Clinical trial NCT02431507: Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety
Official title: Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: apnea
sleep apnea
magnetic sleep apnea device
hyoid bone
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-05-01
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: 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 .

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

Primary outcomes:
measure: Ability of the subject to use the Magnap device for the duration of the study.
timeFrame: 13 months
Secondary outcomes:
measure: Ability of external device to open the airway,
timeFrame: 13 Months
measure: Improve symptoms related to OSA
timeFrame: 13 Months
measure: Measure Patient compliance
timeFrame: 13 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco/Mount Zion Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Michael R Harrison, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenbluth KH, Kwiat DA, Harrison MR, Kezirian EJ. Hyoid bone advancement for improving airway patency: cadaver study of a magnet-based system. Otolaryngol Head Neck Surg. 2012 Mar;146(3):491-6. doi: 10.1177/0194599811429522. Epub 2011 Nov 22.