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 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT01196650
Eligibility Criteria:
Inclusion Criteria:
* Subjects between the ages of 18 and 65 years of age
* Subjects that meet DSM IV diagnostic criteria for Insomnia
* Subjects that report a time in bed NLT 6.5 and NMT 9 hours
* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours
* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep \>1.0 hour
* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset
* On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes
* On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes
* On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights
Exclusion Criteria:
* Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study
* Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
* Subject with a history (past year) of alcohol or substance abuse
* Subject that needs to smoke during the sleep period time
* Subject that reports habitual napping (more than 3 times per week)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01196650
Study Brief:
Protocol Section:
NCT01196650