Impact of Neck Cooling Collar on Exercise Performance in the Heat

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 Overview

• Status: Completed
• Conditions: Hyperthermia
• Intervention / Treatment: Device: Ice Towel; Device: NeuroRescue Cooling Collar

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Physically active (at least 30 minutes of exercise 3-5 days per week) male
2. been cleared by the medical monitor for this study
3. Have a VO2max >45ml/kg/min

Exclusion Criteria:

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. A family member died for no apparent reason, had a heart attack, died from heart problems, or sudden death before the age of 50
6. Current musculoskeletal injury that limits their physical activity
7. Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin)
8. 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.
9. Have a history of heat related illness
10. Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing
11. Have any allergies or adverse reactions to the cold (e.g. Cold Urticaria, Raynauds Phenomenon/Disease, or cryoglobulinaemia)
12. 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.
13. Participant with clinical diagnosis of COVID-19 infection or positive result on a COVID-19 test due to concern about cardiac complications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Passive rest - no intervention provided
Active Comparator: Ice towel cooling; 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.	Device: Ice Towel; 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.
Experimental: NeuroRescue Neck Cooling Collar; 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.	Device: NeuroRescue Cooling Collar; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal Temperature Change	Esophageal Temperature Change	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rectal Temperature Change	Rectal Temperature Change	Up to 4 weeks
Heart Rate Change	Heart rate as beats per minute Change	Up to 4 weeks
Performance Test Change	Reaction Time Test	Up to 4 weeks
Performance Test Change	Broad jump	Up to 4 weeks
Performance Test Change	Agility test	Up to 4 weeks
Performance Test Change	15-min time trial	Up to 4 weeks
Perceptual Scale Change	Rating of Perceived Exertion (6-20, lower exertion indicated by lower number)	Up to 4 weeks
Perceptual Scale Change	Thermal Sensation Scale (0-8, lower number indicates cooler, higher number indicates hotter sensations)	Up to 4 weeks
Perceptual Scale Change	Thirst Scale (1-9, 1 indicates not thirst, 9 indicates very very thirsty)	Up to 4 weeks
Perceptual Scale Change	Fatigue Scale (0-10, 0 indicates no fatigue, 10 indicates extreme fatigue)	Up to 4 weeks
Perceptual Scale Change	Environmental Symptoms questionnaire (0-70, 0 indicates no heat stress)	Up to 4 weeks
Perceptual Scale Change	Profile of mood states (0-260, 0 indicates lower mood disturbance)	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)	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)	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)	Up to 4 weeks

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: NeuroRescue Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): November 23, 2021
• Study Completion (Actual): November 23, 2021

Study Registration Dates

• First Submitted: September 26, 2021
• First Submitted That Met QC Criteria: November 13, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia
• Other Study ID Numbers: H21-0053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes