Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial

NCT ID: NCT05608486

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: AVAILABLE
• Study Classification: EXPANDED_ACCESS

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 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

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.

Intervention Type: DEVICE

Other Intervention Names

Continuous Negative External Pressure (cNEP)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sommetrics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kingman P. Strohl, M.D.

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University School of Medicine

Central Contacts

Eric Koehler

Role: CONTACT

ekoehler@sommetrics.com

760-295-5620

Richard Rose, M.D.

Role: CONTACT

rrose@sommetrics.com

Other Identifiers

SOM-030

Identifier Type: -

Identifier Source: org_study_id