would seem that sleep disorders are not understood very well

[Not Fade]

looks like we have a long way to go to really understand sleep disorders.

Yes YOU do.

I think you are barking up the wrong tree. CPAP machines and masks have evolved to the point that additional improvements in effectiveness, tolerability and cost will only be small gains at high cost. Only so much can be done with a fan blowing into some bodily openings.

The next step is a novel treatment, hopefully cure, that none of us have ever thought about. This may well come from outside the sleep industry. Great leaps in progress are often made by outsiders.

In the meantime, have fun with the attention from rattling off in the forum. You seem to be enthralled with your posts.

[space45]

all I can say is wow, think what you want, enthralled with my posts, whatever, you try to help out, do your part, maybe I should not have gone so deep into what I believe or think, live and learn

BTW the first installment of the open source mask has been done for anyone interested, I refer you to my reply to 49er down near the bottom

viewtopic.php?f=1&t=96961&st=0&sk=t&sd=a&start=15

[robysue]

very true, if every one was paying for their own unit you can bet the price would be a fraction of what they charge now. all the red tape would have never been put in place. very few if any one would pay the extortion price and the price would have to come down to have any chance at all of selling them

and

you have made my point better then I ever could have. ever think why we need all the levels of red tape that exists? what possible good can that extremely large pile of over bearing top heavy completely useless regulatory monstrosity ever hope to archive for the end user? answer, nothing really,

and

some think it needs to be certified and what ever, it would be if your doing a insurance claim, and I know it will never be recognized by any doc, but that is not the goal or point of any of these open source projects I have mentioned. they are solely for education and for anyone to make one if they so choose, they can even use it AT THEIR OWN RISK, if they so choose. no profit on the unit its self, no selling of a unit, no claiming a unit, no doc prescribing one of the units.

and

I do not want or need the open source units recognizes by any authority, they are for personal use only, made by the user for the user. no permission or certificates or any red tape BS that makes the others cost a ton. not needed or wanted. one other thing, IT is not being sold, parts are being bought, or sold depending on the point of reference you use, supplies are as well, all can be bought from others, not just me. my thing is robotics and CNC and automation, that is MY thing, nothing wrong with the PAP thing.

If the devices are marketed (or even freely distributed) as treating or managing Sleep Apnea and are sold (or freely distributed) without a prescription, the FDA will still be on your back because you are making a medical claim that must be verifiable. And verifiable means that the device has been run through the proper testing ($$$) and has met FDA requirements for safety and efficacy. Without the FDA approval, the device---or its parts---cannot legally be sold in the US as a way of treating Sleep Apnea.

And if you don't plan on marketing the device as a way of treating OSA, who the heck would even consider buying it (or even using it if it were totally free)? Folks who believe their problem is just a little snoring (i.e. folks in denial) will continue to buy less invasive, less PAP-looking devices of dubious effectiveness for OSA that clearly state on their label: Not intended to treat sleep apnea. Sleep apnea is serious condition .... like Breathe Right strips. Folks with sleep apnea who have insurance will continue choose to use insurance to pay for an approved device. Folks with sleep apnea who don't have insurance will probably muddle along as they do now in a variety of ways, but very few of them would probably have the energy and know how to deal with a kit that they have to assemble.

would hope someone uses my work to help the PAP community, looks like it will have to be a third world place or some place where they are not so nuts over regulations, you guys can then buy from them if you want. if someone wants to do this I will help them set up to do custom masks and master molds. after awhile I would hope the ones I help and train will take over helping and training others

Those pesky regulations you are complaining about are a large part of why first world medicine is so effective as well as expensive. The regulations insure that medical devices and drugs have been investigated rather rigorously before they are allowed to be marketed as "standard medical treatment". And even so, the system is not perfect---more "bad" drugs get through than you'd think. But at least we no longer deal with snake oil salesmen legally being able to sell their untested and potentially dangerous treatments with claims that treatment will cure or manage specific medical conditions.

one of the reasons I would like to do the sleep lab is to maybe incorporate the lab into a PAP machine that will record tons of data, and it is my hope that the client will then upload the data to a website at some sort of interval, or allow a wireless connection to auto upload it, no personal info or identifying data. just raw info so it can be looked at and evaluated to see if there is any patterns or anything that could help in improving treatment. it will also have the ability to have things added, so a 5 year old unit can have expansion units added to add more functionality and testing as the need arises

If a device is going to be sold or simply distributed along with software that claims to evaluate the data in order so that the software can make suggestions to improve treatment of a medical condition, then both the device and the software are legally medical devices and they're going to need FDA approval. Otherwise the owner/author of the software that is automatically making suggestions on how to improve therapy to the user may be subjected to being charged with practicing medicine without a license.

It's also important to note that what you are talking about in terms of software capabilities goes well beyond what JediMark's SleepyHead software does. The SleepyHead software simply displays the data gathered by legally sold PAPs. The SH program itself does NOT analyze the data and then make specific suggestions on how to improve therapy. Indeed SH comes with the statements:

This software comes with absolutely no warranty, either express of implied. It comes with no guarantee of fitness for any particular purpose. No guarantees are made regarding the accuracy of any data this program displays.

and

DISCLAIMER:

This is NOT medical software. This application is merely a data viewer, and no guarantee is made regarding accuracy or correctness of any calculations or data displayed.

The author will NOT be held liable by anyone who harms themselves or others by use or misuse of this software.

Your doctor should always be your first and best source of guidance regarding the important matter of managing your health.

*** Use at your own risk ***

In other words, SH is not being distributed as a tool that tells you how to manage your OSA; it merely allows you to
view data that is already gathered by your FDA approved machine. If the user cares to analyze that data or ask others to analyze that data (including a doctor), that's one thing. But JediMark's SleepyHead is does NOT send you notices that say things like, "Increase the pressure by 1.5 cm to see if that reduces the number of FL's in your data." And that's why he can legally get away with the statement that SH is NOT medical software.

[space45]

robysue you have made some very good points, thanks for the input

one could do the machine as a home sleep lab to study OSD as well as other sleep disorders, the fact it does what PAP machine does would only be one of the many options it has for the study of sleep disorders at home. no treatment implied, but it could do the job. a way to set up your own programmed algorithm for dealing with any feed back from any input, guys can play with settings and share what works for them.

just a thought

this whole wanting to help and explore options as things seem to not be going so well with PAP machines is not going so well. guess I should have kept my politics and certain believes to myself. I thought after I started down that road it would most likely bite me, but I was already heading in that direction so would be hard to do a treat, I am not good at retreats.

[chunkyfrog]

---What's a deorder?

[space45]

---What's a deorder?

oops
did I mention I was very dyslexic and spell checker is my savior, but does bite me very regularly
it makes me look stupid at times and can make my posts very hard to read at times

[robysue]

this whole wanting to help and explore options as things seem to not be going so well with PAP machines is not going so well. guess I should have kept my politics and certain believes to myself. I thought after I started down that road it would most likely bite me, but I was already heading in that direction so would be hard to do a treat, I am not good at retreats.

Your politics or behavior is not the problem.

It's just that what you're talking about is not as simple as you want it to be. The government regulations are there to protect people from being harmed by badly designed medical equipment. And to provide legal responsibility when someone is harmed by badly designed equipment that manages to get through the far from perfect regulatory system.

[space45]

LOL, Not Fade, your right I have a ton to learn, never said I did not, why do you think I throw out so many ideas and ask for input, I am a great guy for tech and getting things made and solving problems. but this whole people and society interaction thing eludes me when I get revved up and going a mile a minuet. it is 100% tech and working with in the laws of physics and what is possible and what is not possible with in the limitations of today's technology.

I try to think about laws to a point but to be honest I fined the legal system nuttier then a fruit cake and find my self banging my head against things that make no sense at all. when I think of all the things we could do if some laws were changed. I hear the ones that say the laws protect us and are there to keep us safe, well safe is somewhat relative. also there is feeling safe and then really being safe. most feel safest in gun free zones where no one has a gun and every one is equal. this would be fine if there was no such thing as guns and knifes and clubs and what ever other weapon that could be use to give one a advantage over another. now I on the other hand feel way more safe at guns shows or gun range. some will think me nuts, some have it in mind as a firm fact, more so now, but think about it. how many guns shows were attack by a crazy gun man? non. how many gun ranges were targets of mad gun men. non. how many gun free zones have been attack, allot, in fact most every crazy gun man finds himself a gun free zone to carry out his attack. being unarmed at a gun show is way more safer and I feel safer when I am at one, even with the wall to wall guns and guys carrying guns are everywhere. how long would a gun crazed wacko last at a guns show, not long at all, that is why the wackos never show up to one. some would say anyone going to a guns show is a gun crazed wacko.

I look at a PAP and see a high tech blow drier, as in for real, my mom had a hair drier with a hose and plastic cap for drying her hair. the PAP reminds me of that...lol anyway I have a few things to get done and then will make a quick and dirty CPAP, as in a brick, plain and simple. we will see just how hard this task will be. the only possible challenge would be to get the air feed back algorithm just right for maintaining set pressure and to a high degree of accuracy and with a quick response time with out over shooting. I am sure that will not be any real problem, but I would say if there is one that will be it. this unit will be the base of my sleep lab and my backup PAP unit if the main unit fails.

when I see all the things that I find lacking with the modern day PAP machine I do find it hard to pay it any respect, and more so when the price of it is factored in. I saw red as soon as I was told the price from the start by the IRS, and was over the top when I was shelling out good money for what some would call a great deal for a top of the line VPAP, all I saw was the worlds most expensive blow drier repurposed to do the job. to say I felt ripped off and stolen from was just the beginning, down right mad and I vented, allot on the forum, sorry about that. the open source thing was not meant in any way to steal or rip off or anything like that the companies I felt ripped me off. mind you it does seem to work as advertized so one can not argue that, but still it sure feels over the top for price for what you get. one hell of a blow drier...lol sorry, hard not to call it that. also I have some ideas for straps and other head gear not part of the mask, to say it feels like they are not putting much effort into the units also would be my feeling. if they really were wanting a good mask fit and wanting to make things better, where are they, one would think a factory rep would have identified themselves and said hello to me and asked if he could talk to me. now that would take one brave sole with all the ranting I have been doing. or maybe not, I am not that bad and what can I do to him when both of us are behind keyboards. lol

the point is I am fighting my mask some, not much but enough to not be happy, they do seem some what cheap, just saying, and then the price, well you know where I stand there, so I will try some new ideas and if they work, share them, surely that would be OK, my own designs of straps, are they also covered by the FDA? can a simple strap, and suggesting a change or new way to do them be under the FDA and regulations? after all they are only straps. anyway, I may not post what I am doing it this could get me into hot water, in deep enough all ready thanks.

would like input for the strap idea, was hoping I could at least help out with straps and head harness to help get a better seal and fit, they have been on my mind allot lately.

I keep writing books, want to keep it short and sweet like others, but I keep writing books. shocked me to see how long this has got.

looks like we have a long way to go to really understand sleep disorders.

Yes YOU do.
I think you are barking up the wrong tree. CPAP machines and masks have evolved to the point that additional improvements in effectiveness, tolerability and cost will only be small gains at high cost. Only so much can be done with a fan blowing into some bodily openings.
The next step is a novel treatment, hopefully cure, that none of us have ever thought about. This may well come from outside the sleep industry. Great leaps in progress are often made by outsiders.
In the meantime, have fun with the attention from rattling off in the forum. You seem to be enthralled with your posts.

[Goofproof]

You should spend more effort on building "A Replicator", that way you could program it to build anything. I heard the other day, they have a 3D printer that print edible product. So now you can print a gun to shoot supper or just print supper. Jim

[space45]

you have no idea just how much I would love that idea, and not having to cook, or eat my wife's cooking, that would be nice. my wife is wonderful, but a good cook she is not, she really hates to cook, so I do most of it.

a Replicator like in star track would truly change the world, if we had enough power to power it, that would be the next great problem

You should spend more effort on building "A Replicator", that way you could program it to build anything. I heard the other day, they have a 3D printer that print edible product. So now you can print a gun to shoot supper or just print supper. Jim

[musculus]

sleep problem besides, your description sounds awefully like biopolar disorder/manic depression.

[chunkyfrog]

@musculus: --and where did you get your degree in psychiatry?
Your comment is rude and unkind. Everybody can see that.
Odd you can't.

[space45]

sleep problem besides, your description sounds awefully like biopolar disorder/manic depression.

throw in some obsessive compulsive disorder, and a touch of autism and you will be hitting real close I would guess, or at least that is my suspicion, not sure what self diagnoses is worth.
if I start a new book and I like it, it does not hit the ground till it is done, I can not do a thing other then read and snack. it is real bad I have gone days, missed work, nothing else matters but reading that book, so I am careful what books I start and when. it is getting better as I get older but it is still there.

I had a teacher want me out of her class as she was above wasting her time on a retard. she tested me 3 time with 3 different tests to prove I was to dumb to be in her class, I rated genius all 3 tests. she was so pissed that I was smarter then her by a boatload that she put my desk in a big refrigerator box in the back corner of her class and I stopped existing as far as she was concerned. completely and totally ignored.
that was back in the day when they knew nothing about dyslexia, little on how to deal with it or someone that has it, throw in a good case of being very socially disconnected and I came out looking real bad. she was sure I was a complete retard.

got the best education a kid could want, I was with in arms reach of the encyclopedias and I love reading them. I was learning tons of cool things while the class was doing the same old boring as hell stuff. that was when I also got a imaginary friend as the other kids would also not know what to do with me. only bad thing about it was being lonely, it was all good my non existent friend left in a few years and I learned a ton and all was back to norm after awhile.

[Julie]

To Space45 - You know, you've had some excellent advice here, though most of it has told you that what you want to do is impractical and legally (if nothing else) a big problem. We get that you have trouble with the system, your equipment and sleepy self, and have some tech smarts you want to use to fix it all, but I wonder if on reconsidering you come to the conclusion that maybe building a better toaster might be easier (and they still would need regulations, etc.), but might not know how to 'back down' at this point without feeling like you were quitting in public. Well, I think we can all understand where you're coming from - not the first one of us to want to fix lots of things, let alone our OSA, and we admire your intentions and creativity, but would also understand and admire you if you said "well, it was an idea, not a bad one (at all), but maybe for another time and place. It would not make you look like anything other than a someone who recognized and accepted a few realities and had the brains to know it might not be the time for you to pursue the idea as things are, but went to work on something else, or just sat down and took a break... it's ok - there's a time for everything but this may not be that time.

[chunkyfrog]

Space45: You are different, but in a good way.
This forum has its share of geeks and obsessives--I think you will fit right in.