NCT02431507

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Michael Harrison · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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 .

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Magnap	This is a non-randomized clinical trial.Patients 21-70 years diagnosed with moderate to severe obstructive sleep apnea will have the Magnap Magnetic Apnea Device surgically implanted on the subject's hyoid bone and used in conjunction with an external neck brace and magnet to open airway during sleep in treatment of Obstructive Sleep Apnea. We will monitor for safety, brace compliance and improvement of symptoms of sleep apnea for a total of 13 months.

Timeline

• Start date: 2015-09-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2015-05-01
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study