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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT00380003
Eligibility Criteria:
Inclusion Criteria:
* must have a diagnosis of primary insomnia
* over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
* must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period
* must be willing and able to complete a sleep diary and questionnaires
Exclusion Criteria:
* must not have a clinically significant or unstable medical condition that may interfere with sleep
* must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder
* must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants
* must not intentionally nap 3 (or more) times per week
* must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
64 Years
Study:
NCT00380003
Study Brief:
Protocol Section:
NCT00380003