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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT05619133
Eligibility Criteria:
Inclusion Criteria:
Healthy, no chronic disease
* Age between 25 - 65 years.
* Suffer from daytime sleepiness/drowsiness and or a mild mood disturbance (ESS \>5 or BDI equal to or higher than 13 but lower than 20, PSQI \> 5)
* Participants will have to have a desk type of work and/or have 3 hours per day between 9:30 am and 12:30 at their office/home in which they could sit in front of the lamp.
Exclusion Criteria:
Depressive mood (BDI -II \> 20)
* Pregnancy
* Menopause symptoms
* Drug use during the last three months known to interfere with sleep, alertness, the biological clock and/or light sensitivity (i.e. regular usage of sleep medication or stimulating substances)
* Use of immune suppressants. High levels of caffeine intake during a day (5 or more cups, according to https://www.voedingscentrum.nl/encyclopedie/cafeine.aspx#blok7, there are no negative effects expected from 4 caffeine products in normal adults)
* High alcohol intake (more than 4 for men and more than 3 for women, drinks per day) for more than 5 days in the past month, including binge drinking and heavy drinking according to https://www.niaaa.nih.gov/publications/brochures-and- fact-sheets/alcohol-facts-and-statistics.
* Participant is not able to refrain from using recreational drugs during the 4 weeks of the study.
* Shift work schedule in the 3 months prior to participation and/or planned during the 2 weeks of the study
* Environmental factors in everyday life that may disturb sleep and cannot be prohibited (e.g. young children, noisy environment)
* Travel over 2 or more time zones in the month prior to participation
* Travel to sunny holiday locations/wintersports 1 month before participation
* Personal plans that prevent them for using the intervention during 2 consecutive weeks
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT05619133
Study Brief:
Protocol Section:
NCT05619133