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 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Group 1	Group 2	Group 3	Group 4
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

Baseline Characteristics

Arm/Group Title		Group 1	Group 2	Group 3	Group 4	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Number of Measurements Grouped by Level or Error
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2	Group 3	Group 4
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

Adverse Events

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
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
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
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Anatoly Kreinin
• Organization: Maale Carmel Mental Health Center
• Phone: (+972) -4-8559315
• EMail: kranata@gmail.com

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. doi: 10.4088/pcc.v06n0301.

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. doi: 10.1503/cmaj.051351.

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.

• Responsible Party: Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center
• ClinicalTrials.gov Identifier: NCT03229109
• 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