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Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation

Primary Purpose

Nicotine Dependence, Vaping, Smoking

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Use of nicotine product (smoking/vaping)
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Dependence focused on measuring Perfusion, Laser Speckle Contrast Analysis, Laser Doppler Camera, Nicotine, Smoking, Vaping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adult non-smokers, smokers, vapers

Exclusion Criteria:

  • Adults with cardiopulmonary diseases
  • Pregnant women
  • Adults that participating in other surveys

Sites / Locations

  • University Hospital MuensterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No smokers

Smokers/Vapers

Arm Description

Healthy subjects who do not consume any nicotine products

Healthy subjects who consume nicotine products

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 15, 2020
Last Updated
November 22, 2020
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT04645914
Brief Title
Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation
Official Title
Laser Speckle Contrast Analysis to Evaluate the Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Muenster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Vaping, Smoking
Keywords
Perfusion, Laser Speckle Contrast Analysis, Laser Doppler Camera, Nicotine, Smoking, Vaping

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups : consumers of cigarettes/e-cigarettes and non consumers of cigarettes/e-cigarettes
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind through randomization
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No smokers
Arm Type
No Intervention
Arm Description
Healthy subjects who do not consume any nicotine products
Arm Title
Smokers/Vapers
Arm Type
Experimental
Arm Description
Healthy subjects who consume nicotine products
Intervention Type
Behavioral
Intervention Name(s)
Use of nicotine product (smoking/vaping)
Intervention Description
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
Primary Outcome Measure Information:
Title
Perfusion of the extremities for non-smokers, smokers and vapers
Description
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.
Time Frame
30 seconds
Title
Difference of perfusion after smoking/vaping
Description
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.
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
Correlation of perfusion with age
Description
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.
Time Frame
30 seconds
Title
Correlation of perfusion with gender
Description
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.
Time Frame
30 seconds
Title
Correlation of perfusion with quantity of smoking/vaping
Description
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.
Time Frame
30 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult non-smokers, smokers, vapers Exclusion Criteria: Adults with cardiopulmonary diseases Pregnant women Adults that participating in other surveys
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Kyriakou, MD
Phone
00491636915011
Email
andreaskyr93@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Oberhuber, Univ.-Prof.
Phone
00492518345782
Email
alexander.oberhuber@ukmuenster.-de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Kyriakou, MD
Organizational Affiliation
University Hospital Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Muenster
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Kyriakou
Phone
01636915011
Email
andreaskyr93@gmail.com
First Name & Middle Initial & Last Name & Degree
Andreas Kyriakou, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation

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