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

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

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.

Study Overview

• Status: Available
• Conditions: Obstructive Sleep Apnea; Sleep Apnea
• Intervention / Treatment: Device: aerSleep II

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.

• Study Type: Expanded Access

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Sommetrics, Inc.
• Investigators: Principal Investigator: Kingman P. Strohl, M.D., Case Western Reserve University School of Medicine

Study record dates

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: SOM-030