Actively Recruiting
Strategies for Controlling Unintentional Leakage in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure
Led by University of Sao Paulo General Hospital · Updated on 2025-04-30
100
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ways to reduce unintentional oral leaks that occur during continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). This trial focuses on comparing different CPAP methods to manage leaks, as no standard approach currently exists. Higher CPAP levels are linked to more leaks, so the study aims to test strategies to control this issue effectively.
CONDITIONS
Brief Title
Addressing Unintentional Leakage When Using Nasal CPAP - Study A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Adults aged 18 years or older
You will not qualify if you...
- 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
- Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants undergo a 3-day autoCPAP titration to establish baseline CPAP levels before randomization.
1 visit for titration setup and monitoring
Duration - Up to 28 days
Participants use autoCPAP for 7 days and fixed CPAP with progressive reduction over up to 21 days in a randomized order to control unintentional leakage.
Daily use at home with periodic assessments
Trial Site Locations
Total: 2 locations
1
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, Brazil, 55
Actively Recruiting
2
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, Brazil, 03134-002
Actively Recruiting
Research Team
P
Pedro Genta
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here