Since using the Pur-sleep oils

[Sleepy-eyes]

SleepGuy,

I just went to my machine and completely dislodged the diffusion pad and turned the machine on. Guess what happened? Nothing!!!! It didn't budge! So much for that concern!

[DreamStalker]

and if the little suspended cotton ball becomes dislodged from the bulb and goes out the hose I assume it eventually comes out the butt?

all valid questions are relevant.

I suppose all assumptions are valid too ... for some it may never come out the butt because the cotton ball would just get stuck bouncing around inside their head

But really though SD, it is only about $30 ... much less than a mask interface such as the Solya FF. You could easily try it out then raise some valid questions about the air flow mechanics. As Bret mentioned, there is a grate near the top neck of the diffuser where the hose connects to that will prevent the cotton pad from ever getting in the hose. It would just bounce around in the upper half of the diffuser because there is also a grate that prevents it from falling into the HH.

Your discussion on FDA patents and all are also valid and I'm sure Bret will take them into consideration as his product develops a unique niche within the xPAP market.

[SleepGuy]

SleepGuy,

I just went to my machine and completely dislodged the diffusion pad and turned the machine on. Guess what happened? Nothing!!!! It didn't budge! So much for that concern!

Chris, thanks for the feedback. I've tried a number of things like that too with the same results. My concern would arise if someone were to try to use a cotton ball or something like that. So we built in the little grate into the top piece--in case you were wondering what that little plastic X is for.

[Guest]

I thought that was to keep me from taking pot shots at the cat when I am bored!

[northernlights]

Hey everyone:
I've been using Bret's little device for the last three nights, and have been sleeping like a baby. My one concern was if the device could be used with my machine, since with the heated hose, I couldn't break the electrical connection between the hose and the machine. I got around this by putting the diffuser between the mask and the hose - seems to work just fine, and its so light that you hardly notice it's there.
By the way, I used "Spice" last night and dreamt my wife and I were on a tropical island ( I'll leave the rest out!!).
Also hit 2000 hours last night!

Cheers,

Steve.

[SleepGuy]

Hey everyone:
I've been using Bret's little device for the last three nights, and have been sleeping like a baby.

LOL! Steve, I got a nice chuckle out of that one. My wife and I have a 2 month old little girl who basically sleeps with us every night.

And we keep saying to each other: "Whoever thinks that 'sleeping like a baby' is a good thing . . . never slept with a baby."

Very glad to hear it's working out for you so well. I know you were concerned about the connections.

[dsm]

As a guess, I can visualize an impact on the airflow if a device impeded airflow in any way. Even the walls of the average air tube will create turbulence due to the ripples in the hose wall material.

The machines (Autos) that monitor air vibration (snores etc:) and use the observed data to estimate potential apnea events, could be affected by a device that can in any way dampens the vibration & as SD said, that becomes airflow related & not a pressure issue.

From what I've seen of this device, I am not too bothered by this being an issue. But it will be worth experimenting as to where the device gets placed in the air line, at the machine end or at the mask end.

The issue of current Autos (the ones without a separate air pressure sensing air tubes) is that these machines are attempting to make a best estimate of what is taking place 6 foot away at the patient's face & where the patient interface (mask) can be of varying types (mouth, fullface, nasal) with varying fixed leak rates & where the patient may be mouth breathing while using a nasal mask or the mask may be leaking air. The chances of the machine always getting it right are challenging.

When I get the chance I will add my own feedback & thoughts on using one. But, in principle it looks ok.

DSM

[sharon1965]

Hey everyone:
I've been using Bret's little device for the last three nights, and have been sleeping like a baby.

LOL! Steve, I got a nice chuckle out of that one. My wife and I have a 2 month old little girl who basically sleeps with us every night.

And we keep saying to each other: "Whoever thinks that 'sleeping like a baby' is a good thing . . . never slept with a baby."

Very glad to hear it's working out for you so well. I know you were concerned about the connections.

sleepguy,
i hear ya! to me, sleeping like a baby means waking up screaming every 2 hours
i received a notice that the mailman tried to deliver my pur-sleep system today--no one was home but i'll pick it up tomorrow afternoon and i'll be smelling those 'dreamsicles' tomorrow night...looking forward to it
thanks
sharon1965

[MeHoo]

ordered mine too.

i ordered it at like 5pm and it was slated to be shipped like five minutes after that. nice.

My therapy doesnt seem to be faulting at any point except having good numbers doesnt do me any good.

i ordered because my machine seems to have created its own lovely odor from running the humidifier empty on accident.. i have completely removed the humidifier and i still have the odor. this should help with that.

Having much of my work dealing with engineering and design.. i can assure you from the design of this device that i could tell from pics, i do not see how this could cause many problems with the machines operation. the airflow will most likely take a slight hit due to the fact that a spread burst of air hitting an open space tends to disperse rather than simply flow around an object like you would imagine, but i don't see that being a significant factor since the hoses are lined with many bumps that do the same thing.

I want to hook this up with the hepa filter, any clues as to which should go where and if that might mess with my settings? im not overly picky with pressure.. seems any is fine for me so any variation doesnt bug me.

[WifeIsHappyNow]

Perhaps I missed it here...but for all those that have tried this, do you actually feel better than previously? I've heard a lot about numbers being better, sleeping longer, etc...but do you notice a difference in the way you feel? I'm assuming the answer is yes, but don't want to put too much weight into an assumption...

I am on the verge of purchasing one of these, but I don't have a machine that will tell me if my numbers are better and I don't really care too much if I have pleasant scents when I wear my mask, but I would like to find a way to feel better...

FWIW, I appreciate Snoredog asking the tough questions and SleepGuy's willingness to listen and answer them...

Mike

[dsm]

Perhaps I missed it here...but for all those that have tried this, do you actually feel better than previously? I've heard a lot about numbers being better, sleeping longer, etc...but do you notice a difference in the way you feel? I'm assuming the answer is yes, but don't want to put too much weight into an assumption...

I am on the verge of purchasing one of these, but I don't have a machine that will tell me if my numbers are better and I don't really care too much if I have pleasant scents when I wear my mask, but I would like to find a way to feel better...

FWIW, I appreciate Snoredog asking the tough questions and SleepGuy's willingness to listen and answer them...

Mike

Agree,



DSM

(But it is nice when ole SnoreDawg can smile into his writing )

[Niteair]

I have been using Pur-Sleep for almost a month now, and I can definitely say that I fall asleep much faster, sleep completely thru the night, and feel much more energetic during the day. The statistics from my card reader appear on average, the same as before, which is okay, since they have been pretty good anyway. I am very happy with this product, and think that I will feel the same about the Puaira Catalytic Effusion Lamp that I just received yesterday....looks...(smells) good so far.

[christinequilts]

Moved to own thread: PurSleep- Cosmetic or Drug? Safe or Not?

'll be the first to admit I don't always agree with Snoredog, especially some of his view on centrals, but I think he is right to question this- we all should be. I notice the web sites says it okay to use with all CPAP, autoPAP, BiPAP, BiLevel, etc, so it will work with my VPAP Adapt ASV, correct? What about exposure to the eyes if someone uses a Total Face Mask? That's fine too? I didn't see anything in the instructions about testing it out, but if it does seem to negatively affect your xPAP treatment, to discontinue its use immediately...even most cosmetic makeup products include that warning.

And what about where the diffusion pad is held, that's not made of plastic is it? Anyone knows you don't allow essential oils to come in contact with plastic, as they dissolve the plastic, releasing compounds I'd rather not think about. Someone mentioned the rings on lights bulbs as being similar to PurSleep, but they are made of ceramic not only because of the heat of the light bulb, but because ceramic doesn't interact with the oils, as plastic and other man made materials can. Have you done any long term studies on the effect of essential oils in a semi-closed system, applied directly to the nose & mouth- both of which are mucosal membranes?

I'm sure you are also not using any of the essential oils that are warned against using in someone with seizure disorders, high blood pressure or kidney disorders, right? And all of them are safe during pregnancy? And you include instructions for how to flush the skin, should someone accidentally get essential oil on their fingers while putting onto the diffusion pad, since direct skin contact should be avoided with pure essential oils, since they are so strong. And I'm sure your labels list not only the common name, but the full Latin name of each essential oil used, including country of origin when necessary, as German chamomile is different then Roman Chamomile, for example. And I'm a little confused, first everything I read says everything is 100% pure essential oils, then your Creme says it has alcohol in it...that's pretty important for me, considering its usually corn based alcohol and I'm highly allergic to corn.


And I'm still a little confused on if your product is a cosmetic or drug. It sure seems like you are making a lot of drug claims of improving sleep, treating claustrophobia, improving xPAP compliance and such. Is it cleansing, beautifying, promoting attractiveness or altering appearance? Which is it?

"The Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)].

And is it you're a cosmetic because you say are? I don't think the FDA sees it that way (emphasis mine):

How is a product's intended use established?
Intended use may be established in a number of ways. Among them are:
* Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.
* Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
* Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.

http://www.cfsan.fda.gov/~dms/cos-218.html


I think I'll pass on the PurSleep and breath my boring, unadulterated air for now and enjoy my essential oils in other, more conventional ways.

_________________

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

[StillAnotherGuest]

Hey if this thing works, I'll hand 'em out like party favors, like I say here 1.01 times a day, there's a heckuva lot more to sleep than just AHI. But in re: the FDA

The federal Food, Drug and Cosmetic Act defines a "medical device" as a device that is:

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

FDCA § 201(h), 21 U.S.C. § 321(h).

While it is not always necessary to obtain FDA approval for medical devices (the agency maintains detailed regs governing the manufacture of many classes of common medical devices, like toothbrushes), it is necessary to obtain approval for "medical devices" that are not otherwise approved.

your "white paper"

http://www.pur-sleep.com/uploads/WhitePaperv3[1].pdf

sure makes this sound like treatment ("aromatherapy"? That sounds like therapy, doesn't it?) But treatment aimed at changing sleep architecture and efficiency, in my book, fits the FDA definition precisely.

But speaking of medical journals (smooth segue, huh?) that one study is anecdotal:

An Olfactory Stimulus Modifies Nighttime Sleep in Young Men and Women, Namni Goel, Hyungsoo Kim, Raymund P. Lao

Abstract

Aromatherapy is an anecdotal method for modifying sleep and mood. However, whether olfactory exposure to essential oils affects night‐time objective sleep remains untested. Previous studies also demonstrate superior olfactory abilities in women. Therefore, this study investigated the effects of an olfactory stimulus on subsequent sleep and assessed gender differences in such effects. Thirty‐one young healthy sleepers (16 men and 15 women, aged 18 to 30 yr, mean±SD, 20.5±2.4 yr) completed 3 consecutive overnight sessions in a sleep laboratory: one adaptation, one stimulus, and one control night (the latter 2 nights in counterbalanced order). Subjects received an intermittent presentation (first 2 min of each 10 min interval) of an olfactory (lavender oil) or a control (distilled water) stimulus between 23:10 and 23:40 h. Standard polysomnographic sleep and self-rated sleepiness and mood data were collected. Lavender increased the percentage of deep or slow‐wave sleep (SWS) in men and women. All subjects reported higher vigor the morning after lavender exposure, corroborating the restorative SWS increase. Lavender also increased stage 2 (light) sleep, and decreased rapid‐eye movement (REM) sleep and the amount of time to reach wake after first falling asleep (wake after sleep onset latency) in women, with opposite effects in men. Thus, lavender serves as a mild sedative and has practical applications as a novel, nonphotic method for promoting deep sleep in young men and women and for producing gender‐dependent sleep effects.

I'd like to get that study to see the objective results, but if there is a concern, then why not do what snoredog suggests, just a drop someplace else, or a couple snorts before bedtime? The study had their guys having only 8 minutes of contact time before sleep. Why should it be necessary to increase that 50-fold? If some is good, then more is better?
SAG

[dieselgal]

Perhaps I missed it here...but for all those that have tried this, do you actually feel better than previously? I've heard a lot about numbers being better, sleeping longer, etc...but do you notice a difference in the way you feel? I'm assuming the answer is yes, but don't want to put too much weight into an assumption...

I am on the verge of purchasing one of these, but I don't have a machine that will tell me if my numbers are better and I don't really care too much if I have pleasant scents when I wear my mask, but I would like to find a way to feel better...

FWIW, I appreciate Snoredog asking the tough questions and SleepGuy's willingness to listen and answer them...

Mike

To answer your question : In my opinion, this will not improve your sleep apnea condition so it should not improve the way you feel. If you like scents like those people have mentioned it can be a pleasant experience making cpap somehow less aggravating sometimes, but it won't in my experience improve your numbers (unless for some reason you wear your mask more because you like the scent )