Comparing oronasal and nasal CPAP with chinstrap for sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to address the common issue of unintentional leakage during continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). It will compare the effectiveness of an oronasal mask versus a nasal mask with a chinstrap in controlling excessive leaks. Participants will undergo a controlled crossover trial, where they will use each type of mask for a specified duration, with a washout period in between. The study focuses on patients who have persistent excessive leaks despite previous interventions.

Why it matters

Who can join: the full rules

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).

Where it's running

• Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
  São Paulo, Brazil, Brazil Recruiting

Study contacts

• Principal investigator: Pedro Genta — Study Principal Investigator
• Study coordinator: Pedro Genta
• Email: prgenta@gmail.com
• Phone: 551126625486

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.