Addressing Unintentional Leakage When Using Nasal CPAP - Study A

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2028

Conditions
Continuous Positive Airway PressureAdverse EffectObstructive Sleep Apnea
Interventions
DEVICE

CPAP (fixed mode)

Patients will undergo strategies to control excessive leakage while using autoCPAP vs. progressively decreasing fixed nasal CPAP. Before randomization, subjects will undergo an autoCPAP titration for 3 days. Subjects will then be randomized to start the protocol with autoCPAP or fixed CPAP and then will switch to the alternative arm.

DEVICE

APAP (automatic mode)

Patients will undergo strategies to control excessive leakage while using autoCPAP vs. progressively decreasing fixed nasal CPAP. Before randomization, subjects will undergo an autoCPAP titration for 3 days. Subjects will then be randomized to start the protocol with autoCPAP or fixed CPAP and then will switch to the alternative arm.

Trial Locations (2)

55

RECRUITING

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo, São Paulo

03134-002

RECRUITING

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP, São Paulo

All Listed Sponsors
lead

University of Sao Paulo General Hospital

OTHER