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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT01080404
Eligibility Criteria:
Inclusion Criteria:
For the overall study:
1. Age 18-65 years
2. BMI 35 and over with comorbidity (such as sleep apnea)
3. BMI 40 and over without any comorbidities
4. Obtained written consent
Additionally for the randomised substudy:
1. BMI 35-45
2. AHI 5-30
Exclusion Criteria:
1. On-going active treatment of OSA of any kind (during the last 1 month)
2. Pregnancy
3. Alcoholism
4. Eating disorders or severe depression
5. Other severe diseases contra-indicating bariatric surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01080404
Study Brief:
Protocol Section:
NCT01080404