Magnetic device for treating obstructive sleep apnea
Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety
This study is testing a new magnetic device to see if it can help people with obstructive sleep apnea who struggle with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT02431507 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of the Magnap device, a magnet-activated treatment for obstructive sleep apnea (OSA). The device is designed to be less invasive than surgery and more effective than current non-invasive therapies. It involves surgically implanting a magnet on the hyoid bone, with a removable external accessory worn during sleep to prevent airway collapse. The study aims to assess how well this innovative approach works for patients who cannot tolerate traditional therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 70 with moderate to severe obstructive sleep apnea who are intolerant to positive airway pressure therapy.
Not a fit: Patients whose apnea is caused by conditions other than the base of the tongue or those with contraindications for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a new, effective treatment option for patients suffering from obstructive sleep apnea.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in developing less invasive treatments for obstructive sleep apnea.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- University of California San Francisco/Mount Zion Hospital — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Michael R Harrison, MD — University of California, San Francisco
- Study coordinator: Jeff Jensen, BS
- Email: jjensen@magnap.net
- Phone: 415-640-5245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.