The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)

PHASE2RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

February 13, 2024

Primary Completion Date

August 31, 2028

Study Completion Date

August 31, 2028

Conditions
Obstructive Sleep ApneaChronic Obstructive Pulmonary DiseaseOverlap Syndrome
Interventions
DEVICE

bi-level positive pressure non invasive ventilation

Participants randomized to the bi-level arm will be provided with an auto bi-level device that automatically delivers the required pressure. The settings in the auto bi-level will be minimum EPAP of 4 cmH2O, maximum IPAP of 24 cmH2O, and a range of pressure support between 6-10 cmH2O. For those participants who have been randomized to the bi-level group but have not successfully acclimated to the device with the automatic bi-level settings, we will conduct an in-lab titration of the bi-level therapy during the optional Overnight visit 2.

DRUG

Oxygen gas

The dose of nocturnal oxygen in all participants in the oxygen therapy arm will be 2 liters/minute. Patients with daytime hypoxemia, measured as sustained desaturations below 89% during wake time and/or arterial blood PO2 ≤ 55 mmHg, will be excluded from this study (as specified in the exclusion criteria) for ethical reasons since withholding oxygen in hypoxemic patients would be at odds with standard of care.

Trial Locations (1)

92037

RECRUITING

UCSD Sleep Research, La Jolla

All Listed Sponsors
lead

University of California, San Diego

OTHER