Are We Enetring a new Era in OSA Therapy?

Truth is, I should have taken band beginning in elementary school and blown something that required circular breathing.

Any of you going to encourage you grand children (and such) to join band?

Sounds like "snake oil" to me.....or, a very expensive procedure for an EXTREMELY SMALL category of OSA patients.


Den

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The Apnex Inspire device would have cost in excess of $25,000, had it been approved by the FDA.
Approval was refused (in 2012) for lack of positive benefit to the test subjects, who now have to have the implant removed,
A removal fund was created, but who knows if it was enough.
Guinea pigs might have to pay for removal! Lovely!

Look, I am not trying to be a Mr.Negative here, but as a physician for 38 years, one thing that I know is how much we (the medical establishment) don't know. Even stuff we think we know is 50% wrong 10 years later. All I ask is that everyone keep an open mind. I do screening colonoscopies all day long. Someday the medical field might laugh about that. I cannot predict.

WE know CPAP improves AHI, and speaking for myself, I no longer fall asleep during the evening news. Maybe someday, a person with OSA will have something the size of a matchbook under their skin and not have to sleep with an alien attached to their face. It is just a maybe. But I can almost assure everyone that the way that OSA is approached 20 years from now will not resemble the way that it is approached today. That is just about a guarantee.

Wearing a CPAP mask at night is less of a hassle for me than using glasses during the day. I don't care what sits on my face while I'm asleep.

CPAP gets a bad rap number-wise because they factor in the people who don't even use it, for some scientifically incomprehensible reason. CPAP helps almost 100 percent of OSA sufferers who use it all night at the effective pressure. Why include the people not using it when figuring a success rate for an approach? And if you do, then include the people to whom surgery is suggested but who don't actually get the surgery when figuring the surgery success rate and figure in the people to whom oral device is simply mentioned when figuring oral device success rates. Apples to apples. Just sayin'.

I don't wish for a drug or surgery or implant to replace safely, naturally delivered pressurized air. To me, those things would be a major step backward, not forward.

One day an invasive colonoscopy will be replaced with something less invasive, true. But that's no reason to replace something as noninvasive as PAP therapy with something more invasive in order to call that step backward a step forward. In my opinion.

Yes, alternatives need to be explored for the people who can't, or won't, use PAP. But that by no means makes those explorations anything that will ever in any way replace PAP. PAP is just too dang amazing, when used optimally.

But hey, that's just my opinion. And I'm often wrong, according to my wife anyway.

And to add to that, cpap is incredibly economical and safe compared to anything implanted and invasive.
My mother-in-law died with a defective, "recalled" defibrillator inside her--one the manufacturer chose not to replace!

RobertS975 wrote:But I can almost assure everyone that the way that OSA is approached 20 years from now will not resemble the way that it is approached today. That is just about a guarantee.

Well that's odd, because they (the medical establishment) don't see it that way:

Where do you (Colin Sullivan, inventor of "The Thing") see obstructive sleep apnea treatment in 20 years?

I think we will be more effective at prevention. Many of us think that children who snore are the group in whom adult sleep apnea will develop, and that appropriate orthodontic treatment to promote the growth of a larger upper airway will play an important role in prevention. However, I am sure that nasal CPAP will remain a front-line therapy. The search for a magic pill will go on, but they are still not yet on the horizon

http://sleepfoundation.org/ask-the-expe ... uture-cpap

chunkyfrog wrote:The Apnex Inspire...

I think you melded 2 of the companies together CF:

http://www.mddionline.com/article/battl ... orge-ahead

but, yeah, one of 'em folded.

According to some, the "magic pill" for OSA will be here when those with OSA can lose the excess body weight they believe is the cause of their OSA. To me, this device fits in the same category of "snake oil." It sure benefits the pockets of the sellers. Patients not so much.

jnk wrote:CPAP gets a bad rap number-wise because they factor in the people who don't even use it, for some scientifically incomprehensible reason.

And "IMHO" Jeff, HGNS is going to suffer the same fate.

Article wrote:Based on self reports from 123 participants at 12 months, 86% (106 of 123) used the device daily and 93% (115 of 123) used the device at least 5 days a week.

"Self reports"?

I think we can safely estimate that's way off the mark:

http://www.ncbi.nlm.nih.gov/pubmed/8404084
http://www.ncbi.nlm.nih.gov/pubmed/8466125

So Inspire will have to put a compliance monitor in there (easy enough), and when CMS sees a patient who's less than 70% compliant they're going to sneak in there at night, rip the thing out and take it back.

Toss it on the same pile as the Zeos.

RobertS975 wrote:Look, I am not trying to be a Mr.Negative here, but as a physician for 38 years, one thing that I know is how much we (the medical establishment) don't know. Even stuff we think we know is 50% wrong 10 years later. All I ask is that everyone keep an open mind. I do screening colonoscopies all day long. Someday the medical field might laugh about that. I cannot predict.

WE know CPAP improves AHI, and speaking for myself, I no longer fall asleep during the evening news. Maybe someday, a person with OSA will have something the size of a matchbook under their skin and not have to sleep with an alien attached to their face. It is just a maybe. But I can almost assure everyone that the way that OSA is approached 20 years from now will not resemble the way that it is approached today. That is just about a guarantee.

RobertS975,

You're not being negative at all in my opinion. In my opinion, you're doing what any good medical professional does in realizing that medical treatments aren't a one size fits all type of deal and with sleep apnea, there needs to be as many options as possible. For that, you should be commended big time.

49er

CPAP gets a bad rap number-wise because they factor in the people who don't even use it, for some scientifically incomprehensible reason. CPAP helps almost 100 percent of OSA sufferers who use it all night at the effective pressure. Why include the people not using it when figuring a success rate for an approach? And if you do, then include the people to whom surgery is suggested but who don't actually get the surgery when figuring the surgery success rate and figure in the people to whom oral device is simply mentioned when figuring oral device success rates. Apples to apples. Just sayin'.

I have a different take. There haven't been that many studies about why people are intolerant of pap therapy. One of the few ones I have seen has suggested that nasal obstructions issues are a main cause. So if this folks aren't being treated, it is kind of hard to use the machine all night if you can't breathe.

Of course, that isn't the only reason why people are intolerant of the machine. Dr. Park has stated that many people (particular UARS sufferers) get more arousals when wearing a mask due their hypersensitivity. So again, it would be very hard for them to use the machine all night as that would be like as asking folks with autism to sit in a noisy room. Theoretically, they would eventually get use to the machine but what sounds great in theory isn't always the same as what is reality.

I guess my point is that until there are serious studies as why people have difficulty using the machine, I think no one on this board can say for sure what the true success rate is.

I don't wish for a drug or surgery or implant to replace safely, naturally delivered pressurized air. To me, those things would be a major step backward, not forward.

Well, if someone can't tolerate naturally delivered pressurized air in spite of their best efforts, the therapy isn't worth a darn. And if their life is at stake and surgery is available that would give them a shot, I consider this to be progress. Actually, the more options people have regarding any condition, that is progress.

One day an invasive colonoscopy will be replaced with something less invasive, true. But that's no reason to replace something as noninvasive as PAP therapy with something more invasive in order to call that step backward a step forward. In my opinion.

Again, I have a different take. A comparable example is having surgery for sinus issues vs. taking meds. Even though we all agree that surgery is invasive and definitely not risk free, many people would take this option in a heartbeat to be free of taking meds. When this surgery is refined and improved after several years, it is possible that people will view this situation in the same way.

I guess JNK, I don't see the issues as invasive vs. noninvasive but instead I see it as having enough options for what suit's someone's situation and improves the quality of their life.

49er

Until science catches up to what is possible, someday, the rest of us need to concentrate on what works NOW,
and make it less objectionable to those who won't or can't use it; and especially make it as effective as possible for everyone.
This means get rid of the "bricks"! The fact these devices are still made, sold, and PUSHED off on the unsuspecting is deplorable!

For me, there's a big difference between saying "here is something that may one day help some of the people who can't or won't use PAP" and saying "this is well on its way to being something better than PAP and that will make PAP obsolete, replacing it." One statement sounds commendable and praiseworthy to me, but the other sounds like the usual misleading market hype that is meant to drum up investors but mislead patients. It is overreaching when there are no data to make that projection responsibly. That take is the motivation and mind set behind the statements in my posts in this thread.

And my point on apples-to-apples data is that if you are custom-preselecting your participants for your product and only counting the ones using it regularly as designed and doing so successfully, then it is only fair to compare the data from your product with the data from custom-preselected PAP users using PAP regularly as designed and doing so successfully. Otherwise a comparison to PAP is less than genuine.

I agree with a new era, I'm just not certain that the new era isn't going to be more restrictive insurance coverage and less scientific innovation.

I would think that there would have to be overwhelming evidence that this electronic device would be a greater benefit than pap, and, a demonstration that the patient has a medical condition that prevents the successful use of pap.

There are not a lot of reasons why an insurance company would want to foot the bill for a surgical procedure where a less expensive solution is already available. On top of that the current crop often unsuccessful OSA surgeries will make it a tougher sell.

John