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Acute Effects of Whole Body Blue Light Exposure on Blood Pressure

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ClinicalTrials.gov Identifier: NCT03226587
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborators:
Philips GmbH, Innovative Technologies, Aachen
Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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.


Condition or disease Intervention/treatment Phase
Blue Light Procedure: Blue light Procedure: control exposure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Acute Effects of Whole Body Blue Light Exposure on Blood Pressure, Endothelial Function and Vascular Stiffness
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226587


Locations
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Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Philips GmbH, Innovative Technologies, Aachen
Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf
Investigators
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Principal Investigator: Christian Heiß, MD Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf

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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, PD Dr. med. Christian Heiß, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT03226587     History of Changes
Other Study ID Numbers: 15-035
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
blue light
blood pressure
vascular function
endothelial function
health volunteers