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Magnetic Device

Magnap for Obstructive Sleep Apnea (MAGNAP Trial)

N/A
Recruiting
Led By Michael R Harrison, MD
Research Sponsored by Michael Harrison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 months
Awards & highlights

MAGNAP Trial Summary

This trial will study whether the Magnap device is a safe and effective treatment for people with obstructive sleep apnea.

Who is the study for?
This trial is for adults aged 21-70 with moderate to severe obstructive sleep apnea who find standard CPAP therapy intolerable. Candidates must understand the study's procedures and risks, and cannot have conditions that would interfere with Magnap treatment or require MRI, metal implants, or pose surgical risks.Check my eligibility
What is being tested?
The MAGNAP device is being tested for its safety and ability to treat obstructive sleep apnea. This first-in-human study will assess how feasible it is to use this magnetic device as an alternative treatment option.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include discomfort from wearing the device, possible skin irritation at contact points, and unknown risks associated with a new medical device.

MAGNAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 70 years old.
Select...
I have moderate to severe sleep apnea.

MAGNAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability of the subject to use the Magnap device for the duration of the study.
Secondary outcome measures
Ability of external device to open the airway
Improve symptoms related to OSA
Measure Patient compliance

MAGNAP Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment Arm with Magnetic Apnea DeviceExperimental Treatment1 Intervention
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..

Find a Location

Who is running the clinical trial?

Michael HarrisonLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
Michael R Harrison, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Magnap (Magnetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT02431507 — N/A
Obstructive Sleep Apnea Research Study Groups: Treatment Arm with Magnetic Apnea Device
Obstructive Sleep Apnea Clinical Trial 2023: Magnap Highlights & Side Effects. Trial Name: NCT02431507 — N/A
Magnap (Magnetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02431507 — N/A
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT02431507 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this research project?

"Those hoping to enroll in this clinical trial must have been diagnosed with obstructive sleep apnea (OSA) and be aged between 21 and 70. Currently, around 10 individuals are being recruited for the study."

Answered by AI

Is the demographic of this trial inclusive to individuals over four decades old?

"Patients over the age of majority and under 70 years old are welcomed to join this clinical trial."

Answered by AI

How many participants are currently enrolled in this research endeavor?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical trial, first posted September 1st 2015, is actively accepting participants. 10 individuals are required to join the study at a single location."

Answered by AI

Are there any available vacancies in this trial for participants?

"Absolutely. According to clinicaltrials.gov, the trial is currently open for enrollment and was first launched on September 1st 2015. The most recent update occurred on November 2nd 2022 and it requires 10 individuals from one location."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California San Francisco/Mount Zion Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

My cpap is not sufficient to help me feel refreshed when I wake up.
PatientReceived 2+ prior treatments
~0 spots leftby Jun 2024