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Completed

NCT Number: NCT03226587

Acute Effects of Whole Body Blue Light Exposure on Blood Pressure

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.

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Key information

Conditions

Blue Light

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blue light

Procedure

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

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.

Primary outcomes

  1. Change of peripheral blood pressure

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    Change of peripheral blood pressure as measured before, during and up to 2 hours after 30 min blue light as compared to control

Secondary outcomes

  1. Change in endothelial function

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    measured by flow mediated dilation (FMD) before, immediately after 30 min exposure and at 2 h thereafter

  2. Change from baseline heart rate

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    measured by electrocardiography (ECG) before, during and up to 2 hours after 30 min blue light as compared to control

  3. Change from baseline forearm blood flow

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    measured by ultrasound before, immediately after 30 min exposure and at 2 h thereafter

  4. Change from baseline forearm vascular resistance

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    measured by ultrasound before, immediately after 30 min exposure and at 2 h thereafter

  5. Change from baseline central blood pressure

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    measured by applanation tonometry before, immediately after 30 min exposure and at 2 h thereafter

  6. Change from baseline vascular stiffness

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    measured by applanation tonometry before, immediately after 30 min exposure and at 2 h thereafter

  7. Change from baseline NO-species

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    determined by chemiluminescence before, immediately after 30 min exposure and at 2 h thereafter

  8. Change from baseline Cortisol

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    measured before, immediately after 30 min exposure and at 2 h thereafter

  9. Change from baseline Endorphins

    Time frame: baseline, during 30 min exposure and 2 hours thereafter

    measured before, immediately after 30 min exposure and at 2 h thereafter

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf
  • Philips GmbH, Innovative Technologies, Aachen

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2017
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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