Managing unintentional leaks in CPAP therapy for sleep apnea

Strategies for Controlling Unintentional Leakage in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure

This study is testing two different types of CPAP machines to see which one helps people with sleep apnea reduce unintentional leaks while they sleep.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Locations: 2 sites (São Paulo, Brazil and 1 other locations)
• Trial ID: NCT06570616 on ClinicalTrials.gov

What this trial studies

This study aims to address the common issue of unintentional oral leakage during continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA). It will utilize a cross-over controlled randomized trial design to compare the effectiveness of auto-CPAP and progressively reduced fixed CPAP in controlling excessive leaks. Participants will undergo a 7-day auto-CPAP phase followed by a fixed CPAP phase lasting up to 21 days, with the goal of reducing leaks while monitoring apnea-hypopnea indices. If excessive leaks persist, participants may be invited to a subsequent study comparing oronasal CPAP to nasal CPAP with a chinstrap.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with moderate to severe obstructive sleep apnea who experience excessive unintentional leaks while using nasal CPAP.

Not a fit: Patients with central apnea, severe nasal obstruction, or those with unstable heart disease or severe psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved CPAP therapy effectiveness for patients with obstructive sleep apnea by minimizing unintentional leaks.

How similar studies have performed: While the management of unintentional leaks in CPAP therapy has been a topic of interest, this specific approach has not been extensively tested in controlled studies, making it a novel investigation.

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).

Where this trial is running

São Paulo, Brazil and 1 other locations

• Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo — São Paulo, Brazil, Brazil (Recruiting)
• InCor - Instituto do Coração do Hospital das Clínicas da FMUSP — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Pedro Genta — Study Principal Investigator
• Study coordinator: Pedro Genta

Conditions Continuous Positive Airway Pressure; Adverse Effect; Obstructive Sleep Apnea; CPAP; Excessive leak