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Analysis of Sweat Secretion and Body Dehydration Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Ariel University
Information provided by (Responsible Party):
Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center

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

  Show Detailed Description

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

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




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229109


Locations
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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
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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:

Additional Information:

Publications:
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Responsible Party: Anatoly Kreinin, MD, PHD, Head of Psychiatry Department,, Tirat Carmel Mental Health Center
ClinicalTrials.gov Identifier: NCT03229109     History of Changes
Other Study ID Numbers: 04/17
First Posted: July 25, 2017    Key Record Dates
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

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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:
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Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes