Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety

Open to people ages 21-70

• 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

• 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