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

Part of paid clinical trials in San Francisco, California.

Sponsor
Michael Harrison
Study ID
NCT02431507
Status
Recruiting
Apply to this trial

Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnap — 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

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).

Key Dates

Start date
Sep 30, 2015
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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..

Primary Outcome Measure

Ability of the subject to use the Magnap device for the duration of the study. [ Time Frame: 13 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Francisco/Mount Zion HospitalSan FranciscoCalifornia94115
Michael R Harrison, MD
[email protected]
415-235-5812
Jolie Chang, MD (SUB_INVESTIGATOR)
Andrew Murr, MD (SUB_INVESTIGATOR)
David Claman, MD (SUB_INVESTIGATOR)

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By research site
University of California San Francisco/Mount Zion Hospital· San Francisco, CA

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