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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT02821234
Eligibility Criteria:
Inclusion Criteria:
* Insomnia group: patients with insomnia: sleep complaints, of at least 3 nights a week, for at least 3 months, affected daytime functioning.
* control group: no self-reported sleep problems in the last 2 months.
* 20-50 years old.
* Male or female.
* having given written informed consent to participate in the research project.
Exclusion Criteria:
* Night and shift-workers.
* Psychiatric disorder: clinical mood disorder, anxiety disorder, psychosis, bipolar disorder.
* For insomnia group: all sleep disorders other than persistent insomnia.
* For control group: all sleep disorders.
* Progressive neurological diseases that include restless legs syndrome.
* Cardiovascular disease other than treated hypertension.
* Unstable respiratory or endocrinological diseases.
* Drug addiction, alcohol addiction during the previous 6 months.
* Having undertaken trans-meridian travel (± 3H) in the previous 1 month.
* Pregnant or lactating women.
* Chronic pain.
* Hypnotic and psychotropic medication taking or stopped less than 5 half-life periods of molecules before screening V0.
* Patient participating to any other interventional study.
* For MRI: presence of a ferromagnetic foreign body (in particular certain intracranial clips, certain cardiac valves, intraocular foreign body, or subject having worked with metals), the presence of an implanted pacemaker, subject with cardiac or brain valves of ventricular derivation (risk of maladjustment), claustrophobia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT02821234
Study Brief:
Protocol Section:
NCT02821234