Trial Outcomes & Findings for INVSENSOR00027 Clinical Performance Study (NCT NCT03650192)
NCT ID: NCT03650192
Last Updated: 2021-01-29
Results Overview
For each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)
COMPLETED
NA
40 participants
1-5 hours
2021-01-29
Participant Flow
Participant milestones
| Measure |
INVSENSOR00027 Test Group
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INVSENSOR00027 Clinical Performance Study
Baseline characteristics by cohort
| Measure |
INVSENSOR00027 Test Group
n=40 Participants
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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38 Participants
n=99 Participants
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Age, Categorical
>=65 years
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2 Participants
n=99 Participants
|
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Sex: Female, Male
Female
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22 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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18 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
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11 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Asian or Pacific Islander
|
4 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Caucasian
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18 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
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4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Other
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2 Participants
n=99 Participants
|
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Region of Enrollment
United States
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40 participants
n=99 Participants
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PRIMARY outcome
Timeframe: 1-5 hoursFor each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)
Outcome measures
| Measure |
INVSENSOR00027 Test Group
n=40 Participants
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.
|
|---|---|
|
Sensitivity of INVSENSOR00027's Posture Change Detection
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100 percent sensitivity for posture change
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PRIMARY outcome
Timeframe: 1-5 hoursFor each subject's activity (e.g., walking and upright) detection, INVSENSOR00027 output will be compared against observer's notes. Correctly detected activity changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's activity change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection).
Outcome measures
| Measure |
INVSENSOR00027 Test Group
n=40 Participants
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.
|
|---|---|
|
Sensitivity of INVSENSOR00027's Activity Change Detection
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96.7 percent sensitivity for posture change
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PRIMARY outcome
Timeframe: 1-5 hoursPopulation: Fall detection was an optional event per protocol.
Outcome measures
| Measure |
INVSENSOR00027 Test Group
n=3 Participants
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.
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|---|---|
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Sensitivity of INVSENSOR00027's Fall Event Detection
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100 percent sensitivity for fall detection
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SECONDARY outcome
Timeframe: 1-5 hoursPopulation: 2 subjects were excluded due to data collection issues.
Accuracy will be determined by comparing the respiratory rate measurement of the INVSENSOR00027 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00027 RR measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.
Outcome measures
| Measure |
INVSENSOR00027 Test Group
n=38 Participants
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.
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|---|---|
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Respiratory Rate Detection
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1.7 A(RMS) of breaths per minute
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Adverse Events
INVSENSOR00027 Test Group
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