AzTrials
AzTrials

Obstructive Sleep Apnea (OSA)CPAP-APSNCT07464262

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

A study testing CPAP Telemonitoring and CPAP Therapy in people with Obstructive Sleep Apnea (OSA), run by Federal University of São Paulo at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obstructive Sleep Apnea (OSA)
What is being tested?
CPAP Telemonitoring and CPAP Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteBrazil
Study dates
6 Oct 2025to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andre Morente, PharmD contact

+55 11 989633988

crssudeste.andre@gmail.com

Brazil1 site, 1 recruiting
  • Primary Health Care Units - Southeast Regional Health Coordination

    São Paulo, São Paulo, 04023-062

    André Morente, +55 11 989633988, crssudeste.andre@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
CPAP Telemonitoring, CPAP Therapy
Keywords
CPAP Obstructive Sleep Apnea Telemonitoring Digital Health Sleep Apnea Primary Health Care Adherence Remote Monitoring
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAP TelemonitoringDevice

    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 TherapyDevice

    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.

Study groups in NCT07464262
Study groupRoleWhat they receive
CPAP TelemonitoringExperimentalParticipants 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.
Receives: Device: CPAP Telemonitoring
Standard CPAP CareActive comparatorParticipants receive standard Continuous Positive Airway Pressure (CPAP) therapy with routine follow-up provided by primary health care services, without telemonitoring systems or mobile applications.
Receives: Device: CPAP Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CPAP adherence

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

    Measured: 90 days

Secondary outcomes (8)
  1. Residual Apnea-Hypopnea Index (AHI)

    Residual apnea-hypopnea index recorded by the CPAP device during therapy.

    Measured: 90 days

  2. Mask leak

    Mean mask leak values recorded by the CPAP device during treatment.

    Measured: 90 days

  3. Percentage of nights with CPAP use ≥4 hours

    Proportion of nights in which participants used CPAP therapy for at least 4 hours.

    Measured: 90 days

  4. Treatment discontinuation rate

    Proportion of participants who discontinued CPAP therapy during the follow-up period.

    Measured: 90 days

  5. Daytime sleepiness (Epworth Sleepiness Scale)

    Change in daytime sleepiness measured using the Epworth Sleepiness Scale (ESS).

    Measured: Baseline, 6 months and 12 months

  6. Sleep quality (Pittsburgh Sleep Quality Index)

    Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).

    Measured: Baseline, 6 months and 12 months

  7. Anxiety and depression symptoms (Hospital Anxiety and Depression Scale)

    Symptoms of anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).

    Measured: Baseline, 6 months and 12 months

  8. Self-reported cognitive failures

    Cognitive failures assessed using the Cognitive Failures Questionnaire (CFQ).

    Measured: Baseline, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2026
  2. Study start6 Oct 2025
  3. Primary completionOct 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07464262
Sponsor's protocol ID
CPAP-Telemonitoring-APS-Study
Acronym
CPAP-APS
Status last verified
Mar 2026
First submitted
6 Mar 2026
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • 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.

    PubMed 18250209
  • 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.

    PubMed 29140129
  • 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.

    PubMed 30736887

Questions about this trial

What is this clinical trial studying?

A study testing CPAP Telemonitoring and CPAP Therapy in people with Obstructive Sleep Apnea (OSA), run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andre Morente, PharmD (+55 11 989633988, crssudeste.andre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CPAP adherence (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07464262, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in