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 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT07120061
Eligibility Criteria:
Inclusion Criteria :
* Being affiliated or beneficiaries of a social security system.
* Having been informed of the study and having given their free and informed consent, written and signed consent to participate to the study
Plus one of the following inclusion criteria:
* Participant with a suspicion of OSAS without any previous diagnosis or treatment and with Epworth Sleepiness Scale ≥ 11.
* Participant with effective and stable treatment for OSAS (defined by apnea-hypopnea index ≥ 15 per hour) since at least 15 days and intended to be explored by a MWT.
* Participant with effective and stable treatment for narcolepsy type 1 as defined by the ICSD-3 (cataplexy or lack of orexine) since at least 15 days and intended to be explored by a MWT.
* Healthy volunteers with Epworth Sleepiness Scale \< 11.
Exclusion Criteria:
* Comorbid sleep disorders associated with excessive daytime sleepiness (e.g., OSAS and narcolepsy)
* Severe conditions endangering life in the short term
* Participant with cardiovascular, neurological, psychiatric, respiratory, infectious, endocrine, or systematic pathology, which is not stabilized and may require hospitalization or a modification of therapy during the duration of the study
* Introduction or change in dosage of a psychotropic medication in the previous year which may modify the level of arousal in the previous year and modify the MWT results
* Shift or night workers
* Pregnant or breastfeeding woman
* Participants under curatorship or guardianship
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07120061
Study Brief:
Protocol Section:
NCT07120061