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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT01029561
Eligibility Criteria:
Inclusion Criteria for part A:
Patients who are included in the obesity surgery program will be recruited if they fulfill the following criteria:
* Age between 18 and 65 years.
* Body mass index (BMI) \>40 kg/m2 or BMI \> 35 kg/m2 with co-morbidity related to obesity.
Inclusion Criteria for part B:
In the treatment response study we will include patients diagnosed at the baseline polysomnography with severe OSA (AHI \>= 30) who fulfill the inclusion criteria for part A and who do not present specific exclusion criteria for part B.
General Exclusion Criteria (for part A):
* Prior treatment with CPAP.
* Severe or unstable cardiovascular disease (severe or surgically treated valvulopathy, myocardial infarction, unstable angina, cardiac surgery) during the 6 months prior to inclusion in the study.
* Evidence of acute or chronic inflammatory illness different to obesity itself (connective tissue disease, active neoplasia) or associated infectious process during the 6 weeks prior to inclusion in the study.
* Severe cognitive or psychiatric disorder that would make it difficult to complete the clinical questionnaires.
* Severe chronic diseases that may interfere in a significant way with the results of the study.
* Chronic obstructive pulmonary disease defined by FEV1/FVC \< 0.7.
* Pregnancy.
* Alcohol abuse (daily alcohol consumption \>80 g).
* Express decision of the patient to not participate in the study.
Exclusion Criteria for part B:
* Severe or incapacitating somnolence.
* Professional drivers or users of dangerous machinery.
* Congestive cardiac insufficiency or significant valvulopathy or chronic cor pulmonale.
* Use of oral anti-diabetic drugs or insulin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01029561
Study Brief:
Protocol Section:
NCT01029561