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Telemonitoring With CPAP in Severe Obstructive Sleep Apnea in Primary Health Care

NCT07464262 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

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.

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.

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Gustavo Moreira, MD, PhD · Federal University of São Paulo UNIFESP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2026-10-31
Completion
2027-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07464262 on ClinicalTrials.gov