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"Winx" machine sleep study

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"Winx" machine sleep study

Postby Xney » Wed Dec 19, 2012 11:56 am

Just finished a sleep study with a "Winx" machine, which I think just got FDA approval.

To clarify why, I've been an xPAP user (CPAP, VPAP, ASV) for over 3 years. For whatever reason, despite good numbers after an arduous journey to using it successfully, I just don't feel awake. It's like xPAP only helps about 50%. You can search for my old threads if you want to learn more.

Anyways, this is quite honestly just something my doctor and I are trying. I think CPAP would still be the first line of choice for anybody for treatment, and it'll always be better because you have data that you can track. But if for whatever reason it's not working, another alternative is good, maybe.

I've also tried a dental appliance, which only dropped my AHI from the 40s to the 20s, so I figured it wouldn't be too much of an adjustment trying to sleep with this thing. My initial sleep study with CPAP was not fun!

So, if you've never heard of this machine, it works by negative pressure rather than positive pressure. It sucks up your tongue to the top of your mouth, which creates space behind your throat. CPAP "pushes" your throat open with pressure, the Winx "pulls" your throat open. This is another reason CPAP is probably better for most people, because you can almost always find a positive pressure amount which opens things up, whereas I think the negative pressure can work for some people, but not others. I'm not a doctor or a scientist, this is just my impression as a long-time xPAP user.

This is the thing you wear in your mouth:

Image

It creates a vacuum when you 'seal' your throat. When you swallow, the back of your throat closes, and then the vacuum will keep it closed. (It may not close or stay closed for everybody, I think) Then the vacuum will slowly pull your tongue up and keep it there - you can feel this happening. It's a pretty weird sensation at first, and it took me a little time to get used to it. But after a while it didn't feel like something that would keep me up.

I had to take it out a few times overnight to "reset" it - it felt like I had to give my tongue a break. I think it would be something that I'd need to do less and less over time, maybe not at all - just guessing here.

In terms of sleep, I probably got about 5, maybe 6 hours on my sleep study. That's pretty good for me - I don't tend to sleep well in sleep studies. The sleep felt okay, considering everything. I'll have to see what the sleep study says in terms of breathing issues, desats, and arousals. My impression right now is that I'd probably want to try it for a few weeks and compare it to CPAP. At least, I can't think of anything more to try with xPAP. I've tried everything I can think of with it.

Anyways, that's my experience so far. When I get my sleep study, I'll post the info from it.
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Re: "Winx" machine sleep study

Postby Daniel » Wed Dec 19, 2012 4:03 pm

Seems to be very similar to an Oral Appliance......called a TRD (Tongue Restraining Device)....aka Tongue repositioning Device.

These types of OAs are used for folks with insufficient rear teeth to anchor a MAD.

Haven't heard of a 'Winx' though.....probably works on a similar basis to the TRD. Provent also works on the negative pressure basis.

Best of luck. Great if you can keep us up to date on progress.

Daniel.
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Re: "Winx" machine sleep study

Postby Xney » Wed Dec 19, 2012 4:56 pm

Yes, I think it's very similar to a TRD, except it works by air vacuum. Same idea, at least.

"Winx" is the product from a company called Apnicure, I believe.

I'll post the results from my sleep study with it, and then if I get it, how it's working for me (or not). Unlike CPAP, I don't think it'll work for everybody, though.

It's possible I get the exact same results as I'm getting with my xPAP, too. :|
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Re: "Winx" machine sleep study

Postby erinprime » Wed Dec 19, 2012 5:11 pm

The Winx looks really interesting. How did you hear about it, how did you get your hands on one, and how much does it cost? I would definitely be curious about trying it.
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Re: "Winx" machine sleep study

Postby Xney » Wed Dec 19, 2012 5:39 pm

I heard about it from my new, 2nd sleep doctor @ Peninsula Sleep Center in the bay area. I first heard about it like 4 or 5 months ago there. After I've been on my ASV with an AHI of 0 for 3 months, I just need to try something different, so this was an option we had talked about. The company that makes it is local here in the SF bay area, I think.

My understanding is the FDA recently approved it for treatment of OSA, and it's being deployed in certain markets before wider availability. This is just based on what I've read.

In their press materials they define "successful treatment" as AHI reduction of 50%. well, to me, it's when you get it below 5, or maybe below 2. If you're 42+ like me, 50% reduction doesn't cut it. So I need to see what my sleep study with it says.

As far as cost goes, they're in some kind of program right now testing it out, so I don't think it would reflect a permanent purchase or insurance situation with it when it's fully released. If the sleep study looks good, I want to try it out for a few weeks before buying it, anyways.
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Re: "Winx" machine sleep study

Postby Xney » Fri Dec 21, 2012 3:39 pm

Just talked to my doctor over the phone. I don't have my sleep study in hand yet, but apparently the AHI was 0 for the night, RDI was around 5. (Not sure what the RDI was from, could be anything) So that's pretty good, I'm gonna give this thing a shot. Lost the vacuum for a little bit in the study, sort of like having leaks.

:o

Downside is, you don't really have data with this machine, so it will be kind of based on how I feel, but I've been pretty accurate with how my xPAP was working in the past before looking at the numbers.
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Re: "Winx" machine sleep study

Postby CrohnieToo » Sun Dec 23, 2012 3:55 am

Really quite interesting, Xney. Do keep us up to date on how you are doing w/it, please. It sounds like it could well be an alternative for those not "getting it" w/xPAP. We will all be interested in cost as well, of course.
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Re: "Winx" machine sleep study

Postby Xney » Mon Dec 24, 2012 12:57 am

I have the sleep study. The RDI was almost entirely RERAs. There was also some PLMs but I think those were before I fell asleep. Same with most of the RERAs I think. It's just so artificial of a setting that I don't trust a lot besides actual apneas. :)

I'm going to get my machine Jan 2nd and after a few nights of it, I'll post how it's going. If anybody's interested I can also post a review of the machine itself and how it works for me, besides sleep quality.

I'm still convinced due to the lack of data that xPAP should be the first line of treatment. On the winx, you can't tell at all when you stop breathing - you can only tell from the data when the seal is lost.
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Re: "Winx" machine sleep study

Postby CrohnieToo » Tue Dec 25, 2012 1:57 am

It MIGHT help a little bit to get the limited data from a recording oximeter whilst wearing the Winx.
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Re: "Winx" machine sleep study

Postby Xney » Tue Dec 25, 2012 3:01 am

Yeah I'm considering it. But I have been pretty much dead on with CPAP/BiPAP/ASV adjustments in terms of knowing how much better each tweak was, and then the data would back me up. I think I will know if it's working or not.

One interesting thing from that night was that although I only slept about 5 hours in chunks, being woken up, I didn't feel too bad the next morning. I don't know if it's just weird or if it means something. I'm anxious to get my test machine - the ASV feels the same each night no matter what.

In my original sleep study without anything, almost every event I had in my 42 AHI was hypopneas. That kind of tells me that more "space" will help a lot. Oddly enough, the dental appliance I tried didn't really help much, but I think the way the Winx works with the negative pressure, it has a much bigger effect on the "soft tissue" if that's your problem. The dental appliance depends on how much the jaw moves the soft tissue - I guess I didn't have a lot of luck with the appliance because of my anatomy.

I'm really willing to try almost anything at this point - trying not to get my hopes up too much. :)
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Re: "Winx" machine sleep study

Postby blueh2o » Fri Dec 28, 2012 1:35 pm

Xney,
Keep us up to date. Just to correct Daniel, Provent works on based on positive pressure, not negative, created from resistance to exhalation.
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WINX machines info

Postby TwoWheelFree » Wed Jan 09, 2013 5:58 pm

Have read with interest the post regarding the winx. A few responses to what I have read. Some insurance companies are paying for this. Most notable are Blue Cross/Blue Shield of S. Carolina and Arizona. The other insurance companies Lori Schulman, Patient Care Manager @ Apnicure read to me were not familiar (I am guessing these are smaller, more localized insurance companies). And I would bet that this is FDA approved. Would any insurance company be paying if it were not FDA approved? Could it even be marketed for apnea treatment if it were not FDA approved?

I don't know what the cost of the machine is. Lori provided me with a chart that gave $1161.13 as ongoing replaceable item cost for CPAP machine use with $599.60 for ongoing replaceable item cost use of a WINX. Those figures are yearly costs. Hey folks, that is almost a 50% reduction of the annual use costs. That alone should give insurance companies pause. Unless, of course, they do not help pay for the annual use costs.

I suggest apnicure.com for more info.

The machine is being made available where the demand is. I have therefore made the initial steps to make my insurance company aware of this machine. And I am going to make a follow-up appointment with my sleep study people to see if I can make them interested in the training to make this an option.

Comparing all the downsides of machines, surgery, and oral appliances with the published research about WINX along with the post about AHI being O with use of this machine is enough for me to be convinced that this should be an option. option. IMHO, medical providers, insurance companies, medical equipment providers, and big pharma are far too cozy.

I am not above going to government agencies to complain if I get the cold shoulder over use of this machine.
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Re: "Winx" machine sleep study

Postby Xney » Wed Jan 09, 2013 6:46 pm

I have another thread about my experiences with it on a week (now two-week) trial.

FDA approval is not the same as it being as good as CPAP or such. I think they're at the stage where it 'helps' and they have approval for that. Insurances are really the tricky part. I think insurances will start to add it as an option over time. Right now, they're still in the very, very early phase of getting the machine out there.

So far my experiences with it are mostly pretty positive as a second type of thing to try after CPAP. I think it has a long ways to go before it would be tried before CPAP. Insurance costs and such are going to be the trickiest part of using it for the next year or two.

For me, I'd pay out of pocket if I had to if it worked. xPAP simply doesn't help enough, despite awesome compliance and numbers. So my situation is a bit different from people who just don't "like" cpap :)
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Re: "Winx" machine sleep study

Postby Daniel » Wed Jan 09, 2013 8:21 pm

Looks like the Winx Sleep Therapy System received FDA Approval on 31st October 2012:

DEVICE: WINX SLEEP THERAPY SYSTEM
APNICURE, INC. 510(k) NO: K122130254(SPECIAL)
ATTN: CHRIS DANIEL PHONE NO : 650 361 9300
900 CHESAPEAKE DR SE DECISION MADE: 31-OCT-12
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA


It is another step, next one is to get some independent clinical trials (to date all have been financed by Apnicure, and are 'Posters as distinct from 'Peer Reviewed' studies) published.

IMHO, insurers will be slow to agree payment until such time as there are independent figures available.
The medical device market is a slow mover.

Daniel.
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Re: "Winx" machine sleep study

Postby Xney » Wed Jan 09, 2013 8:35 pm

Heh yeah, maybe when we're really old, we can finally get a Winx machine via insurance.. ;)

Well, at the moment I get to try it out and see, at least. It's a start. :)
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