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OpenTrials
Completed

NCT Number: NCT05692947

The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes

This study is investigating the efficacy of CORE™ devices in calculating core body temperature in athletes under varying environmental conditions.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bowerman Sports Science Center at the University of Oregon

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Highly trained or elite athlete
  • Nonsmokers
  • Able to read and speak English
  • No underlying cardiovascular limitations

Exclusion criteria

  • 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

Treatment and study plan

Core body temperature device

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.

Other names: CORE™, CaleraResearch™

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Acronym: CORE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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