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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04186507
Enrollment
75
Registered
2019-12-04
Start date
2020-01-01
Completion date
2021-07-01
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lithium Level Detection in Sweat

Keywords

Lithium, Biosensor, Sweat, Major Depressive Disorder, Schizoaffective Disorder, Bipolar Mood Disorder, Schizophrenia

Brief summary

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

Detailed description

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.

Interventions

COMBINATION_PRODUCTSmartwatch with integrated Li+ sensor (provided by Spectrophon LTD)

To confirm that Li+ is detectable in sweat using Macroduct Sweat Collection System for sweat collection. Current studies demonstrate that Li+ can be detected in saliva and in sweat. To confirm it, patients that are on treatment with Li+ will be recruited for this aim; sweat will be collected and checked for Li+ levels. To develop the algorithm for Spectrophon LTD biosensors for Li+ levels measurement in sweat that will allow assessing the level of Li+ in blood. To evaluate the accuracy and the efficacy of biosensors developed by Spectrophon LTD for Li+ detection in sweat. Following positive results in previous objectives, clinical trial will be conducted to estimate the suitability, efficacy and accuracy of developed biosensors for non-invasive detection of Li+ in sweat.

Sponsors

Ariel University
CollaboratorOTHER
Tirat Carmel Mental Health Center
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Lithium sweat concentration6 monthSmartwatch 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026