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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Israel

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

  1. 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.

  1. 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.

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 groups in NCT03229109
Study groupRoleWhat they receive
Group 1ExperimentalAge 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Receives: Device: Spectrophon dehydration body monitor
Group 2ExperimentalAge 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Receives: Device: Spectrophon dehydration body monitor
Group 3ExperimentalAge 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
Receives: Device: Spectrophon dehydration body monitor
Group 4ExperimentalAge 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.

  1. 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.

  1. First posted25 Jul 2017
  2. Study start3 May 2017
  3. Primary completion27 Jul 2017
  4. Study completion27 Jul 2017

Resources

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)
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
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 21115758
  • 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.

    PubMed 15361924
  • 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.

    PubMed 19124485
  • 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.

    PubMed 16534088
  • 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.

    PubMed 11473658

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.

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