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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 70 years old.

Select...

I have moderate to severe sleep apnea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ability of the subject to use the Magnap device for the duration of the study.

Secondary study objectives

Ability of external device to open the airway

Improve symptoms related to OSA

Measure Patient compliance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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..

0 / 2Eligibility criteria met