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

Inclusion 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 withhistorical transcutaneous carbon dioxide (PtCO2) increase ≥ 10mmHg) and/or daytimehypercapnia (>45 mmHg).

4. Subject is currently using non-invasive positive pressure ventilation (NIV) for 1month.

5. Subject has a previously documented apnea-hypopnea index (AHI) ≥ 5/hr.

6. Subject's expiratory positive airway pressure (EPAP) settings were recently (≤ 12months) reviewed.

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 ahospitalization.

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 theprevious 90 days.

9. Subjects with untreated, non-obstructive sleep apnea (OSA) sleep disorders,including but not limited to: insomnia, periodic limb movement syndrome, or restlessleg syndrome.

10. Subjects who have the following pre-existing conditions: severe bullous lungdisease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, orrecent 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 theopinion of the investigator.