Acute Effects of Whole Body Blue Light Exposure on Blood Pressure

Acute Effects of Whole Body Blue Light Exposure on Blood Pressure, Endothelial Function and Vascular Stiffness

Ultraviolet light exposure was shown to be able to release nitric oxide from the skin into the blood stream and lead to an acute decrease in blood pressure and increase in vascular function. Additionally, preliminary work indicates that UV free blue light also releases nitric oxide in the skin mediating similar effects as seen with ultraviolet light A(UVA). It is the goal of the present experimental study to investigate the hemodynamic effects of whole body blue light exposure including blood pressure, endothelial function and vascular stiffness. Therefore, healthy volunteers will be exposed to 30 minutes whole body blue light (453 nm wavelength) and the change in blood pressure and endothelial function (Flow mediated dilation (FMD)), heart rate, forearm-blood flow, forearm vascular resistance central blood pressure and vascular stiffness ( pulse wave analysis by sphygmocor) will be measured.

In this randomized controlled cross-over study, 20 healthy subjects aged 30 to 60 years will participate.

Study Overview

• Status: Completed
• Conditions: Blue Light
• Intervention / Treatment: Procedure: Blue light; Procedure: control exposure

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Düsseldorf, NRW, Germany, 40225
      • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• healthy, male subjects
• age between 30 and 60 years
• signed patient informed consent

Exclusion Criteria:

• diabetes mellitus
• acute inflammation (CRP >0.5mg/dl)
• cardiac arrythmia
• active cancer
• renal failure
• heart failure (NYHA II-IV)
• arterial hypotension (systolic pressure <100 mmHg)
• treatment with antihypertensive drugs
• dermatosis of the eyelid
• porphyria or hypersensitivity to porphyrins
• congenital or aсquired immune deficiency
• genetic conditions that cause an increased sensitivity to light or an increased risk to dermatological cancer (such as xeroderma pigmentosum, cockayne syndrome, bloom syndrome)
• previous intake or use of photosensitizing drugs, food or cosmetics (e.g. psychiatric medication, antibiotics, cardiovascular drugs, hormone, Hypericum, Bergamot orange) or use of perfumes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue light; Each subject will be undergo a whole body exposure to blue light (453 nm wavelength) for 30 minutes.	Procedure: Blue light; Subjects will be exposed to blue light (453 nm wavelength) for 30 minutes
Placebo Comparator: Control exposure; Each participant will also undergo a control examination, where the body will be covered with a light tight foil during blue light exposure for 30 minutes.	Procedure: control exposure; Subjects will get control exposure to 30 minutes of whole body, which causes only comparable warming of skin as with blue light exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of peripheral blood pressure	Change of peripheral blood pressure as measured before, during and up to 2 hours after 30 min blue light as compared to control	baseline, during 30 min exposure and 2 hours thereafter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in endothelial function	measured by flow mediated dilation (FMD) before, immediately after 30 min exposure and at 2 h thereafter	baseline, during 30 min exposure and 2 hours thereafter
Change from baseline heart rate	measured by electrocardiography (ECG) before, during and up to 2 hours after 30 min blue light as compared to control	baseline, during 30 min exposure and 2 hours thereafter
Change from baseline forearm blood flow	measured by ultrasound before, immediately after 30 min exposure and at 2 h thereafter	baseline, during 30 min exposure and 2 hours thereafter
Change from baseline forearm vascular resistance	measured by ultrasound before, immediately after 30 min exposure and at 2 h thereafter	baseline, during 30 min exposure and 2 hours thereafter
Change from baseline central blood pressure	measured by applanation tonometry before, immediately after 30 min exposure and at 2 h thereafter	baseline, during 30 min exposure and 2 hours thereafter
Change from baseline vascular stiffness	measured by applanation tonometry before, immediately after 30 min exposure and at 2 h thereafter	baseline, during 30 min exposure and 2 hours thereafter
Change from baseline NO-species	determined by chemiluminescence before, immediately after 30 min exposure and at 2 h thereafter	baseline, during 30 min exposure and 2 hours thereafter
Change from baseline Cortisol	measured before, immediately after 30 min exposure and at 2 h thereafter	baseline, during 30 min exposure and 2 hours thereafter
Change from baseline Endorphins	measured before, immediately after 30 min exposure and at 2 h thereafter	baseline, during 30 min exposure and 2 hours thereafter

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Philips GmbH, Innovative Technologies, Aachen; Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf
• Investigators: Principal Investigator: Christian Heiß, MD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: blood pressure; vascular function; endothelial function; health volunteers; blue light
• Other Study ID Numbers: 15-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No