Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
University of Sao Paulo General Hospital
50 participants
Apr 30, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Diagnosis of moderate and severe obstructive sleep apnea;
- Use of CPAP with a nasal mask;
- th 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 Criteria5
- 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).
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Interventions
In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.
In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06570629