hi my name is Victor I'm an ENT surgeon at the Royal National ENT Hospital in central London UK my job on the NHS is to provide surgical care for people with snoring and sleep apnea and what I want to do today is review this device this is called the genio system by nixu and it's a device that helps people with moderate or severe obstructive sleep apnea so what I'll start off with is to explain how it works and how it stops snoring and sleep apnea and then I'll explain the medical evidence behind it and at the end I'll talk to you about my opinions and Impressions about this device now I should mention that the people who made this device Nick saw a company from Belgium they haven't paid me for this video at all these are my own opinions and Impressions about this device but I ought to mention that I'm actively trying to work with the Royal National ENT Hospital University College hospitals and also the surrounding Commissioners in the NHS to provide this device free on the NHS for anyone who has this problem in this in this country in Britain so hopefully this will be available free to all soon now before I get started because of the YouTube algorithm I'd really appreciate it if you were to like And subscribe to my channel it really helps me build more content and provide better quality videos for you now to understand how this device works you need to understand a little bit of anatomy firstly it works on the hypoglossal nerve the hypoglossal nerve is a nerve there's a right and left one and they come down from your brain underneath your chin and up into your tongue just about here it's called hypoglossal because it's hypo underneath that's what hyper means and glossol is another word we use for tongue so what this device does is that it sits underneath the skin just about here it touches the two hypoglossal nerves as they go towards the tongue and one of the functions of the hypoglossal nerve is to bring your tongue forward it drags It Forward like that and by doing that it opens up the back of the airway so that you don't get sleep apnea and snoring so who is this device used for now the genius system by nixler is mainly used for people with moderate or severe sleep apnea particularly those who have tried but fail to be able to use CPAP or a mandible advancement device in this country now if you don't know what sleep apnea is there's lots of information on my website which is consultantsurgentco.uk or if you look on my YouTube channel there'll be plenty of other videos that you can look at basically what obstructive sleep apnea is is when you lie down at night you go to sleep and because the airway collapses down in these people it clapses down so much that you can't breathe and because you can't breathe the heart tests to work very much harder the lungs have to work harder and this has a consequence of causing problems with heart disease Strokes heart attacks diabetes high blood pressure so it's an important condition that not many people know about so obviously this little chip needs to be implanted within the neck so just underneath the skin here just above those two hypoglossal nerves so you'll have a cut which is just across here this chip is implanted inside and the whole operation takes about 30 to 60 Minutes to achieve you can go home the same day so as you can see this microchip is quite small and the idea is that because it's got a very soft plastic over it you shouldn't be able to feel it when it's inside your neck and you can just about forget about it the difference between this hypoglossal nerve stimulator and the other ones on the market is that this isn't implanted with a battery the other stimulators on the market have a battery that's implanted with the microchip so to charge the microchip at night you need to use a battery and this is the battery that nixwork provide this battery Powers the microchip at night and what it does is it sits just underneath your chin like this and you have to wear this whilst you're sleeping each night now there are no needles or any other invasive way of powering the microchip it just works wirelessly through the skin to charge this battery what you need to do is get this charger that Nixa provide and you just plug it in and with uh you put this in the wall socket to just charge it over the day now to use this battery at night you need to be able to keep it close to your chin and so it can charge the microchip underneath the skin the way it does this is by using this sticker so you have to wear this sticker every night so you put the sticker on at night and then you put this like that with the sticker and so that way the battery can wirelessly charge your microchip because there's only a short distance between the two now next to us say that you can't really have a beard when you're using the sticker because it doesn't keep it stuck there so obviously if you have a very large beard this won't won't be anywhere near your chin and therefore you won't be able to power the microchip but if you have a much smaller trimmed beard like I do I think it's all right and look I'll show you how this works you can just get the sticker put it on underneath like this I think you can have a goatee as well and just leave it like that as long as it sticks it'll sit there and charging all night the only problem is when you take this off in the morning wow it's kind of painful you may lose a little bit of hair taking it out so I can appreciate that uh having a beard and not being able to use this is a minor problem but I'm a 21st century guy and my wife has told me I have to wear a beard so I can assure you you can have at least a little bit of a beard um and it should be fine now one of the advantages of not having a battery is that if you have it implanted after about 10 years that battery will just start dying and you'd have to have that replaced with this system you do have to wear the sticky on every night and the sticky plus has to sit there every night but at least you don't have to have another operation every 10 years to get it to work now another thing to mention is that this battery needs to be three and a half centimeters from the microchip for it to be able to power it wirelessly now if you have a lot of fat underneath your chin this will make the distance too large and therefore it wouldn't work the advantage however is just that um during the operation I could just remove that fat and then it will sit a little bit closer so you could guess you could call it a neck liposuction or something like that so what I'm going to do now is show you a video of someone who's had the implant and you can see how the tongue is protruding forward every time the uh the chip activates this is quite an extreme version of this and I suspect that it won't be so stimulated in this person that night what we need to do at night is titrate how much energy goes into those hypoglossal nerves you don't want the tongue to go forward so much that it wakes you up at night and that becomes rather irritating however you want it to come forward enough so that you can sleep and not have sleep apnea and this is a video from inside the thread so you're looking down from the nose down into the throat that little v-shaped thing that you can see there is the voice box and the the big lump that comes um up and the screen that's the back of the tongue falling back and when the implant is activated the tongue gets shifted forward or down on this video and you can see how it opens up the airway stops you from having sleep apnea so now that you've seen how this device Works what I want to do is talk to you about the medical evidence for this device so the first paper was written in a medical journal called laryngoscope This is an excellent journal and it's a case study now a case study means it's basically one person and the The Experience they had with that first patient so the patient that they found was a six-year-old woman with a moderate obstructive sleep apnea and you can see from this result that she went from an Ahi of 24.6 down to an h i of 1.3 with the implant now as you can expect with the paper of this sort the people who have these interventions do extremely well and if you don't exactly know what an Ahi means hirs a number of times that you stop breathing every hour a bit of context for you less than five Ahi so less than five times now that you stop breathing that's considered within the normal limits five to Fifteen so up to 15 times an hour stopping breathing that's considered mild obstructive sleep apnea 15 to 30 is considered moderate obstructive sleep apnea and greater than 30 times every hour is considered severe now this lady had 24 and then after the operation after the implant's been turned on she dropped down to 1.3 so well within the normal range so she had an excellent excellent result if you look at these two graphs before and after the implant you can see also her snoring got better you can see the wiggly lines with the snoring or the loudness that's got better and so she's had a great result and you'd expect a great result in a case study like this they're showing off how well the device has helped this person she has been effectively cured from a snoring sleep apnea so the next paper I want to talk to you about is this paper which is much bigger this is for 22 patients over eight different hospitals between France and Australia now I'll be happy to talk to you about the the study methodology Etc but it's rather boring and what I'll do is I'll go straight on to the results this paper is freely available on the internet if you'd like to have a look at it over a couple horlicks or something anyway moving straight on here are the results this is another table a bit like what we saw before with the results before and after of all the patients and it's an average of all the patients this time so on average patients were 50 improved with this implant now it may not seem quite as good as the last paper but if you imagine using CPAP that's the sort of thing we would expect to see with someone using CPAP well the reason why I say that is that CPAP which is the mask that goes on your face whilst you're using the CPAP mask you'll see Ahi results down to 0.2 0.1 almost zero and that's great but most people can't use CPAP through the whole night they can only use it for about four hours seventy percent of the time now that equates to about two and a half 2.9 hours each night now when you take the mask off in the middle of night and carry on sleeping like you normally do you then go back to your normal Ahi which is approximately 24 in most of these cases so if you average those two out on average most people who are using CPAP well have an Ahi with including their Total Sleep time of about 11 10 to 11. so bringing people down to about 10 that's an excellent result and what you'd expect to see with someone who's using CPAP well the other reason why this result is good is because you've gone from an hi of 20 down to 10 and what that means is that you no longer need to use your CPAP machine anymore and that's what most people would rather not do some people who end up going for an operation like this are so intolerant of having a mask on their face they would rather have an implant to avoid that so now going back to this paper I'll show you some graphs that they've also provided now this one is about the Ahi you can see on the left it goes from pre-operation before the implant and then afterwards down to what it was like after the operation and in this graph we look at the ODI the one that is slightly more representative we think of obstructive sleep happening in terms of how patients feel so you can see that the majority of people who had the implant got better after having the implant even after six months of using it if you look carefully at these graphs however I'm a bit surprised by some of the results you can see at the lower end of the graph that some of these people didn't seem to have sleep apnea at all some of them were less than five so I'm not entirely sure what's going on here and honestly I don't really understand how this could be true because there'll be therefore implanting people who didn't have sleep apnea and that doesn't make any sense to me I'm assuming it's a mistake and so therefore implanting someone who doesn't have sleep apnea with an implant that's meant to stop sleep apnea well you're not going to get much benefit and you can see those people who are less than five the line is almost flat whereas the higher up you go with the higher HR you see a much bigger fall so even though they seem to implant some people who weren't quite as bad as what we'd expect to be using this implant for they still have quite good results so as I said before the average Ahi dropped from 20 down to 10 and the results of these implants are similar to what you'd see with other hypoglossal nerve implants out there now the good thing about this paper is that it also talks about the side effects and the problems that occurred with this implant now three people didn't manage to use the implant because they got infected it seems that most of these people who got infected were from the same hospital so out of the 22 people who finished the trial 30 of people had painful or a difficulty with swallowing and 26 people had difficulty with speaking nineteen percent of people had a blood clot around the implant and a further 19 of people had bruising around the area after the operation eleven percent of people after the operation noticed that when the tongue was protruded forward when the stimulator was turned on the tongue used to rub against some of their teeth and that caused some ulcers there also some people had some pain when the tongue got pulled forward another 11 of people had evidence that the hypogosal nerve was damaged during the operation on saying that it seems like quite a high number but actually most of these problems all got better so for example the damage to the nerve the nerve repaired itself and that was fine and you can imagine when you touch a nerve or you operate near a nerve it's like falling asleep on your arm when you wake up in the morning it takes a bit of time for that nerve to start working again it's the same thing that happens with most nerves that we operate on for a short time they may not work particularly well it doesn't mean that you can't eat or drink but it does make it slightly more difficult whilst the nerve is repairing itself I presume also that the people who have problems with their tongue with it rubbing at their tongue they change the stimulation level on the microchip so it didn't cause so much damage rubbing against the teeth or hurting when the tongue was pulled forward what I did notice on the study is that they said that 30 of people had trouble with the the sticky stuff on their skin some people are quite sensitive to Sticky plasters and I think it's the glue that they're sensitive to now again although it says 30 of people had problems at the end of the trial only one person still had a problem with the sticky plaster that you use underneath your chin it might be worth if you're considering this is to use one of these stickies and stick it on at night just to see if you have a sensitivity to it now in the trial they said that with these people who's like sensitive they gave them some emollient creams moisturizers and things like that and this problem soon resolved itself but there was one person that continued to have problems even after six months so in conclusion I think this implant is is a really good idea there's lots of differences to the other implants available on the market firstly it sits just here it's quite small it's not obtrusive it works on both the nerves at the same time both hypoglossal nerves so with some of the other implants they only work on one nerve and your tongue twists around in its in your mouth at night and that can wake people up whereas you can put a little less stimulation on your tongue and bring it out equally on both sides so that's really good having a bilateral nerve stimulation it also doesn't involve having a battery inside there so you're not encumbered with this battery which after 10 years you need to remove with another operation and replace it it does however mean that you need to charge up a battery every night and stick it under your chin so it's not completely sort of hands-free like the other implants so I think that we need more studies to prove that this works really well and I think it will show it if you look at hypoglossal nerve implants throughout the world for example The Inspired device they've had eight and a half thousand implants implanted around the world particularly in America and I think this implant will really help the overall landscape of implants in obstructive sleep apnea so like I said at the start of the video I'm trying to get this implant available for everyone in Britain free on the NHS so thank you very much for watching I hope you found this video informative please do press the like button and subscribe to my channel it helps me grow this YouTube channel and tell more people about snoring and sleep apnea thank you very much