An expanded access record providing aerSleep II in Obstructive Sleep Apnea and Sleep Apnea, sponsored by Sommetrics, Inc.. Available. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Sommetrics, Inc. · Expanded access
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.
This is a multi-center uncontrolled continuation study designed to mimic real-world use of the aerSleep II System for subjects that have completed the SOM-029 protocol.
Subjects will use the aerSleep II nightly at a fixed pressure of -30 cmH2O. Internal electronics will record various measures of how the device is being used and how it performs.
Subjects will have a video visit with the study site approximately every 30 days, and, if the Investigator feels it is warranted or at the subject's discretion, an in-person visit at the study site will occur approximately every 90 days. During these visits, subjects will be queried for adverse events and asked to complete simple subjective evaluations of their experiences. The Investigator will complete a scale rating how well the device is managing the subject's obstructive sleep apnea (OSA).
Data collected from the device will be retrieved approximately every 90 days to monitor vacuum delivery and subject compliance.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
Browse Sleep Apnea, Obstructive studies →Sommetrics, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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The aerSleep® II System includes a soft silicone collar, which is placed on the anterior neck. Integrated with the collar is a vacuum pump module (VPM), which cordlessly powers the generation of negative pressure within the collar's cavity. This negative pressure pulls the underlying tissues forward, maintaining airway patency.
Also known as: Continuous Negative External Pressure (cNEP)
No study locations are listed for this record.
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Sommetrics, Inc.