Status:
RECRUITING
Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Continuous Positive Airway Pressure
Adverse Effect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 standar...
Detailed Description
Study B will consist of a controlled crossover trial to compare unintentional leak during the use of an oronasal mask versus a nasal mask with a chinstrap, among subjects who remain with excessive lea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06570629
Start Date
April 30 2025
End Date
December 31 2028
Last Update
April 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, Brazil, 55