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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT01926405
Eligibility Criteria:
Inclusion Criteria:
Subjects with hypersomnia (narcolepsy or idiopathic):
* Children and adolescents with hypersomnia (according to ICSD diagnostic criteria 2); narcolepsy or idiopathic hypersomnia (with or without lengthening of sleep),
* aged \> 6 years and \<18 years,
* no treatment,
* Parent consent
Control subjects:
* healthy children and adolescents without any known pathology,
* aged \> 6 years and \<18 years,
* matched on sex and age\> 6 years - \<12 years,\> 12 - \<18 years)
* Parent Consent
Exclusion Criteria:
* Subjects with hypersomnia (narcolepsy or idiopathic):
* Secondary narcolepsy,
* Symptomatic hypersomnia,
* Restless legs syndrome,
* Sleep apnea syndrome,
* Severe neurological, psychiatric, cognitive or endocrinological concomitant disease.
Control subjects:
* Hypersomnia,
* Restless legs syndrome,
* Sleep apnea syndrome,
* Severe neurological, psychiatric, cognitive or endocrinological concomitant disease,
* Sleep disorder evaluated by a score \> 70 on the Sleep Disturbance Scale for Children19,
* Excessive daytime sleepiness according to Epworth scales (score \> 10),
* Abnormal sleep time according to the age (sleep diary).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT01926405
Study Brief:
Protocol Section:
NCT01926405