Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Recruiting
N/A
Interventional Study
Continuous Positive Airway Pressure
Adverse Effect
Obstructive Sleep Apnea
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 50 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Other
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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 c…
Trial Locations
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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…
Contacts