NCT07464262

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Obstructive sleep apnea (OSA) is a chronic sleep-related breathing disorder characterized by recurrent episodes of upper airway obstruction during sleep, leading to intermittent hypoxia and sleep fragmentation. OSA is associated with increased risk of cardiovascular disease, metabolic disorders, neurocognitive impairment, mood disturbances, and reduced quality of life. Continuous Positive Airway Pressure (CPAP) therapy is the most effective treatment for moderate to severe OSA. Despite its proven clinical benefits, adherence to CPAP therapy remains suboptimal in many patients. Barriers to adherence include discomfort with the device, technical difficulties, lack of support, and limited follow-up after treatment initiation. Recent advances in digital health technologies have enabled remote monitoring of CPAP usage and performance. Telemonitoring systems allow healthcare professionals to track adherence, identify technical issues, and provide timely interventions to support patients during treatment. However, evidence regarding the effectiveness of telemonitoring in real-world primary care settings within public health systems remains limited. This study aims to evaluate the impact of CPAP telemonitoring integrated into primary health care on treatment adherence and clinical outcomes among patients with severe OSA. The study will be conducted within the Primary Health Care network of the Southeast Regional Health Coordination of São Paulo, Brazil. A total of 200 adult participants aged 18 to 75 years with a confirmed diagnosis of severe obstructive sleep apnea (apnea-hypopnea index ≥30 events per hour) and who have initiated CPAP therapy within the previous 30 days will be recruited from participating primary health care units. Participants will be randomly assigned in a 1:1 ratio to one of two groups: Intervention group (Telemonitoring): Participants will receive remote monitoring through the AirView® platform (ResMed) and the myAir® mobile application. Healthcare professionals will monitor CPAP usage data, including nightly usage time, residual AHI, leak levels, and therapy pressure. When adherence problems or technical issues are detected, the primary health care team will provide support through phone calls, educational reinforcement, or home visits. Control group (Standard care): Participants will receive routine follow-up provided by primary health care services without access to telemonitoring tools or mobile applications. Participants will be followed for 12 months, with data collection at baseline, 3 months, 6 months, and 12 months. Primary outcomes include: * CPAP adherence (average nightly use and percentage of nights with ≥4 hours of use) * Residual apnea-hypopnea index (AHI) Secondary outcomes include: * Daytime sleepiness assessed using the Epworth Sleepiness Scale * Sleep quality assessed using the Pittsburgh Sleep Quality Index * Anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale * Cognitive complaints assessed using the Cognitive Failures Questionnaire * Patient and health professional perceptions regarding telemonitoring and care processes Quantitative analyses will be conducted using mixed statistical models to evaluate longitudinal outcomes. Qualitative data obtained from semi-structured interviews will be analyzed using thematic content analysis. This study seeks to generate evidence regarding the feasibility and effectiveness of telemonitoring strategies for CPAP therapy within public primary health care systems. The findings may support the implementation of digital monitoring strategies to improve adherence, optimize resource utilization, and enhance the management of obstructive sleep apnea in large-scale health systems.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-06
• Primary completion: 2026-10-01
• Completion: 2027-07-01
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: Brazil