BridgeMD
New treatment option for Obstructive Sleep Apnea (OSA)
Official title Telemonitoring With CPAP in Severe Obstructive Sleep Apnea in Primary Health Care
ClinicalTrials.gov ID: NCT07464262
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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 likely can't join 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...
- 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).
See the full eligibility 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.
- 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 treatment clinical trial that may interfere with study outcomes.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.