Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial

NCT05608486 | Unknown

• 1 other identifier: SOM-030
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea; Sleep Apnea

Interventions

aerSleep II DEVICE

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.

Also known as: Continuous Negative External Pressure (cNEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject completed study SOM-029 (SUPRA).
• The Investigator feels that the subject experienced sufficient benefit from aerSleep II to justify its further use.
• In the Investigator's judgement, the subject will be able to understand and comply with all study procedures.

You may not qualify if:

• The Investigator feels that, for any reason, the subject's participation may not be in his or her best interest.
• Any condition or circumstance that in the opinion of the Investigator is likely to prevent accurate data collection or bias the results.
• The subject is pregnant or plans to become pregnant during the course of the study.

Sponsors & Collaborators

• Sommetrics, Inc.: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kingman P. Strohl, M.D.

  Case Western Reserve University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Koehler

CONTACT

760-295-5620; ekoehler@sommetrics.com

Richard Rose, M.D.

CONTACT

rrose@sommetrics.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 8, 2022
• Last Updated: April 16, 2024

Record last verified: 2024-04