DehydrationNCT03229109
Analysis of Sweat Secretion and Body Dehydration Monitoring
A study testing Spectrophon dehydration body monitor in people with Dehydration, run by Tirat Carmel Mental Health Center at 2 sites in Israel.
Trial summary
Monitoring of a person's physical status is a key point for maintaining of "healthy life". Wearable devices provide a unique possibility for real-time monitoring. This study aims to estimate the accuracy of Spectrophon Dehydration Body Monitor (DBM) incorporated in smartwatch Samsung Gear S2 and sport band Samsung… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Spectrophon dehydration body monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 2 sitesIsrael
- Study dates
- 3 May 2017to 27 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: older than 18, both gender.
- Ability and willingness to sign an informed consent form for participation in the study.
Who cannot join
- Presence of cardiologic or vascular disease.
- Evidence of any other serious medical disorder.
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Mental Health Center
Tirat Carmel, Haifa District, 30200
Tirat Carmel Mental Health Center
Tirat Carmel, Haifa District, 30200
About this study
Official title: Spectrophon Dehydration Body Monitor Accuracy Evaluation
Monitoring of a person's physical status is a key point for maintaining of "healthy life". Wearable devices provide a unique possibility for real-time monitoring. This study aims to estimate the accuracy of Spectrophon Dehydration Body Monitor (DBM) incorporated in smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2 by comparing data obtained by DBM with the total weight lost during exertion.
Read the detailed description
Reduced physical activity is considered as a risk factor for obesity, diabetes, cancer and depression. A proper exercise program can mitigate cognitive and physical decline associated with ageing. Existing general guidelines for physical activity are not universal or appropriate for every person. A personalized approach based on a subject age and unique combination of different physiological parameters would serve as a solution for finding optimal training protocols for individuals. Hence, monitoring basic physiological and biochemical parameters and obtaining information reflecting the body metabolic state is necessary for health status estimation to develop the abovementioned personally-oriented training protocols. Dehydration Body Monitor (DBM) developed by Spectrophon L.T.D. can measure sweat lost, salt concentration in sweat, and sweating dynamics, which can be used for personal physical status monitoring. This is important not only for controlling appropriate body hydration level but also for keeping kidneys "healthy". Currently, only few DBM tools are available on the market, so there is a growing need for new effective accurate real-time DBM sensors.
The main objective of current study is to estimate the accuracy of Spectrophon DBM incorporated in smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2. The secondary aim of the study is to evaluate the safety-in-use of Spectrophon DBM.
Tested device:
Name: Dehydration Body Monitor; Source: Spectrophon, L.T.D.; Model: SP-DBM Firmware version: 1.5
- Experimental Design Healthy adults (n=200) in different age and gender groups were recruited for the study. Samsung Gear S2 smartwatch with Spectrophon DBM attached to the bottom of the smartwatch were placed on the right wrist of each participant. At the same time, Samsung Gear Fit2 sport band with Spectrophon DBM attached to the bottom of the band was placed on the left wrist of the participant. Each participant was subjected to moderate physical activity. Data from Samsung Gear S2 and Samsung Gear Fit2 was obtained simultaneously. In parallel, subject weight was also monitored using commercially available digital balancers (Shekel B-200-P).
The evaluation of the measurement accuracy of the Spectrophon DBM was defined as the difference between subject weight change during the exertion (due to sweating and water consumption) and the volume of sweat detected by Spectrophon DBM.
- Procedures: Participants were weighed prior to the experiment (no clothing after maximal drying) and then subjected to physical activity (walking on the treadmill).
Total duration of study: 90 minutes
5.2 Intensity of exercises:
Participants could choose high or low intensity of exertion:
- High: up to 6.5km/h;
- Low: yo to 6.0km/h; 5.3 Data recording: After DBM application was activated, DBM started recording data (sweat rate and total salt in sweat) every 20 sec. and automatically saved results into archive on a mobile phone linked to Samsung Gear S2 or Samsung Gear Fit2 by Bluetooth. Manual recording of data was conducted during breaks Participants were also weighed during each break (no clothing after maximal drying).
5.4. Drinking During the procedure, subjects could drink up to 500 ml of water. The weight of the bottle was measured and recorded after drinking during breaks. The difference was subtracted to the weight loss calculation.
5.5 Restrictions:
In this experiment, the following was avoided:
- Urination during test (empty before T0)
- Weight loss should not exceed 2%
Participants could cancel the experiment at any point of the procedure if desired.
- Conditions
- Dehydration
- Being tested
- Spectrophon dehydration body monitor
- Keywords
- dehydration, spectrophon, device, perspiration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectrophon dehydration body monitorDevice
Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist Receives: Device: Spectrophon dehydration body monitor |
| Group 2 | Experimental | Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist Receives: Device: Spectrophon dehydration body monitor |
| Group 3 | Experimental | Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist Receives: Device: Spectrophon dehydration body monitor |
| Group 4 | Experimental | Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist Receives: Device: Spectrophon dehydration body monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Measurements Grouped by Level or Error
Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start3 May 2017
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
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
- Investigators
- Anatoly Kreinin, MD, PHD, Principal investigator, Bruce Rappaport Medical Faculty, Technion, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229109
- Sponsor's protocol ID
- 04/17
- Status last verified
- Oct 2019
- First submitted
- 5 Jul 2017
- Last updated
- 31 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010 Dec;33(12):e147-67. doi: 10.2337/dc10-9990.
PubMed 21115758Craft LL, Perna FM. The Benefits of Exercise for the Clinically Depressed. Prim Care Companion J Clin Psychiatry. 2004;6(3):104-111. doi: 10.4088/pcc.v06n0301.
PubMed 15361924Sternfeld B, Weltzien E, Quesenberry CP Jr, Castillo AL, Kwan M, Slattery ML, Caan BJ. Physical activity and risk of recurrence and mortality in breast cancer survivors: findings from the LACE study. Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):87-95. doi: 10.1158/1055-9965.EPI-08-0595.
PubMed 19124485Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.
PubMed 16534088Anastasio P, Cirillo M, Spitali L, Frangiosa A, Pollastro RM, De Santo NG. Level of hydration and renal function in healthy humans. Kidney Int. 2001 Aug;60(2):748-56. doi: 10.1046/j.1523-1755.2001.060002748.x.
PubMed 11473658
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrophon Dehydration Body Monitor Accuracy Evaluation
- ClinicalTrials.gov ID
- NCT03229109
- Acronym / sponsor ID
- 04/17
- Conditions
- Dehydration
- Keywords
- dehydration, spectrophon, device, perspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Tirat Carmel Mental Health CenterOther government
- Collaborators
- Ariel University
- Study start
- 3 May 2017 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Posted 31 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Monitoring of a person's physical status is a key point for maintaining of "healthy life". Wearable devices provide a unique possibility for real-time monitoring. This study aims to estimate the accuracy of Spectrophon Dehydration Body Monitor (DBM) incorporated in smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2 by comparing data obtained by DBM with the total weight lost during exertion.
Detailed description
Reduced physical activity is considered as a risk factor for obesity, diabetes, cancer and depression. A proper exercise program can mitigate cognitive and physical decline associated with ageing. Existing general guidelines for physical activity are not universal or appropriate for every person. A personalized approach based on a subject age and unique combination of different physiological parameters would serve as a solution for finding optimal training protocols for individuals. Hence, monitoring basic physiological and biochemical parameters and obtaining information reflecting the body metabolic state is necessary for health status estimation to develop the abovementioned personally-oriented training protocols. Dehydration Body Monitor (DBM) developed by Spectrophon L.T.D. can measure sweat lost, salt concentration in sweat, and sweating dynamics, which can be used for personal physical status monitoring. This is important not only for controlling appropriate body hydration level but also for keeping kidneys "healthy". Currently, only few DBM tools are available on the market, so there is a growing need for new effective accurate real-time DBM sensors.
The main objective of current study is to estimate the accuracy of Spectrophon DBM incorporated in smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2. The secondary aim of the study is to evaluate the safety-in-use of Spectrophon DBM.
Tested device:
Name: Dehydration Body Monitor; Source: Spectrophon, L.T.D.; Model: SP-DBM Firmware version: 1.5
- Experimental Design Healthy adults (n=200) in different age and gender groups were recruited for the study. Samsung Gear S2 smartwatch with Spectrophon DBM attached to the bottom of the smartwatch were placed on the right wrist of each participant. At the same time, Samsung Gear Fit2 sport band with Spectrophon DBM attached to the bottom of the band was placed on the left wrist of the participant. Each participant was subjected to moderate physical activity. Data from Samsung Gear S2 and Samsung Gear Fit2 was obtained simultaneously. In parallel, subject weight was also monitored using commercially available digital balancers (Shekel B-200-P).
The evaluation of the measurement accuracy of the Spectrophon DBM was defined as the difference between subject weight change during the exertion (due to sweating and water consumption) and the volume of sweat detected by Spectrophon DBM.
- Procedures: Participants were weighed prior to the experiment (no clothing after maximal drying) and then subjected to physical activity (walking on the treadmill).
Total duration of study: 90 minutes
5.2 Intensity of exercises:
Participants could choose high or low intensity of exertion:
- High: up to 6.5km/h;
- Low: yo to 6.0km/h; 5.3 Data recording: After DBM application was activated, DBM started recording data (sweat rate and total salt in sweat) every 20 sec. and automatically saved results into archive on a mobile phone linked to Samsung Gear S2 or Samsung Gear Fit2 by Bluetooth. Manual recording of data was conducted during breaks Participants were also weighed during each break (no clothing after maximal drying).
5.4. Drinking During the procedure, subjects could drink up to 500 ml of water. The weight of the bottle was measured and recorded after drinking during breaks. The difference was subtracted to the weight loss calculation.
5.5 Restrictions:
In this experiment, the following was avoided:
- Urination during test (empty before T0)
- Weight loss should not exceed 2%
Participants could cancel the experiment at any point of the procedure if desired.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Spectrophon dehydration body monitorAge 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| Group 2 | Experimental | Device: Spectrophon dehydration body monitorAge 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| Group 3 | Experimental | Device: Spectrophon dehydration body monitorAge 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| Group 4 | Experimental | Device: Spectrophon dehydration body monitorAge 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: older than 18, both gender.
- Ability and willingness to sign an informed consent form for participation in the study.
Key exclusion criteria (3 listed)
- Presence of cardiologic or vascular disease.
- Evidence of any other serious medical disorder.
- Pregnancy
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 |
|---|---|---|
| Spectrophon dehydration body monitorParticipants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist | Device | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Number of Measurements Grouped by Level or Error
Time frame: 90 minutes
Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21115758Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010 Dec;33(12):e147-67. doi: 10.2337/dc10-9990.
- Background: PubMed 15361924Craft LL, Perna FM. The Benefits of Exercise for the Clinically Depressed. Prim Care Companion J Clin Psychiatry. 2004;6(3):104-111. doi: 10.4088/pcc.v06n0301.
- Background: PubMed 19124485Sternfeld B, Weltzien E, Quesenberry CP Jr, Castillo AL, Kwan M, Slattery ML, Caan BJ. Physical activity and risk of recurrence and mortality in breast cancer survivors: findings from the LACE study. Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):87-95. doi: 10.1158/1055-9965.EPI-08-0595.
- Background: PubMed 16534088Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.
- Background: PubMed 11473658Anastasio P, Cirillo M, Spitali L, Frangiosa A, Pollastro RM, De Santo NG. Level of hydration and renal function in healthy humans. Kidney Int. 2001 Aug;60(2):748-56. doi: 10.1046/j.1523-1755.2001.060002748.x.
- Individual participant dataSharing planned: No
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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.
Anatoly Kreinin, MD, PHD principal investigator
Bruce Rappaport Medical Faculty, Technion, Haifa, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectrophon dehydration body monitor in people with Dehydration, run by Tirat Carmel Mental Health Center at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 31 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Measurements Grouped by Level or Error (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229109, which also lists 5 linked publications.
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 31 Oct 2019.