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Semiconductor Heat Extraction Cooling (SHE-Cool)

Primary Purpose

Hyperthermia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand Cooling at 12-15 degrees celsius
Hand Cooling at 16-20 degrees celsius
hand and back cooling at 12-15 or 16-20 degrees celsius
Passive cooling
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperthermia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Korey Stringer Institute, University of Connecticut

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Cooling

No Intervention

Arm Description

Participants will be actively cooled during rest breaks

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

Outcomes

Primary Outcome Measures

Difference in VO2max between Cycle ergometer and treadmill
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.
Metabolic Heat Production
Participants will be tested for 3-5 minutes at different % of their VO2max. It will include 5 stages.
Change in Rectal Temperature
Rectal thermometer will be self-inserted by participant to assess core temperature
Change in Heart Rate
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
Change in Mean Skin temperature
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
Change in Rating of Perceived Exertion
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.
Change in Performance Measures
Participants will perform a performance battery consisting of a wingate anaerobic power test, grip strength test, and broad jump test
Change Injury Risk Assessment Measures
Participants will perform a injury risk assessment battery consisting of a balance and squat form assessments
Change in Cognitive Measures
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
Change in Recovery
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 Outcome Measures

Change in Thermal Sensation
0-8 Scale (cold to hot) that indicated how cold or hot the participate feels. 0 = extremely cold, 8 = extremely hot
Change in Perception of Fatigue
0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels. High score indicates more fatigue (negative outcome).
Change in Perception of thirst
0-9 (no thirst to extreme thirst) Scale that indicates how thirsty the subject feels. A higher score is considered a negative outcome

Full Information

First Posted
May 27, 2021
Last Updated
May 27, 2022
Sponsor
University of Connecticut
Collaborators
Kelvi - Hypothermia Devices, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04915859
Brief Title
Semiconductor Heat Extraction Cooling
Acronym
SHE-Cool
Official Title
Semiconductor Heat Extraction Cooling During and After Exercise in the Heat
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
Kelvi - Hypothermia Devices, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Cooling
Arm Type
Active Comparator
Arm Description
Participants will be actively cooled during rest breaks
Arm Title
No Intervention
Arm Type
Placebo Comparator
Arm Description
Participants will participate in "passive cooling" where they sit in a chair during rest
Intervention Type
Other
Intervention Name(s)
Hand Cooling at 12-15 degrees celsius
Intervention Description
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
Intervention Name(s)
Hand Cooling at 16-20 degrees celsius
Intervention Description
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
Intervention Name(s)
hand and back cooling at 12-15 or 16-20 degrees celsius
Intervention Description
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
Intervention Name(s)
Passive cooling
Intervention Description
participants will sit in a chair and "passively cool" (no active intervention)
Primary Outcome Measure Information:
Title
Difference in VO2max between Cycle ergometer and treadmill
Description
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.
Time Frame
through study completion, an average of 2 weeks
Title
Metabolic Heat Production
Description
Participants will be tested for 3-5 minutes at different % of their VO2max. It will include 5 stages.
Time Frame
through study completion, an average of 2 weeks
Title
Change in Rectal Temperature
Description
Rectal thermometer will be self-inserted by participant to assess core temperature
Time Frame
through study completion, an average of 2 weeks
Title
Change in Heart Rate
Description
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
Time Frame
through study completion, an average of 2 weeks
Title
Change in Mean Skin temperature
Description
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
Time Frame
through study completion, an average of 2 weeks
Title
Change in Rating of Perceived Exertion
Description
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.
Time Frame
through study completion, an average of 2 weeks
Title
Change in Performance Measures
Description
Participants will perform a performance battery consisting of a wingate anaerobic power test, grip strength test, and broad jump test
Time Frame
through study completion, an average of 2 weeks
Title
Change Injury Risk Assessment Measures
Description
Participants will perform a injury risk assessment battery consisting of a balance and squat form assessments
Time Frame
through study completion, an average of 2 weeks
Title
Change in Cognitive Measures
Description
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
Time Frame
through study completion, an average of 2 weeks
Title
Change in Recovery
Description
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.
Time Frame
through study completion, an average of 2 weeks
Secondary Outcome Measure Information:
Title
Change in Thermal Sensation
Description
0-8 Scale (cold to hot) that indicated how cold or hot the participate feels. 0 = extremely cold, 8 = extremely hot
Time Frame
through study completion, an average of 2 weeks
Title
Change in Perception of Fatigue
Description
0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels. High score indicates more fatigue (negative outcome).
Time Frame
through study completion, an average of 2 weeks
Title
Change in Perception of thirst
Description
0-9 (no thirst to extreme thirst) Scale that indicates how thirsty the subject feels. A higher score is considered a negative outcome
Time Frame
through study completion, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Korey Stringer Institute, University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Semiconductor Heat Extraction Cooling

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