Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05608486
Status:
AVAILABLE
Last Update Posted:
2024-04-16
First Post:
2022-10-31
Brief Title:
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial
Sponsor:
Sommetrics Inc
Organization:
Sommetrics Inc
Study Overview
Official Title:
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial CO-STAR
Status:
AVAILABLE
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CO-STAR
Brief 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 subjects 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 subjects obstructive sleep apnea OSA
Data collected from the device will be retrieved approximately every 90 days to monitor vacuum delivery and subject compliance
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 subjects 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 subjects obstructive sleep apnea OSA
Data collected from the device will be retrieved approximately every 90 days to monitor vacuum delivery and subject compliance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None