Status:
RECRUITING
Addressing Unintentional Leakage When Using Nasal CPAP - Study A
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 A will consist of a cross-over controlled randomized trial to compare unintentional leak during auto-CPAP and during fixed CPAP after the progressive reduction of fixed CPAP, starting at the 90 ...
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 leak line drop events
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 :
100 Patients enrolled
Trial Details
Trial ID
NCT06570616
Start Date
April 30 2025
End Date
December 31 2028
Last Update
April 30 2025
Active Locations (2)
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1
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, Brazil, 55
2
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, Brazil, 03134-002