Lithium Level Detection in Sweat Clinical Trial
Official title:
Indirect Evaluation of Lithium Level in Blood Using Non-invasive Sweat Biosensors
Indirect evaluation of the accuracy and the efficacy of biosensors developed for Li+ detection in sweat.
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.
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