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Over the last decade, e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the user's health. The overall goal of this study is to evaluate the impact of e-cigarettes usage on user's cardiopulmonary health
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-cigarette liquid type 1 | Experimental | Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period. |
|
| E-cigarettes liquid type 2 | Active Comparator | Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period. |
|
| No e-cigarettes | No Intervention | No e-cigarette use |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco flavored liquid type 1 | Drug | A commercially available cartridge-based device with tobacco flavored liquid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak oxygen consumption (VO2 peak) | Participants' peak oxygen consumption (VO2 peak) will be measured using a standardized exercise capacity test performed on a stationary bike. | Change from baseline to 2 weeks |
| Change in Expiratory Volume | Participants expiratory volume will be measured through spirometry using a pulmonary function device. | Change from baseline to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skeletal muscle O2 utilization | Assessment of skeletal muscle oxygen utilization using near-infrared spectroscopy through the ratio of O2 delivery and O2 extraction | Change from baseline to 2 weeks |
| Change in Maximal microvascular dilation |
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Inclusion Criteria:
E-Cigarette group:
Non e-cigarette group
● 21 years of age or older
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Rodriguez Miguelez, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2024 | Feb 24, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| Tobacco flavored liquid type 2 | Drug | A commercially available cartridge-based device with tobacco flavored liquid. |
|
Participants' microvascular function (maximal dilation) will be measured using local thermal hyperemia.
| Change from baseline to 2 weeks |