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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT02112435
Eligibility Criteria:
Inclusion Criteria:
* age between 18 and 65 years
* severe OSA confirmed by polysomnography (PSG) is: 30\> AHI\> 15 with severe daytime sleepiness - Epworth ≥ 10 or AHI\> 30
* patient in failure or refusal of CPAP treatment
* agree to participate and sign the consent form research
* speak and understand French without external assistance
* be in good health (no neurological or psychiatric syndrome).
* have a valid Social Security card (in France and Portugal only)
Exclusion Criteria:
* contra-indicated dental/periodontal states for mandibular advancement splints, such as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized periodontitis or severe parodonthopathies, 3) severe disorders of the temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion
* dental restorations in progress or planned in the next 6 months
* psychiatric and neuromuscular disorders
* untreated cardiovascular diseases and history of stroke or myocardial infarction
* severe or morbid obesity (body mass index\> 35)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02112435
Study Brief:
Protocol Section:
NCT02112435