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

October 6, 2020 updated by: Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center
Indirect evaluation of the accuracy and the efficacy of biosensors developed for Li+ detection in sweat.

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Haifa
      • Tirat Karmel, Haifa, Israel, 30200
        • Tirat Carmel Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Psychiatric Inpatients with MDD, BMD, Schizoaffective Disorder, Schizophrenia.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prelaminary group
To confirm that Li+ is detectable in sweat .
Spectrophon LTD biosensors for Li+ detection in sweat
In this group will be conducted to estimate the suitability, efficacy and accuracy of developed biosensors for non-invasive detection of Li+ in sweat

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.

Other Names:
  • Drug: Lithium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lithium sweat concentration
Time Frame: 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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

January 31, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (ACTUAL)

December 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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