Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 1 of 7)

University of Bern

Status: Completed

Conditions: Exposure to Man-made Visible Light

Treatments: Other: Visible light exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT02882516

COLOR10_a

Details and patient eligibility

About

NOTE: This is the first of in total 7 sub-studies related to the Ethics Committee of the Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 5 arms, in total 350 participants will be assessed in all 7 sub-studies.

General study information: This is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. Primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. The risk for the participants is negligible and comparable to the risk during daily life.

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal color vision
• Right handed
• Written informed consent

Exclusion criteria

• Smoking
• Any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months
• Acute severe traumas
• Chronic diseases with the necessity for medication
• Use of recreational drugs
• Regular intake of medication that would affect the outcome measures
• Regular excessive alcohol use (> 18 standard units / week)
• Transmeridian travel in the last month (crossed > 1 time zone border)
• Night shift word during the last month

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 5 patient groups

Visible light exposure Red 30 lux

Experimental group

Description:

The participants will be exposed to red LED light at a illuminance of 30 lux at eye level for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.

Treatment:

Other: Visible light exposure

Visible light exposure Red 120 lux

Experimental group

Description:

The participants will be exposed to red LED light at a illuminance of 120 lux at eye level for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.

Treatment:

Other: Visible light exposure

Visible light exposure Blue 30 lux

Experimental group

Description:

The participants will be exposed to blue LED light at a illuminance of 30 lux at eye level for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.

Treatment:

Other: Visible light exposure

Visible light exposure Blue 120 lux

Experimental group

Description:

The participants will be exposed to blue LED light at a illuminance of 120 lux at eye level for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.

Treatment:

Other: Visible light exposure

darkness

No Intervention group

Description:

The participants will not be exposed to any light but stay in darkness for 15 minutes. The colored light exposure will be preceded by sitting 8 minutes in darkness and followed by sitting 20 minutes in darkness.