San Francisco, California 94115


Purpose:

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).


Study summary:

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 .


Criteria:

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


NCT ID:

NCT02431507


Primary Contact:

Principal Investigator
Michael R Harrison, MD
University of California, San Francisco

Jill A Imamura-Ching, RN, BSN
Phone: (415) 476-3446
Email: Jill.Imamura-Ching@ucsf.edu


Backup Contact:

N/A


Location Contact:

San Francisco, California 94115
United States

Jill A Imamura-Ching, RN
Phone: 415-476-3446
Email: Jill.Imamura-Ching@ucsf.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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