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临床试验/NCT04071145
NCT04071145Unknown不适用

Using Sensors to Measure Drug Concentrations in Exhaled Breath

Nadav Goldental0 个研究点目标入组 100 人开始时间: 2019年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Correlation between drug concentration and volatile organic compounds VOC concentrations

研究概览

简要总结

The use of blood tests to measure drug concentrations in psychiatric patients is often a crucial part of monitoring and evaluating the course of treatment. Such tests are commonly conducted as part of official protocols, and patients are often tested on a weekly basis.

The current study aims to examine the possibility of using a novel, non-invasive device to measure drug concentrations in exhaled breath as an alternative to blood tests. The device, SniffPhone, uses sensors to detect and measure volatile organic compounds (VOCs) in exhaled breath, and features a small and portable design. Sniff Phone has been previously approved for use in clinical trials and has been used successfully to screen for particular types of cancer and other diseases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Proper ability to give informed consent
  • Psychiatric patients undergoing treatment at Sheba Medical Center
  • Patients with treatment plans that require therapeutic drug monitoring

排除标准

  • Involuntary psychiatric hospitalization
  • Pregnancy

结局指标

主要结局

Correlation between drug concentration and volatile organic compounds VOC concentrations

时间窗: Up to 6 months

Correlation between drug concentration (as measured in blood test) and VOCs (hexanone acetic acid, heptane, hexanal, 3-heptanone, hexanoic acid, heptanal and nonanal) measured using Sniff Phone.

Detection of drug type and concentration in volatile organic compounds (VOCs) profile

时间窗: Up to 6 months

Detection of drug type and concentration in VOCs profile (measured using Sniff Phone)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nadav Goldental

Principal investigator

The Chaim Sheba Medical Center

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