Clinical trial NCT04915859: Semiconductor Heat Extraction Cooling
Official title: Semiconductor Heat Extraction Cooling During and After Exercise in the Heat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperthermia
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Kelvi - Hypothermia Devices, Inc.
First posted: 2021-06-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive four cooling treatment on separate study visits 1)hand cooling at 12-15C 2)hand cooling at 16-20C 3)passive cooling 4)back and hand cooling (at 12-15C or 16-20C depending on results of trials 1-3)
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Difference in VO2max between Cycle ergometer and treadmill
timeFrame: through study completion, an average of 2 weeks
measure: Metabolic Heat Production
timeFrame: through study completion, an average of 2 weeks
measure: Change in Rectal Temperature
timeFrame: through study completion, an average of 2 weeks
measure: Change in Heart Rate
timeFrame: through study completion, an average of 2 weeks
measure: Change in Mean Skin temperature
timeFrame: through study completion, an average of 2 weeks
measure: Change in Rating of Perceived Exertion
timeFrame: through study completion, an average of 2 weeks
measure: Change in Performance Measures
timeFrame: through study completion, an average of 2 weeks
measure: Change Injury Risk Assessment Measures
timeFrame: through study completion, an average of 2 weeks
measure: Change in Cognitive Measures
timeFrame: through study completion, an average of 2 weeks
measure: Change in Recovery
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: Change in Thermal Sensation
timeFrame: through study completion, an average of 2 weeks
measure: Change in Perception of Fatigue
timeFrame: through study completion, an average of 2 weeks
measure: Change in Perception of thirst
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Storrs
country: United States
facility: Korey Stringer Institute, University of Connecticut
state: Connecticut
Study officials:
References: