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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT00555750
Eligibility Criteria:
Inclusion Criteria:
* Age 25-55
* Complaint of insomnia of at least 6 months duration
* DSM-IV diagnosis of Primary Insomnia
* Sleep diary: mean Total Sleep Time \< 6 hours and a mean total wake time (sleep latency + wake after sleep onset) of greater than 60 minutes (in previous 14 days as recorded on sleep diary)
* A willingness to comply with study procedures
* If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, and intrauterine device \[IUD\])
Exclusion Criteria:
* Current diagnosis of DSM-IV Axis I disorder other than Primary Insomnia
* Regular treatment (more than 1 time/week) with CNS active medication within 1 month of fist inpatient visit
* Treatment with medications that interfere with glucose metabolism including anti-diabetic medications or steroidal contraceptives
* Uncontrolled medical illness that would interfere with participation in the study
* Body Mass Index \>32 or \<19.8
* Current symptoms or diagnosis of any moderate to severe sleep disorder other than insomnia
* No menopausal or peri-menopausal symptoms that disrupt sleep
* Pregnant, lactating or planning to become pregnant
* Consumption of \> 2 caffeinated beverages per day (including coffee, tea and/or other caffeine-containing beverages or food) during 3 weeks prior to the start of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT00555750
Study Brief:
Protocol Section:
NCT00555750