Analysis of Sweat Secretion and Body Dehydration Monitoring
Primary Purpose
Dehydration
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Spectrophon dehydration body monitor
Sponsored by
About this trial
This is an interventional screening trial for Dehydration focused on measuring dehydration, spectrophon, device, perspiration
Eligibility Criteria
Inclusion Criteria:
- Age: older than 18, both gender.
- Ability and willingness to sign an informed consent form for participation in the study.
Exclusion Criteria:
- Presence of cardiologic or vascular disease.
- Evidence of any other serious medical disorder.
- Pregnancy
Sites / Locations
- Mental Health Center
- Tirat Carmel Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03229109
First Posted
July 5, 2017
Last Updated
October 30, 2019
Sponsor
Tirat Carmel Mental Health Center
Collaborators
Ariel University
1. Study Identification
Unique Protocol Identification Number
NCT03229109
Brief Title
Analysis of Sweat Secretion and Body Dehydration Monitoring
Official Title
Spectrophon Dehydration Body Monitor Accuracy Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
July 27, 2017 (Actual)
Study Completion Date
July 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tirat Carmel Mental Health Center
Collaborators
Ariel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
dehydration, spectrophon, device, perspiration
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Intervention Type
Device
Intervention Name(s)
Spectrophon dehydration body monitor
Intervention Description
Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist
Primary Outcome Measure Information:
Title
Number of Measurements Grouped by Level or Error
Description
Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)
Time Frame
90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: older than 18, both gender.
Ability and willingness to sign an informed consent form for participation in the study.
Exclusion Criteria:
Presence of cardiologic or vascular disease.
Evidence of any other serious medical disorder.
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anatoly Kreinin, MD, PHD
Organizational Affiliation
Bruce Rappaport Medical Faculty, Technion, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Center
City
Tirat Karmel
State/Province
Haifa
ZIP/Postal Code
30200
Country
Israel
Facility Name
Tirat Carmel Mental Health Center
City
Tirat Karmel
State/Province
Haifa
ZIP/Postal Code
30200
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21115758
Citation
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.
Results Reference
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PubMed Identifier
15361924
Citation
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.
Results Reference
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PubMed Identifier
19124485
Citation
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.
Results Reference
background
PubMed Identifier
16534088
Citation
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.
Results Reference
background
PubMed Identifier
11473658
Citation
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.
Results Reference
background
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Analysis of Sweat Secretion and Body Dehydration Monitoring
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