RECRUITING

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

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Conditions

Obstructive Sleep Apneaapneasleep apneamagnetic sleep apnea devicehyoid bone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2015-09
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02431507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is between 21 and ≤70 years of age
  2. * Subject has moderate to severe obstructive sleep apnea (defined as apnea-hypopnea index of 15-50 events/hour on baseline/screening polysomnogram)
  3. * 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)
  4. * Subject signs and dates a written informed consent form and indicates understanding of the study procedures and risks
  1. * Any evidence that apnea is not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction)
  2. * Any condition likely requiring MRI or has a metal implant
  3. * Any factor that, in the surgeon's judgment, would pose a risk to surgery or placement of a long-term implanted device
  4. * Any factor that, in the surgeon's judgment, would make the subject unlikely to respond to Magnap treatment
  5. * 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
  6. * There are no exclusion criteria based on gender, race or ethnicity

Contacts and Locations

Study Contact

Jeff Jensen, BS
CONTACT
415-640-5245
jjensen@magnap.net
Michael Danty, MS
CONTACT
7074848774
Mrd9940@magnap.net

Principal Investigator

Michael R Harrison, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California San Francisco/Mount Zion Hospital
San Francisco, California, 94115
United States

Collaborators and Investigators

Sponsor: Michael Harrison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-09
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2015-09
Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

  • apnea
  • sleep apnea
  • magnetic sleep apnea device
  • hyoid bone

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea