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

Primary Purpose

Temperature Change, Body

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Core body temperature device
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Temperature Change, Body focused on measuring Exercise, Heat acclimation, Core temperature, Heat loading, Heat stress, Thermoregulation

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bowerman Sports Science Center at the University of OregonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hot/Dry

Hot/Humid

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2022
Last Updated
August 8, 2023
Sponsor
University of Oregon
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1. Study Identification

Unique Protocol Identification Number
NCT05692947
Brief Title
The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes
Acronym
CORE
Official Title
The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temperature Change, Body
Keywords
Exercise, Heat acclimation, Core temperature, Heat loading, Heat stress, Thermoregulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hot/Dry
Arm Type
Experimental
Arm Description
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).
Arm Title
Hot/Humid
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Core body temperature device
Other Intervention Name(s)
CORE™, CaleraResearch™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability to accurately estimate core body temperature
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher T Minson, PhD
Phone
541-346-4206
Email
minson@uoregon.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karen W Needham, BS
Phone
541-346-4206
Email
NEEDHAM@uoregon.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher T Minson, PhD
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bowerman Sports Science Center at the University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Needham
Phone
541-232-2064
Email
needham@uoregon.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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