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

NCT05692947 | Completed FDA Device

• 1 other identifier: STUDY00000607
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Temperature Change, Body

Keywords

Exercise; Heat acclimation; Core temperature; Heat loading; Heat stress; Thermoregulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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).

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).

Device: Core body temperature device

Interventions

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.

Also known as: CORE™, CaleraResearch™

Hot/Dry; Hot/Humid

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oregon: lead

Study Sites (1)

Bowerman Sports Science Center at the University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Body Temperature Changes; Motor Activity; Heat Stress Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Wounds and Injuries

Study Officials

• Christopher T Minson, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: January 20, 2023
• Study Start: September 19, 2022
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: March 4, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)