Novel Self-charging, Medical-Grade Smart Insoles With AI/ML Edge Computing to Monitor Biometrics.

NCT07273422 | Recruiting DMC FDA Device

• 2 other identifiers: IRB_00176473SEMI NBMC, NB18-24-44
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

No Applicable Condition; Study of Physiologic Monitor Alarms

Keywords

remote patient monitoring, energy harvesting,

Outcome Measures

Primary Outcomes (1)

• The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers.

  The sensors will measure: Pulse Oxygen as the percentage saturation of oxygen carried in the red blood cells.

  "From enrollment to the end of observations at 4 weeks"

Secondary Outcomes (1)

• 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"

Other Outcomes (1)

• 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"

Study Arms (1)

Males and female ages 18-100 years old and ambulatory

Other: Observational with data collected

Interventions

Observational with data collected OTHER

Observational with data collection from sensors in insole

Males and female ages 18-100 years old and ambulatory

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the clinic's patient population, their family and friends, and from the general public in the northcentral Pennsylvania region.

You may qualify if:

• Participant is generally health and between 18 and 90 year of age at time of signing consent.
• Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week.

You may not qualify if:

• Age of Participants: 18-90
• Sample Size:
• At Utah:
• All Centers: 120
• Participant is generally health and between 18 and 90 year of age at time of signing consent.
• Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week.
• Flat feet (Pes planus)
• Unilateral leg amputee
• Females who are pregnant, \< 3 months postpartum, or currently lactating.
• Major surgery \< 6 months or minor surgery \< 3 months before enrollment.
• Major infections such as sepsis or pneumonia \< 3 months before enrollment.
• Myocardial infarction or heart failure \< 5 years or less before enrollment.
• Ankle fusion or total replacement
• Morbid obesity BMI \> 40.
• Flat feet (Pes planus) or high arches (Pes cavus)

Sponsors & Collaborators

• Spectrum Ergonomics and Occupational Health Services: lead
• University of Utah: collaborator
• United States Air Force Research Laboratory: collaborator

Study Sites (1)

Spectrum Ergonomics and Occupational Health Services

Williamsport, Pennsylvania, 17701, United States

RECRUITING

Study Officials

• Robert Andosca, PhD

  Inviza Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Hiserman, Bachelor's

CONTACT

15704953298; spectrumergonomics@gmail.com

Ryane Sorenson, Bachelor's

CONTACT

801-585-0302; ryane.sorenson@hsc.utah.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 9, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)