Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety
Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety
The purpose of this study is to determine the safety and feasibility of the Magnap magnetic
 device in the treatment of obstructive sleep apnea (OSA).
Magnap is a magnet-activated treatment for obstructive sleep apnea (OSA) designed to be less
 invasive than reconstructive surgery, more tolerable than positive airway pressure, and more
 effective than non-invasive therapies for OSA. The Magnap device consists of a
 neodymium-iron-boron rare earth magnet with a ferromagnetic directional back-plate encased in
 titanium. The device will be implanted surgically on the hyoid bone. Following surgery, the
 patient is fitted with a custom, removable external neck accessory containing a second
 magnet, which is worn during sleep and prevents airway collapse by attracting the internal
 hyoid magnet with sufficient force to keep the airway open .
Inclusion Criteria:

 -  Patient is between 21 and ≤70 years of age

 -  Subject has moderate to severe obstructive sleep apnea (defined as apnea-hypopnea
 index of 15-50 events/hour on baseline/screening polysomnogram)

 -  Subject is intolerant of positive airway pressure therapy (defined as <2 hours of
 sleep time with use per night for at least 5 nights per week as measured objectively
 by evaluation of continuous positive airway pressure (CPAP) machine memory chip and
 interpreted by the study sleep medicine specialist)

 -  Subject signs and dates a written informed consent form and indicates understanding of
 the study procedures and risks

 Exclusion Criteria:

 -  Any evidence that apnea is not caused by base of tongue (i.e., central apnea,
 neurologic disorder, retropalatal collapse, nasal obstruction)

 -  Any condition likely requiring MRI or has a metal implant

 -  Any factor that, in the surgeon's judgment, would pose a risk to surgery or placement
 of a long-term implanted device

 -  Any factor that, in the surgeon's judgment, would make the subject unlikely to respond
 to Magnap treatment

 -  Congenital anomalies of the larynx, pharynx, or trachea or any other anatomical
 abnormality of the head, neck, or chest that would be a contraindication to placement
 of the Magnap device and usage of the external device

 -  There are no exclusion criteria based on gender, race or ethnicity