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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT00989534
Eligibility Criteria:
Inclusion Criteria:
* normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women)
* normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women
* no personal history of psychiatric or endocrine illness
* no personal history of sleep disorder, usual total sleep time of at least 7 hours
* only female volunteers with normal ovulatory cycles will be included
Exclusion Criteria:
* subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study)
* subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded
* subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
39 Years
Study:
NCT00989534
Study Brief:
Protocol Section:
NCT00989534