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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT04646902
Eligibility Criteria:
CASES (subjects with hypertension with and without OSA)
Inclusion Criteria:
* Adults ≥ 30 years old attending the outpatient clinics of the clinical sites.
* Diagnosis of hypertension defined either as: a) use of antihypertensive drug(s) and stable dose for at least 2 weeks prior to inclusion; or b) in untreated patients: office systolic blood pressure values \>= 140 mmHg and/ or diastolic blood pressure values \>= 90 mmHg.
* Able to understand and communicate effectively with study personnel.
* Giving written informed consent to participate.
Exclusion Criteria:
* Self-reported pregnancy or breastfeeding.
* Patients on haemodialysis or peritoneal dialysis.
* Chronic liver disease with Child-Pugh score B or higher.
* Hypertension attributed to renal artery stenosis, primary hyperaldosteronism, pheochromocytoma, Cushing's syndrome, coarctation of aorta.
* History of any OSA surgical treatment to the palatal and hypopharyngeal regions, notably uvulopalatopharyngoplasty surgery (UPPP), palatal radio frequency ablation, tonsillectomy, lingual tonsillectomy, partial glossectomy, tongue base radio frequency ablation, genioglossal advancement, hyoid suspension, maxillomandibular advancement surgery (MMA) and active use of hypoglossal nerve stimulator.
* Patients with a good adherence to CPAP, defined as the use of CPAP for at least 4 hours/night on 70% of nights during the last 3 months.
* Pulmonary hypertension.
* Current diagnosed oncological disease.
* Patients with known chronic or acute infectious diseases.
* Other current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study
CONTROLS (individuals without hypertension with and without OSA) For each case, an age and gender-matched control will be selected.
Exclusion Criteria:
* Pregnancy or breastfeeding.
* Patients on haemodialysis or peritoneal dialysis.
* Chronic liver disease with Child-Pugh score b or higher.
* History of any OSA surgical treatment to the palatal and hypopharyngeal regions, notably uvulopalatopharyngoplasty surgery (UPPP), palatal radio frequency ablation, tonsillectomy, lingual tonsillectomy, partial glossectomy, tongue base radio frequency ablation, genioglossal advancement, hyoid suspension, maxillomandibular advancement surgery (MMA) and active use of hypoglossal nerve stimulator.
* Patients with a good adherence to CPAP, defined as the use of CPAP for at least 4 hours/night on 70% of nights during the last 3 months.
* Pulmonary hypertension.
* Current diagnosed oncological disease.
* Patients with known chronic or acute infectious diseases.
* Patients with known chronic or acute infectious diseases.
* Other current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT04646902
Study Brief:
Protocol Section:
NCT04646902