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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of moderate and severe obstructive sleep apnea; - Use of CPAP with a nasal mask; - 95th percentile of unintentional leak from the last 7 days above 24 l/min or at least 4 sudden leak line drop events Who Should NOT Join This Trial: - Patients who experience unintentional leakage from the mask/accessories. - Diagnostic polysomnography examination with a predominance of central apnea; - Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and COPD; - Previous surgery for obstructive sleep apnea; - Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosis of moderate and severe obstructive sleep apnea; * Use of CPAP with a nasal mask; * 95th percentile of unintentional leak from the last 7 days above 24 l/min or at least 4 sudden leak line drop events Exclusion Criteria: * Patients who experience unintentional leakage from the mask/accessories. * Diagnostic polysomnography examination with a predominance of central apnea; * Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and COPD; * Previous surgery for obstructive sleep apnea; * Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points).

Treatments Being Tested

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.

Locations (2)

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, Brazil
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, Brazil