Hi - I was diagnosed with moderate sleep apnea earlier this year (28 apneas in one hour, 103 during my study, average time I didn't breath: 19 seconds). It was suggested that I get a C-Pap, but I decided to try a dental device first. Apparently, I was the first person ever at this particular sleep center who didn't immediately go for a C-pap. Although dental devices are an approved treatment for OSA under my medical plan (Aetna), it was a bit of a hassle to get things moving. In fact, I had to pay for the device upfront, but did get reimbursed. Initally, I was very concerned because my dentist had a Silent Nite made for me - and I found out after the fact that is is not FDA approved for OSA, but rather for snoring. She assured me, however, that it should work. I was doubtful, but I had a sleep study done wearing the dental device (and no C-Pap) and the results were pretty good; my rating went down to 17, with 0.03 apenas an hour and 2 during the five hour study. The number of hypopneas increased but overall, it was good enough that my pulmonologist has told me I can get by without a C-Pap -and they will do another sleep study in a year. Granted, the results were not as good as my second study (with a C-Pap), but still much improved. I really wanted to avoid getting a c-Pap and so far, so good. My question is: why has the Silent Nite NOT been approved for OSA? Is it just a question of the manufacturer not going for that status - I know that the company that makes the Silent Nite (Gladwell Labs) does make a Tap device that IS approved for OSA, but my dentist thought that would be hard for me to tolerant. Just wondering if anyone else has had success with the Silent Nite device and if anyone knows about how/why some devices are FDA-approved - and others, not. thanks!

I am confused what a rating of 17 means.  The severity of apnea is rated by AHI (events per hour) and an AHI of 17 is still moderate apnea.  But you say that the number of events/hour was much lower than that.  Are you talking about the number of hypopneas that you had?

Anyway, for a drug or medical device to be put on the market, first a very specific use for it must be identified by the manufacturer and then it goes through clinical trials for that specific use.  So a couple of things could (and probably did) happen with the Silent Nite.  It was tested for snoring and found to be effective for snoring and so went through clinical trials for that use.  But it might be that it was tested for use in OSA as well and was found not to be effective.  I couldn't find anything on the FDA site about it (www.fda.gov).

For drugs, what often happens is that physicians find they are useful for conditions other than what they have gone through clinical trials and labeled for.  For example, they found that using low dose anti-Parkinson's drugs worked well for RLS.  This is called "off-label" use.  The drug companies pick up on it and it is up to the drug companies to take it through clinical trials to be able add that application of the drug to the drug's label.  Usually, that is something drugs companies are willing to do because it means more approved uses for their drug with equals more $.

Vicki


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That which does not kill you makes you stronger-Friedrich Nietzsche
Friedrich must of had apnea.