RECRUITINGINTERVENTIONAL

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

Efficacy of Telemonitoring With CPAP in Severe Obstructive Sleep Apnea: A Randomized Controlled Trial in Primary Health Care

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

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.

DEVICE

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.

Locations (1)

Primary Health Care Units - Southeast Regional Health Coordination

São Paulo, São Paulo, Brazil