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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT00805350
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria
Exclusion Criteria:
* Inpatients.
* Mean screening PSG-WASO for screening night 1+ screening night 2 \< 45 mn, or screening night with PSG-WASO \< 30 mn.
* Mean screening PSG-TST for screening night 1 + screening night 2 ≥7 hours or ≤3hours.
* Mean screening PSG-LPS for screening night 1+ screening night 2 \> 30 mn.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00805350
Study Brief:
Protocol Section:
NCT00805350