Obstructive Sleep ApneaMAGNAPNCT02431507
Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety
A study testing Magnap in people with Obstructive Sleep Apnea, run by Michael Harrison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Magnap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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)
- Subject signs and dates a written informed consent form and indicates understanding of the study procedures and risks
Who cannot join
- Any evidence that apnea is not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction)
- 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
- 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
- There are no exclusion criteria based on gender, race or ethnicity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco/Mount Zion Hospital
San Francisco, California, 94115
Michael R Harrison, MD, 415-235-5812, michael.harrison@ucsf.edu
Jolie Chang, MD
About this study
Official title: Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety
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).
Read the detailed description
Magnap is a magnet-activated treatment for obstructive sleep apnea (OSA) designed to be less invasive than reconstructive surgery, more tolerable than positive airway pressure, and more effective than non-invasive therapies for OSA. The Magnap device consists of a neodymium-iron-boron rare earth magnet with a ferromagnetic directional back-plate encased in titanium. The device will be implanted surgically on the hyoid bone. Following surgery, the patient is fitted with a custom, removable external neck accessory containing a second magnet, which is worn during sleep and prevents airway collapse by attracting the internal hyoid magnet with sufficient force to keep the airway open .
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Magnap
- Keywords
- apnea, sleep apnea, magnetic sleep apnea device, hyoid bone
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnapDevice
Also called Magnetic apnea device
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm with Magnetic Apnea Device | Experimental | 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.. Receives: Device: Magnap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the subject to use the Magnap device for the duration of the study.
Determined by: monitoring for successful device implantation without complications necessitating device removal in all 10 subjects, subjects able to use the device throughout study period once fitted with the brace. Safety will be monitored by tracking all adverse events in 10 subjects and/or complications of treatment.
Measured: 13 months
Secondary outcomes (3)
Ability of external device to open the airway,
Outcomes will be measured by pharyngeal airway measurements taken pre and post implantation with and without the external device and recording improvements of OSA parameters recorded on polysomnogram pre and post-implantation with and without the external device.
Measured: 13 Months
Improve symptoms related to OSA
Measurement of symptom improvement and compliance will be monitored by questionnaires 4 times during the study and by 4 polysomnograms after implantation. All 10 subjects will be required to complete daily or event journal entries describing changes and/or experiences with the brace and OSA symptoms
Measured: 13 Months
Measure Patient compliance
Measurement of symptom improvement will be documented and compared to all post-implantation polysomnograms and compliance will be monitored by daily sleep journal entries by all subjects.questionnaires and journal entries.
Measured: 13 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startSep 2015
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Harrison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Harrison, University of California, San Francisco
- Investigators
- Michael R Harrison, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431507
- Sponsor's protocol ID
- 15-15689
- Acronym
- MAGNAP
- Status last verified
- Dec 2025
- First submitted
- 23 Apr 2015
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rosenbluth KH, Kwiat DA, Harrison MR, Kezirian EJ. Hyoid bone advancement for improving airway patency: cadaver study of a magnet-based system. Otolaryngol Head Neck Surg. 2012 Mar;146(3):491-6. doi: 10.1177/0194599811429522. Epub 2011 Nov 22.
PubMed 22114308
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety
- ClinicalTrials.gov ID
- NCT02431507
- Acronym / sponsor ID
- MAGNAP / 15-15689
- Conditions
- Obstructive Sleep Apnea
- Keywords
- apnea, sleep apnea, magnetic sleep apnea device, hyoid bone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Michael HarrisonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Magnap is a magnet-activated treatment for obstructive sleep apnea (OSA) designed to be less invasive than reconstructive surgery, more tolerable than positive airway pressure, and more effective than non-invasive therapies for OSA. The Magnap device consists of a neodymium-iron-boron rare earth magnet with a ferromagnetic directional back-plate encased in titanium. The device will be implanted surgically on the hyoid bone. Following surgery, the patient is fitted with a custom, removable external neck accessory containing a second magnet, which is worn during sleep and prevents airway collapse by attracting the internal hyoid magnet with sufficient force to keep the airway open .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm with Magnetic Apnea Device | Experimental | Device: MagnapThe 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 may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
- 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)
- Subject signs and dates a written informed consent form and indicates understanding of the study procedures and risks
Key exclusion criteria (6 listed)
- Any evidence that apnea is not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnapAlso: Magnetic apnea deviceThis 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. | Device | Treatment Arm with Magnetic Apnea Device |
Primary outcome
Ability of the subject to use the Magnap device for the duration of the study.
Time frame: 13 months
Determined by: monitoring for successful device implantation without complications necessitating device removal in all 10 subjects, subjects able to use the device throughout study period once fitted with the brace. Safety will be monitored by tracking all adverse events in 10 subjects and/or complications of treatment.
3 secondary outcomes
Ability of external device to open the airway,
Time frame: 13 Months
Improve symptoms related to OSA
Time frame: 13 Months
Measure Patient compliance
Time frame: 13 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 22114308Rosenbluth KH, Kwiat DA, Harrison MR, Kezirian EJ. Hyoid bone advancement for improving airway patency: cadaver study of a magnet-based system. Otolaryngol Head Neck Surg. 2012 Mar;146(3):491-6. doi: 10.1177/0194599811429522. Epub 2011 Nov 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael R Harrison, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnap in people with Obstructive Sleep Apnea, run by Michael Harrison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeff Jensen, BS (415-640-5245, jjensen@magnap.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the subject to use the Magnap device for the duration of the study. (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.