No Applicable Condition; Study of Physiologic Monitor Alarms
Conditions
Keywords
remote patient monitoring, energy harvesting,
Brief summary
This study will evaluate the effectiveness of newly developed self-powered, smart insoles that will be used for remote patient monitoring (RPM) for both military and civilian populations. The present study is part of a project funded by SEMI and the Air Force Research Laboratory (AFRL).
Detailed description
The present study, funded jointly by SEMI and the AFRL, is intended to evaluate the comfort, durability, and sensor accuracy of the smart insoles and associated mobile app. The study will evaluate both generation 1.0 and generation 2.0 of the smart insole. The primary difference between the two generations is the that gen 2.0 will use an improved energy harvester for power generation. The present study is structured in two phases. Phase 1 will evaluate gen 1.0 of the insole in a pilot study at the University of Utah (U of U) with 10 subjects. The subjects will be asked to wear the insole while walking at different speeds on an instrumented treadmill in the Motion Core Analysis Facility at the University of Utah and asked to walk over a ½ mile course on the U of U campus. This study will be overseen by Dr. Shad Roundy. Phase 2 will evaluate gen 2.0 of the insole. A pilot study will take place at the U of U and will mimic the phase 1 study with 10 subjects. Again, the study will be overseen by Dr. Shad Roundy. This will be followed up by a larger field study with 100 subjects who will be asked to take the insoles home and wear them over the course of 4 weeks. The field study will be overseen by Dr. Jeff Hiserman at Spectrum Ergonomics.
Interventions
OTHERObservational with data collected
Observational with data collection from sensors in insole
Sponsors
University of Utah
United States Air Force Research Laboratory
Spectrum Ergonomics and Occupational Health Services
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participant is generally health and between 18 and 90 year of age at time of signing consent. 2. Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week. \-
Exclusion criteria
* Age of Participants: 18-90 Sample Size: At Utah: All Centers: 120 Inclusion Criteria: Inclusion criteria for Phase 1 and Phase 2 pilot studies at UofU 1\. Participant is generally healthy and between 18 and 90 years of age at time of signing consent 2. Participant must be able to walk comfortably for 1 mile. 3. Will seek 5 male and 5 female participants. Inclusion criteria for Phase 2 field studies conducted by Spectrum Ergonomics 1. Participant is generally health and between 18 and 90 year of age at time of signing consent. 2. Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers. | From enrollment to the end of observations at 4 weeks | The sensors will measure: Pulse Oxygen as the percentage saturation of oxygen carried in the red blood cells. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers. | Time Frame: From enrollment to the end of observations at 4 weeks | Description: The sensors will measure: Heart Rate and Heart Rate Variability in beats per minute. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers. | Time Frame: From enrollment to the end of observations at 4 weeks | Description: The sensors will measure: Body temperature as measured in degrees Celsius. |
Countries
United States
Contacts
Primary ContactJeff Hiserman, Bachelor's
Backup ContactRyane Sorenson, Bachelor's
Outcome results
None listed