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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT05044000
Eligibility Criteria:
Inclusion Criteria:
* Patients with PWS genetically confirmed at least 16y old willing to participate and being able to be still in the MRI.
Exclusion Criteria:
1. Age \< 16 years old
2. Presence of uncontrolled Obstructive Sleep Apnea (Residual AHI ≥ 30).
3. Narcolepsy or other sleep disorders with daily somnolence
4. Intolerance to the heavy blanket in spite of previous adaptation sessions
5. Active psychopathological disorder that may interfere with sleep
6. Use of hypnotic or sleep regulator drugs (change of dose in the last 3 months)
7. Contraindications for MRI
8. Impossibility to stay still during MRI adquisition
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05044000
Study Brief:
Protocol Section:
NCT05044000