NCT06570629

Addressing Unintentional Leakage When Using Nasal CPAP - Study B

Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (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 B will consist of a controlled crossover trial to compare unintentional leak during the use of an oronasal mask versus a nasal mask with a chinstrap, among subjects who remain with excessive leak at the end of study A. The order of interventions will be randomized. One of the groups will initially use an oronasal mask for 10 days. A washout period of 7 days under nasal CPAP will follow. After washout, subjects will continue using a nasal mask and will be asked to use a chinstrap for another 10 days. In the other group, the order of interventions will be the opposite.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Oronasal CPAP	In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.
DEVICE	Nasal CPAP plus Chinstrap	In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.

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

1 site across 1 country: Brazil