This is a review of the Genio System from Nyxoah. This is a Hypoglossal nerve stimulator implant for obstructive sleep apnoea and snoring. This device is implanted in your chin, where it stimulates the hypoglossal nerves to your tongue. This brings the tongue forward during sleep and stops obstructive sleep apnoea by keeping the airway clear.
The official website for the Genio System is https://www.nyxoah.com/
I provided Nyxoah with a preview of this video prior to publication and they provided a couple of comments:
With regards the Beard issue -
"Per our experience, adherence of the patch in patient with a beard - even short - is suboptimal and the patch will easily detach itself, thus a suboptimal therapy. Therefore, we strongly advise that patients are really shaved in the patch area."
Obviously Nyxoah have the most experience with this, and if they say you need to shave to use the device, then I guess you have to. I mentioned that if you have a goatie, I'm sure it'll be okay, so long as you are keeping the patch area clean shaven. Also you can avoid plucking out hair every morning with the plaster. I honestly can't believe I'm spending so much time on this - I will try and stop mentioning it now :)
Nyxoah also explained the graph issue where it seemed there were people who were implanted who didn't have OSA.
"In the BLAST OSA study, I understand the confusion regarding patients baseline AHI sometimes below 20. As per the study protocol, baseline AHI was to be minimum 20. All implanted patients had a baseline AHI greater than 20, scored by an independent core lab using the 3% desaturation rule to qualify an hypopnea event (greater than 30% flow reduction combined with a minimum 3% desaturation). This is the standard scoring rule in France and Australia where we run the study.
During the review process by ERJ, the reviewers asked us present data using a 4% desat to quantify the AHI. The rationale was to allow an easier comparison vs Inspire STAR data - US based - where 4% is the standard scoring guideline. So we re-scored all PSGs for all patients with the same core lab. This explains why some BLAST OSA data show patients with reported baseline AHI below 20. "
So basically this is a problem with definitions. Rather annoyingly the American board changes the rules about what counts as an apnoea and hypopnoea every couple of years or so. There are now therefore lots of different definitions out there, and this is confusing for all of us in sleep medicine. Anyway, they used one definition which is used in France and Australia - but then to conform with a previous paper the study had to be altered to another definition which messes up the results. You will be glad to know that in the UK we compare all the different definitions because we are generally boring that way. I hope that explains that issue.
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