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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00900159
Eligibility Criteria:
Inclusion Criteria:
* Age 20-50 (men or women)
* Current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive)
* A willingness and ability 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, or injected) in conjunction with a barrier method, or intrauterine device \[IUD\]).
Exclusion Criteria:
* Current diagnosis of DSM-IV Axis I disorder (other than insomnia)
* Regular treatment (\>1time/wk) with CNS-active medication within 1 month of first inpatient visit
* Uncontrolled medical illness that would interfere with participation in the study
* BMI\>32 or \< 19.8 kg/m2
* Current symptoms or diagnosis of any moderate to severe sleep disorder other than SWSD
* Periodic Leg Movement of Sleep Index (PLMSi)\>20/hr of sleep or Respiratory Desaturation Index (RDI)\>15 on polysomnography (PSG)
* Current alcohol or drug dependence/abuse
* Menopausal or peri-menopausal symptoms that disrupt sleep
* Pregnant, lactating, or planning to become pregnant
* Current smoking of more than 10 cigarettes per day
* Current use of over the counter sleep aids such as Benadryl or melatonin
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT00900159
Study Brief:
Protocol Section:
NCT00900159