No Applicable Condition; Study of Physiologic Monitor AlarmsNCT07273422
Novel Self-charging, Medical-Grade Smart Insoles With AI/ML Edge Computing to Monitor Biometrics.
An observational study of No Applicable Condition; Study of Physiologic Monitor Alarms, run by Spectrum Ergonomics and Occupational Health Services at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- No Applicable Condition; Study of Physiologic Monitor Alarms
- What is being tested?
- Observational with data collected
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Feb 2027
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- -
- 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
- 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.
Who cannot join
- Age of Participants: 18-90
- Sample Size:
- At Utah:
- All Centers: 120
- Exclusion Criteria for Phase 1 and Phase 2 pilot studies at UofU
- Flat feet (Pes planus)
Show all 26Show fewer
- 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.
- Exclusion Criteria for Phase 2 field study at Spectrum Ergonomics
- Flat feet (Pes planus) or high arches (Pes cavus)
- Unilateral leg amputee.
- Brittle Diabetes- hard-to-control diabetes (also called labile diabetes), which is characterized by wide variations in blood glucose in which blood glucose levels can quickly move from too high (hyperglycemia) to too low (hypoglycemia).
- Peripheral neuropathy.
- Loss of sensation in the sole of foot.
- Open wound on the foot.
- Females who are pregnant, < 3 months postpartum, or currently lactating.
- Ankle fusion or total replacement
- 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 < 1 years before enrollment.
- Morbid obesity BMI > 40.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Spectrum Ergonomics and Occupational Health Services
Williamsport, Pennsylvania, 17701
Jeff Hiserman, Bachelor's, 5704953298, spectrumergonomics@gmail.com
Robert Andosca, PhD, (617) 447-1876, randosca@inviza.com
About this study
Official title: Evaluation of Self-powered Smart Insoles
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).
Read the 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.
- Being tested
- Observational with data collected
- Keywords
- remote patient monitoring, energy harvesting,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational with data collectedOther
Observational with data collection from sensors in insole
| Study group | Role | What they receive |
|---|---|---|
| Males and female ages 18-100 years old and ambulatory | Not described Receives: Other: Observational with data collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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.
Description: The sensors will measure: Heart Rate and Heart Rate Variability in beats per minute.
Measured: Time Frame: "From enrollment to the end of observations at 4 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study startJun 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Applicable Condition; Study of Physiologic Monitor AlarmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Spectrum Ergonomics and Occupational Health Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Utah, United States Air Force Research Laboratory
- Responsible party
- Sponsor
- Investigators
- Robert Andosca, PhD, Principal investigator, Inviza Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273422
- Sponsor's protocol ID
- IRB_00176473
- Other IDs
- SEMI NBMC, NB18-24-44
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data will be shared as group data, divided into various groups, i.e. age and gender.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Self-powered Smart Insoles
- ClinicalTrials.gov ID
- NCT07273422
- Acronym / sponsor ID
- IRB_00176473
- Keywords
- remote patient monitoring, energy harvesting,
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Spectrum Ergonomics and Occupational Health ServicesIndustry (pharma, biotech, devices)
- Collaborators
- University of Utah, United States Air Force Research Laboratory
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males and female ages 18-100 years old and ambulatory | – | Other: Observational with data collected |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- -
- 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
Key exclusion criteria (26 listed)
- Age of Participants: 18-90
- All Centers: 120
- Exclusion Criteria for Phase 1 and Phase 2 pilot studies at UofU
- Flat feet (Pes planus)
- Unilateral leg amputee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational with data collectedObservational with data collection from sensors in insole | Other | Males and female ages 18-100 years old and ambulatory |
Primary outcome
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"
The sensors will measure: Pulse Oxygen as the percentage saturation of oxygen carried in the red blood cells.
1 secondary outcome
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: Time Frame: "From enrollment to the end of observations at 4 weeks"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. The data will be shared as group data, divided into various groups, i.e. age and gender.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Andosca, PhD principal investigator
Inviza Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of No Applicable Condition; Study of Physiologic Monitor Alarms, run by Spectrum Ergonomics and Occupational Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeff Hiserman, Bachelor's (15704953298, spectrumergonomics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.