Actively Recruiting
Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
Led by University of Sao Paulo General Hospital · Updated on 2025-04-30
50
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how to manage unintentional oral leaks that occur during continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). This study focuses on evaluating different mask types and strategies to reduce excessive leaks, which are common side effects that have not been standardized or well studied. The trial is part of a controlled, randomized crossover design to compare oral leaks with oronasal masks versus nasal masks combined with chinstraps. Participants who continue to have excessive leaks after an initial phase (Study A) will enter Study B, where they will use CPAP with either an oronasal mask or a nasal mask plus chinstrap for 7 days each. The order of these interventions will be randomized and separated by a 7-day washout period using nasal CPAP alone. This sequence will allow comparison of leak control between the two mask approaches. During the study, participants will be monitored for unintentional leak levels, sleep apnea severity, and side effects using questionnaires such as the CPAP Side-effects questionnaire, the Functional Outcomes of Sleep Questionnaire, and the Pittsburgh questionnaire. The main outcome is the 95th percentile of unintentional leak measured over 27 days. The total study duration includes both intervention periods and washout, with assessments conducted throughout to evaluate treatment effects and participant experience.
CONDITIONS
Brief Title
Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of moderate and severe obstructive sleep apnea
- Current use of CPAP therapy with a nasal mask
- 95th percentile of unintentional leak above 24 l/min over the last 7 days or at least 4 sudden leak drops in one night
- Persistence of excessive leak at the end of Study A
- Adults aged 18 years or older
You will not qualify if you...
- Experiencing unintentional leakage from the mask or accessories
- Predominance of central apnea on diagnostic polysomnography
- Unstable heart disease, bedridden status, neurodegenerative diseases, severe psychiatric disorders, or COPD
- Previous surgery for obstructive sleep apnea
- Severe nasal obstruction (NOSE questionnaire score 55 or higher)
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 - Approximately 21 days
Participants use CPAP with either an oronasal mask or a nasal mask with a chinstrap in a randomized order. Each intervention period lasts 7 days, separated by a 7-day washout period using nasal CPAP.
3 visits (in-person or remote) including baseline, after first intervention, and after second intervention
Trial Site Locations
Total: 1 location
1
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, Brazil, 55
Actively Recruiting
Research Team
P
Pedro Genta
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
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