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RECRUITING
NCT06570629
NA

Addressing Unintentional Leakage When Using Nasal CPAP - Study B

Sponsor: University of Sao Paulo General Hospital

View on ClinicalTrials.gov

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.

Official title: Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-04-30

Completion Date

2028-12-31

Last Updated

2025-04-30

Healthy Volunteers

Yes

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

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

São Paulo, Brazil, Brazil