Temperature Change, BodyCORENCT05692947
The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes
A study testing Core body temperature device in people with Temperature Change, Body, run by University of Oregon at 1 site in United States.
Trial summary
This study is investigating the efficacy of CORE™ devices in calculating core body temperature in athletes under varying environmental conditions. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Core body temperature device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 21 Jun 2024
- Phase
- Interventional
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Highly trained or elite athlete
- Nonsmokers
- Able to read and speak English
- No underlying cardiovascular limitations
Who cannot join
- Currently or previously a habitual smoker (nicotine/cannabis)
- Pregnant, breast feeding, trying to conceive, undergoing treatment to increase sperm count
- Those taking medications that affect cardiovascular function, with the exception of oral contraceptives
- History of stroke, clotting disorders or venous thrombosis
- A history of heat illness or heat injury
- History of obstructive diseases of the gastrointestinal tract including diverticulosis, diverticulitis, inflammatory bowel disease, peptic ulcer disease, Chron's disease, ulcerative colitis, or previous GI surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Bowerman Sports Science Center at the University of Oregon
Eugene, Oregon, 97403
About this study
This study is investigating the efficacy of CORE™ devices in calculating core body temperature in athletes under varying environmental conditions.
Read the detailed description
As athletes exercise, their core body temperature rises, which can affect their performance. Additionally, repeated mild to moderate heat stress, heat acclimation, can be used to improve exercise tolerance and performance. Thus, an athlete can gain performance benefits through monitoring their heat loading while training. The aim of this study is to compare the CORE™ body temperatures recorded during exercise in two different environmental conditions in which the investigators will get a separation of core temperature and skin temperature. The investigators will accomplish this by recruiting trained and elite athletes, ages 18-59, to participate in two exercise sessions in the heat at low (10-20%) and high (80-100%) relative humidity. The investigators will compare the CORE™ temperature estimates against an FDA approved ingestible temperature monitoring device to assess the accuracy of the CORE™ devices.
- Conditions
- Temperature Change, Body
- Being tested
- Core body temperature device
- Keywords
- Exercise, Heat acclimation, Core temperature, Heat loading, Heat stress, Thermoregulation
- Medical subject headings
- Body Temperature Changes, Motor Activity, Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core body temperature deviceDevice
Also called CORE™, CaleraResearch™
This study is to verify the claims of CORE™ body temperature system to estimate core body temperature from skin temperature and heart rate during exercise under varying environmental conditions. Subjects will ingest a temperature sensing pill and be outfitted with skin temperature sensors, a chest strap heart rate monitor, and the CORE and CaleraResearch devices. Athletes will run or cycle in hot/dry and hot/humid conditions for 45 minutes at an absolute workload of 60% VO2 Max/Peak.
| Study group | Role | What they receive |
|---|---|---|
| Hot/Dry | Experimental | Core body temperature, skin temperature, heart rate, and heat perceptions will be collected from elite athletes while running or cycling for 45 minutes in the heat at low humidity (38 degrees Celsius with 10-20% relative humidity). Receives: Device: Core body temperature device |
| Hot/Humid | Experimental | Core body temperature, skin temperature, heart rate, and heat perceptions will be collected from elite athletes while running or cycling for 45 minutes in the heat at high humidity (28 degrees Celsius with 80-100% relative humidity). Receives: Device: Core body temperature device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to accurately estimate core body temperature
The CORE and CaleraResearch devices estimate core body temperature using single-site skin temperature and heartrate as data inputs for their proprietary algorithm. This calculated temperature will be assessed against actual core body temperature, measured with an FDA approved, ingestible, temperature-sensing telemetry pill.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start19 Sep 2022
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each athlete will be asked to exercise for 45 minutes in a hot/dry condition (38 degrees Celsius and 10-20% relative humidity) and a hot/humid condition (28 degrees Celsius and 80-100% relative humidity). Experimental sessions will occur at least seven days apart and participants will be randomly assigned to which condition they experience first.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher T Minson, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692947
- Sponsor's protocol ID
- STUDY00000607
- Acronym
- CORE
- Status last verified
- Aug 2024
- First submitted
- 12 Sep 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes
- ClinicalTrials.gov ID
- NCT05692947
- Acronym / sponsor ID
- CORE / STUDY00000607
- Conditions
- Temperature Change, Body
- Keywords
- Exercise, Heat acclimation, Core temperature, Heat loading, Heat stress, Thermoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 20 Jan 2023 (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 is investigating the efficacy of CORE™ devices in calculating core body temperature in athletes under varying environmental conditions.
Detailed description
As athletes exercise, their core body temperature rises, which can affect their performance. Additionally, repeated mild to moderate heat stress, heat acclimation, can be used to improve exercise tolerance and performance. Thus, an athlete can gain performance benefits through monitoring their heat loading while training. The aim of this study is to compare the CORE™ body temperatures recorded during exercise in two different environmental conditions in which the investigators will get a separation of core temperature and skin temperature. The investigators will accomplish this by recruiting trained and elite athletes, ages 18-59, to participate in two exercise sessions in the heat at low (10-20%) and high (80-100%) relative humidity. The investigators will compare the CORE™ temperature estimates against an FDA approved ingestible temperature monitoring device to assess the accuracy of the CORE™ devices.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each athlete will be asked to exercise for 45 minutes in a hot/dry condition (38 degrees Celsius and 10-20% relative humidity) and a hot/humid condition (28 degrees Celsius and 80-100% relative humidity). Experimental sessions will occur at least seven days apart and participants will be randomly assigned to which condition they experience first.
| Arm | Type | Receives |
|---|---|---|
| Hot/Dry | Experimental | Device: Core body temperature deviceCore body temperature, skin temperature, heart rate, and heat perceptions will be collected from elite athletes while running or cycling for 45 minutes in the heat at low humidity (38 degrees Celsius with 10-20% relative humidity). |
| Hot/Humid | Experimental | Device: Core body temperature deviceCore body temperature, skin temperature, heart rate, and heat perceptions will be collected from elite athletes while running or cycling for 45 minutes in the heat at high humidity (28 degrees Celsius with 80-100% relative humidity). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Highly trained or elite athlete
- Nonsmokers
- Able to read and speak English
- No underlying cardiovascular limitations
Key exclusion criteria (6 listed)
- Currently or previously a habitual smoker (nicotine/cannabis)
- Pregnant, breast feeding, trying to conceive, undergoing treatment to increase sperm count
- Those taking medications that affect cardiovascular function, with the exception of oral contraceptives
- History of stroke, clotting disorders or venous thrombosis
- A history of heat illness or heat injury
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 |
|---|---|---|
| Core body temperature deviceAlso: CORE™, CaleraResearch™This study is to verify the claims of CORE™ body temperature system to estimate core body temperature from skin temperature and heart rate during exercise under varying environmental conditions. Subjects will ingest a temperature sensing pill and be outfitted with skin temperature sensors, a chest strap heart rate monitor, and the CORE and CaleraResearch devices. Athletes will run or cycle in hot/dry and hot/humid conditions for 45 minutes at an absolute workload of 60% VO2 Max/Peak. | Device | Hot/Dry, Hot/Humid |
Primary outcome
Ability to accurately estimate core body temperature
Time frame: 30 minutes
The CORE and CaleraResearch devices estimate core body temperature using single-site skin temperature and heartrate as data inputs for their proprietary algorithm. This calculated temperature will be assessed against actual core body temperature, measured with an FDA approved, ingestible, temperature-sensing telemetry pill.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Christopher T Minson, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core body temperature device in people with Temperature Change, Body, run by University of Oregon 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 4 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: finished, as of the sponsor's last update on 4 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ability to accurately estimate core body temperature (time frame: 30 minutes). 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 4 Mar 2026.