Blue LightNCT03226587
Acute Effects of Whole Body Blue Light Exposure on Blood Pressure
A study testing Blue light in people with Blue Light, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blue Light
- What is being tested?
- Blue light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, male subjects
- age between 30 and 60 years
- signed patient informed consent
Who cannot join
- diabetes mellitus
- acute inflammation (CRP >0.5mg/dl)
- cardiac arrythmia
- active cancer
- renal failure
- heart failure (NYHA II-IV)
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: 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.
- Conditions
- Blue Light
- Being tested
- Blue light, control exposure
- Keywords
- blue light, blood pressure, vascular function, endothelial function, health volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue lightProcedure or surgery
Subjects will be exposed to blue light (453 nm wavelength) for 30 minutes
control exposureProcedure or surgery
Subjects will get control exposure to 30 minutes of whole body, which causes only comparable warming of skin as with blue light exposure.
| Study group | Role | What they receive |
|---|---|---|
| Blue light | Experimental | Each subject will be undergo a whole body exposure to blue light (453 nm wavelength) for 30 minutes. Receives: 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. Receives: Procedure: control exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, during 30 min exposure and 2 hours thereafter
Secondary outcomes (9)
Change in endothelial function
measured by flow mediated dilation (FMD) before, immediately after 30 min exposure and at 2 h thereafter
Measured: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline heart rate
measured by electrocardiography (ECG) before, during and up to 2 hours after 30 min blue light as compared to control
Measured: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline forearm blood flow
measured by ultrasound before, immediately after 30 min exposure and at 2 h thereafter
Measured: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline forearm vascular resistance
measured by ultrasound before, immediately after 30 min exposure and at 2 h thereafter
Measured: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline central blood pressure
measured by applanation tonometry before, immediately after 30 min exposure and at 2 h thereafter
Measured: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline vascular stiffness
measured by applanation tonometry before, immediately after 30 min exposure and at 2 h thereafter
Measured: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline NO-species
determined by chemiluminescence before, immediately after 30 min exposure and at 2 h thereafter
Measured: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline Cortisol
measured before, immediately after 30 min exposure and at 2 h thereafter
Measured: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline Endorphins
measured before, immediately after 30 min exposure and at 2 h thereafter
Measured: baseline, during 30 min exposure and 2 hours thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study startAug 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blue LightStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Philips GmbH, Innovative Technologies, Aachen, Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Christian Heiß, MD, Principal investigator, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226587
- Sponsor's protocol ID
- 15-035
- Status last verified
- Nov 2017
- First submitted
- 22 Jun 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Whole Body Blue Light Exposure on Blood Pressure, Endothelial Function and Vascular Stiffness
- ClinicalTrials.gov ID
- NCT03226587
- Acronym / sponsor ID
- 15-035
- Conditions
- Blue Light
- Keywords
- blue light, blood pressure, vascular function, endothelial function, health volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Philips GmbH, Innovative Technologies, Aachen, Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue light | Experimental | Procedure: Blue lightEach subject will be undergo a whole body exposure to blue light (453 nm wavelength) for 30 minutes. |
| Control exposure | Placebo comparator | Procedure: control exposureEach 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy, male subjects
- age between 30 and 60 years
- signed patient informed consent
Key exclusion criteria (13 listed)
- diabetes mellitus
- acute inflammation (CRP >0.5mg/dl)
- cardiac arrythmia
- active cancer
- renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue lightSubjects will be exposed to blue light (453 nm wavelength) for 30 minutes | Procedure or surgery | Blue light |
| control exposureSubjects will get control exposure to 30 minutes of whole body, which causes only comparable warming of skin as with blue light exposure. | Procedure or surgery | Control exposure |
Primary outcome
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
9 secondary outcomes
Change in endothelial function
Time frame: 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
Change from baseline forearm blood flow
Time frame: 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
Change from baseline central blood pressure
Time frame: 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
Change from baseline NO-species
Time frame: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline Cortisol
Time frame: baseline, during 30 min exposure and 2 hours thereafter
Change from baseline Endorphins
Time frame: baseline, during 30 min exposure and 2 hours thereafter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Heiß, MD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light in people with Blue Light, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of peripheral blood pressure (time frame: baseline, during 30 min exposure and 2 hours thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.