EFFECTS AND UNDERLYING MECHANISMS OF PHOTOBIOMODULATION (PBM) ON HEALTH AND WELL-BEING

• Conditions: Mood, drowsiness, depressive mood, Energy/Tiredness/Tension/Calmness, sleep parameters, resting heart rate, IFN-gamma, TNF-alpha, TGF-beta1, il-1 & il-6, dim light melatonin onset, cortisol (at bedtime), and metabolomics; health; well-being

• Registration Number: NL-OMON53954
• Lead Sponsor: Seaborough Life Sciences B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 80

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)
• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified