HyperthermiaNCT05135117
Impact of Neck Cooling Collar on Exercise Performance in the Heat
A study testing NeuroRescue Cooling Collar and Ice Towel in people with Hyperthermia, run by University of Connecticut at 1 site in United States.
Trial summary
During exercise in the heat, the thermoregulatory system impacts performance in an athletic population. Increased in core body temperature could lead to development of heat-related illnesses and impair physical performance. 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
- Hyperthermia
- What is being tested?
- NeuroRescue Cooling Collar and Ice Towel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 23 Nov 2021
- 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
- Physically active (at least 30 minutes of exercise 3-5 days per week) male
- been cleared by the medical monitor for this study
- Have a VO2max >45ml/kg/min
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
- Current musculoskeletal injury that limits their physical activity
Show all 13Show fewer
- Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin)
- Are a female. Due to the internal body temperature gradient that accompanies the menstrual cycle, inclusion of females may not provide the most controlled internal body temperature data for this study.
- Have a history of heat related illness
- Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing
- Have any allergies or adverse reactions to the cold (e.g. Cold Urticaria, Raynauds Phenomenon/Disease, or cryoglobulinaemia)
- Any COVID-19 related symptoms including fever, cough, shortness of breath or difficulty breathing, gastrointestinal discomfort (nausea, vomiting, and/or diarrhea), repeated shaking with chills, muscle pain (unrelated to exercise), headache, sore throat, new loss of taste or smell, congestion or runny nose.
- Participant with clinical diagnosis of COVID-19 infection or positive result on a COVID-19 test due to concern about cardiac complications.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
During exercise in the heat, the thermoregulatory system impacts performance in an athletic population. Increased in core body temperature could lead to development of heat-related illnesses and impair physical performance. To facilitate heat loss and optimize performance during exercise in the heat, various cooling strategies, including cold water immersion and wearable cooling devices have been previously explored. Although whole body cooling by cold water immersion is considered to be the most effective way to reduce core body temperature, this cooling method would not be feasible for athletes during practice or competition. Therefore, previous studies strongly recommended neck cooling during exercise because of the rate of heat dissipation through the large blood vessel and accessibility compared to other body part. Furthermore, multiple studies reported that the neck cooling could improve aerobic performance (i.e. running distance and time). In addition to physiological changes, human prefer to be cool in the neck region as well as the face in hot environment. Thus, local cooling of the neck is efficient way to reduce thermal discomfort during heat exposure. The novel neck cooling collar device (NeuroRescue Inc., Lafayette, LA) used in the current study may be able to produce powerful effect of conductive cooling, which result in improving performance and also reduce thermal discomfort during exercise in the heat.
While this neck cooling collar would assist athletes in improving sports safety and performance by decreasing skin temperature around the neck, the effectiveness of this neck cooling collar on core temperature was not examined at this point. Moreover, other physiological and perceptual changes are important to assess along with changes in core body temperature. Therefore, this study aims to examine how internal body temperature, heart rate, perceptual measures, and athletic performance are affected by the novel neck cooling collar during exercise in the heat.
- Conditions
- Hyperthermia
- Being tested
- NeuroRescue Cooling Collar, Ice Towel
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroRescue Cooling CollarOther
Between bouts of exercise subjects will be provided cooling on the neck with the NeuroRescue Collar. The custom sized cooling collar has ice water (which is kept around 2 degrees celsius) that is circulated through a neoprene sleeve that is attached to their neck for the cooling period.
Ice TowelOther
Between bouts of exercise subjects will be provided cooling on the neck with a towel. The towel will be kept in ice water (which is kept around 2 degrees celsius) and placed around the neck of the individual during the cooling intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Passive rest - no intervention provided |
| Ice towel cooling | Active comparator | About 6-12 cooling periods of ice towel lasting between 5-20 minutes will be done and equally distributed throughout the respective trials. Towels dipped in ice water will be placed on subjects necks during this time. Receives: Other: Ice Towel |
| NeuroRescue Neck Cooling Collar | Experimental | About 6-12 cooling periods of neck cooling with the NeuroRescue collar lasting between 5-20 minutes will be done and equally distributed throughout the respective trials. Receives: Other: NeuroRescue Cooling Collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Temperature Change
Esophageal Temperature Change
Measured: Up to 4 weeks
Secondary outcomes (15)
Rectal Temperature Change
Rectal Temperature Change
Measured: Up to 4 weeks
Heart Rate Change
Heart rate as beats per minute Change
Measured: Up to 4 weeks
Performance Test Change
Reaction Time Test
Measured: Up to 4 weeks
Performance Test Change
Broad jump
Measured: Up to 4 weeks
Performance Test Change
Agility test
Measured: Up to 4 weeks
Performance Test Change
15-min time trial
Measured: Up to 4 weeks
Perceptual Scale Change
Rating of Perceived Exertion (6-20, lower exertion indicated by lower number)
Measured: Up to 4 weeks
Perceptual Scale Change
Thermal Sensation Scale (0-8, lower number indicates cooler, higher number indicates hotter sensations)
Measured: Up to 4 weeks
Perceptual Scale Change
Thirst Scale (1-9, 1 indicates not thirst, 9 indicates very very thirsty)
Measured: Up to 4 weeks
Perceptual Scale Change
Fatigue Scale (0-10, 0 indicates no fatigue, 10 indicates extreme fatigue)
Measured: Up to 4 weeks
Perceptual Scale Change
Environmental Symptoms questionnaire (0-70, 0 indicates no heat stress)
Measured: Up to 4 weeks
Perceptual Scale Change
Profile of mood states (0-260, 0 indicates lower mood disturbance)
Measured: Up to 4 weeks
Cognitive Functioning Change - Automated Neuropsychological Assessment Metrics (ANAM) Test System
Go/No Go (0-infinity, lower number indicates faster and more accurate response)
Measured: Up to 4 weeks
Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System
Spatial Processing (0-infinity, lower number indicates faster and more accurate response)
Measured: Up to 4 weeks
Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System
Stroop (0-infinity, lower number indicates faster and more accurate response)
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start31 Aug 2021
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
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
- Crossover assignment
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroRescue Inc.
- Responsible party
- Principal investigator, Douglas J Casa, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135117
- Sponsor's protocol ID
- H21-0053
- Status last verified
- Feb 2023
- First submitted
- 26 Sep 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neck Cooling Collar on Exercise Performance in the Heat
- ClinicalTrials.gov ID
- NCT05135117
- Acronym / sponsor ID
- H21-0053
- Conditions
- Hyperthermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- NeuroRescue Inc.
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 26 Nov 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.
During exercise in the heat, the thermoregulatory system impacts performance in an athletic population. Increased in core body temperature could lead to development of heat-related illnesses and impair physical performance. To facilitate heat loss and optimize performance during exercise in the heat, various cooling strategies, including cold water immersion and wearable cooling devices have been previously explored. Although whole body cooling by cold water immersion is considered to be the most effective way to reduce core body temperature, this cooling method would not be feasible for athletes during practice or competition. Therefore, previous studies strongly recommended neck cooling during exercise because of the rate of heat dissipation through the large blood vessel and accessibility compared to other body part. Furthermore, multiple studies reported that the neck cooling could improve aerobic performance (i.e. running distance and time). In addition to physiological changes, human prefer to be cool in the neck region as well as the face in hot environment. Thus, local cooling of the neck is efficient way to reduce thermal discomfort during heat exposure. The novel neck cooling collar device (NeuroRescue Inc., Lafayette, LA) used in the current study may be able to produce powerful effect of conductive cooling, which result in improving performance and also reduce thermal discomfort during exercise in the heat.
While this neck cooling collar would assist athletes in improving sports safety and performance by decreasing skin temperature around the neck, the effectiveness of this neck cooling collar on core temperature was not examined at this point. Moreover, other physiological and perceptual changes are important to assess along with changes in core body temperature. Therefore, this study aims to examine how internal body temperature, heart rate, perceptual measures, and athletic performance are affected by the novel neck cooling collar during exercise in the heat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover assignment
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Passive rest - no intervention provided |
| Ice towel cooling | Active comparator | Other: Ice TowelAbout 6-12 cooling periods of ice towel lasting between 5-20 minutes will be done and equally distributed throughout the respective trials. Towels dipped in ice water will be placed on subjects necks during this time. |
| NeuroRescue Neck Cooling Collar | Experimental | Other: NeuroRescue Cooling CollarAbout 6-12 cooling periods of neck cooling with the NeuroRescue collar lasting between 5-20 minutes will be done and equally distributed throughout the respective trials. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Physically active (at least 30 minutes of exercise 3-5 days per week) male
- been cleared by the medical monitor for this study
- Have a VO2max >45ml/kg/min
Key exclusion criteria (13 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 |
|---|---|---|
| NeuroRescue Cooling CollarBetween bouts of exercise subjects will be provided cooling on the neck with the NeuroRescue Collar. The custom sized cooling collar has ice water (which is kept around 2 degrees celsius) that is circulated through a neoprene sleeve that is attached to their neck for the cooling period. | Other | NeuroRescue Neck Cooling Collar |
| Ice TowelBetween bouts of exercise subjects will be provided cooling on the neck with a towel. The towel will be kept in ice water (which is kept around 2 degrees celsius) and placed around the neck of the individual during the cooling intervention period. | Other | Ice towel cooling |
Primary outcome
Esophageal Temperature Change
Time frame: Up to 4 weeks
Esophageal Temperature Change
15 secondary outcomes
Rectal Temperature Change
Time frame: Up to 4 weeks
Heart Rate Change
Time frame: Up to 4 weeks
Performance Test Change
Time frame: Up to 4 weeks
Performance Test Change
Time frame: Up to 4 weeks
Performance Test Change
Time frame: Up to 4 weeks
Performance Test Change
Time frame: Up to 4 weeks
Perceptual Scale Change
Time frame: Up to 4 weeks
Perceptual Scale Change
Time frame: Up to 4 weeks
Perceptual Scale Change
Time frame: Up to 4 weeks
Perceptual Scale Change
Time frame: Up to 4 weeks
Perceptual Scale Change
Time frame: Up to 4 weeks
Perceptual Scale Change
Time frame: Up to 4 weeks
Cognitive Functioning Change - Automated Neuropsychological Assessment Metrics (ANAM) Test System
Time frame: Up to 4 weeks
Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System
Time frame: Up to 4 weeks
Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System
Time frame: Up to 4 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 3 Feb 2023.
- 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.
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?
A study testing NeuroRescue Cooling Collar and Ice Towel 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 13 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 3 Feb 2023. 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?
Esophageal Temperature Change (time frame: Up to 4 weeks). 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 3 Feb 2023.