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Semiconductor Heat Extraction Cooling (SHE-Cool)

University of Connecticut logo

University of Connecticut

Status

Completed

Conditions

Hyperthermia

Treatments

Other: Passive cooling
Other: hand and back cooling at 12-15 or 16-20 degrees celsius
Other: Hand Cooling at 16-20 degrees celsius
Other: Hand Cooling at 12-15 degrees celsius

Study type

Interventional

Funder types

Other

Identifiers

NCT04915859
H21-0031

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups, including a placebo group

Active Cooling
Active Comparator group
Description:
Participants will be actively cooled during rest breaks
Treatment:
Other: hand and back cooling at 12-15 or 16-20 degrees celsius
Other: Hand Cooling at 16-20 degrees celsius
Other: Hand Cooling at 12-15 degrees celsius
No Intervention
Placebo Comparator group
Description:
Participants will participate in "passive cooling" where they sit in a chair during rest
Treatment:
Other: Passive cooling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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