers are all night impact. The same thing with dental appliances patients they tend to keep it the whole night so the the in this reduction may not be. Like a CPAP or 2.0, but if you use it more hours, you know, it's, it's meaningful. Um. So among all participants with MSA at baseline, this device was asciated with a 33 reduction in AHI on average. 78% were identified as responders and these participants had a reduction of 52% of AHI on average um. And I think that, you know, interesting. Uh, other, uh, elements of clinical trials on severity we have here again, uh, the same numbers, reduction, the responders and uh. Same efficacy story. I'm happy with this. Among all participants with Malo is a baseline, the airport scale. So they look at airport impact. This, we all like airport, I don't like the airport that we have to use it. Um. So all patients, changes in eport uh from baseline with the device, there was 3.4 points reduction on port scale, uh, and the first group, and this is the other groups are 8.4 to 5.9 and 8.6 to 4.3. So I think that airport drop as um reliable and again, those studies were done by good people. When you look at adverse events related to exci or SA, there are not many, um, and I'm gonna show you the contraindications in a minute. Uh, mostly pulling saliva. So when you put the device in the mouth, sometimes, you know, you have a little drooling, so some people drool more. So what I tell people is to grab a Piece of paper and put it under the device so it collects the saliva so you don't. But and it is not a major thing that you have tongue tingling. It's a, you know, some patients they report on, and remember, this is the colors, yes, darker. Uh, this is the second one is tingling, and you have a tooth sensitivity, metallic taste, uh, gag and tight jaw. Sometimes it can happen and this is by week 123456. So those are the side effects. Mhm. Clinical trials. Uh, participants had primary snoring. Again, if you look at this, uh, to strand we got now, yes. What is my, OK. Oh, I lost my control. Onto yeah. OK. So, if you look at this uh photo here, there is a device um above the tongue that is a measurement of pressure. And you can measure how much pressure you're able to generate and then you can also measure how much time you can keep that pressure on force versus endurance, yes, and then if you look at uh. Baseline follow up. Yes, and then you see baseline and follow up. So this is strength. No significant change, yes, and this is endurance baseline versus solova. So there is a significant ability of those patients exposed to the use of the um the stimulator to be able to keep the forces for extended period of time that I think is what you need at night when you sleep for many hours, um. Intensic up there was they didn't see any difference in genial glosses in G tonic or basic or total sleep time. It has in the impact of REM versus not RAM. So it's the daytime, uh impact um on tonicity and endurance. Um, Interesting studies, you have it uh reference there. And I would recommend it to review it. Clinical tries again. Now we see the impact on severity versus hum. So they also did a Shum study that I think is very important. SA means that you don't get enough electrical stimulation to create make a change, and then you can see uh the participants, and this is uh one of the trials and the I here tells you the aperage, yes. And um there was in, in all OSA patients with the device, there was a significant reduction. Well, a reduction on all of them, yes. Uh, and then we'll see what happened with the responders, but with the some device, there was no improvement at all. And uh so how many people are using this? So far worldwide this is up to 2021, 14,000 patients have completed 1.1 million sessions in the United States we have 9,411, completed 808,000 sessions. So, um, there's much more to learn. About this, uh, the other thing I wanted to say that some of the studies, uh, pre and post. Were done by poly sonography with the uh geno glossus measurement of tonicity um you know NG of the geno glossus and they did it at baseline and after uh it, it, you know, twice after a few uh weeks of therapy. So they did it interesting, I, I would say. And some people believe that there is a future here. Regulatory information. So, uh, we. Have vis a vis approved since 2021. I think the penetration in the market is low because people don't get coverage, unfortunately. It's a class to device and again it's indicated for primary snoring and my OSA and there are some trials for moderate OSA. Contraindications and United States is different in the UK. And I have a UK map, not here because it's irrelevant, but uh the, these trials were not done in pregnancy, so, no, if you're pregnant, we don't use it. If you have a pacemaker or, you know, a defibrillator, you use it. I don't know the answer but if you have an inspired in this, but probably I wouldn't use it. Uh, and then if you have implants, dental metallic implants in the mouth in the United States, we don't have the approval, but in, in Europe, yes. And uh if you have mouth ulcers, they are frequent, then there's a problem. And then if you have an AHI more than 15, there is no AB approval for this device. Questions. Switch it on. OK, so my first question is, um, the longest, uh, study to see the efficacy, how long was it? Was it for 1 year, for 2 years? No, I, I don't, we don't have for 2 years yet, but those trials are ongoing, but I think it was like 6 weeks, 3 months. And there is a trial ongoing, but I, I don't know the numbers. The reason why I ask is because I'm thinking of muscular well strength, endurance, whichever, um, but if you exercise in my mind, this is exercising a muscle, um, and if you exercise a muscle you tend to bulk it up. To some degree, so over long term, like over a year or 2 years or 3 years of using this device, is there a risk or a danger of the tongue hypertrophying and then causing a different problem, you know, now it's, it doesn't have the endurance, but long term will it cause obstruction, more obstruction that the increased endurance can't over overcome. Yeah, that was, that was a very good question. And again, and that I would like to go back to. Different sports, if you are, uh, have you ever seen a marathon runner with a large muscles in the legs? You don't. So, and, and also. The size of the tongue and the proportion of fat to muscle goes in your favor, so the tongue looks smaller and uh so I and so far, and again I'm, you know, I have a few patients, but the literature doesn't suggest that there is a muscle hypertrophy like if you're lifting weights because it's, it's uh endurance type of changes, but usually the fat content of the tongue also changes down. So I don't, so far, I think that science will tell, but I, I, I, I don't see any evidence for that. And for the people that I use it, the tongue looks a little. Thinner but I never measured the size of a dog. So 22 questions. 11 is, uh, sometimes we see those patients with mildly sleep apnea, mostly REM with the oxygen saturation goes in the 80s, low 80s, high 70s. What are the changes in oxygenation in this device, #1, and number 2, is that result the same according to positional? It it works better in uh supplying people that in people that have like, I, there's no. I don't have evidence to answer that question. But in general, it's for mild sleep apnea and uh Mostly part of saturation in the 70s. I'm not sure how this is rare, of course you see what happened in re. In these people with REM only sleep apnea, right, so I will answer this way. I'll tell you the way I use it because the evidence is still scarce, so we don't have much. So let's assume you have a patient who doesn't want CPAP, fail CPAP, and is going for a dental appliance, and those are not recommendations, so I'll tell you what I do. So you, you do a study with a dental appliance, you repeat your home testing, the patient is better, but you are not at the place that you would like to be. So I use combination and you can use combination of positional therapy. So multi-modal therapy for sleep apnea is not uncommon. So you have to be creative and uh. That's what we know so far, but it, it is a good question. Yes, I think saturation improves also, but I don't have a number. Yes, um, because the device is inside the mouth, um, is any data about, uh, I'm talking about the contraindication about if the epileptic patient of any activity can use it. And, and the, and the documentation of the, the trials, there is no uh contraindications, nothing is mentioned about epilepsy. Probably You know, probably, uh, Something to consider, but I don't know, but you guys have the answer to that, so I, I don't, I'm not sure. Device is used during the day, right? I mean, if the patient has uncontrolled seizure, probably not a good idea to have anything in the mouth is the epilepsy is on no control, right? Well, those are rare patients that have some control they cannot use it for how many minutes is 20 minutes, 20 minutes every day. It's gonna be very unlikely unless you have really refractory epilepsy and probably you're not a good candidate anyway. That would be say refractory epilepsy with multiple seizures a day is not a good idea. Yeah, the, the, the other thing that, and, and I, I think it's an amazing question. Thank you so much, is that Although the patient may have mild epilepsy, we know what is the impact of suboptimal sleep apnea treatment on a patient with epilepsy. So if a patient has epilepsy, I will never suggest this device to begin with. I will hide it so they don't see it. And, uh, and, and, and go to CPAP, yes, that's for sure. And uh if they want, but I, yeah, I wouldn't use it personally, but I don't think we have any enough patients recruited with epilepsy to see that there is an impact on, on worsening activity, but I wouldn't use it in a patient with epilepsy, um. Yeah, I just wanna know what your data is on your compliance right for that device. Yeah, it's, it's an, it's an interesting question. The The compliance rate is averaged at 83%, sometimes 78%. It all depends how much effort you put on and uh having a communication. Um. I've seen dental appliances done by dentist without a morning aligner, they don't have a yearly follow-up. So if, if you know, if you want to know what your patient is, you need to have assessment, follow-ups and that will improve. You have a um portal so you can see if the patient is not compliant, you can recall them and learn why they stopped using it. Uh, I have a couple of patients so they use it, they don't feel different. So they think it doesn't have any impact and you repeat the sleep study, there is some improvement of AHI. It's not critical that it's gonna change, you know, um, risks for the future. So I tell them to stop. And sometimes people says, let me keep another 3 months because the data again is, is new, 6 weeks and, and I asked them what I tell them is to try to see if you can tolerate. Higher, uh, because you can rechalenge yourself at a higher level of voltage that you take and to see if you can tolerate more and more and maybe it makes a difference, but some people uh get disappointed it doesn't work, and other people they're happy with it because there's no less or again, less noturia. Yeah. What are the costs associated with it? OK, so when the device came, uh, when the device came to the market, the initial price was $700 a unit. And the uh electrode. Yes, uh, it was $75.80 dollars. Right now, I think the device went up to Between 1000 and 1400. It all depends. There are some uh medical entities that you can see and you can buy them, uh. There are two, there's a prescription for all of this device. They have two companies, one is signifier and the other is a little cheaper, and the electrodes can cost anything between $80 every 3 months or $120. That's what I see. All these things, I think, I mean, I don't, I don't have any relationship with the company. If you compare these two co-payments for CPAP supplies that you need every 3 months, I think that uh it's interesting about the economics of uh of, of devices, yes, including talking about dental appliances they are more expensive at the beginning, but when you look at CPAP supplies, filters, tubing, mask, humidifier chambers by year number 2.5 equalizes the cost of a dental appliance ahead of time, and dental appliances are covered now by. Insurance, uh, some dentists are out of network, but including Medicare will pay to the dentists $2100 for a dental device. So I, I hope in the, in the near future as we get approval. Um, you know, through the insurance and Medicare and Medicaid, that this device, we can learn, use it, you know, get the experience, decide if you want to continue using it, including myself, as you have larger number of patients and you get the feedback from them, but that's approximately the cost. So the $75 is the one you have to replace every 3 months. Yeah, so, interesting enough, this thing, the one that you don't want to touch, yes. Um, so, yes, every 3 months, if you don't replace it, the app, it says your device is out of time. Time to order one. It is a, I called them and I said, listen, give patients a break, and he says, no, it's an FDA mandate. Because they look at the material durability and the possibilities for electrodes to be, you know, out of um contractor I'm not an engineer, but FDA said 3 months. So if when you are about that time, you have an opportunity to order through the app and they send it to you or you can go online and buy from different suppliers. I'm asking some homecare companies where they have high volume uh to see when they're gonna have this in place. You know, now homecare companies, they have position of pillows. So, you know, any time of it. Position of pillows for, for supine apnea. Some home care companies they carry on. So we have to think about multimodality in the future. Maybe patients we can do well with a dental appliance, sleeping on supine, and if you still need something, maybe take into consideration or You, you know, you order a CPAP or you make a referral to Doctor Void, who's gonna talk next. Anybody else? Uh, you think that this could be, uh, good options for, for example, this kind of, this kind of poster I had Down syndrome, they have large to maybe can help it to maybe help to the breathing. I don't think they have any recruitment in patients with Down's syndrome, so I wouldn't use it for Down syndrome. Um, so I, I, I don't know how the answer because there is no supporting data for me to think about this. But the, the macroglosia of the patient with Down syndrome is so significant. Um, I'm not, and they have hypotonicity. So I think tonicity. In theory, perhaps they have an improvement. But I don't think it's gonna have an impact in Marrolosa, so I, I wouldn't use it, uh. And also I think it would be difficult to wear because most of the time they have a protrusion of the tongue outside so just most of the time they have the tongue out of the mouth like this, yeah, for multiple reasons that's one of them correct. It's a question, is there any damage or change to the jaw structure with with this, is there any change as far as you know? I mean, this was if you, if you approved in 2021 and the people behind this device, uh, You know, work on these trials for a few years before. I'd, and that I listed there. You know, details of the potential complications and contraindications. So I know you can have some, you know, but I, I don't, uh, facial remodeling, uh, I don't think, uh, because it really, when you put it on and you feel it, you only you feel the tongue contracting. Yes, it's inside the mouth, in the tongue. It doesn't have an impact on the other masticatory muscles, it only touches the tongue. And that's how you feel. That's what you feel. Published May 11, 2024 Created by Related Presenters Omar Burschtin, MD View full profile
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