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

NCT07464262 | Recruiting

• 1 other identifier: CPAP-Telemonitoring-APS-Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

CPAP Obstructive Sleep Apnea Telemonitoring Digital Health Sleep Apnea Primary Health Care Adherence Remote Monitoring

Outcome Measures

Primary Outcomes (1)

• CPAP adherence

  Average nightly use of CPAP therapy measured in hours per night using device-generated data from the CPAP system.

  90 days

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Device: CPAP Telemonitoring

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.

Device: CPAP Therapy

Interventions

CPAP Telemonitoring 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.

CPAP Telemonitoring

CPAP Therapy DEVICE

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.

Standard CPAP Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Primary Health Care Units - Southeast Regional Health Coordination

São Paulo, São Paulo, 04023-062, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 18250209 BACKGROUND

• 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.

  PMID: 29140129 BACKGROUND

• 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.

  PMID: 30736887 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Gustavo Moreira, MD, PhD

  Federal University of São Paulo UNIFESP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre Morente, PharmD

CONTACT

+55 11 989633988; crssudeste.andre@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors responsible for applying psychometric instruments and questionnaires will remain blinded to participant group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Researcher in Psychobiology

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: a telemonitoring group receiving remote monitoring of CPAP therapy through the AirView® platform and myAir® application, and a control group receiving standard care without telemonitoring. Participants will be followed for 12 months with periodic clinical and psychometric assessments.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start: October 6, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

BR (1)