Cryotherapy EffectNCT03643835
Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals
A study testing Thermal Rehab Machine and Forearm Ice Towels in people with Cryotherapy Effect, run by University of North Carolina, Greensboro at 1 site in United States.
Trial summary
Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C with the presence of central nervous dysfunction (altered mental status). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- Thermal Rehab Machine and Forearm Ice Towels
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 31 Dec 2018
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male between the ages of 18-35.
- recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session)
Who cannot join
- chronic health problems,
- fever or current illness at the time of testing
- history of cardiovascular, metabolic, or respiratory disease
- current musculoskeletal injury that limits physical activity
- history of exertional heat illness in the past three years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Greensboro
Greensboro, North Carolina, 27412
About this study
Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C with the presence of central nervous dysfunction (altered mental status). The gold standard method of care for EHS is immediate onsite whole body cooling using cold-water immersion (cooling rates >0.15°C•min-1), which is reported to have the highest cooling rate. In the treatment of EHS, selecting a cooling modality with a high cooling rate becomes crucial to minimize the time above the critical threshold of body temperature at 40°C to less than 30 minutes for the best chance of survival and to minimize the severity of prognosis. However, in situations where cold water immersion is not feasible (in certain military, firefighter, or other remote settings), other cooling modalities must be available that have a cooling capacity similar to that of cold-water immersion. In this proposed study, the investigators aim to examine the cooling rates of the Polar Breeze® device (developed by Statim Technologies, LLC, Clearwater, FL) compared to rotating ice towels, a cooling method often recommended by sports medicine professionals as an alternative to cold-water immersion, and passive rest in participants with exercise-induced hyperthermia.
- Conditions
- Cryotherapy Effect
- Being tested
- Thermal Rehab Machine, Forearm Ice Towels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Rehab MachineDevice
Also called Polar Breeze
The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air
Forearm Ice TowelsOther
Towels that are wetted with ice water and wrapped around participants forearms (length of arm from wrist to elbow)
| Study group | Role | What they receive |
|---|---|---|
| Thermal rehab machine | Experimental | Participants, following exercise-induced hyperthermia, will be cooled using a Thermal Rehab Machine (Polar Breeze, Statim Technologies, LLC, Clearwater Florida), which is a micro-environmental air chiller. The device will be placed over the subjects head and through trans pulmonary cooling, will cool the body. Receives: Device: Thermal Rehab Machine |
| Forearm Ice Towels | Active comparator | Participants, following exercise-induced hyperthermia, will be cooled using forearm ice towels. Cotton-blend towels will be doused in ice-water and then wrapped around participant's forearms (elbow to wrist). The towels will be rotated (re-wetted) every 2 minutes) Receives: Other: Forearm Ice Towels |
| Passive Cooling | No intervention | Participants, following exercise-induced hyperthermia, will undergo a period of passive rest to allow the body to cool via natural mechanisms of evaporation of sweat from the skin's surface and convection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Internal Body Temperature
The rate at which body temperature is reduced during whole body cooling following exercise-induced hyperthermia.
Measured: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 minutes post onset of cooling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start17 Sep 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete three trials under three different body cooling conditions/interventions; passive cooling using the body's natural body cooling mechanisms, body cooling using forearm ice towels, and cooling using the investigational thermal rehab machine.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Collaborators
- Statim Technologies, LLC
- Responsible party
- Principal investigator, William Adams, University of North Carolina, Greensboro
- Investigators
- William M Adams, PhD, Principal investigator, University of North Carolina, Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643835
- Sponsor's protocol ID
- 18-0280
- Status last verified
- Apr 2019
- First submitted
- 15 Aug 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals
- ClinicalTrials.gov ID
- NCT03643835
- Acronym / sponsor ID
- 18-0280
- Conditions
- Cryotherapy Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Collaborators
- Statim Technologies, LLC
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Aug 2018 (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.
Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C with the presence of central nervous dysfunction (altered mental status). The gold standard method of care for EHS is immediate onsite whole body cooling using cold-water immersion (cooling rates >0.15°C•min-1), which is reported to have the highest cooling rate. In the treatment of EHS, selecting a cooling modality with a high cooling rate becomes crucial to minimize the time above the critical threshold of body temperature at 40°C to less than 30 minutes for the best chance of survival and to minimize the severity of prognosis. However, in situations where cold water immersion is not feasible (in certain military, firefighter, or other remote settings), other cooling modalities must be available that have a cooling capacity similar to that of cold-water immersion. In this proposed study, the investigators aim to examine the cooling rates of the Polar Breeze® device (developed by Statim Technologies, LLC, Clearwater, FL) compared to rotating ice towels, a cooling method often recommended by sports medicine professionals as an alternative to cold-water immersion, and passive rest in participants with exercise-induced hyperthermia.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will complete three trials under three different body cooling conditions/interventions; passive cooling using the body's natural body cooling mechanisms, body cooling using forearm ice towels, and cooling using the investigational thermal rehab machine.
| Arm | Type | Receives |
|---|---|---|
| Thermal rehab machine | Experimental | Device: Thermal Rehab MachineParticipants, following exercise-induced hyperthermia, will be cooled using a Thermal Rehab Machine (Polar Breeze, Statim Technologies, LLC, Clearwater Florida), which is a micro-environmental air chiller. The device will be placed over the subjects head and through trans pulmonary cooling, will cool the body. |
| Forearm Ice Towels | Active comparator | Other: Forearm Ice TowelsParticipants, following exercise-induced hyperthermia, will be cooled using forearm ice towels. Cotton-blend towels will be doused in ice-water and then wrapped around participant's forearms (elbow to wrist). The towels will be rotated (re-wetted) every 2 minutes) |
| Passive Cooling | No intervention | –Participants, following exercise-induced hyperthermia, will undergo a period of passive rest to allow the body to cool via natural mechanisms of evaporation of sweat from the skin's surface and convection |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male between the ages of 18-35.
- recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session)
Key exclusion criteria (5 listed)
- chronic health problems,
- fever or current illness at the time of testing
- history of cardiovascular, metabolic, or respiratory disease
- current musculoskeletal injury that limits physical activity
- history of exertional heat illness in the past three years.
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 |
|---|---|---|
| Thermal Rehab MachineAlso: Polar BreezeThe Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air | Device | Thermal rehab machine |
| Forearm Ice TowelsTowels that are wetted with ice water and wrapped around participants forearms (length of arm from wrist to elbow) | Other | Forearm Ice Towels |
Primary outcome
Change in Internal Body Temperature
Time frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 minutes post onset of cooling
The rate at which body temperature is reduced during whole body cooling following exercise-induced hyperthermia.
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 18 Apr 2019.
- Individual participant dataSharing planned: No
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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.
William M Adams, PhD principal investigator
University of North Carolina, Greensboro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Rehab Machine and Forearm Ice Towels in people with Cryotherapy Effect, run by University of North Carolina, Greensboro at 1 site in United States.
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 2 inclusion and 5 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 18 Apr 2019. 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. 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?
Change in Internal Body Temperature (time frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 minutes post onset of cooling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2019.