NCT06570629 Addressing Unintentional Leakage When Using Nasal CPAP - Study B
| NCT ID | NCT06570629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Continuous Positive Airway Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2025-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 drops of leak over one night of nasal CPAP * Persistence of excessive leak at the end of Study A. 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).