Call For Feedback: Puresleep.com Dental Device

Howdy CPAPtalkers,

Today I am wearing my CPAP.com hat and would like to hear your thoughts on the PureSleep.com (different from pursleep.com!) dental device. Here's a link:

https://www.puresleep.com/index.html

I want to know if CPAP.com should carry this product. Here are some starter questions, but feel free to unload your reactions and thoughts as you please:

* Is this a serious medical product that would benefit people searching for "CPAP"?
* Is it misleading to newbies to introduce this as a viable alternative/supplement to CPAP therapy?
* Is it beneficial to CPAP users with moderate Sleep Apnea looking for a better way?

Johnny

Had one from my dentist before cpap machine. I say . . .

Hmmm.... I'd be real interested in what Titrator has to say about this.

If I had the chance to trial this product for free, I'd give it a shot. For one reason only - it's a huge pain to disconnect my machine and drag it up to my BF's house for overnights, and then have to sleep on the futon in the living room anyway, because his bed is too small to accommodate my mask issues.

I would NOT sleep with it 24/7. I might contemplate using it for the odd overnight. I think anything that's helpful is a good product for CPAP.com to carry.

But I haven't used it, so I don't know if it's helpful.

Get some of your staff to try it and evaluate it. Like Titrator!

My motto: Titrator Said It. I Believe It. That Settles It.

LOL,
Babs

* Is this a serious medical product that would benefit people searching for "CPAP"?

I don't think it is. I haven't even considered trying it because I have TMJ and it looks like a disastrous thing for anyone with jaw problems.

* Is it misleading to newbies to introduce this as a viable alternative/supplement to CPAP therapy?

Yes, I think it's misleading. Alternative treatment to CPAP should be discussed with a doctor.

Is it April Fool's already?

I'm kind of in the "Snake Oil" category.
Far too many people either don't know that heavy-duty snoring is a symptom of sleep apnea.....or they want to convince themselves that they wouldn't need to get all of that more expensive equipment if they could just quit snoring. These devices (in my opinion) could contribute to putting people in denial of more serious conditions.

I think it would be false hope for too many. If a person has obstructed nasal passages, sleeping with something stuck in your mouth at night just doesn't strike me as being a viable option.

I'm sure most of us had mild to moderate sleep apnea at some point.....and I'm sure that this device would not have helped ME.

Den

Hey Johnny,
I'll preface this with saying I have not tried this product.
I've been following another thread where it seems like "shills" have come on touting the benefits of "curing apnea" with this product, so from that perspective it seems to be extremely misleading and yes I would opine it adds to newbie confusion.

Do I think it's a legitimate "medical product"?? No. That said, I do believe that people should be free to investigate any avenue that may positively affect their treatment.

Do I think it would help "mild apnea"?? No....I don't believe there is any evidence that moving the jaw unnaturally will prevent the soft tissues from relaxing and blocking the airway......
I'd be curious what Ted would opine regarding the product, and perhaps some on your staff should trial it and let the rest of us know from a "real apnea person" perspective rather than the apparent shills on the other thread!! I would not want to try it if offered -- my jaw is messed up enough already.

From an apnea standpoint, I would put it in the category of "snake oil", or as I stated in the other thread, "I believe it was PT Barnam that said, 'There's a sucker born every minute.....'".

At the price, I think it's a total rip off and I wouldn't even consider trying it.

Hope this helps a bit

cheers
goose

goose wrote: At the price, I think it's a total rip off and I wouldn't even consider trying it.

5+ years ago it cost $300+ from my dentist.
It was absolutely worthless too!

I'm kind of straddling the fence on this issue. A dental device is a medically proven treatment device for the few and proper candidates with the right craniofacial and oral features.

There are supposedly some patients on the various message boards who get good results using a dental device. One of our posters, Velbor, gets better results with his dental device than he does with CPAP or APAP. However, he was carefully evaluated for his oral appliance by a dentist specializing in sleep medicine, then given a PSG to verify results. I think he was also given what was deemed one of the "correct" oral appliances that would solve his SDB. Supposedly not all oral appliances are created equal.

The majority who have reported back to message boards seem to report failed results with dental appliances. Then again, CPAP only enjoys a forty-some-percent compliance rate. A dental device is a medically proven treatment device for the proper candidates. Dental appliances don't seem to treat most apnea patients effectively, but they do seem to treat some well.


So the Puresleep dental appliance cost $60 with a money back guarantee? Honestly, I'd be more inclined to try that than drop $3000 or $4000 down at the dentist. Therein lies the crux of the potential benefit or risk for the general public in my opinion: an alluring and low financial entry barrier for this experiment, but at the risk of potential unsupervised health disaster. Some kind of effective screening or perhaps dissemination of information would be necessary to ethically offset that unsupervised risk of medical disaster IMO.

Johnny,

If they have real data proving the device works showing drastic reduction in AHI from a double blind study done in a teaching university sleep-lab center with no ties to the outcome of the product, I'd be willing to read it in a peer-reviewed medical/dental/sleep journal. I haven't seen that yet. Have you?

Why would you sell something at $60 a pop when you know most people aren't going to get good results? At that price they'll likely return more than they'll keep. It looks like a very expensive night-gard and probably only prevents bruxism. People with severely misaligned teeth or dentures are probably out of luck with this device. Anything else is pure speculation if they haven't done double-blind studies.

Even if the manufacturer were willing to allow 50 victims to try it free as a product challenge, it still won't prove anything because there's no way to prove AHI is reduced.

I agree with previous assessments of Snake Oil. This is not a medical device. Do you really want to go down that road?

I don't know why everyone is climbing on Pure-Sleep's case about this. It is over the counter and sold for less than $70 bucks. Nothing new about a boil-n-bite device. They make NO claims about treating, curing, reducing or anything close to being used for sleep apnea. Intended use of the device is to reduce snoring that's its.

My opinion is: I think listing a device like this on a cpap supply website would suggest or infer it can be used to treat sleep apnea and it clearly doesn't make that claim. It is only the OSA patient who understands the etiology behind obstructive apnea does it make sense this device may help with more than simple snoring. It may also be used as a device to stop or reduce mouth breathing for those prone to that syndrome although Pure-Sleep doesn't seem to make that claim.

If it is sold by cpap.com, I just hope we don't have to filter all the rants and complaints as to why use of this device didn't reduce ones snoring, didn't reduce their apnea, is uncomfortable, causes gum and jaw pain, caused their gums to recede, created TMJ joint pain etc. Right now with it being sold directly by Pure-Sleep we don't have to deal with those rants.

Hell, my opinion is you would be better off selling SleepGuy's PapCap, that thing actually works

disclosure: My daughter is a Dentist and I would love to see her make you a Dental device like this costing >$750 or more but she cannot compete for $70 bucks and she doesn't enjoy lab work all that much as opposed to dentistry.

Howdy All,

The tribe has spoken. Puresleep is off the island.

Thanks,
Johnny

I ran across my brace in a storage box just the other day. I had forgotten that I had one. In 1996 my Dr. sent me to the dentist to be fitted for one, before I had any kind of a sleep study(at the time didn't know what that was). It did not work. Went for a sleep study, had severe apnea. I don't believe the device is usable anymore, but would be curious to know if and how it would work along with my cpap machine?

Hi johnny,

I realize you already made your decision but thought i'd thrown in my 2 (unwanted) cents anyway heh heh

I have NOT used THIS particular device, but I HAVE used ANOTHER device (marketed in Europe) intended to stop snoring. All I can tell you is that if I had been told by anyone that I should have had a sleep study first instead, I would have saved myself 1000+ euro and 3 additional years of going untreated. The device worked for a few weeks/months, just like a too-low CPAP pressure will seem to work for a few week/months for someone who has never been treated with CPAP before.

I personally think these anti-snoring devices are a scan and a rip-off (for the most part), and should only be sold under prescription. I'm all for people using the device if it's medically determined that it will help them, as may be the case in very specific cases. But for the rest, it just delays us getting the REAL diagnosis and the REAL treatment. Hello FDA, WAKE UP!!!

Thanks for asking us, though

I say sell it only in a bundled package with a good pulse-oximeter and plenty of instructions and warnings.

Require the buyer to sign a notarized release.