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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT02720458
Eligibility Criteria:
Inclusion Criteria:
* Patient complaining of persistent insomnia without co-morbidities (DSM-5) and treated for at least 3 months with monotherapy of:
* Zopiclone or Zolpidem with usual doses (3.5 doses per week at least to a maximum of 14 per week) OR Intermediate half-life benzodiazepines included in the appendix 1 list with usual doses (3.5 doses per week at least to a maximum of 14 per week)
* Motivated to stop hypnotic treatment (score \>5 on a 1 to 10 degrees VAS)
* 18 to 75 years old,
* Man or woman,
* Having an internet connection,
* Affiliated to a national health service,
* Having given written informed consent to participate in the trial.
Exclusion Criteria:
* Patient with 2 psychotropic drugs or more taken daily for insomnia complaints (antidepressant, anxiolytic and antihistamine treatments will be allowed if they are prescribed for a stabilized mood and/or anxiety disorder).
* Patient not believing in short-term simple self-help program
* Insomnia with comorbidities other than a stabilized mood and/or anxiety disorder
* Night and shift-workers,
* Current Psychiatric disorder : mood disorder (depression, bipolar disorder) with a BDI score \> 19, anxiety disorder, psychosis
* All sleep disorders other than persistent insomnia (clinical interview),
* Progressive neurological diseases that include restless legs syndrome,
* Unstable Cardiovascular disease,
* Unstable respiratory or endocrinological diseases (clinical interview),
* Drug addiction, alcohol addiction during the previous 6 months (clinical interview),
* Having undertaken trans-meridian travel (± 3H) in the previous 1 month
* Pregnant or lactating woman,
* Current participation in psychotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02720458
Study Brief:
Protocol Section:
NCT02720458