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:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT02398032
Eligibility Criteria:
Inclusion Criteria:
* Recent diagnosis of sleep apnea-hypopnea syndrome with an apnea-hypopnea index (AHI) \> 10 h-1
* No previous treatment for SAHS or hypertension
* Diagnosis by 24-h ambulatory monitoring of blood pressure (AMBP) of isolated nocturnal hypertension (nighttime blood pressure of ≥120 mm Hg systolic or 70 mm Hg diastolic and a daytime blood pressure \<135/85 mm Hg) or day-night sustained hypertension (nighttime blood pressure of ≥120 mm Hg or 70 mm Hg diastolic and a daytime blood pressure of ≥135 mm Hg systolic).
Exclusion Criteria:
* Severe hypertension (\> 180/120 mmHg).
* Previous diagnosis of secondary hypertension.
* Myocardial infarction or stroke in the last three months.
* Severe diurnal sleepiness (Epworth score \> 15)
* Previous diagnosis of chronic obstructive pulmonary disease, asthma, bronchiectasis, lung cancer, restrictive lung disease, chest wall disease or thoracic surgery.
* Previous diagnosis or clinical evidence of heart disease, neuromuscular disease or thyroid dysfunction.
* Morbid obesity (BMI \> 40 Kg/m2)
* Respiratory infection in the last two months.
* Treatment with theophylline or systemic corticosteroids in the last two years.
* Excessive alcohol intake (\>40 g/day)
* Absence of social or familiar support.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02398032
Study Brief:
Protocol Section:
NCT02398032