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Posted: Fri Apr 06, 2007 3:16 pm
by dsm
rested gal wrote:
DreamStalker wrote:Rooster -

You called her no names ... nor have I.
Nope, you two didn't. Nor did most of the people who have responded in this thread. I think Christine was referring to some who did, as in these comments:

"a twit like you"

"freakin' drama queen"

"nosey safety nazi"
DreamStalker wrote: I think she is just very easily offended by anyone who does not agree 100% with her own view of the world.
Having read many extremely helpful posts by christinequilts over the years, I wouldn't characterize her as "easily offended", least of all by people who don't agree with her.

I've always regarded Christine as an extremely intelligent person and a very open minded person. I still do. She obviously felt strongly that Brett's diffuser needs independent testing before being promoted as "safe" to use inside the breathing circuit of medical devices...particularly machines more complicated than a straight cpap. She stated her concerns. When it seemed to her that her concerns were being waved aside, she stated them more strongly. Some others disagreed strongly.

No matter what any of us may think of the FDA, that agency is the regulatory body in the U.S. when it comes to "medical devices." I think Christine did Brett a huge favor. Brett's smart to pursue whatever testing he needs to do to satisfy FDA requirements for promoting his invention as safe to put into the breathing circuit of xpap machines.

I wish Brett well. I thank Christine for bringing up questions that need to be answered. And for being the caring, reasonable person I've always seen her to be.
Apart from minor aspects of this issue, I agree RG. Christine has been a long term provider of very heplful info to people here and her special expertise for me was her wealth of experience with BiLevels devices.

DSM


Whadya Got?

Posted: Fri Apr 06, 2007 3:33 pm
by StillAnotherGuest
GuestForADay wrote:Is this thread closed to new posts?
That depends. Do you have any new material?

Things are starting to get a little lean right about now.

I thought I would be able to do something with Tomjax' Glade thing, working the "Plug-In" angle, but there's nothing really there. Besides, I think that's a chemical thing, so that really don't fit.

After the bit about smokin' the stuff, I'm about out, and the "You are!" "No, you are!" thing is only good for a couple of posts.
SAG

Posted: Fri Apr 06, 2007 3:57 pm
by GuestForADay
Apathy and voyeurism are worse than anything that has appeared on the boards about this topic, and I put forth my own perspective as a *negative!* example:

I would not use the products without independent evidence that they are safe. But I would wait 3-5 years to see if the users (test subjects) develop any respiratory or neurological conditions.

The rationales put forth (FDA GRAS approved as food additives / for cosmetic use / “small” molecules are safe / I use it & love it, ‘therefore it’s good/safe for you too’) have been better than a double back-flip with a twist. So many words – so little content, and yet I’ve been fascinated by it.

His sister died from cancer, someone’s Mother uses the product, she went through an traumatic environmental contamination during childhood, he’s an environmental lawyer, a professor from a prestigious California medical school…that rhymes with Hanford ... it’s like a passionate B-grade soap-opera.

Regardless of CQ’s actions, sooner or later it would have come to the attention of the US FDA. I’ve been waiting for it like a cliff-hanger.

I give credit to the people who believe that they are doing something good: to SleepGuy for trying to develop a product, and to ChristineQuilts, and others, for pointing out legitimate concerns and questions.

I am not proud of my thoughts, and acknowledge that I have taken no positive actions/positions. I am ill with OSAHS and my life is in a downward spiral. I only surf the net looking for help with it, during which I have followed the story on three forums.

I apologize to those who are offended by this post. Perhaps this is my lowest point. I wasn’t always this uncaring and I will try to stop “enjoying the drama”.

Posted: Fri Apr 06, 2007 4:11 pm
by dsm
Hmmmm,

Anyone here live in LA ?

Do you go outside on those days that are foggy / smoggy particularly when there is no breeze & the air is trapped there.

I wonder if the FDA would approve of the air people breath in LA on those bad days. I'll swear that the scent in the air then is more dramatic than anything Pur-sleep produces - but I guess these days the lead content is less than it was



DSM

_________________

CPAPopedia Keywords Contained In This Post (Click For Definition): breeze


Thanks For Your Thoughts

Posted: Fri Apr 06, 2007 4:21 pm
by StillAnotherGuest
GuestForADay wrote:Apathy and voyeurism are worse than anything that has appeared on the boards about this topic, and I put forth my own perspective as a *negative!* example...
Great post, GFAD.
SAG

Re: out of control

Posted: Fri Apr 06, 2007 5:59 pm
by -SWS
tomjax wrote: should we all go and call the FDA on our glade air freshener and the little thingies in our car that dangles from the radio knob?
I just knew someone was going to speak up about those dried up McDonald's french fries haphazardly draped across the car's radio knob.

Carelessness has nothing to do with it I tell ya. It's planned "survival food". Yes! That's it! It's carefully planned survival food! Whew!

Survival french fries, anyone?

Posted: Fri Apr 06, 2007 6:57 pm
by Sleepy-eyes
Now there's something that would alter ones health! They have enough perservatives in them to qualify as survival food, that's for sure. I always found it safer to keep them in a loose assortment on the floor of my car. That way no one would be tempted to steal them.

Posted: Fri Apr 06, 2007 7:08 pm
by deebatt
frete50 wrote:SAG,

You be silly. And thanks for the lightheartedness.

And If I smoked that sounds really good. Maybe this will make me want to start.


Becky


better hurry and get your smoke before the gov't and FDA bans it like they did with cigarettes ....oh wait, they didnt ban anything did they, just gave the tobacco growers a tiney swat on the wrist, gave a warning that cigarette smoking causes cancer . so much for us poor old citizens being looked out for by the FDA

Posted: Fri Apr 06, 2007 10:30 pm
by Rabid1
[quote="dsm"]Hmmmm,

Anyone here live in LA ?

Do you go outside on those days that are foggy / smoggy particularly when there is no breeze & the air is trapped there.

I wonder if the FDA would approve of the air people breath in LA on those bad days. I'll swear that the scent in the air then is more dramatic than anything Pur-sleep produces - but I guess these days the lead content is less than it was



DSM


Posted: Fri Apr 06, 2007 11:35 pm
by Rabid1
As I see it, there are two different arguments on this issue. The 1st is philosophical. Does someone (like Christine) have the right to interfere with our right to make our own decisions?

The second is technical. Does Bret's inline diffuser interfere with the functions of a CPAP, APAP, or BiPAP?

I want to pose a question to all the experts on this forum: What does an APAP, or BiPAP detect? Answer: CHANGE. Change in pressure, change in flow, change in vibration. Correct?

So, I think we can agree, the diffuser is a static portion of the circuit. It doesn't change. Just as every mask, hose, length of hose, and person's face is a part of that circuit. Does anyone think the geometry of a nasal pillow system is the same as a full-face mask? Of course not; but it doesn't matter, the machine doesn't care. It's only looking for changes within the current configuration. If the machine couldn't do that, we'd have to have a different setting for EVERY variable within that circuit.

There are some very respected members of this forum who apparently want to make this much more complex than it should be. Maybe they can step in here and provide something other than "it should be FDA approved" as an argument.

One other thing that's been largely ignored in this thread, is how people using Bret's system FEEL. By far, the vast majority of those people, who like the scents, report better sleep, or at a minimum, a more pleasant CPAP experience. There has not been one single reported incident, other than disliking the scents, of the Pur-Sleep product having a negative effect on CPAP therapy. NOT ONE!!!

Posted: Sat Apr 07, 2007 12:13 am
by dsm
Rabid,

I think the positions are well understood & part of your above post runs the risk of prolonging the matter when nothing new is being explored.

But I am happy to agree 100% on the issue of the impact of the in-line diffuser on any *normal* xPAP air circuit. The answer for me is clearly that there is none.

I say this on the basis of comparing the effect say, that a hybrid mask has on cpap, a bilevel & an Auto. I am in little doubt that the hybrid can cause difficulties for some settings on some Bilevels & Autos. But the mask is a great concept & seems to me to be the best of both worlds in terms of breathing as needed (nose or mouth). Its high leak rate & large 'air well' are challenges for some of the more sensitive machines.

As regards the Pur-sleep in-line diffuser, I can't comprehend that anyone who looks closely at it regarding its lack of obstructions to the airflow and its super dynamic contours, could imagine that the device could do anything that would disturb or warp the algorithms in normal xPAP, (incl Bilevel & Auto machines), to any degree beyond minute. To me, it has no obvious components that could affect the air pulsing ability (vibration) of an xPAP circuit anymore than the difference between a hybrid and a standard mask can. I am satisfied its impedance to the air circuit is negligable to none.

I am left believing that some people got wound up about it without ever having looked at its construction - perhaps the concerned ones fear the ingestion of any substance that seems to them odd (ignoring LA air on a bad day, or Arizona winds in mid summer, & Downtown New York during a garbage strike (yes been there during one)). To this extent I fear some reactions to it were not to me rational (certainly no rational argument that I could see was forward).

I do understand how some levels of lack of understanding can affect some folk when some types of new devices appear. I saw many examples of blind opposition to microwave ovens when they 1st came out. I had been a radar engineer & was fully conversant with the principles of micro-wave energy & their ability to agitate water molecules in organic matter. I also understood the principles of radiation (part of my military training) & knew absolutely that micro-waves had nothing whatsoever to do with irradiation but there were people who flatly refused to eat food cooked at restaurants if it was heated in microwave ovens because they wanted nothing to do with irradiated food. No amount of expertise could tell them differently (I certainly had many such discussions with people about this confusing irradiation with micro-waves. The very 1st microwave oven I owned (back in 1974) was sold to me for a pittance by an unhappy restaurant owner who said he had no option but to get rid of it because he had so many ignorant customers who threatened to never come back unless he did get rid of it. Today those same people are quite probably using them.

It is my humble opinion that we have a little bit of the same lack of understanding going on here now. But c'est la vie.
DSM

_________________

CPAPopedia Keywords Contained In This Post (Click For Definition): CPAP, auto


Posted: Sat Apr 07, 2007 2:30 am
by blarg
Rabid1 wrote:Does someone (like Christine) have the right to interfere with our right to make our own decisions?
Obviously. She's done what's within her rights legally. Now if you think that's moral is another question, but does she have the right? Yes.
Rabid1 wrote:I want to pose a question to all the experts on this forum: What does an APAP, or BiPAP detect? Answer: CHANGE. Change in pressure, change in flow, change in vibration. Correct?
To a point you're correct. However, just because something isn't changing doesn't mean it's not interfering with your treatment. Example: A quarter sized hole in your hose. Doesn't change, does interfere with your treatment.

Now, do I disagree with you that the diffuser probably doesn't interfere with treatment? No. Just don't think this is as simple as you'd like it to be. The decision has already been made to run it through a lab, so let's see what they say.
Rabid1 wrote:There are some very respected members of this forum who apparently want to make this much more complex than it should be. Maybe they can step in here and provide something other than "it should be FDA approved" as an argument.
Sure, how about, "Why not make sure all the bases are covered?" Why is that such a horrible thing?
Rabid1 wrote:There has not been one single reported incident, other than disliking the scents, of the Pur-Sleep product having a negative effect on CPAP therapy. NOT ONE!!!
Yes there has, just that at least I didn't feel the need to do anything other than PM it to the person who asked my opinion, so here you go. When I use any oils in my system, I get a film on the back of my throat and then after about 15 minutes of the weird film, I get a sore throat. As in very sensitive, unable to swallow sore. I was unable to fall asleep using the scents (because of the sore throat), and tried several scents (about once a week over several weeks to minimize environmental issues, and in quantities all the way down to half a drop on a clean pad), but they obviously don't agree with me.

So I really don't see why you're so up in arms about the maker of the products himself wanting to make sure all the bases are covered. I just wish you'd see that even though your experience has been great, it doesn't mean it's as simple as you'd like it to be.
Rabid1 wrote:I know I've not been kind to Christine on this issue. That is an emotional response to someone directly interfering with my life. Someone who has absolutely no right to do so.
Ok, you've misplaced blame a bit. It wasn't her call to the FDA that took the products off the market. It wasn't even her post here. It was SleepGuy. I agree with his decision, but she asked questions (whatever her motivation) and that is her right. Legally. Whether you like it or not.
Rabid1 wrote:Those of you who believe Christine's motives are "righteous" are being naive. It's pretty darn obvious from her posts, that's she's trying to grab the limelight.
What better way to point the limelight at her than to stand up and start screaming about it?


I Can't Even Think Of A Catchy Title

Posted: Sat Apr 07, 2007 5:09 am
by StillAnotherGuest
Rabid1 wrote:I know I've not been kind to Christine on this issue. That is an emotional response to someone...
Well, I guess there's a little "Black Bart" in all of us. But I like your last post, it's a little more in the category of "spirited debate". Once the mudslinging starts, if an issue is already divided, you're going to lose a lot more supporters than you gain.
Does Bret's inline diffuser interfere with the functions of a CPAP, APAP, or BiPAP?
Got me. But it's easy enough to check, and sounds like Bret's doing exactly that.
I want to pose a question to all the experts on this forum: What does an APAP, or BiPAP detect? Answer: CHANGE. Change in pressure, change in flow, change in vibration. Correct?

So, I think we can agree, the diffuser is a static portion of the circuit. It doesn't change.
Not entirely. If you restrict the flow through the circuit, you can alter the basic waveform. And this would not be static in any scenario, because the flow is continually changing, even if your pressure is fixed.
Just as every mask, hose, length of hose, and person's face is a part of that circuit. Does anyone think the geometry of a nasal pillow system is the same as a full-face mask? Of course not; but it doesn't matter, the machine doesn't care. It's only looking for changes within the current configuration. If the machine couldn't do that, we'd have to have a different setting for EVERY variable within that circuit.
I agree, I'll bet there's more restriction in the nares than the diffuser. And as far as this amounting to anything, we're only talking about APAPs and event identification. I don't see where fixed pressure therapy would make a difference.

Nonetheless, one can and should be aware of all these factors. Look at all the threads where machine responses were off the wall because of the variations that you mentioned above, variations that people are basically stuck with?

Some very typical examples of what happens when people make circuit or algorithm changes include:

The IFL1 setting on the 420E whenever you have a flow restriction anywhere.
The AdaptSV "Learn Circuit" (at the least) if you use flow-restrictive interfaces.
And an interesting exchange between RG and DD when an unknown factor crept into a 420E circuit ("it wasn't the tubing!"):

Why Doesn't The 420 Respond Appropriately

So I'd like to see this thing tested in any machine that looks at flow limitations, regardless of how aggressively it does that.
Maybe they can step in here and provide something other than "it should be FDA approved" as an argument.
OK, fulfilling my reputation as a polysyllabic blatherer (inside joke), my offerings from the other thread were:
StillAnotherGuest wrote:
DreamStalker wrote:I had two more zero AHI nights this past week and had my first zero AHI night bit over a month ago shortly after beginning trial use of the diffuser (… and I’m talking about zero AHI over a period of 7 or more hours of uninterrupted sleep here). I cannot say that the EO diffuser is directly correlated to my improved AHI because I have not used it every night and I have not kept a record of which nights I have used it … perhaps I’m just getting really good at making this therapy work? However the coincidence of achieving these recent zero AHIs has given me an incentive to begin tracking my infrequent use of the Pur-Sleep products and my AHI values. Maybe a personal experiment is in order for me?
Snoredog wrote:You mean like is the in-line diffuser device possibly masking your machine's ability to respond to SDB events? That doesn't surprise me.

From what I can tell, this diffuser delivery device is similar to the bacteria filter that installs in-line and has a drop of scented oil on the disc to distribute the scent. Even if it is a low restrictive screen it can impede the ability of the machine to respond to your SDB events.

But a machine like a Resmed Elite with EPR, Remstar with Cflex or autopap/bipap needs that patient airflow "feedback" in order to respond correctly with the exhale relief features offered on these machines.

Another obvious problem with an in-line device like this is when it is used with Autopaps. Autopaps need that patient airflow feedback more than any machine it is how they "listen" to your breathing patterns and respond. When you put a diaphragm in circuit like that, you reduce the sensitivity of the machine to detect SDB events. it is like putting headphones on to hide the outside ambient noise. The machine no longer can respond as sensitive as it did before.

As for your sleeping better as a result? that may very well be only a placebo effect, but I doubt it has very little to do with the actual "smell" and probably more to do with the softer response from the machine with added restriction of the diffuser in the circuit.
Snoredog wrote:The machines we use for OSA are flow-based generators. Flow is the volume of air that flows back and forth as you breathe. While you may have a pressure associated with that flow, it is the flow that the machine uses to determine if you are having a FL, Hypopnea or apnea.
SleepGuy wrote:In answer to your specific question, the diffuser has not yet been tested by an independent lab "to determine if there is any effect on xpap machines ability to sense SDB more specifically is the sensitivity of the machine to respond to events changed in any way." I think that is certainly a fair question and one that will take a bit of time and effort to answer definitively. I am presently working with an independent underwriting lab to develop a testing protocol to accomplish that but expect it to take several months to get to the end of that process.

In the meantime, I have tested the diffuser's performance in comparison to the in-line hepa filter presently on the market and can state that the diffuser's bi-directional airflow is better than the hepa filter.

Everything you have said here about demonstrating that the diffuser has any effect on xpap machines' ability to sense SDB can and should be said about the in-line hepa filter product. I have asked about and looked for independent testing of the in-line hepa filter (in order to assist in the development of testing protocols) but have found none.

I'd be appreciative of any feedback/comments you may be able to pass my way in that regard.
Sure, I'm here to help!

A lot of good points were made in the other thread, so lemme make sure those points are noted here.

Overall, as far as all this goes, I think the only EO you can really talk about if you want to talk about sleep quality is lavender. That's the only substance on the list that has had any documentation whatsoever.

In response to your comment, DS, I would offer the following:

1. If you're not using lavender, the effect is entirely placebo.
2. I see your AHI in your sig hovers around 0.1 to 0.4, as well as occasional 0.0, so this new 0.0 is statistically insignificant.
3. If the Goel study is correct on lavender (and again, lavender, not anything else, and you don't need to do it with a diffuser), an increase in SWS is claimed. SWS is a very stable sleep stage, so the likelihood of having events there is quite small regardless of the instability of light NREM (Stage 1/2). I still gotta get that percentage, but it can't be much more than some minutes worth, so it's contribution to AHI would be negligible.
4. Do we really know if the xPAPs are measuring respiratory events or artifact from sleep fragmentation. If people are claiming they sleep better (there is probably some placebo effect as well, but if part of sleep hygiene is to go to bed in the right frame of mind, then placebo is not really placebo here, that's the desired effect). So perhaps reduced sleep fragmentation makes the "AHI" drop.
5. Does the diffuser change the flow characteristics of the aPAP. Does it create a flow limitation, which now causes the machine to overall increase pressure.
6. Has the ability of the xPAP to recognize events changed.
7. What I find interesting is the example on his website of the diffuser "in action":

Image

Putting the diffuser on a machine that measures proximal airway pressure (pressure measured at the patient vs within the machine) puts out a whole new set of variables.
8. On that same subject, yeah, stick it in an AdaptSV and watch the fun.
9. Comparison to a HEPA filter is inappropriate. That rationale simply says "See, there could be worse things." BTW, a plug for what happens with HEPA filters (and I don't think he's talking about HEPA either, I think he's talking "bacterial", but we can review that at some point if necessary) when they mess up is at

Fun With Bacterial Filters

9. As snoredog suggests, perhaps a less aggressive approach by APAP (which differs from SAG #5, which offers more aggressive approach. Certainly, we gotta say "different", cause something's stuck in there that shouldn't be there.)
10. That effect probably changes the flow by way of the Bernoulli Principle, creating a venturi effect:

Image
A Venturi meter is shown in a diagram, the pressure in "1" conditions is higher than "2", and the relationship between the fluid speed in "2" and "1" respectively, is the same as for pressure.
One other thing that's been largely ignored in this thread, is how people using Bret's system FEEL. By far, the vast majority of those people, who like the scents, report better sleep, or at a minimum, a more pleasant CPAP experience.
Not me, certainly at least as far as lavender goes. There's seems to be a lot of stuff out there supporting lavender in re: improving sleep quality.

And meanwhile, there are a lot of ways you can take advantage of that other than this in-line device, such as using lavender by:

Taking a few inhalations before bedtime (this medically-documented reference was offered by SleepGuy himself).
Simply aromatherapizing the room.
Sprinkling on pillow, mattress or use sachet if you're not on a machine.
Placing the EO near the intake (assuming the EO won't dissolve the impeller. But anybody who offers that argument better explain to me how if it does that, then what must it be doing to lung tissue).
Taking a bath with lavender in it (warm bath adds to the calming effect, that's Sleep Hygiene 101).
Lavender EO massage. Saaaaayyyy,,,you could even have a smoke afterwards.

And have I got a blend for you.
SAG


Or Global Warming, While We're At It...

Posted: Sat Apr 07, 2007 6:19 am
by StillAnotherGuest
Look out, brainstorm! The air intake entrainment idea...

How about using an incense burner (about 25 cents at garage sales) and put a cotton ball in there? A bag of generic cotton balls is like 59 cents, you could change them daily.

Introducing....

SAG-'n-Sleep

Image

Just put a cotton ball with a few drops of EO on it and set the whole thing in front of the air intake.

Counting the 6 bucks for a 10 ml bottle of lavender at Amazon, for 7$ American (64.50$ in Canada) your problems are solved, you have more wicks, more EO, no FDA, no restriction problems.

WearyOne, I'll split the profits.

OK, let's do world hunger next.
SAG

Posted: Sat Apr 07, 2007 7:51 am
by NightHawkeye
Rabid1 wrote:As I see it, there are two different arguments on this issue. The 1st is philosophical. Does someone (like Christine) have the right to interfere with our right to make our own decisions?
. . .
One other thing that's been largely ignored in this thread, is how people using Bret's system FEEL. By far, the vast majority of those people, who like the scents, report better sleep, or at a minimum, a more pleasant CPAP experience. There has not been one single reported incident, other than disliking the scents, of the Pur-Sleep product having a negative effect on CPAP therapy. NOT ONE!!!
It seems clear, Rabid1, that you've lost something which you personally consider valuable to your health. No doubt the Pur-Sleep products have helped you sleep better and feel better. Like you say, others have certainly indicated that the products have helped them as well.

From a personal perspective, it is certainly a loss I'm sure many of us here empathize with, regardless of what we think about Pur-Sleep products. Emotionally, I went through a similar product recall experience four months ago with the only artificial tears eye care product which allowed me to go longer than ten or fifteen minutes without needing to put another drop in my eye.

At first I was simply frustrated when I couldn't find it on store shelves, but then infuriated after finding a couple of bottles which were promply confiscated when I tried to purchase them at the check-out counter. It had taken me a year of trying everything on the market until I eventually found a combination which worked - allowing me to see clearly while needing to apply drops only every hour or so.

The product was recalled for what seemed a silly reason; discoloration of a few bottles which was identified as fungal growth, but of a non-infectious variety. I went through a period of denial, stretching out my remaining supply, hoping that the product would be reintroduced. I searched the internet groups, and found others in my position, but no one had good answers. After a few weeks I started experimenting with other eye drops and again found a combination of drops which worked for me. To my amazement, it didn't take more than a couple of weeks of experimenting to find a combination which worked.

I only offer my experience to suggest to you, Rabid1, (and others) that things probably aren't as bleak as they may seem now. SAG, and others, have pointed out alternatives (some useful, some in jest) which will provide a similarly beneficial aromatic essential oils experience. From what I've read here, the dosage required for facilitating sleep improvements is a small fraction of that provided by the Pur-Sleep products.

The main advancement Pur-Sleep has added (if it's an advancement) is a convenient delivery method. The sleep-inducing benefits of the essential oils are readily available without Pur-Sleep.

I also hasten to point out that the development of any new product or process is usually bumpy. Progress is made and setbacks are encountered.

Hope this helps in some small way.

Regards,
Bill ( . . . kinda wondering what he missed out on, but not interested enough to want to try it)