HyperthermiaNCT04596618
Impact of ICE on Exercise Performance in the Heat
A study testing Forearm cooling in people with Hyperthermia, run by University of Connecticut at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of intermittent forearm cooling on exercise performance in the heat. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia
- What is being tested?
- Forearm cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 9 Dec 2020
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cisgender male between the ages of 18-30 years
- been cleared by the medical monitor for the study
- VO2max >45ml/kg/min
Who cannot join
- 1. have a current musculoskeletal injury that would limit their physical activity or preclude the participant from walking, jogging, running, sprinting, or cutting.
- 2. Chronic health problems that affect your ability to thermoregulate (disorders affecting the liver, kidneys or the ability to sweat normally) 3. Fever or current illness at the time of testing 4. History of cardiovascular, metabolic, or respiratory disease 5. Current musculoskeletal injury that limits their physical activity 6. Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, NSAIDs, aspirin) 7. Are a female 8. Have a history of heat related illness 9. Have any cold allergies or adverse reactions to the cold (i.e. cold urticaria, Raynaud's, cryoglobulinemia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Forearm Immersion Cooling Equipment (ICE) on Exercise Performance in the Heat
The purpose of this study is to determine the effects of intermittent forearm cooling on exercise performance in the heat.
Read the detailed description
The study will be completed in the following timeline:
Visit 1: Baseline and VO2max testing. Visit 2-3: Trial 1 and 2
Visit specific information is described below, however, specific data collection protocols for dependent variables and procedures are included below the description of the study design.
Visit 1: Baseline and VO2max Testing
Participants who are approved to participate will be scheduled for a baseline and VO2max testing day. Upon arrival to the lab, subjects will provide a urine sample in a clean urine cup. Urine specific gravity and urine color will be assessed. Nude body mass will be also be recorded. Privacy will be afforded for each participant while obtaining body mass measures by taking measurements with the participant alone in a private room behind a solid, closed door, and the research reading the scale outside of the room. Participants will only be permitted to continue to the VO2max test if the euhydrated criteria of a urine specific gravity (USG) <1.025 is met. If the participant arrives with a USG between 1.020 and 1.025, the subject will be asked to drink 500 mL of water to ensure proper hydration status. Height will be measured with a tape measure on Visit 1. Percent body fat will be calculated using a 3-site evaluation of skin fold thickness using skin fold calipers. A researcher will use appropriate grasping technique to measure skin fold thickness on the chest, tricep, and abdomen. This will take less than 5 minutes to complete. This information will be used to describe the subject demographics. Participants will also be asked to complete a maximal oxygen uptake (VO2max) test on a treadmill in a thermoneutral environment. This test will provide aerobic fitness levels of the participants. This visit will take approximately 1-2 hours.
Visit 2-3: Trials 1 and 2
Participant numbers will be randomly assigned, and trials will be ordered with a random number generator and assigned to a participant number. These orders will be counterbalanced between participants to ensure that there is not an order effect, and each participant will complete two trials as part of the study. Participants will be allowed to make-up trial visits if they are sick, suffer an injury or do not meet hydration requirements. Participants will be asked if they have a current illness or taking medications to determine whether they can complete the exercise trial. The participant's visit will be rescheduled if they have a fever, current illness or taking medications that influence body temperature.
Participants will complete two trials on two separate days in a randomized counter balanced order:
Trial Cooling Intervention
- Passive Cooling
- Forearm Immersion
The exercise protocol, cooling intervention, and performance battery portions of this study will be conducted in a climatic chamber with ambient temperature approximately 30-40C and relative humidity at approximately 40-60%. Participants will drink approximately 1.4L of water throughout the exercise trial. Upon arrival to the lab, participants will be asked to indicate if they have consumed alcohol or caffeine in the last 24 hours and 12 hours, respectively. They will not be asked to specify exactly what they have consumed, but if they provide a positive indication, their trial will be rescheduled for another day. Participants will provide a small urine sample in a clean urine cup, and a nude body mass will be measured. Upon arrival to the lab, hydration status will be assessed by urine specific gravity, nude body mass and urine color. Participants will only be permitted to continue to the exercise trial if the euhydrated criteria of a urine specific gravity (USG) <1.025 is met. If the participant arrives with a USG between 1.020 and 1.025, the subject will be asked to drink 500 mL of water to ensure proper hydration status. Participants will be given instructions at the prior visit about how to obtain desired hydration status for the upcoming trial. Participants will insert a rectal probe and wear a heart rate monitor strap. Researchers will insert the esophageal probe. Additionally, participants will wear 4-site skin temperature sensors. Researchers will apply the skin temperature sensors with medical tape to the participants' chest, upper arm, thigh, and calf.
Participants will enter the environmental chamber and sit for 10 minutes to become equilibrated. Participants will wear a metabolic mask during this time to assess baseline metabolic heat production. The environmental chamber will be set to 35C ambient temperature, 50% relative humidity. After baseline measures of heart rate, rectal temperature, and metabolic heat production, participants will complete the perceptual indices. Participants will also complete an environmental symptoms questionnaire (ESQ).
The trial will consist of three, 20-minute exercise bouts consisting of walking, running, and sprinting at varying speeds ranging approximately 20-90% of their VO2max. Followed by a 12-minute "half-time" consisting of passive rest. Participants will then complete three more 20-minute exercise bouts consisting of walking, running, and sprinting at varying speeds ranging approximately 20-90% of their VO2max, for a total of six 20-minute bouts.
Each 20-minute exercise bout with be followed by a 3-minute break where cooling will occur. Participants will be allowed to drink 750mL of water throughout each exercise half for a total of 1.4L. The participant will be cooled for approximately 3 minutes after each 20-minute exercise bout with their assigned cooling modality. Rectal temperature, esophageal temperature, skin temperature, heart rate, perceptual measures, and metabolic heat production will be collected at various time points before, during, and after exercise and cooling. Following the completion of the six 20-minute exercise bouts, participants will perform the performance battery. The performance battery will consist of an agility test, grip strength test, broad-jump test, sprint test, and 1-mile time trial test.
Passive Cooling: Participants will be asked to sit in a chair in the climate chamber for passive cooling.
Forearm immersion: The participant will place both of their forearms in approximately 15C water during forearm immersion.
Each trial will be approximately 3 hours.
All devices will be properly cleaned according to manufacturer's instruction prior to use by other participants.
- Conditions
- Hyperthermia
- Being tested
- Forearm cooling
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm coolingDevice
forearm cooling will be performed for active cooling assessment.
| Study group | Role | What they receive |
|---|---|---|
| Forearm Cooling | Active comparator | Participants will be actively cooled during rest breaks. Receives: Device: Forearm cooling |
| No Forearm Cooling | No intervention | Participants will participant in "passive cooling" where they sit in a chair during rest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rectal Temperature
Rectal thermometer will be self-inserted by participant to assess core temperature
Measured: Measured continuously during the duration of the trial (total 150 minutes)
Change in Mean Skin Temperature
4 skin temperature sensors will be placed on the subject (chest, shoulder, thigh, calf)
Measured: Measured continuously during the duration of the trial (total 150 minutes)
Change in Heart Rate
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
Measured: Measured continuously during the duration of the trial (total 150 minutes)
Change in Esophageal Temperature
An esophageal thermometer will be inserted by the researchers to assess participants esophageal temperature.
Measured: Measured continuously during the duration of the trial (total 150 minutes)
Change in Rating of Perceived Exertion (RPE)
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: Measured every 5 minutes during the duration of the trial (total 150 minutes)
Change in Thermal Sensation (TS)
0-8 Scale (cold to hot) that indicated how cold or hot the participate feels. 0 = extremely cold, 8 = extremely hot.
Measured: Measured every 5 minutes during the duration of the trial (total 150 minutes)
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: Measured every 5 minutes during the duration of the trial (total 150 minutes)
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: Measured every 5 minutes during the duration of the trial (total 150 minutes)
Environmental Symptoms
An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable) with the scale ranging from Not at all, a little, somewhat, moderate, a lot, to extreme.
Measured: Before the start of exercise block 1
Environmental Symptoms
An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable) with the scale ranging from Not at all, a little, somewhat, moderate, a lot, to extreme.
Measured: After completion of the performance battery, at time point 180min.
Quick-Board Agility
Agility will be assessed by number of foot taps within 10seconds and then number of hops within 10seconds.
Measured: After the end of 3min cooling period block 6
Broad Jump
Participants will attempt to jump as far forward as they can 3 times, measured in centimeters.
Measured: after the quick-board agility, at time point 153minutes
Grip Strength
Participants will squeeze a hand held dynamometer 3 times, measured in kilograms
Measured: after the Broad jump test, at time point 155minutes
Sprints
On a non-motorized treadmill, participants will sprint for 6sec followed by 24sec of rest, repeat 3 times, belt revolutions will be measured.
Measured: after the grip strength test, at time point 160minutes
One Mile Timed Trial
On a motorized treadmill, participants will run at a self-selected pace until they run a distance of 1-mile, time measured in minutes
Measured: after the sprint test, at time point 170minutes
Metabolic heat production
Using a metabolic mask and metabolic cart, metabolic heat production will be collected.
Measured: Measured during the last 5 minutes of each exercise block for a total of six measurements for a total of 36minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start20 Oct 2020
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants receive two cooling treatments on separate study visits: 1) passive cooling 2) forearm immersion cooling
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas J Casa, University of Connecticut
- Investigators
- Douglas Casa, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596618
- Sponsor's protocol ID
- H20-0092
- Status last verified
- Dec 2020
- First submitted
- 1 Oct 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Forearm Immersion Cooling Equipment (ICE) on Exercise Performance in the Heat
- ClinicalTrials.gov ID
- NCT04596618
- Acronym / sponsor ID
- H20-0092
- Conditions
- Hyperthermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 22 Oct 2020 (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.
The purpose of this study is to determine the effects of intermittent forearm cooling on exercise performance in the heat.
Detailed description
The study will be completed in the following timeline:
Visit 1: Baseline and VO2max testing. Visit 2-3: Trial 1 and 2
Visit specific information is described below, however, specific data collection protocols for dependent variables and procedures are included below the description of the study design.
Visit 1: Baseline and VO2max Testing
Participants who are approved to participate will be scheduled for a baseline and VO2max testing day. Upon arrival to the lab, subjects will provide a urine sample in a clean urine cup. Urine specific gravity and urine color will be assessed. Nude body mass will be also be recorded. Privacy will be afforded for each participant while obtaining body mass measures by taking measurements with the participant alone in a private room behind a solid, closed door, and the research reading the scale outside of the room. Participants will only be permitted to continue to the VO2max test if the euhydrated criteria of a urine specific gravity (USG) <1.025 is met. If the participant arrives with a USG between 1.020 and 1.025, the subject will be asked to drink 500 mL of water to ensure proper hydration status. Height will be measured with a tape measure on Visit 1. Percent body fat will be calculated using a 3-site evaluation of skin fold thickness using skin fold calipers. A researcher will use appropriate grasping technique to measure skin fold thickness on the chest, tricep, and abdomen. This will take less than 5 minutes to complete. This information will be used to describe the subject demographics. Participants will also be asked to complete a maximal oxygen uptake (VO2max) test on a treadmill in a thermoneutral environment. This test will provide aerobic fitness levels of the participants. This visit will take approximately 1-2 hours.
Visit 2-3: Trials 1 and 2
Participant numbers will be randomly assigned, and trials will be ordered with a random number generator and assigned to a participant number. These orders will be counterbalanced between participants to ensure that there is not an order effect, and each participant will complete two trials as part of the study. Participants will be allowed to make-up trial visits if they are sick, suffer an injury or do not meet hydration requirements. Participants will be asked if they have a current illness or taking medications to determine whether they can complete the exercise trial. The participant's visit will be rescheduled if they have a fever, current illness or taking medications that influence body temperature.
Participants will complete two trials on two separate days in a randomized counter balanced order:
Trial Cooling Intervention
- Passive Cooling
- Forearm Immersion
The exercise protocol, cooling intervention, and performance battery portions of this study will be conducted in a climatic chamber with ambient temperature approximately 30-40C and relative humidity at approximately 40-60%. Participants will drink approximately 1.4L of water throughout the exercise trial. Upon arrival to the lab, participants will be asked to indicate if they have consumed alcohol or caffeine in the last 24 hours and 12 hours, respectively. They will not be asked to specify exactly what they have consumed, but if they provide a positive indication, their trial will be rescheduled for another day. Participants will provide a small urine sample in a clean urine cup, and a nude body mass will be measured. Upon arrival to the lab, hydration status will be assessed by urine specific gravity, nude body mass and urine color. Participants will only be permitted to continue to the exercise trial if the euhydrated criteria of a urine specific gravity (USG) <1.025 is met. If the participant arrives with a USG between 1.020 and 1.025, the subject will be asked to drink 500 mL of water to ensure proper hydration status. Participants will be given instructions at the prior visit about how to obtain desired hydration status for the upcoming trial. Participants will insert a rectal probe and wear a heart rate monitor strap. Researchers will insert the esophageal probe. Additionally, participants will wear 4-site skin temperature sensors. Researchers will apply the skin temperature sensors with medical tape to the participants' chest, upper arm, thigh, and calf.
Participants will enter the environmental chamber and sit for 10 minutes to become equilibrated. Participants will wear a metabolic mask during this time to assess baseline metabolic heat production. The environmental chamber will be set to 35C ambient temperature, 50% relative humidity. After baseline measures of heart rate, rectal temperature, and metabolic heat production, participants will complete the perceptual indices. Participants will also complete an environmental symptoms questionnaire (ESQ).
The trial will consist of three, 20-minute exercise bouts consisting of walking, running, and sprinting at varying speeds ranging approximately 20-90% of their VO2max. Followed by a 12-minute "half-time" consisting of passive rest. Participants will then complete three more 20-minute exercise bouts consisting of walking, running, and sprinting at varying speeds ranging approximately 20-90% of their VO2max, for a total of six 20-minute bouts.
Each 20-minute exercise bout with be followed by a 3-minute break where cooling will occur. Participants will be allowed to drink 750mL of water throughout each exercise half for a total of 1.4L. The participant will be cooled for approximately 3 minutes after each 20-minute exercise bout with their assigned cooling modality. Rectal temperature, esophageal temperature, skin temperature, heart rate, perceptual measures, and metabolic heat production will be collected at various time points before, during, and after exercise and cooling. Following the completion of the six 20-minute exercise bouts, participants will perform the performance battery. The performance battery will consist of an agility test, grip strength test, broad-jump test, sprint test, and 1-mile time trial test.
Passive Cooling: Participants will be asked to sit in a chair in the climate chamber for passive cooling.
Forearm immersion: The participant will place both of their forearms in approximately 15C water during forearm immersion.
Each trial will be approximately 3 hours.
All devices will be properly cleaned according to manufacturer's instruction prior to use by other participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants receive two cooling treatments on separate study visits: 1) passive cooling 2) forearm immersion cooling
| Arm | Type | Receives |
|---|---|---|
| Forearm Cooling | Active comparator | Device: Forearm coolingParticipants will be actively cooled during rest breaks. |
| No Forearm Cooling | No intervention | –Participants will participant in "passive cooling" where they sit in a chair during rest. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cisgender male between the ages of 18-30 years
- been cleared by the medical monitor for the study
- VO2max >45ml/kg/min
Key exclusion criteria (2 listed)
- 1. have a current musculoskeletal injury that would limit their physical activity or preclude the participant from walking, jogging, running, sprinting, or cutting.
- 2. Chronic health problems that affect your ability to thermoregulate (disorders affecting the liver, kidneys or the ability to sweat normally) 3. Fever or current illness at the time of testing 4. History of cardiovascular, metabolic, or respiratory disease 5. Current musculoskeletal injury that limits their physical activity 6. Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, NSAIDs, aspirin) 7. Are a female 8. Have a history of heat related illness 9. Have any cold allergies or adverse reactions to the cold (i.e. cold urticaria, Raynaud's, cryoglobulinemia)
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 |
|---|---|---|
| Forearm coolingforearm cooling will be performed for active cooling assessment. | Device | Forearm Cooling |
Primary outcome
Change in Rectal Temperature
Time frame: Measured continuously during the duration of the trial (total 150 minutes)
Rectal thermometer will be self-inserted by participant to assess core temperature
Change in Mean Skin Temperature
Time frame: Measured continuously during the duration of the trial (total 150 minutes)
4 skin temperature sensors will be placed on the subject (chest, shoulder, thigh, calf)
Change in Heart Rate
Time frame: Measured continuously during the duration of the trial (total 150 minutes)
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
Change in Esophageal Temperature
Time frame: Measured continuously during the duration of the trial (total 150 minutes)
An esophageal thermometer will be inserted by the researchers to assess participants esophageal temperature.
Change in Rating of Perceived Exertion (RPE)
Time frame: Measured every 5 minutes during the duration of the trial (total 150 minutes)
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 Thermal Sensation (TS)
Time frame: Measured every 5 minutes during the duration of the trial (total 150 minutes)
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
Time frame: Measured every 5 minutes during the duration of the trial (total 150 minutes)
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
Time frame: Measured every 5 minutes during the duration of the trial (total 150 minutes)
0-9 (no thirst to extreme thirst) Scale that indicates how thirsty the subject feels. A higher score is considered a negative outcome.
Environmental Symptoms
Time frame: Before the start of exercise block 1
An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable) with the scale ranging from Not at all, a little, somewhat, moderate, a lot, to extreme.
Environmental Symptoms
Time frame: After completion of the performance battery, at time point 180min.
An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable) with the scale ranging from Not at all, a little, somewhat, moderate, a lot, to extreme.
Quick-Board Agility
Time frame: After the end of 3min cooling period block 6
Agility will be assessed by number of foot taps within 10seconds and then number of hops within 10seconds.
Broad Jump
Time frame: after the quick-board agility, at time point 153minutes
Participants will attempt to jump as far forward as they can 3 times, measured in centimeters.
Grip Strength
Time frame: after the Broad jump test, at time point 155minutes
Participants will squeeze a hand held dynamometer 3 times, measured in kilograms
Sprints
Time frame: after the grip strength test, at time point 160minutes
On a non-motorized treadmill, participants will sprint for 6sec followed by 24sec of rest, repeat 3 times, belt revolutions will be measured.
One Mile Timed Trial
Time frame: after the sprint test, at time point 170minutes
On a motorized treadmill, participants will run at a self-selected pace until they run a distance of 1-mile, time measured in minutes
Metabolic heat production
Time frame: Measured during the last 5 minutes of each exercise block for a total of six measurements for a total of 36minutes.
Using a metabolic mask and metabolic cart, metabolic heat production will be collected.
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 21 Dec 2020.
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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.
Douglas Casa, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm cooling in people with Hyperthermia, run by University of Connecticut 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 3 inclusion and 2 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 21 Dec 2020. 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 Rectal Temperature (time frame: Measured continuously during the duration of the trial (total 150 minutes)). The study lists 16 primary outcomes in all. 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 21 Dec 2020.