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Obstructive Sleep ApneaSleepFirst-in-humanDevice

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 ↗