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 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT01259895
Eligibility Criteria:
Inclusion Criteria:
* obese (BMI\>30) and normal weight (BMI between 19 and 24,9)
* regular time of sleep between 6.5 and 8 hours
Exclusion Criteria:
* self-reported sleep problems (Pittsburgh Sleep Quality Index score \>5);
* Obstructive sleep apnea (AHI \> 5 in polysomnography)
* night work;
* variable sleep habits or habitual daytime naps;
* regular physical exercise (\>3 hours/week);
* excessive intake of alcohol (\>7 drinks/week);
* excessive intake of caffeine (\>300 mg/day);
* smoking;
* substance abuse;
* use of prescription medications or over-the-counter drugs affecting sleep or metabolism;
* chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, etc.)
* history of neurological, medical or sleep disorders;
* trans-meridian travelling the last month;
* chronotype: extreme morning or extreme evening
* unable to comply with the protocol.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT01259895
Study Brief:
Protocol Section:
NCT01259895