Sleep2Die4 wrote:I think Corky made up the parts about using CPAP for 12 years and using the software. If he used the software he would have been able to answer the questions about the data. (If he used the software he probably would not have been a CPAP failure.)
Credibility on a forum is important. Right now Corky has none with me.
Here is a quote from the MUSC site he/she linked to earlier.
To be eligible for screening and inclusion in the STAR trial, patients must:
• Have failed or not tolerated CPAP
• Have moderate to severe obstructive sleep apnea
• Have a body mass index of less than 32
In my thinking, it's possible the information Corky gave the trials people in relation to the first criteria may not coincide 100% with information he/she would have to post here to satisfy our questions. I suspect he/she started on CPAP 12 years ago, used it for several years, and then gave it up for whatever reason, using that cessation as satisfying the first criteria. In that case he/she has not been on CPAP for 12 years as the subject line says. If in fact Corky has been on CPAP for 12 years he/she wouldn't dare give any information that confirms that as that would serve as a disqualifier based on the failed or not tolerated CPAP criteria. Maybe, just maybe, Corky is hell bent on getting off CPAP, and Inspire is so hell bent on getting candidates for their trials, they are working together to fudge the qualifications that meet the criteria and so appear to FDA (or NIH or whoever) auditors to be fully compliant with the rules. If by any chance this is the case then Corky has a real reason to be vague. It may not be a legit reason, but it could be real.
Be aware that when auditors from any Government agency show up to review your books the paper work has to be in order. That will get you a passing grade unless they dig deeper and find problems not evident in the paperwork. I used to do audits of quality programs of government contractors, and developed what I called the "P" principle. "The Presence of Perfect Paperwork doesn't Preclude the Presence of Piss Poor Performance."
There's no question in my mind the clinical trials are real, and that Corky is a real person who is a real candidate in the program. But his/her participation in the clinical trials may not be 100% above board.