Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety (MAGNAP)
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|ClinicalTrials.gov Identifier: NCT02431507|
Recruitment Status : Recruiting
First Posted : May 1, 2015
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Magnap||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Magnetic Apnea Prevention (MAGNAP) Device to Treat Obstructive Sleep Apnea: First-In-Human Study of Feasibility and Safety|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Treatment Arm with Magnetic Apnea Device
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..
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.
Other Name: Magnetic apnea device
- 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.
- Ability of external device to open the airway, [ Time Frame: 13 Months ]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.
- Improve symptoms related to OSA [ Time Frame: 13 Months ]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
- Measure Patient compliance [ Time Frame: 13 Months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431507
|Contact: Jill A Imamura-Ching, RN, BSN||(415) 476-3446||Jill.Imamura-Ching@ucsf.edu|
|United States, California|
|University of California San Francisco/Mount Zion Hospital||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Jill A Imamura-Ching, RN 415-476-3446 Jill.Imamura-Ching@ucsf.edu|
|Sub-Investigator: Jolie Chang, MD|
|Sub-Investigator: Andrew Murr, MD|
|Sub-Investigator: David Claman, MD|
|Principal Investigator:||Michael R Harrison, MD||University of California, San Francisco|