Impact of Neck Cooling Collar on Exercise Performance in the Heat
Primary Purpose
Hyperthermia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuroRescue Cooling Collar
Ice Towel
Sponsored by
About this trial
This is an interventional treatment trial for Hyperthermia
Eligibility Criteria
Inclusion Criteria:
- 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
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
- Current musculoskeletal injury that limits their physical activity
- 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.
Sites / Locations
- University of Connecticut
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Control
Ice towel cooling
NeuroRescue Neck Cooling Collar
Arm Description
Passive rest - no intervention provided
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.
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.
Outcomes
Primary Outcome Measures
Esophageal Temperature Change
Esophageal Temperature Change
Secondary Outcome Measures
Rectal Temperature Change
Rectal Temperature Change
Heart Rate Change
Heart rate as beats per minute Change
Performance Test Change
Reaction Time Test
Performance Test Change
Broad jump
Performance Test Change
Agility test
Performance Test Change
15-min time trial
Perceptual Scale Change
Rating of Perceived Exertion (6-20, lower exertion indicated by lower number)
Perceptual Scale Change
Thermal Sensation Scale (0-8, lower number indicates cooler, higher number indicates hotter sensations)
Perceptual Scale Change
Thirst Scale (1-9, 1 indicates not thirst, 9 indicates very very thirsty)
Perceptual Scale Change
Fatigue Scale (0-10, 0 indicates no fatigue, 10 indicates extreme fatigue)
Perceptual Scale Change
Environmental Symptoms questionnaire (0-70, 0 indicates no heat stress)
Perceptual Scale Change
Profile of mood states (0-260, 0 indicates lower mood disturbance)
Cognitive Functioning Change - Automated Neuropsychological Assessment Metrics (ANAM) Test System
Go/No Go (0-infinity, lower number indicates faster and more accurate response)
Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System
Spatial Processing (0-infinity, lower number indicates faster and more accurate response)
Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System
Stroop (0-infinity, lower number indicates faster and more accurate response)
Full Information
NCT ID
NCT05135117
First Posted
September 26, 2021
Last Updated
February 1, 2023
Sponsor
University of Connecticut
Collaborators
NeuroRescue Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05135117
Brief Title
Impact of Neck Cooling Collar on Exercise Performance in the Heat
Official Title
Impact of Neck Cooling Collar on Exercise Performance in the Heat
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
NeuroRescue 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
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.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Passive rest - no intervention provided
Arm Title
Ice towel cooling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NeuroRescue Neck Cooling Collar
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
NeuroRescue Cooling Collar
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ice Towel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Esophageal Temperature Change
Description
Esophageal Temperature Change
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Rectal Temperature Change
Description
Rectal Temperature Change
Time Frame
Up to 4 weeks
Title
Heart Rate Change
Description
Heart rate as beats per minute Change
Time Frame
Up to 4 weeks
Title
Performance Test Change
Description
Reaction Time Test
Time Frame
Up to 4 weeks
Title
Performance Test Change
Description
Broad jump
Time Frame
Up to 4 weeks
Title
Performance Test Change
Description
Agility test
Time Frame
Up to 4 weeks
Title
Performance Test Change
Description
15-min time trial
Time Frame
Up to 4 weeks
Title
Perceptual Scale Change
Description
Rating of Perceived Exertion (6-20, lower exertion indicated by lower number)
Time Frame
Up to 4 weeks
Title
Perceptual Scale Change
Description
Thermal Sensation Scale (0-8, lower number indicates cooler, higher number indicates hotter sensations)
Time Frame
Up to 4 weeks
Title
Perceptual Scale Change
Description
Thirst Scale (1-9, 1 indicates not thirst, 9 indicates very very thirsty)
Time Frame
Up to 4 weeks
Title
Perceptual Scale Change
Description
Fatigue Scale (0-10, 0 indicates no fatigue, 10 indicates extreme fatigue)
Time Frame
Up to 4 weeks
Title
Perceptual Scale Change
Description
Environmental Symptoms questionnaire (0-70, 0 indicates no heat stress)
Time Frame
Up to 4 weeks
Title
Perceptual Scale Change
Description
Profile of mood states (0-260, 0 indicates lower mood disturbance)
Time Frame
Up to 4 weeks
Title
Cognitive Functioning Change - Automated Neuropsychological Assessment Metrics (ANAM) Test System
Description
Go/No Go (0-infinity, lower number indicates faster and more accurate response)
Time Frame
Up to 4 weeks
Title
Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System
Description
Spatial Processing (0-infinity, lower number indicates faster and more accurate response)
Time Frame
Up to 4 weeks
Title
Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System
Description
Stroop (0-infinity, lower number indicates faster and more accurate response)
Time Frame
Up to 4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Current musculoskeletal injury that limits their physical activity
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.
Facility Information:
Facility Name
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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Impact of Neck Cooling Collar on Exercise Performance in the Heat
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