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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Brazil
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
RECRUITING
São Paulo
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Pedro Genta
prgenta@gmail.com
551126615486
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
Experimental: AutoCPAP
Subjects will use auto CPAP during 7 days.
Experimental: Fixed
Subjects will start with the CPAP level obtained during auto-CPAP titration. CPAP will be decreased according to the study protocol.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital

This content was sourced from clinicaltrials.gov