ThermometryNCT05247736
Principles and Test Methods of Non-contact Body Thermometry
An observational study of Thermometry, run by Thermal Diagnostics LLC at 1 site in United States.
Trial summary
Long-wavelength infrared (IR) detectors have a more than 20-year history in medical thermometry and have been used widely for febrile screening. However, over the past year and a half, public health entities, medical professionals, and the general public have begun to question the claimed accuracy of non-contact body… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thermometry
- What is being tested?
- Infrared Thermography
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2021to 15 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from those responding to electronic advertisement on St Olaf College internal email lists and message boards. It is expected that the majority of the study population will be students, with a small proportion of Staff and Faculty.
Who may be able to join
- Age > 18.
- Have received a clinical oral thermometry measurement in the past.
Who cannot join
- Contraindication to oral temperature measurement.
- Inability to follow instructions.
- Any diagnosis associated with abnormal core thermoregulation, e.g. autonomic dysfunction.
- Obvious signs of tissue damage present in either inner canthus.
- Facial artery abnormality if previously diagnosed.
- Experienced discomfort while receiving most recent clinical oral thermometry measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Environmental Temperatures on Non-contact Thermal Imaging for Core Body Temperature Measurement
Long-wavelength infrared (IR) detectors have a more than 20-year history in medical thermometry and have been used widely for febrile screening. However, over the past year and a half, public health entities, medical professionals, and the general public have begun to question the claimed accuracy of non-contact body thermometry. The standard assessment of a device's performance relies on clinical testing with febrile individuals, yet this practice may have inadvertently allowed the approval of IR systems that are unable to detect moderate fevers. The ability to test device performance without relying on febrile test participants would have important ramifications for public health, especially if this test discovered undisclosed differences in accuracy in widely used devices.
The aim is to examine the effect of the local environment and the physiology of the human body on the relationship between core body temperature and inner canthi (region near tear duct) skin temperature measured using non-contact thermal imaging and to use of this relationship to test actual device performance at detecting simulated elevated temperatures, without requiring volunteers having actual elevated temperatures. The overall goal of this research study is to validate and improve the science of non-contact core body temperature measurement.
Read the detailed description
It is difficult to assess the performance of non-contact thermometry at detection of febrile subjects unless febrile subjects are included in the test, which severely limits development and independent testing of such devices. The underlying mechanisms of non-contact thermometry might be used to develop a test without requiring the inclusion of febrile subjects, and the development and demonstration of such a test is the object of this study.
Literature review and pilot study revealed the offset between skin temperature and core (oral) body temperature is dependent on air temperature by a linear relationship. In a 70F room, the inner canthi temperature of a human with core (oral-reference) body temperature of 98.6F is 94.4F, a difference of 4.2F. This same individual in an 87F room (after waiting several minutes) will have an inner canthi temperature of 97.0F, a difference of only 1.6F (the actual values may depend on sensor confounds not addressed here). Therefore, one could use a several-minutes exposure to elevated air temperatures (equilibration environment) to simulate an elevated body temperature, by continuing to operate the device under test from a non-elevated air temperature environment (test environment), while taking care to limit the effects of temperature changes and gradients due to the mixing of these two environments.
Subjects will be recruited from a college campus via a recruitment protocol to participate in an up to 2 hour study session. The study session will involve collection of demographic information on a non-identifiable form, five collections of oral thermometry, four 10 minute periods of equilibration inside 4 elevated temperature environments during repeat continuous non-contact thermometry, and measurements via several non-contact test devices operated from within a non-elevated environment through a window into each elevated environment.
- Conditions
- Thermometry
- Being tested
- Infrared Thermography
- Keywords
- non-contact infrared thermometry, thermal imaging, elevated body temperature, febrile
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared ThermographyDiagnostic test
Non-contact body thermometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Bias (CB)
Average difference between device measurement and reference measurement as per ASTM E1965-98
Measured: 10 months
Limits of Acceptability (LA)
Two times standard deviation of device measurement as per ASTM E1965-98
Measured: 10 months
Bland-Altman (BA) Plot
Plot of device minus reference output versus reference output (or versus average of reference and device outputs)
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start22 Jul 2021
- Primary completion15 May 2022 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThermometryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thermal Diagnostics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247736
- Sponsor's protocol ID
- ClinicalStudyAugust2021
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: No identifying information was collected except for thermal images of faces, which were extracted to only numeric inner canthi temperature values per subject. This data is being shared via a github repository.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Environmental Temperatures on Non-contact Thermal Imaging for Core Body Temperature Measurement
- ClinicalTrials.gov ID
- NCT05247736
- Acronym / sponsor ID
- ClinicalStudyAugust2021
- Conditions
- Thermometry
- Keywords
- non-contact infrared thermometry, thermal imaging, elevated body temperature, febrile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Thermal Diagnostics LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 21 Feb 2022 (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.
Long-wavelength infrared (IR) detectors have a more than 20-year history in medical thermometry and have been used widely for febrile screening. However, over the past year and a half, public health entities, medical professionals, and the general public have begun to question the claimed accuracy of non-contact body thermometry. The standard assessment of a device's performance relies on clinical testing with febrile individuals, yet this practice may have inadvertently allowed the approval of IR systems that are unable to detect moderate fevers. The ability to test device performance without relying on febrile test participants would have important ramifications for public health, especially if this test discovered undisclosed differences in accuracy in widely used devices.
The aim is to examine the effect of the local environment and the physiology of the human body on the relationship between core body temperature and inner canthi (region near tear duct) skin temperature measured using non-contact thermal imaging and to use of this relationship to test actual device performance at detecting simulated elevated temperatures, without requiring volunteers having actual elevated temperatures. The overall goal of this research study is to validate and improve the science of non-contact core body temperature measurement.
Detailed description
It is difficult to assess the performance of non-contact thermometry at detection of febrile subjects unless febrile subjects are included in the test, which severely limits development and independent testing of such devices. The underlying mechanisms of non-contact thermometry might be used to develop a test without requiring the inclusion of febrile subjects, and the development and demonstration of such a test is the object of this study.
Literature review and pilot study revealed the offset between skin temperature and core (oral) body temperature is dependent on air temperature by a linear relationship. In a 70F room, the inner canthi temperature of a human with core (oral-reference) body temperature of 98.6F is 94.4F, a difference of 4.2F. This same individual in an 87F room (after waiting several minutes) will have an inner canthi temperature of 97.0F, a difference of only 1.6F (the actual values may depend on sensor confounds not addressed here). Therefore, one could use a several-minutes exposure to elevated air temperatures (equilibration environment) to simulate an elevated body temperature, by continuing to operate the device under test from a non-elevated air temperature environment (test environment), while taking care to limit the effects of temperature changes and gradients due to the mixing of these two environments.
Subjects will be recruited from a college campus via a recruitment protocol to participate in an up to 2 hour study session. The study session will involve collection of demographic information on a non-identifiable form, five collections of oral thermometry, four 10 minute periods of equilibration inside 4 elevated temperature environments during repeat continuous non-contact thermometry, and measurements via several non-contact test devices operated from within a non-elevated environment through a window into each elevated environment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from those responding to electronic advertisement on St Olaf College internal email lists and message boards. It is expected that the majority of the study population will be students, with a small proportion of Staff and Faculty.
Key inclusion criteria (2 listed)
- Age > 18.
- Have received a clinical oral thermometry measurement in the past.
Key exclusion criteria (6 listed)
- Contraindication to oral temperature measurement.
- Inability to follow instructions.
- Any diagnosis associated with abnormal core thermoregulation, e.g. autonomic dysfunction.
- Obvious signs of tissue damage present in either inner canthus.
- Facial artery abnormality if previously diagnosed.
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 |
|---|---|---|
| Infrared ThermographyNon-contact body thermometry | Diagnostic test | – |
Primary outcome
Clinical Bias (CB)
Time frame: 10 months
Average difference between device measurement and reference measurement as per ASTM E1965-98
Limits of Acceptability (LA)
Time frame: 10 months
Two times standard deviation of device measurement as per ASTM E1965-98
Bland-Altman (BA) Plot
Time frame: 10 months
Plot of device minus reference output versus reference output (or versus average of reference and device outputs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: Yes. No identifying information was collected except for thermal images of faces, which were extracted to only numeric inner canthi temperature values per subject. This data is being shared via a github repository.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Thermometry, run by Thermal Diagnostics LLC 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Bias (CB) (time frame: 10 months). The study lists 3 primary outcomes in all. 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 21 Feb 2022.