What this study is
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).
What's being tested
- Magnap
Intervention · DEVICE
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.
Study details
- Official title
- Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety
- Sponsor
- Michael Harrison
- Conditions
- Obstructive Sleep Apnea
- Enrolling
- 10 people
- Starts
- 2015-09
- Est. completion
- 2027-03-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of California San Francisco/Mount Zion Hospital
San Francisco, California, United States
- Michael R Harrison, MD · Contact415-235-5812michael.harrison@ucsf.edu
- Jolie Chang, MD · Sub-investigator
- Andrew Murr, MD · Sub-investigator
- David Claman, MD · Sub-investigator
Recruiting
Study team
Sponsor
Michael Harrison
Study ID 15-15689
Principal investigator
Michael R Harrison, MD
University of California, San Francisco
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.