Addressing Unintentional Leakage When Using Nasal CPAP - Study A
100 patients around the world
Available in Brazil
Study A will consist of a cross-over controlled randomized trial to compare unintentional
leak during auto-CPAP and during fixed CPAP after the progressive reduction of fixed
CPAP, starting at the 90 th percentile obtained during a period of auto-CPAP. The order
of interventions will be randomized. Auto-CPAP with a nasal mask will be used for 7 days.
In the fixed CPAP arm, CPAP will be progressively reduced over a period of up to 21 days
until leak is controlled or residual apnea-hypopnea index increases over 10 events/h.
Subjects that persisted with excessive leak at the end of the Study A will be invited to
Study B.