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Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial

NCT05608486 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2024-04-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sommetrics, Inc.

    lead INDUSTRY

Principal Investigators

  • Kingman P. Strohl, M.D. · Case Western Reserve University School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608486 on ClinicalTrials.gov