Taking people in BrazilNo phase

Telemonitoring With CPAP in Severe Obstructive Sleep Apnea in Primary Health Care

Key facts

Who runs it: Federal University of São Paulo
Where: São Paulo, BrazilSee the site
Trial code: NCT07464262
Status: Recruiting
People taking part: 200 people, planned
Started: 6 Oct 2025
Expected to end: Jul 2027
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: CPAP Telemonitoring
CPAP Therapy
Record updated: 11 March 2026

Who can take part

Age: 18 years to 75 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

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Who can take part

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

Who cannot take part

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
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)
Predominant central sleep apnea (≥50% central events) or Cheyne-Stokes respiration
Inability to maintain follow-up in primary care services of CRS Sudeste
Participation in another interventional clinical trial that may interfere with study outcomes

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Where in Brazil

Primary Health Care Units - Southeast Regional Health CoordinationSão Paulo, BrazilContact: André MorenteTaking people

About the trial

What the trial wants to find out

Obstructive sleep apnea (OSA) is a prevalent sleep disorder associated with cardiovascular, metabolic, cognitive, and psychological complications. Continuous Positive Airway Pressure (CPAP) therapy is the gold standard treatment for moderate to severe OSA; however, long-term adherence remains a major challenge, particularly in real-world primary care settings.

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This study aims to evaluate the effectiveness of telemonitoring using CPAP devices in improving treatment adherence and clinical outcomes among patients with severe OSA receiving care within the Brazilian Primary Health Care system.

This randomized controlled trial will include 200 adult participants with severe OSA who are new users of CPAP therapy and are followed by primary health care units in the Southeast Regional Health Coordination of São Paulo, Brazil. Participants will be randomly allocated into two groups: a telemonitoring intervention group, monitored remotely through the AirView® platform and the myAir® application, and a control group receiving standard care without telemonitoring.

Primary outcomes include CPAP adherence and residual apnea-hypopnea index (AHI). Secondary outcomes include daytime sleepiness, sleep quality, mood, cognitive complaints, and patient perceptions of care. Quantitative clinical data will be collected through CPAP telemonitoring systems and standardized questionnaires, while qualitative data will be obtained through semi-structured interviews with patients and health professionals.

The results of this study may provide evidence supporting the integration of digital health technologies into primary health care services to improve adherence to CPAP therapy and optimize the management of obstructive sleep apnea in public health systems.

The 2 groups in the trial

CPAP TelemonitoringTreatment being tested
Participants receive standard CPAP therapy combined with remote telemonitoring through the AirView® platform and myAir® application. The healthcare team monitors adherence, residual apnea-hypopnea index, mask leak, and therapy parameters, providing proactive support such as phone calls, technical guidance, or home visits when adherence problems or technical issues are detected.
Standard CPAP CareExisting treatment, for comparison
Participants receive standard Continuous Positive Airway Pressure (CPAP) therapy with routine follow-up provided by primary health care services, without telemonitoring systems or mobile applications.
Treatment: CPAP Therapy