Magnap for Obstructive Sleep Apnea

(MAGNAP Trial)

Overseen By David Claman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michael Harrison

Disqualifiers: Central apnea, Neurologic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 13 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new magnetic device called Magnap to determine its safety and effectiveness for people with obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. The trial involves surgically implanting the Magnap device and using a custom brace for 13 months to help improve sleep. It seeks participants who have experienced moderate to severe OSA and have difficulty using regular treatments like CPAP machines. Participants should frequently experience sleep disruptions due to this condition. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for OSA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Magnap device is safe for treating obstructive sleep apnea?

Research has shown that the Magnap device, which uses magnets to treat obstructive sleep apnea (OSA), is being tested for safety and practicality. Current studies are evaluating user-friendliness and effectiveness. Although detailed safety information is not yet available, researchers are closely monitoring for side effects or problems due to the study's early stage. This phase focuses on ensuring the treatment's safety. At present, no major safety issues have been reported, but additional data will help confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for obstructive sleep apnea, which often involve continuous positive airway pressure (CPAP) machines or oral appliances, Magnap offers a new approach by using a magnetic apnea device. This treatment involves surgically implanting a magnetic device and pairing it with a custom-fitted external brace, aiming to alleviate symptoms by physically supporting the airway. Researchers are excited about Magnap because it provides a potentially less cumbersome and more permanent solution than current options, which require nightly use and can be uncomfortable for many patients.

What evidence suggests that the Magnap device is effective for obstructive sleep apnea?

Research has shown that the Magnap device, which participants in this trial will receive, might help treat obstructive sleep apnea (OSA). Earlier studies found that similar devices reduced the time people spent sleeping on their backs, which can worsen OSA symptoms. Many patients achieved an apnea-hypopnea index (AHI) of less than 5 events per hour, indicating mild or no OSA. The device may also enhance sleep quality and overall quality of life. These findings suggest that the Magnap device could effectively reduce the severity of OSA. ^{1 5 6 7 8}

Who Is on the Research Team?

Michael R Harrison, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject signs and dates a written informed consent form and indicates understanding of the study procedures and risks

I am between 21 and 70 years old.

I have moderate to severe sleep apnea.

Exclusion Criteria

Any condition likely requiring MRI or has a metal implant

Any factor that, in the surgeon's judgment, would pose a risk to surgery or placement of a long-term implanted device

Any factor that, in the surgeon's judgment, would make the subject unlikely to respond to Magnap treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Surgical implantation of the MAGNAP device on the hyoid bone

1 week

1 visit (in-person)

Treatment

Participants use the MAGNAP device with a custom external brace to treat obstructive sleep apnea

13 months

Regular follow-up visits and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnap

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Arm with Magnetic Apnea Device Experimental Treatment 1 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..

Who Is Running the Clinical Trial?

Michael Harrison

Lead Sponsor

Trials

3

Recruited

30+

Published Research Related to This Trial

Repelling magnetic implants were effective in preventing airway collapse in a canine model of obstructive sleep apnea, achieving forces comparable to CPAP therapy.

The implants were well tolerated over a 6-month period, with only a 10% extrusion rate and no signs of chronic inflammation, suggesting they could be a safe alternative to CPAP for humans if similar results are observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic airway implants for the treatment of obstructive sleep apnea syndrome. Nelson, LM., Boucher, RP., Stevens, SS.[2019]

The study of 44 patients with varying degrees of obstructive sleep apnea showed that using a mandibular advancement device significantly reduced the number of apneas, with the obstructive apnea-hypopnea index decreasing from 11 to 5 in mild cases, 27 to 7 in moderate cases, and 53 to 14 in severe cases, indicating its efficacy across all severity levels.

The device not only reduced apneas but also improved overall sleep quality, with 28 out of 44 patients achieving a successful treatment outcome, particularly in those with mild and moderate sleep apnea, highlighting the importance of follow-up assessments to monitor for potential silent apneas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a mandibular advancement device on apneas and sleep in patients with obstructive sleep apnea. Marklund, M., Franklin, KA., Sahlin, C., et al.[2019]

In a study of 16 patients with mild to moderate obstructive sleep apnea, the 'It Makes You Sleep' (IMYS) device significantly reduced the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) after three months of treatment.

The IMYS device also improved oxygen saturation levels, indicating its effectiveness in enhancing respiratory function during sleep for patients with obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new design of mandibular advancement device (IMYS) in the treatment of obstructive sleep apnea. Ciavarella, D., Campobasso, A., Suriano, C., et al.[2022]

The functional magnetic system, a mandibular repositioning appliance, significantly improved sleep apnea symptoms in 10 patients over 8 weeks, reducing the respiratory disturbance index and increasing minimal oxygen saturation to normal levels.

The treatment primarily works by enlarging the anterior region of the oral cavity, which correlates with reduced daytime tiredness and snoring, while not affecting the pharyngeal airway passages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cephalometric and polysomnographic analyses of functional magnetic system therapy in patients with obstructive sleep apnea. Gavish, A., Vardimon, AD., Rachima, H., et al.[2013]

Bilateral anterior magnetic phrenic stimulation (BAMPS) effectively distinguishes between patients with obstructive sleep apnea (OSA) and those without by analyzing upper airway dynamics in 28 awake patients, revealing significant differences in flow rates and resistance.

Apneic patients exhibited lower maximum flow (Vimax) and minimum flow (Vimin) compared to nonapneic patients, suggesting that BAMPS could be a useful diagnostic tool for identifying OSA based on specific flow metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discriminative power of phrenic twitch-induced dynamic response for diagnosis of sleep apnea during wakefulness. Verin, E., Similowski, T., Teixeira, A., et al.[2013]

Mandibular advancement devices (MADs) have been shown to be a clinically and cost-effective alternative to continuous positive airway pressure (CPAP) therapy for treating obstructive sleep apnea (OSA), especially in milder cases.

Recent studies indicate that MADs can achieve similar health improvements as CPAP in more severe OSA, and patient preference for MADs may enhance treatment adherence, suggesting they could be a preferable option for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternatives to continuous positive airway pressure 2: mandibular advancement devices compared. Quinnell, TG., Clutterbuck-James, AL.[2014]

In a study of 29 patients with moderate-to-severe Obstructive Sleep Apnea (OSA), the fully customizable Mandibular Advancement Device (IMYS) significantly reduced the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) after three months of use.

The IMYS device also improved oxygen saturation levels, indicating its potential effectiveness as a treatment option for patients with more severe forms of OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a modified mandibular advancement device for OSA treatment in a group of adult patients. Ciavarella, D., Campobasso, A., Cazzolla, AP., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02431507

Magnetic Apnea Prevention(MAGNAP) Device to Treat ... 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).

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT02431507

Magnetic Apnea Prevention(MAGNAP) Device to Treat ... 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).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5443742/

Efficacy of the New Generation of Devices for Positional ... Both therapies reduced time spent in the supine sleep position to a median of 0%. An AHI < 5 events/h was achieved in 43% and 68% of the patients treated with ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130008S090b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Reduction in severity of obstructive sleep apnea. • Preserved sleep quality. • Improved subjective quality of life. • Potential improvement in ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2590238525003662

Article A wearable all-in-one obstructive sleep apnea ... A machine learning algorithm is leveraged to analyze the collected data, enabling real-time apnea detection accuracy of 92.7%. Rigorous ...

6. trialx.com trialx.com/clinical-trials/listings/250424/magnetic-apnea-preventionmagnap-device-to-treat-obstructive-sleep-apneafirst-in-human-study-of-feasibility-and-safety/?&radius=50&query=Obstructive%20sleep%20apnea&smt=true

Magnetic Apnea Prevention(MAGNAP) Device to Treat ... The purpose of this study is to determine the safety and feasibility of the Magnap magnetic device in the treatment of obstructive sleep apnea ( ...

7. clinmedjournals.org clinmedjournals.org/articles/jsdm/journal-of-sleep-disorders-and-management-jsdm-8-041.php?jid=jsdm

Modification of the Phase I Magnap Clinical Trial Protocol The results of this interim report suggest that HSAT can be safely used as a remote adjunct for sleep-related outcome monitoring of novel OSA therapies.

8. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/sleep-apnea

UCSF Sleep Apnea Clinical Trials — San Francisco Bay Area The purpose of this study is to determine the safety and feasibility of the Magnap magnetic device in the treatment of obstructive sleep apnea ( ...