Trial Outcomes & Findings for Analysis of Sweat Secretion and Body Dehydration Monitoring (NCT NCT03229109)
NCT ID: NCT03229109
Last Updated: 2019-10-31
Results Overview
Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
201 participants
Primary outcome timeframe
90 minutes
Results posted on
2019-10-31
Participant Flow
Participant milestones
| Measure |
Group 1
Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 2
Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 3
Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 4
Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
51
|
|
Overall Study
COMPLETED
|
50
|
50
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1
Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 2
Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 3
Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 4
Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=50 Participants
Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 2
n=50 Participants
Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 3
n=50 Participants
Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 4
n=51 Participants
Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=201 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
51 Participants
n=51 Participants
|
201 Participants
n=201 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=201 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=50 Participants
|
25 Participants
n=50 Participants
|
25 Participants
n=50 Participants
|
26 Participants
n=51 Participants
|
101 Participants
n=201 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=50 Participants
|
25 Participants
n=50 Participants
|
25 Participants
n=50 Participants
|
25 Participants
n=51 Participants
|
100 Participants
n=201 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Israel
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
51 Participants
n=51 Participants
|
201 Participants
n=201 Participants
|
PRIMARY outcome
Timeframe: 90 minutesNumber of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)
Outcome measures
| Measure |
Group 1
n=50 Participants
Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 2
n=50 Participants
Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 3
n=50 Participants
Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
Group 4
n=50 Participants
Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
|
|---|---|---|---|---|
|
Number of Measurements Grouped by Level or Error
Samsung Gear S2 : >20% errors in measurements
|
2 Number of measurements
|
2 Number of measurements
|
1 Number of measurements
|
0 Number of measurements
|
|
Number of Measurements Grouped by Level or Error
Samsung Gear Fit2 : <20% errors in measurements
|
47 Number of measurements
|
48 Number of measurements
|
46 Number of measurements
|
49 Number of measurements
|
|
Number of Measurements Grouped by Level or Error
Samsung Gear Fit2 : >20% errors in measurements
|
3 Number of measurements
|
2 Number of measurements
|
4 Number of measurements
|
1 Number of measurements
|
|
Number of Measurements Grouped by Level or Error
Samsung Gear S2 : <20% errors in measurements
|
48 Number of measurements
|
48 Number of measurements
|
49 Number of measurements
|
50 Number of measurements
|
Adverse Events
Age 18-25
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Age 26-35
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Age 36-45
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Age 46-50
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place