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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT05317559
Eligibility Criteria:
Inclusion Criteria:
* healthy adults
* ages 18-40 years
* habitual sleep duration of 6.5-8.5 hours
* habitual sleep onset of 9:00 pm-1:00 am
Exclusion Criteria:
* any sleep disorder as assessed by history and screening questionnaires for obstructive sleep apnea (Berlin) and excessive daytime sleepiness (ESS \>12), and by PSG to exclude sleep apnea (apnea hypopnea index ≥ 15), periodic leg movements (movement arousal index ≥ 15), or REM sleep behavior disorder;
* history of a cognitive or neurological disorder;
* history of a major psychiatric disorder, including but not limited to mood/anxiety, eating, and alcohol/substance abuse disorders;
* depressed mood (Beck Depression Inventory II score ≥ 20);
* diabetes or other endocrine disorders;
* any gastrointestinal disease requiring dietary adjustment;
* blindness or significant vision loss;
* any unstable or serious medical conditions;
* current or recent (within the past month) of psychoactive, hypnotic, stimulant or analgesic medications;
* shift work or other types of self-imposed irregular sleep schedules;
* obesity (body mass index \> 30 kg/m2);
* history of habitual smoking (6 or more cigarettes per week) or drinking (7 or more alcoholic beverages per week) or caffeine consumption greater than 300 mg per day;
* current use of light therapy;
* use of any other legal or illicit substance that may affect sleep and/or appetite;
* allergy to heparin.
* Due to the metabolic stress associated with pregnancy and breastfeeding, patients who were pregnant or breastfeeding were also excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05317559
Study Brief:
Protocol Section:
NCT05317559