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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT05423002
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 - 35 years
* Sex: male or female normal color vision, male dichromat (i.e. tested by CCT, HRR, Farnsworth Munsell 100 Hue Test)
* BMI: 18.5 - 29.9 self-reported weight and height (i.e. normal and overweight according to WHO)
* Signed consent form of participants
* Chronotype: Morningness-Eveningness Questionnaire (31 - 69)
* Sleep Quality: Pittsburgh Sleep Quality Index, PSQI (≤5)
Exclusion Criteria:
* High myopia (\> -6 diopters)
* High hyperopia (\< +6 diopters)
* Transmeridian travel (\>2 time zones) \<1 month prior to the first session of the study
* Shift work \<3 months prior to the beginning of the study
* Ophthalmological or optometric conditions (cataract, glaucoma, retinal detachment, macular conditions, chronic inflammations, eye injuries, or operations)
* General health concerns or disorders, including heart and cardiovascular, neurological, nephrological, endocrinological, and psychiatric conditions
* Medication impacting on visual, neuroendocrine, sleep, and circadian physiology
* For females only: pregnancy, use of hormonal contraceptives, lactation or breastfeeding
* Drug (urinary drug screening) and alcohol use
* Non-compliance with sleep-wake times: \>1 deviation from ±30 minute window sleep and wake-up time
* Extreme chronotype (Munich Chronotype Questionnaire \<2 or \>7)
* Current participation in other clinical trials
Exclusion criteria due to study requirements:
* Inability to understand and/or follow study materials or procedures
* Insufficient knowledge of project language
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05423002
Study Brief:
Protocol Section:
NCT05423002