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

NCT07464262 · tracked via the Priya Life Science Brazil tracker

Sponsor

Federal University of São Paulo

Phase

Not applicable

Started

2025-10-06

Last updated

2026-03-11

Condition(s) studied

Obstructive Sleep Apnea (OSA)

Investigational drug(s) / intervention(s)

CPAP TelemonitoringCPAP Therapy

CPAP Telemonitoring: Continuous Positive Airway Pressure (CPAP) therapy with remote monitoring using the AirView® platform and myAir® application. The system allows healthcare professionals to monitor adherence, residual events, mask leak, and therapy parameters and provide early support to improve treatment adherence.

CPAP Therapy: Standard Continuous Positive Airway Pressure (CPAP) therapy prescribed for the treatment of obstructive sleep apnea, with routine follow-up by primary health care services without remote monitoring.

Study summary

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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

CPAP adherence — 90 days
Average nightly use of CPAP therapy measured in hours per night using device-generated data from the CPAP system.

Trial sites (1)

Facility	City	Region	Status
Primary Health Care Units - Southeast Regional Health Coordination	São Paulo	São Paulo	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07464262 on ClinicalTrials.gov ↗ ← All trials in Brazil