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).
Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety
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 .
Obstructive Sleep Apneaapneasleep apneamagnetic sleep apnea devicehyoid bone
You can join if…
Open to people ages 21 years to 70 years
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
You CAN'T join if...
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
University of California San Francisco/Mount Zion Hospitalaccepting new patients San Francisco, California, 94115, USA