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

NCT02431507 | Recruiting DMC FDA Device

• 1 other identifier: 15-15689
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea

Keywords

apnea; sleep apnea; magnetic sleep apnea device; hyoid bone

Outcome Measures

Primary Outcomes (1)

• Ability of the subject to use the Magnap device for the duration of the study.

  Determined by: monitoring for successful device implantation without complications necessitating device removal in all 10 subjects, subjects able to use the device throughout study period once fitted with the brace. Safety will be monitored by tracking all adverse events in 10 subjects and/or complications of treatment.

  13 months

Secondary Outcomes (3)

• Ability of external device to open the airway,

  13 Months

• Improve symptoms related to OSA

  13 Months

• Measure Patient compliance

  13 Months

Study Arms (1)

Treatment Arm with Magnetic Apnea Device

EXPERIMENTAL

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..

Device: Magnap

Interventions

Magnap 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.

Also known as: Magnetic apnea device

Treatment Arm with Magnetic Apnea Device

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Michael Harrison: lead

Study Sites (1)

University of California San Francisco/Mount Zion Hospital

San Francisco, California, 94115, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 22114308 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael R Harrison, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Jensen, BS

CONTACT

415-640-5245; jjensen@magnap.net

Michael Danty, MS

CONTACT

7074848774; Mrd9940@magnap.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator/ Sponsor

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 1, 2015
• Study Start: September 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)