N/A
Completed N=40
INVSENSOR00027 Clinical Performance Study
Healthy
Source: ClinicalTrials.gov NCT03650192 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Sensitivity of INVSENSOR00027's Posture Change Detection — 100 percent sensitivity for posture change
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of INVSENSOR00027's Posture Change Detection |
100 | — |
| PRIMARY Sensitivity of INVSENSOR00027's Activity Change Detection |
96.7 | — |
| PRIMARY Sensitivity of INVSENSOR00027's Fall Event Detection |
100 | — |
| SECONDARY Respiratory Rate Detection |
1.7 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03650192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.