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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT04474756
Eligibility Criteria:
Inclusion Criteria:
1. Signed written informed consent before participation
2. Age ≥18 years
3. Moderate to severe OSA defined by:
* AHI ≥30 or,
* 15≤ AHI \<30, but associated with excessive daytime sleepiness or,
* 15≤ AHI \<30, with at least two of the following criteria not explained by other factors: severe and daily snoring, choking or suffocating sensation during sleep, non-restorative sleep, daytime fatigue, difficulty concentrating, nocturia (more than one urination per night).
4. Naïve from any mandibular advancement device
5. Patient affiliated to a social security/health insurance system
Exclusion Criteria:
1. One or more of the following contra-indications:
* dental problems (tooth failure, poor distribution or insufficient dental retention)
* periodontal problems: active periodontitis not stabilized. Presence of periodontal pockets, advanced bone loss, significant tooth mobility, insufficient dental plaque control.
* temporomandibular joint disorder (TJD)
* maximum mandibular propulsion distance limited (\< 6 mm)
2. More than 20% of central apnea and hypopnea
3. Severe psychiatric or neuromuscular disorder
4. Body Mass Index (BMI) \> 30 kg/m2
5. Current orthodontic treatment or planned during the study
6. Pregnant women based on clinical exam and medical questioning.
7. Subject in exclusion period of another interventional study
8. Subject under administrative or judicial control
9. Subject unable to understand, follow objectives or methods due to cognition or language problems
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04474756
Study Brief:
Protocol Section:
NCT04474756