Remote CPAP monitoring for severe obstructive sleep apnea in primary care

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

Researchers will randomize 200 adults with severe OSA who are new CPAP users within the Southeast Regional Health Coordination of São Paulo to receive either telemonitoring via the AirView® platform and myAir® app or usual primary care follow-up. The telemonitoring arm allows clinicians to track device usage and performance remotely and provide timely support for technical issues and adherence barriers. Primary outcomes focus on CPAP adherence and relevant clinical measures, with secondary outcomes including patient-reported symptoms and quality of life. The trial is designed to test implementation of digital CPAP follow-up within Brazil's public primary care network.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 75 years.
* Diagnosis of severe obstructive sleep apnea (OSA) confirmed by polysomnography with apnea-hypopnea index (AHI) ≥30 events/hour.
* New CPAP users (≤30 days since initiation of CPAP therapy).
* Resident within the coverage area of the Southeast Regional Health Coordination (CRS Sudeste), São Paulo, Brazil.
* Ability to understand and sign the informed consent form.

Exclusion Criteria:

* Previous CPAP use for more than 30 days prior to enrollment.
* Indication for bilevel ventilation (BiPAP) or non-invasive ventilation due to conditions such as hypoventilation syndromes, chronic hypercapnic COPD, or neuromuscular diseases.
* Predominant central sleep apnea (≥50% central events) or Cheyne-Stokes respiration.
* Recent unstable or severe comorbidity (e.g., decompensated heart failure, acute coronary syndrome within 30 days, stroke within 3 months).
* Severe cognitive impairment or psychiatric disorder that prevents understanding of study procedures or adherence.
* Conditions preventing safe use of CPAP mask (e.g., major craniofacial deformities, facial trauma, extensive facial skin lesions).
* Inability to maintain follow-up in primary care services of CRS Sudeste.
* Participation in another interventional clinical trial that may interfere with study outcomes.

Where it's running

• Primary Health Care Units - Southeast Regional Health Coordination
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Gustavo Moreira, MD, PhD — Federal University of São Paulo
• Study coordinator: Andre Morente, PharmD
• Email: crssudeste.andre@gmail.com
• Phone: +55 11 989633988

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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.