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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-04-30 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Contact & Investigator
Pedro Genta
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT06570629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Continuous Positive Airway Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06570629 currently recruiting?
Yes, NCT06570629 is actively recruiting participants. Contact the research team at prgenta@gmail.com for enrollment information.
Where is the NCT06570629 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06570629 clinical trial?
NCT06570629 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Pedro Genta at Study Principal Investigator. The trial plans to enroll 50 participants.