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Clinical Trials in Brazil / NCT06570629
Recruiting Not applicable

Addressing Unintentional Leakage When Using Nasal CPAP - Study B

NCT06570629 · tracked via the Priya Life Science Brazil tracker
Sponsor
University of Sao Paulo General Hospital
Phase
Not applicable
Started
2025-04-30
Last updated
2025-04-30

Condition(s) studied

Continuous Positive Airway PressureAdverse EffectObstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Oronasal CPAPNasal CPAP plus Chinstrap

Oronasal CPAP: 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.

Nasal CPAP plus Chinstrap: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo São Paulo Brazil Recruiting

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Addressing Unintentional Leakage When Using Nasal CPAP - Study A Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06570629 on ClinicalTrials.gov ↗ ← All trials in Brazil