RecruitingNot ApplicableNCT06570616

Addressing Unintentional Leakage When Using Nasal CPAP - Study A

Strategies for Controlling Unintentional Leakage in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure

Sponsor

University of Sao Paulo General Hospital

Enrollment

100 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

Obstructive Sleep Apnea Continuous Positive Airway Pressure Adverse Effect

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 APAP (automatic mode) and a medical device called CPAP (fixed mode) for people with adverse effect, continuous positive airway pressure, and other related conditions. The study is currently recruiting participants at 2 locations. 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

DEVICECPAP (fixed mode)

Patients will undergo strategies to control excessive leakage while using autoCPAP vs. progressively decreasing fixed nasal CPAP. Before randomization, subjects will undergo an autoCPAP titration for 3 days. Subjects will then be randomized to start the protocol with autoCPAP or fixed CPAP and then will switch to the alternative arm.

DEVICEAPAP (automatic mode)

Locations(2)

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

São Paulo, Brazil, Brazil

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

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NCT06570616

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