Evaluation of Automatic Expiratory Positive Airway Pressure (Auto-EPAP) for Management of Upper Airway Obstruction During Non-Invasive Ventilation With Vivo 45 LS
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Subject has the ability to provide written informed consent.
• Subject is ≥ 18 years old.
• Subject has documented respiratory failure (e.g. sleep hypoventilation with historical transcutaneous carbon dioxide (PtCO2) increase ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg).
• Subject is currently using non-invasive positive pressure ventilation (NIV) for 1 month.
• Subject has a previously documented apnea-hypopnea index (AHI) ≥ 5/hr.
• Subject's expiratory positive airway pressure (EPAP) settings were recently (≤ 12 months) reviewed.
Locations
United States
Arizona
Insomnia and Sleep Institute of Arizona, LLC
RECRUITING
Scottsdale
California
University of California San Diego
RECRUITING
San Diego
Colorado
Delta Waves
RECRUITING
Colorado Springs
South Carolina
Bogan Sleep Consultants
RECRUITING
Columbia
Time Frame
Start Date: 2024-10-03
Estimated Completion Date: 2025-06
Participants
Target number of participants: 20
Treatments
Active_comparator: Auto Night One, Manual Night Two
Will undergo Automatic Expiratory Positive Airway Pressure (EPAP) during Non-Invasive Ventilation in polysomnography (PSG) Night 1; Will undergo Manual EPAP during Non-Invasive Ventilation in PSG Night 2
Active_comparator: Manual Night One, Auto Night Two
Will undergo Manual Expiratory Positive Airway Pressure (EPAP) during Non-Invasive Ventilation in polysomnography (PSG) Night 1; Will undergo Auto-EPAP during Non-Invasive Ventilation in PSG Night 2
Related Therapeutic Areas
Sponsors
Leads: Breas Medical, Inc.
Collaborators: Veranex, Inc.