A review of a new implant for sleep apnoea - the Genio System from Nyxoah

[@PenelopeRose238]

Thank you. I'm comparing Genio vs. Inspire and your video was really helpful. I could get a free clinical trial for genio but any pressure under my chin or around my neck makes me feel like I'm chocking so I don't think I could tolerate having that battery taped to the underside of my chin.

[@screamtoasigh9984]

Looks too big for most women. I was thinking that when I saw it. Same issue with many cervical collars for positional apnea. Can't find one short enough.

[@robo265]

Great video doc this sounds far better than inspire thanks for sharing 😀👍

[@VikVeerENTSurgeon]

Glad you enjoyed it!

[@Surferjo]

love the video what is the COST?

[@teejayare2980]

Hi Dr Veer, The explanation for the AHI < 15 is the difference in scoring criteria between that used in the study inclusion and that used for the publication of the study. The scoring criteria used for inclusion was the AASM recommended, whereas the published data is the AASM acceptable (there is a one-liner in the paper, but the implications of this is understated and brings a lot of confusion by individuals without the knowledge of the scoring rules). Essentially, in the recommended, hypopnoeas are scored where there is a 30% decrease in airflow accompanied by either 1) a 3% decrease in blood oxygen saturation OR 2) an arousal. For the acceptable, there must be a 30% decrease in airflow accompanied by a 4% decrease in blood oxygen saturation (no arousal criteria). It’s much easier to achieve a 3% desaturation than 4% thus there are more hypops scored (contributing to a higher number in the H component of the AHI). In addition, there are more hypops scored simply because the occurrence of arousals are scored following the cessation of flow, regardless of oxygen saturation. So the acceptable criteria (used in the publication) understates the clinical significance of OSA by not including the arousals (frequent arousals lead to significant sleep disturbance). As explained by the above, an AHI of 15-20 has been reduced to 5 when simply changing the scoring criteria. It would be interesting to see publications of the device utilising the recommended criteria since it is conceivable that the electrical pulses might lead to increased sleep disturbance, or that apnoeas might be “treated” but emerge as hypops with arousals when scored.

[@screamtoasigh9984]

Why didn't they just use RDI?

[@maryyoung4410]

The implant surgery has disfigured me. I have a golf ball sized lump in my throat. And the surgical incision is very jagged and ugly. My wardrobe now includes a gaiter around my neck everyday. 6 months out from the surgery and I deeply regret having this thing implanted in my neck. The skin on my neck is perpetually irritated from the adhesive on the patches. I wake up in the middle of the night with the feeling I have a swelled and paralyzed tongue. I also have random intermittent stabbing pains on the right side of my neck near the implant. You can say good bye to good night kisses from your bed partner while wearing the patch and genio. I think tennis balls sewn into the back of a sleep shirt would be a simpler less intrusive remedy for sleep apnea. IMHO

[@desolator1990]

Had a patient have this done and said it was the worse pain he had experienced and recovery for him was a couple of weeks. Ended up having a mandibular advancement device which he found more effective. What is your experience with the recovery period and post op pain?

[@VikVeerENTSurgeon]

I've not heard this before, and it isn't in the papers written about this. Thank you for letting me know, I'll speak to the Nyxoah company about this. Are you based in Australia? This implant hasn't come to America yet. Also I hope this would not happen in the UK. The plan I have set up is that all patients must try CPAP and also try a Mandibular Advancement Device first before even being eligible for the implant. There is very little risk for these two options, and if they work, then there is no need to have an operation. Avoiding an operation, especially one that would cost the NHS a lot of money, is very important IMHO. I do hope your patient is doing much better now. Thank you again for letting me know about your experience.

[@mawashington4632]

Please explain if this is better or worse than the Inspire, sir.

[@isabellaannerose123]

I want to know too

[@isabellaannerose123]

Is this available in the US? Sounds better than the Inspire device

[@culturenomad]

thank you for your insight.

[@lopezl77]

Very informative video, thank you

[@cocoanightnmare]

The very low ODI test cases might have been a control group of sorts, to check for any adverse effects?

[@patelpelat4658]

Silly question to all those extremely well, simple and clear made videos WITHOUT the :"You can click on the link below where you can purchase today, do NOT wait, the usual £699.99 device for only £39,99 AND with my book for FREE !". Unpretentious, kind, funny and unfussy videos. My question:"What about wearing a simple tape the whole night on the mouth, preventing any tongue movements ?" sounds archaic but doesn't it make sense ? Also what is the remedy to the morning headaches when waking up ? Anyway to take the tongue for an hour jog before going to sleep to exhaust her ?

[@xhavertov]

You might be looking for a device called "The Silent Treatment." It has a little gritty part that engages with the papillae of the tongue. It does not hurt. It's like velcro for your tongue. When you sleep, your tongue rises and goes back, engaging even more with the device. Cost for the Silent treatment-2 device, which I use, was 48 dollars.

[@screamtoasigh9984]

What? Your tongue moves with mouth tape. I wear MAD and tape and I can move my mouth.

[@ClaytonColwell-sb5yj]

I've had multiple surgeries for sleep apnea over the past 15 years and even tried multiple CPAP variations. Will the Genio system be available in the United States as well? Is there a way to sign up for the trial?

[@cocoanightnmare]

I watched your video about the Inspire device, but my ENT tells me that my apnea is more severe than Inspire could effect. Does the Genio work on more severe cases?

[@btibz]

Inspire is approved for patients with an AHI’s from 15-100.

[@johnkernodle728]

I am about 4 months into a clinical trial in the U.S. on the Genio System. Doing well, with one issue; my tongue darts to the left, crashing into molars. I have perception of tongue pushing against teeth & of noise from tongue against cheek and teeth clicking together. Has this issue come up in Europe? And would trying a bite guard or MAD be indicated? I use tape to keep my mouth closed currently.

[@halabrahamson3416]

Hi John, I am about to undergo the procedure here in the US. Have you had any relief from the tongue issue? It concerns me a bit. Thanks

[@ClaytonColwell-sb5yj]

@@halabrahamson3416 How did the procedure go? I'm looking for info on the TRIAL or who can PROVIDE THE PROCEDURE it in the US.

[@gilrose12345]

Could accomplish the same reduction of that by sleeping with a bumper belt. AHI mostly supine?

[@jobovens6949]

Great video !

[@VikVeerENTSurgeon]

Glad you enjoyed it

[@blek99]

Great video. Could you tell us what are the approximate costs of the implant without the NHS reimbursement? Thanks

[@VikVeerENTSurgeon]

For a short time the price is about £2.5k but then the price goes up by about 10 fold. The company are going to retract that deal. see my community post about this. The NHS aren't offering this yet, still working on them.

[@blek99]

@@VikVeerENTSurgeon Thank you for the reply. This looks like a compelling treatment option (bar the costs), looks much less intrusive than Inspire. If the long -term efficacy is good we might have a winner here.

[@AmrEllafy]

@@VikVeerENTSurgeon Thanks for the info. The deal is still active?

[@shahirbeebeejaun5942]

Hi Dr, are you still at the royal London ENT? I hope to get an appointment with you soon.

[@VikVeerENTSurgeon]

I still work at the Royal National ENT Hospital. We've just moved to a new building on Huntley street which is near Warren Street tube station. Please also don't get it confused with the royal London hospital which is in East London. My clinics I believe are going to start again in a week or so (COVID19 stopped everything to do with sleep surgery so we could concentrate on cancer and providing airway surgery care for COVID19 patients) I've been randomly cold calling my patients for the meantime, so I'm sorry I didn't get to you yet. Hope to see you soon.

[@samari6191]

Im sure there is an obvious reason but do you know why you couldnt have a magnet to connect the battery to the chip? or something in this way?

[@VikVeerENTSurgeon]

Yeah I asked that too, apparently the magnet isn't strong enough. they tried it out.

[@ChineseEvilQueen]

Is it common to have nosebleeds after the surgery?

[@ЯнинаПопова-з2с]

i believe they have tried the implant for snoring that do not have apnea

[@celticlull]

The cost of Inspire surgery is about $40,000.00 in the united states. I wonder wha the cost for Genio is.

[@ericrader1468]

Do they call ENT surgeons “Mr” in England? It’s kind of a big deal in America

[@VikVeerENTSurgeon]

I worked very hard to get rid of that 'Dr' prefix. I appreciate that it's not a global thing, but i'm still proud of it.

[@SajidKhan-kt6rz]

Hello Doc. I have an AHI of 83. Can this device or other such as Inspire bring down my AHI to less than 5?

[@VikVeerENTSurgeon]

If your problem is related to tongue based obstruction, then there is a good chance it'll be 'curative'

[@teejayare2980]

@Steve Sento this is the upper limit used in the clinical trial. First they have to test the efficacy in a population within a reasonable range to prove the concept/science. Often researchers would use previously defined criteria for comparability. Individuals higher than this cut point most likely have many more risk factors, increasing the severity beyond the control of the device. Although they cannot be included in the trial, once approved, clinicians can use it on anyone they deem would benefit from this therapy. . . Including those outside the parameters of the study. Maybe in conjunction with other treatment options (I. E. UPPP, MAS, tonsillectomy etc. ). People often (incorrectly) lose hope when they see the criteria in clinical trials, fearing they won’t be suitable when it is implemented in clinical practise.

[@SajidKhan-kt6rz]

@@VikVeerENTSurgeon My obstruction is at soft palate tounge and epiglottis

[@corkycork6246]

Will I still have dry mouth throughout the night?

[@VikVeerENTSurgeon]

probably best to unblock your nose first if this is your primary problem.

[@screamtoasigh9984]

Tape your mouth and check your meds they can be causing dry mouth. (And use xylitol mouthwash or candy).

[@MNDanno]

Sooo....Zeus or Genio?

[@NishVeer]

Brilliant!

[@VikVeerENTSurgeon]

Thanks bro!

[@pavelnedved7743]

Unfortunately, I don't understand anything you say because I don't speak English. I am trying to learn something from the commenters by clicking the translate comments to Turkish button. Who knows, maybe you are saying something that can help us, but I cannot understand it because of the English.

[@Erick_The_Green]

He looks like he hasn't slept for 2 days.