Addressing Unintentional Leakage When Using Nasal CPAP - Study A
Recruiting now · Not applicable
Conditions studied: Continuous Positive Airway Pressure, Adverse Effect, Obstructive Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT06570616
- Run by
- University of Sao Paulo General Hospital
- People needed
- 100
- Starts
- 2025-04-30
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2025-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo — São Paulo, Brazil, Brazil (enrolling)
- InCor - Instituto do Coração do Hospital das Clínicas da FMUSP — São Paulo, São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
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