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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT05677620
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 and 70 years of age with the indication for treatment with mandibular advancement device, who refused or cannot tolerate CPAP;
* Body Mass Index (BMI) between 19 and 34.9 Kg/m2;
* The presence of 8 healthy teeth or more per jaw (upper and lower );
* Maximum mandibular protrusion capacity of at least 6 mm.
Exclusion Criteria:
* Significant nasal obstruction; chronic lung disease;
* Class III or IV congestive heart failure according to the New York Heart Association classification;
* Neuromuscular diseases or previous upper airway surgery unrelated to obstructive sleep apnea;
* Uncontrolled periodontitis;
* Tooth mobility;
* Orthodontic treatment;
* Dental prosthesis wholly or partially removable.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05677620
Study Brief:
Protocol Section:
NCT05677620