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 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT06427161
Eligibility Criteria:
Inclusion Criteria:
* All adult patients, diagnosed as having OSA after full night polysomnography. • BMI is between 28 kg/m2 and 40 kg/m2 at enrollment
Exclusion Criteria:
1. Pregnant patients
2. Active infectious disease (flu like symptoms).
3. Serious co-morbidity such as chronic or decompensated liver disease, and chronic kidney disease with creatinine clearance less than 30%.
4. Patients with neuromuscular disorders.
5. Previous trauma to the head, and neck.
6. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction).
7. Tonsil size ≥ +3.
8. Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
9. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
10. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).
11. History of radiation therapy to neck or upper respiratory tract
12. Patients with any cardiac diseases such as heart failure, rheumatic heart diseases, coronary artery disease, and myocardial infarction (MI).
13. Patients take up medications that will alter pain perception.
14. History of dementia or active psychiatric disease that may impact study compliance.
15. Patients who refuse the procedure.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06427161
Study Brief:
Protocol Section:
NCT06427161