Actively Recruiting
Telemonitoring With CPAP in Severe Obstructive Sleep Apnea in Primary Health Care
Led by Federal University of São Paulo · Updated on 2026-03-11
200
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Telemonitoring With CPAP in Severe Obstructive Sleep Apnea in Primary Health Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of severe obstructive sleep apnea with apnea-hypopnea index of 30 or more events per hour
- New users of CPAP therapy within 30 days of starting treatment
- Resident in the Southeast Regional Health Coordination area of Sao Paulo, Brazil
- Able to understand and sign informed consent
You will not qualify if you...
- Previous CPAP use longer than 30 days before enrollment
- Need for bilevel ventilation or non-invasive ventilation due to hypoventilation syndromes, chronic hypercapnic COPD, or neuromuscular diseases
- Predominant central sleep apnea (50% or more central events) or Cheyne-Stokes respiration
- Recent unstable or severe health problems such as decompensated heart failure, recent heart attack, or stroke within 3 months
- Severe cognitive impairment or psychiatric disorder preventing study understanding or adherence
- Conditions preventing safe use of CPAP mask like major facial deformities or trauma
- Unable to maintain follow-up in primary care services of Southeast Regional Health Coordination
- Participation in another interventional clinical trial that could affect study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Primary Health Care Units - Southeast Regional Health Coordination
São Paulo, São Paulo, Brazil, 04023-062
Actively Recruiting
Research Team
A
Andre Morente, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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