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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT04300218
Eligibility Criteria:
Inclusion Criteria:
* Sleep disorder matching chronic insomnia criteria (International Classification of Sleep Disorders-3) - assessed by clinical judgement
* Ability to follow the procedures of the study, fluent Russian language, Good access to internet - assessed by self-report
Exclusion Criteria:
* Presence of dementia (identified by history or a score \< 25 on the Folstein Mini Mental Status Exam) - assessed by clinical judgement
* Severe depression or severe anxiety as measured with the Beck Depression Inventory (BDI-II; score \> 28 ) and the Beck Anxiety Inventory (BAI; score \> 26) - assessed by the questionnaires
* History of severe psychiatric comorbidities other than anxiety and depression (bipolar disorders, psychotic disorders) or substance use disorder - assessed by self-report and clinical history
* Untreated severe obstructive sleep apnea syndrome (apnea-hypopnea index (AHI) \> 15), restless legs syndrome (movement index with arousal \> 15 per hour) or other sleep disorders affecting night sleep - assessed by clinical judgement and clinical history
* pregnancy, lactation - assessed by self-report
* having a serious somatic condition or brain disorders (stroke, Parkinson's disease…) preventing further participation - assessed by self-report
* Having high suicidality risk - assessed by clinical judgement, high total BDI-II score (\> 29) or score \>1 on a BDI-II of suicidality subscale
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04300218
Study Brief:
Protocol Section:
NCT04300218