Study Results
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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NOT_YET_RECRUITING
EARLY_PHASE1
12 participants
INTERVENTIONAL
2024-09-01
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
ALL
Yes
Sponsors
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Brunel University
OTHER
Responsible Party
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Dr Oliver Gibson
Principal Investigator
Central Contacts
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Other Identifiers
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31870-A-Mar/2024- 50405-1
Identifier Type: -
Identifier Source: org_study_id
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