Addressing Unintentional Leakage When Using Nasal CPAP - Study B

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 B," is looking at ways to reduce a common problem for people using CPAP machines to treat obstructive sleep apnea (OSA). Some patients experience unintentional air leaks from their mouths while using a CPAP, which can make treatment less effective. The trial aims to see if using a different type of CPAP called oronasal CPAP—along with a chinstrap—works better than the standard nasal CPAP in controlling these leaks.

To participate in this study, you need to be between 65 and 74 years old and have a diagnosis of moderate to severe obstructive sleep apnea. You must be using a nasal CPAP mask and have experienced excessive air leakage. However, if you have certain conditions like severe heart disease, specific breathing issues, or have already had surgery for sleep apnea, you wouldn’t qualify for this trial. If eligible, participants can expect to try out the oronasal CPAP and share their experiences, helping researchers find better ways to manage leaks and improve treatment for everyone with OSA.

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 drops of leak over one night of nasal CPAP
• • Persistence of excessive leak at the end of Study A.
• 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).