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Acute Effects of Whole Body Blue Light Exposure on Blood Pressure

NCT ID: NCT03226587

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blue Light

Keywords

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blue light blood pressure vascular function endothelial function health volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Blue light

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

Group Type EXPERIMENTAL

Blue light

Intervention Type PROCEDURE

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

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.

Group Type PLACEBO_COMPARATOR

control exposure

Intervention Type PROCEDURE

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

Interventions

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Blue light

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Philips GmbH, Innovative Technologies, Aachen

UNKNOWN

Sponsor Role collaborator

Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf

UNKNOWN

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

PD Dr. med. Christian Heiß

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Heiß, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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15-035

Identifier Type: -

Identifier Source: org_study_id