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Summary

for people ages 21–70 (full criteria)
at San Francisco, California
study started
estimated completion:

Description

Summary

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).

Official Title

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

Details

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 .

Keywords

Obstructive Sleep Apnea apnea sleep apnea magnetic sleep apnea device hyoid bone

Eligibility

You can join if…

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

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

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Michael Harrison
ID
NCT02431507
Lead Scientist
Michael Harrison
Study Type
Interventional
Last Updated
May 1, 2017
I’m interested in this study!