Cooling Via Cryogenx Body Cooling Device

July 18, 2024 updated by: Dr Oliver Gibson, Brunel University

Efficacy of Post Exercise Heat Stress Cooling Via Cyrogenx Body Cooling Device

The aim of this project is to test the rate of cooling following exercise in the heat utilising the CRYOGENX Cryosuit device i) against passive cooling, and ii) to quantify the rate of cooling and compare this rate with established cooling intervention thresholds i.e. -0.11 to 0.15°C.min-1. As this project is to determine the efficacy of the intervention in populations equivalent to sporting and military personnel, these aims will be tested in young (18-40 year old) healthy male and female participants whom participate in regular physical activity. As a commercially funded project, the experimental design implemented will closely replicate that of the independent investigation into the efficacy of the CAERvest® device.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

The inclusion criteria are:

Aged 18 - 40 years Free from known injury, illness and disease and regular use of medications other than oral contraceptives Undertake exercise training >3 times per week for ~30 minutes per session

The exclusion criteria are:

Pregnant Previous history of neuromuscular fatigue Previous history of heat intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rate of change in core temperature during CRYOGENX cooling
Participants will visit the laboratory on three occasions during this randomized, counter-balanced crossover study. The first visit will enable preliminary data collection and familiarisation to take place. The second and third visits will be experimental sessions (CRYOGENX cooling vs regular cooling), with the order of these randomised. The rate of change in core temperature during cooling observed in the two trials will be compared by paired sample t-tests.
Device: Cryogenx cooling
During the cooling phase of both trials established field based cooling approaches e.g., temperate temperature water spraying (30°C, 5 mL.min-1), and air circulation (electric fan 2 m distance, 1.7 m.s-1 will be implemented. During the CRYOGENX cooling trial, the product will be affixed to the participant's torso in accordance with manufacturer's instructions and they will receive cooling via this intervention in addition to water spraying and air circulation. During the control visit, no intervention will be applied however water spraying and air circulation will be received.
Experimental: Rate of change in core temperature during regular cooling
Participants will visit the laboratory on three occasions during this randomized, counter-balanced crossover study. The first visit will enable preliminary data collection and familiarisation to take place. The second and third visits will be experimental sessions (CRYOGENX cooling vs regular cooling), with the order of these randomised. The rate of change in core temperature during cooling observed in the two trials will be compared by paired sample t-tests.
Device: Regular cooling
During the cooling phase of both trials established field based cooling approaches e.g., temperate temperature water spraying (30°C, 5 mL.min-1), and air circulation (electric fan 2 m distance, 1.7 m.s-1 will be implemented. During the CRYOGENX cooling trial, the product will be affixed to the participant's torso in accordance with manufacturer's instructions and they will receive cooling via this intervention in addition to water spraying and air circulation. During the control visit, no intervention will be applied however water spraying and air circulation will be received.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core (rectal) temperature
Time Frame: 12 months
The rate of change of core temperature during cooling will be calculated from realtime data
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brunel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31870-A-Mar/2024- 50405-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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