NCT05608486

Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial

Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial (CO-STAR)

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Sommetrics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Obstructive Sleep Apnea
• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	aerSleep II	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.

Timeline

• First posted: 2022-11-08
• Last updated: 2024-04-16