Health Trials

About this trial

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 criteria

Qualifiers

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 leak line drop events

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • CPAP (fixed mode)
  • APAP (automatic mode)

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

2
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo55, São PauloBrazil, Brazil
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP03134-002, São PauloSão Paulo, Brazil

Sponsors and collaborators

University of Sao Paulo General Hospital

Lead sponsor

Source ClinicalTrials.gov