Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation (NCT06560411) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation
United States23 participantsStarted 2024-10-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has the ability to provide written informed consent.
✕. Subject is not compliant on NIV (e.g., \< 4 hr./night).
✕. Subject is pregnant.
✕. Subject is on oxygen therapy ≥ 5 L/min.
✕. Subject has an invasive interface (e.g. tracheostomy).
✕. Subject has had an acute exacerbation within the last 3 months that resulted in a hospitalization.
✕. Subject is acutely ill, medically complicated, or who are medically unstable.
✕. Subject in whom NIV therapy is otherwise medically contraindicated.
What they're measuring
1
Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment.
Timeframe: Up to Five Weeks
2
Exploratory effectiveness endpoint is to evaluate the log of the subject's mean Apnea Hypopnea Index (AHI) during each overnight polysomnography assessment.
Timeframe: Up to Five Weeks
3
The primary safety endpoint is the occurrence of device-related serious adverse events (SADEs).