Home › Obstructive Sleep Apnea › NCT02431507
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
- Magnap (device)
Sponsor: Michael Harrison · Participants: 10 · Started: 2015-09
Contact the study team
- Jeff Jensen, BS · Phone: 415-640-5245
- Michael Danty, MS · Phone: 7074848774
Official record on ClinicalTrials.gov — NCT02431507
Locations in the U.S.
| California | University 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.