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

Temperature Change, Body Clinical Trial

— CORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692947
• Other study ID #: STUDY00000607
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Oregon
• Contact: Christopher T Minson, PhD
• Phone: 541-346-4206
• Email: minson[@]uoregon.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes
• Temperature Change, Body

Intervention

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.

Locations

Country	Name	City	State
United States	Bowerman Sports Science Center at the University of Oregon	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes