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Completed

NCT Number: NCT04915859

Semiconductor Heat Extraction Cooling

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.

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Key information

Conditions

Hyperthermia Body Temperature Changes Heat Stress Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korey Stringer Institute, University of Connecticut

Storrs, Connecticut, 06269, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hand Cooling at 12-15 degrees celsius

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

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

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

Passive cooling

Other

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

Primary outcomes

  1. Difference in VO2max between Cycle ergometer and treadmill

    Time frame: through study completion, an average of 2 weeks

    Participants will be fitted with a Hans Rudolph mask attached to a breathing tube to measure the expired air delivered to the metabolic cart system during the exercise protocol. The metabolic cart will continuously measure oxygen consumption (VO2) to asess their VO2max value.

  2. Metabolic Heat Production

    Time frame: through study completion, an average of 2 weeks

    Participants will be tested for 3-5 minutes at different % of their VO2max. It will include 5 stages.

  3. Change in Rectal Temperature

    Time frame: through study completion, an average of 2 weeks

    Rectal thermometer will be self-inserted by participant to assess core temperature

  4. Change in Heart Rate

    Time frame: through study completion, an average of 2 weeks

    A heart rate monitor will be worn by participant throughout exercise/cooling protocol

  5. Change in Mean Skin temperature

    Time frame: through study completion, an average of 2 weeks

    Prior to the start of exercise, participants will be instrumented with iButton skin temperature sensors on the chest, arm, thigh, calf, back of hand, and ankle

  6. Change in Rating of Perceived Exertion

    Time frame: through study completion, an average of 2 weeks

    6-20 scale that indicates how hard the participant feels they are working. 6 represents rest and 20 represents maximal exertion. A high score indicates more perceived exertion.

  7. Change in Performance Measures

    Time frame: through study completion, an average of 2 weeks

    Participants will perform a performance battery consisting of a wingate anaerobic power test, grip strength test, and broad jump test

  8. Change Injury Risk Assessment Measures

    Time frame: through study completion, an average of 2 weeks

    Participants will perform a injury risk assessment battery consisting of a balance and squat form assessments

  9. Change in Cognitive Measures

    Time frame: through study completion, an average of 2 weeks

    Participants will perform 2 cognitive tests (Go-Nogo and Stroop) on a laptop to measure reaction time and errors. Both tests should take 5 minutes

  10. Change in Recovery

    Time frame: through study completion, an average of 2 weeks

    Participants will be provided a WHOOP strap and Polar heart rate strap at their first visit. They will be instructed on how to download the associated apps and how to charge and care for the devices. They will be provided instructions with how to take heart rate measures. The WHOOP and heart rate measures will provide data on sleep quality and quantity, strain, and recovery.

Secondary outcomes

  1. Change in Thermal Sensation

    Time frame: through study completion, an average of 2 weeks

    0-8 Scale (cold to hot) that indicated how cold or hot the participate feels. 0 = extremely cold, 8 = extremely hot

  2. Change in Perception of Fatigue

    Time frame: through study completion, an average of 2 weeks

    0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels. High score indicates more fatigue (negative outcome).

  3. Change in Perception of thirst

    Time frame: through study completion, an average of 2 weeks

    0-9 (no thirst to extreme thirst) Scale that indicates how thirsty the subject feels. A higher score is considered a negative outcome

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Kelvi - Hypothermia Devices, Inc.

Registry information

Official study title

Semiconductor Heat Extraction Cooling During and After Exercise in the Heat

Acronym: SHE-Cool

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2021
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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