Note: This post may contain statements that I no longer consider true.
See: The Vivos mRNA Appliance Didn't Improve My Obstructive Sleep Apnea.
Another update for graph lovers. This brings us back up to date with data up to the end of January 2022.
I didn’t use CPAP for an extra week after nasal surgery due to the bleeding incident, so the data starts again on 11th January 2022. I only wore the appliance about 11 hours per day while my nose was recovering and didn’t wear the facemask at all because it’s not particularly comfortable.
I’m now wearing the facemask during the day again but haven’t been sleeping particularly well, possibly because I’ve been grieving my parent’s deaths, so I haven’t tried sleeping with it at night again.
I’ve had a few nights with high central events this month, and I tend to feel very tired on those days:
6 Comments
Jay · March 11, 2022 at 8:04 AM
Why did you decide to use a tooth pusher to fix your airway? There’s no peer-reviewed scientific evidence that Vivos can actually improve airflow in any meaningful way.
The only truly effective physiological intervention is maxilomandibular advancement. Some methods of maxillary expansion also show promise for AHI reduction (in particular EASE). In fact, with EASE you can see a definite expansion of the nasal cavity dimensions on CBCT, whereas something like Vivos will absolutely not have any such discernible dimensional impact (it is nothing more than a teeth pusher).
I can’t think of a gentle way to say this: Vivos and other teeth pusher devices being used to supposedly treat the airway are almost certainly scams. Worse, they pose substantial risk for dentoalveolar health because the treatment tends to move the teeth into very extreme positions and induce alveolar bone loss. So you might have some truly exorbitant bills in your future merely to address that damage.
You seem like a data-driven individual with a keen mind, which makes it all the more baffling that you’ve persisted with this sham treatment modality.
Dr Dae · October 3, 2022 at 12:49 PM
Jay,
Who are you to make these claims? You say an FDA-approved intervention is a sham and dangerous, but what is your evidence? You also include a dead or broken link.
Graham Stoney · October 3, 2022 at 2:41 PM
Vivos’s claim that the mRNA Appliance is FDA-approved is misleading because the Section 510(k) Premarket Notification for it merely argues substantial equivalence to mandibular advancement devices and downplays the claimed airway expansion function of the device. The nature of the 510(k) pre-market approval process means that BioModeling Solutions didn’t have to provide any data to confirm that the appliance works as Vivos now describe in their marketing. Nevertheless, Vivos markets it as a permanent cure for obstructive sleep apnea based primarily on it’s airway expansion function, and then adds that it is FDA-approved. A naive observer is likely to conflate these two points and conclude that the FDA has evaluated the device as being safe and effective as a permanent cure for OSA, when in fact they have not. Vivos pulled the same trick with the mmRNA Appliance. A more recent application to the FDA for approval of the DNA Appliance was rejected by the FDA after they requested more real-world data from the company.
The FDA have not determined that the airway expansion function of the Vivos DNA/mRNA Appliance is safe and effective in adults with obstructive sleep apnea. In my case, the Vivos mRNA Appliance merely tipped my teeth and made no impact on my obstructive sleep apnea.
Mladen · February 24, 2022 at 4:17 AM
Hey Graham, thanks for the updates and keeping us in the loop on whats going on. How are you feeling now since then? Is your nose feeling less congestion and are you seeing less post nasal drip?
Kevin · February 4, 2022 at 5:43 AM
I’m anxious to hear how much the nasal surgery has improved your nose breathing?
Graham Stoney · February 4, 2022 at 8:00 AM
It hasn’t fully healed yet but it’s a lot better already. I can breathe through my nose while lying down on either side now, which wasn’t always possible before. I still have a post nasal drip and the sensation of congestion, but I’m hoping these will disappear over time and I can actually get air through it fine. Cheers, Graham