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Trial record 2 of 2 for:    spectrophon

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Dehydration
Intervention Device: Spectrophon dehydration body monitor
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group 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
Period Title: Overall Study
Started 50 50 50 51
Completed 50 50 50 50
Not Completed 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Total
Hide Arm/Group 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 Total of all reporting groups
Overall Number of Baseline Participants 50 50 50 51 201
Hide Baseline Analysis Population Description
Not relevant
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 50 participants 51 participants 201 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
50
 100.0%
50
 100.0%
51
 100.0%
201
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 50 participants 51 participants 201 participants
Female
25
  50.0%
25
  50.0%
25
  50.0%
26
  51.0%
101
  50.2%
Male
25
  50.0%
25
  50.0%
25
  50.0%
25
  49.0%
100
  49.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 50 participants 50 participants 50 participants 51 participants 201 participants
50 50 50 51 201
1.Primary Outcome
Title Number of Measurements Grouped by Level or Error
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group 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
Overall Number of Participants Analyzed 50 50 50 50
Measure Type: Number
Unit of Measure: Number of measurements
Samsung Gear S2 : <20% errors in measurements 48 48 49 50
Samsung Gear S2 : >20% errors in measurements 2 2 1 0
Samsung Gear Fit2 : <20% errors in measurements 47 48 46 49
Samsung Gear Fit2 : >20% errors in measurements 3 2 4 1
Time Frame 90 minutes
Adverse Event Reporting Description

The trial did not involve any invasive treatments or administration of any medications so no serious adverse events were monitored, which explains why the number of participants at risk for Serious Adverse Events and for All-Cause Mortality is zero.

However, we asked participants to report any discomfort (e.g. allergic reactions) at the place where Samsung watch or band with DBM were worn.

 
Arm/Group Title Age 18-25 Age 26-35 Age 36-45 Age 46-50
Hide Arm/Group Description Spectrophon dehydration body monitor was attached to subject's wrist Spectrophon dehydration body monitor was attached to subject's wrist Spectrophon dehydration body monitor was attached to subject's wrist Spectrophon dehydration body monitor was attached to subject's wrist
All-Cause Mortality
Age 18-25 Age 26-35 Age 36-45 Age 46-50
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Age 18-25 Age 26-35 Age 36-45 Age 46-50
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Age 18-25 Age 26-35 Age 36-45 Age 46-50
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%)   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anatoly Kreinin
Organization: Maale Carmel Mental Health Center
Phone: (+972) -4-8559315
EMail: kranata@gmail.com
Layout table for additonal information
Responsible Party: Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center
ClinicalTrials.gov Identifier: NCT03229109     History of Changes
Other Study ID Numbers: 04/17
First Submitted: July 5, 2017
First Posted: July 25, 2017
Results First Submitted: November 12, 2017
Results First Posted: October 31, 2019
Last Update Posted: October 31, 2019