Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital
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 drops of leak over one night of nasal CPAP
Persistence of excessive leak at the end of Study A.
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
- Oronasal CPAP
- Nasal CPAP plus Chinstrap
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov