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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT04751851
Eligibility Criteria:
Inclusion Criteria:
* French speaker
* Had benzodiazepines and related drugs prescribed to improving sleep, for a minimum of 4 nights per week and for at least 6 months
* Pathological Benzodiazepine Dependence Questionnaire (BDEPQ) score (\>34).
* Motivated to stop hypnotic treatment (score \>5 on a 1 to 10 degrees VAS)
* Subjective complaints of difficulties initiating and/or maintaining sleep for a minimum of 3 nights per week and for at least 6 months, and 4) presence of marked distress or impaired daytime functioning (fatigue, impaired attention and/or concentration). Because hypnotic medications may mask an underlying insomnia problem, participants should meet these criteria either currently (while taking medication) or after previous attempts to discontinue the medication. These criteria are consistent with those for primary insomnia and hypnotic-dependent insomnia.
* Present the diagnoses of insomnia (307.42) and sedative, hypnotic and anxiolytic use disorder (304.10) from the DSM V.
* Having e-literacy (being familiar with emails, videoconferencing, online questionnaires and Internet use)
Exclusion Criteria:
* In acute treatment for psychological or psychiatric problems (e.g., current participation in psychotherapy)
* Be participating in a tapering BZD protocol, or similar
* Currently receiving an active prescription for any antipsychotic medication
* Using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, diphenhydramine, dimenhydrinate)
* Met criteria for a substance use disorder in the last six months (other than nicotine and hypnotics)
* Use of alcohol or cannabis 3 or more nights a week for sleep problems
* Drinking more than 3 alcoholic beverages per day
* Presence of another untreated sleep disorder (e.g., obstructive sleep apnea or periodic limb movements during sleep)
* Presence of major depression or other severe unstabilized psychopathology (e.g., bipolar disorder, psychosis, panic disorder, generalized anxiety disorder, posttraumatic stress disorder, specific phobia, social phobia, or obsessive-compulsive disorder)
* Had a history of psychosis
* Currently suicidal
* Current crisis or with an illness for which the benzodiazepine were required at the time (e.g. acute pain)
* Presence of terminal illness (e.g. cancer, receiving palliative care)
* Unstable cardiovascular, respiratory or endocrinological diseases (clinical interview)
* Had a history of severe cognitive impairment, dementia, seizure disorder (epilepsy either in themselves or in their family), spinal injury
* Pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04751851
Study Brief:
Protocol Section:
NCT04751851