Telemonitoring With CPAP in Severe Obstructive Sleep Apnea in Primary Health Care (CPAP-APS)

Efficacy of Telemonitoring With CPAP in Severe Obstructive Sleep Apnea: A Randomized Controlled Trial in Primary Health Care

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: CPAP Telemonitoring; Device: CPAP Therapy

Detailed Description

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.

Participants will be randomly assigned in a 1:1 ratio to one of two groups:

Intervention group (Telemonitoring): Participants will receive remote monitoring through the AirView® platform (ResMed) and the myAir® mobile application. Healthcare professionals will monitor CPAP usage data, including nightly usage time, residual AHI, leak levels, and therapy pressure. When adherence problems or technical issues are detected, the primary health care team will provide support through phone calls, educational reinforcement, or home visits.

Control group (Standard care): Participants will receive routine follow-up provided by primary health care services without access to telemonitoring tools or mobile applications.

Participants will be followed for 12 months, with data collection at baseline, 3 months, 6 months, and 12 months.

Primary outcomes include:

• CPAP adherence (average nightly use and percentage of nights with ≥4 hours of use)
• Residual apnea-hypopnea index (AHI)

Secondary outcomes include:

• Daytime sleepiness assessed using the Epworth Sleepiness Scale
• Sleep quality assessed using the Pittsburgh Sleep Quality Index
• Anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale
• Cognitive complaints assessed using the Cognitive Failures Questionnaire
• Patient and health professional perceptions regarding telemonitoring and care processes

Quantitative analyses will be conducted using mixed statistical models to evaluate longitudinal outcomes. Qualitative data obtained from semi-structured interviews will be analyzed using thematic content analysis.

This study seeks to generate evidence regarding the feasibility and effectiveness of telemonitoring strategies for CPAP therapy within public primary health care systems. The findings may support the implementation of digital monitoring strategies to improve adherence, optimize resource utilization, and enhance the management of obstructive sleep apnea in large-scale health systems.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andre Morente, PharmD; Phone Number: +55 11 989633988; Email: crssudeste.andre@gmail.com

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04023-062
      • Recruiting
      • Primary Health Care Units - Southeast Regional Health Coordination
      • Contact: André Morente; Phone Number: +55 11 989633988; Email: crssudeste.andre@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: CPAP Telemonitoring; 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.
Active Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP adherence	Average nightly use of CPAP therapy measured in hours per night using device-generated data from the CPAP system.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Apnea-Hypopnea Index (AHI)	Residual apnea-hypopnea index recorded by the CPAP device during therapy.	90 days
Mask leak	Mean mask leak values recorded by the CPAP device during treatment.	90 days
Percentage of nights with CPAP use ≥4 hours	Proportion of nights in which participants used CPAP therapy for at least 4 hours.	90 days
Treatment discontinuation rate	Proportion of participants who discontinued CPAP therapy during the follow-up period.	90 days
Daytime sleepiness (Epworth Sleepiness Scale)	Change in daytime sleepiness measured using the Epworth Sleepiness Scale (ESS).	Baseline, 6 months and 12 months
Sleep quality (Pittsburgh Sleep Quality Index)	Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).	Baseline, 6 months and 12 months
Anxiety and depression symptoms (Hospital Anxiety and Depression Scale)	Symptoms of anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).	Baseline, 6 months and 12 months
Self-reported cognitive failures	Cognitive failures assessed using the Cognitive Failures Questionnaire (CFQ).	Baseline, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Gustavo Moreira, MD, PhD, Federal University of São Paulo UNIFESP

Publications and helpful links

General Publications

• Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2019 Feb 15;15(2):335-343. doi: 10.5664/jcsm.7640.
• Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG.
• Kroshus E, Parsons J, Hainline B. Calling Injury Timeouts for the Medical Evaluation of Concussion: Determinants of Collegiate Football Officials' Behavior. J Athl Train. 2017 Nov;52(11):1041-1047. doi: 10.4085/1062-6050-52.11.17. Epub 2017 Nov 8.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: CPAP Obstructive Sleep Apnea Telemonitoring Digital Health Sleep Apnea Primary Health Care Adherence Remote Monitoring
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CPAP-Telemonitoring-APS-Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) sharing has not yet been determined. Data sharing will depend on institutional policies, ethical approvals, and applicable data protection regulations. Requests for access to de-identified data may be considered after study completion and publication of the main results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No