PurSleep- Cosmetic or Drug? Safe or Not?

[Jeb]

I agree with bookwrm63. This man has repeatedly answered your questions. If he was trying to dodge anyone why would he be hanging around answering all of your questions? I'd have stopped long ago if I was just trying to get one past you. Sheesh.

[WifeIsHappyNow]

I agree...we are all adults and can choose for ourselves...so why can't someone ask questions to make an informed decision without people jumping on them? I don't believe anybody has said anything derogatory about anyone or any product, so why not let questions be asked by those who have concerns?

[birdshell]

I agree with both parties as I read the discussion. However, I am not sure which of the two has the better position. Time will tell that.

As a person who is sensitive/allergic to many fragrances, I can certainly empathize with Christine. When she speaks of her corn allergy, and how important the reporting of the source of every ingredient may be. A peanut allergy, for example, is life-threatening. Some who are even in the same ROOM with a peanut butter sandwich are at severe risk. This is why airplanes and schools have banned peanuts and peanut-based products.

I am allergic a preservative that is used in many medical liquids, such as flu vaccine, some local anesthetics, contact lens solutions, etc. My allergist has told me to avoid even the products that are made in the same factory, such as the flu vaccine with 0.00004 mg of the preservative.

Thus, if Christine or anyone else with an allergy to any of the ingredients, were to use certain of the Pur-Sleep products, it could be a very serious event. Brett, I believe that she is doing you a service by pointing that out. Surely, you seem to be a caring individual with no desire to cause harm, especially by an omission.

Those without allergies often do not really understand the consequences. When one exposure may cause a visit to the emergency room, use of an Epi-Pen, or even disability, the label listing is not a trivial matter.

That said, I would like to point out again that the ResMed Swift manual suggests using an unscented and moisturizer-free soap (such as Dove--stated right in the manual) for cleaning. The problem with this statement is that it is incongruous, as Dove is 1/4 moisturizing cream. Further, the unscented Dove actually contains a masking fragrance--only the sensitive skin version is truly fragrance-free.

I happen to know this because I am very sensitive to fragrances. Thus, I did decide to pass up on the chance to use the Pur-Sleep device in case I would worsen my condition. It is possible that I could develop even more sensitivities if I used the essential oils.

I shall keep looking for additions to this discussion. It is a good one, and I feel for Christine trying to do her own due diligence reading ingredient lists in order to protect herself.

I also respect Brett's point of view, and his effort to explain things as he is viewing his product. I would say that one of the unspoken issues here is the emotional attachment that Brett understandably feels for his product, and that the users of the product who have found success may be feeling. This is counteracted by the difficulty and frustration that Christine has had with ingredient lists that do not accurately state their ingredients OR from what substances they are derived or where they are produced. She seems to practically be providing products for her personal use on a level with that of the pioneers, but even more advanced with cosmetics and other personal products. How many of us would like to revert to that period of time and amount of effort?

The arguments on each side have merit, and the discussion on this forum is desirable. Thank you to all for avoiding any personal attacks or denigration of the others posting on the thread.

[KimberlyinMN]

That said, I would like to point out again that the ResMed Swift manual suggests using an unscented and moisturizer-free soap (such as Dove--stated right in the manual) for cleaning. The problem with this statement is that it is incongruous, as Dove is 1/4 moisturizing cream. Further, the unscented Dove actually contains a masking fragrance--only the sensitive skin version is truly fragrance-free.

Are you sure they recommended Dove? I thought I had read Dawn. (But I'm used to be wrong!) On the MyResMed site, now they recommend using Ivory.

Daily
Wash the mask system with warm, soapy water. Do not use soaps with added scents. We recommend plain Ivory® liquid soap or baby shampoo. Rinse well and allow to air dry out of direct sunlight.

Kimberly

[birdshell]

Kimberley, maybe that is because I did e-mail them about the problem almost a year ago!!!

[christinequilts]

I agree with both parties as I read the discussion. However, I am not sure which of the two has the better position. Time will tell that.

As a person who is sensitive/allergic to many fragrances, I can certainly empathize with Christine. When she speaks of her corn allergy, and how important the reporting of the source of every ingredient may be. A peanut allergy, for example, is life-threatening. Some who are even in the same ROOM with a peanut butter sandwich are at severe risk. This is why airplanes and schools have banned peanuts and peanut-based products.

I shall keep looking for additions to this discussion. It is a good one, and I feel for Christine trying to do her own due diligence reading ingredient lists in order to protect herself.

Thank You BirdShell!

I needed that, as I admit I was feeling attacked by several of the members here. And as anyone who's been around this forum knows, I'm not someone who usually gets involved in the various conflicts, but this was something I do feel passionate about and that I could offer an opinion & information that had not previously been presented. I have attempted to provide reasonable, well thought questions, backing them up with documentation from the FDA & other sites when needed. I know I'm not the first one to question the PurSleep product on this board or other, though it appears I may be the first to provide actual documentation to back up my questions, which still remain unanswered. And I was probably the first to take it to the level of picking up the phone and calling the FDA. I find it interesting that the PurSleep homepage is down and has been since this afternoon. Whether the two events are connected remain to be seen.

If Brett would have taken time to really read and truly think through his responses, he may have noticed many of my unanswered questions could have helped him. In my asking questions, I was providing him with much information, not being mean spirited, or spiteful, as some have suggested.

I stressed to him that I use a VPAP Adapt SV, which as most of you are well aware, is a highly specialized BiPAP recently introduced for the treatment of central apneas in CSR, CSA & CSDB. How it functions is very different and its tolerance are very strict, to the point only 4 of the 5-6 ResMed masks are approved to be used with it, along with its own special hose with an external sensor line, requiring a Learning Circuit be run with any change of the system, including masks. I know not to use something like PurSleep with my VPAP Adapt SV, but does every patient, especially when the web site stated it was suitable for all CPAP/BiPAP/BiLevel Pap?

Along that same line, I stressed my allergies as an example of one issue of many to consider when it comes to marketing an aromatherapy product for use in persons with known breathing disorders. Apnea patients are not alone in using xPAP, its also used in treating COPD and various other respiratory disorders. Apnea patients are not 'just apnea patients', we come to the table with other issues and may not realize the implication of using a so called cosmetic product until its too late.

Yes I stress the labeling, as BirdShell mentioned its a major pet peeve of mine. Do any of you know how many ways corn can be listed on a label? And that it can be used to dust conveyor belts and inside of food packages, but then its not an ingredient? Unfortunately I live in the US, where some days the most important thing is to find more even more ways to use corn- UGHH! Brett's emphasized more then once that they only used pure, 100% essential oils, which is what sticks in your head more so then the fact Creme was not a pure essential oil and contained alcohol. Any 'alcohol' in my point view is assumed to be corn alcohol. That's a lot different then 100% essential oil, isn't? If a company lies about that, what else are they being dishonest about? Start thinking about it, I do and so do many other people.

SAG & I had a friendly banter in the other thread no one seems to picked up on where I had posted a link to recent articles about Lavender and Tea Tree Oils causing adolescent boys to develop breast. I'm not sure if I believe causation, but correlation is high enough to warrant caution, especially if you are the parent of a 12 year old boy with OSA who uses CPAP, who might mistaking assume PurSleep was fine to use, since its only a cosmetic, according to Brett? Or do you think it might be wise if you were marketing said 'cosmetic' to note use by adults only to avoid any potential issue?-a common listing on many cosmetics.

And to set the record straight- Brett seems to assume I have a business to manufacture cosmetic products also, by his comment:

Good luck with your continuing therapy and business ventures.

Again, I believe I was very clear in stating the reason for level of knowledge of labeling laws and familiarity with essential oils were for personal reasons only, specifically related to my allergies. To me, that shows once again he didn't take time to carefully read what I wrote, which must be why several of my questions still go unanswered. I love working with essential oils and creating natural skin care & household cleaners for personal use, but I also know enough about the various laws and potential risk & lawsuits to know I would never want to take on the responsibility of manufacturing for anyone other then myself & my family. If I'm going to make anything to sell, I'll stick to my fabric arts...people don't die from a mistake in a purse.

Finally, one major question still goes unanswered.
How does the PurSleep In-Line Diffuser and Essential Oils:

a) cleanse?

b) beautify?

c) promote attractiveness?

d) alter appearance?

I'd love to hear from some of the users of PurSleep if they felt cleaner, more beautiful, more attractive or if otherwise altered their appearance in any way, shape of form.

[jules]

Christine, I do appreciate the efforts you have been putting forth in this matter and someone calling you mean was totally inapproriate.

I understand very well the issues about putting some fragrance in the cpap circuit.

I understand the issues about even trace amounts of alcohol in personal products as I have things I must avoid.

I understand that your questions (imho) appear not to have been answered.

I understand the lung disease issues, althought I do not have COPD, I have experienced pulmonary failure from what was allegedly safe for the masses mosquito spraying by the city I had lived in.

However, I think we live in times where what was deemed to be safe at some time in the past has turned out toxic. I can't answer for this product but I sure know I would never even consider using it.

_________________

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[StillAnotherGuest]

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?

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.

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.

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":



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:

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.

Yoo-hoo, FDAaaaaaaaaaaaa, look what he's doing to the macheeeeeeeeeeenes........

Anyway, I'd like to see the flow wave of a machine with one of these things in it. Lemme know if someone's gonna toss one.
SAG

[WearyOne]

If you really want some fragrance while you sleep, but are concerned about putting it in-line, I'm wondering...

I posted this in the other "Pur-sleep" thread, but now I've sorta tested it. Why can't you put some lavendar EO in some form, on a difuser or something and sit it right next to (not blocking) the air intake on the xPAP?

With my mask on last night, I held an open jar of Vicks next to that air intake vent and within seconds I could smell it in my mask--and smell it rather strongly.

This, obviously, doesn't address a lot of issues with getting the EO vapor in your eyes or mouth (possibly swallowing air that contains the EO if you're wearing a FF--how good is that?!?). But, it would solve the possible in-line flow issues, wouldn't it? Am I totally off base? Or would carrying the fragrance all the way through the machine damage the machine? More questions without solid answers, I'm guessing.

Pam

[christinequilts]

8. On that same subject, yeah, stick it in an AdaptSV and watch the fun.

Fun? Can I use a Swift with it too? You knooooooow that would add to the fun, not! And should the diffuser be at the humidifier end of the hose or the mask end, as one PurSleep user suggested? Which do you think would cause less problems with an adaptive servo ventilator that's making changes in pressure literally by the micro-second?

I'd only consider putting one on my AdaptSV if there is another volunteer to test it out appropriately first? Any willing volunteers with a spare PurSleep & Adapt? As my recent experiment with a ResMed Swift proved, ResMed ain't kidding around when they say to only use approved accessories & masks.

[Guest]

Jules said,

I think we live in times where what was deemed to be safe at some time in the past has turned out toxic. I can't answer for this product but I sure know I would never even consider using it.

My thoughts and feelings exactly. Inhaling any substance other than air for a third of your entire life (8 hours of every 24) is a significant long-term gamble with the health of your lungs. Maybe it's harmless. Maybe it's not. You may not know until 20-30 years from now.

Yep, CPAP equipment can emit vapors of its own, but the situation looks like this:

Let X = small amount of vapors coming off CPAP equipment solids.
Let Y = large amount of vapors coming off a liquid that's expressly designed to throw vapors into passing air.

Then we have,

CPAP = X
CPAP with this product = X + Y

As you can see, the defense "but CPAP equipment emits vapors itself!" is irrelevant. The debate is not about the constant X, it's about whether or not it's wise to add Y.

I also don't need to hear for the hundredth time that the FDA gave these oils GRAS approval, because it's fairly irrelevant. Somehow I doubt the FDA includes "inhaling the vapors of the substance in a closed respiration circuit for a third of your lifetime" within its definition of "consumption".

Everyone must make up their own mind, but think it over quite hard. Inhaling (additional, unnecessary) vapors in a closed circuit for 8 hours every day... really think about how good of an idea that might be. That's all I ask.

[Sleepy-eyes]

(Doncha jus luv it when someone with strong opinions won't even expose their identity?)