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MAGNAP Device for Obstructive Sleep Apnea

This study is testing a new device called Magnap to treat moderate to severe obstructive sleep apnea (OSA). OSA is a condition where breathing repeatedly stops and starts during sleep. The Magnap device is a magnet that is surgically placed on a bone in your neck (hyoid bone). You would then wear an external neck brace with another magnet during sleep. This magnet attracts the implanted one to keep your airway open. This study aims to see if the Magnap device is safe and can be used effectively. We are looking for 10 participants, aged 21 to 70, who have OSA and cannot tolerate their current positive airway pressure (PAP) therapy.

Study design
This is a non-randomized study with 10 participants. It is testing the Magnap device.
What's involved
You would have the Magnap device surgically implanted. You would then use the device with an external neck brace and magnet during sleep for the duration of the study.
Compensation
Not stated in the trial record.
Follow-up
The study will measure your ability to use the Magnap device for 13 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02431507

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

Recruiting
NAAges 21–70InterventionalTreatment
Michael Harrison
~10 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Magnap

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ability of the subject to use the Magnap device for the duration of the study.
Measured over 13 months

Conditions

Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Michael R Harrison, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Jeff Jensen, BS
[email protected]
415-640-5245
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Ability of the subject to use the Magnap device for the duration of the study.13 months

    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.