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).
Magnap is a magnet-activated treatment for obstructive sleep apnea (OSA) designed to be less invasive than reconstructive surgery, more tolerable than positive airway pressure, and more effective than non-invasive therapies for OSA. The Magnap device consists of a neodymium-iron-boron rare earth magnet with a ferromagnetic directional back-plate encased in titanium. The device will be implanted surgically on the hyoid bone. Following surgery, the patient is fitted with a custom, removable external neck accessory containing a second magnet, which is worn during sleep and prevents airway collapse by attracting the internal hyoid magnet with sufficient force to keep the airway open .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
University of California San Francisco/Mount Zion Hospital
San Francisco, California, United States
RECRUITINGAbility of the subject to use the Magnap device for the duration of the study.
Determined by: monitoring for successful device implantation without complications necessitating device removal in all 10 subjects, subjects able to use the device throughout study period once fitted with the brace. Safety will be monitored by tracking all adverse events in 10 subjects and/or complications of treatment.
Time frame: 13 months
Ability of external device to open the airway,
Outcomes will be measured by pharyngeal airway measurements taken pre and post implantation with and without the external device and recording improvements of OSA parameters recorded on polysomnogram pre and post-implantation with and without the external device.
Time frame: 13 Months
Improve symptoms related to OSA
Measurement of symptom improvement and compliance will be monitored by questionnaires 4 times during the study and by 4 polysomnograms after implantation. All 10 subjects will be required to complete daily or event journal entries describing changes and/or experiences with the brace and OSA symptoms
Time frame: 13 Months
Measure Patient compliance
Measurement of symptom improvement will be documented and compared to all post-implantation polysomnograms and compliance will be monitored by daily sleep journal entries by all subjects.questionnaires and journal entries.
Time frame: 13 Months
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