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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT05939934
Eligibility Criteria:
Inclusion Criteria:
* Patient accepting MAD treatment
* Patient with an apnea-hypopnea index (AHI) greater than 30 events per hour on the initial recording
* Patient with excessive daytime sleepiness during initial treatment (ESE\>10)
* Patient treated for more than 12 months by CPAP with average compliance greater than 5 hours per night
Exclusion Criteria:
* Initial severe daytime sleepiness characterized
* OSAS with ≥ 5 central apneas per hour of sleep at baseline recording
* Previously diagnosed severe cardiac and/or respiratory pathology:
* Body mass index ≥ 35 kg/m2
* Known contraindication to OAM treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05939934
Study Brief:
Protocol Section:
NCT05939934