Acute Effects of Whole Body Blue Light Exposure on Blood Pressure

November 8, 2017 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline, during 30 min exposure and 2 hours thereafter

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline, during 30 min exposure and 2 hours thereafter
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
baseline, during 30 min exposure and 2 hours thereafter
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
baseline, during 30 min exposure and 2 hours thereafter
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
baseline, during 30 min exposure and 2 hours thereafter
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
baseline, during 30 min exposure and 2 hours thereafter
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
baseline, during 30 min exposure and 2 hours thereafter
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
baseline, during 30 min exposure and 2 hours thereafter
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
baseline, during 30 min exposure and 2 hours thereafter
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
baseline, during 30 min exposure and 2 hours thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heinrich-Heine University, Duesseldorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Philips GmbH, Innovative Technologies, Aachen
Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Heiß, MD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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