NCT06570616

Addressing Unintentional Leakage When Using Nasal CPAP - Study A

Strategies for Controlling Unintentional Leakage in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Oral unintentional leak is a common side effect of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. Higher levels of CPAP are associated with higher leak. In the present study, a sequential approach to control excessive unintentional leak will be tested. In study A, the reduction of therapeutic CPAP level will be tested. In study B, oronasal CPAP will be compared to nasal CPAP with a chinstrap.

Detailed description

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.

Conditions

• Continuous Positive Airway Pressure
• Adverse Effect
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2024-08-26
• Last updated: 2025-04-30

Locations

2 sites across 1 country: Brazil