Lithium Level Detection in SweatNCT04186507
Indirect Evaluation of Lithium Level in Blood Using Non-invasive Sweat Biosensors
An observational study of Lithium Level Detection in Sweat, run by Tirat Carmel Mental Health Center at 1 site in Israel.
Trial summary
Indirect evaluation of the accuracy and the efficacy of biosensors developed for Li+ detection in sweat. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lithium Level Detection in Sweat
- What is being tested?
- Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD)
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2020to 1 Jul 2021
- How long will I take part?
- 6 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psychiatric Inpatients with MDD, BMD, Schizoaffective Disorder, Schizophrenia.
Who may be able to join
- 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.
Who cannot join
- Evidence of serious disorder;
- Unstable chronic disease;
- Kidney disease
- Pregnancy;
- Contraindication for Li+ treatment.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tirat Carmel Mental Health Center
Tirat Carmel, Haifa District, 30200
About this study
Indirect evaluation of the accuracy and the efficacy of biosensors developed for Li+ detection in sweat.
Read the 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.
- Conditions
- Lithium Level Detection in Sweat
- Being tested
- Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD)
- Keywords
- Lithium, Biosensor, Sweat, Major Depressive Disorder, Schizoaffective Disorder, Bipolar Mood Disorder, Schizophrenia
- Medical subject headings
- Depressive Disorder, Major, Psychotic Disorders, Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD)Combination product
Also called Drug: Lithium
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lithium Level Detection in SweatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 75 participants (estimated)
- Target duration
- 6 Days
Sponsor and investigators
- Lead sponsor
- Tirat Carmel Mental Health Center
- Sponsor type
- Other government
- Collaborators
- Ariel University
- Responsible party
- Principal investigator, Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186507
- Sponsor's protocol ID
- TiratCarmelMHC
- Status last verified
- Oct 2020
- First submitted
- 2 Dec 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Evaluation of Lithium Level in Blood Using Non-invasive Sweat Biosensors
- ClinicalTrials.gov ID
- NCT04186507
- Acronym / sponsor ID
- TiratCarmelMHC
- Conditions
- Lithium Level Detection in Sweat
- Keywords
- Lithium, Biosensor, Sweat, Major Depressive Disorder, Schizoaffective Disorder, Bipolar Mood Disorder, Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tirat Carmel Mental Health CenterOther government
- Collaborators
- Ariel University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prelaminary group | – | –To confirm that Li+ is detectable in sweat . |
| Spectrophon LTD biosensors for Li+ detection in sweat | – | Combination Product: Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD)In this group will be conducted to estimate the suitability, efficacy and accuracy of developed biosensors for non-invasive detection of Li+ in sweat |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric Inpatients with MDD, BMD, Schizoaffective Disorder, Schizophrenia.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Evidence of serious disorder;
- Unstable chronic disease;
- Kidney disease
- Pregnancy;
- Contraindication for Li+ treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD)Also: Drug: LithiumTo 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. | Combination product | Spectrophon LTD biosensors for Li+ detection in sweat |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lithium Level Detection in Sweat, run by Tirat Carmel Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lithium sweat concentration (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.