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

Recruiting

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

Who can join

Ages 21 to 70 · All sexes

Full 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
* There are no exclusion criteria based on gender, race or ethnicity

About the study

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).

What is being tested

Sponsor: Michael Harrison · Participants: 10 · Started: 2015-09

Contact the study team

Official record on ClinicalTrials.gov — NCT02431507

Locations in the U.S.

CaliforniaUniversity of California San Francisco/Mount Zion Hospital, San Francisco

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.