MagNap Clinical Trial
FREQUENTLY ASKED QUESTIONS
  
1.  How much will this trial cost me?
     This is a cost free trial to patients who are approved to participate.
 
2.  How long with the initial sleep study take?
      The sleep study will take approximately 8 hours and will involve an overnight stay at the                    hospital.
 
3.   Where will the sleep study take place?
      The sleep study will be performed at the UCSF Sleep Disorders Center:
     
      UCSF/Mount Zion Medical Center
      1600 Divisadero St, 5th floor
 
4.  Has this device been tested?
      The device has undergone all tests required by the Food & Drug Administration (FDA) to                gain acceptance for an approved clinical trial. There is no animal model (no other species has         a hyoid bone).  All tests required by the FDA were performed on cadavers.
 
5.  Who authorized this trial?
     Permission for the trial is authorized by the FDA. You can find additional information at                    clinicaltrials.gov. Permission is also granted by the UCSF Committee for Human Research             (CHR), which reviews all FDA material and may require additional protocol changes.
 
6.  Who will evaluate my OSA to determine if I am accepted into the trial?
      You will be evaluated by the study coordinator, research nurse, and the surgeon(s)                              performing the procedure.
 
7.   What will my level of participation be expected during the trial?
      You will be required to establish a mode of communication with the study coordinator to                discuss sleep patterns and for overall monitoring, come in for external brace adjustments as          needed, and undergo 4 additional in-lab sleep studies.

8.  Where will the surgery be performed?
     The surgery will be performed at the UCSF/Mount Zion Medical Center located at
     1600 Divisadero Street, San Francisco, CA 94115.                                     

9.  Who will perform the surgery?
     The surgery will be performed by Dr. Jolie Chang or Dr. Andrew Murr.
 
10. How difficult will the surgery be?
       The surgery is a simple procedure. The surgeon will first make an approximately 3-4 cm                   incision on the front of your neck, under the chin and above the Adam’s apple. A titanium                 disk containing a magnet will be attached to the hyoid bone in your neck using two non-                   absorbable sutures.
 
11. How long will I be in the operating room?
        The surgery will last approximately 1 hour.
 
12. How long will I be in recovery?
        You will be in recovery and transferred to the ward overnight or up to 23 hours before                      being discharged home.
 
13. When will I have my brace made?
        The brace will be fabricated once it is determined that your incision has healed- this is                      approximately one month after the surgery.

14. Should I continue to use my CPAP machine after surgery?
        You can use your CPAP until the brace has been made and you begin the MagNap                                treatment.
 
15. How much pain may be associated with the treatment?
       Minor post-op pain should be expected while healing. Mild skin irritation may occur related           to the treament. This will lessen once we have determined the optimal distance between the         external brace magnet and the implanted magnet. There should little to no discomfort                       associated with remainder of the MagNap brace treatment.
 
16. How will I know if the treatment is working?
        You will know it is working if you are able to tolerate the brace treatment and have a                          decrease in symptoms and severity of OSA.
 
17. Why do I have to have 4 additional sleep studies?
        The sleep studies help us to monitor changes in your apnea and efficacy of the treatment                via data obtained while you are asleep.
 
18.  What happens at the end of the trial?
        The protocol states that the device will be removed at the end of the trial. If the device is                 working satisfactorily and the subject wants to maintain the device, the FDA would be
        notified regarding the status of the device, the wishes of the subject to decline its
        removal, and the plan for long-term wear.