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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT02515357
Eligibility Criteria:
Inclusion Criteria:
1. Presence of obstructive sleep apnea diagnosed through polysomnography
2. Presence of overweight or obesity (Body Mass Index \> 25 kg/m2)
Exclusion Criteria:
1. Presence of central sleep apnea
2. Presence of other causes of sleep disorders, such as narcolepsy, restless leg syndrome or chronic pain syndrome
3. Hospitalization during the last year due to acute or chronic respiratory disease or required use of supplemental oxygen
4. Presence of diabetes mellitus
5. Presence of cardiovascular disease
6. Presence of severe hypertension (blood pressure \> 160/95 mm Hg)
7. Presence of neoplasm
8. Presence of chronic inflammatory diseases
9. Presence of psychiatric disorders, such as major depression, schizophrenia or suicidal ideation
10. Pregnancy or breast feeding (for women)
11. Surgery during the last three months
12. Reception of antipsychotics, antidepressants or other sleep inducing drugs, systematic reception of steroids or hormone replacement therapy for women
13. Excessive alcohol consumption (\> 210 or \> 140 gr of alcohol per week for men and women, respectively)
14. Adherence to a hypocaloric diet for weight loss or changes in dietary habits during the last six months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02515357
Study Brief:
Protocol Section:
NCT02515357