Cooling Via Cryogenx Body Cooling Device

NCT ID: NCT06517147

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Body Temperature Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cryogenx cooling

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Regular cooling

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Pregnant Previous history of neuromuscular fatigue Previous history of heat intolerance
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brunel University

OTHER

Sponsor Role lead

Responsible Party

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Dr Oliver Gibson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Oliver R Gibson, PhD

Role: CONTACT

+44(0)1895 267957 ext. 7957

Other Identifiers

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31870-A-Mar/2024- 50405-1

Identifier Type: -

Identifier Source: org_study_id

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