NCT07464262 Telemonitoring With CPAP in Severe Obstructive Sleep Apnea in Primary Health Care
| NCT ID | NCT07464262 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of São Paulo |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-10-06 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Gustavo Moreira, MD, PhD
PRINCIPAL INVESTIGATOR
Federal University of São Paulo
Frequently Asked Questions
Who can join the NCT07464262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obstructive Sleep Apnea (OSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07464262 currently recruiting?
Yes, NCT07464262 is actively recruiting participants. Contact the research team at crssudeste.andre@gmail.com for enrollment information.
Where is the NCT07464262 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07464262 clinical trial?
NCT07464262 is sponsored by Federal University of São Paulo. The principal investigator is Gustavo Moreira, MD, PhD at Federal University of São Paulo. The trial plans to enroll 200 participants.