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Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety (MAGNAP)

This study is currently recruiting participants.
Verified May 2017 by Michael Harrison, University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02431507
First Posted: May 1, 2015
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Harrison, University of California, San Francisco
  Purpose
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).

Condition Intervention
Obstructive Sleep Apnea Device: Magnap

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety

Resource links provided by NLM:


Further study details as provided by Michael Harrison, University of California, San Francisco:

Primary Outcome Measures:
  • Ability of the subject to use the Magnap device for the duration of the study. [ Time Frame: 13 months ]
    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, [ Time Frame: 13 Months ]
    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 [ Time Frame: 13 Months ]
    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 [ Time Frame: 13 Months ]
    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.


Estimated Enrollment: 10
Study Start Date: September 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm with Magnetic Apnea Device
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..
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.
Other Name: Magnetic apnea device

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431507


Contacts
Contact: Jill A Imamura-Ching, RN, BSN (415) 476-3446 Jill.Imamura-Ching@ucsf.edu

Locations
United States, California
University of California San Francisco/Mount Zion Hospital Recruiting
San Francisco, California, United States, 94115
Contact: Jill A Imamura-Ching, RN    415-476-3446    Jill.Imamura-Ching@ucsf.edu   
Sub-Investigator: Jolie Chang, MD         
Sub-Investigator: Andrew Murr, MD         
Sub-Investigator: David Claman, MD         
Sponsors and Collaborators
Michael Harrison
Investigators
Principal Investigator: Michael R Harrison, MD University of California, San Francisco
  More Information

Publications:
Responsible Party: Michael Harrison, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02431507     History of Changes
Other Study ID Numbers: 15-15689
First Submitted: April 23, 2015
First Posted: May 1, 2015
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Michael Harrison, University of California, San Francisco:
apnea
sleep apnea
magnetic sleep apnea device
hyoid bone

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases