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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04979234
Eligibility Criteria:
Inclusion Criteria:
* Age between 18-65 years
* BMI between 28 to 34.9 kg/m²
* AHI ≥ 30 events/hour
* De novo CPAP user, installed within 2 months prior enrollment
* Must be able to comply with all study requirements for the duration of the study, as outlined in the protocol. This includes complying with the visit schedule as well as study-specific procedures such as clinical assessment, endoscopy, radiography, as well as laboratory investigations
* Must be able to understand and be willing to provide written informed consent;
* Had followed the multidisciplinary bariatric workup (blood analyses, dietician, psychologist and doctor appointments)
Exclusion Criteria:
* Presence of an obesity-hypoventilation syndrome defined as a PaCO2 ≥ 45 mmHg without any other respiratory disease.
* CPAP treatment failure defined as central sleep apnea occurrence under CPAP treatment or a residual AHI \> 5 under optimal CPAP treatment.
* Incompliance to cPAP treatment defined as an observance to cPAP of at least 4 hours per night in average.
* Achalasia and any other esophageal motility disorders
* Current severe esophagitis (grade C and D based on Los Angeles Classification)
* Current Gastro-duodenal ulcer
* Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
* Hypertension: uncontrolled hypertension during the last 3 months;
* Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c \> 10%);
* TBWL \>5% over the last 6 months
* Current severe renal, hepatic, pulmonary disease or cancer;
* Current gastrointestinal stenosis or obstruction
* Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months
* Bariatric surgery, balloon or other endoscopic obesity-related therapy within 6 months of enrollment in this study
* Anticoagulant therapy
* Impending gastric surgery 60 days post-intervention
* Psychiatric disorder refuted after psychological evaluation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04979234
Study Brief:
Protocol Section:
NCT04979234