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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT02831894
Eligibility Criteria:
Inclusion Criteria:
1. be currently using one or more BZD or newer BzRA hypnotics at bedtime for insomnia management;
2. have been using one or more such agents at least 5 nights per week for at least the past 12 months;
3. express interest in discontinuing hypnotic use and learning to manage their insomnia without medications;
4. report one or more failed attempts to discontinue hypnotic use in the past;
5. provide written consent to participate.
6. have an insomnia severity index score \> 10 indicating at least mild insomnia symptoms without sleep medication
Exclusion Criteria:
1. an untreated unstable, or "in-treatment" psychiatric disorder (e.g., major depression in psychotherapy or on a medication regimen that has been changed within the past 2 months)
2. a lifetime diagnosis of any psychotic or bipolar disorder
3. an imminent risk for suicide
4. evidence of alcohol or drug abuse (other than hypnotics) within the past year, since such abuse patterns suggest specialized substance abuse treatment may be indicated
5. unstable or terminal physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia) or sleep disruptive medical condition (e.g. chronic pain)
6. current use of medications known to cause insomnia (e.g., corticosteroids)
7. a history or screening evidence of restless legs syndrome, circadian rhythm sleep disorder (e.g., delayed sleep phase syndrome), sleep apnea (AHI \> 5), or periodic limb movement disorder (PLM index \> 15)
8. habitual bedtimes later than 2:00 AM or rising times later than 10:00 AM; (i) consuming \> 2 alcoholic beverages per day at least 5 times per week
9. pregnant women or mothers with care-taking responsibilities for infants due to the sleep-disruption caused by such circumstances.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02831894
Study Brief:
Protocol Section:
NCT02831894