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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT06435520
Eligibility Criteria:
Inclusion Criteria:
* a history of extended (\> 6 consecutive months) and frequent (\>5 nights/week on average) use of benzodiazepine (BZD) or non-BZD hypnotic medications;
* a desire to decrease/eliminate hypnotic use;
* a history of insomnia that meets DSM-560 criteria for insomnia disorder; and
* willingness to provide written informed consent to participate.
Exclusion Criteria:
* a lifetime diagnosis of any psychotic disorder, suicide attempts, or bipolar disorder;
* presence of an unstable, untreated, or terminal major medical or psychiatric disorder;
* alcohol or drug abuse within the past year;
* current use of a BZD for another disorder in addition to insomnia (e.g., seizure disorder, restless leg syndrome, anxiety disorder);
* pregnancy;
* significant cognitive impairment as suggested by a score of ≤ 24 on the Folstein Mini-Mental State Examination (MMSE);
* current use of medications known to cause insomnia (e.g., high dose corticosteroids);
* untreated comorbid sleep disorders;
* use of a sedating antidepressant or antipsychotic medication solely for sleep; and
* consuming \>2 alcoholic beverages/day ≥5 times/week or any use of marijuana ≥5 times/week.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06435520
Study Brief:
Protocol Section:
NCT06435520