Semiconductor Heat Extraction Cooling

NCT ID: NCT04915859

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2022-01-31

Brief Summary

Heat-related injuries and other physiological stresses continue to be a significant threat to the health and operational effectiveness of the US Armed Forces (Armed Forces Health Surveillance 2011). This is because military personnel are exposed to exertional and environmental heat-stress factors during both deployment and training at US installations in hot and humid climates. Cold water immersion (CWI) is considered the gold standard for the treatment of exertional heat stroke (EHS) and has been shown to increase survival rates to 100% with the implementation of CWI best practices. However, in a field setting other cooling strategies have been developed to aid in the prevention of EHS and other heat-related illnesses. One such proposed strategy is a portable hand cooling device that does not require the use of ice or water. Therefore, the primary purpose of this investigation is to validate hand and back cooling devices using physiological, cognitive, performance, and perceptual responses that occur during and following rest, exercise, and cooling in the heat.

Conditions

Hyperthermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active Cooling

Participants will be actively cooled during rest breaks

Group Type: ACTIVE_COMPARATOR

Hand Cooling at 12-15 degrees celsius

Intervention Type: OTHER

hand cooling at 12-15 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature

Hand Cooling at 16-20 degrees celsius

Intervention Type: OTHER

hand cooling at 16-20 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature

hand and back cooling at 12-15 or 16-20 degrees celsius

Intervention Type: OTHER

hand and back cooling at 12-15 or 16-20 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature while also wearing the back wrap cooling device set to this temperature

No Intervention

Participants will participate in "passive cooling" where they sit in a chair during rest

Group Type: PLACEBO_COMPARATOR

Passive cooling

Intervention Type: OTHER

participants will sit in a chair and "passively cool" (no active intervention)

Interventions

Hand Cooling at 12-15 degrees celsius

hand cooling at 12-15 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature

Intervention Type: OTHER

Hand Cooling at 16-20 degrees celsius

hand cooling at 16-20 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature

Intervention Type: OTHER

hand and back cooling at 12-15 or 16-20 degrees celsius

hand and back cooling at 12-15 or 16-20 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature while also wearing the back wrap cooling device set to this temperature

Intervention Type: OTHER

Passive cooling

participants will sit in a chair and "passively cool" (no active intervention)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• male or female between the ages of 18-45 years
• females only: taking monophasic birth control pill this is to maintain applicability to a large portion of the female population that take birth control and limit the influence of varying estrogen and progesterone levels throughout the menstrual cycle. during the informational session researchers will have this list of brands of monophasic birth control pill brands to determine if the participant is eligible Brevicon Modicon Wera Balziva Gildagia Philith Zenchent Estarylla Previfem Sprintec Ocella Yasmin Zarah Yaz Safyral Beyaz Cryselle Elinest Ogestrel Apri Desogen Juleber Reclipsen Solia Levora Altavera Daysee Lessina Lybrel Amethia Jolessa all trials will only be conducted during the days the participant is on the hormone pill (not on the days during which they are taking the placebo pill)
• been cleared by the medical monitor for this study
• VO2max > 45ml/kg/min (measure obtained only from the VO2max test performed on the treadmill on Visit 1)
• Aerobically active (at least 30 minutes of aerobic exercise 4-5 days per week)

Exclusion Criteria

• Have a current musculoskeletal injury that would limit their physical activity or preclude the participant from walking, jogging, running, sprinting, or cutting.
• Chronic health problems that affect your ability to thermoregulate (disorders affecting the liver, kidneys or the ability to sweat normally)
• Fever or current illness at the time of testing
• History of cardiovascular, metabolic, or respiratory disease
• A family member died for no apparent reason, had a heart attack, died from heart problems, or sudden death before the age of 50
• Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin)
• Have a history of heat related illness
• Have any allergies or adverse reactions to the cold (e.g. Cold Uticaria, Raynauds -Phenomenon/Disease, or Cryoglobulinanemia)
• Have claustrophobia or feelings of discomfort towards sitting in a small, enclosed area
• Have allergies to medical and/or adhesive tape
• Have eating disorders
• History of COVID-19 unless cleared by a physician for exercise at the level exercise required to participate in this study. The physician must be made aware of what is required to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kelvi - Hypothermia Devices, Inc.

UNKNOWN

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Douglas J Casa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Korey Stringer Institute, University of Connecticut

Storrs, Connecticut, United States

Countries

United States

Other Identifiers

H21-0031

Identifier Type: -

Identifier Source: org_study_id