RecruitingNot ApplicableNCT06570629

Addressing Unintentional Leakage When Using Nasal CPAP - Study B

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


Sponsor

University of Sao Paulo General Hospital

Enrollment

50 participants

Start Date

Apr 30, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Nasal CPAP plus Chinstrap and a medical device called Oronasal CPAP for people with adverse effect, continuous positive airway pressure, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOronasal 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.

DEVICENasal 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

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NCT06570629


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