Managing unintentional leaks in CPAP therapy 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 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.

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 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 it's running

• 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
• Email: prgenta@gmail.com
• Phone: 551126615486

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea

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• Functional capacity and muscle function in adults with obstructive sleep apnea

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• Transcutaneous Electrical Stimulation for Obstructive Sleep Apnea

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  Recruiting Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07891702

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.