Addressing Unintentional Leakage When Using Nasal CPAP - Study A

Not Applicable

Not yet recruiting

• Conditions: Continuous Positive Airway Pressure; Adverse Effect; Obstructive Sleep Apnea

• Registration Number: NCT06570616
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-1-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria:<br><br> - Diagnosis of moderate and severe obstructive sleep apnea;<br><br> - Use of CPAP with a nasal mask;<br><br> - 95th percentile of unintentional leak from the last 7 days above 24 l/min or at<br> least 4 sudden leak line drop events<br><br>Exclusion Criteria:<br><br> - Patients who experience unintentional leakage from the mask/accessories.<br><br> - Diagnostic polysomnography examination with a predominance of central apnea;<br><br> - Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe<br> psychiatric disorders and COPD;<br><br> - Previous surgery for obstructive sleep apnea;<br><br> - Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
95th CPAP unintentional leak

Secondary Outcome Measures

Name	Time	Method
CPAP Side-effects questionnaire