Efficacy of Telemonitoring With CPAP in Severe Obstructive Sleep Apnea: A Randomized Controlled Trial in Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- CPAP adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors responsible for applying psychometric instruments and questionnaires will remain blinded to participant group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CPAP Telemonitoring
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.
干预措施: CPAP Telemonitoring (Device)
Standard CPAP Care
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.
干预措施: CPAP Therapy (Device)
结局指标
主要结局
CPAP adherence
时间窗: 90 days
Average nightly use of CPAP therapy measured in hours per night using device-generated data from the CPAP system.
次要结局
- Residual Apnea-Hypopnea Index (AHI)(90 days)
- Mask leak(90 days)
- Percentage of nights with CPAP use ≥4 hours(90 days)
- Treatment discontinuation rate(90 days)
- Daytime sleepiness (Epworth Sleepiness Scale)(Baseline, 6 months and 12 months)
- Sleep quality (Pittsburgh Sleep Quality Index)(Baseline, 6 months and 12 months)
- Anxiety and depression symptoms (Hospital Anxiety and Depression Scale)(Baseline, 6 months and 12 months)
- Self-reported cognitive failures(Baseline, 6 months and 12 months)
研究者
André Rodrigues Morente
Master's Researcher in Psychobiology
Federal University of São Paulo