HyperthermiaSHE-CoolNCT04915859

Semiconductor Heat Extraction Cooling

A study testing Hand Cooling at 12-15 degrees celsius, Hand Cooling at 16-20 degrees celsius and hand and back cooling at 12-15 or 16-20 degrees celsius in people with Hyperthermia, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Hyperthermia
What is being tested?: Hand Cooling at 12-15 degrees celsius, Hand Cooling at 16-20 degrees celsius and hand and back cooling at 12-15 or 16-20 degrees celsius
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 4 Oct 2021to 31 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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)

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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 locations and contacts

1 site in 1 country.

United States1 site

Korey Stringer Institute, University of Connecticut
Storrs, Connecticut, 06269

Other trials in United States

About this study

Official title: Semiconductor Heat Extraction Cooling During and After Exercise in the Heat

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
Being tested: 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
Medical subject headings: Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hand Cooling at 12-15 degrees celsiusOther
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 celsiusOther
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 celsiusOther
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 coolingOther
participants will sit in a chair and "passively cool" (no active intervention)

Study groups in NCT04915859
Study group	Role	What they receive
Active Cooling	Active comparator	Participants will be actively cooled during rest breaks Receives: Other: Hand Cooling at 12-15 degrees celsius; Other: Hand Cooling at 16-20 degrees celsius; Other: hand and back cooling at 12-15 or 16-20 degrees celsius
No Intervention	Placebo comparator	Participants will participate in "passive cooling" where they sit in a chair during rest Receives: Other: Passive cooling

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: through study completion, an average of 2 weeks
Metabolic Heat Production
Participants will be tested for 3-5 minutes at different % of their VO2max. It will include 5 stages.
Measured: through study completion, an average of 2 weeks
Change in Rectal Temperature
Rectal thermometer will be self-inserted by participant to assess core temperature
Measured: through study completion, an average of 2 weeks
Change in Heart Rate
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
Measured: through study completion, an average of 2 weeks
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
Measured: through study completion, an average of 2 weeks
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.
Measured: through study completion, an average of 2 weeks
Change in Performance Measures
Participants will perform a performance battery consisting of a wingate anaerobic power test, grip strength test, and broad jump test
Measured: through study completion, an average of 2 weeks
Change Injury Risk Assessment Measures
Participants will perform a injury risk assessment battery consisting of a balance and squat form assessments
Measured: through study completion, an average of 2 weeks
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
Measured: through study completion, an average of 2 weeks
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.
Measured: through study completion, an average of 2 weeks

Secondary outcomes (3)

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
Measured: through study completion, an average of 2 weeks
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).
Measured: through study completion, an average of 2 weeks
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
Measured: through study completion, an average of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 202131 Jan 2022

First posted7 Jun 2021
Study start4 Oct 2021
Primary completion31 Jan 2022
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HyperthermiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
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)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04915859
Sponsor's protocol ID: H21-0031
Acronym: SHE-Cool
Status last verified: May 2022
First submitted: 27 May 2021
Last updated: 31 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperthermia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Semiconductor Heat Extraction Cooling During and After Exercise in the Heat
ClinicalTrials.gov ID: NCT04915859
Acronym / sponsor ID: SHE-Cool / H21-0031
Conditions: Hyperthermia
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of ConnecticutUniversity, hospital or other
Collaborators: Kelvi - Hypothermia Devices, Inc.
Study start: 4 Oct 2021 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 7 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
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)

Arm	Type	Receives
Active Cooling	Active comparator	Other: Hand Cooling at 12-15 degrees celsius, Other: Hand Cooling at 16-20 degrees celsius, Other: hand and back cooling at 12-15 or 16-20 degrees celsiusParticipants will be actively cooled during rest breaks
No Intervention	Placebo comparator	Other: Passive coolingParticipants will participate in "passive cooling" where they sit in a chair during rest

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hand Cooling at 12-15 degrees celsiushand 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	Other	Active Cooling
Hand Cooling at 16-20 degrees celsiushand 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	Other	Active Cooling
hand and back cooling at 12-15 or 16-20 degrees celsiushand 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	Other	Active Cooling
Passive coolingparticipants will sit in a chair and "passively cool" (no active intervention)	Other	No Intervention

Primary outcome

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.
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.
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
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
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
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.
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
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
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
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.

3 secondary outcomes

Change in Thermal Sensation
Time frame: through study completion, an average of 2 weeks
Change in Perception of Fatigue
Time frame: through study completion, an average of 2 weeks
Change in Perception of thirst
Time frame: through study completion, an average of 2 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
Individual participant dataSharing planned: No

Related trials for Hyperthermia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in VO2max between Cycle ergometer and treadmill (time frame: through study completion, an average of 2 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04915859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.