Addressing Unintentional Leakage When Using Nasal CPAP - Study A

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Aug 21, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Addressing Unintentional Leakage When Using Nasal CPAP - Study A," is looking into how to reduce a common problem that people face when using CPAP machines for obstructive sleep apnea (OSA). Many patients experience unintentional leaks of air through their mouths while using CPAP, which can make the treatment less effective. This study aims to test a method where the CPAP pressure is decreased to see if it helps reduce these leaks.

To be eligible for this trial, participants should be between the ages of 65 and 74 and have a diagnosis of moderate to severe obstructive sleep apnea. They must also be using a nasal CPAP mask and have experienced significant unintentional leaks recently. If you join the trial, you can expect to be part of a controlled study that evaluates different ways to manage these leaks, which could lead to better treatment options for many patients in the future. It's important to note that this trial is not yet recruiting participants, so there's no need to sign up just yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).