Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation

Exclusion Criteria

• •1. Subject is not compliant on NIV (e.g., \< 4 hr./night).
• •2. Subject is pregnant.
• •3. Subject is on oxygen therapy ≥ 5 L/min.
• •4. Subject has an invasive interface (e.g. tracheostomy).
• •5. Subject has had an acute exacerbation within the last 3 months that resulted in a hospitalization.
• •6. Subject is acutely ill, medically complicated, or who are medically unstable.
• •7. Subject in whom NIV therapy is otherwise medically contraindicated.
• •8. Subject has had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
• •9. Subjects with untreated, non-obstructive sleep apnea (OSA) sleep disorders, including but not limited to: insomnia, periodic limb movement syndrome, or restless leg syndrome.
• •10. Subjects who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, or recent cranial surgery or trauma.
• •11. Subject does not comprehend English.
• •12. Subject is unable or unwilling to provide written informed consent.
• •13. Subject is physically and/or mentally unable to comply with the protocol.
• •14. Subject is not suitable to participate in the trial for any other reason in the opinion of the investigator.