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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT03194802
Eligibility Criteria:
Inclusion Criteria:
a) \>= 18 years, b) access to high speed internet and computer, c) disturbance of sleep consisting of a delay in sleep onset, return to sleep or early morning awakening at least 3 nights/week for at least 3 months in duration, d) at least one symptom of daytime impairment, use of medication to promote sleep, e) use of medication to promote sleep (either \<= 1mg lorazepam, \<= .5mg clonazepam, \<= 7.5mg zopiclone, \<= 50 mg trazodone/amitriptyline, f) interested in medication tapering.
Exclusion Criteria:
a) shift work, b) head injury, c) acute crisis, d) seizure disorder, e) use of psychotropic drugs for problems other than sleep, f) use of medication interfering with sleep, g) recreational drug use, h) symptoms suggestive of alternative sleep disorder that is untreated, i) elevated use of alcohol (\> 14 beverages/week for males, \>12 beverages per week for females)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03194802
Study Brief:
Protocol Section:
NCT03194802