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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT02591303
Eligibility Criteria:
Inclusion Criteria:
* Insomnia group: patients with insomnia (DSM-V criteria): sleep complaints, of more than 3 nights a week, more than 3 months, affected daytime functioning
* Control group: no self-reported sleep problems
* 20-50 years old
* Female
* Having given written informed consent to participate in the research project
* Driving license
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,
* Reporting symptoms of menopause and/or taking hormone replacement therapy for menopause symptoms,
* Drug addiction, alcohol addiction during the previous 6 months (smoking is allowed),
* Having undertaken trans-meridian travel (± 3H) in the previous 1 month,
* Pregnant or lactating women.
* Chronic pain.
* Having simulator-sickness during the first practice session
* Hypnotic and psychotropic medication taking or stopped less than 5 half-life periods of molecules before screening V0.
* A change in skin conductance of less than 0.05 microSiemens after an auditory stimulus.
* Left-handedness
* Patient participating to any other interventional study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT02591303
Study Brief:
Protocol Section:
NCT02591303