Analysis of Sweat Secretion and Body Dehydration Monitoring

• ClinicalTrials.gov Identifier: NCT03229109
• Recruitment Status: Completed
• First Posted: July 25, 2017
• Results First Posted: October 31, 2019
• Last Update Posted: October 31, 2019
• Sponsor: Tirat Carmel Mental Health Center
• Collaborator: Ariel University
• Information provided by (Responsible Party): Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center

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.

Condition or disease	Intervention/treatment	Phase
Dehydration	Device: Spectrophon dehydration body monitor	Not Applicable

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:

1. High: up to 6.5km/h;
2. 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:

1. Urination during test (empty before T0)
2. Weight loss should not exceed 2%

Participants could cancel the experiment at any point of the procedure if desired.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Spectrophon Dehydration Body Monitor Accuracy Evaluation
• Actual Study Start Date: May 3, 2017
• Actual Primary Completion Date: July 27, 2017
• Actual Study Completion Date: July 27, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1; Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist	Device: Spectrophon dehydration body monitor; Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist
Experimental: Group 2; Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist	Device: Spectrophon dehydration body monitor; Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist
Experimental: Group 3; Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist	Device: Spectrophon dehydration body monitor; Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist
Experimental: Group 4; Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist	Device: Spectrophon dehydration body monitor; Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist

Outcome Measures

Primary Outcome Measures :

1. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Age: older than 18, both gender.
2. Ability and willingness to sign an informed consent form for participation in the study.

Exclusion Criteria:

1. Presence of cardiologic or vascular disease.
2. Evidence of any other serious medical disorder.
3. Pregnancy

Contacts and Locations

Locations

Israel

Mental Health Center

Tirat Karmel, Haifa, Israel, 30200

Tirat Carmel Mental Health Center

Tirat Karmel, Haifa, Israel, 30200

Sponsors and Collaborators

Tirat Carmel Mental Health Center

Ariel University

Investigators

• Principal Investigator: Anatoly Kreinin, MD, PHD; Bruce Rappaport Medical Faculty, Technion, Haifa, Israel

  Study Documents (Full-Text)

Documents provided by Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center:

Study Protocol and Statistical Analysis Plan  [PDF] March 27, 2017

More Information

Additional Information:

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.

Craft LL, Perna FM. The Benefits of Exercise for the Clinically Depressed. Prim Care Companion J Clin Psychiatry. 2004;6(3):104-111.

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.

Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. Review.

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.

• Responsible Party: Anatoly Kreinin, MD, PHD, Head of Psychiatry Department,, Tirat Carmel Mental Health Center
• ClinicalTrials.gov Identifier: NCT03229109
• Other Study ID Numbers: 04/17
• First Posted: July 25, 2017
• Results First Posted: October 31, 2019
• Last Update Posted: October 31, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center:

dehydration; spectrophon; device; perspiration

Additional relevant MeSH terms:

Dehydration; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes