Astral VAPS AutoEPAP Clinical Trial

Inclusion criteria

for the study are:

• Participant has ability to provide written informed consent
• Participants aged ≥18 years old
• Participant has documented respiratory failure (e.g. sleep hypoventilation with historical PtCO2 increase ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg)
• Participant is currently using non-invasive positive pressure ventilation in ST or VAPS mode for ≥ 3 months
• Participants with a previously documented AHI ≥ 5/hr
• Participants with a recently (≤ 12 months ago) reviewed EPAP setting

Exclusion criteria

for the study are:

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