Safety and Performance Monitoring During Occupational Work II

NCT04923971 | Completed

• 1 other identifier: H21-0016
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

BHSAI is developing a computational system that provides early alerts of a rise and fall in core body temperature to help reduce the risk of thermal 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 cold. Therefore, the primary purpose of this investigation is to validate a body temperature alerting system using physiological responses that occur during rest and exercise in different cold environments. Multiple cold ambient temperatures will be validated.

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (3)

• Change in Rectal Temperature

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

  Measured continuously during one, 120 min rest blocks and 1 20-30 min athletic performance test period.]

• Change in Heart Rate

  A heart rate monitor will be worn by participant throughout the rest period and performance battery protocol

  Measured continuously during one, 120 min rest block and 1 20-30 min athletic performance test period.]

• Change in Mean Skin temperature

  Prior to the start of the protocol, participants will be instrumented with 9-site (Biopac) and 4-site mean skin temperature (iButton) sensors. The Biopac skin temperature sensors will be placed on the finger-tip and base of finger, hand dorsum, big toe, nose, cheek, ear tip, chin, and forehead. The iButton skin temperature sensors will be placed on the chest, arm, thigh, and calf.

  Measured continuously during one, 120 min rest block and 1 20-30 min athletic performance test period.]

Secondary Outcomes (3)

• Change in Rating of Perceived Exertion

  Measured during 1 20-30 min athletic performance test period

• Change in Thermal Sensation

  Every 5 minutes of the rest block (120 mins) and 1 athletic performance battery (20-30 mins)

• Change in Perception of Fatigue

  Every 5 minutes of the rest block (120 mins) and 1 athletic performance battery (20-30 mins)

Study Arms (3)

0C Trial

ACTIVE COMPARATOR

Participants will be sitting in a chair performing hand dexterity tasks in 0C (32F) conditions. Total rest period is 2 hours. After 2 hours, participants will perform athletic performance related tasks consisting of agility, power, muscular strength, and aerobic fitness.

Other: Purdue Pegboard

-10C Trial

ACTIVE COMPARATOR

Participants will be sitting in a chair performing hand dexterity tasks in -10C (14F) conditions.Total rest period is 2 hours. After 2 hours, participants will perform athletic performance related tasks consisting of agility, power, muscular strength, and aerobic fitness.

Other: Purdue Pegboard

-20C Surrogate Trial

ACTIVE COMPARATOR

Participants will be sitting in a chair performing hand dexterity tasks in -10C + 3m/s wind (14F+6 mph wind) conditions. Total rest period is 2 hours. After 2 hours, participants will perform athletic performance related tasks consisting of agility, power, muscular strength, and aerobic fitness.

Other: Purdue Pegboard

Interventions

Purdue Pegboard OTHER

Participants will assemble the pegboard with their left, right, and both hands in each environmental condition.

-10C Trial; -20C Surrogate Trial; 0C Trial

Eligibility Criteria

• Age: 18 Years - 28 Years
• Gender Eligibility Details: Cisgender women, Transgender men, and transgender women are excluded from the current study because the sponsor of the study has requested that this testing be done in physically active cisgender males. It is assumed that they either currently have data on women or transgender women/men to compare this to or have a strategic initiative from a marketing or business perspective that only involves cisgender men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males between the ages of 18-28 years
• Have been cleared to participate by the medical monitor for this study
• Must perform aerobic exercise for 150 minutes per week.

You may not qualify if:

• Are a female
• Have a history of adverse reaction to the cold environments, such as cold urticaria (i.e.
• allergy to the cold) and/or Raynaud's phenomenon \[disorder that causes decreased blood flow to peripheral body parts (e.g. fingers and toes)\]
• Identify any symptoms of COVID-19, which include:
• Fever that exceeds 100.4F
• New loss of smell and/or taste
• Cough
• Shortness of breath/difficulty breathing
• Chills
• Muscle pain
• Fatigue
• Headache
• Sore throat
• Tested positive for COVID-19 within the past 6 months.
• Have a current musculoskeletal injury that would limit their physical activity or preclude the participant from walking, jogging, running, sprinting, or cutting.

Sponsors & Collaborators

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

Study Sites (1)

Korey Stringer Institute

Storrs, Connecticut, 06269-1110, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas Casa

  Korey Stringer Institute, University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants will perform hand-dexterity tasks in three different ambient temperatures 1) 0C 2) -10C, and 3) -20C surrogate (-10C with 3m/s wind speed to simulate -20C conditions)

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: May 28, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)