[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628639":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Federal University of São Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CPAP Telemonitoring","EXPERIMENTAL","Participants receive standard CPAP therapy combined with remote telemonitoring through the AirView® platform and myAir® application. The healthcare team monitors adherence, residual apnea-hypopnea index, mask leak, and therapy parameters, providing proactive support such as phone calls, technical guidance, or home visits when adherence problems or technical issues are detected.",[13],"Device: CPAP Telemonitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard CPAP Care","ACTIVE_COMPARATOR","Participants receive standard Continuous Positive Airway Pressure (CPAP) therapy with routine follow-up provided by primary health care services, without telemonitoring systems or mobile applications.",[19],"Device: CPAP Therapy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","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.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"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.",[15],[31],{"name":32,"affiliation":33,"role":34},"Gustavo Moreira, MD, PhD","Federal University of São Paulo UNIFESP","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Andre Morente, PharmD","CONTACT","+55 11 989633988","crssudeste.andre@gmail.com",[42],{"facility":43,"status":44,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Primary Health Care Units - Southeast Regional Health Coordination","RECRUITING","São Paulo","04023-062","Brazil","BR",{"type":50,"coordinates":51},"Point",[52,53],-46.63611,-23.5475,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":39,"phoneExt":25,"email":40},"André Morente",{"type":34,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"André Rodrigues Morente","Master's Researcher in Psychobiology","100628639","telemonitoring-with-cpap-in-severe-obstructive-sleep-apnea-in-primary-health-care-100628639",false,"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","CPAP-APS","Inclusion Criteria:\n\n* Age between 18 and 75 years.\n* Diagnosis of severe obstructive sleep apnea (OSA) confirmed by polysomnography with apnea-hypopnea index (AHI) ≥30 events\u002Fhour.\n* New CPAP users (≤30 days since initiation of CPAP therapy).\n* Resident within the coverage area of the Southeast Regional Health Coordination (CRS Sudeste), São Paulo, Brazil.\n* Ability to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* Previous CPAP use for more than 30 days prior to enrollment.\n* Indication for bilevel ventilation (BiPAP) or non-invasive ventilation due to conditions such as hypoventilation syndromes, chronic hypercapnic COPD, or neuromuscular diseases.\n* Predominant central sleep apnea (≥50% central events) or Cheyne-Stokes respiration.\n* Recent unstable or severe comorbidity (e.g., decompensated heart failure, acute coronary syndrome within 30 days, stroke within 3 months).\n* Severe cognitive impairment or psychiatric disorder that prevents understanding of study procedures or adherence.\n* Conditions preventing safe use of CPAP mask (e.g., major craniofacial deformities, facial trauma, extensive facial skin lesions).\n* Inability to maintain follow-up in primary care services of CRS Sudeste.\n* Participation in another interventional clinical trial that may interfere with study outcomes.","ALL","18 Years","75 Years",{"count":73,"type":74},200,"ESTIMATED","INTERVENTIONAL",[77],"NA","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.\n\nThis 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.\n\nThis 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.\n\nPrimary 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.\n\nThe 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.",[80],"Obstructive Sleep Apnea (OSA)",[82],"CPAP Obstructive Sleep Apnea Telemonitoring Digital Health Sleep Apnea Primary Health Care Adherence Remote Monitoring","2026-03-06",{"date":85,"type":86},"2026-03-11","ACTUAL",{"date":88,"type":86},"2025-10-06",{"date":90,"type":74},"2027-07",{"name":5,"class":6},1]