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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT00256503
Eligibility Criteria:
Inclusion Criteria:
Primary Insomnia (PI) subjects:
* Difficulty falling or staying asleep for 6 or more months as evidenced by (a) 30 or more minutes to fall asleep on 3 or more nights per week, or (b) early morning awakenings \> 30 minutes prior to desired rise time on 3 or more nights per week
* Reported impaired daytime function attributed to insomnia
Good-Sleeper (GS) controls:
* No history of sleep disorders
* No current sleep complaints and/or complaints of daytime fatigue or sleepiness
* Sleep characterized as restorative and relatively "unperturbable"; and will be defined as: 5-15 minutes to fall asleep and no more than two awakenings per night of \> 5 minutes duration
Exclusion Criteria:
* Significant medical or psychiatric illness
* Diagnosed or occult sleep disorders (evident on screening PSG) other than PI
* Hearing or memory impairments
* Non-fluency in spoken or written English
* History of head injury (w/ loss of consciousness) or seizures
* Prescription medication or recreational drug use within 4 weeks of laboratory study
* Tobacco use or consume more than 3 cups of coffee per day (or an equivalent dose of caffeine)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT00256503
Study Brief:
Protocol Section:
NCT00256503