Nicotine DependenceNCT04645914
Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation
A study testing Use of nicotine product (smoking/vaping) in people with Nicotine Dependence and Vaping, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The survey participants are divided into a smoking and non-smoking group. The smoker group is further divided according to the quantity and quality of nicotine ("normal" smoking, vaping). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Vaping, Smoking
- What is being tested?
- Use of nicotine product (smoking/vaping)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jul 2020to 1 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult non-smokers, smokers, vapers
Who cannot join
- Adults with cardiopulmonary diseases
- Pregnant women
- Adults that participating in other surveys
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
Andreas Kyriakou, 01636915011, andreaskyr93@gmail.com
Andreas Kyriakou, MD
About this study
Official title: Laser Speckle Contrast Analysis to Evaluate the Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation
The survey participants are divided into a smoking and non-smoking group. The smoker group is further divided according to the quantity and quality of nicotine ("normal" smoking, vaping). After reaching a steady state, the cutaneous blood flow at rest in the extremities of all participants is determined by Laser Doppler Imaging as a reference value. Laser Doppler Imaging produces images of the blood flow using perfusion units (PU). Subsequently, the perfusion is measured again after smoking/vaping. The difference in skin perfusion of the extremities is calculated (δ-Perfusion). All measurements are performed under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the patients.
Read the detailed description
After consenting to the study, the subjects are examined using Laser Doppler Camera.
The skin blood flow of the extremities is determined as a reference value. Laser Doppler Imaging produces images of the blood flow using the perfusion units (PU).
All measurements are taken under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the subjects.
For smokers or vapers, the perfusion is measured again after consuming a cigarette or an e-cigarette respectively. The difference of blood flow after smoking or vaping is calculated using both measures.
The total duration of the study per subject is approximately 25-30 minutes.
- Conditions
- Nicotine Dependence, Vaping, Smoking
- Being tested
- Use of nicotine product (smoking/vaping)
- Keywords
- Perfusion, Laser Speckle Contrast Analysis, Laser Doppler Camera, Nicotine, Smoking, Vaping
- Medical subject headings
- Tobacco Use Disorder, Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of nicotine product (smoking/vaping)Behavioural
The smokers/vapers are consuming during the study one nicotine product of their own. The dose is the same as each individual is consuming regularly
| Study group | Role | What they receive |
|---|---|---|
| No smokers | No intervention | Healthy subjects who do not consume any nicotine products |
| Smokers/Vapers | Experimental | Healthy subjects who consume nicotine products Receives: Behavioral: Use of nicotine product (smoking/vaping) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion of the extremities for non-smokers, smokers and vapers
The perfusion of the extremities will be measured in Perfusion Units. The Perfusion Units are calculated directly through the Laser Doppler Camera as a result of the examination.
Measured: 30 seconds
Difference of perfusion after smoking/vaping
The perfusion of the extremities will be measured after the consume of cigarettes/electronic cigarettes in Perfusion Units. The difference between the results of the examination before and after the consume of cigarettes/electronic cigarettes will be measured in Perfusion Units.
Measured: 30 seconds
Secondary outcomes (3)
Correlation of perfusion with age
The age (years) will be controlled as a possible factor that influence the perfusion. Therefore the results in Perfusion Units measured through Laser Doppler Camera will be statistically analyzed taking into consideration the age in years of each subject.
Measured: 30 seconds
Correlation of perfusion with gender
The gender(male or female) will be controlled as a possible factor that influence the perfusion. Therefore the results in Perfusion Units measured through Laser Doppler Camera will be statistically analyzed taking into consideration the gender of each subject.
Measured: 30 seconds
Correlation of perfusion with quantity of smoking/vaping
The quantity of smoking/vaping (packet years/nicotine quantity for vaping) will be controlled as apossible factor that influence the perfusion. Therefore the results in Perfusion Units measured through Laser Doppler Camera will be statistically analyzed taking into consideration the quantity of smoking of each related subject.
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start2 Jul 2020
- Primary completion30 May 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups : consumers of cigarettes/e-cigarettes and non consumers of cigarettes/e-cigarettes
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Kyriakou, University Hospital Muenster
- Investigators
- Andreas Kyriakou, MD, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645914
- Sponsor's protocol ID
- Laser Doppler Camera Study 1
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2020
- Last updated
- 27 Nov 2020
- 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 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Speckle Contrast Analysis to Evaluate the Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation
- ClinicalTrials.gov ID
- NCT04645914
- Acronym / sponsor ID
- Laser Doppler Camera Study 1
- Conditions
- Nicotine Dependence, Vaping, Smoking
- Keywords
- Perfusion, Laser Speckle Contrast Analysis, Laser Doppler Camera, Nicotine, Smoking, Vaping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 27 Nov 2020 (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.
The survey participants are divided into a smoking and non-smoking group. The smoker group is further divided according to the quantity and quality of nicotine ("normal" smoking, vaping). After reaching a steady state, the cutaneous blood flow at rest in the extremities of all participants is determined by Laser Doppler Imaging as a reference value. Laser Doppler Imaging produces images of the blood flow using perfusion units (PU). Subsequently, the perfusion is measured again after smoking/vaping. The difference in skin perfusion of the extremities is calculated (δ-Perfusion). All measurements are performed under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the patients.
Detailed description
After consenting to the study, the subjects are examined using Laser Doppler Camera.
The skin blood flow of the extremities is determined as a reference value. Laser Doppler Imaging produces images of the blood flow using the perfusion units (PU).
All measurements are taken under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the subjects.
For smokers or vapers, the perfusion is measured again after consuming a cigarette or an e-cigarette respectively. The difference of blood flow after smoking or vaping is calculated using both measures.
The total duration of the study per subject is approximately 25-30 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups : consumers of cigarettes/e-cigarettes and non consumers of cigarettes/e-cigarettes
| Arm | Type | Receives |
|---|---|---|
| No smokers | No intervention | –Healthy subjects who do not consume any nicotine products |
| Smokers/Vapers | Experimental | Behavioral: Use of nicotine product (smoking/vaping)Healthy subjects who consume nicotine products |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult non-smokers, smokers, vapers
Key exclusion criteria (3 listed)
- Adults with cardiopulmonary diseases
- Pregnant women
- Adults that participating in other surveys
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 |
|---|---|---|
| Use of nicotine product (smoking/vaping)The smokers/vapers are consuming during the study one nicotine product of their own. The dose is the same as each individual is consuming regularly | Behavioural | Smokers/Vapers |
Primary outcome
Perfusion of the extremities for non-smokers, smokers and vapers
Time frame: 30 seconds
The perfusion of the extremities will be measured in Perfusion Units. The Perfusion Units are calculated directly through the Laser Doppler Camera as a result of the examination.
Difference of perfusion after smoking/vaping
Time frame: 30 seconds
The perfusion of the extremities will be measured after the consume of cigarettes/electronic cigarettes in Perfusion Units. The difference between the results of the examination before and after the consume of cigarettes/electronic cigarettes will be measured in Perfusion Units.
3 secondary outcomes
Correlation of perfusion with age
Time frame: 30 seconds
Correlation of perfusion with gender
Time frame: 30 seconds
Correlation of perfusion with quantity of smoking/vaping
Time frame: 30 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- 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.
Andreas Kyriakou, MD principal investigator
University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of nicotine product (smoking/vaping) in people with Nicotine Dependence and Vaping, run by University Hospital Muenster 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Nov 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Kyriakou, MD (00491636915011, andreaskyr93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion of the extremities for non-smokers, smokers and vapers (time frame: 30 seconds). The study lists 2 primary outcomes in all. 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 27 Nov 2020.