RECRUITINGINTERVENTIONAL
Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety
Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form form and indicates understanding of the study procedures and risks
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Magnap
This is a non-randomized clinical trial.Patients 21-70 years diagnosed with moderate to severe obstructive sleep apnea will have the Magnap Magnetic Apnea Device surgically implanted on the subject's hyoid bone and used in conjunction with an external neck brace and magnet to open airway during sleep in treatment of Obstructive Sleep Apnea. We will monitor for safety, brace compliance and improvement of symptoms of sleep apnea for a total of 13 months.
Locations (1)
University of California San Francisco/Mount Zion Hospital
San Francisco, California, United States