Remote CPAP monitoring for severe obstructive sleep apnea in primary care
Efficacy of Telemonitoring With CPAP in Severe Obstructive Sleep Apnea: A Randomized Controlled Trial in Primary Health Care
This will test whether remote monitoring of CPAP devices helps adults with severe obstructive sleep apnea treated in primary care use their therapy more and improve symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Federal University of São Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07464262 on ClinicalTrials.gov |
What this trial studies
Researchers will randomize 200 adults with severe OSA who are new CPAP users within the Southeast Regional Health Coordination of São Paulo to receive either telemonitoring via the AirView® platform and myAir® app or usual primary care follow-up. The telemonitoring arm allows clinicians to track device usage and performance remotely and provide timely support for technical issues and adherence barriers. Primary outcomes focus on CPAP adherence and relevant clinical measures, with secondary outcomes including patient-reported symptoms and quality of life. The trial is designed to test implementation of digital CPAP follow-up within Brazil's public primary care network.
Who should consider this trial
Good fit: Adults aged 18–75 with polysomnography-confirmed severe OSA (AHI ≥30) who are new CPAP users (≤30 days) and live within the Southeast Regional Health Coordination coverage area are ideal candidates.
Not a fit: Those with predominant central sleep apnea, a current need for bilevel/noninvasive ventilation, prior prolonged CPAP use, recent unstable severe comorbidity, or severe cognitive impairment are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could increase long-term CPAP use and improve symptoms and downstream health risks for people with severe OSA in primary care.
How similar studies have performed: Previous trials and implementation studies have shown telemonitoring can improve CPAP adherence, but results vary and evidence is less established in public primary care settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo
- Primary Health Care Units - Southeast Regional Health Coordination — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Gustavo Moreira, MD, PhD — Federal University of São Paulo UNIFESP
- Study coordinator: Andre Morente, PharmD
- Email: crssudeste.andre@gmail.com
- Phone: +55 11 989633988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.