An interventional study of Core body temperature device in Temperature Change, Body, sponsored by University of Oregon. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by University of Oregon · Not applicable, Interventional, and Basic science
This study is investigating the efficacy of CORE™ devices in calculating core body temperature in athletes under varying environmental conditions.
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.
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's enrollment of 40 is close to the median of 40 across 68 interventional studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →University of Oregon is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: Core body temperature device
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).
Device: Core body temperature device
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.
Also known as: CORE™, CaleraResearch™
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.
Time frame: 30 minutes
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2022 to primary completion in Jun 2024, 21 months.
Of 44 non-industry interventional studies with no phase under Body Temperature Changes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 21 months is above that.
Counting every sponsor, half of 44 studies reached it within 5 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Oregon