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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT06251258
Eligibility Criteria:
Pre-inclusion criteria
* Age between 18 and 65
* Signed consent to participate in the study
* Person affiliated to or benefiting from a social security scheme
* For insomnia group: known insomnia (patient treated for insomnia)
Inclusion criteria:
* Insomnia group: ISI \>14 (between 15 and 28 = clinical insomnia)
* Control group: ISI \< 8 (between 0 and 7 = no insomnia)
Non-pre-inclusion criteria
* Known psychiatric disorders (Characterized depressive episode, Bipolar disorder, Schizophrenia and other delusional disorders, Specified anxiety disorder (social anxiety, generalized anxiety disorder), Obsessive-compulsive disorder (OCD), Eating disorders, Neurodevelopmental disorders (ASD, ADHD), Active addictive disorders (excluding tobacco), ...)
* Taking antidepressant, neuroleptic or thymoregulator medication
* Taking a benzodiazepine with a long half-life (\>12 hours)
* Condition requiring hospitalization in the month preceding the study
* Known sequelae or progressive neurological disease
* Known significant ophthalmological condition
* Pregnancy or breast-feeding
* Person deprived of liberty by judicial or administrative decision
* Person subject to a legal protection measure
* Person under psychiatric care without consent
* For control group: no known insomnia
Non-inclusion criteria :
\- Psychiatric disorders identified during psychiatric interview
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06251258
Study Brief:
Protocol Section:
NCT06251258