Cooling Via Cryogenx Body Cooling Device

NCT06517147 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 31870-A-Mar/2024- 50405-1
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Body Temperature Changes

Outcome Measures

Primary Outcomes (1)

• Core (rectal) temperature

  The rate of change of core temperature during cooling will be calculated from realtime data

  12 months

Study Arms (2)

Rate of change in core temperature during CRYOGENX cooling

EXPERIMENTAL

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

Rate of change in core temperature during regular cooling

EXPERIMENTAL

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

Interventions

Cryogenx cooling 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 CRYOGENX cooling

Regular cooling 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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant Previous history of neuromuscular fatigue Previous history of heat intolerance

Sponsors & Collaborators

• Brunel University: lead

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Oliver R Gibson, PhD

CONTACT

+44(0)1895 267957; oliver.gibson@brunel.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 24, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 31, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07