Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change from baseline in blood flow after smoking
研究概览
简要总结
Heated tobacco products (HTP) are devices which heat, but not burn tobacco. They do not produce cigarette smoke but rather an aerosol. HTPs are marketed as less harmful alternatives to smoking. Use and awareness of these devices have grown exponentially in recent years, with probably millions of people currently using them. There is very little literature about them, so it is quite important to study the effects caused on the human body by these products.
The benefits and risks of HTP use are uncertain. There is no research on the acute oral effects of HTPs in the scientific literature.
详细描述
Measurements of acute oral effects before and after using HTP with bland flavour (HEETS Bronze Selection), with methol flavour (HEETS Blue Selection), conventional cigarette and placebo device:
measurement of exhaled CO changes by Smokerlyzer piCO measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution (LASCA method) measurement of blood pressure and pulse by an automatic blood pressure monitor (Omron M2, Omron Healthcare Inc., Kyoto, Japan)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 18-49 years
- •signed consent form
- •smoking regularly heated tobacco product and/or conventional cigarette for > half year
排除标准
- •not pregnant and not planning pregnancy in the next 6 month BMI index < 30
- •no severe parodontal disease
- •no acute illness in the last 2 weeks
- •no chronic disease (eg.: diabetes)
结局指标
主要结局
Change from baseline in blood flow after smoking
时间窗: baseline, immediately after smoking, and 15 minutes after smoking
The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline), immediately after, and 15 minutes after smoking.
次要结局
未报告次要终点