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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07414420
Eligibility Criteria:
Inclusion Criteria:
* age between 20 and 65 years
* clinically confirmed diagnosis of mild or moderate obstructive sleep apnea (Apnea hypopnea index 15-30 episodes/hour)
* sufficient number of periodontally healthy teeth to support the oral appliance
* written informed consent of conformance with the study protocol
Exclusion Criteria:
* age bellow 20 and over 65 years
* patients not able or not willing to follow the study protocol
* patients with severe OSA (Apnea hypopnea index \> 30 episodes/hour) and/or some other breathing disturbances
* patients with psychiatric, neurological or psychosomatic disorders
* patients with Body Mass Index \> 29kg/sqm
* pregnancy
* presence of the anatomical obstruction in the airways
* severe periodontal disease (III and IV grade)
* pathological changes in the structures of TMJ, muscles or ligaments
* mandibular protrusion less than 3mm
* orthodontic anomalies, malocclusions, II and III skeletal class, and orthodontic appliances
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT07414420
Study Brief:
Protocol Section:
NCT07414420