MagNap Clinical Trial
The Clinical Trial
 
THE ACCEPTANCE PROCESS
 
In order to be accepted into the clinical trial you must adhere to the following criteria:
  • Between 21-70 years of age
  • Moderate to severe sleep apnea
  • Tried other non-invasive therapies
  • Failed CPAP treatment
  • Willing to actively participate in a 13 month             trial
 
To be considered for the trial you will also have to have an
  • Intake Interview
  • Physical Exam
  • Sleep Study
 
TRIAL COSTS
 
This is a cost free Clinical Trial. All of the expenses directly associated with the trial will be paid by the sponsor.
 
MAGNAP, INC.
MagNap, Inc. has developed the OSA implant. We have worked with UCSF for the last 4 years testing structure and function of the device. This intensive testing  lead up to this FDA approved clinical trial.
  
THE SURGERY
 
Once you are accepted into the trial a short 1 hour surgery will be scheduled where the device is attached to the hyoid bone in your neck. A small incision is made in the neck and the device, which is a little bigger than a dime is attached with sutures.
 
 
 
 
 
 
 
 
 
Before the end of the surgery a scope is used to check for position and airway space . After surgery the patient generally spends up to 23 hours or overnight in recovery before returning home.
 
THE SLEEP APNEA TREATMENT
 
Approximately one month after surgery, the patient is fitted with a custom made brace that is held in place by attraction of the two magnets. It is only worn at night or while napping. 
 
 
 
 
 
 
 
You will be required to keep a sleep journal and respond to questionaires regarding your sleep patterns and how the device is working. As part of the trial you will undergo four additional sleep studies to determine the effectiveness of the device.
CLINICALTRIALS.GOV
 
For more information on the  trial you can go to the U.S. Government site  clinicaltrials.gov and type in magnap.
 
It provides more detailed information on the trial and the participating organizations.

Magnap Clinical Trial Video