Recruiting

MAGNAP Device

Sponsor:

Michael Harrison

Code:

NCT02431507

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Magnap

Study Details

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

Study ID

NCT02431507

Start date

Sep, 2015

Status verified date

Dec, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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..

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.

Primary outcome measure

  • Ability of the subject to use the Magnap device for the duration of the study. [ Time Frame: 13 months ]

Central Contacts and Locations

Central contacts

Jeff Jensen, BS

415-640-5245jjensen@magnap.net

Michael Danty, MS

7074848774Mrd9940@magnap.net

Locations

University of California San Francisco/Mount Zion Hospital

Recruiting

San Francisco, California, United States, 94115

Contacts

Michael R Harrison, MD

415-235-5812michael.harrison@ucsf.edu

More Information

Sponsor

Michael Harrison

Last update posted

Jan 22, 2026

Last verified

Dec, 2025

Keywords

  • apnea
  • sleep apnea
  • magnetic sleep apnea device
  • hyoid bone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael Harrison on 2026-01-22.