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

Eligibility Criteria

• 1. Subject has the ability to provide written informed consent.
• 2. Subject is ≥ 18 years old.
• 3. Subject has documented respiratory failure (e.g. sleep hypoventilation with historical transcutaneous carbon dioxide (PtCO2) increase ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg).
• 4. Subject is currently using non-invasive positive pressure ventilation (NIV) for ≥ 3 months.
• 5. Subject has a previously documented apnea-hypopnea index (AHI) ≥ 5/hr.
• 6. Subject's expiratory positive airway pressure (EPAP) settings were recently (≤ 12 months) reviewed.
• 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.