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

Lithium Level Detection in Sweat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04186507
• Other study ID #: TiratCarmelMHC
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2020
• Source: Tirat Carmel Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: July 1, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lithium Level Detection in Sweat

Intervention

Combination Product:
• Smartwatch 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.

Locations

Country	Name	City	State
Israel	Tirat Carmel Mental Health Center	Tirat Karmel	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Tirat Carmel Mental Health Center	Ariel University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lithium sweat concentration	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.	6 month