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临床试验/NCT04186507
NCT04186507Unknown不适用

Indirect Evaluation of Lithium Level in Blood Using Non-invasive Sweat Biosensors

Tirat Carmel Mental Health Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
1
主要终点
Lithium sweat concentration

研究概览

简要总结

Indirect evaluation of the accuracy and the efficacy of biosensors developed for Li+ detection in sweat.

详细描述

Lithium (Li+) is one of the most widely used and studied medications for treating of Bipolar Mood Disorder, resistant cases of Major Psychiatric Disorders and especially Major Depressive Disorder.

After administration, more than 95% of administered dose of Li+ is eliminated unchanged in the urine, less than 5% - in the saliva, sweat, and feces. Up to 40% of patients that are on Li+ therapy encounter adverse effects that can be explained by drug involvement in various biochemical processes. Li+ efficacy and side effect manifestation are obviously determined by the drug concentration in blood. The optimal way to prevent manifestation of side effects is to control that Li+ serum level is within therapeutic range. A blood test is often ordered to monitor the serum level of Li+ to ensure target serum levels are reached. The available methods for blood Li+ are invasive, time consuming, and cause of discomfort for patients, yet are of a great importance as levels of drug in blood outside the therapeutic range may dramatically affect patient health. It is especially of importance for Li+ treatments it has a narrow therapeutic window - 0.6-1.5 mmol/L. Thus, there is a growing need for a reliable, comfortable, and inexpensive method for detection of Li+ in blood that can be performed easily in an in-patient setting and automatically whenever necessary without the need for a clinic visit out-patient setting.

Spectrophon LTD has developed an algorithm that allows calculation of levels of various compounds contained in sweat using standard PPG sensors with special coating and thus to estimate the levels of corresponding chemicals in the bloodstream. This algorithm has proven useful and accurate in clinical trials on detection of dehydration level, blood sodium level, and blood glucose level. We suggest that Spectrophon biosensors can be used to detect the levels of Li+ in sweat that will allow non-invasive estimation of the level of corresponding medication in blood in real-time.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meeting Diagnostic and Statistical Manual 5th edition (DSM-V) criteria for MDD, BMD, Schizoaffective Disorder, Schizophrenia;
  • Patients must be on constant Li+ treatment or prior their first drug administration.
  • Ability and willingness to sign an informed consent form for participation in the study.

排除标准

  • Evidence of serious disorder;
  • Unstable chronic disease;
  • Kidney disease
  • Pregnancy;
  • Contraindication for Li+ treatment.

结局指标

主要结局

Lithium sweat concentration

时间窗: 6 month

Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD) will be placed on the right wrist of each participant for a non-invasive measurement of blood Li+ level.

次要结局

未报告次要终点

研究者

发起方
Tirat Carmel Mental Health Center
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anatoly Kreinin, MD, PHD

Head of Psychiatric Department , Clinical Assistant Professor Anatoly Kreinin, MD, PHD, MHA

Tirat Carmel Mental Health Center

研究点 (1)

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