INVSENSOR00027 Clinical Performance Study

Study Overview
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Brief Summary
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This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Official Title
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INVSENSOR00027 Clinical Performance Study

Conditions
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Healthy

Intervention / Treatment
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* Device: INVSENSOR00027


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years old Physical status of ASA I or II Subjects must be able to read and communicate in English Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement Has completed Health Assessment Questionnaire and passed health assessment screening Exclusion Criteria: Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study Inability to tolerate sitting still or minimal movement for at least 30 minutes Nursing female volunteers Excluded at the Principal Investigator's discretion Refusal to take the pregnancy test (for female subjects) Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population. Refusal to shave hair (neck, chest) off areas where sensors will be applied (male subjects)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INVSENSOR00027 Test group<br>The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor. | Device: INVSENSOR00027<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of INVSENSOR00027's Posture Change Detection | 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) | 1-5 hours | 
| Sensitivity of INVSENSOR00027's Activity Change Detection | For 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). | 1-5 hours | 
| Sensitivity of INVSENSOR00027's Fall Event Detection |  | 1-5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Rate Detection | 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. | 1-5 hours |