Acute Effects of Whole Body Blue Light Exposure on Blood Pressure

NCT03226587 | Completed

• 1 other identifier: 15-035
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blue Light

Keywords

blue light; blood pressure; vascular function; endothelial function; health volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in endothelial function

  baseline, during 30 min exposure and 2 hours thereafter

• Change from baseline heart rate

  baseline, during 30 min exposure and 2 hours thereafter

• Change from baseline forearm blood flow

  baseline, during 30 min exposure and 2 hours thereafter

• Change from baseline forearm vascular resistance

  baseline, during 30 min exposure and 2 hours thereafter

• Change from baseline central blood pressure

  baseline, during 30 min exposure and 2 hours thereafter

Study Arms (2)

Blue light

EXPERIMENTAL

Each subject will be undergo a whole body exposure to blue light (453 nm wavelength) for 30 minutes.

Procedure: Blue light

Control exposure

PLACEBO COMPARATOR

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

Interventions

Blue light PROCEDURE

Subjects will be exposed to blue light (453 nm wavelength) for 30 minutes

Blue light

control exposure PROCEDURE

Subjects will get control exposure to 30 minutes of whole body, which causes only comparable warming of skin as with blue light exposure.

Control exposure

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Philips GmbH, Innovative Technologies, Aachen: collaborator
• Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf: collaborator

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Interventions

Blue Light

Intervention Hierarchy (Ancestors)

Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Officials

• Christian Heiß, MD

  Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Christian Heiß

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 24, 2017
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)