INFORMED CONSENT FOR THE NAPA

(NOCTURNAL AIRWAY PATENCY APPLIANCE)

 I have elected to wear a NAPA while sleeping, in an attempt to curtail my snoring.  I have been told that while this device has had an excellent record in the majority of patients, due to physiological and anatomical variations and individual tolerance of the appliance,  there can be no guarantee that will work for me. 

It has been explained to me that snoring may be a symptom of a more serious sleep/breathing disorder known as obstructive sleep apnea syndrome (OSAS).  A definite diagnosis for OSAS can only be made by a physician with the aid of an overnight sleep test.  In determining whether to consult a physician for this condition an individual should evaluate his or her symptoms.  The main daytime symptom of this condition is sleepiness. 

Some individuals with OSAS obscure their daytime tendency to fall asleep with their constant activity.  The Epworth Sleepiness Scale (ESS) was developed to determine an individual’s basic daytime sleepiness by considering several passive situations. 

I have completed the (ESS) and my score on this questionnaire was _____.  I was told that if I score 10 or more on this test is a strong indication I have OSAS, and should consult a physician.  The ESS does not diagnose OSAS, but only screens.  It is possible to score below 10 on the ESS and still have OSAS.  I was further told that I am aware that my breathing stops more than ten times per hour for periods of over ten seconds, or if I awaken choking or struggling for breath, or have frequent morning headaches I should consult a physician even if my ESS score is as low as 8.

 After the sleep test the physician may or may not prescribe the NAPA, depending upon his or her preference of a treatment modality for OSAS. 

I have been advised that if I decide to go ahead with the NAPA prior to visiting a physician, and my score on the ESS was 10 or more, after receiving my NAPA I should arrange with a physician to take a sleep test, half night with, and half night without the NAPA.  I understand not to do so may be permitting a dangerous medical condition to progress.

 The purpose of the NAPA is to maintain an open airway while sleeping which permits normal silent breathing.  The NAPA is a modification of an orthodontic appliance that has been used for many years in millions of children and thousands of adults, however, as with any removable dental appliance no assurances can be made about its total safety.

 In addition to the above I understand and am aware of the following conditions which are applicable to the NAPA:

 Although the NAPA is derived from an orthodontic appliance, it is not intended to permanently move my jaws or teeth.