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| Name | Class |
|---|---|
| Ariel University | OTHER |
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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.
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
4. 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.
5. 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:
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:
Participants could cancel the experiment at any point of the procedure if desired.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
|
| Group 2 | Experimental | Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
|
| Group 3 | Experimental | Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
|
| Group 4 | Experimental | Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectrophon dehydration body monitor | Device | Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anatoly Kreinin, MD, PHD | Bruce Rappaport Medical Faculty, Technion, Haifa, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Center | Tirat Carmel | Haifa District | 30200 | Israel | ||
| Tirat Carmel Mental Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21115758 | Background | 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. | |
| 15361924 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| FG001 | Group 2 | Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| FG002 | Group 3 | Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| FG003 | Group 4 | Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not relevant
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| BG001 | Group 2 | Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | Number of measurements | 90 minutes |
|
90 minutes
The trial did not involve any invasive treatments or administration of any medications so no serious adverse events were monitored, which explains why the number of participants at risk for Serious Adverse Events and for All-Cause Mortality is zero.
However, we asked participants to report any discomfort (e.g. allergic reactions) at the place where Samsung watch or band with DBM were worn.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Age 18-25 | Spectrophon dehydration body monitor was attached to subject's wrist |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anatoly Kreinin | Maale Carmel Mental Health Center | (+972) -4-8559315 | kranata@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2017 | Oct 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| Tirat Carmel |
| Haifa District |
| 30200 |
| Israel |
| Background |
| Craft 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. |
| 19124485 | Background | Sternfeld 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. |
| 16534088 | Background | Warburton 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. |
| 11473658 | Background | Anastasio 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. |
| BG002 | Group 3 | Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| BG003 | Group 4 | Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
| OG003 | Group 4 | Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 50 |
| EG001 | Age 26-35 | Spectrophon dehydration body monitor was attached to subject's wrist | 0 | 0 | 0 | 0 | 0 | 50 |
| EG002 | Age 36-45 | Spectrophon dehydration body monitor was attached to subject's wrist | 0 | 0 | 0 | 0 | 0 | 50 |
| EG003 | Age 46-50 | Spectrophon dehydration body monitor was attached to subject's wrist | 0 | 0 | 0 | 0 | 0 | 50 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|