NCT02431507 Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety
| NCT ID | NCT02431507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Michael Harrison |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2015-09 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2015-09 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Michael R Harrison, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT02431507 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02431507 currently recruiting?
Yes, NCT02431507 is actively recruiting participants. Contact the research team at jjensen@magnap.net for enrollment information.
Where is the NCT02431507 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT02431507 clinical trial?
NCT02431507 is sponsored by Michael Harrison. The principal investigator is Michael R Harrison, MD at University of California, San Francisco. The trial plans to enroll 10 participants.