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

NCT02431507 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-22

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Michael Harrison

    lead OTHER

Principal Investigators

  • Michael R Harrison, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2026-12-01
Completion
2027-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431507 on ClinicalTrials.gov