Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT04814420
Eligibility Criteria:
Inclusion Criteria:
Group A: 10 patients 18-75-year-old With mild OSA (5\<AHI\<15), confirmed by polysomnography. No previous AF diagnosis on the medical chart
Group B: 10 patients 18-75-year-old With moderate OSA (15\<AHI\<30), confirmed by polysomnography. No previous AF diagnosis on the medical chart
Group C: 10 patients 18-75-year-old With severe OSA (AHI\>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart
Group D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5\<AHI\<15), confirmed by polysomnography. Previous AF diagnosis
* In this group, patients with AF and OSA who already have done MRI might be included.
Group E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI\>30), confirmed by polysomnography. Previous AF diagnosis
\*In this group, patients with AF and OSA who already have done MRI might be included.
Group F (Control): 10 Patients 18-75-year-old No previous OSA and/or AF Diagnosis on the medical chart
Exclusion Criteria:
* History of chronic heart failure (LVEF \< 50%), AF, myocardial infarction, valvular disease.
* Prior cardiac or chest surgery.
* Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea.
* Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices/implants contraindicated for MRI, glomerular filtration rate \<30 ml/min, etc.).
* Pregnancy.
* Inability to give informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04814420
Study Brief:
Protocol Section:
NCT04814420