Actively Recruiting
Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Led by University of Sao Paulo General Hospital · Updated on 2025-04-30
50
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, Brazil, 55
Actively Recruiting
Research Team
P
Pedro Genta
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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