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

NCT ID: NCT02431507

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2026-12-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm with Magnetic Apnea Device

The treatment arm with magnetic apnea device includes: surgical implantation of the magnetic apnea device(MAGNAP) to treat obstructive sleep apnea in each eligible enrolled subject . A custom fitted external brace will be created for wear throughout the 13 months of treatment and evaluated for improvement of symptoms..

Group Type: EXPERIMENTAL

Magnap

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Magnetic apnea device

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael Harrison

OTHER

Sponsor Role: lead

Responsible Party

Michael Harrison

Principal Investigator/ Sponsor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael R Harrison, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco/Mount Zion Hospital

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeff Jensen, BS

Role: CONTACT

jjensen@magnap.net

415-640-5245

Michael Danty, MS

Role: CONTACT

Mrd9940@magnap.net

7074848774

Facility Contacts

Michael R Harrison, MD

Role: primary

michael.harrison@ucsf.edu

415-235-5812

Jolie Chang, MD

Role: backup

Andrew Murr, MD

Role: backup

David Claman, MD

Role: backup

References

Rosenbluth KH, Kwiat DA, Harrison MR, Kezirian EJ. Hyoid bone advancement for improving airway patency: cadaver study of a magnet-based system. Otolaryngol Head Neck Surg. 2012 Mar;146(3):491-6. doi: 10.1177/0194599811429522. Epub 2011 Nov 22.

Reference Type: BACKGROUND

PMID: 22114308 (View on PubMed)

Other Identifiers

15-15689

Identifier Type: -

Identifier Source: org_study_id