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临床试验/NCT04613609
NCT04613609已完成早期 1 期

Vaporized Nicotine and Autonomic Control

Michigan Technological University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
16
试验地点
2
主要终点
Blood pressure (measured from the finger)

研究概览

简要总结

E-cigarettes are marketed as an alternative to smoking for those who want to decrease the health risks of tobacco. Tobacco cigarettes increase heart rate (HR) and arterial pressure, while reducing muscle sympathetic nerve activity (MSNA) through sympathetic baroreflex inhibition. The acute effects of e-cigarettes on arterial pressure and MSNA have not been reported: our purpose was to clarify this issue. Using a randomized crossover design, participants inhaled on a JUUL containing nicotine (59 mg/ml) and a similar placebo e-cigarette (0 mg/ml).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants were not informed if they were to receive nicotine or placebo

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Individuals with a history of hyperthyroidism
  • Women currently taking oral contraceptives, are pregnant or breast-feeding, or trying to become pregnant
  • Individuals currently taking prescription drugs.
  • Individuals with respiratory illnesses (e.g., asthma, chronic obstructive pulmonary disease, reactive airway disease, etc.)
  • Individuals with hypertension (systolic >130 and/or diastolic > 80).
  • Individuals with a history of tobacco or vaporized nicotine use.
  • Individuals who have been diagnosed with diabetes
  • Individuals who are under the age of 18 or over the age of 40

结局指标

主要结局

Blood pressure (measured from the finger)

时间窗: Experiments were separated by one month. Beat-to-beat arterial pressure was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged.

Effects of electronic cigarettes on both systolic and diastolic arterial pressure.

Muscle sympathetic nerve activity (measured with the microneurography technique)

时间窗: Experiments were separated by one month. MSNA was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged.

Effects of electronic cigarettes on muscle sympathetic nerve activity (MSNA)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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