Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety (MAGNAP)
Primary Purpose
Obstructive Sleep Apnea
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnap
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring apnea, sleep apnea, magnetic sleep apnea device, hyoid bone
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
Sites / Locations
- University of California San Francisco/Mount Zion HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm with Magnetic Apnea Device
Arm Description
The treatment arm with magnetic apnea device includes: surgical implantation of the magnetic apnea device(MAGNAP) to treat obstructive sleep apnea in each eligible enrolled subject . A custom fitted external brace will be created for wear throughout the 13 months of treatment and evaluated for improvement of symptoms..
Outcomes
Primary Outcome Measures
Ability 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.
Secondary Outcome Measures
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02431507
Brief Title
Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety
Acronym
MAGNAP
Official Title
Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Harrison
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
apnea, sleep apnea, magnetic sleep apnea device, hyoid bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm with Magnetic Apnea Device
Arm Type
Experimental
Arm Description
The treatment arm with magnetic apnea device includes: surgical implantation of the magnetic apnea device(MAGNAP) to treat obstructive sleep apnea in each eligible enrolled subject . A custom fitted external brace will be created for wear throughout the 13 months of treatment and evaluated for improvement of symptoms..
Intervention Type
Device
Intervention Name(s)
Magnap
Other Intervention Name(s)
Magnetic apnea device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability of the subject to use the Magnap device for the duration of the study.
Description
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
Secondary Outcome Measure Information:
Title
Ability of external device to open the airway,
Description
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
Title
Improve symptoms related to OSA
Description
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
Title
Measure Patient compliance
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelcey Harrison, BA
Phone
(415) 305-5974
Email
Kelcey@magnap.net
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Danty, MS
Phone
7074848774
Email
Mrd9940@magnap.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Harrison, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco/Mount Zion Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael R Harrison, MD
Phone
415-235-5812
Email
michael.harrison@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Jolie Chang, MD
First Name & Middle Initial & Last Name & Degree
Andrew Murr, MD
First Name & Middle Initial & Last Name & Degree
David Claman, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22114308
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.
Results Reference
background
Learn more about this trial
Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety
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