Cooling Via Cryogenx Body Cooling Device

Brunel University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Body Temperature Changes

Treatments: Device: Cryogenx cooling; Device: Regular cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT06517147

31870-A-Mar/2024- 50405-1

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Rate of change in core temperature during CRYOGENX cooling

Experimental group

Description:

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.

Treatment:

Device: Cryogenx cooling

Rate of change in core temperature during regular cooling

Experimental group

Description:

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.

Treatment:

Device: Regular cooling