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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT04406103
Eligibility Criteria:
Inclusion Criteria:
* residents of New Brunswick, Canada
* age 65 or older
* English speaking
* community dwelling with no anticipated change of address for the next 6 months
* current user of BZRAs (3 or more bedtime doses in previous 7 days)
* long-term user of BZRA: use 3 months or longer
* BZRA indication: insomnia.
Exclusion Criteria:
* using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, melatonin, diphenhydramine, dimenhyrdinate)
* use of alcohol or cannabis 3 or more nights a week for sleep problems
* diagnosis of other sleep disorders: sleep terrors, sleep apnea, restless legs syndrome, narcolepsy, sleepwalking
* severe anxiety disorder
* obsessive compulsive disorder
* severe cognitive impairment
* dementia
* seizure disorder
* spinal injury
* chronic psychotic disorder (e.g., schizophrenia)
* bipolar disorder
* cancer
* receiving palliative care
* living in a Long Term Care facility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04406103
Study Brief:
Protocol Section:
NCT04406103