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RipVW wrote: What is a "Sham Device" that is being compared to the Provent in this study?

Well they don't say what the sham is, but the normal way this is done is to choose some device that doesn't treat OSA but leaves the patient and the investigator with the possibility that it does do something. For example, if we weren't all so familiar with breathe-right strips, they might use those as the sham device. Half the patients typically get the real device and half get the sham. Think of it like a placebo that is used in medicine trials.

Greetings!

My airway closes on my exhale. It can happen!

Think back 20+ years, back in the day.....
Remember those paper straws?

If a paper straw became to soft it would close up when you tried to blow through it!
Partial pressure around the inside surface will try to move the inside surface towards the center of the straw, move enough and it closes right up!

LoQ wrote:

Think of it like a placebo that is used in medicine trials.

Thanks! I'd never seen that term--that makes sense.

I still don't understand. The ad said :
"The MicroValve opens and closes, redirecting air through small holes to create resistance upon breathing out."

However, I like the promotional slogan " Take back the night.... bring back the day."

Dang! I didn't get that right. The same thing happens to me with most slogans.
When I get a cold, I can never remember if I should feed it or starve it.

packitin wrote:I still don't understand. The ad said :
"The MicroValve opens and closes, redirecting air through small holes to create resistance upon breathing out."

Possibly you don't understand because it is poorly worded, and most likely you don't have the kind of obstruction this device treats. If you had the problem I have, it would make perfect sense to you. I have trouble exhaling. There is something going wrong with my soft palate, but I don't know exactly what. For the sake of understanding, forget your own experience with OSA, and imagine that your problem is that your uvula is inverting, blocking exhalation (hypothetically). The pressure coming up from your lungs keeps the uvula inverted upward, and prevents air from escaping through your nose. Exerting more pressure with your lungs will never fix the problem, because it just keeps the uvula up and blocking exhalation.

Now imagine that what the device does is creates pressure ON THE OTHER SIDE of the uvula, that is, inside your nose. Now your uvula stays down, allowing air to move through that part of the airway and out through your nose.

Sheesh, people will try to sell anything.

If it ain't got sensors to prove efficacy (and it don't), I don't want it. Period. Well, that is, unless I can find a sleep lab (or center, nod to SAG) I can sleep in every night.

Murphy's Law says someone will sneeze, swallow one, and choke to death during the trial, so I hope they got good insurance!

jnk wrote:If it ain't got sensors to prove efficacy (and it don't), I don't want it. Period.

You would not want my current CPAP equipment, then. It is possible to have successful therapy without all the measurements.

I'm interested in this product, and all I can go on is how I feel. That's all I've got now. If I could try this and it made me feel just as good, I'd certainly consider keeping a supply on hand. I still wouldn't use them every night at the current price, but I'd certainly want them as a luxury and for power outages, if they work just as well.

LoQ wrote:

jnk wrote:If it ain't got sensors to prove efficacy (and it don't), I don't want it. Period.

You would not want my current CPAP equipment, then. It is possible to have successful therapy without all the measurements.

I'm interested in this product, and all I can go on is how I feel. That's all I've got now. If I could try this and it made me feel just as good, I'd certainly consider keeping a supply on hand. I still wouldn't use them every night at the current price, but I'd certainly want them as a luxury and for power outages, if they work just as well.

In case I ever wanted to try something new, could I set my APAP very low as to be ineffective (1 cm) and let it measure AHI like it does now? Just pondering here...

My wife would have to sleep in another room. I think it would be comparable to those toy guns that shoot out the little plastic discs, I'd be afraid of rendering her unconscious.

jnk wrote: <snip>If it ain't got sensors to prove efficacy (and it don't), I don't want it. Period. Well, that is, unless I can find a sleep lab (or center, nod to SAG) I can sleep in every night.

I 100% agree. I have other health issues that make it impossible for me to go by how I feel, so I have to use data of some kind to determine if therapy is working.

"During inhalation the MicroValve opens, allowing the user to breathe in freely. Then, during exhalation, the MicroValve closes and air passing through the nose is directed through two small air channels." That sounds like trying to breathe out through a partially stopped up nose. When this happens to me (quite frequently) I start breathing through my mouth, asleep or not.

Before wising up and getting a sleep study two years ago, I tried A LOT of things that promised to help sleep apnea, stop snoring, or both, but they were all jokes. If the clinical trial (scheduled to finish 9/09) shows it works just as well as xpap for the majorly of OSA sufferers, and insurance will pay for most of the cost, I would considered it, but until them I'm sure not wasting my money. And I'm not sure with the reduced airflow on exhalation that I could tolerate it anyway, what with my stopped up nose issues.

Pam

Did anybody see the cost ?? And I don't think insurance is going to pay....

Q. What is the cost of PROVENT therapy?
A. PROVENT Therapy is $135 for a 30-day supply, ($4.50 per night).

Pam

SharkBait wrote:In case I ever wanted to try something new, could I set my APAP very low as to be ineffective (1 cm) and let it measure AHI like it does now? Just pondering here...

Yes, you could, but the lowest pressure you could set your APAP at is 4 cm (for the min and max, so that it would work like a straight cpap but still gather the additional flow limitations data that "cpap mode" wouldn't record.

However, even if 4 cm was not an "effective" pressure for you, it's still "some" pressure, so could possibly still leave things looking slightly better for you than with no cpap at all. But you'd have the comparison of "with and without" the new thing, at a pressure of 4.

Pressure of 4 can feel pretty stifling inside a mask for many people.

They reference two papers but do not have links to these. I was able to pull one "paper" up on-line. It looked like a poster session at a conference -- not a real paper. They published the abstract from the poster session in the journal. It only deals with patient compliance not efficacy.

Would love to replace my new equipment with a nose plug. Somehow I am skeptical. But you never know!!