Generally, it would be reasonable for a consumer to assume that having FDA approval for a medical device means that the device is safe and effective. Given that my treatment with the Vivos mRNA Appliance failed and left me with tipped teeth, I gave the approval further scrutiny and found that all is not what it seems.

My Background

Prior to having my career destroyed by depression and debilitating fatigue due to undiagnosed obstructive sleep apnea, I was a successful biomedical engineer specialising in design reviews for medical devices. While I’m located in Australia and my local medical device regulator is the Therapeutic Goods Administration, the U.S. is an important market for my previous employer and clients, and smaller regulators like the TGA often take cues from the FDA, so I’m reasonably familiar with their approval process.

The Medical Device Approval Process

The regulatory approval process for a medical device is typically long and complex, involving proving to the regulator that the device has been designed according to quality management standards such as ISO 13485 to ensure that it is safe, and supplying clinical trial data to prove that it is effective. The FDA has two main programs for approving innovative medical devices that are unlike existing products on the market, called the Premarket Approval process and the De Novo process, which impose slightly different regulatory requirements.

In order to reduce both the regulator’s workload and the regulatory burden on companies marketing medical devices, the FDA also has a program called the Premarket Notification (510k) program for devices that are similar to existing products which are already approved. Under this program, the applicant only has to argue that the medical device they wish to market is substantially equivalent to a “predicate device” that has already been approved. They don’t have to demonstrate that the new device is safe and effective, because the FDA assumes that if it’s substantially equivalent to an existing device that has already been proven to be safe and effective, then the new device should be safe and effective too.

This is like the way generic drug manufacturers can get approval for drugs with identical ingredients to existing approved drugs once their patents expire without having to conduct clinical trials.

The mRNA Appliance Approval

Back in 2014 when Dr Singh was marketing the DNA Appliance under the umbrella of BioModelling Solutions, they were granted approval for the mRNA Appliance via the 510(k) program by arguing that it was substantially equivalent to existing mandibular advancement devices on the market, including the SomnoMed MAS RxA, DynaFlex, and Adjustable Dorsal Intraoral Device.

The 510(k) submission for the mRNA Appliance says: “As with the predicate devices, the mRNA device functions by preventing the retruding of the mandible during sleep to obstruct the airway”, referring to the mandibular advancement function of the mRNA Appliance. The submission glosses over the maxillary and mandibular expansion functions, saying: “The only significant difference is to place expansion screw and beta-titanium 3D-axial springs as required for adjustability and the optional occlusal table”.

This is in stark contrast to U.S. patent 7357635 on the DNA Appliance from 10 years earlier which claims to be able to remodel adult jaws and facial bones. That’s certainly a significant difference compared to other mandibular advancement devices; in fact, it’s the basis of Vivos’s main marketing claim that DNA Appliances can permanently cure obstructive sleep apnea.

It’s not unusual for one regulatory body to ignore the databases of other regulatory bodies when making their decisions. Examiners under time pressure to process approvals can rely on the courts to arbitrate over potential mistakes later in the minority of cases that end up being contested commercially. The FDA bought the argument that the mRNA Appliance is just another mandibular advancement device and granted BioModelling Solutions 510(k) approval to market it.

The FDA wrote the company a warning letter critical of the company’s design control procedures, which noted: “In addition, we reviewed your Daytime Nighttime Appliance (DNA) and mandibular Repositioning Nighttime Appliance (mRNA) devices. We have identified several concerns with these devices as they relate, but not limited, to the following: promotional and advertising claims; intended use and device modifications; 510(k); and registration/listing.”

In November 2019, I went to a talk in Sydney presented by Vivos to recruit dentists into their training program where Dr Singh mentioned that the mRNA Appliance was FDA approved and could permanently cure mild to moderate obstructive sleep apnea, which seemed too good to be true. The audience were led to believe that the FDA had assessed the latter claim, which is not the case: They only approved it based on its mandibular advancement function.

Section 510(k) approval letters from the FDA typically note that the Federal Food, Drug, and Cosmetic Act prohibits misbranding, and that device labelling must be truthful and not misleading. It’s not clear to me if Dr Singh addressed the concerns from the FDA’s warning letter, particularly the promotional and advertising claims. I believe that by conflating the 510(k) approval of the mRNA Appliance with Vivos’s claims that it can expand jaws via epigenetics, Dr Singh is indeed misleading potential customers about what the FDA actually examined in the approval process.

DNA Appliances without the mandibular advancement function were not included in the original 510(k) approval because they aren’t mandibular advancement devices. This is why up until recently Vivos has only been claiming FDA approval for the mRNA Appliance.

The mmRNA Appliance Approval

More recently, Vivos have released the mmRNA Appliance, which is like the mRNA Appliance in that it is a DNA Appliance with mandibular advancement function. The difference is in the way the upper and lower appliances connect to advance the mandible.

The Vivos mmRNA Appliance was also approved under 510(k) by arguing substantial equivalence to the mRNA Appliance, saying that “The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient.” They haven’t mentioned that the purpose of the expansion screw is actually to expand the jaws via epigenetic bone remodelling like they do in their marketing. That’s not how a mandibular advancement device works. They proceed to state that: “The mechanism of action is mandibular advancement, the same mechanism of action is used in the primary predicate device” (i.e. the mRNA Appliance). Again, this is not what Vivos claim in their subsequent marketing when they say that the appliance is FDA approved.

Under “Device Function”, the mmRNA Appliance submission states:

“The mmRNA appliance is a customized oral device featuring a lower tray and upper tray. These trays put gentle pressure on the tissue at the back of the throat to prevent the airway from collapsing during sleep.”

Mandibular advancement devices, like the predicate devices cited in the submission, do not function by “putting gentle pressure on the tissue at the back of the throat”; they function by advancing the mandible to open the airway behind the tongue.

It goes on to cite Hoekema’s 300-page PhD thesis from 2007 titled Oral appliance therapy in Obstructive Sleep Apnea-Hypopnea syndrome – A clinical study on therapeutic outcomeswhich compares the effectiveness of oral appliances to CPAP for treating obstructive sleep apnea in a number of studies.

Vivos is often criticised for its lack of published research in mainstream sleep medicine journals, and their ability to provide relevant citations isn’t much better: A PhD theses is a poor substitute for a peer-reviewed publication in a major sleep medicine journal. The thesis doesn’t cover expansion appliances like the mRNA, much less the mmRNA which hadn’t been invented in 2007, and at 300 pages I doubt the examiner would have had the time to read it. There are much more focused and recent meta-analyses available in the peer reviewed literature, such as The Comparison of CPAP and Oral Appliances in Treatment of Patients With OSA: A Systematic Review and Meta-analysis, which took me a full 30 seconds to find on Google Scholar.

The FDA approved the mmRNA Appliance 510(k) submission, which isn’t surprising because they had already approved the mRNA Appliance by 510(k) and the mmRNA Appliance really is very similar to the mRNA Appliance predicate device and they both do mandibular advancement.

What A Tangled Web We Weave

It is common for devices approved under the 510(k) program to reference other predicate devices which were also approved via 510(k), leading to a chain (or more accurately, a tree, since you can cite more than one predicate device) of approvals before you arrive at a device that actually had a full Premarket Approval process complete with design controls and a clinical trial to provide safety and effectiveness data. The list of devices in the mRNA Appliance predicate device tree include:

• mRNA Appliance
  • SomnoMed MAS RxA
    • Bird MSDA
      • TAP Anti-Snoring Device
        • H&M Anti-snoring device
        • Distar, Inc – TheraSnore
  • DynaFlex
    • SomnoMed MAS RxA (see above)
    • Acrylic Herbst Splint Appliance
      • Removable Acrylic Herbst
        • Snore Guard
          • Snore Guard Advance
            • Hays & Meade Anti-Snoring Device
          • SleepRight Original
            • SleepRight Low Profile
              • EZ Splint
                • Dr Hays Bite Guard
                • NTI Tension Suppression System
              • Doctor’s NightGuard
                • Dental Concepts BruxGuard
                • Hollywood Products Mouth Peace
                • GEM Scientific Products, Inc Tension Reliever
    • TAP T
      • TAP Anti-Snoring Device (see above)
      • Thornton Oral Appliance
        • TAP Anti-Snoring Device (see above)
        • SnoreFree – OSAP
        • Distar, Inc – TheraSnore
      • TAP II
        • TAP Anti-Snoring Device (see above)
        • Thornton Oral Appliance (see above)
        • OASYS Oral Airway System
          • Dr Keith Thornton – TOA
            • TAP Anti-Snoring Device (see above)
            • SnoreFree – OSAP (see above)
            • Distar, Inc – TheraSnore (see above)
          • Snore TEC
          • TAP Anti-Snoring Device (see above)
  • Adjustable Dorsal Intraoral Device
    • DynaFlex (see above)

The products at the leaf nodes of the tree also all claimed substantial equivalence to an existing product, but I either couldn’t find their database entries, or the summaries are missing so I can’t tell what the product was that originally underwent Premarket Approval that led to all these mandibular advancement devices being considered safe and effective. Because of the nature of the 510(k) approval process, none of manufacturers for the products listed above were required to provide safety or effectiveness data or to conduct clinical trials. That’s just how the process works.

The DNA Appliance Approval

Things get really weird with the 510(k) approval for the DNA Appliance though: It’s summary argues substantial equivalence to the mRNA Appliance, despite the lack of mandibular advancement function which was the whole basis of the mRNA Appliance’s 510(k) approval.

This time around, under “Device Function”, the DNA Appliance submission states: “The DNA appliance is a customized oral device featuring a lower tray, upper tray, or both, depending on patient need. These trays put gentle pressure on the tissue at the back of the throat to prevent the airway from collapsing during sleep.”

This is obviously cut-and-pasted with a little editing from the mmRNA Appliance submission, again using the inaccurate “gentle pressure” line.

The next paragraph is also almost identical, again citing Hoekema’s PhD thesis on oral appliance therapy even though the oral appliances he examined were all “mandibular repositioning appliances”, another name for mandibular advancement devices, which the DNA Appliance is not.

If it isn’t obvious that mandibular advancement devices function by advancing the mandible, Hoekema notes that: “Studies on the outcomes of the variability in mandibular advancement and bite-opening suggest that a mandibular repositioning appliance (MRA) derives its therapeutic effect mainly from the amount of mandibular advancement imposed by the appliance.” (p237)

The DNA Appliance does not advance the mandible at all, so Hoekema’s research is not relevant here.

They then state a claim about the DNA Appliance consistent with Vivos marketing: “The DNA Appliance aims to expand the nasal airway through jaw expansion and mid-facial redevelopment. In doing so, an oral device may be able to permanently improve the oropharyngeal airway. Studies have shown that the DNA appliance can increase nasal cavity volume and reduce the incidence of apnea-hypopnea episodes.”

The submission does not cite any such studies, and this is not how the predicate device was claimed to work, which was by mandibular advancement. Because of the nature of the 510(k) program, there was no requirement for Vivos to provide evidence to the FDA that the DNA Appliance can “permanently improve the oropharyngeal airway.” All they had to do was argue substantial equivalence to the predicate device.

The cynical part of me thinks that Vivos have been gradually shifting the goal posts to get the FDA to accept a 510(k) submission for the DNA Appliance, and cited an irrelevant 300-page PhD thesis to distract the examiner from the fact that the DNA Appliance is not substantially equivalent to the predicate device, nor any of the mandibular advancement devices in its ancestral approval tree since it does not advance the mandible.

The DNA Appliance simply does not work like the predicate devices upon which the mRNA Appliance was approved because it doesn’t advance the mandible.

No wonder the FDA rejected the DNA Appliance application first time around, requesting real world data to prove that the device is effective. This seems unusual for a 510(k) approval process, so I’m not sure what the FDA were thinking except that it seems in line with their new emphasis on real-world evidence.

This posting about the approval on MedtechDive includes this hilariously vacuous analysis, apparently without realising the irony of it: “The DNA device is identical to the already-marketed mandibular [advancement] appliances except the top and bottom trays do not interlock to advance the jaw.”

The FDA agreed with Vivos’s claim that the DNA appliance is substantially equivalent to a mandibular advancement device, even though it does not advance the mandible.

As far as the real-world data goes, with a claimed 27,000 customers, I would have thought Vivos could supply data on more than just 74 cases. There is no evidence that these cases represent a random sample and are obviously not the entire patient population. With a cure rate of only 27% I’d hardly consider the DNA Appliance very effective at treating obstructive sleep apnea.

The introduction to the real-world data supplied by Vivos is also hilarious: “When conducting maxillary expansion for other indications, several dentists noticed their patients also noticed significant improvements in snoring, sleep apnea, and other symptoms of sleep disordered breathing.”

… as if dentists discovered by accident that the DNA Appliance is supposed to improve breathing.

I also haven’t seen any long-term studies on relapse rates with the DNA Appliance, which is likely to be a problem given that muscle tone in the airway continues to degrade as we age. We don’t just want to expand the airway enough to prevent our current apneas, we also need some leeway for the future collapse of muscle tone, or we’ll be back to having OSA again as we age; possibly when we’re too old for maxillomandibular advancement surgery.

Perhaps all this doesn’t matter given that dentists have been supplying the DNA Appliance to patients with obstructive sleep apnea anyway, despite Vivos not having an investigational device exemption for it. This appears to be legal since the appliance is registered with the FDA as a Class I dental device, and dentists can use it off-label to treat obstructive sleep apnea without FDA approval.

Conclusion

I believe that the FDA have made an obvious logical error in approving the DNA Appliance under the 510(k) program, since it clearly isn’t substantially equivalent to the predicate device. If you’re a potential Vivos customer relying on FDA approval of the DNA Appliance as an indication that it is the permanent cure for obstructive sleep apnea that Vivos claims, note that aside from a cursory look at some real-world data, the FDA appears not to have examined the safety and effectiveness of the DNA Appliance during the approval process.

Thank you to Rich Barton for feedback which helped me improve this article.

FDA Approval of the The Vivos DNA Appliance is Not What It Seems is a post from Chronic Fatigue & Sleep Apnea Survivor

I fell through the cracks for being diagnosed with obstructive sleep apnea for years simply because I didn’t fit the typical profile that general practitioners look for since I wasn’t obese. I was tall and thin. GP’s don’t know to look for retrognathia, even though it’s obvious once you see it, and a lot of online resources regarding sleep apnea don’t mention it either.

Dr David E. McCarty from Empowered Sleep Apnea recently reached out to me to hear my story, because he’s on a mission to help people like me who fall through the cracks. He has a background in sleep medicine and understands how bewildering the condition can be once it is diagnosed, so he also wants to empower people with sleep apnea to sort their way through the myriad of treatment options.

After our chat he was kind enough to send me a copy of his most excellent book Empowered Sleep Apnea, which I highly recommend to anyone with the condition who has been newly diagnosed or isn’t happy with their current treatment. The book has a narrative structure and describes treating sleep apnea as an adventure exploring an island. It’s certainly a journey alright.

The book is available in hardcover or E-book at BookBaby, and if you use the coupon code HUZZAH, you can save $25 off the hardback and 20% off the ebook. David and Ellen also have a most excellent podcast on empowered sleep apnea that’s also worth checking out.

If You’ve Just Been Diagnosed With Sleep Apnea, Empowered Sleep Apnea Is A Good Place To Start is a post from Chronic Fatigue & Sleep Apnea Survivor

The Therapeutic Goods Administration’s (TGA) Database of Adverse Event Notifications (DAEN) – medical devices lists adverse events, such as failures and damage caused by medical devices in Australia. It is compiled from reports made by manufacturers, suppliers and end customers. Since the Vivos mRNA Appliance is used to treat obstructive sleep apnea, it is considered a medical device and is subject to regulation by the TGA.

I reported that the Vivos mRNA Appliance tipped my teeth using the Users Medical Device Incident Report. The Australian Register of Therapeutic Goods (ARTG) number for the Vivos mRNA Appliance is 389679 and my Device Incident Report (DIR) number is 81170. My report should be accessible in the DAEN – medical devices search using there two numbers after 13th November 2022, but in the meantime the TGA’s response states that:

• “The TGA is aware of this type of adverse event and is monitoring the situation.”
• “Reports not investigated are used for monitoring and trending analysis.”
• “In this instance, no further investigation of the reported event will occur.”

The only information about the event in the response is a redacted version of the information I supplied in my event report, so it appears that the TGA haven’t contacted the company or my provider for more information.

This highlights the importance of all users whose treatment with the DNA or mRNA Appliance fails and/or causes them harm to submit an adverse event report with their local medical device regulator. Regulators have limited resources to investigate reports and tend to prioritise those with high severity and lots of instances. The more reports they receive, the greater the chance that they will take action. Regulators have the power to prevent the importation and sale of medical devices that are not safe and effective, and clearly the Vivos mRNA Appliance was neither safe nor effective in my case.

If you have been treated with a Vivos appliance or a DNA Appliance from their predecessor BioModelling Solutions, Inc and had an adverse outcome such as tipping teeth or a failure to generate the expected growth, it is important to report this to your local regulatory agency so that they see sufficient events to warrant an investigation into the safety and efficacy of the appliance. While it is your provider’s legal obligation to do this, it may not be their top priority. I recommend doing it yourself to ensure that it happens.

Here are links to medical device regulators where you can submit your consumer reports:

Australia (TGA): Submit Report. ARTG #389679. Background Information.

US (FDA): Submit Report. Background Information.

Canada (Health Canada): Submit Report. Background Information.

If you’re located in another country and know the links to submit adverse event reports to your local regulatory agency, please and let me know so I can add them to the list above.

I also recommend joining the Vivos DNA/mRNA Appliance Failed Cases Facebook group if you want to connect with other people whose treatment failed for support in regulatory reporting, seeking refunds, correcting damage done by the appliance, moving forward with other treatments, etc.

The TGA’s Response To My Adverse Event Report About My Vivos mRNA Appliance Failure is a post from Chronic Fatigue & Sleep Apnea Survivor

The results were disappointing, to say the least.

Here is a summary table comparing the results of the sleep studies before treatment on 27^th June 2019 and afterwards on 15^th June 2022:

The American Academy of Sleep Medicine’s Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults (2009) uses RDI for categorising severity of OSA, and mine went up slightly between studies. I doubt this is significant given the normal variability between nights and labs.

Ideally, I would have liked to have both before and after studies done in the same lab and scored against the same criteria, but the previous study was done at St Vincent’s Private Hospital who no longer run a sleep lab and I don’t know what software or criteria they used to score it. The latest study was conducted at The Woolcock Institute and scored according to the AASM Manual for the Scoring of Sleep and Associated Events, version 2.2. I don’t know why Australia’s leading sleep and respiratory research organisation isn’t using the latest scoring standard, which is version 2.6.

The American Academy of Sleep Medicine’s more recent Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea (2017) uses AHI to define severity. The small decrease in my AHI between studies is also probably due to inter-study variability, different scoring criteria, or possibly the myofunctional therapy and singing practice I’ve done between studies toning my throat muscles. Even if the Vivos mRNA Appliance did make a small difference, my AHI is still in the severe range, and I still need CPAP to breathe when I’m asleep.

Between studies I also had a septoplasty and turbinate reduction to improve my daytime breathing, but nasal surgery is unlikely to make any impact on obstructive sleep apnea caused by my tongue blocking my airway due to a retrognathic maxilla and mandible.

The relatively high minimum oxygen saturation on all my sleep studies suggests that my problem is not lack of oxygen but respiratory arousal leading to fragmented sleep. Hopefully that means I haven’t sustained significant brain damage during the 10+ years I was chronically ill while my obstructive sleep apnea was undiagnosed and untreated.

Most nights the AHI reported by my CPAP machine is below 5, and the vast majority of events are central, which appear to be induced by CPAP itself since I had no central events on any of my sleep studies. I suspect that the cause of my ongoing daytime fatigue is central events induced by CPAP, although it’s hard to say for sure. Fatigue could also be due to daytime breathing through a compromised airway, or perhaps something else entirely. The machine may also be incorrectly detecting central events. I haven’t had a sleep study with CPAP which may clarify this or dived deep into the data in OSCAR, because I’m more interested in getting rid of the machine entirely and taking it out of the equation.

Since receiving the sleep study results and discussing the failure of the Vivos mRNA Appliance to improve my airway with the sleep specialist Professor Brendon Yee at The Woolcock Institute and one of his retired oral maxillofacial surgeon colleagues, I’ve stopped wearing it.

My Vivos provider said he was disappointed with the sleep study results and it was unlikely a second Vivos mRNA Appliance was going to give me any improvement. I agreed given that the first appliance tipped my teeth and kept winding back during the night when I attempted to expand and advance it any further. He believes that I did get some skeletal expansion from the appliance, but I don’t see it on the CBCT scans, and it’s not reflected in the sleep study results which are more predictive of the daytime alertness and energy levels that really matters to me.

When I asked my provider for a refund of the A$9000 I paid for the appliance due to the lack of any improvement in my sleep apnea, he declined citing the amount of time and effort he had put into supporting my treatment. This seems to be the norm in the medical industry: you pay for a treatment, not for a result.

To say I’m disappointed in my Vivos experience would be an understatement.

I wasn’t sure if the Vivos mRNA Appliance could cure severe sleep apnea, but my provider said I looked like an ideal candidate and Dr Singh has published studies showing it to be effective in some severe cases. To get no improvement at all is extremely disappointing.

I wore the Vivos mRNA Appliance for a little over 16 hours per day prior to the CBCT scan showing that my teeth were tipping, and about 14 hours per day after that. My overall average was 15.1 hours per day. My average facemask use was 4.5 hours a day. Unfortunately, I never managed to sleep well with the facemask, but I doubt that was going to make much difference given that the time I wore it during the day didn’t seem to achieve anything.

Here’s my final usage graph:

My CPAP machine is really an APAP since it’s set to automatically adjust to the minimum pressure required to prevent apneas and hypopneas. If the Vivos mRNA Appliance was being effective, I would have expected the APAP pressure to be reducing over time as it had to work less hard to keep my airway open. This is why I tracked the pressure every month in my treatment updates. However, my pressure trend graph showed only a very slight increase over the time:

So what went wrong? As far as I can tell I did all the right things. I wore the device religiously. I did 750 sessions of myofunctional therapy. I chewed mastic gum. I cycled the appliance hourly during the day. I confirmed that I didn’t have a tongue tie. I expanded the screws at one turn per week as advised by my provider, until the appliance wound itself back each night. At first, I didn’t notice this, so my actual rate of expanding the appliance was about half what I thought. My early updates on this site measured expansion by tracking screw turns and ended up exaggerating my actual appliance expansion. Once I realised it was winding back, I got a taper gauge to measure the gap in the appliance. By then my provider said I had reached the limit of my biological capability and advised me to stop expanding the appliance, which was just as well given that it was actually tipping my teeth rather than growing new bone for them to expand into.

I’ve reported that the Vivos mRNA Appliance tipped my teeth as an adverse event with the Therapeutic Goods Administration’s Database of Adverse Event Notifications (DAEN) – medical devices using the Users Medical Device Incident Report. The Australian Register of Therapeutic Goods (ARTG) number for the Vivos mRNA Appliance is 389679 and my Device Incident Report (DIR) number is 81170. It should be accessible in the DAEN – medical devices search using these two numbers after 13th November 2022, but in the meantime you can read my summary of the TGA’s response here.

While my provider may be content that the appliance failed for me due to my individual biology, regulators look for safety and effectiveness when approving medical devices, and this requires results to be repeatable between patients. The Vivos mRNA Appliance appears to work for some people but not for others, and it’s not clear to me what criteria can be used to predict who it will or won’t work for. I had two Vivos Airway Intelligence Reports done and neither of them suggested that the appliance wouldn’t work for me; otherwise I wouldn’t have pursued treatment with it.

I have created a Facebook group to support people whose Vivos treatment has failed.

So where to from here? I don’t want to feel fatigued for the rest of my life. I don’t see much scope for tweaking CPAP and don’t want to use stimulant medication, so I’ve started consulting with orthognathic surgeons about maxillomandibular advancement (MMA) surgery. I doubt that soft tissue surgery alone is going to cure severe obstructive sleep apnea, and the first orthognathic surgeon I went to said that MMA should be done first since soft tissue procedures like uvulopalatopharyngoplasty (UPPP) can impair the ability to move jaws during orthognathic surgery due to tension of the remaining soft tissue.

The treatment plan from the first orthognathic surgeon I have consulted confirms the tipping of my teeth caused by the Vivos mRNA Appliance that now needs to be corrected. Fortunately, I can do this as part of the orthodontic treatment required to prepare for MMA surgery. Nevertheless, having to correct damage done by a failed appliance is annoying.

Frankly, the thought of having MMA scares the crap out of me, but if I’d started down that path instead of doing Vivos I’d probably be recovered by now. On the other hand, if MMA goes horribly wrong at least I’ll be able to say I excluded Vivos as a possibility by trying it. Obstructive sleep apnea is one nasty mother#&%er. Things that work for one person don’t seem to work for another and whatever you do to treat it there is a risk involved.

The Vivos mRNA Appliance Tipped My Teeth and Didn’t Improve My Obstructive Sleep Apnea is a post from Chronic Fatigue & Sleep Apnea Survivor

Here are this month’s graphs:

Twenty Months Vivos mRNA Appliance Usage

Twentieth Month Vivos mRNA Appliance CPAP Pressure Trend

Twenty Months Vivos mRNA Appliance CPAP Pressure Trend

Twentieth Month Vivos mRNA Appliance AHI and Event Trend

Twenty Months Vivos mRNA Appliance AHI and Event Trend

Twenty Months Vivos mRNA Appliance Update is a post from Chronic Fatigue & Sleep Apnea Survivor

Here are this month’s graphs:

Nineteen Months Vivos mRNA Appliance Usage

Nineteenth Month Vivos mRNA CPAP Pressure Trend

Nineteen Months Vivos mRNA CPAP Pressure Trend

Nineteenth Month Vivos mRNA AHI and Event Trend

Nineteen Months Vivos mRNA AHI and Event Trend

Nineteen Months Vivos mRNA Appliance Update is a post from Chronic Fatigue & Sleep Apnea Survivor

Here are this month’s graphs:

Eighteen Months Appliance Usage

Eighteenth Month CPAP Pressure Trend

Eighteen Months CPAP Pressure Trend

Eighteenth Month AHI and Event Trend

Eighteen Months AHI and Event Trend

Eighteen Months Vivos mRNA Appliance Update is a post from Chronic Fatigue & Sleep Apnea Survivor

I’m still waiting to hear back from Vivos via my provider with their analysis of my mid-treatment CBCT scans taken back in November. Appliance wear isn’t my top priority until I hear from them whether it’s likely to tip my teeth any further. I still sleep with it, but my usage has dropped down to an average of about 12 hours a day this month. I haven’t tried sleeping with the facemask this month since I found that challenging and my highest priority is getting the best sleep I can in the hope of alleviating my daytime fatigue and headaches.

I wear the facemask when I can during the day, but that only averages about 2.5 hours/day since I can’t wear it while I’m doing most of my daily activities and it requires me to have the appliance in.

I think my health is gradually improving but I’m aware I’ve said that before; even before being diagnosed with obstructive sleep apnea. Nevertheless, I’ve been doing weekly swimming lessons and a half hour exercise class at Sydney University Sport and Fitness, samba dance classes with Sydney University Movement and Dance Society, and surfing lessons with Waves of Wellness. I’ve been optimising my sleep hygiene by avoiding eating, TV and lights late in the evenings.

I’ll let you know when I hear more from Vivos. In the meantime, here’s this month’s graphs:

Seventeen Months Vivos mRNA Appliance Update is a post from Chronic Fatigue & Sleep Apnea Survivor

The book tells the story of Nestor’s journey through the world of breathing health, starting out with his own childhood health issues developed as a result of being a chronic mouth breather. He does an experiment where he plugs his nose forcing him to mouth breathe, and notices a decline in his health, including development of sleep apnea which disappeared after he started nasal breathing again. The book doesn’t say how he knew he had sleep apnea though and he didn’t appear to have it confirmed with a sleep study.

Along the way he talks to many of the big names at the forefront (or fringe depending on how you look at it) of the breathing health movement, including Marianna Evans, Patrick McKeown, John Mew, Mike Mew, William Hang, Steven Park, and Theodore Belfor. He also describes research on: sleep at Stanford by Christian Guilleminault, mouth breathing in monkeys by Egil Harvold, the western diet and malocclusion by Weston Price, the connection with the vagus nerve by Stephen Porges, and the evaluation of the Wim Hof method by Andrew Huberman.

Nestor mentions being treated with a Homeoblock by Dr Belfor, but it’s not exactly clear to me why he thought this was necessary of what benefit he got from it. He seemed to think it was worthwhile. Maybe I forgot what he said because I read it while recovering from nasal surgery and wasn’t at my peak mentally.

He explores a bunch of different breathing techniques I have tried including alternate nostril breathing, Buteyko breathing, and Sudarshan Kriya, with an appendix listing the details which are also in videos on his website.

I’d already listened to several podcast interviews he did when the book came out and previously read a bunch of the books and studies he cites so there were no great surprises for me, but it’s still a worthwhile and fun read.

Breath: The New Science of a Lost Art by James Nestor is a post from Chronic Fatigue & Sleep Apnea Survivor

I didn’t use CPAP for an extra week after nasal surgery due to the bleeding incident, so the data starts again on 11^th 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:

Sixteen Month Vivos mRNA Appliance Update is a post from Chronic Fatigue & Sleep Apnea Survivor