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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT00156533
Eligibility Criteria:
Inclusion Criteria:
* Ages 25 - 55
* a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m.
* Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD).
* complaint of disturbed sleep must have the following characteristics: \>30 minutes to fall asleep, and/or \>30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of \>4 nights/ week and a problem duration \>6 months.
Exclusion Criteria:
* Unstable medical or psychiatric illness
* Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.)
* symptoms suggestive of sleep disorders other than insomnia
* polysomnographic data indicating sleep disorders other than insomnia
* Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
* inadequate language comprehension
* pregnancy
* first-degree relatives with bipolar disorder or schizophrenia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT00156533
Study Brief:
Protocol Section:
NCT00156533