Military Alerting System for Monitoring Body Temperature During Active Cooling

NCT04431596 | Completed

• 1 other identifier: H20-0010
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

BHSAI is developing a computational system that provides early alerts of a rise in core body temperature to help reduce the risk of heat injury in the field and during training. The goal of the body temperature alerting system is to use it during rest, exercise in the heat and during body cooling. Using this system during cooling will allow healthcare professionals and military personnel monitor core temperature to ensure cooling is effective (and prevent hypothermia). Therefore, the primary purpose of this investigation is to validate a body temperature alerting system using physiological responses that occur during rest, exercise in the heat and during body cooling. Multiple cooling modalities will be validated. The effectiveness of each cooling modality (passive cooling, mist-fan cooling, hand/forearm immersion) on physiological variables after exercise in the heat will be assessed. Lastly, subject characteristics (demographic and anthropometric characteristics) will be examined to examine their effect on physiological variables during exercise in the heat and during body cooling with each cooling modality.

Conditions

Hyperthermia

Outcome Measures

Primary Outcomes (9)

• Change in Rectal Temperature

  Rectal thermometer will be self-inserted by participant to assess core temperature

  Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)

• Change in Mean Skin Temperature

  7 skin temperature sensors will be placed on the subject (neck, chest, shoulder,back, abdomen, thigh, calf)

  Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)

• Change in Heart Rate

  A heart rate monitor will be worn by participant throughout exercise/cooling protocol

  Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 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 every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 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 every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 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 every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 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 every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)

• Environmental Symptoms

  An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable)

  Before the start of exercise block 1

• Environmental Symptoms

  An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable)

  After the 30 min cooling period in block 3

Secondary Outcomes (20)

• POMS

  Immediately before exercise block 1

• POMS

  Immediately following cooling period in block 1

• POMS

  Immediately following cooling period in block 2

• POMS

  Immediately following cooling period in block 3

• Heart Rate Variability

  Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes), then for 5 minutes 24 hours after

Study Arms (2)

Cooling

ACTIVE COMPARATOR

Participants will be actively cooled during rest breaks.

Device: Forearm cooling; Other: Mist-fan cooling

No Cooling

NO INTERVENTION

Participants will participant in "passive cooling" where they sit in a chair during rest.

Interventions

Forearm cooling DEVICE

forearm immersion will be performed for active cooling assessment.

Cooling

Mist-fan cooling OTHER

A mist-fan will be placed in front of the participant for active cooling.

Cooling

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cisgender man between the ages of 18-35 years
• been cleared by the medical monitor for this study
• VO2max \> 45ml/kg/min

You may not qualify if:

• 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
• 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)
• Identify as cisgender woman, transgender man or transgender woman
• Have a history of heat related illness

Sponsors & Collaborators

• University of Connecticut: lead
• Biotechnology High Performance Computing Software Applications Institute: collaborator

Study Sites (1)

Gampel Pavilion

Storrs, Connecticut, 06269-1110, United States

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Douglas Casa, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants receive three cooling treatments on separate study visits: 1) passive cooling 2) mist-fan cooling and 3) forearm immersion cooling

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 16, 2020
• Study Start: September 4, 2020
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

US (1)