Analysis of Sweat Secretion and Body Dehydration Monitoring
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional

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:

        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.
    

Intervention name(s): Spectrophon dehydration body monitor
Intervention type(s): Device
Intervention description(s): Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: dehydration; spectrophon; device; perspiration