Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial

Obstructive Sleep Apnea Clinical Trial

— CO-STAR  

Official title:

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT05608486
• Other study ID #: SOM-030
• Status: Available

Study information

• Verified date: April 2024
• Source: Sommetrics, Inc.
• Contact: Eric Koehler
• Phone: 760-295-5620
• Email: ekoehler[@]sommetrics.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject completed study SOM-029 (SUPRA).

2. The Investigator feels that the subject experienced sufficient benefit from aerSleep II to justify its further use.

3. In the Investigator's judgement, the subject will be able to understand and comply with all study procedures.

Exclusion Criteria:

1. The Investigator feels that, for any reason, the subject's participation may not be in his or her best interest.

2. Any condition or circumstance that in the opinion of the Investigator is likely to prevent accurate data collection or bias the results.

3. The subject is pregnant or plans to become pregnant during the course of the study.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sommetrics, Inc.