A Comparison of Exhaled Carbon Monoxide Measurements Using the iCOquit Smokerlyzer and Vitalograph Breath CO Monitor vs Carboxyhemoglobin From Venous Samples While Validating a Mobile Research Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- eCO Monitor Accuracy compared to COHb
研究概览
简要总结
The main objective of this study is to determine the accuracy and precision of the iCOquit Smokerlyzer as compared with the gold standard of COHb levels measured in venous plasma samples, as well as assessing its agreement with the Vitalograph BreathCO monitor. Validating the precision and accuracy of the iCOquit Smokerlyzer could establish an additional, less expensive, reliable method for determining smoking status in tobacco research. Additionally, the portability of the device would allow for remote biochemical verification of smoking status, thus enlarging the number of participants that can be included in intervention studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has signed the ICF and is able to read and understand the information provided in the ICF.
- •Is 21 to 65 years of age (inclusive) at screening.
- •No intention of quitting smoking in the next 30 days.
- •Willing and able to comply with the requirements of the study.
- •Owns a smartphone running iOS or Android with text message and data capabilities compatible with the eResearch app.
排除标准
- •Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigators or designated medical staff based on all available assessments from the screening period (e.g., vital signs, physical examination, concomitant medications and medical history).
- •PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts you would be better off dead, or of hurting yourself in some way") at screening.
- •Body mass index (BMI) greater than 40.0 kg/m2
- •Use of any of these products in the past 30 days:
- •Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates),
- •Experimental (investigational) drugs that are unknown to participant,
- •Chronic opioid use.
- •Pregnant or nursing (by self-report) or positive urine pregnancy test.
- •Participant enrollment numbers met.
结局指标
主要结局
eCO Monitor Accuracy compared to COHb
时间窗: Baseline
Determine the accuracy and precision of the iCOquit Smokerlyzer as compared with the gold standard of COHb levels measured in venous plasma samples.
eCO Monitor's agreement with the Vitalograph BreathCO monitor
时间窗: Baseline
Comparing the CO values from the eCO Monitor and the Vitalograph BreathCO monitor.
次要结局
- eRESEARCH APP VALIDATION(Daily for 5 days)